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Medicare Drug Plan

ROCKVILLE, Md. -- Advancing toward a long-sought patient-safety goal of the Food and Drug Administration, the Centers for Medicare and Medicaid Services last month proposed creating a comprehensive, data-driven tracking program for drugs after they have gone to market. The proposal--aimed at using Medicare data to improve the FDA's ability to monitor problems arising from-the use by older Americans of already approved prescription drugs--would equal in scope the extensive pre-marketing trials that preclude a new drug's approval.

The CMS plan, which FDA officials have yet to endorse, would kick into gear in January once Medicare Part D drug benefits become available to the nation's roughly 43 million Medicare recipients. The tracking program would create a database combining Part D prescription drug utilization data with health care information that's already collected by CMS under Medicare. A computer system then could cross-reference the information and detect problems with medications.

The Medicare agency is seeking public comment on the plan.

Even though the CMS proposal seems to be right up the FDA's alley, the FDA has been slow to embrace the concept publicly until it has had a chance to review the proposal. However, it may not be long before the agency endorses the idea. In an interview earlier this year with Drug, Store News, the FDA's acting deputy commissioner for operations Janet Woodcock said: "The FDA is on record multiple times [stating that] we need a strong post-market [tracking] program.

"That's what we don't have in the country, really: a very strong safety net that ... pays for studying the consequences of drug use after [those drags reach the market]," she added.

"The idea is to develop better evidence using the data that we'll be getting through the prescription drug benefit and other data sources that we have,' explained Larry Kocot, senior policy advisor to the Medicare plan policy group at CMS. In this way, we can assist the FDA and the work that they do through the MedWatch system."

Because HIPAA regulations are administered through CMS, patient privacy is not expected to be an issue. "We want to make sure we're HIPAA compliant," he said.

However, Kocot noted, that's not the only challenge in executing the proposal. "We want to make sure that the studies and evidence are developed appropriately so that we have an accurate picture [of drug use across the Medicare population] and so that we don't have flaws in the conclusions," said Kocot, the former senior vice president and general counsel at the National Association of Chain Drug Stores.

While data derived from a senior Medicare population may not shed light on medicine use across the general population, the data certainly would supplement what's currently available. "This is intended to augment other systems out there," Kocot said. "We'll be working with other payers, PBMs, manufacturers, other stakeholders who have an interest in the data and who can take a broader look.

"Having this data on this population is great for looking at this population," he cautioned, "but we won't be able to look across other [patient] populations."

At this point, there simply aren't many large databases covering seniors out there, Kocot said, as the rolls of managed care often are filled by younger, pre-retirement employees.

And databases that would cover as many as 20 million of those younger patients also are under development, according to published reports. United-Health Group currently is developing a monitoring system similar to the one CMS has proposed.

Any proposed data share would do more than better identify possible adverse events across a broad patient population, however. The data also could be used to fine-tune treatment regimens to better serve Medicare recipients--and possibly to reduce costs down the line. "We're also looking to develop better evidence so that beneficiaries and their caregivers can make more informed decisions about treatments," Kocot said.

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