[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Rules and Regulations]
[Pages 65884-65887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26290]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 170
RIN 0991-AB91
2014 Edition Electronic Health Record Certification Criteria:
Revision to the Definition of ``Common Meaningful Use (MU) Data Set''
AGENCY: Office of the National Coordinator for Health Information
Technology (ONC), Department of Health and Human Services.
ACTION: Interim final rule with comment period.
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SUMMARY: This interim final rule with comment period revises one
paragraph in the Common Meaningful Use (MU) Data Set definition at 45
CFR 170.102 to allow more flexibility with respect to the
representation of dental procedures data for electronic health record
(EHR) technology testing and certification.
DATES: Effective date: This regulation is effective on December 4,
2013.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on January 3, 2014.
ADDRESSES: Because of staff and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. You may submit comments,
identified by RIN 0991-AB91, by any of the following methods (please do
not submit duplicate comments):
Federal eRulemaking Portal: You may submit electronic
comments on this regulation to http://www.regulations.gov. Follow the
instructions for ``Comment or Submission'' and enter the filecode to
find the document accepting comments. Attachments should be in
Microsoft Word, Adobe PDF, or Excel; we prefer Microsoft Word.
Regular, Express, or Overnight Mail: Department of Health
and Human Services, Office of the National Coordinator for Health
Information Technology, Attention: Steven Posnack, Patriots Plaza III
Building, Suite 310, 355 E Street SW., Washington, DC 20024. Please
submit one original and two copies.
Hand Delivery or Courier: Department of Health and Human
Services, Office of the National Coordinator for Health Information
Technology, Attention: Steven Posnack, Patriots Plaza III Building,
Suite 310, 355 E Street SW., Washington, DC 20024. Please submit one
original and two copies. (Because access to the interior of the
Patriots Plaza Building is not readily available to persons without
federal government identification, commenters are encouraged to request
an escort from an ONC staff member at the security desk in the main
lobby of the building.)
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:
Inspection of Public Comments: All comments received before the
close of the comment period will be available for viewing by the
public, including any personally identifiable or confidential business
information that is included in a comment. Please do not include
anything in your comment submission that you do not wish to share with
the general public. Such information
[[Page 65885]]
includes, but is not limited to: a person's social security number;
date of birth; driver's license number; state identification number or
foreign country equivalent; passport number; financial account number;
credit or debit card number; any personal health information; or any
business information that could be considered to be proprietary. We
will post all comments received before the close of the comment period
on the following Web site as soon as possible after they have been
received: http://regulations.gov. Follow the search instructions on
that Web site to view public comments.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or 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. SW., Washington, DC 20201 (call ahead to the
contact listed above to arrange for inspection).
I. Background
A. Statutory Basis
1. Standards, Implementation Specifications, and Certification Criteria
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 created ``Title XXX--Health Information
Technology and Quality'' (Title XXX) to improve health care quality,
safety, and efficiency through the promotion of health information
technology (health IT or HIT) and electronic health information
exchange.
Section 3004(b)(3) of the PHSA entitled, ``Subsequent Standards
Activity,'' provides that the ``Secretary shall adopt additional
standards, implementation specifications, and certification criteria as
necessary and consistent'' with the schedule published by the HIT
Standards Committee. We consider this provision in the broader context
of the HITECH Act to grant the Secretary the authority and discretion
to adopt standards, implementation specifications, and certification
criteria that have been recommended by the HIT Standards Committee and
endorsed by the National Coordinator for Health Information Technology
(National Coordinator), as well as other appropriate and necessary HIT
standards, implementation specifications, and certification criteria.
2. HIT Certification Programs
Section 3001(c)(5) of the PHSA provides the National Coordinator
with the authority to establish a certification program or programs for
the voluntary certification of HIT. Specifically, section 3001(c)(5)(A)
specifies that the ``National Coordinator, in consultation with the
Director of the National Institute of Standards and Technology, shall
keep or recognize a program or programs for the voluntary certification
of health information technology as being in compliance with applicable
certification criteria adopted under this subtitle'' (that is,
certification criteria adopted by the Secretary under section 3004 of
the PHSA). The certification program(s) must also ``include, as
appropriate, testing of the technology in accordance with section
13201(b) of the [HITECH] Act.''
