[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Rules and Regulations]
[Pages 62686-62690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25683]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 170
RIN 0991-AB76
Health Information Technology: Revisions to 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: Interim final rule with request for comments.
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SUMMARY: The Department of Health and Human Services (HHS) is issuing
this interim final rule with a request for comment to remove the
implementation specifications related to public health surveillance.
DATES: Effective Date: This interim final rule is effective October 13,
2010.
Comment Date: To be assured consideration, written or electronic
comments must be received at one of the addresses provided below, no
later than 5 p.m. on November 12, 2010.
ADDRESSES: Because of staff and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. You may submit comments,
identified by RIN 0991-AB76, by any of the following methods (please do
not submit duplicate comments).
Federal eRulemaking Portal: Follow the instructions for
submitting comments. Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, we prefer Microsoft Word. http://www.regulations.gov.
Regular, Express, or Overnight Mail: Department of Health
and Human Services, Office of the National Coordinator for Health
Information Technology, Attention: Steven Posnack, Hubert H. Humphrey
Building, Suite 729D, 200 Independence Ave., SW., Washington, DC 20201.
Please submit one original and two copies.
Hand Delivery or Courier: Office of the National
Coordinator for Health Information Technology, Attention: Steven
Posnack, Hubert H. Humphrey Building, Suite 729D, 200 Independence
Ave., SW., Washington, DC 20201. Please submit one original and two
copies. (Because access to the interior of the Hubert H. Humphrey
Building is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the mail drop slots located in the main lobby of the building.)
Inspection of Public Comments: All comments received before the
close of the comment period will be available for public inspection,
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 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 at http://www.regulations.gov.
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 below to arrange for inspection).
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
ARRA American Recovery and Reinvestment Act of 2009
CDC Centers for Disease Control and Prevention
CFR Code of Federal Regulations
EHR Electronic Health Record
HHS Department of Health and Human Services
HIT Health Information Technology
HITECH Health Information Technology for Economic and Clinical
Health
HL7 Health Level Seven
NAICS North American Industry Classification System
OMB Office of Management and Budget
ONC Office of the National Coordinator for Health Information
Technology
ONC-ATCB ONC-Authorized Testing and Certification Body
PHSA Public Health Service Act
RFA Regulatory Flexibility Act
RIA Regulatory Impact Analysis
UMRA Unfunded Mandates Reform Act of 1995
[[Page 62687]]
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. Initial Set of Standards, Implementation Specifications, and
Certification Criteria for EHR Technology; Final Rule
3. Proposed Establishment of Certification Programs for Health
Information Technology; Proposed Rule
4. Temporary Certification Program; Final Rule
II. Discussion of the Interim Final Rule
A. Public Health Surveillance Implementation Specifications
B. Waiver of Proposed Rulemaking and Delay in Effective Date
III. Response to Comments
IV. Collection of Information Requirements
V. Regulatory Impact Statement
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 of the PHSA, as added by the HITECH Act, authorizes the
Secretary of Health and Human Services (the Secretary) to adopt
standards, implementation specifications, and certification criteria to
enhance the interoperability, functionality, utility, and security of
health information technology. Section 3004(b)(1) of the PHSA more
specifically directs the Secretary to adopt an initial set of
standards, implementation specifications, and certification criteria,
and permits their adoption through an interim final rule.
B. Regulatory History
1. Initial Set of Standards, Implementation Specifications, and
Certification Criteria for EHR Technology; Interim Final Rule
On January 13, 2010, HHS published in the Federal Register an
interim final rule with a request for comment, which adopted an initial
set of standards, implementation specifications, and certification
criteria (75 FR 2014). The certification criteria adopted in that
interim final rule established the required capabilities and specified
the related standards and implementation specifications that certified
electronic health record (EHR) technology would need to include to, at
a minimum, support the achievement of meaningful use Stage 1 as
proposed by CMS for eligible professionals and eligible hospitals under
the Medicare and Medicaid EHR Incentive Programs. (For consistency with
subsequent regulatory changes, hereafter, references to ``eligible
hospitals'' shall mean ``eligible hospitals and/or critical access
hospitals''.)
