By Stephen Stone, MD
Has a representative from a drug or device company treated you to lunch? Paid you to attend a lecture? Or even provided you with reprints from a medical journal? If so, information about these sorts of industry payments to physicians will be available to the public for the first time when CMS’ Physician Payment Sunshine Act goes into effect later this year.
Under this program, called Open Payments, companies are required to track and report all payments they make to physicians and teaching hospitals. This data capture began in August 2013, and companies were required to submit their first reports to CMS in March 2014.
This month, CMS opened the registration process on its Enterprise Portal through which physicians can review data about payments they have received from drug and device manufacturers. Through this process, we can access information about payments or other transfers of value we received from industry before that data is made public in September.
Although manufacturers are required to submit payment information to CMS, registration by physicians is voluntary, though it is required if a physician wants to be able to review and dispute the data.
I encourage you to register with CMS so you can review the payment data. Physicians will have a 45-day period in which to review the data and dispute any inaccuracies before it goes public on Sept. 30, 2014. You also should verify your information in the National Plan and Provider Enumeration System (NPPES) to ensure you are being identified correctly.
Once the Open Payments site is fully operational in September, CMS is supposed to notify you when a company reports payments or other transfers of value made to you. However, I would advise you to check the site periodically to ensure the accuracy of the reports. Make a note to check your information every two or three months. If you find a mistake or inaccuracy and notify CMS, they have 15 days to correct the error.
To ensure accurate reporting, all physicians should keep a list of the payments they received and the companies from which they received them, as well as details about services rendered. To facilitate this information-tracking effort, CMS developed a free app that physicians can use to record their payment information on their mobile devices.
(Note: The Open Payments app is for personal information collection and serves as an information repository; it does not interact with CMS systems or CMS contractors, and it cannot be used to directly report data to CMS or its contractors.)
The Open Payments app is easy to download on your Apple or Android device, and it helps you log information about compensation you receive throughout the year.
Typical scenarios in which physicians receive “payments” from industry include consultation, lectures, research, education, honoraria, gifts, entertainment, food and beverages (could be sales-related), travel and lodging, charitable contributions, royalties/licenses, current or prospective ownership or investment interest, grants and compensation for serving as faculty or a speaker for an unaccredited and non-certified continuing education (CME) program (or an accredited or certified CME program under certain circumstances), and grants. Even reprints of journal articles are reported at the reprint price!
- Speaking fees for certain accredited CME activities;
- A transfer of value less than $10, unless the aggregated amount transferred exceeds $100 annually;
- Product samples intended for patient use;
- Patient educational materials that directly benefit patients;
- The loan of a device for a trial period not to exceed 90 days for the purpose of evaluation;
- Items or services provided under a contractual warranty, where the terms of the warranty are set forth in the purchase or lease agreement;
- Discounts including rebates; and in-kind items used for the provision of charity care.
Protect against perception issues
We’re not yet certain if CMS plans to post payment information with contextual explanations. If not, the data could be easily misinterpreted. For example, a dermatologist could receive a significant payment for conducting research, but it may cover only the lab expenses or may go to the employer for overhead. Without that explanation, the payment could be misconstrued by the public.
Once in the public domain, this information can be used freely and, perhaps, out-of-context by political figures, advocacy organizations, media, and others to present misleading or sensational conclusions. Disclosure of industry payments to physicians may spur investigations into potential violations of federal and applicable state laws, including the anti-kickback statutes, False Claims Act, and the Stark law.
For this reason, it’s essential that you carefully monitor the data and act quickly to dispute any inaccuracies.
Dr. Stone is a board-certified dermatologist, professor of dermatology, and director of clinical research at Southern Illinois University School of Medicine.