Section 13201(b) of the HITECH Act requires that with respect to
the development of standards and implementation specifications, the
Director of the National Institute of Standards and Technology, in
coordination with the HIT Standards Committee, ``shall support the
establishment of a conformance testing infrastructure, including the
development of technical test beds.'' The HITECH Act also indicates
that ``[t]he development of this conformance testing infrastructure may
include a program to accredit independent, non- Federal laboratories to
perform testing.''
B. Regulatory History
1. Standards, Implementation Specifications, and Certification Criteria
Rules
In the September 4, 2012 Federal Register (77 FR 54163), the
Secretary issued a final rule (the ``2014 Edition Final Rule'') that
adopted the 2014 Edition EHR certification criteria and a revised
Certified EHR Technology (CEHRT) definition. The standards,
implementation specifications, and certification criteria adopted by
the Secretary established the capabilities that CEHRT must include in
order to, at a minimum, support the achievement of meaningful use (MU)
by eligible professionals (EPs), eligible hospitals, and critical
access hospitals under the Medicare and Medicaid EHR Incentive Programs
beginning with the EHR reporting periods in Federal Fiscal Year/
Calendar Year 2014.
The 2014 Edition Final Rule adopted a definition for the term
Common MU Data Set at 45 CFR 170.102. The definition was created to
reduce the repetitiveness of certification criteria and to make the
certification criteria more concise. The definition includes types of
data that are common among five certification criteria (the ``view,
download, and transmit to a 3rd party,'' ``clinical summary,''
``transitions of care--receive, display, and incorporate transition of
care/referral summaries,'' ``transitions of care--create and transmit
transition of care/referral summaries,'' and ``data portability''
certification criteria) and meant to mirror the data specified by the
Centers for Medicare & Medicaid Services (CMS) in the MU objectives and
measures to which these certification criteria correlate.
2. HIT Certification Programs Rules
In the January 7, 2011 Federal Register (76 FR 1262), the Secretary
issued a final rule establishing the permanent certification program
and its requirements. In the 2014 Edition Final Rule mentioned above,
ONC made revisions to the permanent certification program, including
changing the program's name to the ``ONC HIT Certification Program.''
II. Issue Addressed by This Interim Final Rule
A. Background
The Common MU Data Set definition adopted at 45 CFR 170.102
identifies sixteen kinds of data and (where applicable) associated
vocabulary standards. The definition's fifteenth paragraph (Paragraph
15) identifies the required and optional vocabulary standards for
representing ``procedures'' data for the purposes of testing and
certification.
Paragraph 15 requires that (in all certification criteria in which
this definition is referenced) EHR technology must demonstrate for
testing and certification that it can represent procedures in ``[a]t a
minimum, the version of the standard specified in Sec. 170.207(a)(3)
or Sec. 170.207(b)(2).'' In other words, procedures can be represented
in Systematized Nomenclature of Medicine Clinical Terms (SNOMED
CT[supreg]) or the combination of Health Care Financing Administration
Common Procedure Coding System (HCPCS) and Current Procedural
Terminology, Fourth Edition (CPT-4) vocabularies.
In Paragraph 15, we also provide the option for EHR technology
developers to represent procedures in either the Current Dental
Terminology (CDT) (the standard specified at Sec. 170.207(b)(3)) or
International Classification of Diseases, 10th Revision, Procedure
Coding
[[Page 65886]]
System (ICD-10-PCS) (the standard specified at Sec. 170.207(b)(4)) in
addition to, but not in lieu of, the required vocabulary standards
mentioned above.
B. Revision to Common MU Data Set Definition
In the 2014 Edition Final Rule (77 FR54178), we responded to a
commenter who recommended that we should adopt CDT to represent dental
procedures. Instead of accepting the commenter's suggestion, we
designated CDT as an ``optional'' standard so that it could be used for
testing and certification but only in addition to, and not in lieu of,
SNOMED CT[supreg] or CPT-4/HCPCS. As discussed below, we have
determined after further consideration that this ``optional''
designation does not appropriately reflect that CDT is best suited to
represent dental procedures in EHR technology. The revision to the
Common MU Data Set definition made by this interim final rule is
intended to improve regulatory flexibility and remove an unintended
burden on EHR technology developers who develop products for customers
that need a precise and comprehensive standard in which to record
dental procedures.
