[Federal Register Volume 66, Number 148 (Wednesday, August 1, 2001)]
[Notices]
[Pages 39775-39776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19190]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-4025-PN]
ZRIN 0938-ZA15


Medicare Program; Medicare+Choice Organizations--Application by 
the National Committee for Quality Assurance (NCQA) for Approval of 
Deeming Authority for Medicare+Choice Organizations That Are Licensed 
as a Health Maintenance Organization (HMO)

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

ACTION: Proposed notice.

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SUMMARY: This proposed notice announces the receipt of an application 
from the National Committee for Quality Assurance (NCQA) for 
recognition as a national accreditation program for Health Maintenance 
Organizations (HMOs) that wish to participate in the Medicare+Choice 
program. Regulations set forth at 42 CFR 422.157(b)(1) specify that a 
Federal Register notice will announce our receipt of the accreditation 
organization's application for approval, describe the criteria we will 
use in evaluating the application, and provide at least a 30-day public 
comment period.

DATES: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on August 31, 2001.

ADDRESSES: In commenting, please refer to file code CMS-4023-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission. Mail written comments (one original and 
three copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-4023-PN, P.O. Box 8013, Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be timely 
received in the event of delivery delays.
    If you prefer, you may deliver (by hand or courier) your written 
comments (one original and three copies) to one of the following 
addresses: Room 443-G, Hubert H. Humphrey Building, 200 Independence 
Avenue, SW., Washington, DC 20201, or Room C5-16-03, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and could be considered late.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Patricia Kurtz, (410) 786-4670.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: Comments received timely will be 
available for public inspection as they are received, generally 
beginning approximately 3 weeks after publication of a document, at the 
headquarters of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of 
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view 
public comments, phone (410) 786-7197.
    Copies: To order copies of the Federal Register containing this 
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    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. The Website address is: http://www.access.gpo.gov/nara/index.html.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services through a managed care organization (MCO) that has a 
Medicare+Choice (M+C) contract with the Centers for Medicare & Medicaid 
Services (CMS). The regulations specifying the Medicare requirements 
which must be met in order for an MCO to enter into an M+C 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 MCO must provide and the requirements 
that the organization must meet to be an M+C 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 organization to enter into an M+C contract, the 
organization must be licensed by the State as a risk bearing 
organization as set forth in part 422. Additionally, the organization 
must file an application demonstrating that other Medicare requirements 
in part 422 are met. Following approval of the contract, CMS engages in 
routine monitoring of the M+C organization to ensure continuing 
compliance. The monitoring process is comprehensive and uses a written 
protocol that itemizes the Medicare requirements the M+C organization 
must meet.
    As an alternative for meeting some Medicare requirements, an M+C 
organization may be exempt from CMS monitoring of certain requirements 
in subsets listed in section 1852(e)(4)(C) of the Act as a result of an 
M+C organization's accreditation by a CMS-approved accrediting 
organization (AO). In essence, the Secretary ``deems'' that the 
Medicare requirements are met based on a determination that the AO's 
standards are at least as stringent as Medicare requirements. The term 
for which an AO may be approved by CMS may not exceed 6 years as stated 
in Sec. 422.157(b)(2). For continuing approval, the AO will have to re-
apply to CMS.
    The applicant organization is generally recognized as an entity 
that accredits MCOs that are licensed as an HMO or a PPO.

II. Approval of Deeming Organizations

    Section 1852(e)(4)(C) of the Act requires that within 210 days of 
receipt of an application, the Secretary shall determine whether the 
applicant meets criteria specified in section 1852(e)(4) of the Act. 
Under this criteria, the Secretary will consider for a national 
accreditation body, its requirements for accreditation, its survey 
procedures, its ability to provide adequate resources for conducting 
required surveys and supplying information for use in enforcement 
activities, its monitoring procedures for provider entities found out 
of compliance with the conditions or requirements, and its ability to 
provide the Secretary with necessary data for validation.
    The purpose of this notice is to inform the public of our 
consideration of NCQA's application for approval of deeming authority 
of M+C organizations that are licensed as an HMO for the following six 
categories:
     Quality assurance.
     Access to services.

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     Antidiscrimination.
     Information on advance directives.
     Provider participation rules.
     Confidentiality and accuracy of enrollees' records.
    This notice also solicits public comment on the ability of the 
applicant's accreditation program to meet or exceed the Medicare 
requirements for which it seeks authority to deem.

III. Evaluation of Deeming Request

    On June 27, 2001, NCQA submitted all the necessary information to 
permit us to make a determination concerning its request for approval 
as a deeming authority for M+C organizations that are licensed as an 
HMO. Under Sec. 422.158(a) of the regulations, our review and 
evaluation of a national accreditation organization will consider, but 
not necessarily be limited to, the following information and criteria:
     The equivalency of NCQA's requirements for HMOs to CMS's 
comparable M+C organization requirements.
     NCQA's survey process, to determine the following:

--The frequency of surveys.
--The types of forms, guidelines and instructions used by surveyors.
--Descriptions of the accreditation decision making process, deficiency 
notification and monitoring process, and compliance enforcement 
process.

     Detailed information about individuals who perform 
accreditation surveys including--

--Size and composition of the survey team;
--Education and experience requirements for the surveyors;
--In-service training required for surveyor personnel;
--Surveyor performance evaluation systems; and
--Conflict of interest policies relating to individuals in the survey 
and accreditation decision process.

    --Descriptions of the organization's--
--Data management and analysis system;
--Policies and procedures for investigating and responding to 
complaints against accredited organizations;
--Types and categories of accreditation offered and M+C organizations 
currently accredited within those types and categories.

    In accordance with Sec. 422.158(b), the applicant must provide 
documentation relating to--

--Its ability to provide data in a CMS-compatible format;
--The adequacy of personnel and other resources necessary to perform 
the required surveys and other activities; and
--Assurances that it will comply with ongoing responsibility 
requirements specified in Sec. 422.157(c).

    Additionally, the accrediting organization must provide CMS the 
opportunity to observe its accreditation process on site at a managed 
care organization and must provide any other information that is 
required by CMS to prepare for an onsite visit to the AO's offices. 
These site visits will help to verify that the information presented in 
the application is correct and to make a determination on the 
application.

IV. Response to Comments and Notice Upon Completion of Evaluation

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, 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, if we proceed with a subsequent 
document, we will respond to the major comments in the preamble to that 
document.
    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.
    In accordance with the provisions of E.O. 12866, this proposed 
notice was not reviewed by the Office of Management and Budget.

Section 1853(a)(1)(B) of the Social Security Act (42 U.S.C. 1395w-
23(a)(1)(B))

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare-Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: July 26, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 01-19190 Filed 7-31-01; 8:45 am]
BILLING CODE 4120-01-P