Medicare Program; Approved Renewal of Deeming Authority of the Utilization Review Accreditation Commission for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations, 23054-23055 [2019-10586]
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23054
Federal Register / Vol. 84, No. 98 / Tuesday, May 21, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4188–FN]
Medicare Program; Approved Renewal
of Deeming Authority of the Utilization
Review Accreditation Commission for
Medicare Advantage Health
Maintenance Organizations and Local
Preferred Provider Organizations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
This notice announces our
decision to renew the Medicare
Advantage ‘‘deeming authority’’ of the
Utilization Review Accreditation
Commission (URAC) for health
maintenance organizations and
preferred provider organizations for a
term of 6 years.
DATES: The renewal announced in this
notice is effective on May 31, 2019
through June 2, 2025.
FOR FURTHER INFORMATION CONTACT: Greg
McDonald, (410) 786–8941; or Nick
Proy, (410) 786–8407.
SUPPLEMENTARY INFORMATION:
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
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
VerDate Sep<11>2014
17:50 May 20, 2019
Jkt 247001
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 Utilization Review Accreditation
Commission (URAC) was approved as a
CMS-approved accreditation
organization for MA deeming of HMOs
and PPOs on May 26, 2012, and that
term lapsed on May 25, 2018, prior to
our decision on its renewal application.
On October 13, 2017, URAC submitted
an application to renew its deeming
authority. On that same date, URAC
submitted materials requested by CMS
that included information intended to
address the requirements set out at
§ 422.158(a) through (b) that are
prerequisites for receiving approval of
its accreditation program from CMS.
CMS subsequently requested that
additional materials, including
revisions, be submitted by URAC to
satisfy these requirements. URAC
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 November 8, 2018.
II. Provisions of the Proposed Notice
In the December 26, 2018 Federal
Register (83 FR 66271), we published a
proposed notice announcing URAC’s
request to renew its Medicare
Advantage deeming authority for HMOs
and PPOs. In the December 26, 2018
proposed notice, we detailed our
evaluation criteria. Under section
1852(e)(4) of the Act and § 422.158
(Federal review of accrediting
organizations), we conducted a review
of URAC’s application in accordance
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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
E:\FR\FM\21MYN1.SGM
21MYN1
Federal Register / Vol. 84, No. 98 / Tuesday, May 21, 2019 / Notices
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 URAC’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 December
26, 2018 proposed notice (83 FR 66271)
also solicited public comments
regarding whether URAC’s requirements
met or exceeded the Medicare
conditions of participation as an
accrediting organization for MA HMOs
and PPOs. We received no public
comments in response to the December
26, 2018 proposed notice (83 FR 66271).
III. Provisions of the Final Notice
jbell on DSK3GLQ082PROD with NOTICES
A. Differences Between URAC’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey Requirements
We compared the standards and
survey process contained in URAC’s
application with the Medicare
conditions for accreditation. Our review
and evaluation of URAC’s application
for continued CMS approval were
conducted as described in section II. of
this final notice, and yielded the
following:
• URAC amended its crosswalk to
ensure current URAC standards are
VerDate Sep<11>2014
17:50 May 20, 2019
Jkt 247001
clearly cross-walked to our regulations,
including the following regulatory
requirements for Quality Improvement;
Antidiscrimination, Confidentiality and
Accuracy of Enrollee Records,
Information on Advanced Directives,
and Provider Participation Rules:
§§ 422.101(f); 422.205(b); 422.110(a)
through (b); 422.118(a); 422.128(b);
422.152(a) and (b), (e) through (g);
422.202(a) through (d); 422.206(a)
through (b); 422.208(c), (e) through (g);
422.210(b); 422.212(a) through (d); and
422.216(f) through (h).
• URAC submitted additional
information and/or documentation
regarding its survey process that was
intended to address: § 422.158(a)(2),
(a)(3)(ii), (a)(3)(iii)(A) through (C),
(a)(4)(ii) and (iii), (a)(6) through (10),
and (b)(2).
B. Term of Approval
Based on the review and observations
described in section II. of this final
notice, we have determined that URAC’s
accreditation program requirements
meet or exceed our requirements.
Therefore, we approve URAC as a
national accreditation organization with
deeming authority for MA HMOs and
PPOs, effective May 21, 2019.
V. Collection of Information
Requirements
This notice announces the new term
of approval for the URAC. It does not
impose any information collection
requirements (that is, reporting,
recordkeeping or third-party disclosure
requirements). Consequently, 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.