2. Initial Set of Standards, Implementation Specifications, and
Certification Criteria for EHR Technology; Final Rule
On July 28, 2010, HHS published in the Federal Register a final
rule (75 FR 44590) to complete the Secretary's adoption of the 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 (the ``Standards and Certification
Criteria Final Rule''). The certification criteria adopted in that
final rule establish the required capabilities and specify the related
standards and implementation specifications that certified EHR
technology will need to include to, at a minimum, support the
achievement of meaningful use Stage 1 by eligible professionals and
eligible 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.
3. Proposed Establishment of Certification Programs for Health
Information Technology; Proposed Rule
On March 10, 2010, under the authority granted to the National
Coordinator for Health Information Technology (the National
Coordinator) by section 3001(c)(5) of the PHSA as added by the HITECH
Act, HHS published in the Federal Register (75 FR 11328) a rule
proposing the establishment of two certification programs for purposes
of testing and certifying health information technology. The first
proposal would establish a temporary certification program whereby the
National Coordinator would authorize organizations to test and certify
Complete EHRs and/or EHR Modules. The second proposal would establish a
permanent certification program to replace the temporary certification
program. The permanent certification program included proposals that
would separate the responsibilities for performing testing and
certification, introduce accreditation requirements, establish
requirements for certification bodies authorized by the National
Coordinator related to the surveillance of Certified EHR Technology,
and would include the potential for certification bodies authorized by
the National Coordinator to certify other types of health information
technology besides Complete EHRs and EHR Modules.
4. Temporary Certification Program; Final Rule
On June 24, 2010, HHS published in the Federal Register a final
rule (75 FR 36158) establishing the temporary certification program for
HIT (Temporary Certification Program). The Temporary Certification
Program, established under the authority granted to the National
Coordinator by section 3001(c)(5) of the PHSA, sets forth the process
the National Coordinator will utilize to authorize organizations (ONC-
Authorized Testing and Certification Bodies (ONC-ATCBs)) to test and
certify Complete EHRs and/or EHR Modules to the certification criteria
adopted by the Secretary in the Standards and Certification Criteria
Final Rule. Once tested and certified, a Complete EHR or a combination
of EHR Modules can be adopted by an eligible professional or eligible
hospital to meet the definition of Certified EHR Technology as
specified at 45 CFR 170.102 and used to help qualify for incentive
payments under the Medicare and Medicaid EHR Incentive Programs.
II. Discussion of the Interim Final Rule
A. Public Health Surveillance Implementation Specifications
In the Standards and Certification Criteria Final Rule, we adopted
two content exchange standards for electronic submission to public
health agencies for surveillance and reporting, Health Level Seven
(HL7) versions 2.3.1 and 2.5.1. (45 CFR 170.205(d)) Additionally, in
response to public comment on the interim final rule published January,
2010, we adopted in the Standards and Certification Criteria Final Rule
the following implementation specifications for HL7 2.5.1: Public
Health Information Network HL7 Version 2.5 Message
[[Page 62688]]
Structure Specification for National Condition Reporting Final Version
1.0 and the Errata and Clarifications National Notification Message
Structural Specification. (45 CFR 170.205(d)(2)) We did not, however,
adopt at that time implementation specifications for HL7 2.3.1.
Since the publication of the Standards and Certification Criteria
Final Rule, various stakeholders and state public health agencies have
made numerous inquiries and expressed concerns about the
appropriateness of these implementation specifications. Some
stakeholder representatives indicated that they thought these
implementation specifications may have been adopted in error. They
noted that these implementation specifications do not appear to be
appropriate for implementing the adopted standard, HL7 2.5.1 for public
health surveillance (syndromic surveillance) purposes.
After further review of the implementation specifications and
consultation with the Centers for Disease Control and Prevention (CDC),
we have determined that these implementation specifications were
adopted in error. The adopted implementation specifications provide
direction to public health agencies on the structure and methodology
for using HL7 2.5.1 to report ``Nationally Notifiable Conditions'' to
CDC and do not provide additional clarity for how EHR technology would
need to be designed to implement the adopted standard (HL7 2.5.1) or
enable compliance with the capability identified in the certification
criterion adopted at 45 CFR 170.302(l). Therefore, their adoption
neither provides the appropriate or requisite implementation capability
for the adopted standard, HL7 2.5.1, nor, more importantly, would
enable the user to ``electronically record, modify, retrieve, and
submit syndrome-based public health surveillance information * * *,''
as required by the adopted certification criterion, 45 CFR 170.302(l).
