[Title 42 CFR 423.600]
[Code of Federal Regulations (annual edition) - October 1, 2007 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter IV - CENTERS FOR MEDICARE]
[Subchapter A - GENERAL PROVISIONS]
[Part 423 - VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT]
[Subpart M - Grievances, Coverage Determinations, and Appeals]
[Sec. 423.600 - Reconsideration by an independent review entity (IRE).]
[From the U.S. Government Printing Office]


42PUBLIC HEALTH32007-10-012007-10-01false423.600Sec. 423.600PUBLIC HEALTHCENTERS FOR MEDICAREGENERAL PROVISIONSVOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFITGrievances, Coverage Determinations, and Appeals
Sec. 423.600  Reconsideration by an independent review entity (IRE).

    (a) An enrollee who is dissatisfied with the redetermination of a 
Part D plan sponsor has a right to a reconsideration by an independent 
review entity that contracts with CMS. An enrollee must file a written 
request for reconsideration with the IRE within 60 days of the date of 
the redetermination by the Part D plan sponsor.
    (b) When an enrollee files an appeal, the IRE is required to solicit 
the views of the prescribing physician. The IRE may solicit the views of 
the prescribing physician orally or in writing. A written account of the 
prescribing physician's views (prepared by either the prescribing 
physician or IRE, as appropriate) must be contained in the IRE's record.
    (c) In order for an enrollee to request an IRE reconsideration of a 
determination by a Part D plan sponsor not to provide for a Part D drug 
that is not on the formulary, the prescribing physician must determine 
that all covered Part D drugs on any tier of the formulary for treatment 
of the same condition would not be as effective for the individual as 
the non-formulary drug, would have adverse effects for the individual, 
or both.
    (d) The independent review entity must conduct the reconsideration 
as expeditiously as the enrollee's health condition requires but must 
not exceed the deadlines applicable in Sec. 423.590, including those 
deadlines that are applicable when a request for an expedited 
reconsideration is received and granted.
    (e) 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 reconsideration 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 reconsideration need 
not, in all cases, be of the same specialty or subspecialty as the 
prescribing physician.