[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR423.171]

[Page 406-408]
 
                         TITLE 42--PUBLIC HEALTH
 
                             HUMAN SERVICES
 
PART 423_VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT--Table of Contents
 
       Subpart D_Cost Control and Quality Improvement Requirements
 
Sec.  423.171  Procedures for approval of accreditation as a basis for deeming compliance.

    (a) Required information and materials. A private, national 
accreditation organization applying for approval must furnish to CMS all 
of the following information and materials (when reapplying for 
approval, the organization need furnish only the particular information 
and materials requested by CMS):

[[Page 407]]

    (1) The types of Part D plans and sponsors that it reviews as part 
of its accreditation process.
    (2) A detailed comparison of the organization's accreditation 
requirements and standards with the Medicare requirements (for example, 
a crosswalk).
    (3) Detailed information about the organization's survey process, 
including the following:
    (i) Frequency of surveys and whether surveys are announced or 
unannounced.
    (ii) Copies of survey forms, and guidelines and instructions to 
surveyors.
    (iii) Descriptions of--
    (A) The survey review process and the accreditation status decision 
making process;
    (B) The procedures used to notify accredited Part D sponsors of 
deficiencies and to monitor the correction of those deficiencies; and
    (C) The procedures used to enforce compliance with accreditation 
requirements.
    (4) Detailed information about the individuals who perform surveys 
for the accreditation organization, including the--
    (i) Size and composition of accreditation survey teams for each type 
of plan reviewed as part of the accreditation process;
    (ii) Education and experience requirements surveyors must meet;
    (iii) Content and frequency of the in-service training provided to 
survey personnel;
    (iv) Evaluation systems used to monitor the performance of 
individual surveyors and survey teams; and
    (v) Organization's policies and practice for the participation, in 
surveys or in the accreditation decision process by an individual who is 
professionally or financially affiliated with the entity being surveyed.
    (5) A description of the organization's data management and analysis 
system for its surveys and accreditation decisions, including the kinds 
of reports, tables, and other displays generated by that system.
    (6) A description of the organization's procedures for responding to 
and investigating complaints against accredited organizations, including 
policies and procedures regarding coordination of these activities with 
appropriate licensing bodies and ombudsmen programs.
    (7) A description of the organization's policies and procedures for 
the withholding or removal of accreditation for failure to meet the 
accreditation organization's standards or requirements, and other 
actions the organization takes in response to noncompliance with its 
standards and requirements.
    (8) A description of all types (for example, full or partial) and 
categories (for example, provisional, conditional, or temporary) of 
accreditation offered by the organization, the duration of each type and 
category of accreditation, and a statement identifying the types and 
categories that serve as a basis for accreditation if CMS approves the 
accreditation organization.
    (9) A list of all currently accredited Part D sponsors and MA 
organizations and the type, category, and expiration date of the 
accreditation held by each of them.
    (10) A list of all full and partial accreditation surveys scheduled 
to be performed by the accreditation organization as requested by CMS.
    (11) The name and address of each person with an ownership or 
control interest in the accreditation organization.
    (b) Required supporting documentation. A private, national 
accreditation organization applying or reapplying for approval also must 
submit the following supporting documentation--
    (1) A written presentation that demonstrates its ability to furnish 
CMS with electronic data in CMS compatible format.
    (2) A resource analysis that demonstrates that it's staffing, 
funding, and other resources are adequate to perform the required 
surveys and related activities.
    (3) A statement acknowledging that, as a condition for approval, it 
agrees to comply with the ongoing responsibility requirements of Sec.  
423.168(c).
    (c) Additional information. If CMS determines that it needs 
additional information for a determination to grant or deny the 
accreditation organization's

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request for approval, it notifies the organization and allows time for 
the organization to provide the additional information.
    (d) Onsite visit. CMS may visit the accreditation organization's 
offices to verify representations made by the organization in its 
application, including, but not limited to, review of documents and 
interviews with the organization's staff.
    (e) Notice of determination. CMS gives the accreditation 
organization, within 210 days of receipt of its completed application, a 
formal notice that--
    (1) States whether the request for approval is granted or denied;
    (2) Gives the rationale for any denial; and
    (3) Describes the reconsideration and reapplication procedures.
    (f) Withdrawal. An accreditation organization may withdraw its 
application for approval at any time before it receives the formal 
notice specified in paragraph (e) of this section.
    (g) Reconsideration of adverse determination. An accreditation 
organization that has received a notice of denial of its request for 
approval may request a reconsideration in accordance with subpart D of 
part 488 of this chapter.
    (h) Request for approval following denial. (1) Except as provided in 
paragraph (h)(2) of this section, an accreditation organization that has 
received notice of denial of its request for approval may submit a new 
request if it--
    (i) Has revised its accreditation program to correct the 
deficiencies on which the denial was based.
    (ii) Can demonstrate that the Part D sponsors that it has accredited 
meet or exceed applicable Medicare requirements; and
    (iii) Resubmits the application in its entirety.
    (2) An accreditation organization that has requested reconsideration 
of CMS' denial of its request for approval may not submit a new request 
until the reconsideration is administratively final.

Subpart E [Reserved]