CMS Reconsidering Policy

on Clinical Trials Coverage

The Centers of Medicare & Medicaid Services (CMS) is reconsidering its 2000 policy requiring payment for routine patient care costs in certain clinical trials.  Public comments are being accepted through Aug. 9. 

ASBMT has filed comments emphasizing deficiencies in current reimbursement policies for myelodysplasia and non-Hodgkin lymphoma.

The 2000 national coverage decision (NCD) was a major accomplishment of the entire cancer community, which had worked for most of a decade to achieve coverage of routine patient care costs in quality clinical trials.  With strong support from patient advocates, the Clinton Administration issued an executive memorandum instructing Medicare officials to implement legislation requiring reimbursement of routine patient care costs in clinical trials.

In last month's announcement that it would reconsider its 2000 national policy decision, CMS listed 10 issues on which comment is being sought.  These and information on how to submit comments can be found on the CMS Tracking Sheet for Clinical Trial Policy.

ASBMT President Robert Negrin, in a letter to CMS Director Mark McClellan, said that in some instances the agency’s current imbursement policies do not recognize accepted standards of care.  For example, reimbursement is allowed for ineffective autologous BMT therapies for non-Hodgkin lymphoma (NHL) that has marrow involvement, but is not allowed for curative allogeneic BMT therapies.

Similarly, no reimbursement is given for allogeneic BMT for multiple myeloma, despite ample published literature showing cures for myeloma with allogeneic BMT.