Monday, March 17, 2008

Medicare Restricts Reimbursement for Anemia - Better Patient Care?

A recent FDA advisory committee recommended that anemia medications, Procrit, Epogen, and Aranesp be not used in patients with breast cancer, head and neck cancers and used in patients with incurable cancers. These anemia medications are typically used to support cancer patients, who develop anemia, as a result of chemotherapy. This most recent FDA recommendation follows research studies which reported last year that these medications may have caused more deaths and contributed to tumor growth.

From the article:
  • In its efforts to overturn Medicare's new reimbursement policy, Amgen Corp. spent more than $16 million on lobbying last year and nearly $700,000 on campaign contributions, according to the Center for Responsive Politics. Amgen manufactures all three of the anemia drugs involved — Aranesp, Epogen and Procrit. Johnson & Johnson markets Procrit.
  • The aggressive lobbying campaign succeeded in generating numerous letters and speeches from lawmakers denouncing Medicare's actions and in legislation that would have voided the rule if passed.
  • Many doctors and consumer groups joined in the criticism last year when Medicare made its decision to restrict when it would pay for treatments. Amgen and J&J argued again Thursday that the safety problems cited by FDA have been inconsistently reported across dozens of studies. And they pointed out that only studies involving higher-than-recommended dosing levels showed significant safety risks.
  • The two drug companies have asked for more leeway from Medicare to reimburse doctors for maintaining hemoglobin levels up to 12. The Congressional Budget Office estimated that overturning CMS's decision could increase government spending by as much as $5.3 billion over the next decade.
What is fascinating isn't the science behind this, but the outcry from doctors, lawmakers, and the public when Medicare decided last year only to reimburse doctors if the medications were administered to patients with a hemoglobin of 10 or less (hemoglobin is a measure of the amount of red blood cells). A hemoglobin of 10 was derived from the research that suggested patients given these medications with higher hemoglobins did worse. Although the manufacturers argued that perhaps doctors were administering the medications at higher than recommended levels, doctors generally don't change practice behavior based on medication label warnings as quickly as they do when reimbursement is decreased or no longer covered.

Naturally everyone has a financial stake in seeing this ruling overturned. The pharmaceutical companies will see sales of their medications decrease as there are fewer indications (note their consumer-directed ads about these medications). Doctors will have their reimbursement decreased because they also will have fewer patients to give this medication to, even though the science suggests that many of these patients not only shouldn't get this medication but also that they could do harm. Patients, aligned with their doctors, will see this as a takeaway. Lawmakers, focused on getting re-elected would rather be seen on the side of their constituents, patients and doctors, and lobby against the FDA or Medicare as again taking a valuable benefit away.

Yet, when all is said and done, the heroes in the process, those that are protecting patients by altering doctors' behaviors to comply with the latest in research and those that are protecting the taxpayers by assuring that we are paying for the right care, are buried by massive lobbying and public relations campaigns. Perhaps this is why our healthcare system is in crisis because at the end of the day it isn't about the science, but about where the money goes.

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