I HATE to see stories such as this:
Medicare Says No to Stem Cells for MDS
By Charles Bankhead, Staff Writer, MedPage Today
Published: August 06, 2010
WASHINGTON -- Medicare patients with myelodysplastic syndrome (MDS) will receive coverage for allogeneic hematopoietic stem cell transplantation only when participating in qualified clinical trials, the Centers for Medicare and Medicaid Services (CMS) has ruled.
CMS decided against coverage because available evidence "does not demonstrate that the use of allogeneic hematopoietic stem cell transplantation improves health outcomes in Medicare beneficiaries with MDS."
However, the agency also ruled that allogeneic stem cell transplantation is "reasonable and necessary" for MDS through the Coverage with Evidence Development provisions of Medicare regulations. As a result, Medicare beneficiaries can qualify for coverage of therapy provided through clinical trials that meet certain criteria.
CMS will consider only prospective clinical trials that examine allogeneic hematopoietic stem cell transplantation's effect on the outcomes of relapse-free mortality, progression-free survival, relapse, and overall survival. Trials must address one or more aspects of three questions:
* How does transplantation affect outcomes in Medicare patients with MDS as compared with no transplantation?
* How do the International Prognostic Scoring System score, patient age, cytopenias, and comorbidities affect the outcomes?
* What characteristics of treatment facilities predict clinically meaningful improvement in the outcomes?
The complete text of the CMS decision is available at http://www.cms.gov/mcd/viewdecisionmemo.asp?id=238.
NICE in the UK is notorious for denying life-saving drugs to their citizens (one of the latest is Vidaza for myelodysplastic syndrome, which is a side-effect for CLL patients of FCR). This is one of the few drugs that is available for MDS, but because medical care is under the purview of the government, and not private insurance companies, there is real pressure to save money.
This is not a good development. Look for further degradation of the American health care system to 'save government money'.
Apologies!
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1 comment:
The CMS decision for Medicare is the opposite of medical rationing to save money. Our health care system is based on having the payor (Medicare in this case) be independent from those responsible for determining medical practice. FDA and other agencies determine what is acceptable, customary, usual etc. medical practice - but those agencies are not payors. Those other agencies have not (yet) ruled that transplants are customary medical practice for MDS.
By law, Medicare can only pay for acceptable, cusomary, usual, etc. medical practice. Medicare is bending over backwards trying to help fund transplants for MDS by saying that such transplants are customary in the limited area of clinical trials.
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