[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR423.590]



[Page 1159-1160]

 

                         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 M_Grievances, Coverage Determinations, and Appeals

 

Sec. 423.590  Timeframes and responsibility for making redeterminations.



    (a) Standard redetermination--request for covered drug benefits. (1) 

If the Part D plan sponsor makes a redetermination that is completely 

favorable to the enrollee, the Part D plan sponsor must notify the 

enrollee in writing of its redetermination (and effectuate it in 

accordance with Sec. 423.636(a)(1)) as expeditiously as the enrollee's 

health condition requires, but no later than 7 calendar days from the 

date it receives the request for a standard redetermination.

    (2) If the Part D plan sponsor makes a redetermination that affirms, 

in whole or in part, its adverse coverage determination, it must notify 

the enrollee in writing of its redetermination as expeditiously as the 

enrollee's health condition requires, but no later than 7 calendar days 

from the date it receives the request for a standard redetermination.

    (b) Standard redetermination--request for payment. (1) If the Part D 

plan sponsor makes a redetermination that is completely favorable to the 

enrollee, the Part D plan sponsor must issue its redetermination (and 

effectuate it in accordance with Sec. 423.636(a)(2)) no later than 7 

calendar days from the date it receives the request for redetermination.

    (2) If the Part D plan sponsor affirms, in whole or in part, its 

adverse coverage determination, it must notify the enrollee in writing 

of its redetermination no later than 7 calendar days from the date it 

receives the request for redetermination.

    (c) Effect of failure to meet timeframe for standard 

redeterminations. If the Part D plan sponsor fails to provide the 

enrollee with a redetermination within the timeframes specified in 

paragraphs (a) or (b) of this section, the failure constitutes an 

adverse redetermination decision, and the Part D plan sponsor must 

forward the enrollee's request to



[[Page 1160]]



the IRE within 24 hours of the expiration of the adjudication timeframe.

    (d) Expedited redetermination. (1) Timeframe. A Part D plan sponsor 

that approves a request for expedited redetermination must complete its 

redetermination and give the enrollee (and the prescribing physician 

involved, as appropriate), notice of its decision as expeditiously as 

the enrollee's health condition requires but no later than 72 hours 

after receiving the request.

    (2) How the Part D plan sponsor must request additional information. 

If the Part D plan sponsor must receive medical information, the Part D 

plan sponsor must request the necessary information within 24 hours of 

the initial request for an expedited redetermination. Regardless of 

whether the Part D plan sponsor requests additional information, the 

Part D plan sponsor is responsible for meeting the timeframe and notice 

requirements.

    (e) Failure to meet timeframe for expedited redetermination. If the 

Part D plan sponsor fails to provide the enrollee or the prescribing 

physician, as appropriate, with the results of its expedited 

redetermination within the timeframe described in paragraph (d) of this 

section, the failure constitutes an adverse redetermination decision, 

and the Part D plan sponsor must forward the enrollee's request to the 

IRE within 24 hours of the expiration of the adjudication timeframe.

    (f) Who must conduct the review of an adverse coverage 

determination. (1) A person or persons who were not involved in making 

the coverage determination must conduct the redetermination.

    (2) When the issue is the denial of coverage based on a lack of 

medical necessity (or any substantively equivalent term used to describe 

the concept of medical necessity), the redetermination must be made by a 

physician with expertise in the field of medicine that is appropriate 

for the services at issue. The physician making the redetermination need 

not, in all cases, be of the same specialty or subspecialty as the 

prescribing physician.

    (g) Form and content of an adverse redetermination notice. The 

notice of any adverse determination under paragraphs (a)(2) or (b)(2) of 

this section must--

    (1) Use approved notice language in a readable and understandable 

form;

    (2) State the specific reasons for the denial;

    (3) Inform the enrollee of his or her right to a reconsideration;

    (i) For adverse drug coverage redeterminations, describe both the 

standard and expedited reconsideration processes, including the 

enrollee's right to, and conditions for, obtaining an expedited 

reconsideration and the rest of the appeals process;

    (ii) For adverse payment redeterminations, describe the standard 

reconsideration process and the rest of the appeals process; and

    (4) Comply with any other notice requirements specified by CMS.