Pharmacy Kickback Guidelines

Pharmacy Kickback Guidelines

Healthcare Fraud Control Articles

How many of your pens have a drug name on them? A pen is not valuable enough to cause suspicion of violating anti-kickback laws, but paying a physician to attend a conference might be. Today the HHS Office of Inspector General released their voluntary guidelines for pharmacy manufacturers. The 56-page document outlines what marketing practices could raise red-flags under federal anti-kickback laws.

The guidelines are “designed to help companies prevent health care fraud and abuse by promoting a high level of ethical and lawful corporate conduct,” said Inspector General Janet Rehnquist. They note that marketing practices that are acceptable in other business sectors may be illegal when soliciting Medicare, Medicaid or other federal healthcare business.

Whether a gift, dinner, trip, grant or other renumeration is legal depends on whether the person receiving the gift could generate income for the manufacturer, the value of the gift, whether the value of the gift is dependent on the amount of business generated, potential impact on federal programs, and potential conflicts of interest. Clearly, giving a free vacation to Hawaii for the highest prescriber of a drug would be highly suspect, whereas giving pens to everyone at a medical conference won’t raise red flags. The guidelines help manufacturers and physicians evaluate the legality of the gray areas in between.

In addition to addressing kickbacks, the guidelines address issues of integrity of data provided by manufacturers (particularly data used to calculate average wholesale price, which is the basis of Medicare reimbursement as well as the basis for Medicaid reimbursement in most states) and laws regulating drug samples (doctors should not be able to make money by selling drugs that pharmacy manufacturers give them for free).

Get the press release from OIG Press Release

Get the complete article from OIG Pharmacy Manufacturer Guidelines