[Federal Register Volume 71, Number 57 (Friday, March 24, 2006)]
[Notices]
[Pages 14922-14924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2567]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-4117-PN]


Medicare Program; Application for Deeming Authority for Medicare 
Advantage Health Maintenance Organizations and Local Preferred Provider 
Organizations Submitted by URAC

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

ACTION: Proposed notice.

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SUMMARY: This proposed notice announces URAC's submission of an 
application for deeming authority as a national accreditation 
organization for health maintenance organizations and local preferred 
provider organizations participating in the Medicare Advantage program. 
This announcement describes the criteria to be used in evaluating the 
application and provides information for submitting comments during a 
public comment period that will span at least 30 days.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on April 28, 2006.

ADDRESSES: In commenting, please refer to file code CMS-4117-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/eRulemaking. Click 
on the link ``Submit electronic comments on CMS regulations with an 
open comment period.'' (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-4117-
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 HHS 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: Shaheen Halim, PhD, (410) 786-0641.

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

[[Page 14923]]

by referencing the file code CMS-4117-PN.
    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 Web 
site as soon as possible after they have been received: http://www.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on 
CMS Regulations'' on that Web site to view public comments.

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 uses 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.
    An organization that applies for Medicare Advantage deeming 
authority is generally recognized by the industry as an entity that 
accredits MCOs that are licensed as a health maintenance organization 
(HMO) or a preferred provider organization (PPO). 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 
must re-apply to CMS. 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.
    On June 4, 2004 URAC submitted to CMS an application for deeming 
authority that was later withdrawn. On October 12, 2005, URAC submitted 
an application for approval as an accrediting organization for Medicare 
Advantage HMOs and local PPOs in the following six areas:
     Quality improvement.
     Antidiscrimination.
     Access to services.
     Confidentiality and accuracy of enrollee records.
     Information on advance directives.
     Provider participation rules.
    To be approved for deeming authority, an accrediting organization 
must demonstrate that its accreditation program requirements meet or 
exceed the Medicare requirements for which it is seeking the authority 
to deem compliance.

II. Deeming Application Approval Process

    The application process for deeming authority includes a review of 
URAC's application in accordance with the criteria specified by our 
regulations at Sec.  422.158(a). This includes, but is not limited to, 
the following:
     The equivalency of URAC's requirements for HMOs and PPOs 
to CMS' comparable MA organization requirements.
     URAC'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 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.
    In accordance with section 1865(b)(3)(A) of the Act, this proposed 
notice solicits public comment on the ability of URAC's accreditation 
program to meet or exceed the Medicare requirements for which it seeks 
authority to deem.

III. Evaluation of Application for Deeming Authority

    On October 12, 2005, URAC 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 either HMOs or PPOs. 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 URAC's requirements for HMOs and PPOs 
to CMS' comparable MA organization requirements.
     URAC's survey process, to determine the following:
     The frequency of surveys.

[[Page 14924]]

     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. 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 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: Sections 1852 and 1865 of the Social Security Act (42 
U.S.C. 1395w-22 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: March 8, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicare Services.
[FR Doc. 06-2567 Filed 3-23-06; 8:45 am]
BILLING CODE 4120-01-P