In my newspaper days, it was always a no-no for us reporters to accept free meals or gifts from sources, for fear that they might skew our coverage. And on the flipside, we Chicagoans are always wary when we read of politicians accepting huge campaign donations from law firms or construction companies that turn around and get millions in city business as soon as their pals are elected.
But why shouldn't we expect the same from our doctors? I would want to know if my physician just went on an all-expense-paid golf outing in Hawaii that was paid for by pharmaceutical execs. Wouldn't you?
CMS recently issued its long-awaited final rule on the National Physician Payment Transparency Program: Open Payments, also referred to as the Sunshine Act. Part of the Affordable Care Act of 2010, the program requires manufacturers of drugs, devices, biologicals and medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program to report payments made to doctors and teaching hospitals. CMS hopes to shine a light on any activities that might influence how physicians do their jobs; those who don't comply face fines capped at $150,000 for negligence and $1 million for willful noncompliance.
"You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need," Peter Budetti, M.D., CMS deputy administrator for program integrity, said in a statement. "Disclosure of these relationships allows patients to have more informed discussions with their doctors."
But how aware of these new rules are your clinicians, and how will the changes affect their behavior? More than half of doctors are completely unaware of the Sunshine Act, according to a recent email survey by the technology firm MMIS. And some 63 percent of the 1,000-plus polled said they're "deeply concerned" that a record of such payments will be made available in a publicly searchable database. Hospital leaders should be talking with their doctors and suppliers now to prepare for what's ahead, experts say.
"To have a law like this in place without the proper communication channels — coming from government, from the societies, from the hospitals that physicians work in — would mean that, when this information is published in the public domain, there's going to be quite a few physicians that are upset. There's going to be a misperception about the relationships between industries and physicians and, quite frankly, it's going to be a mess," Michaeline Daboul, president and CEO of MMIS, told me by phone last week.
Other highlights from the MMIS Sunshine Act survey:
- About 21 percent of physicians surveyed said they would sever ties with manufacturers who reported inaccurate information about payments, if disclosed to the public.
- There was a 5 percent increase in the number of docs unfamiliar with the act, compared with the results of last year's survey.
- Some 54 percent of respondents said they've received product samples through industry relationships; 57 percent received food or beverages in the work place; 48 percent took part in an industry-sponsored program; and 2 percent are accepting free event tickets or gifts.
Daboul said that providers need to start communicating and strategizing now, with deadlines just around the corner. Manufacturers and group purchasing organizations need to start collecting data on Aug. 1, according to a CMS press release, and must report the data for August through December by March 31, 2014. CMS is developing an electronic system to gather the info, which will go live Sept. 30, 2014.
The six-month lag between now and the startup in August is to address industry concerns and give companies more time to prepare to start logging this data, said Jonathon Kellerman, principal of PricewaterhouseCoopers' pharmaceuticals and life sciences practice. He also pointed out that there's a review-and-dispute period in the final rule, giving institutions or individuals at least 45 days (along with a 15-day grace period for the other party to respond to the disputes) to peruse and challenge data before they go live on the CMS website.
"What you're seeing is a more collaborative effort between all aspects of health care providers. You have the manufacturers, you have the hospitals, you have the health care professionals, you have CMS all engaged in this process together," Kellerman said.
The biggest unknown is how both patients and the industry will react once the data go live, but mostly Kellerman expects increased cautiousness in medicine, along with doctors and manufacturers who are more educated about the types of interactions they're having with each other.
Howard Brody, M.D., director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston and author of Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, thinks the Sunshine Act is a good first step in addressing conflicts of interest. Strides have been made in public policy, but there aren't a lot of data out there to demonstrate how well these laws are working, he said. He worries that it might take a while for docs to change their old ways.
"There is such a long history of physicians' relying on pharmaceutical detailers both for much of their information about new drugs and for free meals, that I doubt anything will change radically very soon," Brody told me by email last week. "On the research side, the industry pays for about three-fourths of all clinical trials for drugs, so don't expect any big changes there for awhile either."
What do you think? What's your hospital doing to get ready for the Sunshine Act? Share your thoughts in the comment section.