Medicare Program; Approved Renewal of Deeming Authority of the National Committee for Quality Assurance for Medicare Advantage Health Maintenance Organizations and Preferred Provider Organizations
| Published date | 15 March 2021 |
| Record Number | 2021-05322 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services |
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Federal Register / Vol. 86, No. 48 / Monday, March 15, 2021 / Notices
campaign. CDC will carefully consider
all comments submitted into the docket.
Written Public Comment: Written
comments must be received on or before
May 5, 2021.
Oral Public Comment: This meeting
will include time for members of the
public to make an oral comment. Oral
public comment will occur before any
scheduled votes including all votes
relevant to the ACIP’s Affordable Care
Act and Vaccines for Children Program
roles. Priority will be given to
individuals who submit a request to
make an oral public comment before the
meeting according to the procedures
below.
Procedure for Oral Public Comment:
All persons interested in making an oral
public comment at the May ACIP
meeting must submit a request at http://
www.cdc.gov/vaccines/acip/meetings/
no later than 11:59 p.m., EDT, April 30,
2021, according to the instructions
provided.
If the number of persons requesting to
speak is greater than can be reasonably
accommodated during the scheduled
time, CDC will conduct a lottery to
determine the speakers for the
scheduled public comment session.
CDC staff will notify individuals
regarding their request to speak by email
by May 3, 2021. To accommodate the
significant interest in participation in
the oral public comment session of
ACIP meetings, each speaker will be
limited to 3 minutes, and each speaker
may only speak once per meeting.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–05216 Filed 3–12–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4195–FN]
Medicare Program; Approved Renewal
of Deeming Authority of the National
Committee for Quality Assurance for
Medicare Advantage Health
Maintenance Organizations and
Preferred Provider Organizations
AGENCY
: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION
: Final notice.
SUMMARY
: This final notice announces
our decision to renew the Medicare
Advantage ‘‘deeming authority’’ of the
National Committee for Quality
Assurance (NCQA) for health
maintenance organizations and
preferred provider organizations for a
term of 6 years.
DATES
: The decision announced in this
final notice is effective December 30,
2020 through December 30, 2026.
FOR FURTHER INFORMATION CONTACT
: Greg
McDonald, (410) 786–8941.
SUPPLEMENTARY INFORMATION
:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services through a Medicare Advantage
(MA) organization that contracts with
CMS. The regulations specifying the
Medicare requirements that must be met
for a Medicare Advantage Organization
(MAO) to enter into a contract with
CMS are located at 42 CFR part
422.These regulations implement Part C
of Title XVIII of the Social Security Act
(the Act), which specifies the services
that an MAO must provide and the
requirements that the organization must
meet to be an MA contractor. Other
relevant sections of the Act are Parts A
and B of Title XVIII and Part A of Title
XI pertaining to the provision of
services by Medicare certified providers
and suppliers. Generally, for an entity to
be an MA organization, the organization
must be licensed by the state as a risk
bearing organization, as set forth in 42
CFR part 422.
As a method of assuring compliance
with certain Medicare requirements, an
MA organization may choose to become
accredited by a CMS-approved
accrediting organization (AO). By virtue
of its accreditation by a CMS-approved
AO, the MA organization may be
‘‘deemed’’ compliant in one or more
requirements set forth in section
1852(e)(4)(B) of the Act. For CMS to
recognize an AO’s accreditation
program as establishing an MA plan’s
compliance with our requirements, the
AO must prove to CMS that its
standards are at least as stringent as
Medicare requirements for MA
organizations. MA organizations that are
licensed as health maintenance
organizations (HMOs) or preferred
provider organizations (PPOs) and are
accredited by an approved accrediting
organization may receive, at their
request, deemed status for CMS
requirements with respect to the
deemable areas. At this time,
recognition of accreditation does not
include the Part D areas of review set
out at 42 CFR 423.165(b). AOs that
apply for MA deeming authority are
generally recognized by the health care
industry as entities that accredit HMOs
and PPOs. As we specify at
§ 422.157(b)(2)(ii), the term for which an
AO may be approved by CMS may not
exceed 6 years. For continuing approval,
the AO must apply to CMS to renew
their deeming authority for a subsequent
approval period.
