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]

Download as PDF 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 Frm 00039 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

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[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
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