Health Insurance Exchanges; Approval of an Application by the Accreditation Association for Ambulatory Health Care (AAAHC) To Be a Recognized Accrediting Entity for the Accreditation of Qualified Health Plans, 77470-77471 [2013-30522]
Download as PDF
<![CDATA[
77470
Federal Register / Vol. 78, No. 246 / Monday, December 23, 2013 / Notices
recommendations must be received in
one of the following ways by January 2,
2014:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier (CMS–
10510), Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850 and, OMB Office of Information
and Regulatory Affairs, Attention: CMS
Desk Officer, New Executive Office
Building, Room 10235, Washington, DC
20503, Fax Number: 202–395–6974.
Dated: December 17, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–30434 Filed 12–18–13; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–9953–FN]
Health Insurance Exchanges; Approval
of an Application by the Accreditation
Association for Ambulatory Health
Care (AAAHC) To Be a Recognized
Accrediting Entity for the Accreditation
of Qualified Health Plans
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve the
Accreditation Association for
Ambulatory Health Care (AAAHC) for
recognition as an accrediting entity for
the purposes of fulfilling the
accreditation requirement as part of
qualified health plan (QHP)
certification.
SUMMARY:
This notice is effective on
December 23, 2013.
tkelley on DSK3SPTVN1PROD with NOTICES
DATE:
FOR FURTHER INFORMATION CONTACT:
Rebecca Zimmermann, (301) 492–4396.
SUPPLEMENTARY INFORMATION:
I. Background
Regulations at 45 CFR 156.275(c)
require qualified health plan (QHP)
VerDate Mar<15>2010
18:12 Dec 20, 2013
Jkt 232001
issuers to be accredited on the basis of
local performance of its QHPs by an
accrediting entity recognized by the
Secretary (the Secretary) of the
Department of Health and Human
Services (HHS). In a final rule published
on July 20, 2012 titled, ‘‘Data Collection
To Support Standards Related to
Essential Health Benefits; Recognition of
Entities for the Accreditation of
Qualified Health Plans (77 FR 42658),’’
we established the first phase of an
intended two-phase approach to
recognize accrediting entities and
proposed both the National Committee
for Quality Assurance (NCQA) and
URAC as recognized accrediting
entities. On November 23, 2012, we
notified the public that NCQA and
URAC had both met the requirements in
the July 2012 final rule to be recognized
as accrediting entities
(§ 156.275(c)(1)(iv)) and were
recognized by the Secretary 1 as
accrediting entities for the purposes of
QHP certification.
On February 25, 2013, we published
a subsequent final rule, titled,
‘‘Standards Related to Essential Health
Benefits, Actuarial Value, and
Accreditation’’ (78 FR 12834),2 which
amended § 156.275(c) to establish an
application and review process to allow
additional accrediting entities to seek
recognition. The application submitted
by an accrediting entity must include
documentation described in
§ 156.275(c)(4) and demonstrate, in a
concise and organized fashion, how the
accrediting entity meets the
requirements of § 156.275(c)(2) and (3).
Specifically, to be recognized, an
accrediting entity must provide current
accreditation standards and
requirements, processes, and measure
specifications for performance measures
to demonstrate via a crosswalk that it
meets the conditions described in
§ 156.275(c)(2) and (c)(3). Further, once
recognized, § 156.275(c)(4)(ii) requires
accrediting entities to provide the
Secretary with any proposed changes or
updates to the accreditation standards
and requirements, processes, and
measure specifications for performance
measures with 60 days’ notice prior to
public notification. Lastly,
§ 156.275(c)(5) requires recognized
accrediting entities, when authorized by
an accredited QHP issuer, to provide
1 Certain authority under the Affordable Care Act
has been delegated from the Secretary to the
Administrator of CMS. 76 FR 53903 through 53906,
(August 30, 2011).
2 Patient Protection and Affordable Care Act;
Standards Related to Essential Health Benefits,
Actuarial Value, and Accreditation; Final Rule, 78
FR 12834, 12854–12855 (February 25, 2013) (45
CFR 156.275(c)).
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
specific QHP issuer accreditation survey
data elements, other than personally
identifiable information, to the
Exchange in which the issuer plans to
operate one or more QHPs during the
annual certification or as changes occur
in the data elements throughout the
coverage year.
