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Jan 24, 2011
 |  BioCentury  |  Regulation

CMS's visible hand

CMS aiming at transplant setting to keep cutting ESA use in ESRD patients

The Medicare Evidence Development & Coverage Advisory Committee held a meeting last week to discuss the efficacy of erythropoiesis-stimulating agents in renal transplant patients, an indication that is not on the label, for which ESAs have never been tested, that FDA has never considered, and that is not the reason transplant patients with end-stage renal disease are treated with ESAs.

The Centers for Medicare & Medicaid Services is providing only a bare bones reason for convening the MEDCAC meeting, but the logical conclusion is the hearing is part of the agency's ongoing effort to save money by returning to the use of blood transfusions as its standard for controlling anemia in ESRD patients.

That was clear in the comments by Clifford Goodman, chair of MEDCAC and SVP at The Lewin Group, a healthcare consultancy. At least twice during the meeting, Goodman reminded the panel about the cost of ESRD care relative to other indications reimbursed by CMS.

"The ESRD population comprises little more than 1% of patients on Medicare, but it accounts for fully 6% of expenditures, which is disproportionate," Goodman said.

MEDCAC was asked to vote on three high-level questions.

On the first question - whether there is a link between levels of panel reactive antibody (PRA) and graft survival - the average vote among MEDCAC voting members was 2.9 on a scale of 1-5, where 1 is "low confidence," 3 is "intermediate confidence," and 5 is "high confidence."

The PRA assay measures the level of anti-human antibodies in the blood, with higher PRA levels associated with sensitization and graft rejection.

On a follow-up to question one, whether current PRA assays actually predict graft survival, the average vote was 3.33.

On the second question - whether there is evidence to show that...

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