Page 70 - Medicare Benefit Policy Manual

• Extensive breadth of listings,
• Quick processing from application for inclusion to listing,
• Detailed description of the evidence reviewed for every individual listing,

• Use of pre-specified published criteria for weighing evidence,
• Use of prescribed published process for making recommendations,
• Publicly transparent process for evaluating therapies,
• Explicit "Not Recommended" listing when validated evidence is appropriate,
• Explicit listing and recommendations regarding therapies, including sequential
use or combination in relation to other therapies,
• Explicit "Equivocal" listing when validated evidence is equivocal, and,
• Process for public identification and notification of potential conflicts of interest
of the compendias’ parent and sibling organizations, reviewers, and committee
members, with an established procedure to manage recognized conflicts.

Furthermore, the provisions discussed in section 182(b) of MIPPA bring more uniformity
in compendia conflict of interest disclosure practices and allow the public the ability to
monitor how these policies impact compendia off-label recommendations.

C. Process for Changing List of Compendia

CMS will provide an annual 30-day open request period starting January 15 for the public
to submit requests for additions or deletions to the compendia list contained on the CMS
Web site at http://www.cms.hhs.gov/CoverageGenInfo/02_compendia.asp.

Complete requests as defined in section 50.4.5.1.D will be posted to the Web site
annually by March 15 for public notice and comment. The request will identify the
requestor and the requested action CMS is being asked to make to the list. Public
comments will be accepted for a 30-day period beginning on the day the request is posted
on the Web site. In addition to the annual process, CMS may generate a request for
changes to the list at any time an urgent action is needed to protect the interests of the
Medicare program and its beneficiaries.

D. Content of Requests

For a request to be considered complete, and therefore accepted for review, it must
include the following information:

• The full name and contact information (including the mailing address, e-mail
address, and telephone number) of the requestor. If the requestor is not an
individual person, the information shall identify the officer or other representative
who is authorized to act for the requestor on all matters related to the request.

• Full identification of the compendium that is the subject of the request, including
name, publisher, edition if applicable, date of publication, and any other