Beginning in August, medical device manufacturers, pharmaceutical companies and group purchasing organizations (GPOs) will be required to track and report all payments and transfers of value to physicians and teaching hospitals. Known as the Sunshine Act, the rule is now called the National Physician Payment Transparency Program (Open Payments).
Payment data will be collected from Aug. 1 through Dec. 31, 2013, and reported to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014. CMS will publish the data on a public website by September 2014. After that, annual postings will be made on June 30.
While you are not required to submit information, you will receive a general notification when information is submitted to CMS and have the opportunity to review, challenge and correct reports 45 days prior to data publication.
Q. What payments/transfers are reported?
A. Manufacturers must disclose the form of the payment/transfer, such as cash/equivalent, in-kind items or services, stock, stock options or any other ownership interest, dividend, profit or return on investment. Payments made indirectly to a physician or to third-party beneficiary are included. The payment/transfer must be categorized as a consulting fee, non-consulting compensation, honorarium, gift, entertainment, food and beverage, travel and lodging, education, research, charitable contribution, royalty or license, current or prospective ownership interest, faculty/speaker compensation, grant, space rental or facility fee.
Q. What ownership interests are reported?
A. Manufacturers and GPOs must report ownership interests held by physicians and their immediate family members, unless the ownership interest is available to the public and listed on a stock exchange, such as mutual funds and publicly traded securities.
Q. Are payments for medical research writing and/or publication included in reporting research payments?
A. A payment reported as research falls within a research payment category if subject to either a: 1) written agreement, 2) contract or 3) research protocol. Payments for medical research writing and/or publication would be included in the research payment, if the activity was included in the written agreement or research protocol and paid as a part of the research payment.
Q. What else is exempt from reporting?
A. Included are free drug samples and educational materials provided for and given to patients (not textbooks or journal reprints), discounts and rebates, buffet meals, snacks, soft drinks and coffee generally available to all participants of large-scale conferences or similar events, and transfers valued at less than $10, unless calendar year aggregate exceeds $100.
Q. Can I do anything to prepare?
A. To receive periodic email updates, register with the CMS listserve. If you want notices about the annual review period, you will need to register with CMS but this is not yet available. For now, keep records of all payments/transfers you receive and be proactive with manufacturers and GPOs to make sure your information is correct.
Read more here or call the ISMA legal staff at (800) 257-4762 or (317) 261-2060.