Medicare Encouraged to Adopt Policies on Diagnostics, Avoid Creating Additional CED Access Barriers

On Sept. 9, the Alliance was joined by 17 organizations in asking the Centers for Medicare and Medicaid Services (CMS) to:

• Avoid creating additional access barriers for therapeutics and diagnostics subject to coverage with evidence development (CED) restrictions. In the proposed rule, CMS proposed to lower payment to providers when a CED trial includes the use of placebos. Evidence from prior CED trials have shown that payment reductions to providers participating in CED trials results in severe reductions in available sites of care, further restricting access for Medicare beneficiaries.
  
• Encourage CMS to adopt their proposal to pay separately for radiopharmaceuticals used in diagnostic testing that cost more than $630. Including these more costly radiopharmaceuticals in a single bundled payment for a diagnostic currently results in the provider losing money and often deciding not to make such tests available.

CMS’s proposals were included in the agency’s Fiscal Year 2025 Hospital Outpatient Prospective Payment System/Ambulatory Surgical Center proposed payment rule.

To read the comment letter, click here.