The ANESTHESIOGY™ 2013 annual meeting is here and from the impressive list of speakers and events set in the backdrop of beautiful San Francisco, the annual meeting will undoubtedly be memorable. But as you attend this year’s meeting, there is a significant provision of the Affordable Care Act you should know about: the Physician Payments Sunshine Act, which requires drug manufacturers, device manufacturers and group purchasing organizations (GPOs) to disclose payments and transfers of value given to physicians.
What is the Physician Payments Sunshine Act?
The Physician Payments Sunshine Act, which was included in the Affordable Care Act (Section 6002), was signed into law on March 23, 2010. Subsequent to being signed into law, the Centers for Medicare & Medicaid Services (CMS) promulgated regulations to implement the Sunshine Act. The Physician Payments Sunshine Act requires drug manufacturers, device manufacturers and GPOs to collect information on payments and transfers of value to physicians worth $10 or more or worth more than $100 to physicians in aggregate from August 1 to December 31 in 2013. In future years, the manufacturers will collect information from January 1 to December 31, and the $10 and $100 thresholds will be indexed to inflation.
Since August 1, 2013 drug manufacturers, device manu-facturers and GPOs are required to collect information on payments and transfers of value given to physicians. The manufacturer must report the data to CMS by March 31, 2014. Physicians will have 45 days to review and dispute this data. If the physician has a dispute with a manufacturer that cannot be resolved there will be an additional 15 days to achieve a resolution. CMS will publish the reported data beginning September 30, 2014.
What Information Must Applicable Manufacturers Report?
Payments or transfers of value could include anything an applicable manufacturer gives to a physician, including food and beverage, honoraria, travel, lodging, etc. However, in pages 68-69 of the Final Rule, CMS outlines a number of exclusions:
• Payments or other transfers of value provided as compensation for speaking at a certified and accredited continuing medical education (CME) event only if the applicable manufacturer does not pay the physician directly or choose the speaker.
• Buffet meals, snacks, soft drinks or coffee made available to all participants in a large-scale conference or similar large-scale event.
• Indirect payments or other transfers of value where the applicable manufacturer is unaware of the identity of the covered recipient.
• Product samples, including coupons and vouchers that can be used by a patient to obtain samples, which are not intended to be sold and are intended for patient use.
• Educational materials and items that directly benefit patients or are intended to be used by or with patients, including the value of an applicable manufacturer’s services to educate patients regarding a covered drug, device, biological or medical supply.
• The loan of a covered device or a device under development, or the provision of a limited quantity of medical supplies for a short-term trial period, not to exceed a loan period of 90 days or a quantity of 90 days of average daily use, to permit evaluation of the device or medical supply by the covered recipient.
• Items or services provided under a contractual warranty (including service or maintenance agreements), whether or not the warranty period has expired, including the replacement of a covered device, where the terms of the warranty are set forth in the purchase or lease agreement for the covered device.
• A transfer of anything of value to a physician-covered recipient when the covered recipient is a patient, research subject or participant in data collection for research, and not acting in the professional capacity of a covered recipient.
• Discounts, including rebates.
• In-kind items used for the provision of charity care.
• A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security or mutual fund.
• In the case of an applicable manufacturer who offers a self-insured plan or directly reimburses for health care expenses, payments for the provision of health care to employees and their families.
• In the case of a covered recipient who is a licensed non-medical professional, a transfer of anything of value to the covered recipient if the transfer is payment solely for the non-medical professional services of the licensed non-medical professional.
• In the case of a covered recipient who is a physician, a transfer of anything of value to the covered recipient if the transfer is payment solely for the services of the covered recipient with respect to an administrative proceeding, legal defense, prosecution, or settlement or judgment of a civil or criminal action and arbitration.
• A payment or transfer of value to a covered recipient if the payment or transfer of value is made solely in the context of a personal, non-business-related relationship.
How Could the Sunshine Act Affect Physician Anesthesiologists?
While the burden of reporting this data is not on the physician anesthesiologists, you should do due diligence to ensure that the data being publically reported about you is accurate. This due diligence includes keeping records at the time of the transaction with the manufacturer or GPO. Recently, CMS created a free OPEN PAYMENTS mobile app that would allow physicians to track their transactions. Additionally, physician anesthesiologists can and should request their data from manufacturers prior to the date that the manufacturers submit this data to CMS.