On July 29, 2013, the HIT Standards Committee transmitted a
recommendation to the National Coordinator stating that we should adopt
CDT as a ``required'' vocabulary standard for EHR technology testing
and certification.\1\ It is our understanding that this recommendation
sought to emphasize that the EHR technology testing and certification
process should support and make available as a pathway for
certification the representation of dental procedures using CDT alone,
rather than its current ``optional'' designation as a standard to be
used in addition to SNOMED CT[supreg] or CPT-4/HCPCS. In consideration
of that recommendation, we conducted fact-finding with experts in CDT
and EHR technology developers who develop products that use this
terminology to better understand how our decision to designate CDT as
``optional'' has impacted EHR technology testing and certification. We
also sought to determine whether either of the two required vocabulary
standards adopted to represent procedures (namely, SNOMED CT[supreg] or
CPT-4/HCPCS) is sufficiently equivalent to CDT such that a regulatory
change would be unnecessary.
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\1\ http://www.healthit.gov/facas/FACAS/health-it-standards-committee/health-it-standards-committee-recommendations-national-coordinator.
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Our fact-finding uncovered two important points. First,
stakeholders confirmed that CDT is specifically designed for and used
to represent dental procedures. Additionally, they stated that although
SNOMED CT[supreg] and CPT-4/HCPCS as clinical terminologies are best
for most other medical settings, those standards sparingly include
dental procedure codes. Stakeholders indicated that CDT was far and
above the best-suited standard to represent dental procedures because
of its depth, breadth, and specific focus on these unique types of
procedures. Second, they indicated that the current wording of
Paragraph 15(i) in the Common MU Data Set definition would cause undue
burden, and unnecessary work and costs for EHR technology developers
who develop EHR technologies primarily to record dental procedures.
Additionally, they asserted that the revision of this portion of the
Common MU Data Set definition would significantly improve their ability
to complete the testing and certification process in a timely manner.
Further, stakeholders indicated that because Paragraph 15(i) requires
EHR technology (designed either as comprehensive or stand-alone/
supplemental offering) to represent procedures using SNOMED CT[supreg]
or CPT-4/HCPCS, EHR technology developers who primarily develop
products for doctors of dental surgery and dental medicine would have
to build those standards into their products, even though CDT would be
more appropriate to represent dental procedures and better support
these customers' specific coding needs.
Given the HIT Standards Committee's recommendation and the related
fact-finding we conducted, we have decided to revise Paragraph 15 in
the Common MU Data Set definition. This revision will allow EHR
technology that has been primarily developed to record dental
procedures to be tested and certified to CDT alone (for either a
Complete EHR or EHR Module certification), rather than in addition to
SNOMED CT[supreg] or CPT-4/HCPCS. Moreover, this change will enable EHR
technology developers who serve customers with a need to record
specific dental procedures to develop and seek testing and
certification for EHR technologies without the previously mentioned
burden and cost associated with supporting additional and less precise
standards in their products. We emphasize, however, that this limited
revision to the regulation is intended only for EHR technology that has
been primarily developed to record dental procedures. In all other
cases, EHR technology must continue to be tested and certified using
SNOMED CT[supreg] or CPT-4/HCPCS to represent procedures.
Accordingly, we have revised Paragraph 15 of the Common MU Data Set
definition at Sec. 170.102 to include CDT in Paragraph 15(i) as a
vocabulary standard to which EHR technology can be tested and certified
to represent dental procedures (instead of SNOMED CT[supreg] or CPT-4/
HCPCS) in the limited circumstance where EHR technology is primarily
developed to record dental procedures. ICD-10-PCS (now Paragraph
15(ii)) continues to be designated optional for testing and
certification.
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register to provide a period for public comment before the
provisions of the rule take effect in accordance with section 553(b) of
the Administrative Procedure Act (5 U.S.C. 553(b)). However, we can
waive the notice and comment procedure if we find good cause that a
notice and comment procedure is impracticable, unnecessary, or contrary
to the public interest, and incorporate a statement of the finding and
the reasons in the final notice or rule that is issued (5 U.S.C.
553(b)(3)(B)).
