Comments Submitted to Medicare
on Reimbursement for Clinical Trials
A revision of federal policies on reimbursement of treatment for Medicare patients in clinical trails has been proposed by the Centers for Medicare and Medicaid Services (CMS). ASBMT, together with the National Marrow Donor Program, has submitted comments.
The current reimbursement policy, in effect since 2000, has Medicare paying for patient care services within clinical trials that otherwise would be reimbursed outside of clinical trials. This overall policy would not change under the proposed new rules, but there would be a variety of additional requirements.
The comments submitted by ASBMT offered general support for the revisions, but raised several concerns about an exclusion from studies of Medicare participants younger than 65, an exclusion of self certification and IND-exempt studies, requirements for the publication of flawed studies or the premature results of studies, and the absence of a provision to “grandfather” patients currently enrolled in clinical trials.
Available online are:
· comments submitted by ASBMT
· the CMS-proposed policy revisions
· comments submitted by 64 other individuals and organizations
CMS is expected to publish its final rules by July 9.