[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR423.350]

[Page 391-393]
 
                         TITLE 42--PUBLIC HEALTH
 
                    CHAPTER IV--CENTERS FOR MEDICARE
                          & MEDICAID SERVICES,
                        DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES
 
PART 423_VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT--Table of Contents
 
 Subpart G_Payments to Part D Plan Sponsors For Qualified Prescription 
                              Drug Coverage
 
Sec.  423.350  Payment appeals.

    (a) Payment determinations--(1) Payment methods subject to appeal. 
If CMS did not apply its stated payment methodology correctly, a Part D 
sponsor may appeal the following:
    (i) The reconciled health status risk adjustment of the direct 
subsidy as provided in Sec.  423.343(b).
    (ii) The reconciled reinsurance payments under Sec.  423.343(c).
    (iii) The reconciled final payments made for low-income cost sharing 
subsidies provided in Sec.  423.343(d); or
    (iv) Final risk-sharing payments made under Sec.  423.336).

[[Page 392]]

    (2) Payment information not subject to appeal. Payment information 
submitted to CMS under Sec.  423.322 and reconciled under Sec.  423.343 
is final and may not be appealed nor may the appeals process be used to 
submit new information after the submission of information necessary to 
determine retroactive adjustments and reconciliations.
    (b) Request for reconsideration--(1) Time for filing a request. The 
request for reconsideration must be filed within 15 days from the date 
of the notice of the adverse determination.
    (2) Content of request. The request for reconsideration must specify 
the findings or issues with which the Part D sponsor disagrees and the 
reasons for the disagreements. Excluding new payment information, the 
request for reconsideration may include additional documentary evidence 
the sponsor wishes CMS to consider.
    (3) Conduct of informal written reconsideration. In conducting the 
reconsideration, CMS reviews the payment determination, the evidence and 
findings upon which it was based, and any other written evidence 
submitted by the Part D sponsor or by CMS before notice of the 
reconsidered determination is made.
    (4) Decision of the informal written reconsideration. CMS informs 
the sponsor of the decision orally or through electronic mail. CMS sends 
a written decision to the Part D sponsor on the sponsor's request.
    (5) Effect of CMS informal written reconsideration. A 
reconsideration decision, whether delivered orally or in writing, is 
final and binding unless a request for hearing is filed in accordance 
with paragraph (c) of this section, or it is revised in accordance with 
Sec.  423.346.
    (c) Right to informal hearing. A Part D sponsor dissatisfied with 
the CMS reconsideration decision is entitled to an informal hearing as 
provided in this section.
    (1) Manner and timing for request. A request for a hearing must be 
made in writing and filed with CMS within 15 days of the date the Part D 
sponsor receives the CMS reconsideration decision.
    (2) Content of request. The request for informal hearing must 
include a copy of the CMS reconsideration decision (if any) and must 
specify the findings or issues in the decision with which the Part D 
sponsor disagrees and the reasons for the disagreements.
    (3) Informal hearing procedures. (i) CMS provides written notice of 
the time and place of the informal hearing at least 10 days before the 
scheduled date.
    (ii) The hearing are conducted by a CMS hearing officer who neither 
receives testimony nor accepts any new evidence that was not presented 
with the reconsideration request. The CMS hearing officer is limited to 
the review of the record that was before CMS when CMS made both its 
initial and reconsideration determinations.
    (iii) If CMS did not issue a written reconsideration decision, the 
hearing officer may request, but not require, a written statement from 
CMS or its contractors explaining CMS' determination, or CMS or its 
contractors may, on their own, submit the written statement to the 
hearing officer. Failure of CMS to submit a written statement does not 
result in any adverse findings against CMS and may not in any way be 
taken into account by the hearing officer in reaching a decision.
    (4) Decision of the CMS hearing officer. The CMS hearing officer 
decides the case and sends a written decision to the Part D sponsor, 
explaining the basis for the decision.
    (5) Effecting of hearing officer decision. The hearing officer 
decision is final and binding, unless the decision is reversed or 
modified by the Administrator in accordance with paragraph (d) of this 
section.
    (d) Review by the Administrator. (1) A Part D sponsor that has 
received a hearing officer decision upholding a CMS initial or 
reconsidered determination may request review by the Administrator 
within 15 days of receipt of the hearing officer's decision.
    (2) The Administrator may review the hearing officer's decision, any 
written documents submitted to CMS or to the hearing officer, as well as 
any other information included in the record of the hearing officer's 
decision and determine whether to uphold, reverse or modify the hearing 
officer's decision.

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    (3) The Administrator's determination is final and binding.

Subpart H [Reserved]