II. Provisions of the Proposed Notice
On September 13, 2013, we published
in the Federal Register a proposed
notice 3 announcing the receipt of an
application from the Accreditation
Association for Ambulatory Health Care
(AAAHC) to be a recognized accrediting
entity for the purposes of fulfilling the
accreditation requirement as part of
qualified health plan certification. In the
proposed notice, we provided a detailed
analysis of whether AAAHC meet the
requirements as specified in our
regulations at § 156.275. In addition, we
solicited public comments on whether it
was appropriate to recognize AAAHC as
an accrediting entity for the purpose of
QHP certification; AAAHC’s
accreditation standards for QHP issuers
including whether or not AAAHC’s
standards meet the requirements in
§ 156.275; whether AAAHC had any
deficiencies in its standards; the content
of the proposed clinical quality
measures and their appropriateness for
use in QHP accreditation; the rigor of
the scoring methodology; and if the
network adequacy standards will ensure
sufficient network of providers for QHP
enrollees.
III. Analysis of and Response to Public
Comments on the Proposed Notice
We received nine public comments in
response to the September 13, 2013
proposed notice. Five commenters
supported the recommendation to
recognize AAAHC as an accrediting
entity for the purposes of QHP
accreditation; whereas two commenters
did not support the proposal to
recognize AAAHC as an accrediting
entity. Two commenters provided
comments that were outside the scope
of the proposed notice.
One commenter questioned the
comparability of AAAHC’s standards to
other HHS-recognized accrediting
entities. Another commenter requested
that more child measures be included in
the clinical quality metrics. Both of
these commenters thought that the
accreditation standards were not
sufficiently transparent.
3 Health Insurance Exchanges; Application by the
Accreditation Association for Ambulatory Health
Care To Be a Recognized Accrediting Entity for the
Accreditation of Qualified Health Plans; 78 FR
56711–56714 (September 13, 2013).
E:\FR\FM\23DEN1.SGM
23DEN1
Federal Register / Vol. 78, No. 246 / Monday, December 23, 2013 / Notices
While there may be some instances
where AAAHC’s standards differ from
other recognized accrediting entities,
AAAHC has met the criteria to be
recognized by HHS based on our
standards in § 156.275(c). We believe
there is a sufficient number of measures
applicable to children included in the
proposed clinical quality metrics and
further note that the AAAHC’s measure
set is identical to the set used by a
different HHS-recognized accrediting
entity (that is, URAC). Lastly, the
accreditation standards are propriety
documents and we have not required
any of the recognized accrediting
entities to make their standards public.
Therefore, we cannot require AAAHC to
make their standards public.
In addition, we have previously
indicated that we may, at a later date,
modify the recognition process of
accrediting entities and will solicit
comments on any proposed future
rulemaking that time.
IV. Provisions of the Final Notice
Upon completion of our analysis,
including evaluation of comments
received as a result of the proposed
notice, we have determined that the
AAAHC meets the requirements and
criteria described in the July 20, 2012
final rule, titled ‘‘Data Collection To
Support Standards Related to Essential
Health Benefits; Recognition of Entities
for the Accreditation of Qualified Health
Plans’’ (77 FR 42658) to be recognized
as an accrediting entity. This final
notice acknowledges the approval of
AAAHC’s application. The AAAHC is
now recognized by the Secretary of
HHS 4 as an accrediting entity for the
purposes of QHP certification.
V. Collection of Information
Requirements
tkelley on DSK3SPTVN1PROD with NOTICES
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.
Dated: December 17, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2013–30522 Filed 12–20–13; 8:45 am]
BILLING CODE 4120–01–P
4 Delegated
to CCIIO, 76 FR 53903 through 53906
(August 30, 2011).
VerDate Mar<15>2010
18:12 Dec 20, 2013
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License for: Convection Enhanced
Delivery of a Therapeutic Agent With a
Surrogate Tracer for Treating Cancer
and Urological Diseases
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404.7,
that the National Institutes of Health
(NIH), Department of Health and Human
Services, is contemplating the grant of
an exclusive worldwide license to
practice the inventions embodied in:
HHS Ref. No E–202–2002/0 ‘‘Method for
Convection Enhanced Delivery of
Therapeutic Agents’’, U.S. Provisional
Patent Application 60/413,673 (filed
September 24, 2002; expired),
International Patent Application No.
PCT/US2003/30155 (filed September 24,
2003; nationalized), U.S. Patent
Application 7,371,225, European Patent
Application 03756863.1, Australian
Patent 2003299140, to Medicenna
Therapeutics, Inc. having a principle
place of business in 1075 West Georgia
St., Vancouver, BC, Canada V6E 3C9.
The United States of America is an
assignee to the patent rights of these
inventions.
