In his speech to the American Medical Association, President Obama made an oblique reference to the costliest drug Medicare buys -- recombinant erythropoietin (EPO), which is used to treat anemia in dialysis, cancer and HIV-AIDS patients. It came during his call for creating a pathway at the Food and Drug Administration for approving follow-on biologics.
We need to introduce generic biologic drugs into the marketplace. (Applause.) These are drugs used to treat illnesses like anemia. But right now, there is no pathway at the FDA for approving generic versions of these drugs. Creating such a pathway will save us billions of dollars.
It turns out that at the very moment the president was speaking, a suburban Washington research institute was filing a citizens petition asking the Centers for Medicare and Medicaid Services to scale back its reimbursement of EPO used in dialysis. The petition was filed by the Medical Technology and Practice Patterns Institute, which has documented the cardiovascular risks associated with the promiscuous use of EPO.
According to the petition, several recent studies have shown that raising hemoglobin levels above the FDA-approved label increases risk of heart attacks, strokes and death by as much as 50 percent in dialysis patients, who are already at risk of heart disease. The petition also quotes Nancy-Ann DeParle, now the president chief health care aide, who, while running CMS (it was then called the Health Care Financing Administration or HCFA) expressed concerns about the cardiovascular risks associated with overuse of the drug.
MTPPI chief researcher Dennis Cotter estimates that CMS now pays about $2 billion a year for EPO, which is manufactured by Amgen. If reimbursement stopped when dialysis clinics went over the FDA-approved level, the agency could save about half that amount or $10 billion over the next decade. That's 1 percent of what is needed to pay for health care reform.
However, there's a chance that health care reform improperly managed could bungle away those savings. As part of reform, the government is considering turning to bundled payments for many of its most costly diseases, including dialysis program (it's called the End Stage Renal Disease program). If the initial bundle includes money to pay for the current high use of EPO, the dialysis clinics would appropriately cut back on EPO use but pocket the extra money for themselves.
Cotter says both for safety and financial reasons, the reimbursement level should be cut immediately -- before CMS establishes the bundled payments for dialysis clinics treating patients suffering from ESRD.
Comments
We wish that President Obama
We wish that President Obama take a close look at CMS' oversight and enforcement of dialysis facilities. The newly revised Conditions are not a replacement for timely inspections/surveys of dialysis facilities. Even though there are specific Conditions related to Quality Improvement, etc., often problems are not brought to the attention of the QI committee until there is a severe negative outcome. Although there are specific indicators in place, there continue to be major practices that if not implemented correctly will result in either potential or actual negative outcomes, including death. There needs to be an effective inspection process, that if implemented without bias, and objectively, by well-trained surveyors, will identify those practices that are not otherwise noted by facility staff.. Often, again these (ineffective practices) result in harm. Providers rally round CMS to ensure their facilities are timely inspected so that new facilities can open and treat patients. Why do we not see providers rallying round and talking to CMS about inspecting their existing facilities, especially those who have had major deficiencies and those which have not been inspected in over five years?
Roberta Mikles, RN, Director, Health Care Patient Advocates
uncompensated advocates striving for quality safe care for all patients in all health care settings
The already gray line