[Federal Register: February 27, 2009 (Volume 74, Number 38)]
[Notices]
[Page 8967-8969]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe09-91]
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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.
[[Page 8968]]
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:
The equivalency of URAC's requirements for PDP sponsors to
CMS's comparable PDP sponsor 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;
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+ 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 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:
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.
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