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[FR Doc. 2010-17210 Filed 07/13/2010 at 8:45 am; Publication Date: 07/28/2010]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 170
RIN 0991-AB58
Health Information Technology: Initial Set of Standards, Implementation
Specifications, and Certification Criteria for Electronic Health Record Technology
AGENCY: Office of the National Coordinator for Health Information Technology
(ONC), Department of Health and Human Services.
ACTION: Final Rule.
SUMMARY: The Department of Health and Human Services (HHS) is issuing this final
rule to complete the adoption of an initial set of standards, implementation specifications,
and certification criteria, and to more closely align such standards, implementation
specifications, and certification criteria with final meaningful use Stage 1 objectives and
measures. Adopted certification criteria establish the required capabilities and specify the
related standards and implementation specifications that certified electronic health record
(EHR) technology will need to include to, at a minimum, support the achievement of
meaningful use Stage 1 by eligible professionals, eligible hospitals, and/or critical access
hospitals (hereafter, references to “eligible hospitals” in this final rule shall mean
“eligible hospitals and/or critical access hospitals”) under the Medicare and Medicaid
EHR Incentive Programs. Complete EHRs and EHR Modules will be tested and certified
according to adopted certification criteria to ensure that they have properly implemented
adopted standards and implementation specifications and otherwise comply with the
adopted certification criteria.
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DATES: Effective Date: This final rule is effective [INSERT DATE 30 DAYS AFTER
PUBLICATION IN THE FEDERAL REGISTER]. The incorporation by reference of
certain publications listed in the rule is approved by the Director of the Federal Register
as of [INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL
REGISTER].
FOR FURTHER INFORMATION CONTACT: Steven Posnack, Director, Federal
Policy Division, Office of Policy and Planning, Office of the National Coordinator for
Health Information Technology, 202-690-7151
SUPPLEMENTARY INFORMATION:
Acronyms
ANSI American National Standards Institute
CAH Critical Access Hospital
CCD Continuity of Care Document
CCHIT Certification Commission for Health Information Technology
CCR Continuity of Care Record
CDA Clinical Document Architecture
CDC Centers for Disease Control and Prevention
CFR Code of Federal Regulations
CGD Certification Guidance Document
CMS Centers for Medicare & Medicaid Services
CPOE Computerized Provider Order Entry
EHR Electronic Health Record
FIPS Federal Information Processing Standards
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HHS Department of Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996
HIT Health Information Technology
HITECH Health Information Technology for Economic and Clinical Health
HITSP Healthcare Information Technology Standards Panel
HL7 Health Level Seven
ICD International Classification of Diseases
ICD-9-CM International Classification of Diseases, 9th Revision, Clinical
Modification
ICD-10-PCS International Classification of Diseases, 10th Revision, Procedure Coding
System
ICD–10–CM International Classification of Diseases, 10th Revision, Clinical
Modification
IHS Indian Health Service
LOINC Logical Observation Identifiers Names and Codes
NCPDP National Council for Prescription Drug Programs
NLM National Library of Medicine
OCR Office for Civil Rights
OMB Office of Management and Budget
ONC Office of the National Coordinator for Health Information Technology
PHSA Public Health Service Act
PQRI Physician Quality Reporting Initiative
REST Representational state transfer
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RFA Regulatory Flexibility Act
SNOMED-CT Systematized Nomenclature of Medicine Clinical Terms
SOAP Simple Object Access Protocol
UCUM Unified Code for Units of Measure
UMLS Unified Medical Language System
XML eXtensible Markup Language
Table of Contents
I. Background
A. Legislative History
B. Regulatory History
1. Initial Set of Standards, Implementation Specifications, and Certification Criteria
for EHR Technology Interim Final Rule
2. Interdependencies with Other HITECH Provisions and Relationship to Other
Regulatory Requirements
II. Overview of the Final Rule
III. Section-by-Section Discussion of the Final Rule and Response to Comments
A. Introduction
B. General Comments
C. Definitions – §170.102
1. Definition of Disclosure
2. Definition of Standard
3. Definition of Implementation Specification
4. Definition of Certification Criteria
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5. Definition of Qualified EHR
6. Definition of Complete EHR
7. Definition of EHR Module
8. Definition of Certified EHR Technology
9. Definition of Human Readable Format
10. Definition of User
D. Final Rule Amendments to Adopted Standards, Implementation Specifications, and
Certification Criteria §§170.202, 170.205, 170.207, 170.210, 170.302, 170.304, 170.306
1. Flexibility and Innovation
2. Transport Standards
3. Certification Criteria and Associated Standards and Implementation Specifications
a. General Certification for Complete EHRs or EHR Modules - §170.302
b. Specific Certification for Complete EHRs or EHR Modules Designed for an
Ambulatory Setting - §170.304
c. Specific Certification for Complete EHRs or EHR Modules Designed for an
Inpatient Setting - §170.306
d. Adoption and Realignment of Certification Criteria to Support the Final
Requirements for Meaningful Use Stage 1.
E. Additional Comments
F. Comments Beyond the Scope of this Final Rule
IV. Collection of Information Requirements
V. Regulatory Impact Analysis
A. Introduction
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B. Why is this Rule Needed?
C. Executive Order 12866 – Regulatory Planning and Review Analysis
1. Comment and Response
2. Executive Order 12866 Final Analysis
a. Costs
b. Benefits
D. Regulatory Flexibility Act Analysis
1. Comment and Response
2. Final RFA Analysis
E. Executive Order 13132 – Federalism
Regulation Text
I. Background
A. Legislative History
The Health Information Technology for Economic and Clinical Health (HITECH)
Act, Title XIII of Division A and Title IV of Division B of the American Recovery and
Reinvestment Act of 2009 (ARRA) (Pub. L. 111–5), was enacted on February 17, 2009.
The HITECH Act amended the Public Health Service Act (PHSA) and established “Title
XXX – Health Information Technology and Quality” to improve health care quality,
safety, and efficiency through the promotion of health information technology (HIT) and
the electronic exchange of health information. Section 3004(b)(1) of the PHSA requires
the Secretary of Health and Human Services (the Secretary) to adopt an initial set of
standards, implementation specifications, and certification criteria by December 31, 2009
to enhance the interoperability, functionality, utility, and security of health information
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technology. Section 3004(b)(1) of the PHSA also permits the Secretary to adopt the
initial set of standards, implementation specifications, and certification criteria on an
interim, final basis.
B. Regulatory History
1. Initial Set of Standards, Implementation Specifications, and Certification Criteria
for EHR Technology Interim Final Rule
On December 30, 2009, the Federal Register made available for public inspection,
an interim final rule (the Interim Final Rule) with a request for comments, which adopted
an initial set of standards, implementation specifications, and certification criteria. As
noted in this rulemaking (75 FR 2014), we described how Congress fundamentally tied
the adopted standards, implementation specifications, and certification criteria to the
incentives available under the Medicare and Medicaid EHR Incentive Programs by
requiring the meaningful use of Certified EHR Technology. Congress outlined several
goals for meaningful use, one of which included the “use of certified EHR technology in
a meaningful manner.” This means that to qualify for incentives, an eligible professional
or eligible hospital must both adopt Certified EHR Technology and demonstrate
meaningful use of this technology.
The initial set of standards, implementation specifications, and certification
criteria adopted in the Interim Final Rule established the capabilities that Certified EHR
Technology would need to include to, at a minimum, support eligible professionals’ and
eligible hospitals’ efforts to achieve what had been proposed for meaningful use Stage 1
under the Medicare and Medicaid EHR Incentive Programs proposed rule.
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2. Interdependencies with Other HITECH Provisions and Relationship to Other
Regulatory Requirements
In addition to our discussion of how the standards, implementation specifications,
and certification criteria adopted in the Interim Final Rule correlated with the Medicare
and Medicaid EHR Incentive Programs proposed rule, we also discussed our approach to
align adopted standards, implementation specifications, and certification criteria with
new and pending HITECH Act regulatory actions and with other already established
regulatory requirements. We also explained our approach for aligning these standards,
implementation specifications, and certification criteria with: the adopted standard and
certification criterion related to the Health Insurance Portability and Accountability Act
of 1996 (HIPAA) Privacy Rule Accounting of Disclosures Regulation under the HITECH
Act; alignment with the HIPAA Privacy and Security Regulations; the Medicare Part D
Electronic Prescribing Regulations; and the HIPAA Transactions and Code Sets
Standards Regulations.
II. Overview of the Final Rule
We are amending part 170 of title 45 of the Code of Federal Regulations (CFR) to
complete the adoption of the initial set of standards, implementation specifications, and
certification criteria as required by section 3004(b)(1) of the PHSA and realign them with
the final objectives and measures established for meaningful use Stage 1. After
reviewing and considering public comments on our adopted standards, implementation
specifications, and certification criteria, we have made several revisions to support the
final meaningful use objectives and measures, clarify certain certification criteria to
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resolve identified technical challenges related to some of the standards and
implementation specifications we adopted, and to provide for additional flexibility.
III. Section-by-Section Discussion of the Final Rule and Response to Comments
A. Introduction
This section summarizes the nearly 400 timely comments received by ONC
related to the Interim Final Rule. In some cases, due to the simultaneous publication and
topical similarity of the notice of proposed rulemaking for meaningful use Stage 1,
commenters inadvertently submitted comments to our regulation docket on
regulations.gov instead of the Centers for Medicare & Medicaid Services (CMS)
regulation docket, and vice versa. Recognizing this oversight, CMS and ONC shared
misplaced comments between the offices and we included within our review all
comments that could be reasonably identified as comments on the Interim Final Rule.
We have organized the preamble of this final rule along the following lines. First,
we respond to general comments, including those related to the scope and applicability of
the final rule that we believe are necessary to clarify upfront. Next, we respond to
comments regarding the definitions of certain defined terms. We then respond to public
comments on each certification criterion, and where an adopted certification criterion also
references standards and implementation specifications, we include our response to
public comments on the related standards and implementation specifications. These
concepts were separately discussed in the Interim Final Rule and we believe that
discussing the certification criteria together with associated standards and implementation
specifications will improve the clarity of the final rule and will allow us to more fully
address public comments in a broader context. We include the following table at the
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beginning of the discussion of each certification criterion section to illustrate the final
meaningful use Stage 1 objectives for eligible professionals and eligible hospitals and to
show how we have revised adopted certification criteria in response to the revised
meaningful use objectives and measures and public comments.
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure Certification Criterion
Eligible
Professional and/or
Eligible
Professional and/or
Interim Final Rule Text:
Certification Criterion
Eligible Hospital &
Critical Access
Hospital Objective
Eligible Hospital &
Critical Access
Hospital Measure
Final Rule Text:
Certification Criterion
Finally, in considering public comments on the Interim Final Rule, we analyzed
whether we had structured the regulation text in an optimal and understandable manner.
For several provisions, we received comments requesting additional clarification and we
felt that the original regulatory structure contributed to the commenters’ confusion.
Because of those comments and in an effort to better structure the regulation text for
future revisions, we have revised the structure conceptually to group content exchange
standards and associated implementation specifications and vocabulary standards, and
separated them into different sections. In line with this “conceptual” restructuring, we
have determined that specifying how a Complete EHR or EHR Module must comply
with an adopted standard should be solely reflected in the certification criteria. As a
result, several certification criteria have been revised to more clearly reflect how a
Complete EHR or EHR Module must comply with adopted standards and, where
applicable, the relevant adopted implementation specifications.
B. General Comments
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Some commenters appear to have misinterpreted or misunderstood the scope of
the Interim Final Rule and the applicability of the adopted standards, implementation
specifications, and certification criteria. We would therefore like to clarify these
concepts at the beginning of this final rule and are providing the following responses to
the relevant comments.
Comments. Some commenters seem to have construed the adoption of standards,
implementation specifications, and certification criteria as including requirements that
apply to the health care providers that will use the Certified EHR Technology, rather than
as required capabilities of the Certified EHR Technology itself. These commenters, for
instance, questioned whether entities using Certified EHR Technology must comply with
adopted standards and implementation specifications when electronically using or
transmitting health information within or among components of the legal entity or
alternatively whether the standards apply solely to transmissions between legal entities.
Other commenters specifically requested clarification regarding the adopted standards
that are required to be used internally within each provider’s office, institution, or closed
system and which standards are required for purposes of electronically exchanging health
information among such entities. Some comments implied that the Interim Final Rule
should have specified when an eligible professional or eligible hospital would be required
to use adopted standards. One commenter specifically requested that the adopted
standards apply only to the electronic exchange of health information between legal
entities.
Response. As stated in §170.101, we specify that “[t]he standards,
implementation specifications, and certification criteria adopted in this part apply to
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Complete EHRs and EHR Modules and the testing and certification of such Complete
EHRs and EHR Modules.” In §§170.200 and 170.300, we further specify that “[t]he
standards and implementation specifications adopted in this part apply with respect to
Complete EHRs and EHR Modules” and that “[t]he certification criteria adopted in this
subpart apply to the testing and certification of Complete EHRs and EHR Modules.”
The purpose of this final rule, therefore, is to adopt standards, implementation
specifications, and certification criteria to test and certify that a Complete EHR or EHR
Module provides certain capabilities, and where applicable, to require that those
capabilities be implemented in accordance with adopted standards and implementation
specifications. The adopted standards, implementation specifications, and certification
criteria were not intended to impose independent requirements on the entities using
Certified EHR Technology. Unlike certain other regulatory requirements to which
eligible professionals or eligible hospitals may be subject, it is not within the intended
scope of this final rule to specify the requirements for entities using Certified EHR
Technology.
We understand the commenters’ point though that an adopted standard and
implementation specification could apply equally to electronic transactions between legal
entities as well as to transmissions within an entity. This final rule, however, is not
intended to specify the conditions under which adopted standards and implementation
specifications must be used, only that a Complete EHR or EHR Module, in order to be
certified, must include specified capabilities that are implemented in accordance with
those standards, implementation specifications, and certification criteria. We anticipate
that other regulations, as well as the clinical and business needs of HIT users, anticipated
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efficiencies and desired quality improvements, and technical, architectural, and enterprise
limitations will determine when entities will utilize the capabilities required of Certified
EHR Technology. Additionally, we would note that Complete EHRs and EHR Modules
will, in many cases, be tested and certified independent of the environment within which
they will be implemented. Consequently, specifying when an entity that implements
Certified EHR Technology must utilize a particular capability in its operating
environment exceeds the scope of this rule.
To further demonstrate this point, Certified EHR Technology implemented by an
eligible professional will need to possess the capability to generate an electronic
prescription according to one of the standards we have adopted. To specify the contexts
in which an electronic prescription (generated according to the adopted standard) must be
transmitted would go beyond the scope of certification. Moreover, it would raise a more
serious and practical consideration. Attempting to specify when entities must utilize the
capabilities of Certified EHR Technology would add an unnecessary level of complexity
to this rule and create the potential for conflicts with other regulations promulgated by the
HHS. For instance, HHS has already promulgated at least two sets of regulations
identifying when health care providers need to use specific standards and the contexts in
which those standards must be used. Under the HIPAA Transactions and Code Sets
Standards regulations, HHS specifies at 45 CFR 162.923(a) that “[e]xcept as otherwise
provided in this part, if a covered entity conducts with another covered entity (or within
the same covered entity), using electronic media, a transaction for which the Secretary
has adopted a standard under this part, the covered entity must conduct the transaction as
a standard transaction.” (Emphasis added.) Consequently, in the HIPAA context,
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covered entities must use adopted transaction standards for covered transactions both
within the covered entities and with outside entities. The Medicare Part D electronic-
prescribing (e-prescribing) regulations implement a different approach for certain e-
prescribing transactions. Health care providers that electronically prescribe Part D drugs
for Part D eligible individuals under 42 CFR 423.160(a)(3)(iii), “may use either HL7
messages or the NCPDP SCRIPT Standard to transmit prescriptions or prescription-
related information internally when the sender and the recipient are part of the same legal
entity. If an entity sends prescriptions outside the entity (for example, from an HMO to a
non-HMO pharmacy), it must use the adopted NCPDP SCRIPT Standard or other
applicable adopted standards.” Therefore, we believe that it is unnecessary and outside
of the intended scope of this rule to specify the contexts or circumstances under which
adopted standards and implementation specifications must be utilized.
Moreover, we anticipate that future meaningful use objectives and measures will
specify, as necessary and appropriate, the conditions under which certain health care
providers will need to use adopted standards and implementation specifications. The
context, for instance, governing when a standard must be used will, in some cases, be
directly related to whether and how an eligible professional or eligible hospital must
meaningfully use Certified EHR Technology. For example, a final meaningful use Stage
1 objective requires that eligible professionals and eligible hospitals use Certified EHR
Technology to record demographics including, among other fields, race and ethnicity.
While we have adopted the race and ethnicity codes published by the Office of
Management and Budget (OMB), in the context Medicare and Medicaid EHR incentive
programs, the meaningful use of Certified EHR Technology will dictate whether such
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codes must be used “inside” an organization. Another example of when a meaningful use
objective establishes the context in which a standard must be used is the objective that
requires eligible professionals and eligible hospitals to use Certified EHR Technology to
maintain an up-to-date problem list of current and active diagnoses. The measure
associated with this objective requires that entries be recorded in “structured data” and in
this context we adopted ICD-9 or SNOMED-CT® to provide that structure. As a result,
Certified EHR Technology must be capable of using ICD-9 or SNOMED-CT® when an
eligible professional or eligible hospital seeks to maintain an up-to-date problem list.
In other instances, the Department does not specify explicitly in regulation the
context for certain meaningful use objectives and whether meaningful use of Certified
EHR Technology would require the use of a standard for electronic transactions solely
between two different legal entities, or for all transactions, or for most transactions with
certain exemptions.
Comments. Several commenters requested that we provide more information
about the standards we expect the Secretary to adopt in order to support future stages of
meaningful use. These commenters noted, along with referencing the timelines for
making changes to HIT, that it would benefit the HIT industry if we could provide a
roadmap, framework, or more descriptive “glide path” for future standards adoption
activities.
Response. We anticipate that future stages of meaningful use will require us to
adopt additional standards, implementation specifications, and certification criteria. We
also expect that standards we have adopted will continue to be revised and updated over
time, to reflect current technology, changing medical practice and regulatory
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requirements. We will therefore need to continue to harmonize those adopted standards
with other standards to support interoperability. We anticipate that the standards required
to support future stages of meaningful use will need a framework that supports
harmonization across different meaningful use scenarios and that supports early real
world testing. We plan to work closely with the HIT Standards Committee to develop a
forward looking agenda and to make known in advance the types of standards,
implementation specifications, and certification criteria on which we will seek
recommendations from the HIT Standards Committee. We believe this will benefit the
HIT industry by providing greater transparency of the standards adoption activities and
will serve as an early indication for the public of candidate standards that are being
identified for possible adoption.
C. Definitions – §170.102
In this section, we respond to public comment on the definitions adopted in the
Interim Final Rule. We address the definition of Certified EHR Technology last after we
provide clarifications related to the definitions of Complete EHR and EHR Module.
1. Definition of Disclosure
Comments. A few commenters noted that the definition of disclosure was too
broad or asked that we refine the adopted definition to be more limited and to only apply
in certain circumstances. One commenter noted that this was a new definition.
Response. As we explained in the preamble of the Interim Final Rule, this
definition repeated the text specified at 45 CFR 160.103 (the General Provisions section
for the HIPAA regulations). Because the Interim Final Rule created a new part in Title
45 of the CFR, the definition of disclosure as it is used in the HIPAA regulations would
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not necessarily have applied to our use of the term in this rule. Therefore, to prevent
unnecessary ambiguity for the regulated community, we adopted the definition of the
term as it is defined at 45 CFR 160.103.
In light of public comment and to prevent any future regulatory inconsistency that
would require rulemaking to correct, we have revisited our approach of repeating the text
of the definition of disclosure from 45 CFR 160.103 and have decided to cross reference
45 CFR 160.103 in the definition of disclosure. The final definition will read: disclosure
is defined as it is in 45 CFR 160.103.
2. Definition of Standard
Comment. A commenter stated that our definition of standard was
comprehensive from a technical perspective, but believed the definition was incomplete
from a policy perspective. The commenter argued that for interoperability to be
successful, it was essential that standards be created through collaborative, consensus-
based processes that take into consideration the needs and concerns of all interested
stakeholders. For that reason, the commenter suggested, in order for the definition to be
whole from both a technical and policy perspective, we should add to the definition the
phrase “developed through the use of open, collaborative, consensus-based processes.”
Response. While we appreciate the commenter’s point, we believe that the
proposed language is unnecessary and potentially problematic. Federal agencies are
already required under the National Technology Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 3701 et seq.) and OMB Circular A-1191 to use, wherever practical,
technical standards that are developed or adopted by voluntary consensus standards
bodies to carry out policy objectives or activities, with certain exceptions. In drafting the
1 http://www.whitehouse.gov/omb/circulars_a119
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Interim Final Rule, we briefly discussed relevant provisions of the NTTAA and OMB
Circular A-119, our compliance with the statute and the Circular, and we requested
comments on our approach to the selection of standards. We also explained that both the
NTTAA and OMB Circular A-119 provide for certain exceptions to selecting only
standards developed or adopted by voluntary consensus standards bodies, namely when
doing so would be “inconsistent with applicable law or otherwise impractical.” In the
Interim Final Rule, we identified those instances in which we had and had not adopted
voluntary consensus standards. In the instances in which we had not adopted voluntary
consensus standards, we provided two principal reasons: first, that in most cases a
voluntary consensus standard that could meet the requisite technical goals was simply
unavailable; and second, that to the extent a potentially equivalent voluntary consensus
standard was available, the standard was too limiting and did not meet our policy goals,
including allowing for greater innovation by the industry. In this final rule, we have
adopted only voluntary consensus standards, except for two government-unique standards
(CMS Physician Quality Reporting Initiative (PQRI) 2009 Registry XML Specification
and the Office of Management and Budget Standards for Maintaining, Collecting, and
Presenting Federal Data on Race and Ethnicity), a functional standard relating to
vocabularies included in RxNorm, and the specified standards to protect electronic health
information. We are aware of no voluntary consensus standards that would serve as
alternatives to these standards for the purposes that we have identified. We encourage
the HIT Standards Committee to obtain public input, hold hearings on, and recommend to
the National Coordinator standards that have been developed or adopted by voluntary
consensus standards bodies.
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3. Definition of Implementation Specification
We did not receive any comments applicable to the definition of implementation
specification and consequently did not make any changes to the definition.
4. Definition of Certification Criteria
Comments. One commenter expressly stated its support for our definition of
certification criteria.
Response. We appreciate the commenter’s support for our definition of
certification criteria and have not made any changes to the definition in this final rule.
5. Definition of Qualified EHR
Comments. A couple of commenters asserted that there is uncertainty in the
industry with respect to what constitutes an EHR due both to the seemingly inconsistent
definitions of terms in the HITECH Act and to the alternative definitions published by
different organizations and associations. The commenters made specific reference to the
definition of “Qualified Electronic Health Record” (“Qualified EHR”) at section 3000 of
the PHSA and to the term “EHR” found in the HITECH Act at section 13400 of Subtitle
D. The latter defines EHR as “an electronic record of health-related information on an
individual that is created, gathered, managed, and consulted by authorized clinicians and
staff.” The former defines Qualified EHR as “an electronic record of health-related
information on an individual that: (1) includes patient demographic and clinical health
information, such as medical history and problem lists; and (2) has the capacity: (i) to
provide clinical decision support; (ii) to support physician order entry; (iii) to capture and
query information relevant to health care quality; and (iv) to exchange electronic health
information with, and integrate such information from other sources.” Both commenters
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recommended that the definition of Qualified EHR be clarified with one commenter
suggesting that the definition should follow the definition of EHR as it relates to health
care providers.
Response. We appreciate these comments and recognize that the existence of
multiple terms that include the word “EHR” can be confusing. However, we believe that
Congress intended for HHS to apply the definition of a Qualified EHR found in section
3000 of the PHSA to this regulation for specific reasons that cannot be overlooked. As a
result, we have decided not to adopt the recommendation to follow the definition of the
term EHR that is found in Subtitle D of the HITECH Act. We discuss additional
responses to comments on the definition of Qualified EHR below.
Comments. A few commenters requested that we expand the definition of
Qualified EHR to include a variety of additional functionality and that a Qualified EHR
be able to comply with business or legal requirements. These comments requested that
we add required elements for an EHR to constitute a Qualified EHR, including that the
EHR: have a record-keeping capability for legal purposes; include certain requirements
for usability; enable health care providers to perform several other actions not specified
in the definition; and that certain elements of patient demographic information be
specified.
Response. We understand the rationale behind these commenters’ suggestions,
but we do not believe that it is necessary to add more prerequisite capabilities to the
definition of Qualified EHR. We believe Congress defined Qualified EHR to include a
minimum level of capabilities. Furthermore, to meet the definition of Certified EHR
Technology, a Qualified EHR must be certified in accordance with a certification
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program established by the National Coordinator. As a result, we believe that any
additional capabilities a Qualified EHR would need to possess to allow an eligible
professional or eligible hospital to be in a position to qualify for incentive payments
under the Medicare and Medicaid EHR incentive programs will be more appropriately
addressed through the Secretary’s adoption of additional standards, implementation
specifications, and certification criteria.
Comments. Some commenters requested that we clarify some of the terms in the
definition of Qualified EHR such as “capture,” “query,” “other sources,” and “relevant to
health care quality” with respect to how they related to Certified EHR Technology.
Another commenter expressly stated that if we only intended to repeat the statutory
definition of Qualified EHR without modification, we should at least clarify the meaning
of demographic information.
Response. We do not believe that additional clarity is needed or desirable for
such terms because the meanings are context specific. The intended meanings of these
terms will depend significantly on the contexts in which the terms are used and the
associated capabilities of the Certified EHR Technology. The terms’ meanings may also
be affected by any standards and implementation specifications that are associated with
those capabilities and adopted. In certain circumstances, for instance, the meaning of the
phrase “other sources” as used in the definition of Qualified EHR will depend on the
specific context in which electronic health information is being integrated or exchanged,
and perhaps on whether the source is external to or internal within the Complete EHR or
the EHR Module. Similarly, the meanings of the terms or phrases “capture,” “query,”
“relevant to health care quality” and “demographic” information may vary according the
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context of the required capabilities of the EHR technology. In each of these instances,
we believe that the adopted certification criteria and meaningful use objectives and
measures will provide these contexts, identify the associated required capabilities, and
consequently clarify the intended meanings of these terms.
6. Definition of Complete EHR
Comments. Some commenters supported our definition of Complete EHR and
believed that it was understandable, sufficient, and reasonable. Other commenters,
however, suggested that the definition of Complete EHR was too narrow, because the
term is tied to only those certification criteria adopted by the Secretary. These
commenters argued that the Complete EHR and the adopted certification criteria should
be more comprehensive and should include functionality that is not presently required for
a Complete EHR to achieve certification. Many of these commenters referenced the
Health Level Seven (HL7) EHR System Functional Model (EHR-S FM) and contended
that what we had defined as a Complete EHR did not align with or include all of the
functionality specified in the EHR-S FM. One commenter requested that we clarify what
we meant by “we fully expect some EHRs to have capabilities beyond those addressed by
certification criteria” when we made this point during our discussion of the definition of
Complete EHR in the preamble of the Interim Final Rule. Other commenters
recommended specific wording changes to the definition.
Response. In the Interim Final Rule we defined Complete EHR to mean “EHR
technology that has been developed to meet all applicable certification criteria adopted by
the Secretary.” We clarified that the term Complete EHR is “meant to encompass EHR
technology that can perform all of the applicable capabilities required by certification
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criteria adopted by the Secretary and distinguish it from EHR technology that cannot
perform those capabilities.” We believe that commenters misunderstood the scope and
purpose of the regulatory definition and believe that the definition effectively fulfills its
regulatory purpose. We intend for the definition of Complete EHR to be used to clearly
identify EHR technology as being able to perform, at a minimum, all of the applicable
capabilities required by certification criteria adopted by the Secretary, and thereby, as
providing eligible professionals or eligible hospitals with the technical capabilities they
need to support their achievement of meaningful use of Certified EHR Technology. It is
in this context that we view such EHR technology as “complete.”
We recognize that many commenters recommended a definition of “Complete
EHR” that would be more comprehensive than the definition we provided. Many
commenters contended that HIT exists and is available for eligible professionals and
eligible hospitals to implement, and much of it includes a myriad of capabilities far
surpassing the capabilities required to meet the definition of Complete EHR. We do not
dispute that point. We also understand that the capabilities included in a Complete EHR,
as defined for the purposes of this regulation, may not encompass all of the capabilities a
specific eligible professional or eligible hospital or for that matter any health care
provider, may deem essential to meet their unique business needs and use cases.
This definition, however, does not in any way preclude any additional capabilities
from being included in a Complete EHR or implemented in a complementary fashion.
The definition sets forth a floor, not a ceiling, and serves to signify that once tested and
certified to all applicable certification criteria, a Complete EHR meets the definition of
Certified EHR Technology. For this reason, we did not seek to craft this definition in a
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way that signified that a Complete EHR would be able to provide all of the capabilities a
health care provider desired or deemed necessary, or that the entity’s EHR could only
include the capabilities for which the Secretary has adopted certification criteria. Nor did
we define Complete EHR according to a particular functional model, because doing so
would have been inconsistent with the regulatory purpose of the definition.
In light of public comment and to further clarify the regulatory purpose of the
definition of Complete EHR as well as make clear that a Complete EHR should not be
misinterpreted to mean EHR technology that is any more comprehensive than the
certification criteria to which it was tested and certified, we have added the phrase “at a
minimum” to the definition. The final definition of Complete EHR will therefore read
“EHR technology that has been developed to meet, at a minimum, all applicable
certification criteria adopted by the Secretary.”
As a related point, we would also note that an eligible professional or eligible
hospital would need to use a capability that is included among the adopted certification
criteria to meet the associated meaningful use objective or measure. The eligible
professional or eligible hospital therefore could not attempt to use a capability that is
superfluous to certification to demonstrate the meaningful use of “Certified EHR
Technology.” We understand that the Medicare and Medicaid EHR Incentive Programs
final rule discusses this issue more fully in several places, and we defer to those
discussions concerning the requirements for achieving meaningful use of Certified EHR
Technology.
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Comment. In the context of the definition of Complete EHR, one commenter
asked for clarification regarding how many certification criteria a Complete EHR must be
developed to meet.
Response. For the purposes of meeting the definition of Complete EHR, EHR
technology designed for an ambulatory setting (to be used by eligible professionals) must
be certified to all of the certification criteria adopted at 45 CFR 170.302 and 45 CFR
170.304, and EHR technology designed for an inpatient setting (to be used by eligible
hospitals) must be certified to all of the certification criteria adopted at 45 CFR 170.302
and 45 CFR 170.306.
7. Definition of EHR Module
Comments. Numerous commenters strongly supported our inclusion of a modular
approach to meet the definition of Certified EHR Technology. Many of these
commenters saw this approach as a way to spur greater innovation in the HIT
marketplace, provide more choices for health care providers, and generally broaden the
appeal of HIT and expedite its adoption. Some commenters noted, however, that they
believed the definition needed further clarification with respect to what would constitute
an EHR Module. In most cases, these commenters provided examples of technologies
that they believed should meet the definition of EHR Module and they sought
confirmation that these technologies would meet the definition. Included among these
technologies were radiology information systems (RIS), picture archiving and
communication systems (PACS), PHRs, speech recognition software, electrocardiogram
systems, remote patient monitoring (RPM) devices, and other electronic devices
including non-health care devices.
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Response. In the Interim Final Rule, we defined an EHR Module to mean “any
service, component, or combination thereof that can meet the requirements of at least one
certification criterion adopted by the Secretary.” Consequently, EHR Modules, by
definition, must provide a capability that can be tested and certified in accordance with at
least one certification criterion adopted by the Secretary. Therefore, if an EHR Module
does not provide a capability that can be tested and certified at the present time, it is not
HIT that would meet the definition of EHR Module. We stress “at the present time,”
because as new certification criteria are adopted by the Secretary, other HIT could be
developed and then tested and certified in accordance with the new certification criteria
as EHR Modules.
We encourage eligible professionals and eligible hospitals to use any and all HIT
they believe will help make the health care they deliver more effective and efficient.
However, unless the HIT is tested and certified to at least one certification criterion for
use as part of Certified EHR Technology, it does not constitute an EHR Module for the
purposes of this regulation. Eligible professionals and eligible hospitals are not
prohibited from using or implementing this HIT, but again, at the present time, such HIT
cannot constitute an EHR Module and serve as a necessary component of Certified EHR
Technology for eligible professionals or eligible hospitals to use when seeking to achieve
meaningful use as defined in the Medicare and Medicaid EHR Incentive Programs final
rule.
In response to these comments, we would also like to clarify our
conceptualization of an EHR Module. An EHR Module could provide a single capability
required by one certification criterion or it could provide all capabilities but one, required
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by the certification criteria for a Complete EHR. In other words, we would call HIT
tested and certified to one certification criterion an “EHR Module” and HIT tested and
certified to nine certification criteria an “EHR Module,” where ten certification criteria
are required for a Complete EHR. We have not made any changes to the definition of
EHR Module as a result of these comments or the comments addressed below.
Comment. One commenter asked whether we meant to include in the definition
of EHR Module “interfaces” that perform data mapping or transformation. The
commenter raised this question while noting that some organizations use multiple
interfaces to interconnect their HIT systems and that it would be an arduous task for these
organizations to ensure that all individual interfaces are certified. Another commenter
sought clarification regarding what we meant when we stated as an example in the
Interim Final Rule that EHR Modules could be “an interface or other software program
that provides the capability to exchange electronic health information.”
Response. As discussed above, to meet the definition of EHR Module, HIT
would need to provide a capability that could be tested and certified to at least one
certification criterion. If a certification criterion has therefore been adopted that requires
a particular capability for exchanging electronic health information, an interface or other
software program that provides that capability could be tested and certified as an EHR
Module. In many circumstances, an interface or program may provide valuable
functionality, but not a capability for which a certification criterion has been adopted.
For example, software implemented by an eligible professional that performs data
translation or mapping between two databases or data sets may provide critical
functionality, yet that software would not constitute an EHR Module. Similarly,
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interfaces between “HIT systems” may be critical to the functionality of the separate
systems, but they themselves would not be EHR Modules.
In those circumstances in which an interface or other software program is an
integral component of an EHR Module without which it would not be able to be tested
and certified, then such interface or other software program, though not itself an EHR
Module, would function as a critical piece of the overall EHR Module presented for
testing and certification. For example, a software program that would permit an eligible
professional or eligible hospital to electronically exchange health information with other
eligible professionals or eligible hospitals could be tested and certified as an EHR
Module, if it provides the capability to electronically exchange health information
according to standards adopted by the Secretary. In this example, whatever comprises
the software program would be considered part of the EHR Module that is tested and
certified.
Finally, in situations where an eligible professional or eligible hospital believes
that it has multiple HIT systems that would each meet the definition of EHR Module, we
suggest that the eligible professional or eligible hospital evaluate whether these systems
could be combined with other systems to constitute a Complete EHR. If they are capable
of being combined to form a Complete EHR, it may be more expeditious and beneficial
for an eligible professional or eligible hospital to simply seek Complete EHR testing and
certification.
Comments. A few commenters requested that we clarify how EHR Modules
would be tested and certified to adopted privacy and security certification criteria. Other
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commenters asked whether we meant to allow for there to be EHR Modules that provided
only privacy and security capabilities.
Response. These comments pertain to the certification programs rule, and are
outside of the scope of this rule. We therefore respond to these comments in the
Temporary Certification Program final rule (75 FR 36158).
8. Definition of Certified EHR Technology
Comments. Multiple commenters commended ONC for recognizing the need to
certify EHR Modules and enabling certified EHR Modules to be used in combination to
meet the definition of Certified EHR Technology. These commenters noted that this
approach makes it clear that eligible professionals and eligible hospitals will have the
flexibility to select certified EHR modules that are the most useful to them, and can
achieve meaningful use either with combinations of certified HIT or a single EHR
system. However, some commenters mentioned that the definition is unnecessarily
ambiguous, and subject to possible alternative interpretations. Some commenters also
commented on certain statements in the preamble regarding EHR Modules and queried
how a proper combination of EHR Modules could be used to meet the definition of
Certified EHR Technology. Other commenters, while acknowledging that adopted
certification criteria will determine in part what constitutes Certified EHR Technology,
urged ONC to revise the definition to include only patient care functionality. Finally, a
few commenters offered specific word changes for the definition to improve its clarity.
Response. In the Interim Final Rule, we defined Certified EHR Technology to
mean “a Complete EHR or a combination of EHR Modules, each of which: (1) Meets the
requirements included in the definition of a Qualified EHR; and (2) Has been tested and
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certified in accordance with the certification program established by the National
Coordinator as having met all applicable certification criteria adopted by the Secretary.”
With respect to a combination of EHR Modules, we clarified in the preamble of the
Interim Final Rule that:
“As long as each EHR Module has been separately tested and certified in
accordance with the certification program established by the National
Coordinator…to all of the applicable certification criteria adopted by the
Secretary, a proper combination of certified EHR Modules could meet the
definition of Certified EHR Technology. To clarify, we are not requiring the
certification of combinations of certified EHR Modules, just that the individual
EHR Modules combined have each been certified to all applicable certification
criteria in order for such a “combination” to meet the definition of Certified EHR
Technology.”
Many commenters appeared to be confused by the inclusion of “each of which” in
the definition of Certified EHR Technology. Other commenters also stated that “each of
which” was awkwardly placed, making it difficult to interpret how the combination of
EHR Modules must satisfy the subsequent requirements of the definition. This confusion
also made it difficult to understand the clarifying remarks reiterated above regarding our
intention to avoid implying that a combination of certified EHR Modules had to be
certified a second time when a proper combination had been created. We generally agree
with these comments and are revising the definition slightly to avoid this ambiguity and
to clarify that the definition of Certified EHR Technology can be met in either of two
ways.
The first way that the definition of Certified EHR Technology can be met is for a
Complete EHR to: 1) meet the requirements included in the definition of a Qualified
EHR, and 2) be tested and certified in accordance with the certification program
established by the National Coordinator as having met all applicable certification criteria
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adopted by the Secretary. The second way that the definition of Certified EHR
Technology can be met is if each constituent EHR Module of a combination of EHR
Modules has been tested and certified in accordance with the certification program
established by the National Coordinator as having met all applicable certification criteria
adopted by the Secretary and the resultant combination also meets the requirements
included in the definition of a Qualified EHR.
As previously written, it was unclear to many commenters that the comma
preceding “each of which” was meant to separately apply a Complete EHR and
“combination of EHR Modules” to the subsequent requirements. Our intention was that a
combination of EHR Modules would have to provide the capabilities necessary to meet
the definition of a Qualified EHR and that the EHR Modules combined would have each
been tested and certified in accordance with the certification criteria applicable to each
EHR Module.
In response to commenters, we have decided to revise the definition of Certified
EHR Technology to state explicitly the two distinct ways the definition can be met. The
revised definition will read as follows. Certified EHR Technology means:
1) A Complete EHR that meets the requirements included in the definition of a
Qualified EHR and has been tested and certified in accordance with the certification
program established by the National Coordinator as having met all applicable
certification criteria adopted by the Secretary; or
2) A combination of EHR Modules in which each constituent EHR Module of the
combination has been tested and certified in accordance with the certification program
established by the National Coordinator as having met all applicable certification criteria
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adopted by the Secretary, and the resultant combination also meets the requirements
included in the definition of a Qualified EHR.
