Page 71 - Medicare Benefit Policy Manual

information needed for the accurate and precise identification of the specific
compendium.

• A complete, written copy of the compendium that is the subject of the request. If
the complete compendium is available electronically, it may be submitted
electronically in place of hard copy. If the compendium is available online, the
requestor may provide CMS with electronic access by furnishing at no cost to the
Federal Government sufficient accounts for the purposes and duration of the
review of the application in place of hard copy.

• The specific action that the requestor wishes CMS to take, for example to add or
delete a specific compendium.

• Detailed, specific documentation that the compendium that is the subject of the
request does or does not comply with the conditions of this rule. Broad,
nonspecific claims without supporting documentation cannot be efficiently
reviewed; therefore, they will not be accepted.

• A publicly transparent process for evaluating therapies, which includes the
following: (1) internal or external request for listing of a therapy recommendation,
including criteria used to evaluate the request (the complete application), (2)
listing of all the evidentiary materials reviewed or considered for inclusion in the
compendium (3) listing of all individuals who substantively participated in the
review and development of the request, and (4) minutes and voting records of
meetings for the review and disposition of the request. The information from an
internal or external request for inclusion of a therapy in a compendium are
available to the public for a period of not less than 5 years, which includes
availability on the compendium’s Web site for a period of not less than 3 years,
coincident with the compendium’s publication.

• A publicly transparent process for identifying potential conflicts of interests that
provides: (1) direct or indirect financial relationships, and (2) ownership or
investment interests that exist between individuals or the spouse or minor child of
individuals who have substantively participated in the development or disposition
of compendia recommendations, and the manufacturer or seller of the drug or
biological being reviewed by the compendium. This information shall be
identified and made timely available in response to a public request for a period of
not less than 5 years, which includes availability on the compendium’s Web site
for a period of not less than 3 years, coincident with the compendium’s
publication.

A request may have only a single compendium as its subject. This will provide greater
clarity to the scope of the Agency’s review of a given request. A requestor may submit
multiple requests, each requesting a different action.

E. Submission of Requests