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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services 

          - [CMS-4077-FN] 
          - RIN 0928-ZA59 

# AGENCY:

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

# ACTION:

Final notice. 

# SUMMARY:

This final notice announces the approval of the National Committee for Quality Assurance for deeming authority as a national accreditation program for local preferred provider organizations that wish to participate in the Medicare Advantage program. 

# FOR FURTHER INFORMATION CONTACT:

Gwyneveyre Pasquale, (410) 786-7701. 

## I. Background 

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 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 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); that is, 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 § 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 must 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. Deeming Application Approval Process 

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 must publish a finding of approval or denial of the application within 210 days from the receipt of the completed application. 

## III. Provisions of the Proposed Notice 

                        On September 24, 2004, we published a proposed notice in the                         **Federal Register**                         (69 FR 57310) announcing the National Committee for Quality Assurance's (NCQA's) request for recognition as a national accreditation program for PPOs that wish to participate in the MA program. This notice informed the public of our consideration of NCQA's application for approval as a deeming authority for 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.

In the notice, we described our evaluation criteria. Under § 422.158(a), we conducted a review of NCQA's application in accordance with the criteria specified by our regulations, which include, but are not limited to, the following: 
      - The equivalency of NCQA's requirements for PPOs to CMS' 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.                               ( print page 78445)    

In accordance with § 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 § 422.157(c) of our regulations.

In accordance with section 1865(b)(3)(A) of the Act, the proposed notice also solicited public comment on the ability of the NCQA's accreditation program to meet or exceed the Medicare requirements for which it seeks authority to deem. We did not receive any public comment in response to the proposed notice. 

## IV. Provisions of the Final Notice 

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. 

We compared the standards contained in NCQA's PPO crosswalk and its survey process with the Medicare regulations and the PPO survey monitoring guide. Our review and evaluation of NCQA's deeming application determined that the NCQA standards meet or exceed those established by the Medicare program. Therefore, we recognize NCQA as a national accreditation organization for local preferred provider organizations that wish to participate in the Medicare Advantage program, effective October 20, 2004 through October 20, 2010. 

## V. Collection of Information Requirements 

This final notice does not impose any information collection and record keeping requirements subject to the Paperwork Reduction Act (PRA). Consequently, it does not need to be reviewed by the Office of Management and Budget (OMB) under the authority of the PRA. 

## VI. Executive Order 12866 Statement 

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

Authority:Sections 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: November 24, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & Medicaid Services. 

[FR Doc. 04-28154 Filed 12-29-04; 8:45 am] 

BILLING CODE 4120-01-P