On Wednesday, March 30, 2011, the Centers for Medicare & Medicaid Services issued a proposed decision memorandum to cover on-label use of Sipuleucel-T (PROVENGE®) under a national coverage determination.  PROVENGE® is the only FDA-approved autologous cellular immunotherapy treatment for metastatic prostate cancer.  It is labeled for use in men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Coverage of off-label use would be determined by Medicare’s local contractors.

The draft NCD does not include information on what guidance, if any, CMS will give to the local MACs on operationalizing this NCD including what clinical criteria they will require to document medical necessity. While Noridian has published very clear and guidance on what will be required clinically to substantiate medical necessity for a beneficiary to receive Provenge; there is a concern that under the NCD, it would be unclear to physicians what amount of medical documentation would be required.

CMS will accept public comments on this proposed decision through April 29, 2011.  A final decision will be announced within 90 days. For more details, or to submit a public comment, please see the Proposed Decision Memorandum.

Click Here to read submitted comments.