[Federal Register Volume 74, Number 38 (Friday, February 27, 2009)]
[Notices]
[Pages 8967-8969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-4142-PN]


Medicare Program; Application of the Utilization Review 
Accreditation Commission (URAC) for Deeming Authority for Medicare 
Prescription Drug Plan (PDP) Sponsors

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

ACTION: Proposed notice.

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SUMMARY: This proposed notice announces the application of the 
Utilization Review Accreditation Commission (URAC) for deeming 
authority as a national accreditation organization for prescription 
drug plan sponsors participating in the Voluntary Medicare Prescription 
Drug Benefit Program. This announcement describes the criteria to be 
used in evaluating the application and provides information for 
submitting comments during 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 March 30, 2009.

ADDRESSES: In commenting, please refer to file code CMS-4142-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.regulations.gov. Follow the 
instructions for ``Comment of Submission'' and enter the file code to 
find the document accepting comments.
    2. By regular 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-4142-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.

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    3. By express or overnight mail. You may send 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-4142-PN, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    4. 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:
    a. Room 445-G, Hubert H. Humphrey Building, 200 Independence 
Avenue, SW., Washington, DC 20201
    (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.)
    b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.

FOR FURTHER INFORMATION CONTACT: Sue Bradshaw, (410) 786-2896.

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 Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also 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 1-800-743-3951.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
prescription drug benefits through a Prescription drug plan (PDP) 
sponsor that has a prescription drug plan contract with the Centers for 
Medicare & Medicaid Services (CMS). The regulations specifying the 
Medicare requirements that must be met in order for a PDP sponsor to 
enter into a prescription drug plan contract with CMS are located at 42 
CFR part 423. These requirements implement Part D of Title XVIII of the 
Social Security Act (the Act), which specifies the prescription drug 
benefits that a PDP sponsor must provide and the requirements that the 
organization must meet to be a PDP sponsor. Other relevant sections of 
the Act are parts A and B of Title XVIII and part A of Title XI of the 
Act, pertaining to the provision of services by Medicare certified 
providers and suppliers.
    Generally, for an organization to enter into a PDP contract, the 
organization must be licensed by the State as a risk bearing 
organization as set forth at 42 CFR 423.504(b)(2) of our regulations. 
Additionally, the organization must file an application demonstrating 
that it meets other Medicare requirements in part 423 of our 
regulations. Following approval of the contract, we engage in routine 
monitoring and oversight audits of the PDP sponsors to ensure 
continuing compliance. The monitoring and oversight audit process is 
comprehensive and uses a written protocol that itemizes the Medicare 
requirements that the PDP sponsors must meet.
    As an alternative for meeting some Medicare requirements, a PDP 
sponsor may be exempt from CMS monitoring of certain requirements in 
subsets listed in section 1860D-4(j) of the Act (cross-referencing 
section 1852(e)(4)(B) of the Act) as a result of a PDP sponsor's 
accreditation by a CMS-approved accrediting organization (AO). In 
essence, the Secretary ``deems'' that the PDP has met the Medicare 
requirements via its accreditation, based on a previous determination 
that the AO's standards are at least as stringent as Medicare 
requirements. As we specify at Sec.  423.168(b)(2)(ii) 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 PDP sponsor deeming authority 
is generally recognized by the industry as an entity that accredits PDP 
sponsors that are licensed as prescription drug plan sponsors. 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) (redesignated in 2008 as 
section 1865(a)(2)) of the Act.
    On October 14, 2008 URAC submitted to CMS an application for 
deeming authority with respect to Part D sponsors' compliance with the 
following PDP plan requirements, as set out at 42 CFR 423.165(b):
    [ssbox] Access to covered drugs;
    [ssbox] Confidentiality and accuracy of enrollee prescription drug 
records;
    [ssbox] Drug utilization management, quality assurance measure and 
systems, medication therapy management; and,
    [ssbox] The sponsors' programs to control fraud, waste and abuse. 
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. Provisions of the Proposed Notice

    The purpose of this proposed notice is to notify the public of the 
application of the Utilization Review Accreditation Commission for 
deeming authority as a national accreditation organization for 
prescription drug plan sponsors participating in the Voluntary Medicare 
Prescription Drug Benefit Program. This announcement describes the 
criteria to be used in evaluating the application and provides 
information for submitting comments during a 30-day public comment 
period.

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.  422.171(a). This includes, but is not limited to, 
the following:
    <bullet> The equivalency of URAC's requirements for PDP sponsors to 
CMS's comparable PDP sponsor requirements.
    <bullet> 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.
    <bullet> 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;

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    + Surveyor performance evaluation systems; and
    + Conflict of interest policies relating to individuals in the 
survey and accreditation decision process.
    <bullet> 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 PDP sponsors and MA organizations 
currently accredited within those types and categories.
    In accordance with Sec.  423.171(b) of our regulations, the 
applicant must provide documentation relating to the following:
    <bullet> Its ability to provide data in a CMS compatible format.
    <bullet> The adequacy of personnel and other resources necessary to 
perform the required surveys and other activities.
    <bullet> Assurances that it will comply with ongoing responsibility 
requirements specified in Sec.  423.168(c) of our regulations.
    Additionally, the accrediting organization must provide CMS with 
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.
    In accordance with section 1865(a)(3)(A) of the Act and our 
regulations at Sec.  423.168(b)(1), this proposed notice solicits 
public comment on the ability of URAC's accreditation program to meet 
or exceed the Medicare requirements for PDP sponsors which it seeks 
authority to deem as being in compliance with such requirements. In 
accordance with Sec.  423.168(b)(1)(iii), comments are due [at least 
30] days after the date of publication of this proposed notice.

III. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

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.

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.

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

    Dated: February 13, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-4320 Filed 2-26-09; 8:45 am]
BILLING CODE 4120-01-P