[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66271-66273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27802]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-4188-PN]


Medicare Program; Request for Renewal of Deeming Authority of the 
Utilization Review Accreditation Commission (URAC) for Health 
Maintenance Organizations and Preferred Provider Organizations

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice announces that CMS is considering 
granting approval of the Utilization Review Accreditation Commission's 
(URAC) renewal application for Medicare Advantage ``deeming authority'' 
of Health Maintenance Organizations and Preferred Provider 
Organizations. This new 6-year term of approval would begin on the date 
of publication of the final notice. This notice also announces a 30-day 
period for the public to submit comments on CMS' renewal of the 
application.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. January 25, 2019.

ADDRESSES: In commenting, refer to file code CMS-4188-PN. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-4188-PN, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-4188-PN,

[[Page 66272]]

Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

FOR FURTHER INFORMATION CONTACT: Greg McDonald, (410) 786-8941; or Nick 
Proy, (410) 786-8407.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments.

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 their 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 for 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 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 
its initial 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.

II. Provisions of the Proposed Notice

    The purpose of this notice is to notify the public of URAC's 
request to renew its Medicare Advantage deeming authority for HMOs and 
PPOs. URAC submitted all the necessary materials (including its 
standards and monitoring protocol) to enable us to make a determination 
concerning its request for approval as an accreditation organization 
for CMS. This renewal application was determined to be complete on 
November 8, 2018. Under section 1852(e)(4) of the Act and Sec.  422.158 
(federal review of accrediting organizations), our review and 
evaluation of URAC will be conducted as discussed below.

A. Components of the Review Process

    The review of URAC's renewal application for approval of MA deeming 
authority includes, but is not limited to, the following components:
    <bullet> The types of MA plans that it would review as part of its 
accreditation process.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 for the participation, 
in surveys or in the accreditation decision process, by an individual 
who is professionally or financially affiliated with the entity being 
surveyed.
    <bullet> A description of the organization's data management and 
analysis system for the surveys and accreditation decisions, including 
the kinds of reports, tables, and other displays generated by that 
system.
    <bullet> 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.
    <bullet> A description of the organization's policies and 
procedures for 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.
    <bullet> A description of all types (for example, full, partial) 
and categories (for

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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.
    <bullet> A list of all currently accredited MA organizations and 
the type, category, and expiration date of the accreditation held by 
each of them.
    <bullet> A list of all full and partial accreditation surveys 
scheduled to be performed by the accreditation organization.
    <bullet> The name and address of each person with an ownership or 
control interest in the accreditation organization.
    <bullet> CMS will also consider 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).

B. Notice Upon Completion of Evaluation

    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a notice in the 
Federal Register announcing the result of our evaluation. Section 
1852(e)(4)(C) of the Act provides a statutory timetable to ensure that 
our review of deeming applications is conducted in a timely manner. The 
Act provides us with 210 calendar days after the date of receipt of an 
application to complete our survey activities and application review 
process. At the end of the 210-day period, we must publish an approval 
or denial of the application in the Federal Register.

III. Collection of Information Requirements

    This document does not impose 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.).

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

    Dated: December 14, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-27802 Filed 12-21-18; 8:45 am]
 BILLING CODE 4120-01-P