The contemplated exclusive license
may be in a field of use directed to the
treatment of cancers and urological
disorders that express IL–4 receptor on
their cell surface by administering
cpIL4–PE38KDEL by convection
enhanced deliver along with a Gd-DTPA
surrogate tracer.
DATES: Only written comments and/or
applications for a license that are
received by the NIH Office of
Technology Transfer on or before
January 22, 2014 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Michael Shmilovich, Esq, CLP,
Senior Licensing and Patent Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5019; Facsimile: (301) 402–0220; Email:
shmilovm@mail.nih.gov. A signed
confidential disclosure agreement may
be required to receive copies of the
patent application assuming it has not
already been published under either the
publication rules of either the U.S.
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
77471
Patent and Trademark Office or the
World Intellectual Property
Organization.
SUPPLEMENTARY INFORMATION: The
invention is a method for monitoring
the spatial distribution of therapeutic
substances by MRI or CT that have been
administered to tissue using convection
enhanced delivery, a technique that is
the subject of now expired NIH-owned
U.S. Patent No. 5,720,720 (HHS Ref. E–
173–1992/0). The tracer is a molecule,
detectable by MRI or CT, which
functions as a surrogate for the motion
of the therapeutic agent through the
solid tissue. In other particular
embodiments, the tracer is the
therapeutic agent conjugated to an
imaging moiety. The method of this
invention uses non-toxic
macromolecular MRI contrast agents
such as chelated Gd(III). These
macromolecular imaging agents have
clearance properties that mimic the
pharmacokinetic properties of coadministrated drugs, so as to be useful
in quantifying the range and dosage
level of therapeutic drugs using MR
imaging.
The prospective exclusive license will
be royalty-bearing and comply with the
terms and conditions of 35 U.S.C. 209
and 37 CFR 404.7. The prospective
exclusive license may be granted unless,
within 30 days from the date of this
published notice, NIH receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR 404.7.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: December 17, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–30430 Filed 12–20–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Clinical Center; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
E:\FR\FM\23DEN1.SGM
23DEN1
]]>Agencies
[Federal Register Volume 78, Number 246 (Monday, December 23, 2013)]
[Notices]
[Pages 77470-77471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30522]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9953-FN]
Health Insurance Exchanges; Approval of an Application by the
Accreditation Association for Ambulatory Health Care (AAAHC) To Be a
Recognized Accrediting Entity for the Accreditation of Qualified Health
Plans
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This final notice announces our decision to approve the
Accreditation Association for Ambulatory Health Care (AAAHC) for
recognition as an accrediting entity for the purposes of fulfilling the
accreditation requirement as part of qualified health plan (QHP)
certification.
DATE: This notice is effective on December 23, 2013.
FOR FURTHER INFORMATION CONTACT: Rebecca Zimmermann, (301) 492-4396.
SUPPLEMENTARY INFORMATION:
I. Background
Regulations at 45 CFR 156.275(c) require qualified health plan
(QHP) issuers to be accredited on the basis of local performance of its
QHPs by an accrediting entity recognized by the Secretary (the
Secretary) of the Department of Health and Human Services (HHS). In a
final rule published on July 20, 2012 titled, ``Data Collection To
Support Standards Related to Essential Health Benefits; Recognition of
Entities for the Accreditation of Qualified Health Plans (77 FR
42658),'' we established the first phase of an intended two-phase
approach to recognize accrediting entities and proposed both the
National Committee for Quality Assurance (NCQA) and URAC as recognized
accrediting entities. On November 23, 2012, we notified the public that
NCQA and URAC had both met the requirements in the July 2012 final rule
to be recognized as accrediting entities (Sec. 156.275(c)(1)(iv)) and
were recognized by the Secretary \1\ as accrediting entities for the
purposes of QHP certification.
---------------------------------------------------------------------------
\1\ Certain authority under the Affordable Care Act has been
delegated from the Secretary to the Administrator of CMS. 76 FR
53903 through 53906, (August 30, 2011).
---------------------------------------------------------------------------
On February 25, 2013, we published a subsequent final rule, titled,
``Standards Related to Essential Health Benefits, Actuarial Value, and
Accreditation'' (78 FR 12834),\2\ which amended Sec. 156.275(c) to
establish an application and review process to allow additional
accrediting entities to seek recognition. The application submitted by
an accrediting entity must include documentation described in Sec.
156.275(c)(4) and demonstrate, in a concise and organized fashion, how
the accrediting entity meets the requirements of Sec. 156.275(c)(2)
and (3). Specifically, to be recognized, an accrediting entity must
provide current accreditation standards and requirements, processes,
and measure specifications for performance measures to demonstrate via
a crosswalk that it meets the conditions described in Sec.
