Paying For Placebo Is ‘Biggest Change’ In Medicare CED Policy, Official Says
This article was originally published in The Pink Sheet Daily
The director of Medicare’s coverage group sees the ability to pay physicians for providing a placebo in clinical trials required under a ‘coverage with evidence development’ determination as a major improvement in its recent guidance for CED.
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The director of Medicare’s coverage and analysis group says that, at the moment, no biopharma products are being considered for a national coverage determination. Another official says Medicare cannot use comparative effectiveness data in making reimbursement decisions.
CMS’ guidance on its “coverage with evidence development” policy for Medicare Part B does not elaborate on the scope of its application to off label drug use, only stating the agency could apply CED to drugs that have received FDA approval for at least one indication.
Agency decides against requiring coverage with evidence development for off-label uses.