As discussed in the Temporary Certification Program final rule, a pre-coordinated
integrated bundle of EHR Modules would fall under the second definition of Certified
EHR Technology, although each EHR Module of the bundle would be tested and
certified at the same time rather than separately. Therefore, provided that a proper
combination of EHR Modules has been created, combinations of EHR Modules could be
tested and certified either at the same time or at separate times, to meet the definition of
Certified EHR Technology.
Finally, we believe that commenter suggestions to revise the definition of
Certified EHR Technology to reference specific certification criteria are misguided. The
definition, regardless of the certification criteria that must be included in a Complete
EHR or combination of EHR Modules, must be able to accommodate changes in
certification criteria over time. Accordingly we believe that the final definition meets this
intended goal and conveys a clear meaning.
Comments. Some commenters appeared to interpret our definition as providing
that EHR Modules must be used to meet the definition of Certified EHR Technology. Of
these commenters, some requested that we clarify whether health care providers would be
required to obtain certification of EHR Modules that no vendors support. Other
commenters asked whether non-certified “EHR modules” could be used in combination
with a Complete EHR or in combination with EHR Modules that are used to meet the
definition of Certified EHR Technology.
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Response. We would like to make clear that eligible professionals and eligible
hospitals are not required to use EHR Modules in order to meet the definition of Certified
EHR Technology. The use of EHR Modules is completely voluntary and provides an
alternate avenue for eligible professionals and eligible hospitals who seek to implement
more customized HIT solutions while still meeting the definition of Certified EHR
Technology. Commenters who expressed concerns about their responsibility for seeking
certification for EHR Modules for which no vendor supports did not provide specific
examples, and we are uncertain as to the basis for their concerns. Regardless, we
reiterate that the use of EHR Modules is voluntary and we believe that most eligible
professionals and eligible hospitals that are adopting HIT for the first time will have a
variety of Complete EHRs available from which to choose.
We also clarify that only those EHR Modules that provide capabilities necessary
to meet the definition of Certified EHR Technology will need to be tested and certified.
That being said, eligible professionals and eligible hospitals are free to utilize any other
type of HIT to complement or in combination with Certified EHR Technology, including
HIT that provides capabilities for other purposes not related to meaningful use.
Comments. Some commenters suggested that our definition was too broad.
Most of these commenters argued that we should permit eligible professionals to adopt
only Complete EHRs and EHR Modules that were certified as including only those
capabilities applicable to their specialty or practice. In other words, these commenters
sought for the definition of Certified EHR Technology to be interpreted in such a way as
to permit different specialty-oriented variations of Certified EHR Technology to exist.
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Response. At the present time, we believe that the definition of Certified EHR
Technology already includes some of the flexibility these commenters request. We
permit, for example, a Complete EHR designed for an ambulatory setting and a Complete
EHR designed for an inpatient setting both to meet the definition of Certified EHR
Technology, even though each is compliant with a slightly different set of applicable
certification criteria. In that regard, we believe we have integrated a balanced and
appropriate amount of flexibility into the definition of Certified EHR Technology, which
will also allow us to make additional refinements over time. We believe that it is
possible based on industry need for us to specify in a future rulemaking sets of applicable
certification criteria for Complete EHRs and EHR Modules designed for particular
clinical settings.
9. Definition of Human Readable Format
Comments. A number of commenters across several certification criteria
requested that we clarify the meaning of “human readable format.” These commenters
questioned what human readable format meant when it was used in the certification
criteria and offered examples of what they thought would constitute human readable
format such as, style sheets and PDFs. A couple of commenters suggested that human
readable format should consider patients’ linguistic needs. A commenter requested we
discuss the compliance requirements associated with the Americans with Disabilities Act
and the relevant sections of the Rehabilitation Act of 1973 to ensure human readable
format was meant to include an obligation to provide people with disabilities alternative
formats such as large print or Braille.
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Response. In the Interim Final Rule, we discussed the meaning of human
readable format and provided examples of what we believe would constitute human
readable format. We reiterate that discussion below.
We believe that in order to recognize the enormous potential of HIT, greater
standardization in future years is necessary. In that regard, we recognize that
more advanced interoperability requires health information to be represented by
specific vocabularies and code sets that can be interpreted by EHR technology as
well as converted and presented in a readable format to the users of such
technology. At the present time we recognize that implementing certain
vocabularies and code sets in EHR technology is a difficult, technical
undertaking. For that reason, we have not adopted specific vocabularies and code
sets for a number of the exchange purposes … We have, however, as a
transitional step, adopted certification criteria that require Certified EHR
Technology to be capable of presenting health information received in human
readable format. By human readable format, we mean a format that enables a
human to read and easily comprehend the information presented to them
regardless of the method of presentation (e.g., computer screen, handheld device,
electronic document). This would likely require information in coded or machine
readable format to be converted to, for example, its narrative English language
description. In an effort to further the transition to, and prevalence of, more
specific vocabularies and code sets, we are interested in public comment
regarding industry readiness if we were to adopt certification criteria requiring the
use of additional vocabularies and code sets in parallel with meaningful use Stage
2. Such certification criteria could include not only that Certified EHR
Technology be capable of presenting information in human readable format but
also that it be capable of automatically incorporating certain vocabulary or code
sets (i.e., machine readable information).
The term human readable format is used in two contexts, when coded health
information should be displayed to an eligible professional or (to a health care
professional within) an eligible hospital using Certified EHR Technology and in the
circumstances where Certified EHR Technology must be capable of generating an
electronic copy of health information for individuals. Each context may dictate a
different human readable format. For example, the use of a style sheet may be
appropriate for both health care professionals that are interacting with Certified EHR
Technology as well as individuals who receive an electronic copy of their health
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information to access at a later time. In other circumstances it may be more appropriate
for a health care professional to view health information in human readable format on
their handheld device while an individual may seek an electronic document, such as a
PDF. Given the requests for additional clarity regarding the meaning of human readable
format, we have decided to define the term in this final rule as follows: Human readable
format means a format that enables a human to read and easily comprehend the
information presented to him or her regardless of the method of presentation (e.g.,
computer screen, handheld device, electronic document).
We noted in the Interim Final Rule that the standards, implementation
specifications, and certification criteria adopted by the Secretary applied to Complete
EHRs and EHR Modules, not to persons or entities. We also stated that nothing required
by the Interim Final Rule should be construed as affecting existing legal requirements
under other Federal laws. Accordingly, this final rule does not affect an eligible
professional or eligible hospital’s requirements to comply with other Federal laws in the
event health information is provided in human readable format and persons with
disabilities require reasonable accommodations.
10. Definition of User
Comments. A number of commenters commenting on several certification
criteria requested that we clarify the mean
ng of the term “user.”
Response. We recognize that the term user is referenced in the certification
criteria and at times could be interpreted differently. We believe this flexibility is
necessary because a user may be different depending on the certification criterion and the
context within which the capability it specifies is used. Accordingly, we believe a user
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could be a health care professional or office staff, someone who might interact directly
with Certified EHR Technology or that it could also be software program or service.
D. Final Rule Amendments to Adopted Standards, Implementation Specifications, and
Certification Criteria §§170.202, 170.205, 170.207, 170.210, 170.302, 170.304, 170.306
1. Flexibility and Innovation
Comments. Many commenters requested that we provide more flexibility in the
final rule to accommodate new developments in HIT. These commenters agreed with our
approach to identify minimum standards for certain code sets and they recommended a
similar approach for other standards. Some commenters suggested alternative
approaches to adopting standards, such as adopting standards at a higher level of
abstraction (e.g., HL7 2.x, where “x” could be any version within the version 2 family)
and accompanying the adopted standards with detailed implementation specifications or
guidance outside of the rulemaking process.
Response. We appreciate commenters’ support for the “minimum standard”
approach that we established in the Interim Final Rule. We believe that code sets are an
appropriate type of standard to set as a “minimum.” In the Temporary Certification
Program final rule, we discuss the approaches available to the Secretary to identify and
accept newer versions of adopted minimum code set standards. Below, we discuss how
we have added flexibility into this final rule and how we can add flexibility in future
rulemakings.
In many cases, however, our flexibility may be limited due to legal requirements
to adopt substantive requirements through following the procedures of the Administrative
Procedure Act (APA). Depending upon the circumstances and subject matter, we may
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not be able to alter the substantive standards that apply to Certified EHR Technology
solely through guidance. In addition, a real and practical need to ensure consistency
among various standards regulations constrains the amount of flexibility we can
incorporate into the standards we adopt.
In addition, in accordance with Office of the Federal Register regulations related
to “incorporation by reference,” which we follow for this final rule, the publications we
reference are “limited to the edition of the publication that is approved” and do not
include “[f]uture amendments or revisions of the publication.” Consequently, we do not
include regulatory language that refers, for instance, to “Version 1.X” when “X” remains
a variable.
We do believe, however, that additional flexibility can be added into this and
future rulemakings through at least one of four currently identified means.
•
Alternative Standards. In the Interim Final Rule and in this final rule, we have
adopted “alternative” standards (and applicable implementation specifications) for
several certification criteria. As a general rule, when an adopted certification
criterion refers to two or more standards as alternatives, use of at least one of the
alternative standards will be considered compliant with the certification criterion.
For the certification criterion at §170.302(k)(1), for instance, we have adopted
HL7 2.3.1 and HL7 2.5.1 as alternatives, and the use of either standard (and the
applicable implementation specifications) would be sufficient to comply with the
certification criterion. In each of these instances, we have tried to balance the
need for flexibility with the goal of advancing interoperability, while also taking
into account that the HIT industry has not yet migrated to a single specific
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standard for certain purposes. In some cases, this balancing has required the
adoption of certification criteria that requires certain EHR technology to be
capable of receiving electronic health information formatted according to a
standard that it is not natively capable of generating. For example, with respect to
patient summary records, we have adopted the Continuity of Care Document and
Continuity of Care Record standards as alternatives. As a condition of
certification, section 170.304(i)(1) provides as an additional requirement that
upon receipt of a patient summary record formatted in the alternative standard, the
EHR technology must be capable of displaying the patient summary record in
human readable format. We believe this final rule correctly balances at this stage
of EHR adoption our goal of promoting interoperability with the HIT industry's
ability to comply with the certification criteria and its need for flexibility.
Consistent with our long-term goals for interoperability, we anticipate that this
balance will need to change as the HIT industry migrates to single specific
standards for particular purposes.
•
Minimum Code Set Standards. As previously discussed in the Interim Final Rule,
we adopted several minimum code set standards. It is important to note that these
code set standards set the floor, not the ceiling, for testing and certification. If,
and when, the Secretary accepts a newer version of an adopted minimum standard
code set, the Secretary will, in effect, raise the ceiling for what is permitted for
testing and certification as well as whether Certified EHR Technology can be
upgraded to that newer version without adversely affecting the Certified EHR
Technology’s certified status. For context purposes we repeat a portion of the
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Interim Final Rule’s preamble that discussed our approach to minimum code set
standards.
“We have implemented this approach by preceding references to specific adopted
standards with the phrase, ‘at a minimum.’ In those instances, the certification
criterion requires compliance with the version of the code set that has been
adopted through incorporation by reference, or any subsequently released version
of the code set. This approach will permit Complete EHRs and EHR Modules to
be tested and certified, to, ‘at a minimum,’ the version of the standard that has
been adopted or a more current or subsequently released version.”
We would note that consistent with this approach the Secretary has proactively
identified and deemed acceptable newer versions of the following adopted “minimum
standard” code sets:
1) LOINC version 2.3, released on February 26, 2010; and
2) CVX – Vaccines Administered, March 17, 2010.
We are consequently using this opportunity to inform Complete EHR and EHR
Module developers, prospective ONC-Authorized Testing and Certification Bodies, and
the rest of the public of the Secretary’s recognition of these newer versions of certain
adopted “minimum standard” code sets. We reiterate that use of these newer versions is
voluntary. We also note in accordance with 45 CFR 170.455(b)(2) that Certified EHR
Technology may be upgraded to comply with these newer versions at any time without
adversely affecting the certification status of the Certified EHR Technology.
•
Optional Standards, Implementation Specifications, and Certification Criteria.
We believe that additional flexibility and specificity can be introduced into this
and future cycles of rulemaking through the adoption and designation of
“optional” standards, implementation specifications, and certification criteria.
Optional standards, implementation specifications, and certification criteria would
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be voluntary and would not be required for testing and certifying a Complete
EHR or EHR Module. We believe that optional standards, implementation
specifications, and certification criteria will also help better prepare the HIT
industry for future mandatory certification requirements.
•
Standards and Backwards Compatibility. In previous rulemakings, specifically
the Secretary’s adoption of electronic prescribing (e-prescribing) standards (70
FR 67579) related to the Medicare Part D prescription drug program, HHS
discussed a process to improve flexibility in regulatory requirements which
involves “backwards compatibility.” HHS described backwards compatibility as
meaning that a newer version of a standard retains at a minimum the full
functionality of the version previously adopted in regulation, and that the newer
version would permit the successful completion of the applicable transaction(s)
with entities that continue to use the older version(s). HHS discussed that if a
newer version of a standard were backward compatible with an adopted standard,
it would be possible to pursue a more expedited approach to permit the utilization
of the newer version while still remaining in compliance with the law. We
believe that the approach established in the e-prescribing rulemaking could be
leveraged in many situations for the standards and implementation specifications
adopted for HIT certification. However, we note that this approach can only be
implemented when a newer version of a standard is technically capable of fully
functioning with the adopted version of the standard to conduct the specified
transaction.
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Much like minimum code set standards, we could foresee possibly
adopting a backward compatible version of a previously adopted standard and
allowing entities to voluntarily use the newer version for a period of time. In such
cases, much like a minimum code set standard, Complete EHR and EHR Module
developers would be permitted to have their Complete EHR or EHR Module
certified according to the adopted backward compatible version, and eligible
professionals and eligible hospitals in possession of Certified EHR Technology
would be permitted to upgrade voluntarily their Certified EHR Technology to
include the adopted backwards compatible version. Given that we anticipate
adopting new or modified standards, implementation specifications, and
certification criteria every two years in sync with the initiation of a new
meaningful use stage, we believe that the Secretary’s adoption of backward
compatible versions of standards would generally be limited to intermediate years
(i.e., 2012 and 2014). To accomplish the adoption of a backwards compatible
version, we would take an approach very similar to the approach described in the
final e-prescribing regulation.
We would first review whether the new version of an adopted standard
retains at a minimum the full functionality of the adopted version of the standard
as well as whether it enables the successful completion of the applicable
transaction(s) with entities that continue to use the older version(s). We would
then review whether a standard should be updated with a new version and
whether use of either the new version or the older version would be considered
compliant as well as whether use of the new version would conflict with any
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already existing regulatory requirements. If we believe that the Secretary’s
adoption of a newer version of a standard on a voluntary basis would be
appropriate, we would then seek the advice of the HIT Standards Committee to
evaluate the newer version of the standard and to solicit relevant public input.
The Secretary would then recognize or adopt for voluntary use the new version of
the standard in a Federal Register publication. At that point, use of either the new
or old version would be considered compliant. Entities that would voluntarily
adopt the later backward compatible version of the standard would remain
obligated to accommodate the earlier adopted version without modification. Prior
to the Department formally retiring the older version of the standard and
mandating the use of the later version, the Department would engage in notice and
comment rulemaking.
2. Transport Standards
Comments. Generally, commenters echoed one of two responses: some urged for
the complete removal of SOAP and REST and others requested that we provide detailed
implementation specifications for SOAP and REST along with the identification of the
transactions to which SOAP and REST were applicable. Some commenters also stated
that neither standard was sufficiently specified in order to ensure interoperability, while
others pointed out that it appeared that we had globally applied the usage of SOAP or
REST to all adopted standards, which, if true, would cause conflicts with several adopted
standards (e.g., it was noted that the HL7 standards we adopted utilize Minimum Lower
Layer Protocol (MLLP) as the transport standard and not SOAP or REST).
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Response. We have considered the public comments received on this matter and
we are convinced that it is prudent to remove the adopted standards, SOAP and REST.
We did not intend for the significant potential conflicts identified by commenters to occur
as a result of our adoption of SOAP and REST. We have determined that it would be
more appropriate and reasonable for us not to require at the present time specific
transport standards as a condition of certification. We hope that this will reduce some of
the burden on Complete EHR and EHR Module developers and provide greater
opportunities for innovation. With that said, we plan to carefully watch the impact of this
decision and its affect on interoperability. We encourage Complete EHR and EHR
Module developers to utilize transport standards that will help the industry coalesce
around common methods for electronic health information exchange, and we plan to
examine this decision in future rulemakings.
3. Certification Criteria and Associated Standards and Implementation
Specifications
We have organized our discussion of the final certification criteria according to
the order in which they are currently specified at 45 CFR 170 subpart C. We note that
the final regulatory citations will have changed for many certification criteria and
encourage the public to review, in full, the final regulatory text specified in subpart C of
part 170 in the regulation text of this final rule. We begin with the certification criteria at
45 CFR 170.302 (general certification criteria for Complete EHRs and EHR Modules),
move on to 45 CFR 170.304 (specific certification criteria for Complete EHRs and EHR
Modules designed for an ambulatory setting) and end with 45 CFR 170.306 (specific
certification criteria for Complete EHRs or EHR Modules designed for an inpatient
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setting). We also include, where appropriate, a discussion of the adopted standard(s) and
implementation specifications associated with each certification criterion. For each final
certification criterion, we start with an overview of the final version and then discuss and
respond to public comments.
a. General Certification for Complete EHRs or EHR Modules - §170.302
§170.302(a) - Drug-drug, drug-allergy, drug-formulary checks
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Implement drug-
drug and drug-
allergy interaction
checks
The EP/eligible
hospital/CAH has
enabled this
functionality for
the entire EHR
reporting period
Interim Final Rule Text:
(1)Alerts. Automatically and electronically generate and
indicate in real-time, alerts at the point of care for drug-drug
and drug-allergy contraindications based on medication list,
medication allergy list, age, and computerized provider order
entry (CPOE).
(3)Customization. Provide certain users with administrator
rights to deactivate, modify, and add rules for drug-drug and
drug-allergy checking.
(4)Alert statistics. Automatically and electronically track,
record, and generate reports on the number of alerts responded
to by a user.
Final Rule Text:
§170.302(a)
(1) Notifications. Automatically and electronically generate
and indicate in real-time, notifications at the point of care for
drug-drug and drug-allergy contraindications based on
medication list, medication allergy list, and computerized
provider order entry (CPOE).
(2) Adjustments. Provide certain users with the ability to
adjust notifications provided for drug-drug and drug-allergy
interaction checks.
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Implement drug-
formulary checks
The EP/eligible
hospital/CAH has
enabled this
functionality and
has access to at
least one internal or
external drug
formulary for the
entire EHR
reporting period
Interim Final Rule Text:
(2)Formulary checks. Enable a user to electronically check if
drugs are in a formulary or preferred drug list in accordance
with the standard specified in §170.205(b).
Final Rule Text:
§170.302(b)
Drug-formulary checks. Enable a user to electronically check
if drugs are in a formulary or preferred drug list.
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Comments. Based on the example given in the preamble of the Interim Final
Rule, several commenters believed that we required real-time alerts to utilize a pop-up
message or sound. Commenters stated that the method of delivering real-time alerts
should not be included in the regulation as it would restrain innovation. One commenter
expressed concern that the requirements of this certification criterion were overly specific
with respect to how the Certified EHR Technology needed to perform the tasks rather
than focusing on the desired result. The commenter recommended the certification
criterion be modified to ensure that such alerts are clearly visible to the physicians at the
point-of-care. Some commenters recommended that the term “notification” should
replace the term “alert” for this and other certification criterion because the term alert
implied a particular implementation whereas notification was more neutral.
Response. Unfortunately, many of the commenters who reacted to our example
also believed that it was a requirement. We simply added the example of a pop-up
message or sound in the preamble of the Interim Final Rule to make the requirement
clear. The use of a pop-up message or sound was not a specified requirement in the
regulation text. We agree with the commenters who explained that there may be better
ways to provide alerts. For the purposes of testing and certification, we leave it entirely
up to Complete EHR and EHR Module developers to innovate in this area and provide
capabilities that are both easy to use and prevent medical errors. Additionally, we agree
with the commenters who suggested that we replace “alert” with “notification,” and we
have made that change globally across all certification criteria that used the term alert.
Comments. A few commenters requested clarification of the requirement to track
and report on the number of alerts responded to by a user. A commenter requested
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clarification on why the number of alerts is captured but not what the user did with the
alert and if this data is going to be used to rate providers based upon the number of alerts
they received. Two commenters requested that “responded to by a user” be clarified and
asked whether it meant that a user had taken a different action as a result of the alert.
One commenter recommended removing the alert requirement unless it is more clearly
specified. One commenter recommended deleting the requirement on alert statistics
because it could lead to alert fatigue. A few commenters expressed concern about the
ability to deactivate, modify, and add rules for drug-drug and drug-allergy checking.
These commenters recommended that this capability be removed because of the risk to
patient safety. A commenter noted that treating physicians should have the ability to
ignore alerts in light of other clinical facts about the patient and felt that providing the
ability to delete or modify alerts in a way that would be inconsistent with current medical
standards would be irresponsible and contrary to the meaningful use goal of preserving
the health and safety of patients. Other commenters requested clarification as to whether
the ability to “deactivate” rules implied the ability to remove specific rules or drug pairs
as they exist in commercially-available clinical decision support (CDS) databases; the
ability to “modify” rules implied that an administrator would be able to change the rules
as they exist in these commercially-available CDS databases; and the ability to “add” new
rules implied that the administrator could create new rules in commercially-available
CDS databases. The commenters interpreted “modify” to mean, for example, the ability
to override or change severity setting; and “add” to mean activating a category of CDS,
such as drug-drug interactions, but not individual rules; and “deactivate” as the ability to
“turn off” specific types of rules. Another commenter requested clarification as to
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whether the requirement for customization would be met if a system administrator were
to set the selected severity level to reflect the collective decision of a practice or if alerts
must be tailored on an EP-by-EP basis. A commenter requested clarification on what
qualifies as a "response" to an alert. One commenter recommended that the rule clarify
that “responded to by a user” means in a way which meaningfully addresses the alerts. A
couple of commenters stated that centrally hosted services would have problems
complying with the customization requirements because the hosting vendor takes
responsibility for the administration, maintenance and updating of the clinical decision
support rules including alerts for drug interactions alerts, including drug-drug, drug-
allergy and drug-problem. These commenters were concerned that allowing each of their
clients to create local drug-interaction rules would slow their ability to provide important
updates to their client base, since this would require navigation of a complex hierarchy of
preferred local rules. These local rules would also introduce clinical risk if old local rules
could create a conflict with a clinically appropriate global, updated rule.
Response. Based on the significant number of comments presenting diverse
interpretations of these provisions, we determined that this certification criterion needed
further clarification and have revised it accordingly. Our intention related to the alert
statistics capability had been to mirror the clinical decision support capability. With
respect to customization, we sought to provide users of Certified EHR Technology with a
way to adjust the severity level for which alerts are presented. In response to public
comment, and to clarify what we believe Certified EHR Technology must include as a
condition of certification, we have removed the “alert statistics” part of the certification
criterion altogether and revised the “customization” part of the certification criterion to
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more clearly specify this capability. Our revisions focus on Certified EHR Technology’s
capability to allow certain users (e.g., those with administrator rights) with the ability to
adjust notifications provided for drug-drug and drug-allergy checks (e.g., set the level of
severity for which notifications are presented).
Comment. A commenter stated that use of age as a required data element in this
certification criterion is a problem because drug databases handle age in non-standard
ways. It was also stated that for geriatric patients weight is also considered along with
age.
Response. We agree with this commenter. After considering this comment,
particularly in light of the potentially divergent interpretations of this certification
criterion we noted above, we have removed “age” from the certification criterion. It was
never our intention, as could have been anticipated, to require that Certified EHR
Technology be capable of performing checks that relate type or dosage of drugs to the
patient’s age, or “drug-age checks.”
Comment. A commenter encouraged ONC to add adverse drug events to the
certification criterion and to identify candidate standards for its inclusion to support
meaningful use Stage 2.
Response. We appreciate the suggestion and believe that identifying adverse drug
events is important. Because the final meaningful use Stage 1 requirements under the
Medicare and Medicaid EHR incentive programs do not include such a requirement,
though, we do not believe that it would be appropriate at the present time to add such a
requirement as a condition of certification. This does not preclude Complete EHR or
EHR Module developers from including such functionality.
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Comment. A couple of commenters requested clarification on what CPOE means
in the certification criterion. A commenter requested that ONC clarify that this
certification criterion applies only to the order-entry workflow and is not applicable to
other office processes or work flows which might involve the same clinical data but
which would not necessarily generate these alerts.
Response. We clarify for commenters that our inclusion of CPOE in the
certification criterion is meant to indicate that notifications should occur based on new
medication orders, in addition to a patient’s current medications and medication allergies,
as they are being entered. In response to the other commenter’s request for clarification,
we believe that notifications will occur during the order-entry workflow.
Comment. A commenter requested that the rule be clarified to explicitly require
that drug-drug, drug-allergy, and drug formulary checks occur based on information and
medication lists in an individual’s complete medical record derived from all relevant
providers, not only the drug list of the specific provider.
Response. We clarify that we expect Certified EHR Technology to perform drug-
drug and drug-allergy checks based on medication list and medication allergy list
information included within Certified EHR Technology as structured data. We recognize
that Certified EHR Technology may also store health information in scanned documents,
images, and other non-interoperable non-computable formats and, consequently, do not
expect Certified EHR Technology to be capable of reading or accessing the information
in these other formats for the purposes of performing drug-drug and drug-allergy checks.
Comment. A commenter requested that ONC clarify that EHR vendors will not
be required to remove the option to disable drug-drug and drug-allergy checks.
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Response. While we do not require that the option to disable drug-drug and drug-
allergy checks be removed as a condition of certification, we note that in order for an
eligible professional or eligible hospital to become a meaningful user of Certified EHR
Technology this capability must be enabled.
Comments. Several commenters noted that the NCPDP Formulary and Benefits
standard is not used in an inpatient setting. The commenters consequently requested
clarification as to how the standard can be used in an inpatient setting. Some of the
commenters noted that for inpatient settings, hospitals typically relied on their own
formularies for performing the types of checks specified. Another commenter requested
clarification whether the correct content exchange standard was National Council for
Prescription Drug Programs (NCPDP) Formulary and Benefits Standard version 1.0 and
that if it was, the commenter recommended its adoption. Another commenter noted that
some State Medicaid formularies are not yet available via nationwide e-prescribing
networks and recommended that ONC encourage the implementation of State Medicaid
formularies within the NCPDP Formulary and Benefits Standard via a nationwide e-
prescribing network.
Response. We agree with those commenters who identified the inconsistency of
applying the Formulary and Benefits standard to the inpatient setting. Because the CMS
proposed meaningful use objectives applied to both eligible professionals and eligible
hospitals, we did not make the distinction as to when a Complete EHR or EHR Module
would need to include the Formulary and Benefits standard. However, in light of these
comments and to support the final meaningful use measure, we have determined that it
would be appropriate to adopt a more general certification criterion that would be
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applicable to both Complete EHRs and EHR Modules designed for ambulatory and
inpatient settings. Accordingly, we have removed any reference to a particular standard
because an eligible professional or eligible hospital that does not have external access to a
drug formulary would be able to satisfy this meaningful use measure by checking an
internally managed drug formulary. Although the Formulary and Benefits standard is no
longer required as a condition of certification, we note that eligible professionals who
seek to comply with the electronic prescribing requirements associated with Medicare
Part D eligible individuals will need to use this standard as they do today. Additionally,
we do not agree that it is within the scope of this rulemaking to address State Medicaid
Agencies’ participation in nationwide e-prescribing networks.
Comments. Many commenters noted that the drug-formulary requirement should
not apply to Complete EHRs and EHR Modules designed for an inpatient setting because
there was no proposed requirement for meaningful use Stage 1 for eligible hospitals to
electronically prescribe. Many of the commenters recommended removing this as a
requirement for eligible hospitals while retaining it with the criteria for eligible
professionals. A few commenters specifically recommended adding it to the criterion for
electronic prescribing. Several commenters recommended that if the requirement were
kept for hospitals it should be written as a separate criterion to address the query of a
hospital’s drug formulary during the order entry process and not the NCPDP Formulary
and Benefits standard. A commenter stated that current industry practice among vendors
of EHR technology is to provide a “generic” national formulary rather than the formulary
for a particular plan. The commenter recommended that the functionality require that a
user actually perform an eligibility check before access is provided and, in response to
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that check, the functionality show the correct formulary and benefits information, rather
than just generic data.
Response. We believe that our discussion above regarding the removal of the
standard associated with this certification criterion addresses many of the concerns raised
by commenters. However, we disagree with the suggestion that Complete EHRs and
EHR Modules designed for an inpatient setting should not be required to include this
capability. This capability is required to be enabled for the purposes of meeting the
meaningful use Stage 1 measure. Consistent with the final meaningful use Stage 1
objectives which separated drug-drug and drug-allergy checks from drug-formulary
checks, we have separated out these capabilities into two different certification criteria.
Comments. A commenter stated a concern that this criterion, combined with
future meaningful use requirements, will shift providers’ focus from prescribing the best
drug for the patient to prescribing what is covered by the patient’s insurance plan or
generic brands. Another commenter stated that adding formulary checks to the workload
of physicians will decrease physicians’ efficiency and increase their costs.
Response. In this rule, the Secretary is completing the adoption of the initial set
of standards, implementation specifications, and certification criteria for the certification
of Complete EHRs and EHR modules. The certification criteria ensure that Certified
EHR Technology includes certain capabilities. The extent to which health care providers
must use those capabilities and how they integrate EHR technology into their practice
falls outside the scope of this rule. We therefore do not believe that these concerns are
within the scope of this rulemaking.
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Comment. A commenter recommended that “drug-test checks” should be added.
The commenter stated that many drugs require some form of laboratory testing to ensure
that drugs are prescribed appropriately. The commenter stated, for example, that an
anticoagulant medication should not be prescribed unless there is a test result on record
that shows that giving this drug would not cause harm.
Response. Presently, drug-test checking is not a required capability for eligible
professionals and eligible hospitals to use in order to successfully meet the requirements
of meaningful use Stage 1. Accordingly, we do not believe that it would be appropriate
to require Certified EHR Technology to be capable of performing drug-test checks as a
condition of certification at the present time.
§170.302(b) - Maintain up-to-date problem list
Meaningful Use
Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Maintain an up-todate
problem list of
current and active
diagnoses
More than 80% of all
unique patients seen by the
EP or admitted to the
eligible hospital’s or CAH’s
inpatient or emergency
department (POS 21 or 23)
have at least one entry or an
indication that no problems
are known for the patient
recorded as structured data
Interim Final Rule Text:
Maintain up-to-date problem list. Enable a user to
electronically record, modify, and retrieve a patient’s
problem list for longitudinal care in accordance with:
(1) The standard specified in §170.205(a)(2)(i)(A); or
(2) At a minimum, the version of the standard
specified in §170.205(a)(2)(i)(B).
Final Rule Text:
§170.302(c)
Final rule text remains the same as Interim Final
Rule text, except for references to adopted standards,
which have been changed.
Comments. Several commenters expressed concerns about the use of ICD-9-CM
because it is primarily used for billing and administrative purposes and may not
accurately represent the true clinical meaning of a problem or condition when it is
documented at the point of care. One commenter stated a concern that the problem list
standards do not allow for capturing of free text that health care providers use when an
appropriate code is in neither SNOMED-CT® nor ICD-9-CM.
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Response. The comments are correct in that ICD-9-CM is primarily used for
billing and administrative purposes. SNOMED-CT® is offered as an alternative standard
that will support more clinical descriptions of patient problems or conditions. We believe
that with the adoption of both SNOMED-CT® and ICD-9-CM, healthcare providers
should have adequate coverage for patient diagnoses and conditions. We are discouraging
the use of free text for documenting problem lists since this will limit the usefulness of
problem lists for clinical reminders, decision support and other patient safety and quality
reporting.
Comments. Several commenters recommended that only SNOMED-CT® be
adopted, or alternatively, that we expressly indicate an intention to move away from ICD9CM
and ICD-10 in the future. Another commenter recommended against the adoption
of SNOMED-CT® because the commenter felt that our adoption of SNOMED-CT®
would require eligible professionals and eligible hospitals to use both ICD-9-CM and
SNOMED-CT®. One commenter recommended that a publicly vetted and HHS
approved standard mapping between ICD-9-CM and SNOMED CT® should be made
available at the public’s expense.
Response. We agree conceptually that a single standard for clinical information
would be desirable in the long term. However, presently both ICD-9-CM and SNOMEDCT
® are used by EHR technology to code clinical information, and adopting both would
provide users with additional flexibility. Moreover, we anticipate that as meaningful use
objectives and measures evolve over time, we will receive additional public input and
experience related to these standards and may eventually be able to adopt only one
standard.
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Comments. A few commenters asked for clarification as to whether SNOMEDCT
® or ICD-9CM codes needed to be included within Certified EHR Technology or if
these standards were only necessary when electronic health information is exchanged.
Some of these commenters also requested that we permit any coding system to be used as
long as it can be mapped to the appropriate format when electronic health information is
to be exchanged.
Response. As previously discussed, meaningful use requirements will typically
specify whether an adopted standard will have to be used among components of a
business organization or solely for the electronic exchange of health information with
other legal entities. The measure for this final meaningful use objective provides that
entries be recorded as structured data. The certification criterion specifies that ICD-9CM
or SNOMED-CT® are the code sets which must be included in Certified EHR
Technology, and are therefore the code sets that would be used to record entries as
structured data.
Comments. A few commenters recommended the removal of “longitudinal care”
in the certification criterion. These commenters cited our clarification in the preamble
that by longitudinal care we meant “over multiple office visits.” These commenters
questioned how this language would be applicable to an inpatient setting since patients
are typically treated for acute episodes and not over multiple office visits.
Response. The reference to longitudinal care is intended to convey that the
problem list must be comprehensive in the sense that it must be capable of including
entries provided over an extended period of time. Consequently, for Complete EHRs and
EHR Modules to be certified for an ambulatory setting, they will need to be designed to
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enable the user to electronically record, modify, and retrieve a patient’s problem list over
multiple encounters. For an inpatient setting, they will need to enable the user to
electronically record, modify, and retrieve a patient’s problem list for the duration of an
entire hospitalization. This clarification was also requested in relation to the medication
list and medication allergy list certification criteria and we have not repeated our
response. As a result, we have retained “longitudinal care” in each certification criterion
where the term is referenced and only make this clarification once.
Comment. A commenter suggested that we include a reasonable expectation of
what constitutes “up-to-date” in the reference to “up-to-date” problem list.
Response. We referred this comment to CMS, and it is addressed in the final rule
on the Medicare and Medicaid EHR Incentive Programs.
§170.302(c) - Maintain active medication list
Meaningful
Use Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Maintain active
medication list
More than 80% of all unique
patients seen by the EP or
admitted to the eligible
hospital’s or CAH’s inpatient
or emergency department
(POS 21 or 23) have at least
one entry (or an indication
that the patient is not
currently prescribed any
medication) recorded as
structured data
Interim Final Rule Text:
Maintain active medication list. Enable a user to
electronically record, modify, and retrieve a patient’s
active medication list as well as medication history for
longitudinal care in accordance with the standard
specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.302(d)
Maintain active medication list. Enable a user to
electronically record, modify, and retrieve a patient’s
active medication list as well as medication history for
longitudinal care.
Comments. A few commenters agreed with the certification criterion. One
commenter requested that we provide more clarity on the use of term “retrieve.” The
commenter questioned whether we intended to use the word “retrieve” in the certification
criterion to mean solely the retrieval of information available to Certified EHR
Technology or if we intended for it to also include the interactive retrieval of medication
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list information from external sources. The commenter suggested we clarify that
“retrieve” meant retrieval of only information internally available to Certified EHR
Technology. Other commenters, similar to their comments on the problem list
certification criterion, stated that there needed to be more clarity with respect to how the
reference to “longitudinal care” applied to a Complete EHR or EHR Module used by an
eligible hospital.
Response. We clarify that for this certification criterion, and all other certification
criteria, the term “retrieve” means the retrieval of information directly stored and
managed by Certified EHR Technology and that it does not mean the retrieval of
information from external sources, unless explicitly stated otherwise. We also take this
opportunity, in the context of our response regarding “longitudinal care” above, to clarify
that “medication history” is intended to include a record of prior modifications to a
patient’s medications.
Comment. A commenter stated that there needs to be more clarity with respect to
whether an EHR Module must maintain a list of all active medications or if a specialty
system, such as a cardiology system, could maintain a list of medications specific to its
specialty use and provide the list to the enterprise EHR.
Response. If an EHR Module developer seeks to have its “medication list EHR
Module” certified, the EHR Module must provide the capabilities specified by the
certification criterion. We do not intend to limit how the EHR Module could
appropriately provide these capabilities (i.e., whether the EHR Module must itself enable
the user to electronically record, modify, and retrieve a patient’s active medication list for
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longitudinal care, or whether the EHR Module could be designed to provide those
capabilities through its interaction with a device or devices at the enterprise level).
Comment. One comment stated that this criterion should include a provision to
include the ability to transmit this information to public health entities as required by law.
Response. Nothing we adopt in this final rule precludes such a capability from
being included in a Complete EHR or EHR Module. That is not, however, currently a
necessary requirement for certification.
Comments. One commenter stated that it would need to perform extensive
reprogramming to accommodate the standard we adopted if it meant modifying
underlying medication databases. This commenter suggested that this standard as it
applied to the maintenance of medication lists be deferred. Along those lines, a couple of
commenters stated that more clarification was needed with respect to whether RxNorm
identifiers needed to be stored internally within Certified EHR Technology or only
needed to be used upon the electronic exchange of health information. Other commenters
expressly stated that the mapping of the vocabulary be limited to instances where the
electronic exchange of health information would take place.
Response. We understand these commenters’ concerns and agree that it would be
premature to require the use of the adopted standard in this context. In that regard, we
seek to clarify for commenters our intention, which was solely to associate this adopted
standard (as some commenters suggested) with the certification criteria that require the
capability to electronically exchange health information. We recognize that continuing to
associate this standard with the adopted certification criterion could potentially impose a
significant burden on the industry, which we did not intend. Accordingly, we have
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removed from this certification criterion the requirement to use this standard. We discuss
our response to comments on the standard itself in the context of the patient summary
record certification criterion.
§170.302(d) - Maintain active medication allergy list
Meaningful Use
Stage 1
Objective
Meaningful Use Stage 1 Measure Certification Criterion
Maintain active
medication allergy
list
More than 80% of all unique patients
seen by the EP or admitted to the
eligible hospital’s or CAH’s inpatient
or emergency department (POS 21 or
23) have at least one entry (or an
indication that the patient has no
known medication allergies)
recorded as structured data
Interim Final Rule Text:
Maintain active medication allergy list.
Enable a user to electronically record,
modify, and retrieve a patient’s active
medication allergy list as well as medication
allergy history for longitudinal care.
Final Rule Text:
Unchanged
Now §170.302(e)
Comments. Much like the prior certification criterion, many commenters signaled
their support for this certification criterion. Other commenters raised the same points
related to this certification criterion as they did for the medication list certification
criterion.
