Date

Press release


MEDICARE EXPANDS COVERAGE FOR STEM CELL TRANSPLANTATION FOR PRIMARY AMYLOID LIGHT CHAIN AMYLOIDOSIS

MEDICARE EXPANDS COVERAGE FOR STEM CELL TRANSPLANTATION FOR PRIMARY AMYLOID LIGHT CHAIN AMYLOIDOSIS
APPROVES COVERAGE OF NEW DRUG FOR PROSTATE CANCER

The Centers for Medicare & Medicaid Services (CMS) announced today that it is expanding Medicare coverage of autologous stem cell transplantation (AuSCT) for primary amyloid light chain (AL ) Amyloidosis.

 

“This decision is part of Medicare’s ongoing commitment to ensure access to the most up-to-date cancer treatment alternatives and increase access at any age for its beneficiaries,” said CMS Administrator Mark B. McClellan, M.D., Ph.D.

 

AuSCT can treat AL Amyloidosis, a rare blood disorder that affects the heart, kidneys, nervous system and gastrointestinal system and results in extensive organ system impairment. In this transplantation, stem cells are retrieved from a patient’s bone marrow or blood, stored, and then transplanted back into the patient following high dose chemotherapy used to treat various cancers.

 

Before this reconsideration, this procedure was non-covered for beneficiaries age 64 and older.  After CMS analyzed the medical and scientific evidence and considered the recommendations of professional societies and other experts in the field, it determined that AuSCT can provide a health benefit for Medicare beneficiaries of any age with primary AL Amyloidosis.

 

The expanded coverage decision recommends coverage for beneficiaries who meet the following specific criteria: amyloid deposition in 2 or fewer organs and cardiac left ventricular ejection fraction of greater than 45 percent.  The final decision is responsive to public comments on the proposed decision that suggested eliminating a serum creatinine requirement of 2.0mg/dL or less and lowering the ejection fraction to 45 percent.

 

In addition, CMS has released a final decision memorandum to extend coverage of Abarelix (Plenaxis™), a drug for the treatment of prostate cancer. This NCD will make available a new cancer drug for Medicare beneficiaries.

 

The final decision memoranda published today by CMS are on its web site, www.cms.hhs.gov.  The new coverage will be effective today.