The National Committee for Quality
Assurance (NCQA) was last approved as
a CMS-approved accreditation
organization for MA deeming of HMOs
and PPOs for a 6-year term beginning on
October 19, 2014, and that term lapsed
on October 18, 2020, prior to our
decision on its renewal application.
NCQA did not accredit or re-accredit
any HMOs or PPOs for MA deeming
between that date and December 30,
2020, the effective date of its re-
approval. On May 22, 2020, NCQA
submitted an application to renew its
deeming authority. On that same date,
NCQA submitted materials requested by
CMS that included information
intended to address the requirements set
out at § 422.158(a) and (b) that are
prerequisites for receiving approval of
its accreditation program from CMS.
CMS subsequently requested that
additional materials and revisions be
submitted by NCQA to satisfy these
requirements. NCQA submitted all the
necessary materials to enable us to make
a determination concerning its request
for approval as an accreditation
organization, and the renewal
application was determined to be
complete on August 28, 2020.
II. Provisions of the Proposed Notice
In the November 9, 2020 Federal
Register (85 FR 71346), we published a
proposed notice announcing NCQA’s
request to renew its Medicare
Advantage deeming authority for HMOs
and PPOs. In the November 9, 2020
proposed notice, we detailed our
evaluation criteria. Under section
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Federal Register / Vol. 86, No. 48 / Monday, March 15, 2021 / Notices
1852(e)(4) of the Act and § 422.158
(Federal review of accrediting
organizations), we conducted a review
of NCQA’s application in accordance
with the criteria specified by our
regulations which include, but are not
limited to the following:
•The types of MA plans that it would
review as part of its accreditation
process.
•A detailed comparison of the AO’s
accreditation requirements and
standards with the Medicare
requirements (for example, a crosswalk)
in the following 5 areas: Quality
Improvement, Anti-Discrimination,
Confidentiality and Accuracy of
Enrollee Records, Information on
Advance Directives, and Provider
Participation Rules.
•Detailed information about the
organization’s survey process,
including—
++ Frequency of surveys and whether
surveys are announced or unannounced.
++ Copies of survey forms, and
guidelines and instructions to
surveyors.
++ Descriptions of—
— The survey review process and the
accreditation status decision making
process;
— The procedures used to notify
accredited MA organizations of
deficiencies and to monitor the
correction of those deficiencies; and
— The procedures used to enforce
compliance with accreditation
requirements.
•Detailed information about the
individuals who perform surveys for the
accreditation organization, including—
++ The size and composition of
accreditation survey teams for each type
of plan reviewed as part of the
accreditation process;
++ The education and experience
requirements surveyors must meet;
++ The content and frequency of the
in-service training provided to survey
personnel;
++ The evaluation systems used to
monitor the performance of individual
surveyors and survey teams; and
++ The organization’s policies and
practice with respect to the
participation, in surveys or in the
accreditation decision process, by an
individual who is professionally or
financially affiliated with the entity
being surveyed.
•A description of the organization’s
data management and analysis system
with respect to its surveys and
accreditation decisions, including the
kinds of reports, tables, and other
displays generated by that system.
•A description of the organization’s
procedures for responding to and
investigating complaints against
accredited organizations, including
policies and procedures regarding
coordination of these activities with
appropriate licensing bodies and
ombudsmen programs.
•A description of the organization’s
policies and procedures with respect to
the withholding or removal of
accreditation for failure to meet the
accreditation organization’s standards or
requirements, and other actions the
organization takes in response to
noncompliance with its standards and
requirements.