Response. We believe our responses to the problem list and medication list
certification criteria are applicable to these repeated comments.
Comments. Many commenters suggested that non-medication allergies be added
to this certification criterion. A few commenters stated that it could jeopardize patient
safety if not all allergens were included in Certified EHR Technology.
Response. Patient safety is one of HHS’s top priorities. At the present time, the
final meaningful use objective and measure focus on medication allergies. Accordingly,
we have adopted a certification criterion to support this objective and measure. We
would like to reiterate, however, that a certification criterion sets the floor not the ceiling
for the capabilities Certified EHR Technology must include. We encourage Complete
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EHR and EHR Module developers to provide more comprehensive capabilities than those
currently required for achieving certification.
§170.302(e) - Record and chart vital signs
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Record and chart
changes in vital
signs:
•
Height
•
Weight
•
Blood pressure
•
Calculate and
display BMI
•
Plot and display
growth charts for
children 2-20
years, including
BMI
For more than 50%
of all unique
patients age 2 and
over seen by the
EP or admitted to
eligible hospital’s
or CAH’s inpatient
or emergency
department (POS
21 or 23), height,
weight and blood
pressure are
recorded as
structured data
Interim Final Rule Text:
(1)Vital signs. Enable a user to electronically record, modify,
and retrieve a patient’s vital signs including, at a minimum,
the height, weight, blood pressure, temperature, and pulse.
(2)Calculate body mass index. Automatically calculate and
display body mass index (BMI) based on a patient’s height
and weight.
(3) Plot and display growth charts. Plot and electronically
display, upon request, growth charts for patients 2-20 years
old.
Final Rule Text:
§170.302(f)
(1)Vital signs. Enable a user to electronically record, modify,
and retrieve a patient’s vital signs including, at a minimum,
height, weight, and blood pressure.
(2) Unchanged
(3) Unchanged
Comment. One commenter noted that the units of measurement should be
specified in the EHR with regards to vital signs. For example that height should be
specified in inches or centimeters.
Response. We do not believe that this level of specificity is necessary. We
expect that Complete EHR and EHR Module developers will include the units of measure
that their customers believe are necessary to meet their needs, which in many cases will
include those that patients routinely request. We also expect that many Complete EHR
and EHR Module developers will offer both metric units and U.S. units of measurement,
as a standard business practice.
Comments. In what appeared to be a reaction to the proposed meaningful use
objective and measure, some commenters requested that we remove BMI as part of the
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certification criterion for Complete EHR or EHR Modules designed for an inpatient
setting. The rationale provided was that acute care providers would not be required to
track BMI.
Response. While we can understand these commenters’ concern, we believe that
BMI is a simple mathematical calculation that Certified EHR Technology should be
capable of performing regardless of the setting for which it is designed.
Comment. One commenter recommended that BMI and age components should
be used to create an alert when an unhealthy BMI is indicated for a patient and that
Certified EHR Technology should record whether the patient was informed of the
unhealthy BMI status.
Response. We believe that this recommendation is overly specific, is more
germane to meaningful use, and exceeds the type of capability we believe should be
specified as a condition of certification.
Comments. A few commenters noted this certification criterion applies more
directly to specialties that predominantly treat children. For other specialties, this
criterion would add unnecessary cost and complexity to many HIT products that they
would use. Many commenters suggested that a growth chart component should not be
required for EHR technology designed for an inpatient setting, as it is not feasible to track
this data in a meaningful way over a long enough period of time in an inpatient setting
(which is typically of a short and infrequent duration). A couple of commenters
suggested that non-traditional forms of growth charts should be accepted. One
commenter suggested that the certification criterion establish a baseline, but should not
limit the expansion of this capability to other ages. Other commenters made specific
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suggestions for different age ranges, such as including children under the age of two and
lowering the upper age to ages less than 20 years old (e.g., 18).
Response. As we stated above with respect to the calculation of BMI, we believe
that Certified EHR Technology should be capable of performing this capability
regardless of the setting for which it is designed. Moreover, with respect to whether
growth charts should be applicable to Complete EHRs and EHR Modules designed for an
inpatient setting, we remind commenters that children’s hospitals qualify as eligible
hospitals under the Medicaid EHR incentive program and will also need to demonstrate
meaningful use of Certified EHR Technology. We do not preclude Complete EHR and
EHR Module developers from designing novel approaches to displaying growth charts.
Finally, we concur with the commenter that suggested this certification criterion should
be a baseline. We reiterate that this certification criterion establishes a floor, not a
ceiling, and we encourage Complete EHR and EHR Module developers to include
additional functionality where it will enhance the quality of care that eligible
professionals and eligible hospitals can provide.
Comments. Similar to the comments above, many commenters suggested the
growth chart requirement should include children under age 2. The charting would then
include: weight, length, pulse oximetry, head circumference, and blood pressure (with
percentiles based on age and weight).
Response. For Stage 1, the related meaningful use objective addresses ages 2-20.
In order to remain consistent with and support this objective, we do not believe that it is
necessary at this time to require a capability for charting any additional ages as a
condition of certification.
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Comment. One commenter requested that we clarify whether “plot and
electronically display” means to plot height, weight, and BMI over time or against
national norms.
Response. We clarify that we expect a growth chart to plot the height, weight,
and BMI over time, as compared to national norms. While the regulation text does not
specifically require comparison to national norms, we understand that this type of
information is typically provided along with the growth chart itself to provide greater
relevance and meaning for the growth charts. We encourage Complete EHR and EHR
Module developers to include this feature.
Comment. A commenter suggested that SNOMED-CT® be used for designation
of BMI.
Response. Although we agree that SNOMED-CT® could be used to code BMI,
we only require that Certified EHR Technology be capable of calculating BMI. We do
not believe that it is necessary, as a condition of certification, to specify how BMI should
be coded. That being said, we do not preclude the use of SNOMED-CT® to code BMI.
Comment. One commenter suggested that the certification criterion should be
better aligned with the final meaningful use objective and measure. The commenter
noted that the criterion includes temperature and pulse, which is not included in the
meaningful use objective and measure.
Response. We agree with the comment and have removed temperature and pulse
from the certification criterion.
§170.302(f) - Smoking status
Meaningful Use
Stage 1
Objective
Meaningful Use Stage 1
Measure Certification Criterion
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Record smoking
status for patients
13 years old or
older
More than 50% of all
unique patients 13 years
old or older seen by the
EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23) have
smoking status recorded
as structured data
Interim Final Rule Text:
Smoking status. Enable a user to electronically record,
modify, and retrieve the smoking status of a patient.
Smoking status types must include: current smoker,
former smoker, or never smoked.
Final Rule Text:
§170.302(g)
Smoking status. Enable a user to electronically record,
modify, and retrieve the smoking status of a patient.
Smoking status types must include: current every day
smoker; current some day smoker; former smoker;
never smoker; smoker, current status unknown; and
unknown if ever smoked.
Comments. Several commenters stated that the smoking status certification
criterion was overly prescriptive because it specified certain status variables. These
commenters agreed that recording smoking status is crucial to health improvement
efforts, but contended that mandating certain fields was the wrong approach. Many of
these commenters stated that they were unaware of defined industry standard value set
for smoking terminology and other suggested that our reference to specific types of
smokers be removed. Others asked whether these variables were examples or the only
responses allowed. A few commenters agreed with this certification criterion as
reasonable and appropriate because it would provide value for both clinical care and
public health. Commenters recommended that besides what we had specified, the
certification criterion should also reference packs per day history information,
secondhand smoke exposure, and alcohol consumption information. Other commenters
recommended that the certification criterion be changed to reflect tobacco use rather than
smoking.
Response. We have adopted this certification criterion to fully support the final
meaningful use objective and measure, which in response to comments has been revised
to further clarify the purpose of the objective and measure. We therefore disagree with
those commenters who stated that this certification criterion is too prescriptive.
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Concurring with CMS, we believe that the fields associated with this measure should
mirror those expressed in the Centers for Disease Control and Prevention, National
Center for Health Statistics, National Health Interview Survey related to smoking status
recodes.2 Accordingly, the final certification criterion further specifies and slightly
broadens the smoking statuses we expect Certified EHR Technology to be capable of
recording. Generally speaking, we understand that a “current every day smoker” or
“current some day smoker” is an individual who has smoked at least 100 cigarettes
during his/her lifetime and still regularly smokes everyday or periodically, yet
consistently; a “former smoker” would be an individual who has smoked at least 100
cigarettes during his/her lifetime but does not currently smoke; and a “never smoker”
would be an individual who has not smoked 100 or more cigarettes during his/her
lifetime.3 The other two statuses (smoker, current status unknown; and unknown if ever
smoked) would be available if an individual’s smoking status is ambiguous. The status
“smoker, current status unknown” would apply to individuals who were known to have
smoked at least 100 cigarettes in the past, but their whether they currently still smoke is
unknown. The last status of “unknown if ever smoked” is self-explanatory.
§170.302(g) - Incorporate laboratory test results
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure Certification Criterion
Incorporate clinical
lab-test results into
certified EHR
technology as
structured data
More than 40% of all
clinical lab tests
results ordered by the
EP or by an authorized
provider of the eligible
hospital or CAH for
patients admitted to its
inpatient or emergency
department (POS 21 or
Interim Final Rule Text:
(1) Receive results. Electronically receive clinical
laboratory test results in a structured format and display
such results in human readable format.
(2) Display codes in readable format. Electronically
display in human readable format any clinical laboratory
tests that have been received with LOINC® codes.
(3) Display test report information. Electronically display
all the information for a test report specified at 42 CFR
2 Smoking status recodes: http://www.cdc.gov/nchs/nhis/tobacco/tobacco_recodes.htm
3 ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/datasets/DATA2010/Focusarea27/O2701a.pdf
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23) during the EHR
reporting period
whose results are
either in a
positive/negative or
numerical format are
incorporated in
certified EHR
technology as
structured data
493.1291(c)(1) through (7).
(4) Update. Enable a user to electronically update a
patient’s record based upon received laboratory test
results.
Final Rule Text:
§170.302(h)
(1) Unchanged
(2) Display test report information. Electronically display
all the information for a test report specified at 42 CFR
493.1291(c)(1) through (7).
(3) Incorporate results. Electronically attribute, associate,
or link a laboratory test result to a laboratory order or
patient record.
Comments on 170.302(g)(1)
Comments. A few commenters suggested that we specify in the regulation that
the reference to receiving clinical laboratory test results in a “structured format” means in
HL7 version 2.3.1 format. These commenters further recommended that we refer to HL7
version 2.3.1 within the certification criterion. These commenters stated that many
Complete EHR and EHR Module developers already use HL7 2.3.1 and that adopting it
as a standard would spur industry-wide adoption and also set the stage for driving
adoption of future HL7 standards, like HL7 2.5.1, in the later stages of meaningful use.
A commenter in support of including HL7 2.3.1 stated that it was concerned that if we
did not specify a standard for this requirement that there could be confusion regarding
which version of the standard should be used, and that laboratories would have to
continue to support multiple standards. Another commenter also noted that we did not
specify a standard format for the laboratory results that Certified EHR Technology must
be capable of receiving. This commenter, however, stated that many EHRs are compliant
with HL7 2.5.1 for the purposes of receiving laboratory results. The commenter also
recommended that we apply this certification criterion differently for ambulatory and
inpatient settings by requiring that Complete EHRs and EHR Modules designed for an
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ambulatory setting be required to receive HL7 2.5.1 formatted laboratory test results and
those designed for an inpatient setting be required to receive HL7 2.3.1 formatted
laboratory test results. One commenter suggested that our objectives could be better
supported if we stated that in this certification criterion a requirement that laboratory
results must be received electronically using HL7 transactions with implementation
guidance.
Response. While we understand the intent of these commenters’ suggestions, we
do not believe that it is within the scope of this rule to dictate the standard by which
laboratories transmit test results. The scope of this rule is the adoption of certification
criteria that specify required capabilities of Certified EHR Technology (in this case,
receiving laboratory information in structured format) and not, in this instance, specifying
the standard by which laboratories must transmit test results.
Comment. A commenter requested that we clarify how this certification criterion
is applicable to hospital settings. The commenter asked whether we intended for the
capability of receiving laboratory test results to include results obtained during a patient’s
stay at the hospital or if we meant to also include the receipt of laboratory test results
from other time periods. They suggested requiring only those laboratory test results
obtained during the patient stay.
Response. For the purposes of demonstrating compliance with this certification
criterion, we do not specify the contexts (e.g., a patient stay) under which laboratory test
results are received. Rather, consistent with the meaningful use objective and measure
and the capabilities required by this certification criterion, we specify that when
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laboratory test results are received in structured format by Certified EHR Technology,
that the results can be incorporated.
Comment. One commenter requested that we clarify whether the structured data
requirement applies to all laboratories (including reference labs, hospital
abs, physician
office labs, and physicians performing their own lab tests).
Response. This certification criterion requires Complete EHRs and EHR
Modules to provide the capability to receive clinical laboratory test results in a structured
format as a condition of certification. It does not speak to how laboratories must send the
test results.
Comments on 170.302(g)(2)
Comments. Some commenters requested clarification on this specific capability
within the certification criterion regarding what needed to be displayed in the context of
LOINC codes. These commenters suggested that we not require the display of the actual
LOINC code, but the description associated with the LOINC code. A commenter
suggested that we identify a subset of common LOINC codes instead of requiring that
tens of thousands of LOINC codes be supported for the purposes of certification. Other
commenters suggested that we offer guidance in the form of a “starter set” of LOINC
codes to encourage the use of the standard. One commenter requested that we confirm its
understanding of this specific part of the certification criterion, which is that Certified
EHR Technology must demonstrate the capability to import LOINC coded results from
an external source. Finally, one commenter noted that the heading for the standard at
§170.205(a)(2)(iii) should just refer to “laboratory test results” and not “laboratory orders
and results.”
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Response. We clarify that we do not expect Certified EHR Technology to
natively (or internally) support LOINC in its entirety, which is why we do not believe
that it is necessary to specify a subset of common LOINC codes. Given the diverse
comments and requests for clarification on this specific aspect of the certification
criterion, we agree with commenters that we should not require a LOINC code that has
been received, to then be displayed. Accordingly, we have decided to remove this
requirement from the certification criterion. We do, however, wish to further clarify our
current approach to Certified EHR Technology’s use of LOINC codes. Presently, we
expect Certified EHR Technology to be able to reuse a LOINC code once it has been
received and is accessible to Certified EHR Technology. We do not expect, as we
mention above, that Certified EHR Technology will have to crosswalk or map internal or
local codes to LOINC codes. This clarification is applicable to the standard that we have
adopted regarding LOINC codes now specified at §170.207. This response is applicable
to similar comments we received on other certification criteria that also referenced the
use of LOINC codes. Finally, we agree with the commenter who suggested that we
revise the heading of the standard at §170.205(a)(2)(iii). We have done this as part of the
overall restructuring of the regulation text.
Comments on 170.302(g)(3)
Comments. Some commenters agreed with the capability specified in
170.302(g)(3). One noted a concern that modifications to either a certified Complete
EHR or certified EHR Module could potentially result in the failure of Certified EHR
Technology to display the test report information as required by the regulations and,
thereby, put the laboratory in technical violation of the CLIA regulations. These
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commenters reasoned that because a Complete EHR or EHR Module must be tested and
certified to be in compliance with 42 CFR 493.1291(c)(1) through (7) that certification
should replace any requirement for the laboratory to confirm that the information has
been properly transmitted and meets the CLIA requirements. These commenters also
asserted that a laboratory should be relieved of any further regulatory responsibility under
42 CFR 493.1291(c)(1) through (7) for the display of the required report information to
the physician or subsequent viewers of the information if the Certified EHR Technology
has been implemented by an eligible professional or eligible hospital. One commenter
reiterated the point by stating that because Certified EHR Technology would be required
to display the required CLIA report elements, laboratories should not be unfairly held
accountable for any elements that may be removed or altered by other parties from the
test report before received by the physician.
Response. While we can understand the concern expressed by these commenters,
we reiterate that the scope of our authority under this final rule only applies to
capabilities that Certified EHR Technology must include. As a result, we cannot provide
the regulatory relief that these commenters seek.
Comments on 170.302(g)(4)
Comments. A couple of commenters questioned whether we intended for the
“updates” to be manual updates of electronic records. If that were true, some
commenters were concerned that would create workflow problems and reduce the
availability of results. Other commenters suggested that either the user be able to create
an additional record, rather than be permitted to change the “official” record or that an
adequate audit trail be preserved of the existing data and any updates, since an update
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may result in disparities with the official record of test results. These commenters
wanted to ensure that the laboratory's record would be the same as the record maintained
in the EHR. One commenter stated that paragraph (g)(4) could imply process and system
behavior that we did not intend to require. The commenter stated that it is common
practice in a hospital setting for lab results to be transmitted in high volume from a lab
system to an EHR and made available for review to the clinician through the EHR,
without a need for a user to review each transaction before updating the EHR to make the
results available. Another commenter made a similar point and questioned whether an
“update” meant manual intervention, which they stated would be impracticable in a
hospital setting. One commenter stated that most EHR technology already links orders to
lab results in an established way. The commenter also indicated that the certification
criterion we adopted requires changes to a process that most EHR developers have
already implemented and introduces inefficiencies for both EHR developers and health
care providers.
Response. We appreciate the issues raised by commenters on this specific
capability and have revised this part of the certification criterion to more clearly express
our expectation for Certified EHR Technology and to be responsive to and consistent
with commenters’ suggestions. We intended for an update to mean, as indicated by the
meaningful use objective and measures, that a laboratory test result would be
incorporated in Certified EHR Technology with the originating laboratory order or with a
patient’s record in any one of the methods specified. Accordingly we have revised this
specific capability to more clearly reflect our intent. We believe this addresses
commenters’ concerns and requests for clarification and would permit batches of
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laboratory test results to be electronically linked to laboratory orders or patient records
without manual intervention.
Comments. Some commenters noted that small and medium size practices have
had a difficult time working with commercial laboratory vendors to provide interfaces
from which they can receive lab test results. These commenters noted that laboratory
vendors typically charge too much for their services and do not prioritize establishing
connections with small and medium size practices because they do not have the same
volume of laboratory referrals as large practices.
Response. This certification criterion requires as a condition of certification that
Certified EHR Technology be capable of supporting electronic laboratory interfaces. We
understand the concerns raised by commenters pertaining to the difficulty of certain
practices being able to obtain laboratory interfaces and note that the meaningful use Stage
1 measure associated with this certification criterion is included in the “menu set”
specified by CMS which we believe should help assuage some commenters’ concerns.
We do not believe that the ability of a practice (regardless of size) to obtain an interface
or other type of connection is an issue that is within the scope of this final rule to address.
Comment. One commenter recommended that we revise this certification
criterion to require that laboratory domain expertise be exhibited when laboratory
information is displayed. The commenter further elaborated by stating that laboratory
results are not homogeneous, and that specific laboratory domain expertise is necessary
to design the ways in which the data associated with certain laboratory results (e.g.,
microbiology, molecular pathology) are displayed in EHR systems to ensure appropriate
presentation and interpretation.
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Response. With the exception of displaying the required elements specified at 42
CFR 493.1291(c)(1) through (7), we do not require as a condition of certification any
additional display requirements. Accordingly, we do not preclude Complete EHR and
EHR Module developers from designing more specific displays of laboratory results that
may need to be displayed in a more complex fashion.
Comment. One commenter requested that we clarify that Certified EHR
Technology did not need to enable the EHR Technology user to receive voluminous raw
or pre-final-report lab data, and further, that not providing this capability would not
disqualify a Complete EHR or EHR Module from becoming certified.
Response. Enabling a Complete EHR or EHR Module to receive “raw or prefinal-
report lab data” is not required under this or any other adopted certification
criterion.
Comment. One commenter suggested that we modify this certification criterion
to require transmission of cancer related lab tests and results to cancer registries as
required by law.
Response. Because this certification criterion is about incorporating lab test
results in Complete EHRs and EHR Modules and does not require any electronic
transmissions, we do not believe that this is an appropriate requirement to consider.
§170.302(h) - Generate patient lists
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure Certification Criterion
Generate lists of
patients by specific
conditions to use
for quality
improvement,
Generate at least
one report listing
patients of the EP,
eligible hospital or
CAH with a
Interim Final Rule Text:
Generate patient lists. Enable a user to electronically select,
sort, retrieve, and output a list of patients and patients’ clinical
information, based on user-defined demographic data,
medication list, and specific conditions.
reduction of
disparities, research
specific condition Final Rule Text:
§170.302(i)
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or outreach Generate patient lists. Enable a user to electronically select,
sort, retrieve, and generate lists of patients according to, at a
minimum, the data elements included in:
(1) Problem list;
(2) Medication list;
(3) Demographics; and
(4) Laboratory test results.
Comments. Several commenters requested clarification regarding the set of
variables that should be included in the demographic information for the patient lists.
Some of these commenters suggested that the gender, race, ethnicity and preferred
language of the patient should be included in this data set. One commenter suggested
that the final rule should explicitly adopt and incorporate the recommendations of a
report published by the Institute of Medicine in mid-2009 entitled, “Race, Ethnicity and
Language Data: Standardization for Health Care Quality Improvement.”
Response. We appreciate the commenters’ suggestions, and we have used them
to clarify this certification criterion. It was our intention that Certified EHR Technology
would be able to leverage the information, specifically the structured data it has available
to it, to assist eligible professionals and eligible hospitals to generate patient lists. We
have clarified this certification criterion to express this intent. Accordingly, we expect
that Certified EHR Technology will be able to generate patient lists according to certain
data elements for which structured data will be available: medical problems; medications;
demographics; and laboratory test results. While we respect the work completed by the
Institute of Medicine, we do not believe that the public has had an adequate opportunity
to consider its recommendations related to demographics in the context of certification,
and we are therefore not including them as a condition of certification at this time. We
encourage the HIT Standards Committee to consider this report as it recommends
standards to the National Coordinator.
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Comments. Several commenters requested further clarification regarding the
meaning of “patient's clinical information.” Other commenters stated that this phrase was
too vague and was not included as part of the proposed meaningful use objective or
measure and should therefore be removed. Some commenters requested further
definition of the term “specific conditions,” particularly to clarify whether this term refers
to problems and diagnoses. Clarification was also requested regarding whether this
information includes: a patient summary; the patient's entire medical history; and patient
encounter notes. One commenter recommended that we clarify how the lists must be
structured and suggested that we specify time periods for patient histories. One
commenter requested clarification of the term “output,” and suggested that it should
mean to produce a list for internal use and that it does not refer to exporting the patient
list to a system or destination external to the office of an eligible professional.
Response. We appreciate the concerns raised by these commenters and after
further consideration agree that the terms referenced by commenters could be interpreted
in multiple ways. Accordingly we have removed “patient’s clinical information” and
“specific conditions” from the certification criterion, and have reframed the certification
criterion to more directly align with the meaningful use measure by changing “output” to
“generate.” We sought to clarify that we intended that Certified EHR technology would
be capable of electronically producing or “generating” patient lists for an eligible
professional or eligible hospital’s subsequent use. We do not require as a condition of
certification that time periods be associated with a patient list, but presumably time (i.e.,
the age of the information) could be one factor an eligible professional or eligible hospital
could also use to sort their lists (e.g., patients with XYZ problem recorded in the past 3
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months). We believe that these revisions make this certification criterion clearer while
addressing these commenters’ concerns.
§170.302(i) - Report quality measures
Meaningful Use
Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Eligible
Professionals:
Report ambulatory
clinical quality
measures to CMS
or the States
Eligible Hospitals
and CAHs: Report
hospital clinical
quality measures to
CMS or the States
For 2011, provide aggregate
numerator, denominator, and
exclusions through attestation
as discussed in section
II(A)(3) of [the Medicare and
Medicaid EHR Incentive
Programs final rule]
For 2012, electronically
submit the clinical quality
measures as discussed in
section II(A)(3) of [the
Medicare and Medicaid EHR
Incentive Programs final rule]
Interim Final Rule Text:
(1) Display. Calculate and electronically display
quality measures as specified by CMS or states.
(2) Submission. Enable a user to electronically
submit calculated quality measures in accordance
with the standard and implementation
specifications specified in §170.205(e).
Final Rule Text:
§170.304(j)
(1) Calculate.
(i) Electronically calculate all of the core clinical
measures specified by CMS for eligible
professionals.
(ii) Electronically calculate, at a minimum, three
clinical quality measures specified by CMS for
eligible professionals, in addition to those clinical
quality measures specified in paragraph (1)(i).
(2) Submission. Enable a user to electronically
submit calculated clinical quality measures in
accordance with the standard and implementation
specifications specified in §170.205(f).
§170.306(i)
(1) Calculate. Electronically calculate all of the
clinical quality measures specified by CMS for
eligible hospitals and critical access hospitals.
(2) Submission. Enable a user to electronically
submit calculated clinical quality measures in
accordance with the standard and implementation
specifications specified in §170.205(f).
Comments. Many commenters stated that the Physician Quality Reporting
Initiative (PQRI) 2008 Registry XML specifications apply only in the context of eligible
professionals. Some of these commenters went on to state that hospitals are not familiar
with PQRI and have been submitting quality measurement data to CMS under a separate
program. A few commenters recommended that this standard requirement be removed
while several others stated we should adopt both Quality Reporting Document
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Architecture (QRDA) and the PQRI XML Registry specification in this rulemaking and
move to a single standard in the next rulemaking. Other commenters recommended that
QRDA not be adopted in this rulemaking. Several commenters suggested that an
implementation specification for eligible hospitals be created if we intend to continue to
require that quality measure be reported in the PQRI Registry XML format. One
commenter expressed a concern that if the PQRI 2008 Registry XML standard is
maintained as the adopted standard that there is a danger that the certification Complete
EHR and EHR Module developers obtain may become obsolete before Stage 1 has run its
course. Finally, a couple of commenters suggested that ONC consider deferring the
naming of a standard for submission of clinical quality measures until Stage 2 and instead
only require what is necessary to support clinical quality measure submission in Stage 1.
Response. Many commenters misinterpreted our intent with respect to the
adoption of the PQRI 2008 Registry XML specification as the standard for electronically
submitting quality reporting data to CMS. Presently, CMS requires the submission of
aggregate, summary level data for the purposes of meaningful use and not data at the
patient-specific level. It is our understanding that the PQRI 2008 Registry XML
specification is capable of serving as the “envelope” for aggregate, summary level data.
Accordingly, we do not believe that, as some commenters suggested, an eligible
hospital’s familiarity with the PQRI program is relevant to the adoption of this standard
for this specified purpose. Nor do we believe that a specific implementation of this
standard is necessary for hospital settings as the standard’s purpose and the type of data it
will transmit to CMS will be the same – aggregate, summary level data. Through recent
discussions with CMS since the publication of the Interim Final Rule we have determined
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that the PQRI 2009 Registry XML specification, a more recent version of the standards
we adopted in the Interim Final Rule is a suitable replacement for 2008 version, and
accordingly, we have adopted the 2009 version in its place. We believe this revision
should assuage some commenters’ concerns about the obsolescence of the adopted
standard and reduce concerns that a wholly different standard would be adopted in the
near future. If adopting a different standard for Certified EHR Technology becomes
necessary, we would do so only after engaging in subsequent rulemaking.
Comments. A few commenters stated that many of the clinical quality measures
proposed by CMS do not have electronic specifications and contended that it would be
difficult for any vendor to have embedded these measures in their EHR products in a
timely manner. But, these same commenters stated that when the specifications become
available, that HHS should ensure through the certification process that the products are
capable of generating accurate data. Many commenters expressed concerns that the
certification criterion was too vague or too broad (because it implicitly referenced all of
the quality measures CMS had proposed). Some of the commenters recommended that
this certification criterion be removed, while others recommended that it focus on a
subset of measures in order to constrain the amount of electronic measure specifications a
Complete EHR or EHR Module developer would need to address in order to be certified.
At least one of these latter commenters indicated that our adopted certification criteria
created uncertainty for Complete EHR and EHR Module Developers. This commenter
asked that we clarify what clinical quality measures would need to be tested in order to
satisfy this certification criterion and if there would be a baseline for eligible hospital
measures as well as some identified core set of measures for eligible professionals.
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Along these same lines, another commenter recommended that EHR technology should
be tested and certified only to the clinical quality measures applicable to the medical
specialties of the eligible professionals that the EHR technology is intended to support
and to whom it is marketed. Other commenters expressed concerns about timing and that
a significant amount of effort would be required to reprogram Complete EHRs and EHR
Modules to capture, calculate, and report the final meaningful use Stage 1 measures.
Many commenters also stated that the proposed quality measures are not yet ready for
automated reporting, that a significant amount of work is still required by the measure
developer community, and that the value sets for these quality measures have not been
validated. Several commenters objected to the reference to “States” in the certification
criterion and recommended that it be removed. These commenters contended that the
certification criterion should be limited to the “federal requirements” and further that it
was unrealistic to expect Complete EHR and EHR Module developers to also comply
with 50 separate State requirements as a condition of certification.
Response. We understand that CMS has worked to significantly increase the
availability of a number of electronic measure specifications that are associated with
specific clinical quality measures. In light of the final approach CMS has taken with
respect to clinical quality measures for meaningful use Stage 1, we have revised this
certification to better align it with the Medicare and Medicaid EHR Incentive Programs
final rule requirements. We also agree with those commenters that requested we
explicitly focus the report of clinical quality measures certification criterion, and the
certification criteria in general, on Federal requirements and have removed the reference
to “or States” in this certification criterion.
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To better align this certification criterion with the final approach to clinical
quality measures in the Medicare and Medicaid EHR Incentive Programs final rule, we
have determined that it is no longer sufficient to specify one general certification criterion
for both Complete EHRs and EHR Modules designed for either an ambulatory or
inpatient setting. Accordingly, the final rule in §§170.304 and 170.306 will include a
specific certification criterion for each setting. Complete EHRs and EHR Modules
designed for an ambulatory setting will be required to be tested and certified as being
compliant with all 6 of the core (3 core and 3 alternate core) clinical quality measures
specified by CMS for eligible professionals (Section II(A)(3) of the Medicare and
Medicaid EHR Incentive Programs final rule). Complete EHRs and EHR Modules
designed for an ambulatory setting will also be required to be tested and certified as being
compliant with, at a minimum, 3 of the additional clinical quality measures CMS has
identified for eligible professionals (Section II(A)(3)of the Medicare and Medicaid EHR
Incentive Programs final rule). We believe this revision provides clarity and flexibility
and reduces the potential burden for Complete EHR and EHR Module developers (who
may have been unfamiliar with certain clinical quality measures because of the type of
eligible professional they serve) to become compliant with this certification criterion. As
a result, Complete EHR and EHR Module developers for the ambulatory setting may
provide Certified EHR Technology with a certain level of variability in terms of clinical
quality measure capabilities. To provide further transparency for potential eligible
professionals regarding the clinical quality measures to which a Complete EHR or EHR
Module has been tested and certified, we specified that an ONC-Authorized Testing and
Certification Body would need to report such information to the National Coordinator,
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and further, that the Complete EHR or EHR Module developer would need to make sure
this information is available and communicated to prospective purchasers as part of the
Complete EHR or EHR Module’s certification.
Complete EHRs and EHR Modules designed for an inpatient setting will be
required to be tested and certified as being compliant with all of the clinical quality
measures specified by CMS (Section II(A)(3) of the Medicare and Medicaid EHR
Incentive Programs final rule) for eligible hospitals. Again, we believe this revision
provides greater clarity and reduces the potential burden for Complete EHR and EHR
Module developers.
Comments. One commenter suggested that we separate the calculation and the
submission parts of this certification criterion into two separate certification criteria.
Response. We disagree. We see no basis for separating these two parts of this
certification criterion into two separate certification criteria. However, we believe that it
is necessary to specify two different certification criteria to account for the different
clinical quality measures that eligible professionals and eligible hospitals will need to
report. Accordingly, we have adopted separate certification criteria for Complete EHRs
and EHR Modules designed for ambulatory and inpatient settings and referenced the
respective quality measures for each in the appropriate certification criterion.
Comments. One commenter suggested that all approved PQRI registries be
automatically certified as an EHR Module.
Response. We do not believe that it is prudent or appropriate to automatically
deem certain HIT as certified. That being said, if a PQRI registry can adequately perform
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the capability specified by the certification criterion, it could be certified as an EHR
Module.
Comments. Several commenters stated that Certified EHR Technology should be
capable of collecting quality measurement data and calculating results for reporting to
avoid having eligible professionals and eligible hospitals perform these processes
manually. These commenters also stated that Certified EHR Technology should be
capable of accurately and reliably reporting quality measurement data. Some
commenters recommended that a Complete EHR or EHR Module only be required to be
certified to existing e-measure specifications.
Response. We agree that the collection of clinical quality measurement data and
the calculation of results for submission to CMS should be performed by Certified EHR
Technology. We also agree that Complete EHRs or EHR Modules should only be
required to be tested and certified to developed electronic measure specifications. This is
why CMS has only specified clinical quality measures for eligible professionals and
eligible hospitals in the Medicare and Medicaid EHR Incentive Programs final rule for
which electronic measure specifications have been developed. Complete EHR and EHR
Module developers should follow these electronic measure specifications in order to
accurately calculate clinical quality measures.
Comments. Several commenters recommended that the certification criterion
should be revised to include the word “accurately.”
Response. We expect that clinical quality measures would be accurately
calculated and do not see a need to specifically include the word in the certification
criterion.
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§170.302(j) - Check insurance eligibility and §170.302(k) - Submit claims
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Removed from
final rule
Removed from
final rule
Interim Final Rule Text:
Enable a user to electronically record and display patients’
insurance eligibility, and submit insurance eligibility queries
to public or private payers and receive an eligibility response
in accordance with the applicable standards and
implementation specifications specified in §170.205(d)(1) or
(2).
Final Rule Text:
Removed
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure Certification Criterion
Removed from
final rule
Removed from
final rule
Interim Final Rule Text:
Enable a user to electronically submit claims to public or
private payers in accordance with the standard and
implementation specifications specified in §170.205(d)(3).
Final Rule Text:
Removed
Comments. Many commenters recommended that the certification criteria for
administrative transactions be removed because they considered the administrative
capabilities that we required to be outside of the scope of an electronic health record and
stated further that their inclusion did not align with the HIT industry’s common view of
what constituted EHR technology. A large number of commenters conveyed specific
challenges including: these functions are usually handled by practice management
systems which generally are separate from an EHR, although on occasion some vendors
include these functionalities in their EHRs; practice management systems adoption is
already very high and requiring certification for these products would be unnecessary and
burdensome, given the wide variety and number of vendors and significant potential for
increasing costs for providers; providers interested in achieving meaningful use would
have to abandon a working practice management system if their practice management
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vendors were unwilling or unable to get certified; and many providers currently use
clearinghouses to convert paper claims into electronic claims to submit to CMS and other
payers. Several commenters recommended retaining the administrative transactions
certification criteria because it would eventually reduce administrative costs across the
health care system. Many commenters requested that we clarify several aspects of these
certification criteria while some other commenters noted that significant progress has
been made in using electronic eligibility inquires and claims transactions outside of an
EHR context. Those commenters expressed concern that the inclusion of administrative
transaction capability in this rule would create confusion, ambiguity, and potentially
duplicate efforts. A couple of commenters noted that some payers do not accept
electronic claims and eligibility checks. One commenter expressly noted that including
the administrative functionalities would decrease innovation by creating a large barrier to
entry for EHR innovators. Finally, a couple of commenters noted that health care
providers would face significant challenges in the transition to ASC X12N 5010 and
ICD-10 and lost productivity.
Response. In concert with CMS, we have considered commenters’ rationale for
and against the inclusion of these certification criteria. We have tried to summarize
above several technical and programmatic challenges commenters identified if
administrative transaction capability were included within the certification requirements.
Due to the removal of these objectives from the meaningful use Stage 1 requirements, we
do not believe that it would be appropriate to continue to require, as a condition of
certification, that Complete EHRs and EHR Modules include these capabilities.
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Accordingly, we have removed the adopted standards, implementation specifications, and
certification criteria related to these administrative transactions from this final rule.
As CMS explains in more detail in the Medicare and Medicaid EHR Incentive
Programs final rule, the subsequent inclusion of administrative simplification
requirements as part of meaningful use Stage 2 is an important long-term policy goal.
Administrative simplification can improve the efficiency and reduce unnecessary costs in
the health care system as a whole; the small percentage of paper claims submitted
represents a disproportionately high administrative cost for health plans; the
reconciliation of billing charges for services not eligible for payment creates a significant
burden for providers, health plans, and most significantly, for patients. Moreover, we
believe that the integration of administrative and clinical information systems is
necessary to support effective management and coordinated care in physician practices.
For example, the ability to: leverage clinical documentation in support of appropriate
charge capture (e.g., for preventive counseling, or immunizations provided); link lists of
patients needing clinical reminders with patient contact information; stratify quality
measures by patient demographic factors (e.g., race/ethnicity) and insurer status (e.g.,
Medicare beneficiaries).
Additionally, we believe that important benefits can be recognized through the
future adoption of administrative transactions standards and certification criteria for
Complete EHRs and EHR Modules. Through the use of EHR Modules, eligible
professionals and eligible hospitals have the opportunity to use practice management
systems or clearinghouses that provide the capability to conduct administrative
transactions as components of Certified EHR Technology. In that regard, we recognize
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the concerns expressed by some commenters that the developers of some practice
management systems may not be prepared to seek certification for these legacy systems
in 2010 or 2011. We also acknowledge that the required compliance date of January 1,
2012 for ASC X12N version 5010 transactions would further complicate the certification
process associated with meaningful use Stage 1. However, we believe that after the ASC
X12N version 5010 transition has occurred, and we approach the October 1, 2013
compliance date for HIPAA covered entities to use ICD-10, our decision to delay the
adoption of administrative transactions certification criteria will prove beneficial for the
adoption of Certified EHR Technology.
In order to meet upcoming administrative simplification deadlines, most health
care providers will have to upgrade their practice management systems or implement new
ones. This will provide an important opportunity to align EHR technology capabilities
and standards for administrative transactions with the administrative simplification
provisions that the Affordable Care Act provides for health plans and clearinghouses.
Therefore, we intend to include for adoption, administrative transactions standards and
certification criteria to support meaningful use Stage 2 rulemaking, and expect health
care providers and Complete EHR and EHR Module developers to take this into
consideration leading up to 2013.
Comments. Many commenters recommended that we remove the implementation
specification, CORE Phase 1 (CORE), which we previously adopted. Several
commenters noted that CORE is only useful if it has also been adopted by health plans,
and they explained that not all health plans had adopted CORE. A few commenters
expressed concern with CORE stating that it adds requirements to the HIPAA Standard
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Transactions and did not follow the work of the standards development organization that
maintains administrative transactions. A few commenters also believed that following
CORE results in non-compliant ASC X12N 4010 transactions. Other commenters noted
that it appeared that we had required CORE for both ASC X12N 4010 and 5010 standard
transactions, but that CORE Phase 1 is only applicable to ASC X12N 4010 standard
transactions and cannot be used with ASC X12N 5010 standard transactions. A few
commenters requested that we clarify whether providers and vendors will be required to
receive CORE certification. Several commenters recommended ONC retain CORE
Phase 1. A few commenters noted that CORE promotes uniformity and can provide
significant reduction in transaction costs. A couple commenters recommended that ONC
adopt subsequent CORE standards in future stages.
