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Lawmakers seek to aid anemia-drug producers in dispute with Medicare |
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By Jeffrey Young
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Posted: 10/02/07 07:19 PM [ET] |
The makers of a costly and controversial anemia medication have found congressional champions in their fight against the Bush administration’s efforts to curtail Medicare spending on their products.
Reps. Anna Eshoo (D-Calif.) and Mike Rogers (R-Mich.) introduced legislation Friday that would overturn a decision by the Centers for Medicare and Medicaid Services (CMS) to limit the circumstances under which Medicare will pay for anti-anemia treatments of cancer patients using the drugs, called erythropoiesis-stimulating agents but more commonly referred to as EPO.
The Eshoo-Rogers legislation maintains that CMS’s revised payment policy puts patients at risk by restricting Medicare coverage of EPO drugs.
For Amgen and Johnson & Johnson, which market EPO drugs, the legislation represents a part of their campaign to turn back the tide of bad news regarding their products. Recent studies have raised questions as to the safety of the drugs for cancer and kidney dialysis patients, leading the Food and Drug Administration to add strong new warnings to their labels and CMS to reexamine its payment policies for the drugs.
These lawmakers stepped in after the drug makers and their allies in the cancer-care provider community failed to convince CMS to reconsider its decision, which it rendered in July.
Eshoo and Rogers, along with 222 colleagues, wrote CMS shortly after the agency announced its new policy, questioning the rationale behind the agency’s decision and suggesting it would hurt cancer patients. Last week, Rep. Edolphus Towns (D-N.Y.) wrote the agency demanding documentation to justify the new policy.
The Eshoo-Rogers legislation takes the form of a Congressional Review Act joint resolution, a rarely used tool that allows Congress to overturn regulatory decisions made by federal agencies.
The resolution may never come to a vote, but its introduction serves as a strong reminder to CMS that the special interests with a stake in Medicare coverage of EPO have friends in Congress.
Although the new CMS policy affects the use of the drugs only for cancer patients, not dialysis patients, the drug, dialysis and cancer-center industries — not to mention their investors — have been closely watching for signs that Medicare’s hearty appetite for EPO drugs could be waning. CMS’s decisions on which drugs or medical devices to cover also tend to serve as the template for what private insurance companies will pay for.
In addition, Congress has been intensifying its scrutiny of Medicare spending on EPO, which represents the single largest drug expense for the program. In 2005, Medicare spent $2 billion on EPO drugs to treat anemia in patients with end-stage renal disease undergoing kidney dialysis, and nearly another $1 billion to treat cancer patients suffering from anemia resulting from chemotherapy.
Because EPO is administered in doctors’ offices or dialysis facilities, CMS pays the providers for the drug under Medicare Part B, not through the Medicare Part D prescription-drug benefit, which covers medicines taken by patients at home.
Amgen markets the brand-name drugs Epogen and Aranesp, while Johnson & Johnson sells Procrit. There is no generic version of these three drugs, which are virtually identical to one another.
The drug makers are not the only special interests that pushed for CMS to alter its “national coverage determination” on EPO for cancer patients when the proposal came out in May. The American Society for Clinical Oncology, the American Society of Hematology and the cancer treatment center company US Oncology also are participating in the effort.
Some key lawmakers view the EPO manufacturers skeptically, however, citing Medicare’s rising spending on the drugs. The House Ways and Means Committee’s version of legislation to reauthorize the State Children’s Health Insurance Program included provisions that would have reduced spending on Medicare’s dialysis benefit by $400 million, largely through reduced drug expenses.
Rep. Pete Stark (D-Calif.), chairman of the Ways and Means Health Subcommittee, has been particularly critical of Medicare spending on EPO.
Stark has argued that Medicare payments for EPO for dialysis patients encourage providers to overuse the drug, driving up costs and endangering patients.
Last week, Stark issued a statement noting that Medicare pays $9.10 per 100 units of Amgen’s Epogen, compared to the $8.03 paid by the Department of Veterans Affairs (VA). According to Stark, Medicare would save $187 million annually if it purchased Epogen at the VA rate.
“Because Medicare pays significantly more for Epogen than do either the Veterans Administration or large dialysis chains, its payment policies create an incentive for over-prescription,” Stark said. |
