On February 11, 2013, ADEA disseminated a memorandum on the applicability of the Physician Payment Sunshine Act (Sunshine Act), see memorandum here. Under the Sunshine Act, physician is defined to include doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors, who are legally authorized to practice by the State in which they practice. Applicable manufacturers are required to disclose certain payments or other transfers of value made to the following recipients:
- A health professional, other than a physician who is an employee of an applicable manufacturer; or
- A teaching hospital, any institution that receives payments under section 1886 (d)(5)(B) of the ACA.
The Centers for Medicare and Medicaid Services (CMS) is beginning to roll out the Sunshine Act. CMS's Deputy Director for the Data Sharing and Partnership Group, Anita Griner, has stated that data accuracy is the agency's top priority as it implements the Sunshine Act, created under Section 6002 of the Affordable Care Act.
On June 17, 2013, Griner spoke to physicians attending the American Medical Association's House of Delegates meeting. She emphasized that medical professionals have the right to challenge data going to CMS under the provision. "Data accuracy is the number one goal of our program," Griner said. "We want the data put on the public website to be complete and accurate. We do not want it to be disputed. We do not want it to be inaccurate. We do not want to perpetuate any false information about a physician or teaching hospital. So data accuracy is key. And that will come from you tracking your own transfers and checking the website before it goes public."
On August 1, 2013, manufacturers of pharmaceuticals, medical devices, and biologicals will commence complying with the Sunshine law's National Physician Payment Transparency Program, which CMS is calling OPEN PAYMENTS. The program requires companies to track items of value provided to physicians and teaching hospitals, and submit annual reports on such activities. The data will be published annually as a strategy for preventing inappropriate influences on research, education, and clinical decision-making.
Below is a list of data that should be reported:
- Covered manufacturers must report payments or other transfers of value (TOVs) made to physicians and teaching hospitals.
- Covered manufacturers and applicable group purchasing organizations (GPOs) must report certain ownership or investment interests held by physicians or their immediate family members.
- GPOs must report payments or other TOVs made to physician owners or investors if they held ownership or an investment interest at any point during a particular reporting year.
Additional information about CMS’ OPEN PAYMENTS program is available here. Starting in 2014, physicians and teaching hospitals will be able to:
- Register to access their data prior to public position,
- Initiate data disputes, and
- Work with applicable manufacturers and applicable GPOs on dispute resolution.
To ensure data accuracy, CMS is required to conduct audits of the data submitted and levy civil monetary penalties against applicable manufacturers and applicable GPOs for failing to submit data or submitting inaccurate data.