The Centers for Medicare & Medicaid Services will offer greater clarity on when it will require data collection as a condition of Medicare Part B coverage in a second draft of its guidance on the topic.

"CMS is planning to issue more specific criteria for applying [coverage with evidence development] in the next draft guidance document," a recent agency ^FDL-1 'fact sheet' states. The fact sheet addresses several common stakeholder concerns based on comments CMS received on its first draft CED guidance.

Under its "coverage with evidence development" policy, CMS could require registries or other data gathering as a condition for covering a product under Part B (¹ Also see "CMS Proposes Broad Criteria For Linking Reimbursement To Data Collection" - Pink Sheet, 11 April, 2005., p. 24).

The draft guidelines proposed a broad range of circumstances under which use of CED would be appropriate; CMS indicated that the second draft guidance will more narrowly define the circumstances under which CED would be used.

"Because these guidelines will stipulate specific circumstances under which CED will be used, we anticipate that CED will be applied in a limited number of" coverage decisions, the fact sheet states.

In comments on the draft, the Pharmaceutical Research & Manufacturers of America and the Biotechnology Industry Organization requested the agency issue a second draft and more clearly define circumstances when CED would be used (² Also see "Part B “Evidence Development” Plan Needs Defined Scope – Manufacturers" - Pink Sheet, 13 June, 2005., p. 21).

CMS received comments on the first draft from 65 organizations, including PhRMA, BIO, and several individual manufacturers.

The second draft guidance "will provide more information about CED and address the questions and concerns raised by the public," the agency said.

CMS plans to issue the second draft of the CED guidance "in the next few months." The document will be available for public comment for 30 days with issuance of a final guidance slated for year-end.

CMS also plans to hold a second Open Door Forum to gather feedback; the agency held an Open Door Forum on CED in May (³ Also see "CMS Plans Limited Use Of “Coverage With Evidence Development” Option" - Pink Sheet, 16 May, 2005., p. 15).

CMS To Give More Specifics For Use Of Coverage With Evidence Development

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