Response. As previously mentioned, we have decided to align our revisions with
the changes made in the Medicare and Medicaid EHR Incentive Programs final rule and
to remove, as noted above, the standards, implementation specifications, and certification
criteria associated with administrative transactions. Consistent with that approach, we
are removing the CORE Phase 1 implementation specification for the reasons submitted
in comments.
§170.302(l) - Medication reconciliation
Meaningful Use Stage
1
Objective
Meaningful Use Stage 1
Measure Certification Criterion
The EP, eligible
hospital or CAH who
receives a patient from
another setting of care
or provider of care or
believes an encounter
The EP, eligible hospital or
CAH performs medication
reconciliation for more than
50% of transitions of care in
which the patient is
transitioned into the care of
Interim Final Rule Text:
Medication reconciliation. Electronically
complete medication reconciliation of two or
more medication lists by comparing and
merging into a single medication list that can be
electronically displayed in real-time.
is relevant should
perform medication
reconciliation
the EP or admitted to the
eligible hospital’s or CAH’s
inpatient or emergency
department (POS 21 or 23)
Final Rule Text:
§170.302(j)
Medication reconciliation. Enable a user to
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electronically compare two or more medication
lists.
Comments. Many commenters suggested that for this certification criterion we
clarify whether we intended for the process of medication reconciliation to be automatic
or to support an eligible professional or eligible hospital in performing this task. Many
saw the former as a potential risk to patient safety. Although several different reasons
were given, many commenters recommended that we revise the certification criterion to
indicate that two or more medication lists be simultaneously displayed in order to permit
an eligible professional or eligible hospital to then reconcile the medication lists.
Response. We have reviewed commenters’ concerns and intend to clarify the
language in this certification criterion. We recognize that the technical foundation and
safety checks are not currently in place for automated medication reconciliation. We did
not intend to imply that automated reconciliation needed to occur through our use of the
word “electronically.” We used the term “electronically” to express our expectation that
eligible professionals and eligible hospitals would be able to use Certified EHR
Technology to complete this task. Accordingly, we have revised this certification
criterion to require that Certified EHR Technology be capable of providing a user with
the ability to electronically compare two or more medication lists (e.g., between an
externally provided medication list and the current medication list in Certified EHR
Technology). We expect that this could be done in a number of ways and we do not want
to preclude Complete EHR and EHR Module developers from innovating, provided that
the desired outcome is reached. For example, a user could be presented with two
electronic lists side-by-side and move medications from one list to the other and then
select the final current list. Alternatively, a user could view one list and two PDFs of
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other medications and use this capability to update the current medication list. We do,
however, see great promise in making this capability more comprehensive and anticipate
exploring ways to improve the utility of this capability before we adopt a subsequent
round of certification criteria.
Comments. Several commenters supported this certification criterion, but wanted
clarification regarding how we expected testing and certification to be accomplished,
especially if only one medication list was in use.
Response. We believe that the clarifications and revisions to the certification
criterion and the discussion above clarify how we intend for this certification criterion to
be tested.
Comments. Several commenters requested that we clarify the meanings of
“medication reconciliation,” “transitions of care,” and “relevant encounter.”
Response. These terms are not used in the certification criterion. We encourage
commenters to review the Medicare and Medicaid EHR Incentive Programs final rule to
see how these terms have been clarified in response to public comments.
§170.302(m) - Submission to immunization registries
Meaningful Use
Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Capability to
submit electronic
data to
immunization
registries or
Immunization
Information
Systems and actual
submission in
accordance with
applicable law and
practice
Performed at least one test
of certified EHR
technology's capacity to
submit electronic data to
immunization registries and
follow up submission if the
test is successful (unless
none of the immunization
registries to which the EP,
eligible hospital or CAH
submits such information
have the capacity to receive
the information
electronically)
Interim Final Rule Text:
Submission to immunization registries.
Electronically record, retrieve, and transmit
immunization information to immunization registries
in accordance with:
(1) One of the standards specified in §170.205(h)(1)
and, at a minimum, the version of the standard
specified in §170.205(h)(2); or
(2) The applicable state-designated standard format.
Final Rule Text:
§170.302(k)
Submission to immunization registries.
Electronically record, modify, retrieve, and submit
immunization information in accordance with:
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(1) The standard (and applicable implementation
specifications) specified in §170.205(e)(1) or
§170.205(e)(2); and
(2) At a minimum, the version of the standard
specified in §170.207(e).
Comments. A significant majority of commenters recommended that we remove
paragraph (m)(2) related to the applicable state-designated format. These commenters
contended that such a requirement was vague, could be problematic from an
interoperability perspective, and would make certification impracticable.
Response. We agree with those commenters that requested we explicitly focus
the certification criterion and certification in general on Federal requirements. We have
therefore removed the reference to “applicable stated-designated standard format” in the
certification criterion. Additionally, we have reviewed this certification criterion and
have determined that our reference to “immunization registries” is unnecessary. We are
primarily concerned with Certified EHR Technology’s ability to transmit the
immunization information in a standardized format, and do not believe that it is necessary
to specify a particular recipient in the certification criterion.
Comments. Many commenters supported our adoption of both HL7 2.3.1 and
HL7 2.5.1. Some commenters acknowledged that HL7 2.3.1 was more commonly used
for the purpose of submitting information to immunization registries while other
commenters suggested that we only adopt HL7 2.5.1. Some commenters recommended
that we keep our adopted standards the way they are. Others recommended that we only
adopt HL7 2.3.1 because most immunization registries cannot comply with HL7 2.5.1.
Response. We appreciate that commenters support our adoption of both HL7
2.3.1 and HL7 2.5.1. We understand that both standards are currently in use and for that
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reason we have permitted either to be used for purposes of certification. We also
understand that eligible professionals and eligible hospitals will have to use the standard
that the immunization registry or Immunization Information System in their jurisdiction
can receive and, as a result, we have adopted the two most common standards utilized for
the transmission of immunization information.
Comment. One commenter noted that it would be very helpful to provide a
source for mapping from the NDC code on the vaccine packaging to the CVX/MVX
codes used for interoperability, in anticipation of supporting barcode scanning of
vaccines. Another commenter noted that while some mapping has occurred between
CPT and CVX, they were not aware of a translation map from NDC to CVX. They also
stated that even though a list of CVX codes is available, they were not aware of a
downloadable immunization database using CVX codes. They considered this lack of a
database a significant burden and impediment to compliance. The commenter concluded
by suggesting that CPT codes be used instead of CVX codes, because CPT codes are
used for billing purposes and would be readily available.
Response. The CDC maintains an openly available list of updated CVX codes as
well as a mapping of CVX codes to CPT codes on their website.4 Moreover, we believe
that CVX codes are more appropriate than CPT codes because as the commenter
referenced, CPT codes are used for billing purposes. In that regard, we believe that
because there is a publicly available mapping between CVX and CPT, it would not be
difficult or burdensome to map CPT codes to CVX codes. NDC codes were not adopted
as a standard to represent immunizations and we do not believe that requiring their use
4 www.cdc.gov/vaccines/programs/iis/stds/cpt.htm
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for the purposes of demonstrating compliance with this certification criterion would be
appropriate.
Comment. One commenter recommended that we revise the certification
criterion combined with associated standards to state “For the purposes of electronically
submitting information to immunization registries Certified EHR Technology must be
capable of using a certified EHR module or portal provided by a state immunization
registry which is capable of submitting and retrieving coded immunization information or
capable of using HL7 2.3.1 or HL7 2.5.1 as a content exchange standard and the CDC
maintained HL7 standard code set CVX—Vaccines Administered as the vocabulary
standard.” The basis for this commenter’s suggestion was that providers in its state link
to the state’s immunization module through EHRs and that all immunization data are
stored immediately in the state’s registry. The commenter further clarified that since the
data resides in the state registry natively, there is no need to transmit this information.
Response. In light of this commenter’s suggestion, we have revised the
certification criterion to replace the word “transmit” with “submit” to better align this
certification criterion with the meaningful use objective and measure. We believe that
submission of immunization data would encompass this commenter’s existing method.
Comment. One commenter stated that they believed the use of CVX is neither
mature nor widespread.
Response. We disagree. Our information indicates that CVX codes are widely
used for reporting to immunization registries.
Comment. Some commenters identified implementation specifications that are
available for the standards we had adopted for transmitting immunization information. A
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couple of these commenters specifically recommended using implementation
specifications that would identify message types necessary for transmissions to
immunization registries. Commenters also suggested using the CDC’s implementation
guides, and explicitly recommended that we adopt the CDC public health information
network (PHIN) implementation guide version 2.2 associated with HL7 2.3.1 for the
transmission of immunization information and the CDC implementation guide as well as
the implementation guide associated with HL7 2.5.1.
Response. In the Interim Final Rule, we expressed our interest in receiving public
comment on whether there were additional implementation specifications that we should
adopt. We also noted that we would consider adopting implementation specifications for
any or all of the standards adopted in the Interim Final Rule. After further consideration
of commenters’ recommendations and consultation with the CDC, we agree with these
commenters and believe that adopting implementation specifications for the transmission
of immunization information would benefit EHR technology developers and users.
Moreover, given commenters’ general requests for greater specificity and our stated goal
of greater interoperability, we believe that it would be appropriate to adopt the following
implementation specifications for the submission of immunization data. For HL7 2.3.1
we have adopted the “Implementation Guide for Immunization Data Transactions using
Version 2.3.1 of the Health Level Seven (HL7) Standard Protocol, Implementation Guide
Version 2.2.” We are aware that this implementation specification has been successfully
adopted numerous times in various contexts since its publication four years ago and do
not believe that it will be burdensome for Complete EHR and EHR Module developers to
implement these specifications. For HL7 2.5.1, we have adopted the “Implementation
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Guide for Immunization Messaging Release 1.0.” This implementation specification
represents the collaborative effort of the American Immunization Registry Association
(AIRA) and the CDC. We have also consulted with CDC, and the CDC confirms the
appropriateness and supports the usage of these implementation specifications in this
context. We encourage migration to this newer implementation specification and believe
that it will likely advance interoperability across the country and improve query
capabilities.
Comment. A commenter recommended that we clarify that the certification
criterion should be limited to verifying the ability of the system to record, retrieve, and
transmit immunization information.
Response. The purpose of testing and certifying a Complete EHR or EHR
Module to this certification criterion is to verify that it can perform the capabilities
included in the certification criterion.
Comment. A couple of commenters strongly supported the transmission of
immunization data to state and local immunization registries but requested that the data
requirements be expanded to include the transmission of information regarding diseases
such as cystic fibrosis to pediatric registries.
Response. Presently, we do not believe that it is necessary or appropriate to
expand this certification criterion in this manner. We emphasize, though, that this should
not preclude eligible professionals or eligible hospitals from using Certified EHR
Technology to submit other types of information as medically appropriate and if the
recipient of the information is capable of receiving the data.
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Comment. A commenter recommended including the term “modify” in the
certification criterion.
Response. We agree, and consistent with our other certification criteria that
include the term “modify,” we have added this term.
§170.302(n) - Public health surveillance
Meaningful Use
Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Capability to
submit electronic
syndromic
surveillance data to
public health
agencies and actual
submission in
accordance with
applicable law and
practice
Performed at least one test of
certified EHR technology's
capacity to provide electronic
syndromic surveillance data to
public health agencies and
follow-up submission if the test
is successful (unless none of the
public health agencies to which
an EP, eligible hospital or CAH
submits such information have
the capacity to receive the
information electronically)
Interim Final Rule Text:
Public health surveillance. Electronically record,
retrieve, and transmit syndrome-based public
health surveillance information to public health
agencies in accordance with one of the standards
specified in §170.205(g).
Final Rule Text:
§170.302(l)
Public health surveillance. Electronically record,
modify, retrieve, and submit syndrome-based
public health surveillance information in
accordance with the standard (and applicable
implementation specifications) specified in
§170.205(d)(1) or §170.205(d)(2).
Comments. A couple of commenters supported the adoption of certification
criteria related to public health reporting. One commenter believed that this certification
criterion should be implemented as adopted.
Response. We appreciate commenters’ support of this certification criterion.
Comment. One commenter recommended that we defer any vocabulary standard
for public health reporting and surveillance until a later date. Another commenter
expressed concern that we would adopt as a standard, “according to applicable public
health agency requirements,” because they thought it could be problematic for hospital
systems with facilities in two or more states, as their EHR technology would have to meet
whatever standards each state elected to use.
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Response. We clarify for commenters that we adopted two content exchange
standards for electronic submission to public health agencies for surveillance and
reporting. We did not adopt a specific vocabulary standard, nor did we include the
phrase one commenter stated that we included. However, we have, consistent with our
rationale in the immunization submission certification criterion, removed our reference to
“public health agencies” as the recipient of information. Also, consistent with the
certification criterion above, we have replaced the term “transmit” with “submit.”
Comments. A couple of commenters stated that compliance with HL7 2.5.1 not
be included in this adopted set of standards. One commenter suggested HL7 2.5.1 should
be adopted in a future rulemaking. Another commenter suggested that HL7 2.3.1 be
required for the purposes of certification. Another commenter recommended that the
standard be HL7 2.3.1, because in its opinion many public health agencies cannot comply
with HL7 2.5.1 while another commenter took the opposite position and recommended
HL7 2.5.1.
Response. Given the diversity in implementations and public health agencies’
ability to receive information in a given standard, we believe that the flexibility included
in this criterion is necessary for the foreseeable future. However, relative to the general
comments we received regarding the adoption of implementation specifications for
adopted standards, we have adopted the following implementation specifications for HL7
2.5.1: Public Health Information Network HL7 Version 2.5 Message Structure
Specification for National Condition Reporting Final Version 1.0 and the Errata and
Clarifications National Notification Message Structural Specification. We believe that
these implementation specifications provide the additional clarity commenters were
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seeking and will enable Complete EHR and EHR Module developers to focus their
efforts on a more specific implementation of the HL7 2.5.1 standard. We do not believe
that a suitable implementation specification for HL7 2.3.1 exists for the purpose of public
health surveillance and reporting.
Comments. Multiple commenters stated concerns that the Federal government
and state governments, as well as other public health agencies, do not have the capability
to receive information electronically in a standardized format. One commenter stated
that while they supported using the HL7 standards, some agencies are only able to accept
public health submissions if they have an HL7-based feed. Several commenters
suggested that the public health reporting requirement be delayed until a single, national
standard exists. One commenter stated that requiring EHRs to “electronically record,
retrieve, and transmit syndrome-based public health surveillance information to public
health agencies” is a worthwhile future goal, but they strongly questioned the likelihood
that it could be accomplished within the 2011-2012 timeframe. The commenter also
noted that the certification criterion did not specify which agencies (local, state, Federal)
are included, and that most of those agencies are not prepared to receive biosurveillance
data electronically in the format specified. The commenter concluded that it would be
difficult for any EHR to prove compliance with the certification criterion as written and
recommended the following alternative: “Electronically record, retrieve, and be capable
of producing an electronic message containing syndrome-based public health surveillance
information in accordance with one of the standards specified in §170.205(g).”
Response. We recognize that some public health agencies do not yet have the
capability of electronically receiving information. We do not believe that this should
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serve as a limiting factor, however, or preclude Certified EHR Technology from having
the capability to transmit information in a standard format.
Comment. One commenter commented that if a public health agency is unable to
accept the data, separate reports could be filed with the public health agency to ensure
compliance with the standards.
Response. The commenter’s point is unclear, as is its proposal. We therefore
reiterate that Certified EHR Technology must be capable of transmitting health
information in accordance with the standards adopted by the Secretary, regardless of
whether a specific public health agency can accept or receive the information.
Comment. One commenter suggested that if current interfaces comply with
public health surveillance data using older versions of HL7, the organizations should be
allowed to keep these versions and not be required to upgrade to a newer version.
Response. We permit a Complete EHR or EHR Module to be tested and certified
to either HL7 2.3.1 or HL7 2.5.1. No other versions will be considered compliant with
the adopted standards or certification criterion.
Comment. One commenter recommended that we specify acceptable testing
methods. The commenter also recommended that the testing methods should include an
evaluation of HL7 conformance, completeness, and accuracy of test messages sent to a
state public health agency with a demonstrated capability for electronic laboratory
reporting.
Response. We do not specify the testing methods applicable to the certification
criterion, because that information is outside the scope of this final rule.
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Comment. One commenter suggested that adverse events be reported to public
health agencies.
Response. Our certification criterion does not preclude other types of reportable
events from occurring. Presently, we do not believe that it is appropriate to modify the
certification criterion to explicitly refer to adverse events.
Comment. One commenter recommended that because some public health
agencies do not have the ability to receive public health surveillance information in
electronic format, we should clarify that this certification criterion is limited to verifying
the ability of the system to record, modify, retrieve, and submit such information based
on at least one test of these capabilities.
Response. We reiterate, that the purpose of certification is to verify that a
Complete EHR or EHR Module can perform these capabilities. That should not be
construed to mean that an eligible professional or eligible hospital is exempt from using
Certified EHR Technology to meet the meaningful use objective and measure.
Comment. A commenter recommended including the word “modify” in the
certification criterion.
Response. Consistent with our rationale above, we have added the word modify to
the certification criterion.
§170.302(o) - Access control
Meaningful Use Stage 1
Objective
Meaningful Use Stage 1
Measure Certification Criterion
Protect electronic health
information created or
maintained by the
certified EHR technology
through the
implementation of
Conduct or review a
security risk analysis per 45
CFR 164.308 (a)(1) and
implement security updates
as necessary and correct
identified security
Interim Final Rule Text:
Access control. Assign a unique name and/or
number for identifying and tracking user
identity and establish controls that permit only
authorized users to access electronic health
information.
appropriate technical
capabilities
deficiencies as part of its
risk management process
Final Rule Text:
§170.302(o)
Page 100 of 228
Unchanged
Comment. One commenter explicitly noted its support for this certification
criterion. We received other comments that included some mention of “access” but did
not expressly focus on the certification criterion or provide any related suggestions or
recommendations.
Response. We appreciate the comment supporting this certification criterion.
This certification criterion remains unchanged from the certification criterion adopted in
the Interim Final Rule.
§170.302(p) - Emergency access
Meaningful Use Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Protect electronic health
information created or
maintained by the
certified EHR technology
through the
Conduct or review a security
risk analysis per 45 CFR
164.308 (a)(1) and
implement security updates
as necessary and correct
Int
rim Final Rule Text:
Emergency access. Permit authorized users
(who are authorized for emergency
situations) to access electronic health
information during an emergency.
implementation of
appropriate technical
capabilities
identified security
deficiencies as part of its risk
management process
Final Rule Text:
§170.302(p)
Unchanged
Comment. One commenter asked that we clarify the circumstances that would
qualify as an “emergency” and further clarify whether compliance with this certification
criterion is intended to pre-empt conflicting or stricter state laws that may limit this type
of access or require patient consent. Further, the commenter questioned whether we were
implying that some authorized users of Certified EHR Technology would not be
authorized for emergency situations or whether we intended for any authorized user to be
entitled to access in an emergency situation. Finally, another commenter requested
clarification as to whether emergency access is driven by organizational policies and
whether capturing such access in an audit log is appropriate.
Page 101 of 228
Response. We have adopted certification criteria to ensure that Certified EHR
Technology includes certain capabilities, in this case that Certified EHR Technology be
capable of permitting authorized users to access electronic health information during an
emergency. The criterion is not intended to specify what constitutes an emergency or
who would be authorized to access electronic health information in an emergency. In a
medical emergency, those determinations would be made under specific factual
circumstances and in accordance with applicable state and federal laws, organizational
policies and procedures, and the relevant standard of care.
With respect to emergency access, we note that HHS stated in the HIPAA
Security Final Rule (68 FR 8355):
We believe that emergency access is a necessary part of access controls and,
therefore, is properly a required implementation specification of the ‘‘Access
controls’’ standard. Access controls will still be necessary under emergency
conditions, although they may be very different from those used in normal
operational circumstances. For example, in a situation when normal
environmental systems, including electrical power, have been severely damaged
or rendered inoperative due to a natural or manmade disaster, procedures should
be established beforehand to provide guidance on possible ways to gain access to
needed electronic protected health information.
We believe that this certification criterion is consistent with the HIPAA Security Rule.
Some commenters appeared to interpret our reference to “emergency” in
“emergency access” as solely constituting a clinical or life threatening emergency related
to a patient for which access would be required. We believe that emergency could
encompass that scenario, as well as a broader range of possibilities, including normal
patient care when timely access to electronic health information becomes critical.
Therefore, we have not sought to limit the development of emergency access capabilities
for Certified EHR Technology to a particular scenario.
Page 102 of 228
Comment. One commenter suggested that we require automated notification of
user activity to system administrators when emergency access is invoked.
Response. We appreciate this suggestion. However, at the present time, we do
not believe that this requirement should be a condition of certification because a person
or entity’s organizational policies and procedures may ensure timely notification of
appropriate personnel.
§170.302(q) - Automatic log-off
Meaningful Use Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Protect electronic health
information created or
maintained by the certified
EHR technology through the
Conduct or review a security
risk analysis per 45 CFR
164.308 (a)(1) and implement
security updates as necessary
Interim Final Rule Text:
Automatic log-off. Terminate an
electronic session after a predetermined
time of inactivity.
implementation of
appropriate technical
capabilities
and correct identified security
deficiencies as part of its risk
management process
Final Rule Text:
§170.302(q)
Unchanged
Comments. One commenter supported this requirement. Another commenter
concurred with the purpose of the certification criterion, but noted that it may be difficult
in some circumstances for eligible professionals or eligible hospitals to implement this
capability if the Certified EHR Technology is offered as a service and multiple
individuals are using the Certified EHR Technology at the same time.
Response. We appreciate the commenters’ support for the adoption of this
certification criterion. We believe that automatic logoff capabilities are commonplace
and that this certification criterion can be met by any Complete EHR or EHR Module
developer. We are aware that many web services today logoff customers after a period of
inactivity and do not believe this requirement is unduly burdensome for any Complete
EHR or EHR Module developer.
§170.302(r) - Audit log
Page 103 of 228
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Protect electronic
health information
created or
maintained by the
certified EHR
technology through
the implementation
of appropriate
technical
capabilities
Conduct or review
a security risk
analysis per 45
CFR 164.308 (a)(1)
and implement
security updates as
necessary and
correct identified
security
deficiencies as part
of its risk
management
process
Interim Final Rule Text:
(1) Record actions. Record actions related to electronic health
information in accordance with the standard specified in
§170.210(b).
(2) Alerts. Provide alerts based on user-defined events.
(3) Display and print. Electronically display and print all or a
specified set of recorded information upon request or at a set
period of time.
Final Rule Text:
§170.302(r)
(1) Record actions. Record actions related to electronic health
information in accordance with the standard specified in
§170.210(b).
(2) Generate audit log. Enable a user to generate an audit log
for a specific time period and to sort entries in the audit log
according to any of the elements specified in the standard at
170.210(b).
Comments. Several commenters recommended that we add to the standard
specified at §170.210(b) “access,” “reading,” or “viewing” as triggers for when actions
needed to be recorded as part of an audit log. One commenter recommended expanding
the audit content to include maintaining the before-access content of the information
accessed as well as the after-access content. Some commenters requested clarification of
the intended meaning of the reference to recording the action of “printing.” Commenters
recommended expanding or replacing “print” in the standard with other types of output
methods such as extraction, copy, exchange, report, and export. Some commenter stated
that the print function in many operating systems and software products is a multiple step
process that is difficult for any system to audit. Other commenters expressed concerns
that the requirement to audit all printing would be difficult because there were numerous
ways to circumvent the specific action of printing, such as using the print screen function
and printing out the image of the screen shot. One commenter stated that auditing of the
print function would be possible, but complete auditing of all possible ways of printing
would be impracticable.
Page 104 of 228
Response. We appreciate the thoughtfulness and thoroughness of the comments
provided on this standard. We agree with commenters that auditing the action of
printing, as it was originally envisioned, could be circumvented in such ways as to make
the burden of trying to accurately audit such occurrences outweigh the benefit.
Accordingly, we have removed “printed” from the standard. We also agree with
commenters that our omission of “access” should be corrected and we have added
“accessed” to the standard. We view the action of “access” to encompass “reading” or
“viewing” and consequently have not included those terms as well. Finally, we believe
that the action of “accessed” is a superset of actions which may include “export” and for
that reason have not included, per some commenters’ suggestions, the word “exported” in
the standard. Additionally, to provide greater clarity, we have added in “and by whom”
toward the end of the standard in order to more clearly specify that the actions recorded
should be associated with the user identification that is recorded.
The final standard will read as follows: “The date, time, patient identification, and
user identification must be recorded when electronic health information is created,
modified, accessed, or deleted; and an indication of which action(s) occurred and by
whom must also be recorded.”
Comments. Some commenters requested that we clarify the term “user
identification” in the standard specified at §170.210(b) and recommended the use of
existing standards-based definitions, such as HL7’s definition of author which includes
person, organization, or device.
Response. We specified in the standard that the date, time, patient identification,
and user identification must be recorded when certain actions take place. The HL7’s
Page 105 of 228
definition of author is consistent with our expectation. While we believe that in most
cases a user will be a health care professional performing an action using Certified EHR
Technology, it is also possible that a device or another software process or program could
perform any one of these actions. We do not intend to preclude Complete EHR and EHR
Module developers from including these and other types of specific features.
Comment. One commenter stated that the audit alert criterion exceeds reasonable
expectations for Certified EHR Technology to provide automatic alerts, and
recommended that the audit criteria focus on record access rather than electronic alerts.
Several commenters suggested that alerts are not well defined and should be removed
from the criteria. Several commenters expressed concern that the audit alerting criterion
goes beyond what is required by HITECH and HIPAA and exceeds the current
capabilities of products in the market, and recommends that the alerting criterion be
eliminated from the final rule. Some commenters recommended against the adoption of
certification criterion that requires EHR systems to create an unlimited and open-ended
series of rules to produce user-defined alerts, and suggested that we should clearly define
which actions should be recorded and what alerts should be defined and provided in an
audit log. Several commenters stated that the use of the phrase “based on user-defined
events” in the criterion could be easily misinterpreted or misunderstood to extend beyond
“entity-defined” events to include individual patient preferences. Some of the
commenters that expressed concerns also contended that it would be difficult to test and
certify this portion of the certification criterion.
Response. Again, we appreciate the thoroughness of the commenters’
suggestions. With respect to alerts based on user-defined events, we had intended for
Page 106 of 228
Complete EHRs or EHR Modules designed to provide this capability to be capable of
being configured by a specific user of Certified EHR Technology or based on
organizational policy to generate alerts when certain actions (defined in the standard) had
taken place. For example, a user-defined event could be when a patient’s health
information is accessed outside of normal business hours. In this case, it was our
expectation that Certified EHR Technology would alert a specific user of the Certified
EHR Technology or the organization’s information security staff. We understand the
point that commenters raise, however, about the potential for misinterpretation of this
certification criterion and the consequent potential burden.
Our overall intent for the third paragraph of this certification criterion was to
ensure that Certified EHR Technology provided the capability for eligible professionals
and eligible hospitals to gain access to a specified portion, or a complete representation,
of the Certified EHR Technology’s audit log. We believe that this capability is essential
for eligible professionals and eligible hospitals for risk analysis and other purposes.
Therefore, in concert with the feedback commenters provided on the second paragraph,
we analyzed whether combining the third paragraph with the second paragraph into a
single paragraph would express a clearer requirement. Accordingly, we have merged the
two paragraphs and have adopted in the final rule a requirement that we believe more
clearly expresses our intent for this certification criterion. We also note for clarification
that the phrase “any of the elements specified by 170.210(b)” would also include, for
example, “date” or that information has been “deleted.”
Finally, we believe that it is important for our privacy and security certification
criteria to remain consistent with the HIPAA Security Rule to the degree that Certified
Page 107 of 228
EHR Technology includes technical capabilities that are associated with assisting HIPAA
covered entities comply with applicable legal requirements. We disagree, however, with
those commenters who stated that we did not have a sufficient legal basis to adopt this
certification criterion the way we did because it went beyond the HIPAA Security Rule.
What a HIPAA covered entity must do to remain in compliance with the HIPAA Security
Rule is separate and distinct from the capabilities that a Complete EHR or EHR Module
must include in order to be certified. We do not believe that we are precluded by the
HITECH Act from adopting certification criteria that go beyond the requirements
specified by the HIPAA Security Rule. We believe that the HITECH Act, while directing
that standards, implementation specifications, and certification criteria be consistent with
the HIPAA standards, authorizes the Secretary to adopt certification criteria more broadly
for the electronic use and exchange of health information. Section 3004(b)(1) of the
PHSA, as added by the HITECH Act, requires the Secretary, for instance, to adopt an
initial set of standards, implementation specifications, and certification criteria to enhance
the interoperability, functionality, utility, and security of health information technology.
With respect to the concern expressed that this certification criterion requires
capabilities that exceed the current capabilities of products in the market, we disagree.
Based on our understanding of the current EHR technology in the market, we believe that
the capabilities we have specified in the criterion and the embedded standard are already
common industry practice, and further, that the industry has expanded the functionality
available in audit logs.
Comment. One commenter suggested we defer our adoption of the standard until
the next rulemaking related to meaningful use.
Page 108 of 228
Response. We disagree. As stated above, we believe that audit log capabilities
are an essential component of Certified EHR Technology. As we mentioned above, we
believe that the actions we have specified in the standard, in response to public comment,
are already common industry practice. Moreover, audit logs will provide valuable
information to eligible professionals and eligible hospitals in the event of a security
incident.
Comments. Several commenters acknowledged the importance of the audit log,
but emphasized that the audit log requirements should address the availability of the audit
log and its security. Several commenters recommended that additional requirements be
added, including that the audit log always be on during normal production for the
minimum elements specified in 170.210(b), be maintained in a secure manner, be
produced in a human readable format, and be retained in conjunction with the retention
period of the record.
Response. We agree with these commenters on the merits of their suggestions. In
particular, we note that audit logs provide an important resource for eligible professionals
and eligible hospitals. Audit logs can assist in the identification of security incidents,
such as unauthorized access, as well as serve to deter users from conducting fraudulent or
abusive activities and detect such activities. The purpose of adopted certification criteria
is to specify the capabilities Complete EHRs and EHR Modules must include in order to
be certified, not when such capabilities must be used. Accordingly, we do not believe
that it would be appropriate to specify in this certification criterion the time period for
which an audit log should be “on.” We agree with commenters that audit logs should be
maintained in a secure manner. For this reason, we have preserved the capability we
Page 109 of 228
adopted in the Interim Final Rule as part of the integrity certification criterion that
specified that Certified EHR Technology must be capable of detecting alterations to audit
logs. We encourage the HIT Standards Committee to consider additional capabilities that
could be specified related to audit logs.
Comment. One commenter recommended that the IHE Audit Trail and Node
Authentication (ATNA) Integration Profile be used, but that its use be constrained to the
electronic transactions among organizations, rather than electronic transmissions within
an organization.
Response. We decided to defer our adoption of the ATNA standard because it
can be configured in multiple ways and we did not believe that it would be appropriate at
this time to require a specific implementation as a condition of certification. Our deferral
does not preclude Complete EHR and EHR Module developers from using the standard,
however.
Comment. One commenter requested clarification between “read” audits and
“write” audits, and how each is to be used. The commenter suggested that not requiring
the capability of “read” audits will significantly reduce the ability of auditors to identify
and investigate inappropriate use of health information when records are accessed but not
manipulated. The commenter noted that auditing all read operations for all data elements
within an EHR is infeasible. The commenter further suggested that “read” operations
should be audited only when certain demographic health information needed to identify a
patient (e.g., name, record number, date of birth, address) is presented to or can be known
by the user.
Page 110 of 228
Response. As discussed above, we have adopted in the standard the action of
“accessed” which would encompass the action of “read.” At the present time, we only
identify certain data elements in the adopted standard that must be recorded and believe
that this specificity will help reduce any potential burden associated with recording the
action of “accessed.”
§170.302(s) - Integrity
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Protect electronic
health information
created or
maintained by the
certified EHR
technology through
the implementation
of appropriate
technical
capabilities
Conduct or review
a security risk
analysis per 45
CFR 164.308 (a)(1)
and implement
security updates as
necessary and
correct identified
security
deficiencies as part
of its risk
management
process
Interim Final Rule Text:
(1)In transit. Verify that electronic health information has not
been altered in transit in accordance with the standard
specified in §170.210(c).
(2) Detection. Detect the alteration and deletion of electronic
health information and audit logs, in accordance with the
standard specified in §170.210(c).
Final Rule Text:
§170.302(s)
(1) Create a message digest in accordance with the standard
specified in 170.210(c).
(2) Verify in accordance with the standard specified in
170.210(c) upon receipt of electronically exchanged health
information that such information has not been altered.
(3) Detection. Detect the alteration of audit logs.
Comments. Several commenters requested a definition of “in transit.” Other
commenters suggested that hashing of messages in transit be limited to circumstances of
transmission over public networks only. These commenters suggested that messages
transmitted over private networks be exempt from complying with this standard. One
commenter suggested that in addition to message hashing, digital signatures should be
required on messages in transit. Another commenter stated that requiring hashing of
messages in transit is overly burdensome. One commenter requested that we clarify
whether we intended §170.302(s)(1) to require that the receiver of a message always
verify messages received rather than simply demonstrate the capability to use hashing.
Page 111 of 228
Response. We intend for this certification criterion to support, at a minimum, the
HIPAA Security Rule implementation specification provided at 45 CFR 164.312(e)(2)(i)
“[i]mplement security measures to ensure that electronically transmitted electronic
protected health information is not improperly modified without detection until disposed
of.” Because this certification criterion specifies a capability that Certified EHR
Technology must include, we do not believe that it is necessary or appropriate for us to
address whether hashing is applicable to public and private networks. Additionally, we
clarify that Certified EHR Technology must include the capability to check the integrity
of health information that has been received through electronic exchange. However,
similar to our approach to many adopted certification criteria, we do not specify the
instances in which this capability needs to be executed. Nevertheless, in response to
public comments we have attempted to clarify this certification criterion. We clarify that
we expect Certified EHR Technology to be capable of creating a message digest and
when in receipt of a message digest, to use the message digest to verify that the contents
of the message have not been altered. We have revised the certification criterion to
clarify our intent.
Additionally, based on these revisions in the certification criterion, we wish to
clarify the wording of the integrity standard specified at 170.210(c). The standard
currently includes the words “or higher” at the end of the standard. To provide more
certainty to the industry of our intended meaning, we are replacing those words with
more accurate terminology. We have modified the standard to read as follows: “A
hashing algorithm with a security strength equal to or greater than SHA-1 must be used to
verify that electronic health information has not been altered.” More information on
Page 112 of 228
SHA-1 and other secure hash algorithms can be found in FIPS 180-35 while more
information on the security strength of certain hashing algorithms can be found in NIST
Special Publication 800-107.6
Comments. Some commenters noted that §170.302(s)(2) refers to the use of the
adopted standard which specifies the use of hashing to detect audit log alteration or
deletion and that such a requirement is inappropriate. Other commenters recommended
that hashing should not, at the present time, be used for detecting alterations to data at
rest.
Response. We have considered these comments and agree with these commenters
that this requirement requires further clarification. We note that part of this requirement
as adopted in the Interim Final Rule (“detect … deletion of electronic health
information”) is redundant with the standard we specify for audit logs which requires that
deletions of electronic health information be recorded. For this reason, we have removed
the reference to the detection of deleted electronic health information and have opted for
a more concise requirement that alterations to audit logs be detected. In response to
public comment, we have chosen not to specify a standard for detecting alterations to
audit logs at this time.
Comment. One commenter requested clarification as to how message hashing
should work when messages are part of a multi-part transmission process, e.g., through
switches, clearinghouses, and other brokers.
Response. We expect Certified EHR Technology to be capable of generating a
hash of electronic health information and upon receipt of such information, verifying that
5 http://csrc.nist.gov/publications/fips/fips180-3/fips180-3_final.pdf
6 http://csrc.nist.gov/publications/nistpubs/800-107/NIST-SP-800-107.pdf
Page 113 of 228
it has not been altered when it has been electronically exchanged. We recognize that
certain situations may not be conducive to the use of hashes, which is why, as we noted
above, we do not specify the instances in which hashing must be used, just that Certified
EHR Technology include these capabilities.
Comment. One commenter stated that secure transmission requirements are
“inappropriate” because they do not support any meaningful use requirements.
Response. We disagree. Meaningful use requires the electronic exchange of
health information and the protection of such information. We believe that the only
practical and effective way that electronic health information can be exchanged in a
meaningful manner is if the integrity of the information can be maintained. Information
“integrity” is also one of the three pillars of securing or “protecting” electronic
information.
§170.302(t) - Authentication
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Protect electronic
health information
created or
maintained by the
certified EHR
technology through
the implementation
of appropriate
technical
capabilities
Conduct or review
a security risk
analysis per 45
CFR 164.308 (a)(1)
and implement
security updates as
necessary and
correct identified
security
deficiencies as part
of its risk
management
process
Interim Final Rule Text:
(1)Local. Verify that a person or entity seeking access to
electronic health information is the one claimed and is
authorized to access such information.
(2)Cross network. Verify that a person or entity seeking
access to electronic health information across a network is the
one claimed and is authorized to access such information in
accordance with the standard specified in §170.210(d).
Final Rule Text:
§170.302(t)
Authentication. Verify that a person or entity seeking access
to electronic health information is the one claimed and is
authorized to access such information.
Comments. One commenter expressly supported this certification criterion. A
majority of commenters expressed concerns related to §170.302(t) and the cross-
enterprise authentication standard specified at §170.210(d). Some commenters
Page 114 of 228
misinterpreted our example and stated that Security Assertion Markup Language (SAML)
should not be required or be a named standard. One commenter suggested expanding the
set of examples we provided. Other commenters requested that the standard and the
related portion of the certification criterion be removed because it was too burdensome to
implement at the present time, was overly broad, and could be subject to multiple
interpretations. Other commenters contended that there is an insufficient infrastructure to
support cross-enterprise authentication. One commenter stated that cross-enterprise
authentication would not reside in an EHR application, but rather in the network
infrastructure.
Response. We have considered the concerns issued by commenters and agree that
the burden associated with cross enterprise authentication is unnecessarily high and
cross-network authentication should not be a condition of certification at the present time.
As a result, we have removed this specific part of the certification criterion and the
associated standard.
Comment. A commenter requested clarification as to whether “user name and
password” would be sufficient to authorize a user or whether biometrics would be
required.
Response. We do not believe that it is appropriate to specify, as a condition of
certification, the types of factors that users could utilize to authenticate themselves.
§170.302(u) - Encryption
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure Certification Criterion
Protect electronic
health information
created or
maintained by the
certified EHR
Conduct or review
a security risk
analysis per 45
CFR 164.308 (a)(1)
and implement
Interim Final Rule Text:
(1) General. Encrypt and decrypt electronic health information
according to user-defined preferences in accordance with the
standard specified in §170.210(a)(1).
(2) Exchange. Encrypt and decrypt electronic health
Page 115 of 228
technology through
the implementation
of appropriate
technical
capabilities
security updates as
necessary and
correct identified
security
deficiencies as part
of its risk
management
process
information when exchanged in accordance with the standard
specified in §170.210(a)(2).
Final Rule Text:
§170.302(u)
General encryption. Encrypt and decrypt electronic health
information in accordance with the standard specified in
§170.210(a)(1), unless the Secretary determines that the use of
such algorithm would pose a significant security risk for
Certified EHR Technology.