156.275(c)(2) and (c)(3). Further, once recognized, Sec.
156.275(c)(4)(ii) requires accrediting entities to provide the
Secretary with any proposed changes or updates to the accreditation
standards and requirements, processes, and measure specifications for
performance measures with 60 days' notice prior to public notification.
Lastly, Sec. 156.275(c)(5) requires recognized accrediting entities,
when authorized by an accredited QHP issuer, to provide specific QHP
issuer accreditation survey data elements, other than personally
identifiable information, to the Exchange in which the issuer plans to
operate one or more QHPs during the annual certification or as changes
occur in the data elements throughout the coverage year.
---------------------------------------------------------------------------
\2\ Patient Protection and Affordable Care Act; Standards
Related to Essential Health Benefits, Actuarial Value, and
Accreditation; Final Rule, 78 FR 12834, 12854-12855 (February 25,
2013) (45 CFR 156.275(c)).
---------------------------------------------------------------------------
II. Provisions of the Proposed Notice
On September 13, 2013, we published in the Federal Register a
proposed notice \3\ announcing the receipt of an application from the
Accreditation Association for Ambulatory Health Care (AAAHC) to be a
recognized accrediting entity for the purposes of fulfilling the
accreditation requirement as part of qualified health plan
certification. In the proposed notice, we provided a detailed analysis
of whether AAAHC meet the requirements as specified in our regulations
at Sec. 156.275. In addition, we solicited public comments on whether
it was appropriate to recognize AAAHC as an accrediting entity for the
purpose of QHP certification; AAAHC's accreditation standards for QHP
issuers including whether or not AAAHC's standards meet the
requirements in Sec. 156.275; whether AAAHC had any deficiencies in
its standards; the content of the proposed clinical quality measures
and their appropriateness for use in QHP accreditation; the rigor of
the scoring methodology; and if the network adequacy standards will
ensure sufficient network of providers for QHP enrollees.
---------------------------------------------------------------------------
\3\ Health Insurance Exchanges; Application by the Accreditation
Association for Ambulatory Health Care To Be a Recognized
Accrediting Entity for the Accreditation of Qualified Health Plans;
78 FR 56711-56714 (September 13, 2013).
---------------------------------------------------------------------------
III. Analysis of and Response to Public Comments on the Proposed Notice
We received nine public comments in response to the September 13,
2013 proposed notice. Five commenters supported the recommendation to
recognize AAAHC as an accrediting entity for the purposes of QHP
accreditation; whereas two commenters did not support the proposal to
recognize AAAHC as an accrediting entity. Two commenters provided
comments that were outside the scope of the proposed notice.
One commenter questioned the comparability of AAAHC's standards to
other HHS-recognized accrediting entities. Another commenter requested
that more child measures be included in the clinical quality metrics.
Both of these commenters thought that the accreditation standards were
not sufficiently transparent.
[[Page 77471]]
While there may be some instances where AAAHC's standards differ
from other recognized accrediting entities, AAAHC has met the criteria
to be recognized by HHS based on our standards in Sec. 156.275(c). We
believe there is a sufficient number of measures applicable to children
included in the proposed clinical quality metrics and further note that
the AAAHC's measure set is identical to the set used by a different
HHS-recognized accrediting entity (that is, URAC). Lastly, the
accreditation standards are propriety documents and we have not
required any of the recognized accrediting entities to make their
standards public. Therefore, we cannot require AAAHC to make their
standards public.
In addition, we have previously indicated that we may, at a later
date, modify the recognition process of accrediting entities and will
solicit comments on any proposed future rulemaking that time.
IV. Provisions of the Final Notice
Upon completion of our analysis, including evaluation of comments
received as a result of the proposed notice, we have determined that
the AAAHC meets the requirements and criteria described in the July 20,
2012 final rule, titled ``Data Collection To Support Standards Related
to Essential Health Benefits; Recognition of Entities for the
Accreditation of Qualified Health Plans'' (77 FR 42658) to be
recognized as an accrediting entity. This final notice acknowledges the
approval of AAAHC's application. The AAAHC is now recognized by the
Secretary of HHS \4\ as an accrediting entity for the purposes of QHP
certification.
---------------------------------------------------------------------------
\4\ Delegated to CCIIO, 76 FR 53903 through 53906 (August 30,
2011).
---------------------------------------------------------------------------
V. 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.
Dated: December 17, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-30522 Filed 12-20-13; 8:45 am]
BILLING CODE 4120-01-P
