CMS Rule Would Make Drug, Device Makers’ Payments to Docs Transparent

The Centers for Medicare & Medicaid Services late Wednesday released its 121-page proposed rule designed to reveal potential conflicts of interest between drug, biological and medical device companies and the physicians and teaching hospitals that prescribe and use them.

The proposed rule, also called the Physician Payment Sunshine Act, which was required by Section 6002 in the Affordable Care Act, would mean about 150 manufacturers of drugs, or biologics, 1,000 makers of medical devices or medical supplies, and 420 group purchasing organizations will be required to report payments, to physicians and teaching hospitals. Such payments are defined to include gifts, fees, meals and travel expenses.

"When people are faced with the difficult task of choosing the right doctor, they need all the information they can gather," CMS deputy administrator for Program Integrity Peter Budetti, MD, said in a statement.  "If your doctor is taking money from manufacturers of prescription drugs, suppliers of wheelchairs or other devices, you deserve to know about it.

"Disclosure of these relationships will discourage the inappropriate influence on clinical decision-making that sometimes occurs while still allowing legitimate partnerships," Budetti said.

The ACA specified that details of these transactions should be made publicly available and searchable on a federal website.

CMS missed its deadline by about 10 weeks. The proposed rule delays the start time from Jan. 1, as set forth in the Affordable Care Act, to after the final rule is published next year.

It defines eligible transfers of value as amounts of $10 or more. Covered teaching hospitals are defined as those that receive graduate medical education payments.