Will Disclosing Physician Gifts Impact Prescribing Habits?

A federal law that requires pharmaceutical companies to disclose the identity of physicians who receive their gifts or payments will not be enforced until 2013, and a recent study casts doubts on the effects it will have on medical practice and health care costs after it takes effect.

In a study published May 28 in Archives of Internal Medicine, researchers found that similar state disclosure laws, which have been in place for the past several years, did not bring about substantial change in physicians’ prescribing behaviors.

Genevieve Pham-Kanter, Ph.D., an assistant professor at the Colorado School of Public Health and an assistant professor of economics at the University of Colorado Denver, and colleagues compared the experiences of Maine and West Virginia, which enacted physician payment disclosure laws in 2004, with those of four states without such laws.

Specifically, the authors looked at whether the required disclosures in the two states could be linked to changes in the brand-name and generic drugs prescribed in two drug classes, selective serotonin reuptake inhibitors (SSRIs) and cholesterol-lowering statins. To pair up states with similar demographics, Maine was compared with New Hampshire and Rhode Island, and West Virginia was compared with Kentucky and Delaware.

For Maine, the effect of the disclosure law was associated with small but statistically significant reductions in prescription claims for brand-name statins and SSRIs before and after the enactment of the disclosure laws, ranging from 0.8 percent to 5.3 percent, compared with prescription practices in New Hampshire and Rhode Island. The authors called the effects of Maine’s disclosure law “negligible.”

For West Virginia, no statistically significant difference was seen in either prescription drug class compared with Kentucky and Delaware.

In 2010, the Physician Payment Sunshine Act was passed by Congress as part of the Patient Protection and Affordable Care Act. The law requires pharmaceutical and medical-device manufacturers to collect information on physicians who have a financial relationship with the company and report those relationships to the Centers for Medicare and Medicaid Services (CMS) annually. The agency will then post these data on the Internet for public access. The law does not prohibit gifts and payments to physicians or preempt certain state laws that ban such transactions.

Payments, gifts, meals, and travel valued at $10 or more or totaling $100 in one year are required to be reported, as are consulting fees, research funding, and industry-sponsored medical education. Drug samples and educational materials, however, are not included in the requirement.

In December 2011, CMS released proposed regulations to enforce the reform law’s disclosure mandate and received a flood of comments from various stakeholders. APA submitted numerous comments to CMS, including recommendations that CMS should promptly notify physicians included in the reports to allow time for them to review and correct any errors and that when a physician and a manufacturer disagree on reported data, the presumption of error should fall on the manufacturer.

“CMS agreed with a number of our suggestions, including making the date of data collection concurrent with the January 1, 2013, effective date” of the implementation, said Nicholas Meyers, director of APA’s Department of Government Relations.

On May 3, CMS announced that the final regulations will be delayed and released later this year, and companies can expect to start collecting reportable data beginning January 1, 2013, instead of January 1, 2012, as initially required by the law.

It remains unclear, however, how these publicly available data will be used, who will use them, and to what effect. It has been suggested that public disclosure of the identity of physicians who receive gifts or payments from drug companies and the value of what they receive could deter physicians from undue influence, since consumers may be wary of physicians who have a relationship with industry, and physicians may eventually stop favoring more expensive products. Determing the impact of the Sunshine Act will have to wait for CMS implementation after 2013.