Based on the HITSC's recommendation and our own fact-finding
discussed above, we believe it would be contrary to the public interest
to undergo notice and comment rulemaking to revise Paragraph 15 of the
Common MU Data Set definition at Sec. 170.102. It is our understanding
from stakeholders that if this revision is not made in a timely manner,
some EHR technology developers may not be able to achieve certification
at all for their products and, as a result, may forgo seeking
certification altogether. Such a result could significantly curtail the
market for certified EHR technology developed to meet the needs of
certain types of health care professionals (for example, doctors of
dental surgery and dental medicine). Additionally, in cases where these
EHR technology developers would forge ahead to get their products
certified based on the current Common MU Data Set definition, we
anticipate that they would incur unnecessary costs (which potentially
could be passed on to customers) associated with incorporating SNOMED
CT[supreg] or CPT-4/HCPCS into their products solely because they must
demonstrate compliance with these standards for certification. This
change to the regulation will relieve a burden on some
[[Page 65887]]
developers by allowing their products to be certified to CDT alone.
From the broader perspective of the Medicare and Medicaid EHR
Incentive Programs, we believe that this revision to the Common MU Data
Set definition will mitigate the risk that some EHR technology
developers would limit or cease development of EHR technology
specifically designed for doctors of dental surgery and dental
medicine. If certified EHR technology designed to meet their specific
needs is not available, these EPs may not qualify for EHR incentive
payments and could be subject to future downward payment adjustments
under Medicare. Additionally, the expected time it would take to
complete the notice and comment rulemaking process could compromise the
timely availability of 2014 Edition certified EHR technologies for
doctors of dental surgery and dental medicine seeking to participate
for the first time or continue their participation in the Medicare and
Medicaid EHR Incentive Programs.
For the reasons stated, we believe that a notice and comment period
would be contrary to the public interest. We therefore find good cause
for waiving the notice and comment period to revise the Common MU Data
Set definition.
IV. Response to Comments
Because of the number of public comments we normally receive on
Federal Register documents, we are not able to acknowledge or respond
to them individually. We will consider all comments we receive by the
date and time specified in the DATES section of this preamble, and,
when we proceed with a subsequent document, we will respond to the
comments in the preamble of that document.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it does not need to be
reviewed by the Office of Management and Budget under the authority of
the Paperwork Reduction Act of 1995 (44 U.S.C. 35).
VI. Regulatory Impact Statement
We have examined the impact of this interim final rule as required
by Executive Order 12866 on Regulatory Planning and Review (September
30, 1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (February 2, 2011), 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), and Executive Order 13132 on Federalism (August
4, 1999).
In following Executive Orders 12866 and 13563, we have determined
that this interim final rule does not reach the economic threshold
($100 million or more in any one year) such that a regulatory impact
analysis (RIA) needs to be prepared. Thus, this rule is not considered
a major rule and an RIA has not been prepared. This rule is not being
treated as a ``significant regulatory action'' under section 3(f) of
Executive Order 12866. Accordingly, the rule has not been reviewed by
the Office of Management and Budget.
Similarly, with respect to the RFA, we do not believe that the
change in this interim final rule with comment period alters any of the
prior analyses we performed for the 2014 Edition Final Rule; and
therefore, the Secretary certifies that this interim final rule with
comment period will not have a significant economic impact on a
substantial number of small entities.
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a final rule (including an interim
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has federalism
implications. Because this interim final rule with comment period does
not impose any costs on state or local governments, the requirements of
Executive Order 13132 are not applicable.
Section 202 of the Unfunded Mandates Reform Act of 1995 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. The current inflation-
adjusted statutory threshold is approximately $141 million.
This interim final rule with comment period will not impose an
unfunded mandate on state, local, and tribal governments or on the
private sector that will reach the threshold level.
List of Subjects in 45 CFR Part 170
Computer technology, Electronic health record, Electronic
information system, Electronic transactions, Health, Health care,
Health information technology, Health records, Hospitals, Reporting and
recordkeeping requirements, Public health.
For the reasons set forth in the preamble, the Department amends 45
CFR subtitle A, subchapter D, part 170 as follows:
PART 170--HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION
SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION
PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY
0
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.
0
2. Section 170.102 is amended by revising paragraph (15) of the Common
MU Data Set definition to read as follows:
Sec. 170.102 Definitions.
* * * * *
Common MU Data Set
* * * * *
(15) Procedures--
(i)(A) At a minimum, the version of the standard specified in Sec.
170.207(a)(3) or Sec. 170.207(b)(2); or
(B) For EHR technology primarily developed to record dental
procedures, the standard specified in Sec. 170.207(b)(3).
(ii) Optional. The standard specified at Sec. 170.207(b)(4).
* * * * *
Dated: October 24, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-26290 Filed 11-1-13; 8:45 am]
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