•A description of all types (for
example, full, partial) and categories (for
example, provisional, conditional,
temporary) of accreditation offered by
the organization, the duration of each
type and category of accreditation and a
statement identifying the types and
categories that would serve as a basis for
accreditation if CMS approves the
accreditation organization.
•A list of all currently accredited MA
organizations and the type, category,
and expiration date of the accreditation
held by each of them.
•A list of all full and partial
accreditation surveys scheduled to be
performed by the accreditation
organization.
•The name and address of each
person with an ownership or control
interest in the accreditation
organization.
•CMS also considers NCQA’s past
performance in the deeming program
and results of recent deeming validation
reviews or look-behind audits
conducted as part of continuing federal
oversight of the deeming program under
§ 422.157(d).
In accordance with section
1865(a)(3)(A) of the Act, the November
9, 2020 proposed notice (85 FR 71346)
also solicited public comments
regarding whether NCQA’s
requirements met or exceeded the
Medicare conditions of participation as
an accrediting organization for MA
HMOs and PPOs.
III. Analysis of and Responses to Public
Comments on the Proposed Notice
We received one public comment
which is outside the scope of the MA
deeming application renewal process.
IV. Provisions of the Final Notice
A. Differences Between NCQA’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey Requirements
We compared the standards and
survey process contained in NCQA’s
application with the Medicare
conditions for accreditation. Our review
and evaluation of NCQA’s application
for continued CMS approval were
conducted as described in section II. of
this final notice, and yielded the
following:
•Pursuant to § 422.158(a)(2), NCQA
amended its crosswalk and standards to
ensure current NCQA standards are
clearly cross-walked to our regulations
in each of five deemable areas: Quality
Improvement, Anti-discrimination,
Confidentiality and Accuracy of
Enrollee Records, Information on
Advance Directives, and Provider
Participation Rules.
•NCQA submitted additional
information and/or documentation
regarding its survey process that was
intended to address our regulations at
§§ 422.158(a)(1), (a)(3)(i), (a)(3)(ii),
(a)(3)(iii)(A) through (C), (a)(4)(iii), (a)(6)
through (11), and (b)(1) and (2).
B. Term of Approval
Based on the review and observations
described in section II. of this final
notice, we have determined that
NCQA’s accreditation program
requirements meet or exceed our
requirements. Therefore, we approved
NCQA as a national accreditation
organization with deeming authority for
MA HMOs and PPOs on December 30,
2020 for a term of approval to continue
through December 30, 2026. We
informed NCQA of their renewal via a
letter from CMS dated December 30,
2020.
V. Collection of Information
Requirements
This notice announces the new term
of approval for NCQA. Since it does not
impose information collection
requirements, that is, reporting,
recordkeeping or third party disclosure
requirements, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
VI. Regulatory Impact Statement
In accordance with the provisions of
Executive Order 12866, this regulation
was not reviewed by the Office of
Management and Budget.
The Acting Administrator of the
Centers for Medicare & Medicaid
Services (CMS), Elizabeth Richter,
having reviewed and approved this
document, authorizes Lynette Wilson,
who is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
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Federal Register / Vol. 86, No. 48 / Monday, March 15, 2021 / Notices
Dated: March 10, 2021.
Lynette Wilson,
Federal Register Liaison, Department of
Health and Human Services.
[FR Doc. 2021–05322 Filed 3–12–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Engineered Tumor
Infiltrating Lymphocytes for Cancer
Therapy; Correction
AGENCY
: National Institutes of Health,
HHS.
ACTION
: Notice; correction.
SUMMARY
: The Department of Health and
Human Services, National Institutes of
Health published a Notice in the
Federal Register on February 25, 2021.
That Notice requires a correction in the
SUPPLEMENTARY INFORMATION
section.