§170.302(v)
Encryption when exchanging electronic health information.
Encrypt and decrypt electronic health information when
exchanged in accordance with the standard specified in
§170.210(a)(2).
Comments. A number of commenters stated that transmissions of health
information over leased or private network lines should not be subject to the encryption
of data in transit requirement.
Response. Certified EHR Technology must include the capability to encrypt and
decrypt information regardless of the transmission method used. This certification
criterion and related standard do not specify the circumstances under which encryption
and decryption must be performed; they simply require the capability. If an eligible
professional or eligible hospital determines that encryption is an appropriate and
necessary safeguard, we believe that Certified EHR Technology should provide the
capability to implement encryption. Overall, we want to ensure that Certified EHR
Technology is capable of assisting eligible professionals and eligible hospitals to
implement more secure technical solutions if they determine, based on their risk analysis,
that technical safeguards such as encryption are reasonable and appropriate, or required.
Comment. One commenter requested further clarification of the phrase
“encrypted and integrity protected link.” Several commenters recommended that
Transport Layer Security (TLS) ought to be specifically named as a required protocol.
Page 116 of 228
Other commenters also expressed concern that unless TLS is explicitly named, all
example protocols would be required to be supported.
Response. The example list of protocols that would meet the certification
criterion is not intended to be exhaustive or suggest that Complete EHRs or EHR
Modules must be capable of using all of the listed protocols to be certified. The example
list of protocols in the Interim Final Rule was included solely for illustrative purposes.
We have, however, consistent with the way we have restructured the regulatory text for
some standards (to better associate them with the adopted certification criterion that
reference them), modified this standard to simply express that the standard is any
encrypted and integrity protected link.
Comments. Several commenters suggested replacing the functional description of
the encryption standard with a specific reference to FIPS 140-2. These commenters also
noted that HHS had included such a reference in an update to its guidance specifying the
technologies and methodologies that render protected health information unusable,
unreadable, or indecipherable that was included in the Breach Notification for Unsecured
Protected Health Information Interim Final Rule, published on August 24, 2009 (74 FR
42740), and further, requested that we make our standard consistent with this guidance.
Some commenters explicitly recommended that AES be specified as the encryption
algorithm standard.
Response. We have considered these commenters’ points and have decided to
revise our adopted standard to be more flexible regarding the encryption algorithms we
permit EHR Technology to implement to be certified. We have also sought to clarify
how our adopted standard relates to the guidance included in the breach notification
Page 117 of 228
interim final rule. We have revised the general encryption standard to read as follows:
“Any encryption algorithm identified by the National Institute of Standards and
Technology (NIST) as an approved security function in Annex A of the Federal
Information Processing Standards (FIPS) Publication 140-2.”
The National Institute of Standards and Technology (NIST) published Federal
Information Processing Standards (FIPS) Publication 140-2 to specify the security
requirements for cryptographic modules. As part of FIPS 140-X conformance, NIST
publishes “annexes” of different “approved” security protocols. For purposes of
encryption, NIST maintains “Annex A” which identifies “approved security functions.”
Annex A identifies both symmetric and asymmetric key encryption algorithms that NIST
has identified for use in accordance with FIPS 140-2. In response to commenters’
concerns, we believe that leveraging NIST’s work in this area provides for a clearer
requirement for compliance and provides Complete EHR and EHR Module developers
with the ability to use one or more secure encryption algorithms for the purposes of
demonstrating compliance with this certification criterion. We believe this flexibility will
benefit eligible professionals and eligible hospitals because they may be able to leverage
a broader suite of secure encryption algorithms. As noted in Special Publication 800111,
which is specified in the guidance included in the breach notification interim final
rule for the encryption of data at rest, “[w]henever possible, AES should be used for the
encryption algorithm because of its strength and speed.”
We point out that the adopted certification criterion identifies certain discretionary
authority that the Secretary is retaining with respect to acceptable encryption algorithms.
We have adopted the list of approved encryption algorithms that NIST has identified and
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referenced in FIPS 140-2 Annex A, which is being incorporated by reference. While the
list is intended to be current, we anticipate that NIST will on an as-needed basis revise
and update the list, based on the development of new technologies or perhaps on
identified vulnerabilities associated with a particular algorithm. Regardless of any
revisions to this list by NIST, this version of Annex A that is incorporated by reference
will remain effective for purposes of serving as the adopted encryption standard. With
that said, if the Secretary determines that one of the listed encryption algorithms poses a
significant security risk for Certified EHR Technology, the Secretary will notify the
public on the Department’s website (and perhaps with some time delay in the Federal
Register), and will direct ONC-ATCBs or ONC-ACBs not to test and certify Complete
EHRs and EHR Modules according to the specified compromised algorithm. The
Department would then follow-up with rulemaking as necessary and appropriate to
update the adopted list of acceptable encryption algorithms.
Comments. Many commenters expressed concerns that the rule would require the
encryption of data at rest. One commenter recommended that encryption not be a
required functionality of EHR systems, but defined as limited to devices. Some
commenters stated that requiring EHR systems to be capable of encryption would hinder
adoption.
Response. We require that Certified EHR Technology must be capable of
encrypting electronic health information. We do not specify the policies surrounding the
use of encryption by an eligible professional or eligible hospital nor do we specify that it
should only apply to devices. Rather we intend for Certified EHR Technology to be
technologically capable of encryption, thereby allowing, if desired or required, an eligible
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professional or eligible hospital who adopts Certified EHR Technology to use this
capability. We disagree that requiring Certified EHR Technology be capable of
encryption would hinder adoption. To the contrary, we believe that Certified EHR
Technology capable of encrypting electronic health information will be desired,
especially in light of the new breach notification requirements established by the
HITECH Act and the Breach Notification for Unsecured Protected Health Information
Interim Final Rule. We also take this opportunity to make a technical correction to this
certification criterion. We inadvertently combined both encryption capabilities under the
same paragraph and per our reaffirmed interpretation expressed in the Temporary
Certification Program, we believe that the scope of one certification criterion starts at the
first paragraph level and includes all subparagraphs. As a result, we view these as two
distinct capabilities and have created a separate certification criterion for each.
Comments. One commenter stated that the security requirements, particularly for
encryption, are lower than the security standards it already meets. This commenter
consequently believes that our adoption of this standard would require it to reduce the
security of its products. Another commenter stated that encryption technology should not
be integrated into an EHR product, but should instead be implemented through other
means as part of the system on which an EHR may be installed.
Response. We believe that Certified EHR Technology must be capable of
performing encryption. Because of the flexibility in the adopted standard, however, how
encryption is technically implemented is up to the Complete EHR or EHR Module
developer to determine within the parameters of Annex A of FIPS 140-2. Given the
changes we have made to the general encryption standard, we believe that the full range
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of the most secure encryption algorithms are available for Complete EHR and EHR
Module developers to implement.
Comments. A few commenters stated that the term “user-defined preferences” in
the certification criteria was too vague and allowed too much latitude for divergent
interpretations of the requirement. Other commenters noted that users do not always get
to define such preferences as they would conflict with overarching organizational
policies.
Response. We intended the phrase, “according to user-defined preferences” in the
Interim Final Rule, to mean that users would have the ability to elect when they wanted
encryption to occur, for example, at log-off. We recognize that organizational policies,
software as service models and other architectures in which Certified EHR Technology
may be implemented, could lead to encryption being instituted in significantly different
ways and, as a result, we have removed the reference to “user-defined preferences.”
§170.302(v) - Accounting of disclosures
Meaningful Use Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Protect electronic health
information created or
maintained by the certified
EHR technology through the
implementation of
Conduct or review a
security risk analysis per
45 CFR 164.308 (a)(1) and
implement security updates
as necessary and correct
Interim Final Rule Text:
Record disclosures made for treatment,
payment, and health care operations in
accordance with the standard specified in
§170.210(e).
appropriate technical
capabilities
identified security
deficiencies as part of its
risk management process
Final Rule Text:
§170.302(w)
Certification criterion made optional, while the
text of this certification criterion remains
unchanged
Comments. Many commenters asserted that the certification criterion and
accompanying standard for accounting of disclosures for treatment, payment, and health
care operations (as these terms are defined at 45 CFR 164.501) would be a resource
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intensive process and too administratively, technically, and financially burdensome. A
large portion of commenters further conveyed specific challenges including: the ability to
differentiate between a “use” and a “disclosure” (as these terms are defined at 45 CFR
160.103); storing three years worth of disclosures, which many noted could be
voluminous; that health care providers, especially hospitals, have decentralized systems,
which today are manually accessed to create an accounting of disclosures; the
development time for such a capability would take more time than is available before the
meaningful use Stage 1 effective date; that it would be difficult to account for these types
of disclosures in real-time without a code set for disclosures; that this requirement could
affect workflow; and the scope of electronic exchanges that the term “disclosure” would
encompass is unclear. A majority of commenters also echoed that the Secretary should
use discretion provided by the HITECH Act to delay the compliance date for accounting
of disclosures for treatment, payment, and health care operations. Commenters supported
this suggestion by pointing out that the Secretary has not yet formally established the
policies for accounting of disclosures. They explained that the HITECH Act requires the
Secretary to promulgate a rule no later than six months after the Secretary has adopted a
standard for accounting of disclosures, which has not yet occurred. Many of these
commenters suggested that the certification criterion and standard should be removed or
their adoption delayed until after the technical specifications for accounting of
disclosures can be harmonized with the Secretary’s forthcoming promulgation of a
regulation on this issue. Other commenters noted that the HIT Policy Committee
included accounting of disclosures in its suggestions as a meaningful use Stage 3
objective. In response to the questions we posed, several commenters noted that to whom
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the disclosure was made (recipient) should be an important element included in an
accounting of disclosures. One commenter noted that the standard should be the same as
what is currently applicable to disclosures that are not for treatment, payment, and health
care operations and cited the requirements at 45 CFR 164.528(b)(2). Other commenters
stated that the adopted certification criterion should be an audit log.
Response. We appreciate the thoroughness, specificity, and detail provided by
many of those who commented on this certification criterion. We recognize that
significant technical and policy challenges remain unresolved. Accordingly, we do not
believe that the capability to account for disclosures should be a condition of certification
at the present time. As discussed in the beginning of the preamble of this final rule, we
have decided to make this certification criterion “optional” instead of removing it.
Additionally, the standard will remain unchanged as currently worded and as applicable
to the certification criterion to provide guidance to Complete EHR and EHR Module
developers that choose to adopt this capability at this time. As an optional certification
criterion, though, Complete EHR or EHR Module will not be required to possess the
capability for certification. As we stated previously in the Interim Final Rule, we plan to
work collaboratively with the Office for Civil Rights (OCR) as it develops the regulatory
policy related to this requirement. We anticipate updating this certification criterion and
the related standard in a future rulemaking to reflect OCR’s final policies regarding
accounting of disclosures.
Comment. Several commenters requested that we clarify what is meant by a
“description of the disclosure.” Some commenters noted that it would not be possible to
include these descriptions in an accounting without code sets for the various types of
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disclosures. These commenters also indicated that this requirement could have serious
workflow implications unless it can be fully automated.
Response. We recognize the technological challenges associated with effectively
and efficiently addressing this aspect of the standard which some commenters mentioned.
We also recognize that the regulated community is awaiting the proposed rule and
subsequent final rule that will implement important privacy provisions of the HITECH
Act. As we discussed in the Interim Final Rule, we intended to leave Complete EHR and
EHR Module developers with the flexibility to innovate in this area and to develop new
solutions to address the needs of their customers. We anticipated that a “description of
the disclosure” would, at the present time, be a free text field that would have included
any information that could be readily and electronically associated with the disclosure.
For example, we envisioned that some descriptive information could be included such as
the words “treatment,” “payment,” or “health care operations” separately or together as a
general category. We also assumed that Complete EHR and EHR Module developers
could find innovative ways to associate certain electronically available information with
the disclosures, such as, to whom the disclosure was made. Again, for the time being, we
have made this certification criterion optional, and will wait for OCR to promulgate final
regulations for accounting of disclosures, before revisiting whether this certification
criterion should be required.
b. Specific Certification for Complete EHRs or EHR Modules Designed for an
Ambulatory Setting - §170.304
§170.304(a) - Computerized provider order entry
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure Certification Criterion
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Use CPOE for
medication orders
directly entered by
any licensed
healthcare
professional who
can enter orders into
the medical record
per state, local and
professional
guidelines
More than 30% of
unique patients
with at least one
medication in
their medication
list seen by the EP
or admitted to the
eligible hospital’s
or CAH’s
inpatient or
emergency
department (POS
21 or 23) have at
least one
medication order
entered using
CPOE
Interim Final Rule Text:
Enable a user to electronically record, store, retrieve, and
manage, at a minimum, the following order types:
(1) Medications;
(2) Laboratory;
(3) Radiology/imaging; and
(4) Provider referrals.
Final Rule Text:
§170.304(a)
Computerized provider order entry. Enable a user to
electronically record, store, retrieve, and modify, at a
minimum, the following order types:
(1) Medications;
(2) Laboratory; and
(3) Radiology/imaging.
Comments. A couple of commenters noted that within the confines of many
hospitals, just about any “order” can be entered, so the process of order entry is defined.
For providers, the commenter noted that the ability to perform orders varies. The
commenter inquired whether a specific meaning for order entry was intended for this
certification criterion. A few commenters supported the certification criterion. One
commenter recommended that referrals to dieticians, speech therapists, child life and
social services be added to the order types, as well as durable medical equipment,
orthotics, and prosthetics. Another commenter recommended that CPOE include a
Patient Plan of Care (PPOC) because, according to the commenter, PPOC requires the
content necessary for electronic data interoperability. The commenter felt that PPOC
within an EHR would help to achieve the integration goals that promote the appropriate
exchange of medical information for the optimal coordination of patient care in different
healthcare settings. Another commenter suggested that we narrow the CPOE
requirements to focus on medications, laboratory tests, and imaging tests. One
commenter stated that based on the discussions of CPOE in the Interim Final Rule and
the Medicare and Medicaid EHR Incentive Programs proposed rule, we should consider a
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request for a consultation or a provider referral made by an eligible professional in a
private practice to constitute an order that should be handled functionally through CPOE.
Response. We agree with the commenter that suggested that we narrow our
focus, in order to reduce the burden associated with this certification criterion.
Accordingly, we have removed “provider referrals” from the certification criterion.
Complete EHR and EHR Module developers may include additional orders as they see fit
and as recommended by some commenters, however in order to be certified they must
include at a minimum the three order types (medications, laboratory, and
radiology/imaging) specified in the certification criterion. Many commenters generally
supported these three specified order types and we note that while the final meaningful
use Stage 1 objective focuses on medication orders, we believe that for the purposes of
certification and to equip eligible professionals with a basic set of ordering capabilities, it
is appropriate to continue to maintain these three order types. (This response also applies
to the change we made in the CPOE certification criterion for Complete EHRs or EHR
Modules designed for an inpatient setting). Finally, in further reviewing this certification
criterion in light of comments received, we have also determined that it would be
appropriate and clearer to replace the term “manage” with “modify” to be more
consistent with the terminology used in other certification criteria. We have also made
this change in the CPOE certification criterion for Complete EHRs and EHR Modules
designed for an inpatient setting.
Comment. A commenter stated that the lab industry does not have any standards
for order entry, and even among lab providers, their operating units utilize different
standards. The commenter contended that this lack of consistency in order entry would
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require EHRs to build custom interfaces to every lab. They recommended that we
require that Certified EHR Technology provide the ability to link the results to the
original order. Another commenter recommended that the certification criterion include
the requirement for standardized bi-directional laboratory interfaces, including
functionality pertinent to all the laboratory order data needed for the laboratory to
conduct proper testing, patient matching and billing (including limited coverage rules and
printing of Advance Beneficiary Notices (ABNs)).
Response. In the certification criterion discussed above regarding incorporating
laboratory test results, we have required that Certified EHR Technology be capable of
electronically attributing, associating, or linking a laboratory test result to a laboratory
order or patient record. Bidirectional exchange (including electronic transmission of
laboratory orders) is not a requirement of meaningful use Stage 1 and is beyond the scope
of this rule.
Comments. Several commenters recommended we clarify that the user of CPOE
includes the eligible professional and any authorized user in the office of the eligible
professional (EP). They also recommended that CPOE be deemed to include the scenario
in which only the actual orders are entered by the EP, with the additional billing and
demographic information entered by authorized users in the EP’s office or even by third
parties (e.g. laboratory personnel in the patient service center of a laboratory that collects
specimens from the patient).
Response. As we stated in an earlier response, the standards, implementation
specifications, and certification criteria adopted in this final rule apply to Complete EHRs
and EHR Modules. We have focused on whether Certified EHR Technology must
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include a capability and how it must perform the capability. As a result, it is not within
the scope of this rulemaking to specify the persons who would need to use CPOE.
Comment. A commenter suggested that we not create controlled vocabularies or
value sets in the regulation but rather refer to and adopt existing controlled vocabularies
or subsets. The commenter also stated that the regulation introduces a requirement to
record, store, retrieve and manage orders, though no vocabularies are specified and
further pointed out that there are no vocabularies or standards for orders, images, or
referrals in any part of the Interim Final Rule. The commenter recommended that the
Department focus its efforts on identifying and adopting standards for computable and
interoperable representations of these elements and processes before directing eligible
professionals to implement “CPOE.”
Response. We appreciate the commenter’s concern. This is an initial set of
standards, implementation specifications, and certification criteria and we expect to adopt
more standards, implementation specifications, and certification criteria in the future as
necessary to improve the comprehensiveness of certain capabilities.
Comment. A commenter requested that we clarify whether only imaging and
radiology reports were intended to be included in this capability, or, if we intended to
include the images themselves in addition to the imaging reports as part of the
certification criteria. The commenter recommended that we further clarify the criterion
and moreover, adopt the DICOM standard in the initial set of standards, as an essential
step in meeting the CPOE capability.
Response. We clarify that the adopted certification criteria related to CPOE
pertain only to the ordering, and not to the delivery of results (reports or images). As a
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result, we do not believe that this commenter’s recommendation is applicable to this
certification criterion.
Comment. A commenter recommended that the CPOE certification criterion
should include a prompt for an authorized user of the CPOE to include diagnosis codes at
order entry.
Response. We do not believe that it would be appropriate to specify this type of
capability as a condition of certification because it is not central to the meaningful use
objective and measure this certification criterion is intended to support.
§170.304(b) - Electronically exchange prescription information
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Generate and
transmit
permissible
prescriptions
More than 40% of
all permissible
prescriptions
written by the EP
Interim Final Rule Text:
Enable a user to electronically transmit medication orders
(prescriptions) for patients in accordance with the standards
specified in §170.205(c).
electronically
(eRx)
are transmitted
electronically
using certified
EHR technology
Final Rule Text:
§170.304(b)
Electronic prescribing. Enable a user to electronically generate
and transmit prescriptions and prescription-related information in
accordance with:
(1) The standard specified in §170.205(b)(1) or §170.205(b)(2);
and
(2) The standard specified in 170.207(d).
Comments. Many commenters supported the adoption of NCPDP SCRIPT 8.1
and the inclusion of NCPDP SCRIPT 10.6. These commenters also encouraged the
exclusive adoption of NCPDP 10.6 for meaningful use Stage 2. One commenter stated
that more clarification was needed as to which NCPDP SCRIPT standard was required
for certification.
Response. In the Interim Final Rule, we stated that we expected that CMS would
identify as a backwards compatible standard NCPDP SCRIPT 10.6 and permit its use as
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an alternative to NCPDP SCRIPT 8.1 for the electronic transmission of prescription and
certain other prescription-related information for Medicare Part D covered drugs
prescribed for Part D eligible individuals (75 FR 38026). Further, we stated that “if
SCRIPT 10.6 is permitted, prior to any modification of the provisions of this interim final
rule in response to public comment, we would expect to change our requirement to
simply permit either SCRIPT 8.1 or SCRIPT 10.6.” Accordingly, we have modified this
certification criterion to specify that Complete EHR and EHR Module developers may
seek to have their Complete EHR or EHR Module tested and certified to either solely
NCPDP SCRIPT 8.1 or 10.6. Additionally, we have also replaced the standard adopted
in the Interim Final Rule and have adopted both NCPDP SCRIPT 8.1 and NCPDP
SCRIPT 10.6. As discussed in the beginning of the preamble, we have revised our
approach to specifying the certification criteria to more clearly focus on the capabilities
with which they must be associated. Therefore, we have modified this certification
criterion to specify that a Complete EHR or EHR Module would be compliant with this
certification criterion if it has the capability of generating and transmitting prescription
and prescription-related information according to NCPDP SCRIPT 8.1 while also using
the adopted vocabulary standard, or if it is capable of generating and transmitting
prescriptions and prescription-related information according to NCPDP SCRIPT 10.6
while also using the adopted vocabulary standard.
Comments. Several commenters supported the adoption of RxNorm and the use
of RxNorm code sets as a vocabulary standard. One commenter recommended that
RxNorm be adopted in Stage 1 while one commenter stated that Stage 2 is likely the
earliest timeframe practicable for implementation. Others suggested that more testing
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was needed before RxNorm could be adopted in full. Some commenters stated that
RxNorm is not complete and requested guidance on how gaps in RxNorm will be
addressed. A couple commenters stated a concern that current drug databases do not map
to RxNorm and that in order to develop interfaces for electronic prescribing services,
pharmacies and developers will need to expend significant effort. Other commenters
stated that more clarification was needed with respect to the description of the adopted
standard and one of those commenters recommended that the description be changed to
“a drug data source provider that demonstrates group domain comprehensiveness.”
Response. We have consolidated and addressed our adopted vocabulary standard
for medications under this certification criterion. However, our response and subsequent
clarifications are applicable to all certification criteria that reference this vocabulary
standard.
As we explained in the Interim Final Rule, we determined that the HIT industry
would benefit from a certain degree of flexibility with respect to the coding of
medications. To provide this flexibility while also establishing a glide path to full
adoption of RxNorm, we adopted a standard that permits the use of one of many different
vocabulary standards. We specified that a Complete EHR or EHR Module would be
compliant with the adopted vocabulary standard if it utilized “[a]ny code set by an
RxNorm drug data source provider that is identified by the United States National
Library of Medicine as being a complete data set integrated within RxNorm.” We
specified the standard this way in order to establish what we believe is an important
bridge to full RxNorm adoption and will help facilitate this transition over time. Our
adoption of this standard stems from our belief that Complete EHRs and EHR Modules
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should be capable of classifying and categorizing medications for the purpose of clinical
quality measurement and clinical decision support. The National Library of Medicine
(NLM) maintains the Unified Medical Language System® (UMLS®), which contains the
mapping between RxNorm and commonly utilized drug vocabularies.
At the time we published the Interim Final Rule, we noted that NLM, according to
the most recent RxNorm release, listed a number of RxNorm drug data source providers
with complete data sets integrated within RxNorm. After the Interim Final Rule was
published, NLM subsequently released several more RxNorm versions. NLM has also
reorganized the RxNorm documentation in a way that we believe more clearly specifies
the intent of our standard. Accordingly, we believe that this standard, particularly in
response to public comments, can be further clarified. In addition, to permit the
development or mapping and use of other vocabularies independent of NLM, we have
dropped the requirement that NLM explicitly identify the acceptable data sources.
Instead, the standard now permits the use of codes from any drug vocabulary successfully
included in RxNorm. To provide guidance and clarification to the industry, we will
recognize any source vocabulary that is identified by NLM’s RxNorm Documentation as
a source vocabulary included in RxNorm. We are therefore revising the standard to state:
“Any source vocabulary that is included in RxNorm, a standardized nomenclature for
clinical drugs produced by the United States National Library of Medicine.” We note
that in section 3.1, of the most recent release of the “RxNorm Documentation (06/07/10,
Version 2010-3)7,” NLM has identified the following source vocabularies as being
included in RxNorm.
•
GS - Gold Standard Alchemy
7 http://www.nlm.nih.gov/research/umls/rxnorm/docs/2010/rxnorm_doco_full_2010-3.html
Page 132 of 228
•
MDDB - Medi-Span Master Drug Data Base
•
MMSL - Multum MediSource Lexicon
•
MMX - Micromedex DRUGDEX
•
MSH - Medical Subject Headings (MeSH)
•
MTHFDA - FDA National Drug Code Directory
•
MTHSPL - FDA Structured Product Labels
•
NDDF - First DataBank NDDF P
us Source Vocabulary
•
NDFRT - Veterans Health Administration National Drug File - Reference
Terminology
•
SNOMED CT - SNOMED Clinical Terms (drug information)
•
VANDF - Veterans Health Administration National Drug File
We clarify for commenters that the standard we have adopted is a functional
standard that enables the use of any source vocabulary that is included within RxNorm.
Consequently, any one of these “source vocabularies” identified by NLM may be used, or
any other source vocabulary successfully included within RxNorm.
Comments. A few commenters stated concerns about this certification criterion
causing two different workflows because of the restrictions placed on the electronic
prescribing of controlled substances.
Response. The Drug Enforcement Agency has since published an interim final
rule (75 FR 16236) on the requirements related to the electronic prescribing of controlled
substances. At the present time, we do not require as a condition of certification for
Complete EHRs and EHR Modules that they be capable of enabling compliance with the
current DEA provisions for the electronic prescribing of controlled substances.
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Comments. A couple of commenters stated that the prescribing capabilities must
allow for weight-based dosing calculation with intelligent rounding and that without this,
e-prescribing will not be helpful to pediatricians.
Response. We recognize that this is an important capability for pediatricians;
however, we do not believe that it necessary to require it as a condition of certification at
the present time. Again, this does not preclude Complete EHR and EHR Module
developers from including this capability.
Comments. A few commenters expressed concerns about some pharmacies not
being capable of receiving electronic prescriptions which they stated could cause a
negative impact on the workflow. One commenter suggested that we add a “where
possible” to the certification criterion.
Response. While we recognize that some pharmacies may be unable to receive
electronic prescriptions at the present time, we do not believe this limitation should affect
the capability that Certified EHR Technology must provide. Further, we do not believe
that inserting “where applicable” would be beneficial because it would make the criterion
unnecessarily ambiguous. This phrase would relate to when electronic prescribing should
be conducted, not how it should be done, which is the focus of this certification criterion.
Comment. A commenter stated that the electronic prescribing process should be
linked to the contraindication and formulary conflict process and should provide
automatic alerts. Another commenter recommended that information relating to the
language the patient speaks should be required as part of the electronic prescribing
process, so that pharmacy is notified of a patient’s need for language assistance.
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Response. We do not believe that it would be appropriate to expand the
certification criterion as suggested at this time. This does not preclude a Complete EHR
or EHR Module developer from pursuing other ways to optimize how a Complete EHR
or EHR Module may function.
§170.304(c) - Record demographics
Meaningful Use
Stage 1
Objective
Meaningful Use Stage
1 Measure
Certification Criterion
Record
demographics
•
preferred
language
•
gender
More than 50% of all
unique patients seen by
the EP or admitted to
the eligible hospital’s or
CAH’s inpatient or
Interim Final Rule Text:
Enable a user to electronically record, modify, and
retrieve patient demographic data including preferred
language, insurance type, gender, race, ethnicity, and date
of birth.
•
race
•
ethnicity
•
date of birth
emergency department
(POS 21 or 23) have
demographics recorded
as structured data
Final Rule Text:
§170.304(c)
Record demographics. Enable a user to electronically
record, modify, and retrieve patient demographic data
including preferred language, gender, race, ethnicity, and
date of birth. Enable race and ethnicity to be recorded in
accordance with the standard specified at 170.207(f).
Comments. Several commenters recommended that we adopt the OMB race and
ethnicity codes.
Response. We agree with these commenters and have adopted the OMB race and
ethnicity codes. In the Medicare and Medicaid EHR Incentive Programs proposed rule
(75 FR 1855), CMS stated that race and ethnicity codes should follow current Federal
standards. We note that the OMB race and ethnicity codes constitute a government-
unique standard for the purposes of the National Technology Transfer and Advancement
Act of 1995 (NTTAA). We have adopted this standard because it provides an easily
understood structure and format for electronically transmitting the data elements
identified in the meaningful use Stage 1 objective, the standard is readily available, in
general it provides the best standard to use to support our policies goals. Moreover, we
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are unaware of any alternative voluntary consensus standard that accomplishes the same
purpose.
Comments. Several commenters recommended additional elements for the
certification criterion for us to consider adding. One commenter recommended that we
include more demographic data items to allow successful matching with prior admissions
and further that we consider requiring the inclusion of social security number, birthplace,
and years of education, if available. A couple commenters requested that we add
occupation and industry status as well because they are already required for cancer
registries. Another commenter suggested that we add family history to demographics
that should be captured and reported. One commenter suggested that we also include a
patient's functional status. Many commenters suggested that we encourage self-reporting
of demographics and indicate whether information was self-reported. Finally, one
commenter stated that EHRs are not appropriate source of legal documentation for births
and deaths.
Response. While we understand commenters’ intentions, we do not believe that it
would be appropriate to expand this certification criterion beyond what is required to
support meaningful use. Again, as we have previously stated, this does not preclude a
Complete EHR or EHR Module developer from including the capability to record
additional demographic information. Finally, consistent with the Medicare and Medicaid
EHR Incentive Programs final rule, we have removed the capability to record insurance
type from the certification criterion.
§170.304(d) - Generate patient reminder list
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure Certification Criterion
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Send reminders to
patients per patient
preference for
preventive/ follow
up care
More than 20% of
all unique patients
65 years or older or
5 years old or
younger were sent
an appropriate
reminder during
the EHR reporting
period
Interim Final Rule Text:
Electronically generate, upon request, a patient reminder list
for preventive or follow-up care according to patient
preferences based on demographic data, specific conditions,
and/or medication list.
Final Rule Text:
§170.304(d)
Patient reminders. Enable a user to electronically generate a
patient reminder list for preventive or follow-up care
according to patient preferences based on, at a minimum, the
data elements included in:
(1) Problem list;
(2) Medication list;
(3) Medication allergy list;
(4) Demographics; and
(5) Laboratory test results.
Comments. Several commenters stated that they support this certification
criterion. Other commenters requested further definition of the term “specific
conditions,” particularly whether this term refers to data as contained in the problem list.
One commenter suggested that the criterion text be modified to read: “Electronically
generate, upon request, a patient reminder list for preventive or follow-up care according
to patient or physician preferences based on demographic data, specific conditions,
and/or medication list.” Several commenters requested further definition of the term
“patient preferences.” Clarification was requested about the meaning of the term, how
these preferences would be recorded, how the preferences would be used, and whether
the preferences should be automated. A question was raised by two commenters about
how many choices should be allowed for the preferred reminder delivery method due to
additional EHR system programming that may be needed to support the set of choices.
One commenter was concerned about whether there would be a cost to physician
practices to implement this requirement and whether the practices will have the capacity
to accommodate this requirement. Another commenter suggested that this requirement
be moved to meaningful use stage 2 to allow more time for EHRs to be enhanced.
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Several commenters requested clarification of the term “upon request.” One commenter
wanted to know which persons would be authorized to request the patient reminder list
and how often. Another commenter suggested that the phrase “upon request” be
removed, as it believed that outpatient physicians could make significant advances in the
health of their patients by generating and delivering reminders at every encounter.
Response. In response to comments, we have revised this certification criterion to
more clearly articulate the capability we expect Certified EHR Technology to include.
CMS discusses and clarifies the intended meaning of “patient preferences” in the
Medicare and Medicaid EHR Incentive Programs final rule and because this term is
derived from the meaningful use objective, we encourage commenters to review CMS’s
responses to their requests for clarification. Consistent with the revisions we made to the
“generate patient lists” certification criterion, we believe that Certified EHR Technology
should be able to leverage the information, specifically the structured data it had available
to it, to assist eligible professionals and eligible hospitals generate a patient reminder list.
We have removed “upon request” from the certification criterion, because, after further
review, we believe that the action of requesting a list is implied by the certification
criterion and the meaningful use measure, and therefore, unnecessary to further specify.
Comments. Two commenters stated that specialists will use patient reminders
differently than primary care providers. These commenters worried that some patients'
preferences may exceed a system's current capabilities and one commenter requested that
the phrase “with respect to system capability” be added after “patient preferences.”
Response. We understand these commenters’ points of view, however, we do not
believe that this addition is necessary given the references in the certification criterion to
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specified data elements and CMS’s express desire to consider patient preferences as
described in the Medicare and Medicaid EHR Incentive Programs final rule.
Comments. Two commenters asked whether this requirement refers to the
creation of a list for the internal purposes of the eligible professional and his/her staff
only and does not refer to or require electronic communication to a patient.
Response. Yes, we expect Certified EHR Technology to be capable of generating
a patient reminder list for an eligible professional and his/her staff. The meaningful use
measure establishes the requirement for an eligible professional to take action once the
reminder list has been generated.
Comments. Two commenters suggested that the set of variables contained in the
demographic information for the patient lists note the preferred language of the patient.
Response. Preferred language is included in demographics and we do not believe
that it is necessary to expressly call it out as part of this certification criterion.
§170.304(e) - Clinical decision support
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Implement one
clinical decision
support rule
relevant to
specialty or high
clinical priority
along with the
ability to track
compliance that
rule
Implement one
clinical decision
support rule
Interim Final Rule Text:
(1) Implement rules. Implement automated, electronic clinical
decision support rules (in addition to drug-drug and drug-
allergy contraindication checking) according to specialty or
clinical priorities that use demographic data, specific patient
diagnoses, conditions, diagnostic test results and/or patient
medication list.
(2) Alerts. Automatically and electronically generate and
indicate in real-time, alerts and care suggestions based upon
clinical decision support rules and evidence grade.
(3) Alert statistics. Automatically and electronically track,
record, and generate reports on the number of alerts responded
to by a user.
Final Rule Text:
§170.304(e)
(1) Implement rules. Implement automated, electronic clinical
decision support rules (in addition to drug-drug and drug-
allergy contraindication checking) based on the data elements
included in: problem list; medication list; demographics; and
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laboratory test results.
(2) Notifications. Automatically and electronically generate
and indicate in real-time, notifications and care suggestions
based upon clinical decision support rules.
Comments. Several commenters were explicitly supportive of this certification
criterion, while others offered specific suggestions and requests for clarification. Several
commenters requested that we specify the decisions support rules that should be included.
One commenter asked if we could clarify whether a Complete EHR or EHR Module
developer would have to include specific rules that individual eligible professionals
would want or whether those rules could be added later. Another commenter asked for
clarification regarding several terms including “diagnostic test results,” whether a
“condition” was equivalent to “problem,” as well as whether the rules would be
associated with quality measures.
Response. In consideration of commenters’ request for clarification and to more
closely align this certification criterion with the meaningful use measure, we have revised
this certification criterion. We have removed the terms that caused some confusion with
commenters and believe that these revisions will provide more specificity and will make
compliance with the certification criterion easier. Moreover, we clarify that with respect
to notifications, that “real-time” means at the point of clinical decision making (i.e.,
notifications must be provided when an eligible professional is using Certified EHR
Technology and not run overnight and provided in the morning, for instance).
Comments. A number of commenters asked questions and requested
clarifications regarding “alerts.” One commenter requested whether it is the number of
alerts that is important or the type of alerts that is important and how we expect an
eligible professional to respond to an alert. The commenter also asked if we could clarify
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what would qualify as a "response." One commenter stated that whether we intended for
the examples (pop-up or sound) to be inclusive of the types of alerts we expected
Certified EHR Technology would include and whether this was deemed more valuable
than a more passive notification. The commenter suggested that the word “alert” be
replaced with “notification” while another suggested the word “advisory.” Some
commenters requested clarification regarding “alerts responded to by a user” and whether
there was an expectation that alerts communicate structured reasons. These commenters
also asked whether users would enter a reason for any overrides or, in the case of
notifications, the user would simply acknowledge the alert by clicking “OK.” The
commenters also questioned whether ignored alerts should be tracked? Many of these
commenters recommended removing §170.304(e)(3). Alternatively, one commenter
recommended that we not only consider the number of alerts “responded to” but also the
action prompted and whether or not that action was taken.
Response. We thank commenters for the thorough feedback on this certification
criterion. We have already addressed in our responses above the concerns raised by
commenters and will not repeat them here. With respect to the third part of this
certification criterion, we have considered public comment and have decided to remove
the requirement from the certification criterion. We also removed this requirement to be
more consistent with CMS’s expectations for meaningful use, which do not include
requiring the tracking of alerts at this time.
Comments. A few commenters asked for clarification on what we meant by
"evidence grade" and what standard for evidence grading will be applied in order to
determine compliance with this objective. Other commenters noted that “evidence
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grade” as a part of the rules to trigger alerts is not widely available in the marketplace and
that using evidence grade in this manner could be burdensome and present a significant
maintenance issue.
Response. We have considered public comment, and agree that evidence grade is
not as widely available in the marketplace as we had anticipated. We therefore remove
our reference to “evidence grade” in the certification criterion.
§170.304(f) - Electronic copy of health information
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Provide patients
with an electronic
copy of their health
information
(including
diagnostic test
results, problem
list, medication
lists, medication
allergies), upon
request
More than 50% of
all patients of the
EP or the inpatient
or emergency
departments of the
eligible hospital or
CAH (POS 21 or
23) who request an
electronic copy of
their health
information are
provided it within 3
business days
Interim Final Rule Text:
Enable a user to create an electronic copy of a patient’s
clinical information, including, at a minimum, diagnostic test
results, problem list, medication list, medication allergy list,
immunizations, and procedures in:
(1) Human readable format; and
(2) On electronic media or through some other electronic
means in accordance with:
(i) One of the standards specified in §170.205(a)(1);
(ii) The standard specified in §170.205(a)(2)(i)(A), or, at a
minimum, the version of the standard specified in
§170.205(a)(2)(i)(B);
(iii) One of the standards specified in §170.205(a)(2)(ii);
(iv) At a minimum, the version of the standard specified in
§170.205(a)(2)(iii); and
(v) The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.304(f)
Electronic copy of health information. Enable a user to create
an electronic copy of a patient’s clinical information,
including, at a minimum, diagnostic test results, problem list,
medication list, and medication allergy list in:
(1) Human readable format; and
(2) On electronic media or through some other electronic
means in accordance with:
(i) The standard (and applicable implementation
specifications) specified in §170.205(a)(1) or §170.205(a)(2);
and
(ii) For the following data elements the applicable standard
must be used:
(A) Problems. The standard specified in §170.207(a)(1) or, at
a minimum, the version of the standard specified in
§170.207(a)(2);
(B)Laboratory test results. At a minimum, the version of the
standard specified in §170.207(c); and
(C) Medications. The standard specified in §170.207(d).
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Comment. A commenter recommended that durable medical equipment and
supplies be added to the minimum list.
Response. In the context of the Meaningful Use Stage 1 objective and measure,
we do not believe that it is appropriate, at the present time, to add durable medical
equipment in the certification criterion. However, that does not preclude Complete EHRs
and EHR Modules from having that additional capability.
Comments. A few commenters requested clarification as to the underlying intent
of the certification criterion and whether it was intended that a patient be provided with a
complete medical record or simply a “snapshot.” Commenters also asked how
longitudinal the copy must be and requested that we specify a time period that the
electronic copy must cover. A commenter stated that eligible professionals should be
able to limit the applicable time period by episode of care or other parameters. The
commenter noted that state law also specifies the information that can be provided to a
patient without the provider serving as an intermediary. A few commenters requested
clarification that the medication list is limited to the current medication list. A
commenter recommended that the certification criterion be limited only to information
readily available to the provider at the conclusion of a patient encounter.
