CLC COMMENTS ON CMS PROPOSAL ON COVERAGE WITH EVIDENCE DEVELOPMENT
(June 6, 2005)
Filed via E-mail
RE: Draft Guidance for the Public, Industry
and CMS Staff:
Dear Dr. McClellan:
The undersigned organizations in the Cancer Leadership Council (CLC) represent cancer patients, providers and research organizations. Both the CLC and our individual organizations have been engaged in advocacy on Medicare coverage issues for a number of years and have welcomed a newly collaborative approach to those issues on the part of the Centers for Medicare & Medicaid Services (CMS). We regard the draft Guidance on "Factors CMS Considers in Making a Determination of Coverage with Evidence Development" as a continuation of several promising trends in CMS policy: first, a willingness to assume a more expansive approach to coverage of new or unproven technologies; and second, a new emphasis on the collection of data as part of a move toward measurement of quality in treatment of cancer and other serious or life-threatening diseases.
The draft Guidance will raise questions for
some, including providers who may be called upon to collect data without
mechanisms for reimbursement for their efforts, as well as device manufacturers
who may doubt that coverage is in fact being expanded. For cancer patients,
the primary concern is whether the new coverage with evidence development
(CED) policy will interfere in any way with the strong coverage protections
for cancer drugs set forth in the current Medicare law.
The current leadership of CMS has been very progressive with respect to coverage issues, and we support this additional incremental step toward expanded coverage and enhanced evidence development while encouraging clarification of the matters discussed herein. Thanks to CMS and its coverage staff for their responsiveness to the needs of people with cancer.
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