Sunshine law sheds light on gifts


Has a pharmaceutical rep treated you to lunch? Have you agreed to test a new product for a device manufacturer? Did you accept honoraria from a society?

These and other so-called value transfers made between Aug. 1 and Dec. 31, 2013, and annually thereafter, will be reported to the federal government under the National Physician Payment Transparency Program, also known as “Open Payments.” The 2013 data will be posted on the Internet no later than Sept. 30, 2014. Data for subsequent years will be posted by June 30 of the following year.

Physicians can review data submitted about them, but they must register with Centers for Medicare & Medicaid Services (CMS) to do so.

“We do encourage physicians and teaching hospitals to register with CMS because this affords them a very important opportunity to then review their data prior to public posting and dispute data that they feel is inaccurate,” Anita Griner told healthcare providers during a National Provider Call hosted by CMS in May. Griner is deputy group director for CMS’s Center for Program Integrity, which is implementing the regulation.

The Affordable Care Act mandated the program to increase transparency and public awareness of the relationship between drug and device manufacturers and physicians, as well as teaching hospitals. The law is designed to prevent “dishonest influence on research, education and clinical decision-making” and “stop conflicts of interest that can harm patients and their care,” according to CMS.

Physicians covered include MDs, DOs and doctors of podiatry, optometry, chiropractic medicine, dentistry and dental surgery. Medical residents are excluded, as are physicians employed by the covered manufacturers.

Products covered include any drug, device, or biological or medical supply that:

  • Is eligible for payment by Medicare, Medicaid or CHIP (Children’s Health Insurance Program), either individually or as a part of a bundled payment;
  • Requires a prescription to be dispensed; or
  • Requires pre-market approval by, or pre-market notification to, the U.S. Food and Drug Administration.

Applicable manufacturers are required to report all payments, whether or not they are related to a covered drug, device, or biological or medical supply. There are a total of 16 categories of payments that must be reported, including current or prospective ownership or investment interest in a covered product by a physician or any family member.

However, indirect payments are also reportable. An indirect payment becomes reportable, for example, if a manufacturer or group purchasing organization (GPO) makes a payment (or transfer of value) to an intermediary such as a specialty society, which then provides that payment to a physician or teaching hospital.

Some items are excluded from reporting, such as drug samples intended exclusively for distribution to patients and educational materials that directly benefit patients, among other things. Items costing less than $10 are exempt.

However, if a physician receives numerous value transfers worth less than $10 in the same category from a manufacturer or GPO and the value transfers aggregate to more than $100, then they would be reported.

What should physicians do?

Physicians are not required to submit any information to Open Payments, but they are encouraged to keep a record of any payments, gifts, entertainment, consulting fees, etc., provided to them.

While registration is not required, CMS encourages physicians to register so they can review data submitted about them. For physician groups, each physician must register individually.

Ask manufacturers for a pre-submission review before March 31, 2014, the deadline for sending information to CMS. This can help to ensure the data’s accuracy.

Once information is compiled and before it is made public, registered physicians will have 45 days to review the data and work with manufacturers to correct faulty information. Manufacturers will have a subsequent 15 days to submit corrections to CMS. Information still in dispute when the website goes public will be so marked. For more information, visit the Open Payments website at