Dated: May 2, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–10586 Filed 5–20–19; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
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Fmt 4703
Sfmt 4703
23055
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0801]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exports:
Notification and Recordkeeping
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 20,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0482. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Exports: Notification and
Recordkeeping Requirements—21 CFR
1.101
OMB Control Number 0910–0482—
Extension
Section 801 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
381) charges the Secretary of Health and
Human Services, through FDA, with the
responsibility of helping to ensure that
exports of unapproved new drugs,
biologics, devices, animal drugs, food,
cosmetics, and tobacco products which
are not to be sold in the United States
E:\FR\FM\21MYN1.SGM
21MYN1
Agencies
[Federal Register Volume 84, Number 98 (Tuesday, May 21, 2019)]
[Notices]
[Pages 23054-23055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10586]
[[Page 23054]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-4188-FN]
Medicare Program; Approved Renewal of Deeming Authority of the
Utilization Review Accreditation Commission for Medicare Advantage
Health Maintenance Organizations and Local Preferred Provider
Organizations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces our decision to renew the Medicare
Advantage ``deeming authority'' of the Utilization Review Accreditation
Commission (URAC) for health maintenance organizations and preferred
provider organizations for a term of 6 years.
DATES: The renewal announced in this notice is effective on May 31,
2019 through June 2, 2025.
FOR FURTHER INFORMATION CONTACT: Greg McDonald, (410) 786-8941; or Nick
Proy, (410) 786-8407.
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 Sec.
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 Utilization Review Accreditation Commission (URAC) was approved
as a CMS-approved accreditation organization for MA deeming of HMOs and
PPOs on May 26, 2012, and that term lapsed on May 25, 2018, prior to
our decision on its renewal application. On October 13, 2017, URAC
submitted an application to renew its deeming authority. On that same
date, URAC submitted materials requested by CMS that included
information intended to address the requirements set out at Sec.
422.158(a) through (b) that are prerequisites for receiving approval of
its accreditation program from CMS. CMS subsequently requested that
additional materials, including revisions, be submitted by URAC to
satisfy these requirements. URAC 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 November 8, 2018.
II. Provisions of the Proposed Notice
In the December 26, 2018 Federal Register (83 FR 66271), we
published a proposed notice announcing URAC's request to renew its
Medicare Advantage deeming authority for HMOs and PPOs. In the December
26, 2018 proposed notice, we detailed our evaluation criteria. Under
section 1852(e)(4) of the Act and Sec. 422.158 (Federal review of
accrediting organizations), we conducted a review of URAC'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
[[Page 23055]]
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 URAC'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 Sec. 422.157(d).
In accordance with section 1865(a)(3)(A) of the Act, the December
26, 2018 proposed notice (83 FR 66271) also solicited public comments
regarding whether URAC's requirements met or exceeded the Medicare
conditions of participation as an accrediting organization for MA HMOs
and PPOs. We received no public comments in response to the December
26, 2018 proposed notice (83 FR 66271).
III. Provisions of the Final Notice
A. Differences Between URAC's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared the standards and survey process contained in URAC's
application with the Medicare conditions for accreditation. Our review
and evaluation of URAC's application for continued CMS approval were
conducted as described in section II. of this final notice, and yielded
the following:
URAC amended its crosswalk to ensure current URAC
standards are clearly cross-walked to our regulations, including the
following regulatory requirements for Quality Improvement;
Antidiscrimination, Confidentiality and Accuracy of Enrollee Records,
Information on Advanced Directives, and Provider Participation Rules:
Sec. Sec. 422.101(f); 422.205(b); 422.110(a) through (b); 422.118(a);
422.128(b); 422.152(a) and (b), (e) through (g); 422.202(a) through
(d); 422.206(a) through (b); 422.208(c), (e) through (g); 422.210(b);
422.212(a) through (d); and 422.216(f) through (h).
URAC submitted additional information and/or documentation
regarding its survey process that was intended to address: Sec.
422.158(a)(2), (a)(3)(ii), (a)(3)(iii)(A) through (C), (a)(4)(ii) and
(iii), (a)(6) through (10), and (b)(2).
B. Term of Approval
Based on the review and observations described in section II. of
this final notice, we have determined that URAC's accreditation program
requirements meet or exceed our requirements. Therefore, we approve
URAC as a national accreditation organization with deeming authority
for MA HMOs and PPOs, effective May 21, 2019.
V. Collection of Information Requirements
This notice announces the new term of approval for the URAC. It
does not impose any information collection requirements (that is,
reporting, recordkeeping or third-party disclosure requirements).
Consequently, 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.
Dated: May 2, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-10586 Filed 5-20-19; 8:45 am]
BILLING CODE 4120-01-P