[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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