How are funding decisions made for Medicare and Medicaid? What drugs are to be funded? These questions have recently come to our attention as many of us have attempted to have Medicare fund our use of Provenge.
The administration of Medicare is actually broken into 15 different regions, or MACs (Medicare Administrative Contractors). Each MAC is responsible for deciding what treatments and drugs are to be reimbursed by Medicare. Initially, decisions are made at the MAC level, so it is possible that some MACs will approve a treatment or drug while others will not.
In some instants, the Federal organization, the Center for Medicare & Medicaid Services (CMS) , will step in and create a national policy for all the MACs. In the instances of funding for Provenge, CMS has just announced that it will be reviewing Provenge and eventually make a national policy decision on reimbursement. This process can easily take up to one year! In the mean time, CMS has instructed the MACs to continue to make individual regional decisions. So, until CMS provides a national guideline, some MACs will pay for Provenge, some may not pay and others will continue to make you jump through hoops to get it covered!
CMS has established a thirty day (30) (the month of July) public comment period for us the public to add our own “testimony”. I believe that a large public demand will help push an approval for all men who are on Medicare and who need Provenge to extend their life. Do not under estimate the power of numbers; take a lesson from the breast cancer community. We can be as strong as the breast cancer community and rally around the national approval of Provenge for men on Medicare and Medicaid.
Comments can be left at: http://www.cms.gov/mcd/m_nca.asp?id=247:
I have included my comments which you are free to copy. Better, modify mine or write your own. It will take only a few minutes of your time, but you could help extend someone’s life.
Sipuleucel-T (Provenge) should, without question, be approved by CMS nationally for all men with advanced prostate cancer. Very quickly, after it received approval from the Food and Drug Administration (FDA), the National Comprehensive Cancer Network updated its prostate cancer management guidelines to recommend, as a category 1 recommendation, the clinical use for Sipuleucel-T for men with minimally symptomatic disease, an ECOG performance score of 0 or 1, and a life expectancy of at least 6 months. A category 1 recommendation means that, “The
recommendation is based on high level evidence (use of randomized controlled trials).
Multiple blind clinical trials demonstrated a very clear survival advantage for men in the treatment arms. The survival advantage was best (six months) with men who were in the age range of being Medicare eligible.
National coverage for Sipuleucel-T should be granted immediately. According to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (NCI), 32,050 men will die in 2010 from advanced prostate cancer. Continuing to delay CMS’S approval would be unethical. We cannot afford to continue to tolerate an unnecessary delay while 32,050 men face their death. These men are our veterans, our fathers, our husbands, our partners and our brothers. How can we abandon them now?
Malecare (www.malecare.org) urges CMS to approve Sipuleucel-T on a national level.
Joel T Nowak, MA, MSW
Director of Advocacy & Advanced Prostate Cancer Programs