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Physicians’ Participation in the Open Payments Program: As if the Anti-Kickback Statute Wasn’t Enough !

sunshine act scope


By: David Hirshfeld

By now we are all too familiar with the commandment “Thou shaltneither pay nor receive, nor solicit the payment or receipt, of anything of value in exchange for referring an individual to a person for the furnishing of an item or service for which payment may be made by a Federal health care program.”  Many of us have restructured, redefined, contorted and construed our arrangements so that they fit neatly within a statutory Safe Harbor to the anti-kickback legislation.  Then, in the name of “Patient Protection,” comes the Open Payments Program (also known as the “Physician Payment Sunshine Act”).

The Open Payments Program was created by The Patient Protection and Affordable Care Act, with the intent of increasing the public’s awareness of financial arrangements between certain drug/medical supply manufacturers and/or group purchasing organizations (“GPOs”) and physicians.  As a result, even if an arrangement fits squarely within a Safe Harbor, payments from manufacturers and/or GPOs to physicians may have to be disclosed to the public through a website. Physician registration and participation in the Open Payments Program is optional.  We’ve known about the Program for just over two years, but here we are at the close of the first reporting period; so I though it a good time to get my physician friends thinking about whether to register and participate.

The Open Payments Program requires applicable drug/medical supply manufacturers and GPOs to report all payments or transfers of value they make to physicians so that CMS can publish that information.  Only manufacturers and GPOs that produce or purchase items and services covered by Medicare, Medicaid or The Children’s Health Insurance Program and that require a prescription or FDA approval to dispense must report.  All sorts of payments or items of value must be reported; including, for example, consulting fees, honoraria, gifts, entertainment, education, research, royalties, and rental payments.  However, payments made to physicians who are bona fide employees of the manufacturer or GPO are exempt from the reporting requirement.  Regardless of employment status, physicians’ investment or ownership interests in manufacturers or GPOs must also be reported.

The applicable manufacturers and GPOs were supposed to collect information regarding their payments to physicians from August 1, 2013 through December 31, 2013; and are supposed to register with the Program and relay that data to CMS by March 31, 2014 so that it can be published by September 30, 2014.  Registration was supposed to begin January 1, 2014; but since it’s the Federal government, and health care, the official opening of registration has been postponed to “Early 2014.”  The data collection and reporting periods for years after 2013 will span from each January 1st through December 31st.  Physicians do not have to register since they are not required to collect or report data; but physicians are given the opportunity to register so that they can review and, if necessary, correct the data being reported about them.

If you have received payments that are likely to be reported, then I urge you to consider registering with the Program and reviewing what is being reported about you since the information is quite specific.  If you have received a reportable payment or transfer of value, then your name and address, the amount of the payment or transfer of value, the source of the payment or transfer, and a description of the covered item related to the payment or transfer of value will be published.  Physician participants will have a total of sixty days to review and contest information before it is published.  You can even track your reportable data right from your smartphone with an app called “Open Payments Mobile for Physicians” available through the Apple Store and Google Play Store.