Page 72 - Medicare Benefit Policy Manual

Requests must be in writing and submitted in one of the following two ways (no
duplicates please):

1. Electronic requests are encouraged to facilitate administrative efficiency. Each
solicitation will include the electronic address for submissions.

2. Hard copy requests can be sent to: Centers for Medicare & Medicaid Services,
Coverage and Analysis Group, Mailstop C1–09–06, 7500 Security Boulevard, Baltimore,
MD 21244.

Allow sufficient time for hard copies to be received prior to the close of the open request
period.

F. Review of Requests

CMS will consider a compendium’s attainment of the desirable characteristics specified
in 50.4.5.1.B when reviewing requests. CMS may consider additional, reasonable factors
in making a determination. For example, CMS may consider factors that are likely to
impact the compendium’s suitability for this use, such as a change in the compendium’s
ownership or affiliation, and the standards applicable to the evidence considered by the
compendium. CMS may consider that broad accessibility by the general public to the
information contained in the compendium may assist beneficiaries, their treating
physicians, or both, in choosing among treatment options. CMS will also consider a
compendium’s grading of evidence used in making recommendations regarding off-label
uses, and the process by which the compendium grades the evidence. CMS may, at its
discretion, combine and consider multiple requests that refer to the same compendium,
even if those requests are for different actions. This facilitates administrative efficiency
in the review of requests.

G. Publishing Review Results

CMS will publish decisions on the CMS Web site within 90 days after the close of the
public comment period.

(This instruction was last reviewed by CMS in December 2009.)

50.4.6 - Less Than Effective Drug
(Rev. 1, 10-01-03)
B3-2049.4.C.5

This is a drug that has been determined by the Food and Drug Administration (FDA) to
lack substantial evidence of effectiveness for all labeled indications. Also, a drug that has
been the subject of a Notice of an Opportunity for a Hearing (NOOH) published in the
“Federal Register” before being withdrawn from the market, and for which the Secretary
has not determined there is a compelling justification for its medical need, is considered