[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Rules and Regulations]
[Pages 65884-65887]
From the Federal Register Online via the Government Printing 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]
BILLING CODE 4150-45-P