Response. We expect Certified EHR Technology to be capable of generating an
electronic copy of health information that includes the minimum elements required as a
condition of certification. We do not believe that it is appropriate to dictate the
timeframe such information must encompass, but we would expect that it would include,
at a minimum, the most current information that is available and accessible within the
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Certified EHR Technology. We do not believe that limiting this certification criterion to
specify that just the information available at the end of an encounter is consistent with
our policy objectives.
Comments. Many commenters requested a definition of “diagnostic test results.”
One commenter suggested that for Stage 1, the definition of diagnostic test result be
made clear and be limited to, at a minimum, lab results.
Response. This term is derived from the Medicare and Medicaid EHR Incentive
Programs final rule, and its meaning is described there. We encourage commenters to
review the Medicare and Medicaid EHR Incentive Programs final rule.
Comments. Several commenters requested that ONC define how relevant
procedures are determined for the certification criterion. The commenters suggested that
a subset of procedures (e.g., surgeries, catheterizations) be defined to avoid generating
huge lists of “small” procedures (e.g., venipunctures). These commenters expressed that
it was critical for the rule to provide a clear, clinically-relevant definition of which types
of procedures are to be included.
Response. We appreciate the comment and have revised this certification
criterion to remove “procedures” as well as “immunizations,” to be more consistent with
the final meaningful use objective and measure and for greater clarity.
Comment. A commenter requested clarification on how an electronic copy will
be disseminated, and provided examples such as a web-portal, email, and compact disc.
Response. We do not specify the method by which an individual must receive an
electronic copy of the specified health information, only that Certified EHR Technology
be capable of electronically generating an electronic copy in human readable format and
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in accordance with one of the adopted summary record standards. While Certified EHR
Technology must be capable of creating an electronic copy of a patient’s health
information as specified in this certification criterion, we encourage Complete EHR and
EHR Module developers to also include the capability to generate an electronic copy in a
manner that allows eligible professionals (and eligible hospitals as this capability relates
to Complete EHRs and EHR Modules designed for an inpatient setting) to comply with
applicable provisions of the HIPAA Privacy and Security Rules.
Comment. A commenter requested that we add a requirement for alerts to prompt
users to ask patients if they want a copy of their health information and include the ability
to record whether the information was actually provided and the patient’s preference on
the format of the information. The commenter believed that this requirement is necessary
because many patients are not aware that they can make such a request.
Response. While potentially useful as a reminder, we do not believe that this
capability should be a condition of certification. This capability would exceed the scope
of the relevant meaningful use Stage 1 objective and measure. We also note that
Complete EHR and EHR Module developers are not precluded from including this
capability in their EHR technology.
Comment. A commenter noted that with our emphasis on the representation of
clinical information in the format of a CCD or CCR, it is unclear whether the certification
criterion is enough to meet patients’ expectations.
Response. We recognize that this minimum information may not satisfy every
patient’s interests, however, we believe that the information specified represents a core
set of information that most patients will appreciate is more readily accessible to them.
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Comment. A commenter requested clarification on the use of the word “and” in
the certification criterion and questioned whether it suggested that the Certified EHR
Technology must generate two outputs to produce an electronic copy (i.e., a copy in
human readable format and a copy as a CCD or CCR). The commenter made this inquiry
because it believed that the certification criterion could be met through the production of
a CCD or CCR with an appropriate style sheet. Additionally, a commenter stated that it
is unclear whether the electronic copy of the health information provided to patients must
be in a CCD or CCR format for Stage 1 or if alternative formats are allowed. This
commenter recommended that we clarify and distinguish between the electronic medium
carrying the information and the content enclosed.
Response. Yes, in order to meet this certification criterion, Certified EHR
Technology must be able to generate an electronic copy that is in human readable format
and as a CCD or CCR. If Certified EHR Technology is capable of generating one copy
that could meet both of these requirements, we would consider that to be a compliant
implementation of this capability.
§170.304(g) - Timely access
Meaningful Use Stage
1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Provide patients with
timely electronic
access to their health
information (including
lab results, problem
list, medication lists,
medication allergies)
within four business
days of the information
being available to the
EP
More than 10% of all unique
patients seen by the EP are
provided timely (available to
the patient within four
business days of being
updated in the certified EHR
technology) electronic access
to their health information
subject to the EP’s discretion
to withhold certain
information
Interim Final Rule Text:
Enable a user to provide patients with online
access to their clinical information, including, at
a minimum, lab test results, problem list,
medication list, medication allergy list,
immunizations, and procedures.
Final Rule Text:
§170.304(g)
Timely access. Enable a user to provide patients
with online access to their clinical information,
including, at a minimum, lab test results,
problem list, medication list, and medication
allergy list.
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Comments. Many commenters suggested that we should replace the word
“online” with “electronic” to be more clearly aligned with meaningful use and to not
preclude other forms of legitimate electronic access.
Response. We disagree. The purpose and intent of this certification criterion and
its associated meaningful use objective and measure (as clarified in the Medicare and
Medicaid EHR Incentive Programs final rule) is to ensure that patients have the ability to
access their health information when they see fit to do so. Accordingly, referring to
“electronic” in this certification criterion would not ensure that Certified EHR
Technology provides the desired capability.
Comments. A few commenters asked for clarification on the meaning of
“procedures” and type of results to be listed in the electronic copy, for example, lab test
results, problem list, medication lists, or others specified by the eligible professional.
Response. As discussed above, we have revised this certification criterion to
remove “procedures” as well as “immunizations,” to be more consistent with the final
meaningful use objective and measure.
§170.304(h) - Clinical summaries
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Provide clinical Clinical summaries Interim Final Rule Text:
summaries for provided to (1) Provision. Enable a user to provide clinical summaries to
patients for each patients for more patients for each office visit that include, at a minimum,
office visit than 50% of all
office visits within
3 business days
diagnostic test results, problem list, medication list,
medication allergy list, immunizations and procedures.
(2) Provided electronically. If the clinical summary is
provided electronically it must be:
(i) Provided in human readable format; and
(ii) On electronic media or through some other electronic
means in accordance with:
(A) One of the standards specified in §170.205(a)(1);
(B) The standard specified in §170.205(a)(2)(i)(A), or, at a
minimum, the version of the standard specified in
§170.205(a)(2)(i)(B);
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(C) One of the standards specified in §170.205(a)(2)(ii);
(D) At a minimum, the version of the standard specified in
§170.205(a)(2)(iii); and
(E) The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.304(h)
Clinical summaries. Enable a user to provide clinical
summaries to patients for each office visit that include, at a
minimum, diagnostic test results, problem list, medication list,
and medication allergy list. If the clinical summary is
provided electronically it must be:
(1) Provided in human readable format; and
(2) Provided on electronic media or through some other
electronic means in accordance with:
(i) The standard (and applicable implementation
specifications) specified in §170.205(a)(1) or §170.205(a)(2);
and
(ii) For the following data elements the applicable standard
must be used:
(A) Problems. The standard specified in §170.207(a)(1) or, at
a minimum, the version of the standard specified in
§170.207(a)(2);
(B)Laboratory test results. At a minimum, the version of the
standard specified in §170.207(c); and
(C) Medications. The standard specified in §170.207(d).
Comments. Several commenters requested that “diagnostic test results” be further
defined, with one commenter suggesting that lab results be the minimum and other
commenters suggesting a more comprehensive list, including diagnostic imaging results.
Many commenters requested clarification on the list of procedures and asked whether this
would include only procedures in a recent hospitalization or historically all procedures
performed on the patient. One commenter questioned why immunization data appeared
in the list and believed its inclusion was inconsistency with the other items.
Response. We have made revisions to this certification criterion consistent with
the changes that we have already discussed above, including the removal of certain terms.
Comment. One commenter expressed concern that patient summaries are most
useful when the patient/family literacy and the context of the health and follow-up care
are taken into consideration. The commenter noted further that as written there is little
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flexibility in this certification criterion and that many patients will be overwhelmed with
technical data that comes with little context for understanding it.
Response. We understand the commenter’s point; however, we do not believe
that certification (which will validate whether a Complete EHR or EHR Module can
perform this capability in a manner compliant with the standards adopted by the
Secretary) is the appropriate mechanism to address this commenter’s concerns.
Comment. One commenter urged that patient summaries be affirmatively offered
to the patient, without their requesting them, and that the offer be provided in their native
language with the offer documented in the EHR.
Response. We do not believe that it is within the scope of this final rule to require
eligible professionals to offer patient summaries to patients.
Comments. Several commenters requested that this rule clarify that providers
would only be responsible for the completeness and accuracy of the clinical summary to
the extent they provided or did not provide the relevant data (e.g. if another provider has
not forwarded data, they are not responsible).
Response. We do not believe that this behavior can be addressed by the
certification criterion, nor do we believe that it is within the scope of this final rule.
§170.304(i) - Exchange clinical information and patient summary record
Meaningful Use
Stage 1
Objectives
Meaningful Use
Stage 1 Measures Certification Criterion
Capability to
exchange key
clinical information
(for example,
problem list,
medication list,
medication
allergies, diagnostic
test results), among
providers of care
Performed at least
one test of certified
EHR technology's
capacity to
electronically
exchange key
clinical information
Interim Final Rule Text:
(1) Electronically receive and display. Electronically receive a
patient’s summary record, from other providers and
organizations including, at a minimum, diagnostic tests
results, problem list, medication list, medication allergy list,
immunizations, and procedures in accordance with
§170.205(a) and upon receipt of a patient summary record
formatted in an alternate standard specified in §170.205(a)(1),
display it in human readable format.
(2) Electronically transmit. Enable a user to electronically
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and patient
authorized entities
electronically
----------------------The
EP, eligible
hospital or CAH
who transitions
their patient to
another setting of
care or provider of
care or refers their
patient to another
provider of care
should provide
summary of care
record for each
transition of care or
referral
---------------------The
EP, eligible
hospital or CAH
who transitions or
refers their patient
to another setting
of care or provider
of care provides a
summary of care
record for more
than 50% of
transitions of care
and referrals
transmit a patient summary record to other providers and
organizations including, at a minimum, diagnostic test results,
problem list, medication list, medication allergy list,
immunizations, and procedures in accordance with:
(i)One of the standards specified in §170.205(a)(1);
(ii)The standard specified in §170.205(a)(2)(i)(A), or, at a
minimum, the version of the standard specified in
§170.205(a)(2)(i)(B);
(iii)One of the standards specified in §170.205(a)(2)(ii);
(iv)At a minimum, the version of the standard specified in
§170.205(a)(2)(iii); and
(v)The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.304(i)
(1) Electronically receive and display. Electronically receive
and display a patient’s summary record, from other providers
and organizations including, at a minimum, diagnostic tests
results, problem list, medication list, and medication allergy
list in accordance with the standard (and applicable
implementation specifications) specified in §170.205(a)(1) or
§170.205(a)(2). Upon receipt of a patient summary record
formatted according to the alternative standard, display it in
human readable format.
(2) Electronically transmit. Enable a user to electronically
transmit a patient summary record to other providers and
organizations including, at a minimum, diagnostic test results,
problem list, medication list, and medication allergy list in
accordance with:
(i) The standard (and applicable implementation
specifications) specified in §170.205(a)(1) or §170.205(a)(2);
and
(ii) For the following data elements the applicable standard
must be used:
(A) Problems. The standard specified in §170.207(a)(1) or, at
a minimum, the version of the standard specified in
§170.207(a)(2);
(B) Laboratory test results. At a minimum, the version of the
standard specified in §170.207(c); and
(C) Medications. The standard specified in §170.207(d).
Comments. A few commenters supported our adoption of the Continuity of Care
Record (CCR) standard for patient summary records; a couple commenters expressed no
preference; while many commenters were opposed to our adoption of CCR as an
alternate standard and did not believe that it was an appropriate selection. Several
commenters did not comment on the merits of adopting CCD and CCR but rather
expressed general concern that adopting two standards would be wasteful, counter-
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productive, confusing, time-consuming, and reduce interoperability. Of the commenters
that supported the adoption of CCR, most expressed their appreciation for the flexibility
we had provided. These commenters contended that CCR was easier to implement and
would make it easier for smaller Complete EHR and EHR Module developers to enter the
market and get certified. One commenter suggested that if we intended to keep both
CCD and CCR as adopted standards that we specify the transactions for which each
standard should apply. This commenter recommended that CCD be used for exchanging
summary records between health care providers and that CCR be used for exchanging
summary records to PHRs. Of the commenters that opposed our selection of CCR, many
of them recommended that we adopt the CCD standard as the sole standard for summary
records. These commenters principally referenced that the CCD was a harmonization of
CDA and CCR. Some commenters stated that we did not provide sufficient rationale for
adopting CCR and we had reopened a debate over the two standards that was purportedly
previously settled. Some commenters were concerned that CCR could not support
certain information, particularly, in the hospital setting. These commenters contended
that CCR could not support discharge information and that CCR cannot provide input
into clinical decision support due to the lack of a common definition of how data is
structured. Other commenters referenced that CCR is not extensible and questioned its
ability to be used for quality reporting. Several commenters recommended that, short of
adopting solely CCD, we provide clearer guidance to the industry regarding what
standard we expect to adopt for future stages of meaningful use because CCD and CCR
are not based on a common information model.
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Response. We appreciate the constructive comments and recommendations
provided by commenters. We address our adoption of the patient summary record
standards in this certification criterion because we believe that it is the most applicable
place to do so. Section 3004(b)(1) of the PHSA requires the Secretary to adopt an initial
set of standards, implementation specifications, and certification criteria. Section
3004(b)(2) of the PHSA provided the Secretary with additional flexibility in considering
what standards, implementation specifications, and certification criteria to adopt in the
initial set. Section 3004(b)(2) states that “[t]he standards, implementation specifications,
and certification criteria adopted before the date of the enactment of this title through the
process existing through the Office of the National Coordinator for Health Information
Technology may be applied towards meeting the requirement of paragraph (1).”
Accordingly, we looked at all of the standards, implementation specifications, and
certification criteria recognized by the Secretary at any point in time prior to the
enactment of the HITECH Act to determine whether they should be included in this
initial set. Contrary to some commenters statements, the CCR patient summary record
standard was in fact recognized by the Secretary in 2008 (73 FR 3976) as part of the
HITSP Consumer Empowerment Interoperability Specification (HITSP V2.1 2007 IS03).
We understand that in January, 2009, the Secretary recognized (74 FR 3604) an updated
HITSP IS03 which removed the CCR standard. We do not believe that section
3004(b)(2) precludes the Secretary from considering all possible standards that were part
of the “prior process.” To the contrary, we believe the HITECH Act provided the
Secretary with the authority and flexibility to determine which standards would be best to
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include in this initial set. Accordingly, we adopted both the CCR and CCD as patient
summary record standards.
We adopted both standards for a few reasons. First, we are aware, contrary to
some commenters’ statements, that a significant segment of the HIT industry still uses the
CCR patient summary record standard and that some health care providers prefer the
CCR over the CCD. For this reason, we did not want to mandate, at such an early stage,
that all of these early adopters adopt a different summary record standard for the purposes
of meaningful use Stage 1, given that electronic health information exchange is not
required. Second, we understand that in some circumstances the CCR is easier, faster,
and requires fewer resources to implement than the CCD. We have therefore concluded
that it was appropriate to adopt the CCR standard for patient summary records in this
initial set of standards. Finally, we believe that at the present time, each standard could
equally be used to satisfy the requirements of meaningful use Stage 1.
Comments. Numerous commenters questioned why we did not adopt the HITSP
C32 implementation specification for the CCD. These commenters requested that we
adopt the C32 implementation specification. They noted that it had been accepted by the
industry, tested and implemented in several operating environments, and was supported
by multiple EHR technology developers. A few commenters requested additional
clarification regarding our adoption of a “level 2” CCD as part of this standard and stated
that use of a level 2 CCD was inconsistent with our adoption of several adopted
vocabulary standards. These commenters questioned whether we intended to adopt a
level 3 CCD. At least one commenter recommended the removal of our reference to
levels. Another commenter stated that problem list, medication list, medication allergy
Page 153 of 228
list, procedures, etc. are commonly referred to as “sections” of the CDA or CCD
document, not "fields." They stated that sections may contain narrative text using the
CDA XML format for text, and need not contain level 3 entries; however, they believed
that in order to use the specified clinical vocabularies found in the Interim Final Rule in
an interoperable fashion, the codes from these selected vocabularies must appear in level
3 entries. Some commenters also noted this and recommended that we adopt CCD and
specify that the standard must be implemented in accordance with the HITSP C32
implementation specification, using the vocabulary standards we had adopted in the
Interim Final Rule. One commenter noted that units of measure are components of
structured entries (CDA level 3) in these sections. The commenter supported specified
clinical vocabularies and level 3 CCD because the commenter felt that level 3 would be
necessary to properly communicate the information.
Response. We have considered public comments and, in response, have made
two changes. Both are related to our adoption of the CCD standard. In the Interim Final
Rule we explicitly included a reference to “level 2” to indicate that we expected a
Complete EHR or EHR Module would be capable of generating a level 2 CCD. After
further consideration, we agree that removing “level 2” from the adopted standard will
help clarify the requirements regarding the implementation of CCD. As some
commenters pointed out, the coded data elements we expect to populate the fields of the
CCD would necessitate “level 3” entries. Thus, we have removed the reference to “level
2.” We also agree, that the HITSP C32 (version 2.5) implementation specification for
CCD would be appropriate to adopt. We understand that a majority of Complete EHR
and EHR Module developers who have implemented the CCD standard do so according
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to the HITSP C32 implementation specification, and consequently we do not believe that
this would be a significant burden. We further clarify that, for the purposes of testing and
certification, a compliant CCD implemented according to the HITSP C32 must include
the information for those entries “required” by the HITSP C32. Additionally, we note
that as specified by this certification criterion, we expect that certain health information
for which other certification criteria require to be recorded will be used to populate
certain “optional” entries specified by the HITSP C32 implementation specification (e.g.,
problems from a problem list should in most cases be available to populate the “condition
content module” section of the HITSP C32). Accordingly, we expect that the test data
used to evaluate whether a Complete EHR or EHR Module can successfully generate a
CCD according to the HITSP C32 will include the data specified in the certification
criterion to populate the “optional” entries for which we have adopted vocabulary
standards (e.g., problems). Moreover, from a consistency perspective, we expect that the
same test data referenced above, which would be used to test and certify a CCD
implemented according to the HITSP C32 would also be used to test and certify a
Complete EHR or EHR Module’s ability to populate a CCR. This principle is also
applicable to Complete EHRs and EHR Modules designed for an inpatient setting.
Comment. One commenter noted that although CVX is identified as the required
standard for interaction with state immunization registries, no standard for
“immunizations” is outlined for the clinical summary. They presumed that CVX could
be used for this purpose, but stated that CVX does not include a dose or date or reaction.
Response. Consistent with the changes we have made elsewhere in the final rule,
we have removed “immunizations” from this certification criterion.
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Comment. A commenter suggested that ONC strike the following from the
certification criteria “and upon receipt of a patient summary record formatted in an
alternate standard specified in §170.205(a)(1), display it in human readable format.”
Another commenter stated that data transport is not addressed in the standards, and the
criterion instead refers to “transmit.” The commenter suggested changing the first part of
the criterion to “display” instead of “receive,” and the second part of the criterion to
“export” instead of “transmit.”
Response. We disagree and have not made these changes. We believe that this
certification criterion expresses the capabilities we expect Certified EHR Technology will
include. Furthermore, the action of “exporting” a patient summary record does not
indicate or require that Certified EHR Technology is actually capable of transmitting a
patient summary record to Certified EHR Technology implemented by a different eligible
professional or eligible hospital.
Comment. A commenter requested clarification on how historical data from
paper records should be treated for the purpose of certification. If historical data is on
paper, the standards for display are inapplicable.
Response. Data from paper records would not be a relevant factor for the
purposes of testing and certification. We are concerned with whether Complete EHRs
and EHR Modules have implemented specific capabilities in compliance with the
certification criteria adopted by the Secretary.
Comments. A couple of commenters requested definition of “diagnostic test
result” and “procedures” in the context of this criterion.
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Response. Again, we do not believe that it is appropriate to define “diagnostic
test result” in this final rule since the term is derived from the Medicare and Medicaid
EHR Incentive Programs final rule. Consistent with other revisions we have made in the
final rule, we have removed “procedures” from the certification criterion.
Comment. At least one commenter requested that we clarify what Certified EHR
Technology needs to be capable of meeting this certification criterion. The commenter
asked whether the generation of a CCD or CCR would constitute compliance with this
criterion or would the import and human readable display of both document types be
required.
Response. We clarify that compliance with this certification criterion can be
achieved by demonstrating that the Complete EHR or EHR Module is capable of
receiving and displaying patient summary records that comply with either patient
summary record standard (and if the alternative standard is used, displaying the non-
natively implemented patient summary record standard in human readable format) and
generating and transmitting a patient summary record according to one of the patient
summary record standards populated with the specified data types and their applicable
standard(s). For example, a Complete EHR designed to generate patient summary
records in the CCD standard would need to be capable of generating and transmitting
patient summary records in accordance with CCD. Upon receipt of a patient summary
record formatted according to the CCR standard, the Complete EHR must also be capable
of displaying the CCR-formatted patient summary record in human readable format. We
clarify that we also expect that the Complete EHR designed to natively generate a CCD
would be tested and certified as being capable of properly displaying any CCD that it
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receives and have added the term “display” in the beginning of the certification criterion.
This change is also applicable to the certification criterion for Complete EHRs and EHR
Modules designed for an inpatient setting.
Comment. A commenter requested that we clarify how we intended adopted
vocabularies to be used. The commenter queried whether vocabulary standards that we
had adopted apply to EHRs or to transactions that EHRs conduct. The commenter further
requested that we clarify whether a local/proprietary medication vocabulary could be
mapped to RxNorm, and whether a local/proprietary problem list vocabulary could be
mapped to SNOMED-CT®. Finally, the commenter asked if mapping is permitted, and
if so, requested that we identify the subsets of these vocabularies that should be used.
Response. For purposes of electronically exchanging a patient summary record,
we expect the patient summary record to include health information that is coded, where
applicable, in accordance with adopted vocabulary standards. Therefore, unless
otherwise required in the context of a meaningful use objective and measure, an eligible
professional (or eligible hospital) would be permitted to map or crosswalk
local/proprietary codes to the adopted vocabulary standards prior to transmitting a patient
summary record. We do not believe that it would be appropriate to specify subsets of
adopted vocabularies at this time and would seek additional input from the HIT Standards
Committee or public comment prior to specifying vocabulary subsets.
Comment. A commenter stated that the adopted data exchange standards do not
provide for the inclusion of narrative text results, such as a radiology report, or images of
scanned paper documents. The commenter questions how meaningful use objectives will
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be achieved without these and recommends that implementation guidance be issued that
includes specific references to content or vocabulary standards.
Response. We have not adopted standards for radiology reports or images;
however, both the CCR and CCD can be used to convey narrative text and objects such
as scanned documents.
Comments. A couple of commenters requested clarification as to the testing we
expected to occur related to a Complete EHR or EHR Module’s compliance with this
certification criterion. These commenters questioned whether the generation of a CCD
and XDS (HITSP/TP13)/FTP/email of a document would meet the certification criterion
requirements.
Response. We clarify that because we have removed the adopted transport
standards, we do not require as a condition of certification that a specific transport
standard be used to transmit a generated CCD.
Comments. One commenter expressly agreed with the expectations of the
certification criterion. Another commenter stated that this functionality is crucial to
support the patient/family-centered medical home. One commenter recommended that
the Certified EHR Technology be designed so that the amount of data transmitted could
be adjusted by physicians so they do not violate the HIPAA Privacy Rule’s “minimum
necessary” requirements.
Response. We appreciate commenters’ support for this certification criterion and
agree that patient summary records serve a valuable purpose. Presently, we do not
believe that it is appropriate to require as a condition of certification a capability
associated with the HIPAA Privacy Rule’s minimum necessary requirements because
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such requirements are generally context specific and determined when a HIPAA covered
entity uses or discloses protected health information or when a HIPAA covered entity
requests protected health information from another HIPAA covered entity. We do not
preclude, however, Complete EHR and EHR Module developers from including
additional features to assist HIPAA covered entities comply with these and other HIPAA
Privacy Rule requirements.
Comment. A commenter recommended that the summary care record should
include the durable medical equipment and supplies used by the patient.
Response. Presently, the correlated meaningful use objective and measure do not
specify that a patient summary record must contain information regarding durable
medical equipment. Accordingly, we do not believe that it would be appropriate to
require this as a condition of certification.
c. Specific Certification for Complete EHRs or EHR Modules Designed for an Inpatient
Setting - §170.306
§170.306(a) - Computerized provider order entry
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Use CPOE for
medication orders
directly entered by
any licensed
healthcare
professional who
can enter orders
into the medical
record per state,
local and
professional
guidelines
More than 30% of
unique patients
with at least one
medication in their
medication list
seen by the EP or
admitted to the
eligible hospital’s
or CAH’s inpatient
or emergency
department (POS
21 or 23) have at
least one
medication order
entered using
CPOE
Interim Final Rule Text:
Enable a user to electronically record, store, retrieve, and
manage, at a minimum, the following order types:
(1) Medications;
(2) Laboratory;
(3) Radiology/imaging;
(4) Blood bank;
(5) Physical therapy;
(6) Occupational therapy;
(7) Respiratory therapy;
(8) Rehabilitation therapy;
(9) Dialysis;
(10) Provider consults; and
(11) Discharge and transfer.
Final Rule Text:
§170.306(a)
Computerized provider order entry. Enable a user to
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electronically record, store, retrieve, and modify, at a
minimum, the following order types:
(1) Medications;
(2) Laboratory; and
(3) Radiology/imaging.
A commenter recommended that we clarify what is meant by order entry because
the commenter believes that within the confines of many hospitals, just about any “order”
can be performed. A few commenters requested that “diet orders” be added to the list of
CPOE order types in order to prevent inconsistent patient care. Another commenter
recommended that speech-language pathology and audiology also be added. Two
commenters noted that the certification criterion specifies a long list of order types. The
commenters recommended that we not attempt to create an exhaustive list. One of the
commenters also noted that no information is given as to what constitutes adequate
functionality for any of the orders after the first three order types and that some, such as
“dialysis” may not be appropriate order functionality for a general EHR system for
hospitals. Both commenters recommended that we remove all orders from four through
10 and replace them with a single provision “other order types.”
Response. Consistent with the revisions we made to the CPOE certification
criterion associated with Complete EHRs and EHR Modules designed for an ambulatory
setting, we agree with those commenters who recommended that we specify a minimum
core set of orders as a condition of certification. Accordingly, we identify medication,
laboratory, and radiology/imaging as the minimum types of orders a Complete EHR or
EHR Module designed for inpatient settings must include in order to be certified. While
this certification criterion is now the same as the certification criterion for Complete
EHRs and EHR Modules designed for an ambulatory setting, we have not combined and
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moved the CPOE certification criteria to the general certification criteria section. Rather,
we have kept the certification criteria for CPOE separate because we anticipate that these
certification criteria could in the future include different requirements, specific to the
settings for which Complete EHRs and EHR Modules are developed.
Comment. A commenter repeated a question it raised with respect to CPOE for
eligible professionals. The commenter requested that we clarify whether only imaging
and radiology reports were intended to be included in this capability, or, if we intended to
include the images themselves in addition to the imaging reports as part of the
certification criteria. The commenter recommended that we further clarify the criterion
and requested that the DICOM standard be adopted in the initial set of standards, as an
essential step in meeting the CPOE capability.
Response. We refer this commenter to our previous response above regarding
this issue.
§170.306(b) - Record demographics
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Record demographics
•
preferred language
•
gender
•
race
•
ethnicity
More than 50% of
all unique patients
seen by the EP or
admitted to the
eligible hospital’s
Interim Final Rule Text:
Enable a user to electronically record, modify, and retrieve
patient demographic data including preferred language,
insurance type, gender, race, ethnicity, date of birth, and
date and cause of death in the event of mortality.
•
date of birth or CAH’s inpatient Final Rule Text:
•
date and
preliminary cause
of death in the
event of mortality
in the eligible
hospital or CAH
or emergency
department (POS
21 or 23) have
demographics
recorded as
structured data
§170.306(b)
Record demographics. Enable a user to electronically
record, modify, and retrieve patient demographic data
including preferred language, gender, race, ethnicity, date of
birth, and date and preliminary cause of death in the event
of mortality. Enable race and ethnicity to be recorded in
accordance with the standard specified at §170.207(f).
Many commenters expressed the same comments with respect to this certification
criterion as they did for the record demographics certification criterion for Complete
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EHRs and EHR Modules designed for ambulatory setting. These commenters
recommended the addition of other demographic information for additional clarity, as
discussed above.
Comment. A commenter stated that an EHR is not an appropriate source of legal
documentation for births and deaths because they indicated that it is not possible to obtain
official birth and death certificates from a provider or hospital.
Response. In concert with and following the changes made to this meaningful use
objective which are explained in more detail in the Medicare and Medicaid EHR
Incentive Programs final rule, we believe that the changes we have made to this specific
part of the certification criterion address this commenter’s concern.
§170.306(c) - Clinical decision support
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Implement one
clinical decision
support rule related
to a high priority
hospital condition
along with the
ability to track
compliance with
that rule
Implement one
clinical decision
support rule
Interim Final Rule Text:
(1) Implement rules. Implement automated, electronic clinical
decision support rules (in addition to drug-drug and drug-
allergy contraindication checking) according to a high priority
hospital condition that use demographic data, specific patient
diagnoses, conditions, diagnostic test results and/or patient
medication list.
(2) Alerts. Automatically and electronically generate and
indicate in real-time, alerts and care suggestions based upon
clinical decision support rules and evidence grade.
(3) Alert statistics. Automatically and electronically track,
record, and generate reports on the number of alerts responded
to by a user.
Final Rule Text:
§170.306(c)
(1) Implement rules. Implement automated, electronic clinical
decision support rules (in addition to drug-drug and drug-
allergy contraindication checking) based on the data elements
included in: problem list; medication list; demographics; and
laboratory test results.
(2) Notifications. Automatically and electronically generate
and indicate in real-time, notifications and care suggestions
based upon clinical decision support rules.
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This certification criterion is now exactly th
same as the certification criterion
applicable to Complete EHRs and EHR Modules designed for an ambulatory setting. As
a result, our responses and subsequent changes to the certification criterion above are also
applicable to this certification criterion. While this certification criterion is now the same
as the certification criterion for Complete EHRs and EHR Modules designed for an
ambulatory setting, we have not combined and moved the clinical decision support
certification criteria to the general certification criteria section because the focus of the
meaningful use objective is different and specific to eligible hospitals. We also believe
that it is useful to keep these certification criteria separate because we anticipate that
these certification criteria could in the future include different requirements, specific to
the settings for which Complete EHRs and EHR Modules are developed.
Comments. Some commenters requested that we clarify the meaning of high
priority hospital condition.
Response. We have removed this term, consistent with the other revisions we
made to this certification criterion.
§170.306(d) - Electronic copy of health information
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
Provide patients
with an electronic
copy of their health
information
(including
diagnostic test
results, problem
list, medication
lists, medication
allergies, discharge
summary,
procedures), upon
request
More than 50% of
all patients of the
EP or the inpatient
or emergency
departments of the
eligible hospital or
CAH (POS 21 or
23) who request an
electronic copy of
their health
information are
provided it within 3
business days
Interim Final Rule Text:
Enable a user to create an electronic copy of a patient’s
clinical information, including, at a minimum, diagnostic test
results, problem list, medication list, medication allergy list,
immunizations, procedures, and discharge summary in:
(1) Human readable format; and
(2) On electronic media or through some other electronic
means in accordance with:
(i) One of the standards specified in §170.205(a)(1);
(ii) The standard specified in §170.205(a)(2)(i)(A), or, at a
minimum, the version of the standard specified in
§170.205(a)(2)(i)(B);
(iii) One of the standards specified in §170.205(a)(2)(ii);
(iv) At a minimum, the version of the standard specified in
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§170.205(a)(2)(iii); and
(v) The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.306(d)
(1) Enable a user to create an electronic copy of a patient’s
clinical information, including, at a minimum, diagnostic test
results, problem list, medication list, medication allergy list,
and procedures:
(i) In human readable format; and
(ii) On electronic media or through some other electronic
means in accordance with:
(A) The standard (and applicable implementation
specifications) specified in §170.205(a)(1) or §170.205(a)(2);
and
(B) For the following data elements the applicable standard
must be used:
(1) Problems. The standard specified in §170.207(a)(1) or, at a
minimum, the version of the standard specified in
§170.207(a)(2);
(2) Procedures. The standard specified in §170.207(b)(1) or
§170.207(b)(2);
(3) Laboratory test results. At a minimum, the version of the
standard specified in §170.207(c); and
(4) Medications. The standard specified in §170.207(d).
(2) Enable a user to create an electronic copy of a patient’s
discharge summary in human readable format and on
electronic media or through some other electronic means.
Comment. A commenter expressed concern that requiring organizations to
provide anything on electronic media was dangerous and counterproductive to the
HITECH Act’s HIPAA Privacy and Security Rule changes. This commenter also stated
that thumb drives and CD/DVD burners are not available to staff. The commenter
recommended that we remove this certification criterion and adopt a patient portal
requirement in the next round of rulemaking.
Response. While we understand that in certain locations (e.g., areas that are
readily accessible to patients) health care professionals do not normally have access to
use certain ancillary features at their workstations, we disagree that requiring
organizations to provide patients with an electronic copy present problems related to
HITECH modifications to the HIPAA privacy and security requirements. We do not
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specify that electronic media such as thumb drives or CDs must be used. An eligible
hospital will be able to determine, consistent with its security posture, if certain electronic
media is permissible and if so, what types. It will also be able to determine the means
and location through which an electronic copy may be provided, e.g., at the records
management department or office. As the commenter suggested, a patient portal would
be an acceptable mechanism to provide an electronic copy.
Comment. A commenter stated the certification criterion for eligible hospitals
should be limited to information or tests performed during the course of a patient visit or
hospital stay and include only summary information of diagnostic test results or of
information that is clinically significant and discovered during the encounter or
admission. Other commenters requested that we clarify the reference to procedures. The
commenters asked that the regulations specify whether the EHR technology must enable
the user to create an electronic copy of procedures associated with the most recent
hospitalization, or any historical procedures, or the procedures that the patient should
follow-up to do after discharge.
Response. At a minimum, Certified EHR Technology must be capable of
generating an electronic copy of health information that includes the elements specified
by the certification criterion in an electronic copy. We do not specify the time period for
which the electronic copy must cover as a condition of certification.
Comment. A commenter requested that we consider eliminating the reference to
standards in this certification criterion for Stage 1 and focusing on human readable
formats.
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Response. We disagree, as doing so would run counter to our long term goals and
would not help build the foundation necessary for more comprehensive capabilities to be
added in the future.
Comments. A few commenters noted that neither the CCD nor CCR contain an
applicable section for discharge summary. One commenter recommended that because
the provision of an electronic copy of discharge instructions was required by another
certification criterion, that discharge instructions should be removed as an element in this
electronic copy.
Response. We reviewed commenters’ concerns and agree that there is no
applicable section for a discharge summary. Therefore, we have revised this certification
criterion to reflect that while the other data elements can be conveyed using the patient
summary record standards (CCR or CCD), we are not requiring the use of any standards
for the discharge summary section. In order to support the meaningful use objective and
measure, however, we note that we do expect Certified EHR Technology to be capable of
providing a electronic copy of a discharge summary like a patient summary record, in
human readable format and on electronic media or through some other electronic means.
Other electronic means could include, for example, the discharge summary represented as
a CCD plus the "Hospital Course" CDA section or provided as a PDF. We have revised
the certification criterion accordingly.
We note that our responses to the following comments also apply to other
certification criteria that reference procedures.
Comments. A commenter requested clarification as to what we meant by
"procedures" for hospitals, because coding for medical procedures typically occurs after
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the patient has been discharged. Another commenter requested that we further clarify the
subset of relevant procedures that should be included. The commenter explained that it
believed including CPT-4 or ICD-9 codes seemed inappropriate for clinical summaries
since these codes are used for “procedures as billed,” and the commenter further asked
whether we intended to include only major procedures.
Response. We clarify that the adopted standard pertains to the vocabulary that
would be used to express procedures, regardless of how they are selected, or included.
Comments. A commenter stated that with an X12 837 standard transaction, ICD9-
CM is accompanied by a flag that indicates whether this code is being used to bill for
services meant to eliminate a diagnosis. The commenter stated that neither the CCR nor
the CCD support such a flag, and concluded that there was no way to know whether ICD9-
CM codes used in either CCD or CCR could accurately convey a patient’s problems.
The commenter also recommended SNOMED-CT® should be used with a CCD, because
ICD-9 codes have too little clinical detail. Another commenter favored the use of
SNOMED-CT® as well and stated that SNOMED-CT® would be more clinically
accurate and better suited for our purposes. Another commenter encouraged us to adopt
the Current Dental Terminology.
Response. The diagnoses included within the patient summary record are meant
to convey clinically relevant conditions as recorded in Certified EHR Technology’s
problem list, rather than billing diagnoses. While we agree that SNOMED-CT® provides
additional clinical detail, this is often not available in current practice. Furthermore,
while its use is not precluded, we do not believe that it is necessary to adopt the Current
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Dental Terminology as a condition of certification for all Complete EHRs and EHR
Modules.
Comments. A commenter recommended against the adoption of the alternative
standard (CPT-4), unless we subsidized the cost of licensing CPT-4 as has been done for
certain other code sets. Some commenters expressed concerns about the license
requirements and one commenter stated that the license cost will likely be passed down
from the EHR developer to the eligible professional or eligible hospital. Some
commenters believed that if we intended to keep this alternative standard, we should
make it freely available.
Response. We understand that most current EHR technology already includes the
CPT-4 code-sets, and we believe that this indicates that the licensing costs are not
prohibitive. Regardless, we have adopted an alternative standard to CPT-4, SNOMEDCT
®, which is freely available.
Comment. A commenter noted that the certification criterion references
immunizations but the Medicare and Medicaid EHR Incentive Programs proposed rule
did not include immunizations in the objective. The commenter suggested that we
modify our certification criterion to match the proposed rule.
Response. We have removed this term, consistent with the previous revisions we
have made to other certification criteria above.
§170.306(e) - Electronic copy of discharge information
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure Certification Criterion
Provide patients
with an electronic
copy of their
discharge
instructions at time
More than 50% of
all patients who are
discharged from an
eligible hospital or
CAH’s inpatient
Interim Final Rule Text:
Enable a user to create an electronic copy of the discharge
instructions and procedures for a patient, in human readable
format, at the time of discharge on electronic media or
through some other electronic means.
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of discharge, upon
request
department or
emergency
Final Rule Text:
§170.306(e)
department (POS Electronic copy of discharge instructions. Enable a user to
21 or 23) and who create an electronic copy of the discharge instructions for a
request an patient, in human readable format, at the time of discharge on
electronic copy of electronic media or through some other electronic means.
their discharge
instructions are
provided it
Comment. A few commenters expressed support for this certification criterion.
Some commenters requested that we clarify the meaning of “procedures” in the context
of this certification criterion.
