[Federal Register Volume 76, Number 213 (Thursday, November 3, 2011)]
[Notices]
[Page 68192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Temporary Certification Program; Notice of Extension

AGENCY: Office of the National Coordinator for Health Information 
Technology, HHS.

ACTION: Notice.

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SUMMARY: This notice announces the decision made by the National 
Coordinator for Health Information Technology (the National 
Coordinator) to extend the Temporary Certification Program.

    Authority:  Section 3001(c)(5) of the Public Health Service Act 
(PHSA) as added by the Health Information Technology for Economic 
and Clinical Health (HITECH) Act.

FOR FURTHER INFORMATION CONTACT: Steve Posnack, Director, Federal 
Policy Division, Office of Policy and Planning, Office of the National 
Coordinator for Health Information Technology.

SUPPLEMENTARY INFORMATION: On June 24, 2010, the Office of the National 
Coordinator for Health Information Technology (ONC) published a final 
rule (75 FR 36158) to establish a temporary certification program for 
health information technology. The temporary certification program 
would ensure that Certified EHR Technology was available for adoption 
and use by eligible professionals (EPs), eligible hospitals, and 
critical access hospitals (CAHs) for the Medicare and Medicaid EHR 
Incentive Programs beginning in 2011. On January 7, 2011, ONC published 
a final rule (76 FR 1262) to establish a permanent certification 
program for health information technology, which would eventually 
replace the temporary certification program. Under 45 CFR 170.490 and 
as discussed in the temporary certification program final rule (75 FR 
36184), the temporary certification program will sunset on December 31, 
2011, or if the permanent certification program is not fully 
constituted at that time, then upon a subsequent date that is 
determined to be appropriate by the National Coordinator. As we 
explained in the temporary certification program final rule (75 FR 
36185), to determine whether the permanent certification program is 
fully constituted, the National Coordinator will consider whether there 
are a sufficient number of ONC-Authorized Certification Bodies (ONC-
ACBs) and accredited testing laboratories to address current market 
demand. We refer readers to the final rule (76 FR 1262) for more 
information about accreditation, testing, and certification activities 
under the permanent certification program.
    After consulting with the current ONC-Approved Accreditor (ONC-AA) 
for the permanent certification program (the American National 
Standards Institute (ANSI)) and the National Institute of Standards and 
Technology (NIST), which administers the National Voluntary Laboratory 
Accreditation Program (NVLAP) for health information technology, we do 
not anticipate that there will be a sufficient number of accredited 
testing laboratories or ONC-ACBs until summer 2012. We base this 
conclusion on ANSI and NVLAP's estimations of the amount of time needed 
to complete the accreditation of certification bodies and testing 
laboratories, as well as our estimation of the time period for the 
National Coordinator to review the applications of accredited 
certification bodies and subsequently authorize them as ONC-ACBs.
    On this basis, the National Coordinator has determined it is 
necessary to extend the temporary certification program past the 
established sunset date of December 31, 2011. If the National 
Coordinator were to take no action, the temporary certification program 
would end on that date without a replacement program fully in place to 
ensure the continued availability of Certified EHR Technology for EPs 
and hospitals that seek to achieve meaningful use and participate in 
the EHR Incentive Programs. We believe that the sunset of the temporary 
certification program should be tied to the effective date of the final 
rule that we intend to issue in summer 2012, which is expected to adopt 
new and revised standards, implementation specifications, and 
certification criteria for EHR technology in support of the next stage 
of meaningful use under the Medicare and Medicaid EHR Incentive 
Programs. We believe aligning the sunset of the temporary certification 
program with the effective date of this forthcoming final rule would 
provide certainty to health care providers, EHR technology developers, 
and other stakeholders, while also ensuring a sufficient number of 
accredited testing laboratories and ONC-ACBs exist to meet market 
demand. Although we believe this timeline is feasible based on current 
expectations as discussed above, we recognize unanticipated events may 
make it necessary to reconsider the sunset date for the temporary 
certification program. We will publish another Federal Register notice 
to inform the public of any changes to our expected sunset date for the 
temporary certification program.
    As stated in the temporary certification program final rule (75 FR 
36184), when the temporary certification program sunsets, ONC-
Authorized Testing and Certification Bodies (ONC-ATCBs) will be 
prohibited from accepting new requests to test and certify EHR 
technology and will be permitted up to six months after the sunset date 
to complete all testing and certification activities associated with 
requests received prior to the sunset date. If these activities are not 
completed within the 6-month period, the EHR technology would have to 
be resubmitted for testing and certification under the permanent 
certification program.

    Dated: October 28, 2011.
Farzad Mostashari,
National Coordinator for Health Information Technology.
[FR Doc. 2011-28492 Filed 11-2-11; 8:45 am]
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