What is in this article?:
- The Implications of the Physician Payments Sunshine Act for CME Providers
- Open Payments and CME
- How CME Providers and Stakeholders Can Comply with Open Payments
- Additional Areas of Importance for CME Providers and Stakeholders
- Any Questions?
During the past 50 years, we have seen an unprecedented extension in life expectancy, from age 68 in 1950 to age 78 today. Many of our health improvements are due to new therapies and treatments created by collaborations between physicians and industry.
Along with these breakthroughs come enduring concerns that physician-industry collaboration can raise ethical issues, such as potential conflicts of interest. To allay these concerns, Congress passed the Physician Payments Sunshine Act, section 6002 of the Affordable Care Act, in 2009.
The Sunshine Act, now called Open Payments, does not directly change or prohibit relationships between manufacturers, physicians, teaching hospitals, or continuing medical education providers. Rather, the legislation and regulations require applicable pharmaceutical, biological, and device manufacturers, and group purchasing organizations, to report certain payments they make to physicians or teaching hospitals. Manufacturers were required to begin tracking their payments to physicians and teaching hospitals on August 1, 2013. They will collect data through December 31, 2013 (with the first report due March 31, 2014). Reporting is required annually thereafter. A manufacturer or GPO that fails to report or reports inaccurately may face annual fines up to $1.15 million.
Once manufacturers collect, record, and report the required information, the Center for Program Integrity at the Centers for Medicare & Medicaid Services, which issued the final regulations and is responsible for oversight and implementation of them, will aggregate payments to all physicians and teaching hospitals and post them on a searchable, public Web site after September 30, 2014.
The act’s definition of “physician” includes all licensed medical and osteopathic doctors, dentists, dental surgeons, podiatrists, optometrists, and chiropractors, regardless of whether they are currently practicing or whether they are enrolled with CMS. Non-U.S. physicians are excluded, but several countries have enacted similar legislation (e.g., France, U.K., Slovakia, Russia, and the Netherlands). It does not apply to medical residents, pharmacists, physician’s assistants, nurses, or nurse practitioners. However, CMS recently clarified in its Frequently Asked Questions page that “fellows” are not considered residents, and therefore, payments to fellows are reportable.