We have also heard from ONC-ATCBs as well as EHR technology
developers that the erroneous adoption of these implementation
specifications creates significant ambiguity and concern regarding
whether these implementation specifications must be used for testing
and certification. They correctly point out that because these
implementation specifications are inappropriate for the adopted
standard and would likely frustrate achieving the capability specified
in the adopted certification criterion at 45 CFR 170.302(l), testing
and certifying in accordance with them would be wasteful and
unproductive. We understand further that while the erroneously adopted
implementation specifications could be used to specify the structure
and methodology for using HL7 2.5.1, their purpose is to facilitate the
electronic exchange of de-identified Nationally Notifiable Conditions
for notifiable disease reporting, which would not fulfill the
fundamental requirements of syndromic surveillance. In contrast to
notifiable disease reporting, where only data on patients with a
notifiable disease diagnosis is sent to a public health agency,
syndromic surveillance requires data from all patients that were seen
in a health care setting. Moreover, syndromic surveillance requires
data elements that the adopted implementation specifications do not
address including: A patient's chief complaint; date/time of visit;
severity of illness (e.g., patient's disposition status), specific
indicators (e.g., pulse oximetry, measured temperature), and age.
The adoption of these implementation specifications also presents
an unnecessary obstacle for EHR technology developers, who are
currently faced with the dilemma of implementing HL7 2.3.1 (even though
their customers may need HL7 2.5.1 to report to their state public
health agency), or alternatively, HL7 2.5.1 according to the
inappropriate implementation specifications, or unnecessarily to both
standards, in order to seek certification. We believe that each of
these alternatives places an unnecessary and unwarranted burden on EHR
technology developers.
For all of these reasons, we are revising 45 CFR 170.205(d)(2) to
remove these particular adopted implementation specifications. We are
also removing from 45 CFR 170.302(l) the text ``(and applicable
implementation specifications)'' to provide additional clarity and to
remove the unnecessary and unwarranted burden on ONC-ATCBs and perhaps
ONC-ACBs. In addition, we are removing the reference to the
implementation specifications in 45 CFR 170.299(g) where it is
incorporated by reference.
B. Waiver of Proposed Rulemaking and Delay in Effective Date
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 (APA) (5 U.S.C.553(b)). We also
ordinarily provide a 30-day delay in the effective date of the
provisions of a rule in accordance with section 553(d) of the APA (5
U.S.C. 553(d)). However, we can waive both the notice and comment
procedure and the 30-day delay in effective date if the Secretary finds
for good cause that a notice and comment procedure and a 30-day delay
are impracticable, unnecessary, or contrary to the public interest, and
incorporates a statement of the finding and the reasons in the final
notice or rule that is issued.
In this case, we find that notice and comment rulemaking is
contrary to the public interest because it would unnecessarily delay
the implementation of a complex statutory scheme and prevent the
realization of certain legislative goals within the statutory
timeframe. Under the HITECH Act, ONC and CMS promulgated several rules
that establish a regulatory framework through which eligible
professionals and eligible hospitals may seek to qualify for certain
Medicare and Medicaid programs incentive payments. The Medicare and
Medicaid EHR Incentive Programs final rule established the initial
criteria eligible professionals and eligible hospitals must meet in
order to qualify for an incentive payment, along with other program
participation requirements. The HIT Standards and Certification
Criteria interim final and final rules provided for the adoption of an
initial set of standards, implementation, specifications, and
certification criteria for electronic health record technology. In a
separate final rule, ONC established a temporary certification program
that allows Complete EHRs and EHR Modules to be tested and certified to
the adopted certification criteria.
