“We're trying to be pragmatic,” replied Dr. Shantanu Agrawal, director of the CMS data-sharing and partnership group, explaining that the agency would not get too preoccupied with “who picked up what” at a large buffet.
The Sunshine Act appears as Section 6002 of the Patient Protection and Affordable Care Act, and was championed by Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.).
The CMS is rebranding the requirements as the “Open Payment Program” and wants to create a national transparency program for payments made to physicians and teaching hospitals by drug and medical-device manufacturers and group purchasing organizations, Agrawal said.
More than 90% of physicians report having some type of business relationship with industry sources, Agrawal said. About 80% report receiving food or beverages in the workplace from industry sources. Pharmaceutical companies, he said, spent $15.7 billion in 2011 on face-to-face sales and promotional activities.
That figure may be going down, however. Some major drug companies, including Pfizer and GlaxoSmithKline, reported spending significantly less last year on courting doctors.
Beginning Aug. 1, drug and device companies will need to start keeping track of transfers of value worth more than $10 to physicians and teaching hospitals. (In Nielsen's example, the value of enjoying a cup of coffee and pastry at a drugmaker's expense would fall below the threshold.)
Physicians will have the opportunity to review what is reported about them in the second quarter of next year, and the reports will be made public on Sept. 30, 2014.
“We hope that you keep track of your own transfers of value,” said Anita Griner, deputy director of the CMS data-sharing and partnership group. Griner said physicians' records would be help resolve disputes. The CMS, though, will not mediate them, she said. If industry and doctors cannot agree on the figure, the CMS will post the industry-supplied number and mark it as under dispute.
The CMS will audit some of the reports supplied by manufactures and GPOs, and disputes could trigger an audit.
While Agrawal acknowledged that relationships between physicians and manufacturers contribute to important innovations, he emphasized the concerns raised by conflicts of interest. Those conflicts, he said, become “far more magnified” because 60% of physicians reporting an industry relationship are involved in medical education and 40% are involved in creating clinical practice guidelines.
Griner reviewed with the audience how the business relationships of physicians, teaching hospitals, podiatrists and chiropractors would be subject to reporting. When she asked if physician assistants and nurse practitioners would be subject to sunshine reports, the audience replied in unison: “No, but they should be.”
Follow Andis Robeznieks on Twitter: @MHARobeznieks
