[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Notices]
[Pages 57310-57311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-4077-PN]
RIN 0928-ZA59


Medicare and Medicaid Programs; Application by the National 
Committee for Quality Assurance Preferred Provider Organization for 
Deeming Authority for Medicare Advantage

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 for recognition as a 
national accreditation program for preferred provider organizations 
that wish to participate in the Medicare Advantage program. The statute 
requires that within 60 days of receipt of an organization's complete 
application, we 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: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on October 25, 2004.

ADDRESSES: In commenting, please refer to file code CMS-4077-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments. (Attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word.)
    2. By mail. You may mail written comments (one original and two 
copies) to the following address ONLY: Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Attention: CMS-4077-
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 hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-3159 in advance to schedule your arrival 
with one of our staff members; Room 445-G, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Heidi Adams, (410) 786-1094.

SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments 
from the public on all issues set forth in this proposed notice to 
assist us in fully considering issues and developing policies. You can 
assist us by referencing the file code CMS-4077-PN and the specific 
``issue identifier'' that precedes the section on which you choose to 
comment.
    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. After the close of the 
comment period, CMS posts all electronic comments received before the 
close of the comment period on its public website. 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) 786-7195.
    This Federal Register document is available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. The web site address is: http://www.gpoaccess.gov/fr/index.html.

I. Background

[If you choose to comment on issues in this section, please include the 
caption ``Background'' at the beginning of your comments.]

    Under the Medicare program, eligible beneficiaries may receive 
covered services through a managed care organization (MCO) that has a 
Medicare Advantage (MA) (formerly, Medicare+Choice) contract with the 
Centers for Medicare & Medicaid Services (CMS). The regulations 
specifying the Medicare requirements that must be met in order for an 
MCO to enter into an MA 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 
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 organization to enter into an MA contract, the 
organization must be licensed by the State as a risk bearing 
organization as set forth in part 422 of our regulations. Additionally, 
the organization must file an application demonstrating that it meets 
other Medicare requirements in part 422 of our regulations. Following 
approval of the contract, we engage in routine monitoring and oversight 
audits of the MA organization to ensure continuing compliance. The 
monitoring and

[[Page 57311]]

oversight audit process is comprehensive and incorporates ongoing 
analysis of various performance data in addition to biennial audits by 
CMS staff who use a written protocol that itemizes the Medicare 
requirements the MA organization must meet.
    As an alternative for meeting some Medicare requirements, an MA 
organization may be exempt from CMS monitoring of certain requirements 
in subsets listed in section 1852(e)(4)(B) of the Act as a result of an 
MA 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. As we specify at 
Sec.  422.157(b)(2) of our regulations, the term for which an AO may be 
approved by CMS may not exceed 6 years. 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 a health maintenance 
organization (HMO) or a preferred provider organization (PPO).

II. Approval of Deeming Organizations

[If you choose to comment on issues in this section, please include the 
caption ``Approval of Deeming Organizations'' at the beginning of your 
comments.]

    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 1865(b)(2) of the Act. 
Under these 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.
    Section 1865(b)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accreditation body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days from our receipt of a completed 
application to publish approval or denial of the application.
    The purpose of this notice is to inform the public of our 
consideration of National Committee for Quality Assurance's (NCQA's) 
application for approval of deeming authority of MA organizations that 
are licensed as a PPO for the following six categories:
     Quality improvement.
     Access to services.
     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

[If you choose to comment on issues in this section, please include the 
caption ``Evaluation of Deeming Request'' at the beginning of your 
comments.]

    On August 4, 2004, NCQA submitted all the necessary information to 
permit us to make a determination concerning its request for approval 
as a deeming authority for MA organizations that are licensed as a PPO. 
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 PPOs to CMS's 
comparable MA 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; and
    + Types and categories of accreditation offered and MA 
organizations currently accredited within those types and categories.
    In accordance with Sec.  422.158(b) of our regulations, 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) of our regulations.
    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 CMS 
requires 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

    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.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a final notice in 
the Federal Register announcing the result of our evaluation.

V. Regulatory Impact Statement

    In accordance with the provisions of Executive Order 12866, this 
regulation was not reviewed by the Office of Management and Budget.

    Authority: Section 1852 and 1865 of the Social Security Act (42 
U.S.C. 1395w-23 and 1395bb).

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

    Dated: September 8, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-21199 Filed 9-23-04; 8:45 am]
BILLING CODE 4120-01-P