WLF filed comments on June 6, 2005, with the Centers for Medicare & Medicaid Services (CMS), the agency of the U.S. Department of Health and Human Services that operates the Medicare program, asking the agency to withdraw its proposal to tie reimbursement for selected new treatments to the patient’s participation in a clinical trial or a similar evidence-gathering process.

WLF argued that such requirements may restrict patients’ access to needed care and that CMS has numerous alternative tools with which to spur research. WLF further argued that CMS has not justified such requirements under the Medicare statute’s “reasonable and necessary” provision governing reimbursement.