In this regulatory framework, private organizations are provided
the opportunity to apply to the National Coordinator for authorization
as an ONC-Authorized Testing and Certification Body (ONC-ATCB). Once an
organization is granted ONC-ATCB status and obtains authorization from
the National Coordinator to test and certify Complete EHRs and/or EHR
Modules, it will be subject, depending on the scope of its
authorization, to the requirements specified at 45 CFR 170.445
(Complete EHR testing and certification) and/or 45 CFR 170.450 (EHR
Module testing and certification). These provisions require ONC-ATCBs
to test and certify Complete EHRs and/or EHR Modules to all applicable
certification criteria adopted by the Secretary at subpart C of part
170. Consequently, an ONC-ATCB's failure to adhere to the testing and
certification requirements of 170.445 and/or 170.450 could subject that
ONC-ATCB to adverse action by
[[Page 62689]]
the National Coordinator in accordance with 45 CFR 170.465 (Revocation
of authorized testing and certification body status). Because ONC-ATCBs
are required to test and certify Complete EHRs and/or EHR Modules in
accordance with all applicable certification criteria, including 45 CFR
170.302(l), and 45 CFR 170.302(l) requires that a Complete EHR or EHR
Module would need to perform the specified capabilities in accordance
with, in certain scenarios, the erroneously adopted implementation
specification, the Complete EHR or EHR Module certified in accordance
with those provisions would not be capable of fulfilling the
fundamental requirements of syndromic surveillance, as explained above.
Consequently, a Complete EHR or EHR Module that was developed in
accordance with HL7 Version 2.5.1 and would otherwise meet all other
applicable certification criteria could not be successfully certified
until the removal of the implementation specifications adopted in
error. We therefore believe that if left unchanged the erroneous
adoption of these implementation specifications would significantly and
adversely impact the ability of ONC-ATCBs from issuing, and EHR
technology developers from receiving, certifications in a timely
manner.
For all of 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 for the removal of the
erroneously adopted implementation specifications.
We also believe that a 30-day delay in the effective date is
contrary to the public interest for the reasons stated above and
because this interim final rule with comment would alleviate an
unnecessary burden on the health IT industry and impose no additional
legal requirements upon the regulated community. We therefore find good
cause for waiving the 30-day delay in the effective date for the
removal of the relevant implementation specifications. We note,
however, that we are providing the public with a 30-day period
following publication of this interim final rule to submit comments.
III. 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 to that document.
IV. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
V. Regulatory Impact Statement
We have examined the impacts of this interim final rule with
comment 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 (as amended by Executive Orders 13258 and
13422) 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 1 year). This interim final rule with comment
does not reach the economic threshold and, thus, is not considered a
major rule. Therefore, an RIA has not been prepared.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Individuals and States are not included in the
definition of a small entity. The entities impacted by this interim
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
receipts which ``indicates the maximum allowed for a concern and its
affiliates to be considered small entities.'' We are not preparing an
analysis for the RFA because we have determined, and the Secretary
certifies, that this interim final rule with comment imposes no new
requirements on small entities and, as such, will not have a
significant impact on a substantial number of small entities.
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 1 year of $100 million in
1995 dollars, updated annually for inflation. In 2010, that threshold
level is currently approximately $135 million. This interim final rule
with comment 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 requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this interim final rule with comment does not
impose any costs on State or local governments, the requirements of
Executive Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this
interim final rule with comment was reviewed by the Office of
Management and Budget.
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 insurance, Health records,
Hospitals, Incorporation by reference, Laboratories, Medicaid,
Medicare, Privacy, Reporting and recordkeeping requirements, Public
health, Security.
0
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
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.
[[Page 62690]]
0
2. Section 170.205 is amended by revising paragraph (d)(2) to read as
follows:
Sec. 170.205 Content exchange standards and implementation
specifications for exchanging electronic health information.
* * * * *
(d) * * *
(2) Standard. HL7 2.5.1 (incorporated by reference in Sec.
170.299).
* * * * *
0
3. Section 170.299 is amended by revising paragraph (g) to read as
follows:
Sec. 170.299 Incorporation by reference.
* * * * *
(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 Sec. 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 Sec.
170.205.
(3) HL7 2.5.1 Implementation Guide for Immunization Messaging
Release 1.0, May 1, 2010, IBR approved for Sec. 170.205.
(4) [Reserved]
0
4. Section 170.302 is amended by revising paragraph (l) to read as
follows:
Sec. 170.302 General certification criteria for Complete EHRs or EHR
Modules.
* * * * *
(l) Public health surveillance. Electronically record, modify,
retrieve, and submit syndrome-based public health surveillance
information in accordance with the standard specified in Sec.
170.205(d)(1) or Sec. 170.205(d)(2).
* * * * *
Dated: October 6, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-25683 Filed 10-8-10; 11:15 am]
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