Response. We have revised this certification criterion to be consistent with the
changes to the meaningful use objective and measure in the Medicare and Medicaid EHR
Incentive Programs final rule, which removes the word “procedures” from the
meaningful use objective.
Comment. A commenter requested that we clarify the meaning of the phrase “at
time of discharge” and specifically, whether it means literally at the time when a patient
is discharged or more broadly, soon after the discharge occurs, in which case the
instructions could be made available to the patient, for example, through a web portal.
Response. This phrase is derived from the Medicare and Medicaid EHR
Incentive Programs final rule, and CMS has provided clarifying remarks related to this
comment.
Comment. One commenter recommended that the certification criterion include
consideration of the patient’s preferred language.
Response. Like our prior responses, we do not believe that requiring this
information is appropriate or necessary to include as a condition of certification.
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However, we do not preclude Complete EHRs and EHR Modules from being designed to
reference a patient’s preferred language.
§170.306(f) - Exchange clinical information and summary record.
Meaningful Use
Stage 1
Objectives
Meaningful Use
Stage 1 Measures
Certification Criterion
Capability to
exchange key
clinical information
(for example,
discharge
summary,
procedures,
problem list,
medication list,
medication
allergies, diagnostic
test results), among
providers of care
and patient
authorized entities
electronically
---------------------The
EP, eligible
hospital or CAH
who transitions
their patient to
another setting of
care or provider of
care or refers their
patient to another
provider of care
should provide
summary of care
record for each
transition of care or
referral
Performed at least
one test of certified
EHR technology's
capacity to
electronically
exchange key
clinical information
---------------------The
EP, eligible
hospital or CAH
who transitions or
refers their patient
to another setting
of care or provider
of care provides a
summary of care
record for more
than 50% of
transitions of care
and referrals
Interim Final Rule Text:
(1) Electronically receive and display. Electronically receive a
patient’s summary record from other providers and
organizations including, at a minimum, diagnostic test results,
problem list, medication list, medication allergy list,
immunizations, procedures, and discharge summary in
accordance with §170.205(a) and upon receipt of a patient
summary record formatted in an alternate standard specified in
§170.205(a)(1), display it in human readable format.
(2) Electronically transmit. Enable a user to electronically
transmit a patient’s summary record to other providers and
organizations including, at a minimum, diagnostic results,
problem list, medication list, medication allergy list,
immunizations, procedures, and discharge summary in
accordance with:
(i) One of the standards specified in §170.205(a)(1);
(ii) The standard specified in §170.205(a)(2)(i)(A), or, at a
minimum, the version of the standard specified in
§170.205(a)(2)(i)(B);
(iii) One of the standards specified in §170.205(a)(2)(ii);
(iv) At a minimum, the version of the standard specified in
§170.205(a)(2)(iii); and
(v) The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.306(f)
(1) Electronically receive and display. Electronically receive
and display a patient’s summary record from other providers
and organizations including, at a minimum, diagnostic test
results, problem list, medication list, medication allergy list,
and procedures in accordance with the standard (and
applicable implementation specifications) specified in
§170.205(a)(1) or §170.205(a)(2). Upon receipt of a patient
summary record formatted according to the alternative
standard, display it in human readable format.
(2) Electronically transmit. Enable a user to electronically
transmit a patient’s summary record to other providers and
organizations including, at a minimum, diagnostic results,
problem list, medication list, medication allergy list, and
procedures in accordance with:
(i) The standard (and applicable implementation
specifications) specified in §170.205(a)(1) or §170.205(a)(2);
and
(ii) For the following data elements the applicable standard
must be used:
(A) Problems. The standard specified in §170.207(a)(1) or, at
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a minimum, the version of the standard specified in
§170.207(a)(2);
(B) Procedures. The standard specified in §170.207(b)(1) or
§170.207(b)(2);
(C) Laboratory test results. At a minimum, the version of the
standard specified in §170.207(c); and
(D) Medications. The standard specified in §170.207(d).
Overall this certification criterion is very similar to the certification criterion
applicable to Complete EHRs and EHR Modules designed for an ambulatory setting. As
a result, our responses and subsequent changes to the certification criterion above are also
applicable to this certification criterion. Below are the comments that are unique to this
certification criterion.
Comment. A few commenters requested clarification on what is meant by the
term “discharge summary.” The commenter stated that neither the CCD nor the CCR has
a document section or module for a “discharge summary.” One commenter suggested
that we either define the term or remove it. At least one commenter suggested that
discharge summary be initially permitted to be an unstructured CDA instead of requiring
the use of a CCD. As an alternative, it was suggested that the CCD combined with the
"Hospital Course" CDA section be allowed to qualify as the discharge summary.
Response. As noted in one of our responses above, we recognize that neither
CCD nor CCR specifically supports the inclusion of discharge summary. In the Medicare
and Medicaid EHR Incentive Program final rule, CMS references discharge summary in
the meaningful use objective as an example of “key clinical information” but further
clarifies within the preamble of that rule that it is up to an eligible professional or eligible
hospital to determine what constitutes key clinical information. In that regard, CMS
notes that we specify the minimum set of information that Certified EHR Technology
must be capable of electronically transmitting. Given our prior statements regarding the
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ability of CCD and CCR to support the inclusion of the discharge summary and the
principle expressed by CMS that we specify a minimum set of information in the adopted
certification criterion, we believe that in this instance it is appropriate to exclude
discharge summary from the certification criterion.
§170.306(g) - Reportable lab results
Meaningful Use
Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Capability to
submit electronic
data on reportable
(as required by
state or local law)
lab results to public
health agencies and
actual submission
in accordance with
applicable law and
practice
Performed at least one test of
certified EHR technology’s
capacity to provide electronic
submission of reportable lab
results to public health agencies
and follow-up submission if the
test is successful (unless none of
the public health agencies to
which eligible hospital or CAH
submits such information have
the capacity to receive the
information electronically)
Interim Final Rule Text:
Electronically record, retrieve, and transmit
reportable clinical lab results to public health
agencies in accordance with the standard
specified in §170.205(f)(1) and, at a minimum,
the version of the standard specified in
§170.205(f)(2).
Final Rule Text:
§170.306(g)
Reportable lab results. Electronically record,
modify, retrieve, and submit reportable clinical
lab results in accordance with the standard (and
applicable implementation specifications)
specified in §170.205(c) and, at a minimum, the
version of the standard specified in
§170.207(c).
Comment. One commenter requested that we clarify the meaning of “LOINC
when LOINC codes have been received from a laboratory.” The commenter questioned
whether the information exchange for which this criterion would apply is solely exchange
within an organization or only between organizations.
Response. For a more detailed response to this request for clarification, we refer
to the relevant comments and responses relating to the “incorporate laboratory test
results” certification criterion, where we discuss this issue at length.
Comment. One commenter stated that it believed the standards we have adopted
are too general or at too high a level for vendors to be able to implement them uniformly.
This commenter suggested that we clarify when lab results should be transmitted, for
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instance upon the occurrence of particular trigger events, or in response to specific
messages, and in accordance with a reporting time table. The commenter queries, for
example, if EHR systems should use discharge as a trigger for the transmission of a
reportable condition using encounter level demographic segments, or whether EHR
systems should provide a periodic batch reporting of reportable conditions (e.g. daily or
weekly).
Response. We clarify that the certification criterion does not specify, and is not
intended to specify, the requirements for how the reports are to be triggered nor the
periodicity of the reporting requirements. As a certification criterion, it only specifies
capabilities necessary for certification.
Comment. A commenter recommended that we clarify the meaning of
“reportable” in the certification criterion.
Response. Each public health jurisdiction maintains its list of diseases or
conditions that require notification of public health authorities by law. The CDC and the
Council of State and Territorial Epidemiologists also maintain a list of nationally
notifiable conditions (www.cdc.gov/ncphi/disss/nndss/phs/infdis.htm). We reiterate, the
adoption of this certification criterion is not intended to affect applicable Federal or state
law concerning public health authority notification requirements.
Comments. Many commenters requested further specification of the data format
for transmitting information to public health agencies. Most of these comments
recommended HL7 2.5.1 version, although at least one commenter noted that HL7 2.3.1
was still being used by some public health agencies. Another commenter suggested that
either standard be allowed to accommodate for the variation in public health departments’
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ability to receive these reports. Many commenters raised the concern that the criterion
appears to place the burden of compliance on the sender. This problem could be
compounded if states and localities adopt multiple standards, which would make both
compliance and certification testing difficult and burdensome. Several commenters
raised the concern that some public health agencies are not capable of receiving
electronic data. One commenter suggested removing the language “or applicable state-
designated standard format” and directly specifying the format in the final rule. One
commenter suggested having the states agree upon a standard format. At least one
commenter requested additional clarity, suggesting that the HL7 message profile types be
specified: ORU message for public health reporting, ADT for syndromic surveillance,
and VXU for immunizations. One commenter also requested that we clarify whether
HL7 V3 constructs would be allowable.
Response. We agree with the majority of commenters, who requested greater
specificity for this certification criterion. Many of these commenters suggested adopting
implementation specifications for the adopted standard (HL7 2.5.1). In response to those
comments, and to more fully support this meaningful use objective and measure which
specify the submission of laboratory results to public health, we have decided to adopt
the HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public
Health, Release 1 (US Realm) to further constrain how HL7 2.5.1 is formatted for the
purposes of submitting laboratory test results to public health. With respect to the
comment regarding HL7 V3, we do not believe that the industry and public health
departments are currently able to support the HL7 V3 constructs on a widespread basis
and are therefore not adopting them.
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Comment. One commenter suggested adding the term “modify” to the
certification criterion, while one commenter requested clarification on the term
“retrieve.”
Response. Consistent with the changes we have made to the other certification
criterion, we have included the word “modify.”
Comments. A few commenters suggested the use of SNOMED-CT® and UCUM
for reporting.
Response. We do not believe that the industry and public health departments are
currently able to support the use of SNOMED-CT® and UCUM for reporting on a
widespread basis.
d. Adoption and Realignment of Certification Criteria to Support the Final Requirements
for Meaningful Use Stage 1.
In the Interim Final Rule, we noted that the Secretary was adopting an initial set
of standards, implementation specifications, and certification criteria to “establish the
capabilities and related standards that certified electronic health record (EHR) technology
will need to include in order to, at a minimum, support the achievement of the proposed
meaningful use Stage 1.” We also noted that the reason we routinely referred to eligible
professionals and eligible hospitals in the Interim Final Rule was “because we have
closely aligned the initial set of standards, implementation specifications, and
certification criteria adopted by this rule to focus on the capabilities that Certified EHR
Technology must be able to provide in order to support the achievement of the proposed
criteria for meaningful use Stage 1 by eligible professionals and eligible hospitals under
the Medicare and Medicaid EHR Incentive Programs.” In this regard, and as many
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commenters acknowledged and expressed in their comments, this final rule and the
Medicare and Medicaid EHR Incentive Program final rule are closely and inextricably
linked. Recognizing the unique connection between these two rules, some commenters
went so far as to issue CMS and ONC a single set of comments recommending changes
to both rules in context. Many other commenters treated both rules as almost being one
in the same, acknowledging that a change in Medicare and Medicaid EHR Incentive
Programs final rule would need to be reflected in this final rule. Other commenters
submitted comments to ONC on the Medicare and Medicaid EHR Incentive Programs
proposed rule, and to CMS on the Interim Final Rule. As we discussed previously, CMS
and ONC shared these comments between the offices and we included within our review
all comments that could be reasonably identified as comments on the Interim Final Rule.
The following three certification criteria have been adopted as part of the initial
set of certification criteria, implementation specifications, and standards in order to
realign the adopted certification criteria with the final meaningful use Stage 1
requirements and to ensure that Certified EHR Technology will provide such capabilities.
Record Advance Directives
In the Medicare and Medicaid EHR Incentive Programs proposed rule, the
Department explained that the HIT Policy Committee had recommended that eligible
hospitals “record advance directives.” Due in part to the ambiguity of the
recommendation, the Department discussed but did not include the objective “Record
Advance Directives” for the reasons explained by CMS. In its final rule, however, the
Department stated that based on comments received as well as resolution of some of the
ambiguity associated with the measure, CMS was including this objective among its
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meaningful use Stage 1 objectives. The Department noted that some commenters
reported that having this information available would allow eligible hospitals to make
decisions that were better aligned with the patient’s express wishes. The “record advance
directives” certification criterion would ensure that Certified EHR Technology enables
users to electronically record whether a patient has an advance directive, which in turn
will help ensure that a patient’s wishes are known and can be followed.
Meaningful Use
Stage 1
Objective
Meaningful Use Stage 1
Measure
Certification Criterion
Record advance
directives for
patients 65 years
old or older
More than 50% of all unique
patients 65 years old or older
admitted to the eligible
hospital’s or CAH’s inpatient
department (POS 21) have an
indication of an advance
directive status recorded
Final Rule Text:
§170.306(h)
Advance directives. Enable a user to
electronically record whether a patient has an
advance directive.
Comments. The Department received several comments that we should include
the capability to record advance directives as part of meaningful use of Certified EHR
Technology and, specifically, that it should be a requirement that pertains to eligible
hospitals. Other commenters reported that having this information available for the
patient would allow eligible hospitals to make decisions that were better aligned with the
patient’s express wishes. The HIT Policy Committee clarified that the purpose of the
meaningful use Stage 1 measure would be to indicate whether a patient has an advanced
directive. Furthermore, the committee recommended limiting this measure to patients 65
and older.
Response. We agree that the capability for a Complete EHR or EHR Module
designed for an inpatient setting should be included as a condition of certification.
Including this certification criterion in this final rule will enable eligible hospitals to meet
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a meaningful use objective they would otherwise not have been able to meet. We do not
believe that the capability we have required will be a significant burden for Complete
EHR and EHR Module developers and assume that some already have this or a similar
type of capability already built in.
Patient-Specific Education Resources
The Medicare and Medicaid EHR Incentive Programs proposed rule discussed but
did not include the objective of providing “access to patient specific education resources
upon request,” primarily because of the belief that there was a paucity of knowledge
resources integrated within EHRs that are also widely available. CMS also noted that the
ability to provide patient education resources in multiple languages might be limited. In
response to comments, the Medicare and Medicaid EHR Incentive Programs final rule
included this objective and a related measure, finding that the availability of education
resources linked to EHRs is in fact more widely available than the Department had
previously indicated in the proposed rule. The Medicare and Medicaid EHR Incentive
Programs final rule expressly requires that more than 10 percent of all unique patients
seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency
department (POS 21 or 23) during the EHR reporting period must be provided patient-
specific education resources in order to meet the related meaningful use stage 1 objective.
To support the achievement of this objective and measure, we are therefore adopting as a
certification criterion the capability of enabling a user to electronically identify and
provide patient-specific education resources that include particular types of data
elements.
Meaningful Use
Stage 1
Objective
Meaningful Use Stage 1 Measure Certification Criterion
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Use certified EHR
technology to identify
More than 10% of all unique
patients seen by the EP or admitted
Final Rule Text:
§170.302(m)
patient-specific to the eligible hospital’s or CAH’s Patient-specific education resources. Enable
education resources inpatient or emergency department a user to electronically identify and provide
and provide those (POS 21 or 23) are provided patient-specific education resources
resources to the patient-specific education according to, at a minimum, the data
patient if appropriate resources elements included in the patient’s: problem
list; medication list; and laboratory test
results; as well as provide such resources to
the patient.
Comments. The Department received many comments, including comments from
both the HIT Policy Committee and MedPAC, that this capability should be included
among the certification criteria for Certified EHR Technology, to enable eligible
professionals and eligible hospitals to achieve meaningful use. Commenters indicated
that the availability of education resources that could be linked to EHR technology is
widely available.
Response. We agree that this capability should be included as a certification
criterion for a Complete EHR or EHR Module designed for an ambulatory or inpatient
setting. Accordingly, we have included this certification criterion in the general
certification section. We clarify that we do not specify how Certified EHR Technology
must be used to provide such resources to a patient. That is, such resources could be
printed out, faxed, or emailed.
Automated Calculation of Percentage-based Meaningful Use Measures
While the Interim Final Rule only expressly provided for the calculation of BMI
and the calculation and electronic display of certain quality measures, the Department’s
operating assumption in the Interim Final Rule was that Certified EHR Technology
would provide for the automated calculation of meaningful use Stage 1 measures. The
Medicare and Medicaid EHR Incentive Programs proposed rule for instance stated that
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CMS and ONC had worked together to define certain terms, such as numerator and
denominator, for the calculation of percentages to demonstrate the successful attainment
of the meaningful use objectives. The Medicare and Medicaid EHR Incentive Programs
final rule confirmed that “the ability to calculate the measure is included in certified EHR
technology.” To make explicit the Department’s operating assumption, to confirm some
commenters’ original understanding, and to respond to other commenters’ points, we are
adopting the following certification criterion regarding the automated calculation of
percentage-based meaningful use measures.
Meaningful Use
Stage 1
Objective
Meaningful Use
Stage 1 Measure
Certification Criterion
N/A N/A Final Rule Text:
§170.302(n)
Automated measure calculation. For each meaningful use
objective with a percentage-based measure, electronically
record the numerator and denominator and generate a report
including the numerator, denominator, and resulting
percentage associated with each applicable meaningful use
measure.
Comments. The Department received several comments noting that Certified
EHR Technology should be expressly required, as a condition of certification, to
automatically calculate the meaningful use measures for which eligible professionals and
eligible hospitals would need to report percentages to CMS or States at the end of an
EHR reporting period. Some commenters explicitly noted that ONC should require the
automated calculation of certain measures as a condition of certification. Commenters
pointed out that this was already a certification requirement for clinical quality measures
and it would be inconsistent not to require automated calculation for the functionality
measures as part of certification. Many commenters expressed concerns about the
difficulties of capturing the denominators for the meaningful use measures that required
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percentage calculations. They pointed out that the formulas CMS identified for many
objectives would require providers to conduct labor-intensive counts of paper documents
such as prescriptions or laboratory results in order to compute the denominators of the
percentage based measures. Commenters also indicated that if Certified EHR
Technology did not include this capability that it would dramatically increase the burden
on potential meaningful users to demonstrate meaningful use and could potentially serve
as a factor in their decision to participate in the Medicare and Medicaid EHR incentive
programs.
Response. We agree with commenters that unless we expressly adopt a
certification criterion to specify that Certified EHR Technology must be capable of
performing percentage-based calculations for meaningful use measures that it would
present a significant burden to eligible professionals and eligible hospitals and could
deter them from participating in the Medicare and Medicaid EHR incentives programs.
Accordingly, we believe that it is critical to adopt the certification criterion specified
above. We clarify that Certified EHR Technology must be capable of calculating all
denominators for those meaningful use measures which are percentage-based and for
which CMS requires an eligible professional or eligible hospital to submit the results at
the end of an EHR reporting period. (CMS provides a detailed discussion in the
Medicare and Medicaid EHR Incentive Programs final rule on denominators.) We note
that as discussed in the Medicare and Medicaid EHR Incentive Programs final rule under
the heading “Discussion of the Burden Created by the Measures associated with the Stage
1 Meaningful Use Objectives,” an eligible professional or eligible hospital is responsible
for verifying that the denominator produced by Certified EHR Technology is complete.
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The eligible professional or eligible hospital would be expected to know whether data
had been incorrectly entered into Certified EHR Technology or whether all patient
records were included in Certified EHR Technology. For Stage 1 meaningful use
criteria, CMS identifies these measures in the table in its final rule with the headings:
“Measures with a Denominator of Unique Patients Regardless of Whether the Patient’s
Records Are Maintained Using Certified EHR Technology” and “Measures with a
Denominator of Based on Counting Actions for Patients whose Records are Maintained
Using Certified EHR Technology.” We do not require, as a condition of certification,
that a Complete EHR or EHR Module provide results for the meaningful use measures
that only require a “yes/no” attestation since these results should be readily apparent.
These measures are also identified by CMS in the table in its final rule with the heading
“Measures Requiring Only a Yes/No Attestation.” We do not believe that adoption of
this certification criterion poses a significant technical challenge. Rather, we believe that
this capability will provide Complete EHR and EHR Modules developers with a platform
from which to innovate and compete regarding, for example, the EHR products’ ease of
use.
E. Additional Comments
Comments. In response to our request for public comment, several commenters
recommended that we adopt certification criteria requiring technical capabilities to
provide greater access for people with disabilities. These commenters also pointed to a
few standards currently being used to assure accessibility, including the Web Content
Accessibility Guidelines (WCAG 2.0) and the Electronic and Information Technology
Accessibility Standards. The commenters requested that we coordinate more with the
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disability communities on accessibility and usability and how HIT will impact members
of this community. The commenters requested that we clarify the applicability of
accessibility standards and that we add technological non-discrimination as a goal to
guide future standards work.
Response. We appreciate the thorough and thoughtful comments provided related
to accessibility. We believe that HIT has the potential to provide all persons with more
efficient access to their health information. In that regard, we solicited public comment
on the issue of accessibility and certification to garner more information about available
standards and to begin a path forward that included these standards as part of the overall
standards adoption process. We reiterate what we discussed in the interim final rule
when we provided the context for our solicitation of public comment on accessibility.
“Nothing required by this interim final rule should be construed as affecting
existing legal requirements under other Federal laws. While the capabilities
provided by Certified EHR Technology may assist in the compliance with certain
legal requirements, they do not in any way remove or alter those
requirements….As another example, in providing patients with access to their
online health information, it is important to note that the accessibility
requirements of the Americans with Disabilities Act of 1990 and Section 504 of
the Rehabilitation Act of 1973 still apply to entities covered by these Federal civil
rights laws. Additionally, Title VI of the Civil Rights Act of 1964 and its
implementing regulations protect persons from unlawful discrimination on the
basis of race, color and national origin. Under Title VI and its implementing
regulations, recipients of Federal financial assistance must take reasonable steps
to ensure meaningful access to their programs, services, and activities by eligible
limited English proficient persons.”
While we have not yet adopted specific accessibility standards as a condition of
certification, we believe that the adoption of such standards in a future rulemaking would
prove beneficial, to enable all persons (including health care providers with disabilities)
to have equitable access to EHR technology and the electronic information it generates.
In the interim, we encourage Complete EHR and EHR Module developers to design their
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EHR technology with the needs of users of assistive technology in mind, and remind
eligible professionals and eligible hospitals who seek to adopt Certified EHR Technology
to review and comply with applicable legal obligations regarding accessibility. Among
the ways of designing certain capabilities with accessibility in mind, we would encourage
Complete EHR and EHR Module developers to consider implementing, for example, the
WCAG 2.08 when providing web-oriented content so that it is more accessible to persons
with disabilities. We expect the HIT Standards Committee to identify accessibility-
oriented standards9 when it issues recommendations regarding the standards that the
Secretary should adopt in future years.
Comments. Several commenters made recommendations related to standards that
we could adopt to support future stages of meaningful use. Other commenters expressed
concerns related to the “candidate Stage 2 standards” that we referenced in the Interim
Final Rule. Finally, commenters requested that Certified EHR Technology include
specific capabilities that had no relationship to meaningful use.
Response. We have reviewed these comments and appreciate the forethought
provided by commenters. Given that these suggestions were not germane to the policies
associated with the Interim Final Rule we have not considered them for the purposes of
promulgating this final rule.
F. Comments Beyond the Scope of this Final Rule
8 http://www.w3.org/TR/WCAG20/
9 As previously mentioned, there are several accessibility standards for electronic and information
technology currently in use. For example, Section 508 of the Rehabilitation Act requires Federal agencies
to ensure that electronic and information technology that they develop, procure, maintain, or use is
accessible to persons with disabilities and authorizes the Architectural and Transportation Barriers
Compliance Board (Access Board) to promulgate standards setting forth the technical and functional
performance criteria necessary to implement the requirements of Section 508. Information regarding the
Electronic and Information Technology Standards can be found on the Access Board’s website at
http://www.access-board.gov/508.htm.
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In response to the Interim Final Rule, some commenters chose to raise issues that
are beyond the scope of our proposals. We do not summarize or respond to those
comments in this final rule.
IV. Collection of Information Requirements
This final rule contains no new information collection requirements subject to
review by the OMB under the Paperwork Reduction Act (PRA).
V. Regulatory Impact Analysis
A. Introduction
We have examined the impacts of this final rule as required by Executive Order
12866 on Regulatory Planning and Review (September 30, 1993, as further amended),
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), section 202 of the Unfunded
Mandates Reform Act of 1995 (2 U.S.C. 1532) (UMRA), Executive Order 13132 on
Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic, environmental,
public health and safety effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically significant effects
($100 million or more in any one year). We have determined that this final rule is not an
economically significant rule because we estimate that the costs to prepare Complete
EHRs and EHR Modules to be tested and certified will be less than $100 million per
year. Nevertheless, because of the public interest in this final rule, we have prepared an
RIA that to the best of our ability presents the costs and benefits of the final rule.
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The RFA requires agencies to analyze options for regulatory relief of small
businesses if a rule has a significant impact on a substantial number of small entities. For
more information on Small Business Administration’s (SBA’s) size standards, see the
SBA’s website.10 We examine the burden of the final regulation in Section V.D below.
Section 202 of the UMRA also requires that agencies assess anticipated costs and
benefits before issuing any rule whose mandates require spending in any one year of
$100 million in 1995 dollars, updated annually for inflation. In 2010, that threshold is
approximately $135 million. This rule will not impose an unfunded mandate on States,
tribal government or the private sector of more than $135 million annually.
Executive Order 13132 establishes certain requirements that an agency must meet
when it promulgates a proposed rule (and subsequent final rule) that imposes substantial
direct costs of compliance on State and local governments, preempts State law, or
otherwise has Federalism implications. We do not believe that the final rule imposes
substantial direct compliance costs on State and local governments, preempts State law,
or otherwise has Federalism implications.
B. Why is this Rule Needed?
Section 3004(b)(1) of the PHSA requires the Secretary to adopt an initial set of
standards, implementation specifications, and certification criteria. On January 13, 2010,
the Secretary published in the Federal Register an interim final rule to adopt the initial set
of standards, implementation specifications, and certification criteria. This final rule has
been published to amend previously adopted standards, implementation specifications,
and certification criteria in order to realign such standards, implementation specifications,
and certification criteria with final meaningful use Stage 1 objectives and measures, and
10 http://sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf.
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to respond to public comments received. Certification criteria and associated standards
and implementation specifications will be used to test and certify Complete EHRs and
EHR Modules in order to make it possible for eligible professionals and eligible hospitals
to adopt and implement Certified EHR Technology. The use of Certified EHR
Technology is one of the requirements an eligible professional or eligible hospital needs
to meet in order to qualify for an incentive payment under the Medicare and Medicaid
EHR Incentive Programs.
C. Executive Order 12866 – Regulatory Planning and Review Analysis
1. Comment and Response
Comments. A few commenters offered opinions related to the cost estimates
included in the Interim Final Rule. One commenter disagreed with our approach. This
commenter contended that our analysis followed a simplistic, linear model that did not
account for the other potential costs that Complete EHR and EHR Module developers
and health care providers would bear. The commenter suggested that we address other
costs in our calculations including: whether a Complete EHR or EHR Module developer
has adequate resources available to modify its HIT in order to prepare for certification;
the loss of a Complete EHR or EHR Module developer’s net worth and dislocation of
jobs if it fails and goes out of business; and the resulting impacts that would occur if a
Complete EHR and EHR Module developer went out of business and left behind
customers (some or many of which could then be ineligible for Medicare and Medicaid
EHR Incentive Programs) with unsupported HIT. Another commenter questioned the
cost estimates in the Interim Final Rule, but acknowledged that it was not prepared to
offer alternative cost estimates. The commenter did state that it believed our dollar
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values seemed low and that the gap of 25%, representing previously CCHIT-certified-
EHRs that will need additional preparation to be tested and certified to the certification
criteria adopted by the Secretary, also seemed low. The commenter suggested a 40-50%
gap. The commenter also recommended that we revise our cost estimates based on the
certification criteria in the final rule to: consider costs associated with workflow redesign
within an eligible professional or eligible hospitals environment; factor in the costs for
“interoperability implementation” (no further explanation was provided); account for the
costs associated with implementing the clinical quality measures certification criterion;
account for the costs for hardware capable of supporting the adopted security
requirements; and factor in the costs for internal resources and customer resources. One
commenter noted that the cost related to dentistry EHR technology may be higher due to
what it perceived as a lack of commercially available EHR technology and that additional
costs may be incurred by dentistry EHR developers that are not as familiar as EHR
developers for other health providers with the certification criteria adopted by the
Secretary. One commenter agreed with the $10,000 to $250,000 cost range we estimated
for the per-certification-criterion preparation, while another commenter seemed to
misinterpret this estimate as being the total cost to prepare a Complete EHR or EHR
Module. This commenter offered that it could take over 2,500 hours to prepare a
Complete EHR for certification. One commenter appeared to associate the costs related
to the preparation of a Complete EHR to be tested and certified with the actual cost to be
tested and certified, but nonetheless expressed concern that we had estimated that it
would cost a Complete EHR developer whose EHR technology had not previously been
certified no less than $1.2 million to become compliant with the Interim Final Rule’s
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requirements. The commenter requested that HHS provide assistance to EHR vendors
with revenues of less than $1 million in order to help offset the costs of the certification
process.
Response. We appreciate commenters’ recommendations and suggestions related
to our cost analysis. While we understand why some commenters recommended
additional factors for us to consider as part of our analysis, we do not believe many of
those factors are relevant for two primary reasons: 1) we believe that it is improbable that
this rule will result in the outcomes speculated and their associated costs; and 2) the
factors contributing to or causing the increased costs are outside the scope of this rule
(e.g., hypothetical business failure and job loss, workflow redesign) and could not be
reasonably or accurately estimated. In this regard, we reiterate what we stated in the
Interim Final Rule related to how costs would be estimated. “This interim final rule
estimates the costs commercial vendors, open source developers, and relevant Federal
agencies will incur to prepare Complete EHRs and EHR Modules to be tested and
certified to adopted standards, implementation specifications, and certification criteria.
The Medicare and Medicaid EHR Incentive Programs proposed rule estimates the
impacts related to the actions taken by eligible professionals or eligible hospitals to
become meaningful users, including purchasing or self-developing Complete EHRs or
EHR Modules. The HIT Certification Programs proposed rule estimates the testing and
certification costs for Complete EHRs and EHR Modules.” Accordingly, we disagree
with the commenter who contended that our estimates were too simplistic and linear. We
believe that in the absence of any additional data or an alternative model (which no
Page 190 of 228
commenter provided), our assumptions are sound and our analysis is reasonable for
estimating the costs associated with complying with this final rule.
We believe that it is important to note to commenters that compliance with this
final rule is voluntary and as such, seeking to have a Complete EHR or EHR Module
certified is voluntary. A Complete EHR or EHR Module developer is not required to
comply with this final rule in order to operate its business. Rather, a Complete EHR or
EHR Module developer will need to rely upon this final rule only if it ultimately seeks to
have its EHR technology tested and certified as being compliant with the certification
criteria adopted by the Secretary. Consequently, if a Complete EHR or EHR Module
developer does not have the resources available to redesign its Complete EHR or EHR
Module to incorporate the standards and implementation specifications or meet the
certification criteria adopted in this rule, this rule does not create any new expenses for its
business. Given this clarification, we believe that our estimates represent a higher than
likely number of Complete EHR and EHR Module developers that will prepare their HIT
to be tested and certified to the certification criteria adopted by the Secretary, and thus,
the highest potential cost.
We considered whether an hourly preparation cost should replace the assumptions
we made in the Interim Final Rule, but found it difficult to determine what reasonable
low and high hour ranges would be even if we were to assume 2500 hours to be the
average. Further, for the purposes of testing this alternative approach, we assumed that it
would be reasonable for the employees of a Complete EHR or EHR Module developer
responsible for preparing a Complete EHR or EHR Module for testing and certification to
be paid equivalent to a Federal employee with a Federal Salary Classification of GS-15
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Step 1 ($59.30/hr plus 21.35/hr for benefits) given the educational and professional
experience we believe would be necessary to lead this type of activity. Multiplying the
total hourly rate by the 2500 hours yields a total preparation cost of approximately
$201,000. Thus, even if we were to assume that a high average for preparation of a
Complete EHR or EHR Module would be double what the commenter stated, it would
only represent close to $400,000 in preparation costs. Accordingly, we believe that our
estimates are in fact comparatively high and the estimate range covers a wide range of
possibilities.
In the absence of additional data or any evidence to the contrary from public
comment to guide revisions to our estimates, we are finalizing them according to the data
and assumptions we identified in the Interim Final Rule. We believe that our estimates
are sound, based on reasonable assumptions and data, and sufficiently accommodate
varying costs for different types of Complete EHR and EHR Module developers. We
believe that the additional clarity and specificity we have provided for some certification
criteria and the removal of some required capabilities would further contribute to
lowering the cost estimates for complying with this final rule. Consequently, we
anticipate actual costs will fall somewhere between the low and mid-point ranges of our
estimates rather than between the mid-point and high ranges of our estimates.
Finally, with respect to the commenter who expressed concern regarding the total
costs associated with developing a Complete EHR which had never been certified, we
note that our estimates should not be construed to imply that a Complete EHR developer
would have to spend over $1 million in order to prepare a Complete EHR. To the
contrary, had we calculated our low range for preparing a Complete EHR based on the
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absolute low we estimated for a per certification cost ($10,000), the total cost would have
only been $240,000, or one-fifth the cost we estimated in the Interim Final Rule. The
approach we took in the Interim Final Rule was designed to be inclusive of a middle
range of possibilities, but was never meant to preclude the possibility that a Complete
EHR developer could design a Complete EHR that was compliant with the certification
criteria adopted by the Secretary for less than we estimated. Also in response to the
commenter’s request, we do not believe that it would be appropriate, nor are we
authorized, to provide subsidies to Complete EHR or EHR Module developers for the
costs of the preparing a Complete EHR or EHR module for testing and certification.
2. Executive Order 12866 Final Analysis
a. Costs
This final rule adopts standards, implementation specifications, and certification
criteria and consequently establishes the capabilities that Complete EHRs or EHR
Modules will need to demonstrate in order to be certified. Our analysis focuses on the
direct effects of the provisions of this final rule – the costs incurred by Complete EHR
and EHR Module developers to prepare Complete EHRs and EHR Modules to be tested
and certified in accordance with the certification criteria adopted by the Secretary. That
is, we focus on the technological development costs necessary to include the capabilities
in a Complete EHR or EHR Module that will be compliant with the certification criteria
adopted by the Secretary. Again, as noted above, the actual cost a Complete EHR or
EHR Module developer will incur to be tested and certified is accounted for in our
certification programs final rules.
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As we noted in the Interim Final Rule, we analyzed previously developed CCHIT
ambulatory and inpatient certification criteria and believe that many of those criteria, but
not all, require the exact same capabilities as the certification criteria adopted by the
Secretary at 45 CFR 170.302, 45 CFR 170.304, and 45 CFR 170.306. Generally
speaking, we believe this overlap includes most of the clinically oriented capabilities
required by the certification criteria adopted by the Secretary. Accordingly, we believe
that a significant number of previously CCHIT-certified-EHRs will only incur moderate
costs to prepare for certification. For the purpose of estimating costs, we presume that
previously CCHIT-certified-EHRs include the functionality to meet the definition of a
Complete EHR. As a result, for our estimates in Table 1, we anticipate that these
previously CCHIT-certified-EHRs will again be prepared for certification as Complete
EHRs. We estimated in the Interim Final Rule that there were 74 CCHIT-certified-EHRs
certified to its 2008 ambulatory certification criteria and 17 CCHIT-certified-EHRs
certified to its 2007 or 2008 inpatient certification criteria.11,12,13 Of these 74 and 17
previously CCHIT-certified-EHRs, we expect that 90% will be prepared and submitted
for certification according to the certification criteria adopted by the Secretary. We do
not believe that it is realistic to assume that 100% of previously CCHIT-certified-EHRs
will be prepared for certification for a number of reasons. These reasons include: 1) a
recognition that mergers and acquisitions within the marketplace have reduced the
11 Some are marked with a conditional certification either “Pre-Market: These are conditionally certified
EHRs which are new products that are fully certified once their operational use at a physician office site
has been verified.” or “eRx Conditional: These are conditionally certified pending advanced ePrescribing
EHRs that are in the process of verifying their ability to conduct medication history, formulary and
eligibility checking through a national network for electronic-prescribing transactions.” We do not believe
that these caveats have any discernible effect on our estimates.
12 http://www.cchit.org/products/Ambulatory --when certification years 2006 and 2007 are unchecked.
While 78 EHRs are now listed, we do not believe that changing our estimate would have a measureable
effect on the overall costs.
13 http://www.cchit.org/products/Inpatient
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number of previously CCHIT-certified-EHRs; 2) that the subsequent resources needed to
market and promote Certified EHR Technology may not be available at the present time;
and 3) that some previously CCHIT-certified-EHRs will be tested and certi
ied as EHR
Modules rather than Complete EHRs. Given these assumptions, we have estimated the
number of previously CCHIT-certified-EHRs that will be prepared to be tested and
certified will be 65 and 15, ambulatory and inpatient, respectively. We also believe it is
reasonable to assume that of these 65 and 15, some will require more preparation than
others (i.e., we assume that some EHRs that were previously CCHIT-certified will
include more capabilities than what they had when CCHIT originally tested and certified
them, and they may consequently be able to more easily meet the certification criteria
adopted by the Secretary). Based on this assumption, we have created low and high
ranges for the costs to prepare previously CCHIT-certified ambulatory and inpatient
EHRs.
In creating our low and high ranges for the tables below, we assumed based on
our analysis of previously developed and required CCHIT certification criteria that
certain capabilities (e.g., the capability to maintain a medication list) will have been
widely implemented and deployed in HIT so that there will be little or no need to modify
Complete EHRs or EHR Modules for certification. We also assumed that the
certification criteria adopted by the Secretary range from relatively simple capabilities
(e.g., recording a patient’s smoking status) to more sophisticated capabilities (e.g.,
clinical decision support). As a result, we have made a general assumption that the costs
to prepare Complete EHRs and EHR Modules to be tested and certified will vary
depending on a number of factors including, but not limited to, whether the Complete
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EHR or EHR Module: 1) already includes the capability; 2) includes some aspect of the
capability which would need to be updated; 3) does not currently include the capability at
all. We believe it is reasonable to estimate that it will cost somewhere between $10,000
and $250,000 per certification criterion to prepare a Complete EHR for testing and
certification taking into account the factors identified directly above. We have used this
per certification criterion range as the basis for our low and high cost range estimates.
For the ease of our calculations, we have rounded to “40” the number of certification
criteria that the Secretary is adopting.
For Table 1 we have made the following assumptions based on our understanding
of the capabilities present in previously CCHIT-certified-EHRs: 1) in general, Complete
EHR developers who previously obtained a CCHIT certification for their EHR
technology will possess a Complete EHR that will meet approximately 75% of the
adopted certification criteria and, as a result, these Complete EHR developers may need
to make more comprehensive adjustments to their Complete EHRs in order to prepare the
Complete EHRs to be tested and certified to the remaining 25% of the certification
criteria adopted by the Secretary; 2) the average low and high per certification criterion
cost for ambulatory EHRs previously certified by CCHIT which need to be prepared for
testing and certification will be $50,000 and $150,000, respectively; and 3) the average
low and high per certification criterion cost for previously CCHIT-certified inpatient
EHRs to be prepared for testing and certification will be $75,000 and $200,000,
respectively.
