CMS Administrator McClellan Proposes Medicare-Based Prescription Drug Monitoring System

CMS Administrator Mark McClellan has proposed using billing data and health care information collected from Medicare beneficiaries to create a more effective post-market surveillance system for prescription drugs, the Los Angeles Times reports. He suggested collecting adverse-event information from Medicare beneficiaries who enroll in the new prescription drug benefit, which begins Jan. 1, 2006.

Officials would use billing data from the benefit and combine it with health care information already collected by Medicare when beneficiaries submit claims. A computer system then could cross-reference the information and detect problems with medications.

FDA's current surveillance network uses voluntary submission of reports to the Adverse Event Reporting System database. The system collects about 400,000 reports of adverse events annually but detects only 10% of serious drug reactions -- a figure most experts believe "only scratches the surface," according to the Times.

While the system can detect rarer side effects effectively, it is not reliable in identifying whether a drug caused a common medical problem, such as a heart attack, or risks that emerge several years after a drug has launched. In addition, the system does not provide information on how many people are taking each drug, which is important for calculating the prevalence of any problem.

"The electronic systems we would need are already going to be in place," McClellan said, adding, "We need them for Medicare to determine what to pay. The incremental cost of doing this is very low ... well under $10 million a year."

McClellan said beneficiaries' personal information would be protected and federal officials would have a more effective and faster system for detecting problems. He added, "In an era when we should be depending on electronic systems, it should not take five years and millions of patients before we get to a potential problem."

McClellan also said a Medicare monitoring system could help determine which drug treatments are most cost-effective. According to the Times, Sens. Chuck Grassley (R-Iowa) and Max Baucus (D-Mont.) are considering legislation that would allow Medicare to establish such a monitoring system.

An FDA spokesperson said the agency is "exploring [the] possibility" of creating a Medicare-based drug monitoring system but added that "[i]t really is too early." Participants of a recent FDA drug safety advisory committee meeting discussed ways to improve the drug monitoring system, including a Medicare-based one.

However, after two days of deliberations, "[n]o one at [FDA] was willing to say, 'OK, this is what we would like to do,'" panel member Curt Furberg, an epidemiologist at Wake Forest University, said. Panel Chair Peter Gross, chair of the Department of Internal Medicine at Hackensack University Medical Center, said he believes the Medicare proposal is a good idea but added that he did not "get the sense that (the FDA officials) were latching on to it."

Raymond Woosley, vice president of the University of Arizona Health Sciences Center, said, "I think it's a huge opportunity. We're going to be spending billions of dollars on medications for the elderly, and we're calling it a 'benefit.' But if we don't have a way to monitor outcomes from the use of these medicines, it may not be a benefit." Woosley said he believes FDA ultimately will support such a system.

However, Henri Manasse, a spokesperson for the American Society of Health-System Pharmacists, said, "Some people may be afraid of this data. If this system were to detect a lot of bad prescribing related to the marketing practices of the pharmaceutical industry, the industry would not be very happy. So there could be some political downside, but medically it could help deliver the best care for the available money" (Alonso-Zaldivar, Los Angeles Times, 6/5).

Additional information on the Medicare drug benefit is available online.