Medicare Compliance & Reimbursement

HHS could use the data it collects from drug companies to answer this key question.

Starting in 2012, drug companies must fork over annual reports to HHS spelling out the types and volumes of drug samples they've tendered to individual physicians. And that data could open a window into a world that the government may be hankering to analyze. Baltimore attorney Joshua Freemire thinks the reporting requirement, which is mandated by the healthcare reform legislation, could be designed to give "federal authorities the data they need to assess how the free sample system affects prescription patterns." (He emphasizes that this is, however, only a guess.)

Backing up his conjecture, however, Freemire points out that the new reporting requirement is actually a Food & Drug Administration provision. The information will ... be in HHS' possession and presumably assessed by the FDA," adds Freemire, noting that the FDA monitors how drug and device companies market their products. And one accusation, in general, leveled against pharma companies (fairly or not), is that they use free samples to encourage physicians to prescribe the "latest and greatest" drug -- even when that drug offers only a marginal improvement over cheaper medications, says Freemire. "Encouraging the prescriptions ... helps pharma companies recoup some of their massive R&D investments," he adds. "But health reform advocates have long argued that it unnecessarily drives up" healthcare costs for patients and payors, including the federal government.

Thus, the government's goal in collecting the drug sample data could be to see if the free sample system "generally increases or decreases the costs imposed on the [healthcare] system," Freemire surmises.

Bottom line: The drug sample reporting provision should "provoke some thought" among pharma companies.