Table 1. Estimated One-Time Costs for Complete EHR Developers to Prepare Previously
CCHIT-Certified-EHRs to be Tested and Certified (3-year-period) – Totals Rounded
Type Number
Prepared
One Time Cost Per
EHR ($M)
Total Cost for All EHRs over 3-year
Period ($M)
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for
Certification Low High
Midpoint
Low High Mid-point
2008
Ambulatory
CCHIT-
Certified-
EHR 65 $0.50 $1.5 $1.0 $32.5 $97.5 $65.0
2007/2008
Inpatient
CCHIT-
Certified-
EHR 15 $0.75 $2.0 $1.38 $11.25 $30.0 $20.63
Total 80 $43.75 $127.50 $85.63
The second type of cost we estimate includes the costs that we expect for CCHIT-
certified ambulatory EHRs certified prior to 2008 (“out-of-date CCHIT-Certified-EHRs”)
and never previously CCHIT-certified-EHRs to be prepared to be tested and certified as
Complete EHRs rather than as EHR Modules.14 We assume the EHR technology that
falls into this category may require more extensive changes than previously CCHITcertified-
EHRs identified in Table 1. Again, we have estimated low and high preparation
cost ranges. We assume that there will be very little growth in the Complete EHR market
due to the market share15 represented by the previously CCHIT-certified-EHRs included
in Table 1 and the upfront costs required to bring a Complete EHR to market. As a
result, we expect there to be 8 and 5 Complete EHRs (for use by eligible professionals
and eligible hospitals, respectively) prepared to be tested and certified to all of the
applicable certification criteria adopted by the Secretary.16
14 CCHIT began testing and certifying inpatient EHRs in 2007 and we assume that all of those EHRs are
included in Table 1 which is why they are not included in this discussion.
15 http://www.cchit.org/about --“...EHR products certified by mid-2009, representing over 75% of the
marketplace.”
16 This estimate is premised in part on the fact that IHS’s RPMS EHR was not included in Table 1 and that
it will be preparing the RPMS EHR as a Complete EHR to meet the applicable certification criteria adopted
by the Secretary for both ambulatory and inpatient settings.
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Again, using our general assumptions discussed above (40 certification criteria
and a low and high range of $10,000 to $250,000 per certification criterion) we have
made the following additional assumptions in our Table 2 calculations based on our
understanding of the capabilities currently present in these EHR technologies: 1) in
general, Complete EHR developers who have out-of-date CCHIT-Certified-EHRs or who
never previously had their Complete EHRs certified by CCHIT will possess Complete
EHRs that will meet approximately 40% of the adopted certification criteria and, as a
result, these Complete EHR developers may need to make more comprehensive
adjustments to their Complete EHRs in order to prepare the Complete EHRs to be tested
and certified to the remaining 60% of the certification criteria adopted by the Secretary;
2) the average low and high per certification criterion costs for Complete EHRs for
eligible professionals to be prepared to be tested and certified will be $50,000 and
$150,000, respectively; and 3) the average low and high per certification criterion costs
for Complete EHRs for eligible hospitals to be prepared to be tested and certified will be
$75,000 and $200,000, respectively.
Table 2. Estimated One-Time Costs for Complete EHR Developers to Prepare Never CCHITCertified-
EHRs and Out-of-Date CCHIT-Certified-EHRs to be Tested and Certified (3 year
period) – Totals Rounded
Type
Number
Prepared for
Certification
One Time Cost Per
EHR ($M)
Total Cost for All EHRs over 3-year
Period ($M)
Low High
Midpoint
Low High Mid-point
Complete
EHRs for
Eligible
Professionals 8 $1.2 $3.6 $2.4 $9.6 $28.8 $19.2
Complete
EHRs for
Eligible
Hospitals 5 $1.8 $4.8 $3.3 $9.0 $24.0 $16.5
Total 13 $18.60 $52.80 $35.70
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Finally, the third type of cost we estimate relates to the number of EHR Modules
we expect to be prepared to be tested and certified and the costs associated with that
preparation. We clarify as noted in the Temporary Certification Program final rule that
these EHR Modules are not “self-developed,” and we assume that an EHR Module
developer interested in commercially marketing its EHR Module to eligible professionals
and eligible hospitals would develop them. We assumed in the Interim Final Rule that
certain types of EHR Modules (e.g., computerized provider order entry; quality reporting;
online patient portals) would be more likely than others to be prepared to be tested and
certified, and we estimated based on our assumption that there would be 7 EHR Modules
prepared to be tested and certified for each of the 7 types of EHR Modules we identified.
This estimate (number of modules X types of modules) resulted in an approximate
number of 50 EHR Modules that would be prepared to be tested and certified. Again, we
have provided low and high preparation cost estimates in Table 3 below. We assume that
some of EHR Modules prepared for certification will be capable of meeting applicable
certification criteria with little modification while other EHR Modules will not. Given
the potential differences in preparation costs and combinations of certification criteria to
create EHR Modules, we believe it is reasonable to estimate a wide range of costs for
preparing these types of EHR Modules for testing and certification. We estimated in the
Interim Final Rule and reiterate below a low average one-time cost of $100,000 to
prepare an EHR Module, based on the assumption that some of the less sophisticated
EHR Modules would only be prepared to be tested and certified to 1 or 2 certification
criteria. We estimated in the Interim Final Rule and reiterate below, a high average cost
one-time cost of $500,000 to prepare an EHR Module, based on the assumption that some
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of the more sophisticated EHR Modules would only be prepared to be tested and certified
to 1 or 2 of the more complicated certification criteria or would be prepared to be tested
and certified to multiple certification criteria.
Table 3. Estimated One-Time Costs to EHR Module Developers to Prepare EHR Modules to be
Tested and Certified (3 year period) – Totals Rounded
Type
Number
Prepared
One Time Cost Per EHR
Module ($M)
Total Cost All EHR Modules over 3year
Period ($M)
Low High
Midpoint
Low High Mid-point
EHR
Modules 50 $0.1 $0.5 $0.3 $5.0 $25.0 $15.0
Total 50 $5.0 $25.0 $15.0
In total, if we were to distribute the costs to prepare Complete EHRs and EHR
Modules between 2010 and 2012 evenly per year, we believe they would likely be in the
range of $67.35 to $205.3 million or $22.45 to $68.43 million per year with an annual
cost mid-point of approximately $45.44 million. However, we do not believe that the
costs will be spread evenly over these three years due to market pressures and the fact
that higher upfront incentive payments are available under the Medicare and Medicaid
EHR Incentive Programs. We assume this factor will motivate a greater ratio of
commercial vendors and open source developers of Complete EHRs and EHR Modules
to prepare such technology for testing and certification in 2010 and 2011 rather than
2012. As a result, we believe as represented in Table 4 that the costs attributable to this
final rule will be distributed as follows: 45% for 2010, 40% for 2011 and 15% for 2012.
Table 6. Distributed Total Preparation Costs for Complete EHR and EHR Module
Developers (3 year period) – Totals Rounded
Year Ratio
Total Low
Cost Estimate
($M)
Total High
Cost Estimate
($M)
Total Average
Cost Estimate
($M)
2010 45% $30.31 $92.39 $61.35
2011 40% $26.94 $82.12 $54.53
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2012 15% $10.10 $30.80 $20.45
3-Year Totals $67.35 $205.3 $136.33
Note that these cost estimates do not include additional costs to prepare for testing
and certification that will likely be incurred when we adopt additional standards,
implementation specifications, and certification criteria to support meaningful use Stages
2 and 3. We will account for costs associated with these additional standards,
implementation specifications, and certification criteria in future rulemaking.
b. Benefits
We believe that there will be several benefits arising from this final rule. By
adopting the revisions to this initial set, the Secretary will set in motion what we believe
will be an iterative process to further enhance the interoperability, functionality, utility,
and security of health information technology and to support the meaningful use of
Certified EHR Technology. The capabilities specified in the adopted certification criteria
will help ensure that health care providers have the necessary information technology
tools to improve patient care, reduce medical errors and unnecessary tests. The standards
adopted will aid in fostering greater interoperability. We also believe that this final rule
will serve as a catalyst for a more competitive and innovative marketplace. Finally,
adopted certification criteria can be used by Complete EHR and EHR Module developers
as technical requirements to ensure that their HIT can be tested and certified and
subsequently adopted and implemented as Certified EHR Technology. Adopting these
certification criteria will also ultimately help enable eligible professionals and eligible
hospitals to qualify for incentive payments under Medicare and Medicaid EHR Incentive
Programs.
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D. Regulatory Flexibility Act Analysis
1. Comment and Response
Comment. Some commenters noted that we incorrectly referenced the proportion
of businesses in the marketplace that would qualify as small businesses under the SBA’s
size standard. The commenters cited a presentation by CCHIT which indicated that
potentially up to 75% of Complete EHR developers who design Complete EHRs for
ambulatory settings would qualify as small businesses.
Response. We appreciate commenters pointing out this additional information.
We have revised the discussion accordingly in the final RFA analysis. However, we do
not believe that this additional information substantially changes our analysis. We do not
believe that any relief can be provided to small businesses under the SBA size standard
that would not undercut our programmatic goals and objectives. A Complete EHR or
EHR Module developer will need to design a Complete EHR or EHR Module that can be
tested and successfully certified to all applicable certification criteria adopted by the
Secretary in order for the Complete EHR or EHR Module to attain certification.
Accordingly, we see no viable alternatives to reducing the requirements in the final rule
or providing for alternatives to adopted certification criteria. Additionally, we believe
that the regulation builds in a certain amount of flexibility already in that a small business
without the resources available to develop a Complete EHR has the option to develop an
EHR Module which will presumably require less of an investment (time and money) to
develop.
2. Final RFA Analysis
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The RFA requires agencies to analyze options for regulatory relief of small
businesses if a rule has a significant impact on a substantial number of small entities.
While Complete EHRs and EHR Module developers represent a small segment of
the overall information technology industry, we believe that the entities impacted by this
final rule most likely fall under the North American Industry Classification System
(NAICS) code 541511 “Custom Computer Programming Services” specified at 13 CFR
121.201 where the SBA publishes “Small Business Size Standards by NAICS Industry.”
The size standard associated with this NAICS code is set at $25 million in annual
receipts17 which “indicates the maximum allowed for a concern and its affiliates to be
considered small entities.”
Based on our analysis, we believe that there is enough data generally available to
establish that between 75% and 90% of entities that are categorized under the NAICS
code 541511 are under the SBA size standard, but note that the available data does not
show how many of these entities will develop a Complete EHR or EHR Module. We
also note that with the exception of aggregate business information available through the
U.S. Census Bureau and the SBA related to NAICS code 541511, it appears that many
Complete EHR and EHR Module developers are privately held or owned and do not
regularly, if at all, make their specific annual receipts publicly available. As a result, it is
difficult to locate empirical data related to many of the Complete EHR and EHR Module
developers to correlate to the SBA size standard.
17 The SBA references that annual receipts means “total income” (or in the case of a sole proprietorship,
“gross income”) plus “cost of goods sold” as these terms are defined and reported on Internal Revenue
Service tax return forms.
http://www.sba.gov/idc/groups/public/documents/sba_homepage/guide_to_size_standards.pdf
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We estimate that this final rule could have effects on Complete EHR and EHR
Module developers, some of which may be small entities. However, we believe that we
have established the minimum amount of requirements necessary to accomplish our
policy goals and that no appropriate regulatory alternatives could be developed to lessen
the compliance burden associated with this final rule. In order for a Complete EHR or
EHR Module to provide the capabilities an eligible professional or eligible hospital will
be required to use under the Medicare and Medicaid EHR Incentive Programs final rule,
it will need to comply with the applicable certification criteria adopted by the Secretary.
Moreover, we note that this final rule does not impose the costs cited in the regulatory
impact analysis as compliance costs, but rather as investments which Complete EHR and
EHR Module developers voluntarily take on and expect to recover with an appropriate
rate of return. Accordingly, we do not believe that the final rule will create a significant
impact on a substantial number of small entities. The Secretary certifies that this final
rule will not have a significant impact on a substantial number of small entities.
E. Executive Order 13132--Federalism
Executive Order 13132 establishes certain requirements that an agency must meet
when it promulgates a proposed rule (and subsequent final rule) that imposes substantial
direct requirement costs on State and local governments, preempts State law, or otherwise
has federalism implications.
Nothing in this final rule imposes substantial direct compliance costs on State and
local governments, preempts State law or otherwise has federalism implications. We are
not aware of any State laws or regulations that are contradicted or impeded by any of the
standards, implementation specifications, or certification criteria that have been adopted.
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The Office of Management and Budget reviewed this final rule.
List of Subjects
45 CFR Part 170
Computer technology, Electronic health record, Electronic information system,
Electronic transactions, Health, Health care, Health information technology, Health
insurance, Health records, Hospitals, Incorporation by reference, Laboratories, Medicaid,
Medicare, Privacy, Reporting and recordkeeping requirements, Public health, Security.
.
For the reasons set forth in the preamble, 45 CFR subtitle A, subchapter D, part 170, is
amended as follows:
PART 170 – HEALTH INFORMATION TECHNOLOGY STANDARDS,
IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA
AND CERTIFICATION PROGRAMS FOR HEALTH INFORMATION
TECHNOLOGY
.
1. The authority citation for part 170 continues to read as follows:
Authority: 42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 5 U.S.C. 552.
.
2. Amend §170.102 by revising the definitions of “Complete EHR,” “Certified EHR
Technology,” and “Disclosure” and adding the definition of “Human readable format”
to read as follows:
§170.102 Definitions.
* * * * *
Certified EHR Technology means:
(1) A Complete EHR that meets the requirements included in the definition of a Qualified
EHR and has been tested and certified in accordance with the certification program
established by the National Coordinator as having met all applicable certification criteria
adopted by the Secretary; or
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(2) A combination of EHR Modules in which each constituent EHR Module of the
combination has been tested and certified in accordance with the certification program
established by the National Coordinator as having met all applicable certification criteria
adopted by the Secretary, and the resultant combination also meets the requirements
included in the definition of a Qualified EHR.
Complete EHR means EHR technology that has been developed to meet, at a minimum,
all applicable certification criteria adopted by the Secretary.
Disclosure is defined as it is in 45 CFR 160.103.
* * * * *
Human readable format means a format that enables a human to read and easily
comprehend the information presented to him or her regardless of the method of
presentation.
* * * * *
.
3. Revise subpart B to read as follows:
Subpart B—Standards and Implementation Specifications for Health Information
Technology
Sec.
170.200 Applicability.
170.202 [Reserved]
170.205 Content exchange standards and implementation specifications for exchanging
electronic health information.
170.207 Vocabulary standards for representing electronic health information.
170.210 Standards for health information technology to protect electronic health
information created, maintained, and exchanged.
170.299 Incorporation by reference.
§170.200 Applicability.
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The standards and implementation specifications adopted in this part apply with respect
to Complete EHRs and EHR Modules.
§170.202 [Reserved]
§170.205 Content exchange standards and implementation specifications for
exchanging electronic health information.
The Secretary adopts the following content exchange standards and associated
implementation specifications:
(a) Patient summary record. (1) Standard.
Health Level Seven Clinical Document
Architecture (CDA) Release 2, Continuity of Care Document (CCD) (incorporated by
reference in §170.299). Implementation specifications. The Healthcare Information
Technology Standards Panel (HITSP) Summary Documents Using HL7 CCD
Component HITSP/C32 (incorporated by reference in §170.299).
(2) Standard. ASTM E2369 Standard Specification for Continuity of Care Record and
Adjunct to ASTM E2369 (incorporated by reference in §170.299).
(b) Electronic prescribing. (1) Standard. The National Council for the Prescription Drug
Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT standard,
Implementation Guide, Version 8, Release 1 (Version 8.1) October 2005
(incorporated by reference in §170.299)
(2) Standard. NCPDP SCRIPT Standard, Implementation Guide, Version 10.6
(incorporated by reference in §170.299).
(c) Electronic submission of lab results to public health agencies. Standard. HL7 2.5.1
(incorporated by reference in §170.299). Implementation specifications. HL7
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Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public
Health, Release 1 (US Realm) (incorporated by reference in §170.299).
(d) Electronic submission to public health agencies for surveillance or reporting. (1)
Standard. HL7 2.3.1(incorporated by reference in §170.299).
(2) Standard. HL7 2.5.1(incorporated by reference in §170.299). Implementation
specifications. Public Health Information Network HL7 Version 2.5 Message
Structure Specification for National Condition Reporting Final Version 1.0 and Errata
and Clarifications National Notification Message Structural Specification
(incorporated by reference in §170.299).
(e) Electronic submission to immunization registries. (1) Standard. HL7 2.3.1
(incorporated by reference in §170.299). Implementation specifications.
Implementation Guide for Immunization Data Transactions using Version 2.3.1 of the
Health Level Seven (HL7) Standard Protocol Implementation Guide Version 2.2
(incorporated by reference in §170.299).
(2) Standard. HL7 2.5.1 (incorporated by reference in §170.299). Implementation
specifications. HL7 2.5.1 Implementation Guide for Immunization Messaging
Release 1.0 (incorporated by reference in §170.299).
(f) Quality reporting.
Standard. The CMS Physician Quality Reporting Initiative (PQRI)
2009 Registry XML Specification (incorporated by reference in §170.299).
Implementation specifications. Physician Quality Reporting Initiative Measure
Specifications Manual for Claims and Registry (incorporated by reference in
§170.299).
§170.207 Vocabulary standards for representing electronic health information.
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The Secretary adopts the following code sets, terminology, and nomenclature as the
vocabulary standards for the purpose of representing electronic health information:
(a) Problems. (1) Standard. The code set specified at 45 CFR 162.1002(a)(1) for the
indicated conditions.
(2) Standard. International Health Terminology Standards Development Organization
(IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED
CT®) July 2009 version (incorporated by reference in §170.299).
(b) Procedures. (1) Standard. The code set specified at 45 CFR 162.1002(a)(2).
(2) Standard. The code set specified at 45 CFR 162.1002(a)(5).
(c) Laboratory test results. Standard. Logical Observation Identifiers Names and Codes
(LOINC®) version 2.27, when such codes were received within an electronic
transaction from a laboratory (incorporated by reference in §170.299).
(d) Medications. Standard. Any source vocabulary that is included in RxNorm, a
standardized nomenclature for clinical drugs produced by the United States National
Library of Medicine.
(e) Immunizations. Standard. HL7 Standard Code Set CVX - Vaccines Administered,
July 30, 2009 version (incorporated by reference in §170.299).
(f) Race and Ethnicity. Standard. The Office of Management and Budget Standards for
Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity,
Statistical Policy Directive No. 15, October 30, 1997 (available at
http://www.whitehouse.gov/omb/rewrite/fedreg/ombdir15.html).
§170.210 Standards for health information technology to protect electronic health
information created, maintained, and exchanged.
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The Secretary adopts the following standards to protect electronic health information
created, maintained, and exchanged:
(a) Encryption and decryption of electronic health information—(1) General. Any
encryption algorithm identified by the National Institute of Standards and Technology
(NIST) as an approved security function in Annex A of the Federal Information
Processing Standards (FIPS) Publication 140-2 (incorporated by reference in §170.299).
(2) Exchange. Any encrypted and integrity protected link.
(b) Record actions related to electronic health information. The date, time, patient
identification, and user identification must be recorded when electronic health
information is created, modified, accessed, or deleted; and an indication of which
action(s) occurred and by whom must also be recorded.
(c) Verification that electronic health information has not been altered in transit.
Standard. A hashing algorithm with a security strength equal to or greater than SHA-1
(Secure Hash Algorithm (SHA-1) as specified by the National Institute of Standards and
Technology (NIST) in FIPS PUB 180-3 (October, 2008)) must be used to verify that
electronic health information has not been altered.
(d) Record treatment, payment, and health care operations disclosures. The date, time,
patient identification, user identification, and a description of the disclosure must be
recorded for disclosures for treatment, payment, and health care operations, as these
terms are defined at 45 CFR 164.501.
§170.299 Incorporation by reference.
(a) Certain material is incorporated by reference into this subpart with the approval of the
Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce
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any edition other than that specified in this section, the Department of Health and
Human Services must publish notice of change in the Federal Register and the
material must be available to the public. All approved material is available for
inspection at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-6030 or go to
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.h
tml. Also, it is available for inspection at U.S. Department of Health and Human
Services, Office of the National Coordinator for Health Information Technology,
Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave, S.W.,
Washington, DC 20201, call ahead to arrange for inspection at 202-690-7151, and is
available from the sources listed below.
(b) Health Level Seven, 3300 Washtenaw Avenue, Suite 227, Ann Arbor, MI 48104;
Telephone (734) 677-7777 or http://www.hl7.org/.
(1) Health Level Seven Standard Version 2.3.1 (HL7 2.3.1), An Application Protocol
for Electronic Data Exchange in Healthcare Environments, April 14, 1999, IBR
approved for §170.205.
(2) Health Level Seven Messaging Standard Version 2.5.1 (HL7 2.5.1), An
Application Protocol for Electronic Data Exchange in Healthcare Environments,
February 21, 2007, IBR approved for §170.205.
(3) Health Level Seven Implementation Guide: Clinical Document Architecture
(CDA) Release 2 – Continuity of Care Document (CCD), April 01, 2007, IBR
approved for §170.205.
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(4) HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to
Public Health, Release 1 (US Realm) HL7 Version 2.5.1: ORU^R01, HL7
Informative Document, February, 2010, IBR approved for §170.205.
(5) [Reserved]
(c) ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken,
PA, 19428-2959 USA; Telephone (610) 832-9585 or http://www.astm.org/.
(1) ASTM E2369-05: Standard Specification for Continuity of Care Record (CCR),
year of adoption 2005, ASTM approved July 17, 2006, IBR approved for
§170.205.
(2) ASTM E2369-05 (Adjunct to E2369): Standard Specification Continuity of Care
Record, - Final Version 1.0 (V1.0), November 7, 2005, IBR approved for
§170.205.
(d) National Council for Prescription Drug Programs, Incorporated, 9240 E. Raintree
Drive, Scottsdale, AZ 85260– 7518; Telephone (480) 477–1000; and Facsimile (480)
767–1042 or http://www.ncpdp.org.
(1) National Council for Prescription Drug Programs Prescriber/Pharmacist Interface
SCRIPT Standard, Implementation Guide, Version 8, Release 1, October 2005,
IBR approved for §170.205.
(2) SCRIPT Standard, Implementation Guide, Version 10.6, October, 2008,
(Approval date for ANSI: November 12, 2008), IBR approved for §170.205.
(3) [Reserved]
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(e) Regenstrief Institute, Inc., LOINC® c/o Medical Informatics The Regenstrief
Institute, Inc 410 West 10th Street, Suite 2000 Indianapolis, IN 46202-3012;
Telephone (317) 423-5558 or http://loinc.org/.
(1) Logical Observation Identifiers Names and Codes (LOINC®) version 2.27, June
15, 2009, IBR approved for §170.207.
(2) [Reserved]
(f) U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894;
Telephone (301) 594-5983 or http://www.nlm.nih.gov/.
(1) International Health Terminology Standards Development Organization
Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®),
International Release, July 2009, IBR approved for §170.207.
(2) [Reserved]
(g) Centers for Disease Control and Prevention, National Centers for Immunization and
Respiratory Diseases Immunization Information System Support Branch –
Informatics 1600 Clifton Road Mailstop: E-62 Atlanta, GA 30333
(1) HL7 Standard Code Set CVX - Vaccines Administered, July 30, 2009, IBR
approved for §170.207.
(2) Implementation Guide for Immunization Data Transactions using Version 2.3.1 of
the Health Level Seven (HL7) Standard Protocol Implementation Guide
Version 2.2, June 2006, IBR approved for §170.205.
(3) HL7 2.5.1 Implementation Guide for Immunization Messaging Release 1.0, May
1, 2010, IBR approved for §170.205.
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(4) Public Health Information Network HL7 Version 2.5 Message Structure
Specification for National Condition Reporting Final Version 1.0, including
Errata and Clarifications, National Notification Message Structural
Specification, 8/18/2007, August 18, 2007, IBR approved for §170.205.
(5) [Reserved]
(h) Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality,
7500 Security Boulevard, Baltimore, Maryland 21244; Telephone (410) 786-3000
(1) CMS PQRI 2009 Registry XML Specifications, IBR approved for §170.205.
(2) 2009 Physician Quality Reporting Initiative Measure Specifications Manual for
Claims and Registry, Version 3.0, December 8, 2008 IBR approved for §170.205.
(i) National Institute of Standards and Technology, Information Technology Laboratory,
National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD
20899–8930, http://csrc.nist.gov/groups/STM/cmvp/standards.html
(1) Annex A: Approved Security Functions for FIPS PUB 140-2, Security
Requirements for Cryptographic Modules, Draft, January 27, 2010, IBR
approved for §170.210.
(2) [Reserved]
(j) American National Standards Institute, Health Information Technology Standards
Panel (HITSP) Secretariat, 25 West 43rd Street – Fourth Floor, New York, NY
10036, http://www.hitsp.org
(1) HITSP Summary Documents Using HL7 Continuity of Care Document (CCD)
Component, HITSP/C32, July 8, 2009, Version 2.5, IBR approved for
§170.205.
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.
4. Revise subpart C to read as follows:
Subpart C—Certification Criteria for Health Information Technology
Sec.
170.300 Applicability.
170.302 General certification criteria for Complete EHRs or EHR Modules.
170.304 Specific certification criteria for Complete EHRs or EHR Modules designed for
an ambulatory setting.
170.306 Specific certification criteria for Complete EHRs or EHR Modules designed for
an inpatient setting.
§170.300 Applicability.
(a) The certification criteria adopted in this subpart apply to the testing and certification
of Complete EHRs and EHR Modules.
(b) When a certification criterion refers to two or more standards as alternatives, use of at
least one of the alternative standards will be considered compliant.
(c) Complete EHRs and EHR Modules are not required to be compliant with certification
criteria that are designated as optional.
§170.302 General certification criteria for Complete EHRs or EHR Modules.
The Secretary adopts the following general certification criteria for Complete EHRs or
EHR Modules. Complete EHRs or EHR Modules must include the capability to perform
the following functions electronically, unless designated as optional, and in accordance
with all applicable standards and implementation specifications adopted in this part:
(a) Drug-drug, drug-allergy interaction checks. (1) Notifications.
Automatically and
electronically generate and indicate in real-time, notifications at the point of care for
drug-drug and drug-allergy contraindications based on medication list, medication
allergy list, and computerized provider order entry (CPOE).
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(2) Adjustments. Provide certain users with the ability to adjust notifications provided
for drug-drug and drug-allergy interaction checks.
(b) Drug-formulary checks.
Enable a user to electronically check if drugs are in a
formulary or preferred drug list.
(c) Maintain up-to-date problem list. Enable a user to electronically record, modify, and
retrieve a patient’s problem list for longitudinal care in accordance with:
(1) The standard specified in §170.207(a)(1); or
(2) At a minimum, the version of the standard specified in §170.207(a)(2).
(d) Maintain active medication list. Enable a user to electronically record, modify, and
retrieve a patient’s active medication list as well as medication history for
longitudinal care.
(e) Maintain active medication allergy list. Enable a user to electronically record, modify,
and retrieve a patient’s active medication allergy list as well as medication allergy
history for longitudinal care.
(f) Record and chart vital signs. (1) Vital signs. Enable a user to electronically record,
modify, and retrieve a patient’s vital signs including, at a minimum, height, weight,
and blood pressure.
(2) Calculate body mass index. Automatically calculate and display body mass index
(BMI) based on a patient’s height and weight.
(3) Plot and display growth charts. Plot and electronically display, upon request,
growth charts for patients 2-20 years old.
(g) Smoking status. Enable a user to electronically record, modify, and retrieve the
smoking status of a patient. Smoking status types must include: current every day
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smoker; current some day smoker; former smoker; never smoker; smoker, current
status unknown; and unknown if ever smoked.
(h) Incorporate laboratory test results--(1) Receive results. Electronically receive clinical
laboratory test results in a structured format and display such results in human
readable format.
(2) Display test report information. Electronically display all the information for a test
report specified at 42 CFR 493.1291(c)(1) through (7).
(3) Incorporate results. Electronically attribute, associate, or link a laboratory test
result to a laboratory order or patient record.
(i) Generate patient lists.
Enable a user to electronically select, sort, retrieve, and
generate lists of patients according to, at a minimum, the data elements included in:
(1) Problem list;
(2) Medication list;
(3) Demographics; and
(4) Laboratory test results.
(j) Medication reconciliation. Enable a user to electronically compare two or more
medication lists.
(k) Submission to immunization registries. Electronically record, modify, retrieve, and
submit immunization information in accordance with:
(1) The standard (and applicable implementation specifications) specified in
§170.205(e)(1) or §170.205(e)(2); and
(2) At a minimum, the version of the standard specified in §170.207(e).
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(l) Public health surveillance. Electronically record, modify, retrieve, and submit
syndrome-based public health surveillance information in accordance with the
standard (and applicable implementation specifications) specified in §170.205(d)(1)
or §170.205(d)(2).
(m) Patient-specific education resources. Enable a user to electronically identify and
provide patient-specific education resources according to, at a minimum, the data
elements included in the patient’s: problem list; medication list; and laboratory test
results; as well as provide such resources to the patient.
(n) Automated measure calculation. For each meaningful use objective with a
percentage-based measure, electronically record the numerator and denominator and
generate a report including the numerator, denominator, and resulting percentage
associated with each applicable meaningful use measure.
(o) Access control. Assign a unique name and/or number for identifying and tracking
user identity and establish controls that permit only authorized users to access
electronic health information.
(p) Emergency access. Permit authorized users (who are authorized for emergency
situations) to access electronic health information during an emergency.
(q) Automatic log-off. Terminate an electronic session after a predetermined time of
inactivity.
(r) Audit log. (1)—Record actions. Record actions related to electronic health
information in accordance with the standard specified in §170.210(b).
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(2) Generate audit log. Enable a user to generate an audit log for a specific time
period and to sort entries in the audit log according to any of the elements specified in
the standard at §170.210(b).
(s) Integrity.
(1) Create a message digest in accordance with the standard specified in
§170.210(c).
(2) Verify in accordance with the standard specified in §170.210(c) upon receipt of
electronically exchanged health information that such information has not been
altered.
(3) Detection. Detect the alteration of audit logs.
(t) Authentication. Verify that a person or entity seeking access to electronic health
information is the one claimed and is authorized to access such information.
(u) General encryption. Encrypt and decrypt electronic health information in accordance
with the standard specified in §170.210(a)(1), unless the Secretary determines that the
use of such algorithm would pose a significant security risk for Certified EHR
Technology.
(v) Encryption when exchanging electronic health information. Encrypt and decrypt
electronic health information when exchanged in accordance with the standard
specified in §170.210(a)(2).
(w)Optional. Accounting of disclosures. Record disclosures made for treatment,
payment, and health care operations in accordance with the standard specified in
§170.210(d).
§170.304 Specific certification criteria for Complete EHRs or EHR Modules
designed for an ambulatory setting.
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The Secretary adopts the following certification criteria for Complete EHRs or EHR
Modules designed to be used in an ambulatory setting. Complete EHRs or EHR Modules
must include the capability to perform the following functions electronically and in
accordance with all applicable standards and implementation specifications adopted in
this part:
(a) Computerized provider order entry. Enable a user to electronically record, store,
retrieve, and modify, at a minimum, the following order types:
(1) Medications;
(2) Laboratory; and
(3) Radiology/imaging.
(b) Electronic prescribing. Enable a user to electronically generate and transmit
prescriptions and prescription-related information in accordance with:
(1) The standard specified in §170.205(b)(1) or §170.205(b)(2); and
(2) The standard specified in §170.207(d).
(c) Record demographics. Enable a user to electronically record, modify, and retrieve
patient demographic data including preferred language, gender, race, ethnicity, and
date of birth. Enable race and ethnicity to be recorded in accordance with the
standard specified at §170.207(f).
(d) Patient reminders. Enable a user to electronically generate a patient reminder list for
preventive or follow-up care according to patient preferences based on, at a
minimum, the data elements included in:
(1) Problem list;
(2) Medication list;
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(3) Medication allergy list;
(4) Demographics; and
(5) Laboratory test results.
(e) Clinical decision support—(1) Implement rules. Implement automated, electronic
clinical decision support rules (in addition to drug-drug and drug-allergy
contraindication checking) based on the data elements included in: problem list;
medication list; demographics; and laboratory test results.
(2) Notifications. Automatically and electronically generate and indicate in real-time,
notifications and care suggestions based upon clinical decision support rules.
(f) Electronic copy of health information. Enable a user to create an electronic copy of a
patient’s clinical information, including, at a minimum, diagnostic test results,
problem list, medication list, and medication allergy list in:
(1) Human readable format; and
(2) On electronic media or through some other electronic means in accordance with:
(i) The standard (and applicable implementation specifications) specified in
§170.205(a)(1) or §170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A)Problems. The standard specified in §170.207(a)(1) or, at a minimum, the
version of the standard specified in §170.207(a)(2);
(B) Laboratory test results. At a minimum, the version of the standard
specified in §170.207(c); and
(C) Medications. The standard specified in §170.207(d).
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(g) Timely access. Enable a user to provide patients with online access to their clinical
information, including, at a minimum, lab test results, problem list, medication list,
and medication allergy list.
(h) Clinical summaries.
Enable a user to provide clinical summaries to patients for each
office visit that include, at a minimum, diagnostic test results, problem list,
medication list, and medication allergy list. If the clinical summary is provided
electronically it must be:
(1) Provided in human readable format; and
(2) Provided on electronic media or through some other electronic means in
accordance with:
(i) The standard (and applicable implementation specifications) specified in
§170.205(a)(1) or §170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A)Problems. The standard specified in §170.207(a)(1) or, at a minimum, the
version of the standard specified in §170.207(a)(2);
(B) Laboratory test results. At a minimum, the version of the standard
specified in §170.207(c); and
(C) Medications. The standard specified in §170.207(d).
(i) Exchange clinical information and patient summary record—(1) Electronically
receive and display. Electronically receive and display a patient’s summary record,
from other providers and organizations including, at a minimum, diagnostic tests
results, problem list, medication list, and medication allergy list in accordance with
the standard (and applicable implementation specifications) specified in
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§170.205(a)(1) or §170.205(a)(2). Upon receipt of a patient summary record
formatted according to the alternative standard, display it in human readable format.
(2) Electronically transmit. Enable a user to electronically transmit a patient summary
record to other providers and organizations including, at a minimum, diagnostic test
results, problem list, medication list, and medication allergy list in accordance with:
(i) The standard (and applicable implementation specifications) specified in
§170.205(a)(1) or §170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A)Problems. The standard specified in §170.207(a)(1) or, at a minimum, the
version of the standard specified in §170.207(a)(2);
(B) Laboratory test results. At a minimum, the version of the standard
specified in §170.207(c); and
(C) Medications. The standard specified in §170.207(d).
(j) Calculate and submit clinical quality measures—(1) Calculate (i)Electronically
calculate all of the core clinical measures specified by CMS for eligible professionals.
(ii) Electronically calculate, at a minimum, three clinical quality measures
specified by CMS for eligible professionals, in addition to those clinical quality
measures specified in paragraph (1)(i).
(2) Submission. Enable a user to electronically submit calculated clinical quality
measures in accordance with the standard and implementation specifications specified
in §170.205(f).
§170.306 Specific certification criteria for Complete EHRs or EHR Modules
designed for an inpatient setting.
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The Secretary adopts the following certification criteria for Complete EHRs or EHR
Modules designed to be used in an inpatient setting. Complete EHRs or EHR Modules
must include the capability to perform the following functions electronically and in
accordance with all applicable standards and implementation specifications adopted in
this part:
(a) Computerized provider order entry. Enable a user to electronically record, store,
retrieve, and modify, at a minimum, the following order types:
(1) Medications;
(2) Laboratory; and
(3) Radiology/imaging.
(b) Record demographics. Enable a user to electronically record, modify, and retrieve
patient demographic data including preferred language, gender, race, ethnicity, date
of birth, and date and preliminary cause of death in the event of mortality. Enable
race and ethnicity to be recorded in accordance with the standard specified at
§170.207(f).
(c) Clinical decision support—(1) Implement rules. Implement automated, electronic
clinical decision support rules (in addition to drug-drug and drug-allergy
contraindication checking) based on the data elements included in: problem list;
medication list; demographics; and laboratory test results.
(2) Notifications. Automatically and electronically generate and indicate in real-time,
notifications and care suggestions based upon clinical decision support rules.
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(d) Electronic copy of health information. (1) Enable a user to create an electronic copy
of a patient’s clinical information, including, at a minimum, diagnostic test results,
problem list, medication list, medication allergy list, and procedures:
(i) In human readable format; and
(ii) On electronic media or through some other electronic means in accordance
with:
(A)The standard (and applicable implementation specifications) specified in
§170.205(a)(1) or §170.205(a)(2); and
(B) For the following data elements the applicable standard must be used:
(1) Problems. The standard specified in §170.207(a)(1) or, at a minimum,
the version of the standard specified in §170.207(a)(2);
(2) Procedures. The standard specified in §170.207(b)(1) or
§170.207(b)(2);
(3) Laboratory test results. At a minimum, the version of the standard
specified in §170.207(c); and
(4) Medications. The standard specified in §170.207(d).
(2) Enable a user to create an electronic copy of a patient’s discharge summary in
human readable format and on electronic media or through some other
electronic means.
(e) Electronic copy of discharge instructions.
Enable a user to create an electronic copy
of the discharge instructions for a patient, in human readable format, at the time of
discharge on electronic media or through some other electronic means.
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(f) Exchange clinical information and patient summary record—(1) Electronically
receive and display. Electronically receive and display a patient’s summary record
from other providers and organizations including, at a minimum, diagnostic test
results, problem list, medication list, medication allergy list, and procedures in
accordance with the standard (and applicable implementation specifications) specified
in §170.205(a)(1) or §170.205(a)(2). Upon receipt of a patient summary record
formatted according to the alternative standard, display it in human readable format.
(2) Electronically transmit. Enable a user to electronically transmit a patient’s
summary record to other providers and organizations including, at a minimum,
diagnostic results, problem list, medication list, medication allergy list, and
procedures in accordance with:
(i) The standard (and applicable implementation specifications) specified in
§170.205(a)(1) or §170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A)Problems. The standard specified in §170.207(a)(1) or, at a minimum, the
version of the standard specified in §170.207(a)(2);
(B) Procedures. The standard specified in §170.207(b)(1) or §170.207(b)(2);
(C) Laboratory test results. At a minimum, the version of the standard
specified in §170.207(c); and
(D)Medications. The standard specified in §170.207(d).
(g) Reportable lab results.
Electronically record, modify, retrieve, and submit reportable
clinical lab results in accordance with the standard (and applicable implementation
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specifications) specified in §170.205(c) and, at a minimum, the version of the
standard specified in §170.207(c).
(h) Advance directives.
Enable a user to electronically record whether a patient has an
advance directive.
(i) Calculate and submit clinical quality measures—(1) Calculate. Electronically
calculate all of the clinical quality measures specified by CMS for eligible hospitals
and critical access hospitals.
(2) Submission. Enable a user to electronically submit calculated clinical quality
measures in accordance with the standard and implementation specifications specified
in §170.205(f).
Dated:__July 9, 2010__________________
___________________________
Kathleen Sebelius,
Secretary.
BILLING CODE: 4150-45-P
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