SUPPLEMENTARY INFORMATION
:
Correction
In the Federal Register of February
25, 2021, in FR Doc. 2021–03873, on
page 11548, as found within the
SUPPLEMENTARY INFORMATION
section,
correct to read:
The use of the Licensed Patent Rights to
develop, manufacture, distribute, sell, and
use autologous tumor infiltrating lymphocyte
(TIL) adoptive cell therapy products for the
treatment of metastatic melanoma, lung,
breast, bladder, and HPV-positive cancers.
Specifically excluded from this Agreement
are cell therapy products involving TIL
genetically modified for reactivity against
cancer-specific mutations or TIL selected for
reactivity against cancer-specific mutations,
unless such cell therapy products are a
combination of unselected, unmodified TIL
therapy with the Licensee’s proprietary
technologies or the Licensee’s in-licensed
technologies.
The field of use described in the
Notice was found to be incorrect. The
correction addresses this discrepancy by
accurately stating the field of use which
the NIH intends to grant to Iovance
Biotherapeutics, Inc for the disclosed
federally owned invention.
ADDRESSES
: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center,
Telephone: (240)–276–5484; Email:
andy.burke@nih.gov.
Dated: March 9, 2021.
Daniel R Hernandez,
Federal Register Officer, National Institutes
of Health.
[FR Doc. 2021–05272 Filed 3–12–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development,
Production, and Commercialization of
Ebola Neutralizing Single Monoclonal
Antibody for the Treatment of Ebola
Virus Disease in Humans
AGENCY
: National Institutes of Health,
HHS.
ACTION
: Notice.
SUMMARY
: The National Institute of
Allergy and Infectious Diseases, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
U.S. and European Patents and Patent
Applications listed in the
Supplementary Information section of
this Notice to Ridgeback
Biotherapeutics, L.P., located in Miami,
Florida.
DATES
: Only written comments and/or
applications for a license which are
received by the National Institute of
Allergy and Infectious Diseases’
Technology Transfer and Intellectual
Property Office on or before March 30,
2021 will be considered.
ADDRESSES
: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Daniel Lee, J.D., Technology
Transfer and Patent Specialist, National
Institute of Allergy and Infectious
Diseases Technology Transfer and
Intellectual Property Office by email
(daniel.lee5@nih.gov) or phone (301–
761–6327).
SUPPLEMENTARY INFORMATION
:
Intellectual Property
E–045–2015: Neutralizing Antibodies to
Ebolavirus Glycoprotein and Their Use
1. United States Provisional Patent
Application No. 62/087,087, filed 3
December 2014 (HHS Reference No. E–
045–2015–0–US–01);
2. International Patent Application
No. PCT/US2015/060733, filed 13
November 2015 (HHS Reference No. E–
045–2015–0–PCT–02);
3. European Patent Application No.
15797815.6, filed 13 November 2015
(HHS Reference No. E–045–2015–0–EP–
03); and
4. United States Patent No.
10,273,288, issued 30 April 2019 (HHS
Reference No. E–045–2015–0–US–05).
The patent and patent application
rights in these inventions have been
assigned and/or exclusively licensed to
the government of the United States of
America.
The prospective exclusive license
territory may be worldwide and the
fields of use may be limited to the
following: Development, production,
and commercialization of Ebola
neutralizing monoclonal antibody
mAb114, as a single antibody not in
combination with other monoclonal
antibodies, for the treatment of Ebola
virus disease in humans.
This technology discloses the
discovery, isolation, production, and
advancement in the development of
recombinant neutralizing antibodies
specific to the Ebola virus glycoprotein,
varying Ebola virus glycoprotein
recognition profiles, and increasing
neutralization potency for a therapeutic
in a patient diagnosed with Ebola virus.
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR 404. The
prospective exclusive license will be
royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published Notice, the National
Institute of Allergy and Infectious
Diseases 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.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
commercialization license. In response
to this notice, the public may file
comments or objections. Comments and
objections, other than those in the form
of a license application, will not be
treated confidentially, and may be made
publicly available. License applications
submitted in response to this notice will
be presumed to contain business
confidential information. and any
release of information from these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
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