CHICAGO — Are doctors going to need to start reporting when one of their vendors buys them a Danish and cup of coffee? How will the government even know whether a physician's sister has stake in a pharmaceutical company? And, with their scope of practice growing in some states, why shouldn't nurse practitioners and physician assistants be subjected to the same scrutiny?
Those were some of the questions on the tongues of doctors Monday during a session at the American Medical Association's annual meeting of its house of delegates. The topic of conversation: the so-called Sunshine Act, which requires manufacturers of drugs, devices and other medical supplies covered by CMS to report any sorts of payments made to doctors and teaching hospitals.
Aug. 1 is when vendors have to start collecting such data, and more than a few doctors in attendance seemed a little uneasy about how this is all going to shake out. "Unbelievable" and "insane" were a couple of the words I heard whispered out of docs' mouths during the session, as CMS officials ran through some of the particulars.
Massachusetts enacted a similar law a couple of years ago, and doctors weren't really prepared for the media storm that followed, Lynda Young, a pediatrician in Worchester, Mass., told me after the session. Physicians take part in a lot of harmless clinical trials, and some instances were taken out of context, she believes, when data started going public in the Bay State.
"Our colleagues do a lot of clinical trials to see about drug safety, drug efficacy. The public doesn't understand that," Young said. "All they understand is that that doctor got a lot of money — 'more money than I make in a year' — and that's why, 'when I go to the pharmacy, I have to pay more for my medicine.' That's the perception, and sometimes they're not wrong."
While data collection starts this summer, it won't be made public for quite some time. The first cycle will track financial relationships between Aug. 1 through the end of this year, and vendors won't actually have to submit information to CMS until March 31, 2014. Physicians and teaching hospitals will have a 45-day window to challenge the data, and details won't actually be published until Sept. 30, 2014. Those who don't comply face fines capped at $150,000 for negligence and $1 million for willful noncompliance.
Shantanu Agrawal, M.D., the medical director of the Center for Program Integrity at CMS, rattled off numbers showing the need for such an "open payments program." About 94 percent of physicians have some sort of relationship with the manufacturing side of health care, and 83 percent have reported receiving food and beverages in the workplace. The pharma industry alone spent $15.7 billion in 2011 on face-to-face sales and promotional activities with physicians.
Those numbers become all the more important, Agrawal said, when you consider that 60 percent of those provider-manufacturer relationships involved medical education, and 40 percent were related to creating clinical practice guidelines. CMS will try to toe the line, however, making sure to bolster transparency, but not stifle experimentation and innovation.
"We are trying to promote or create a delicate balance," Agrawal said. "On the one hand, it is a transparency program. We do want to get the data out to the public to view and understand. But on the other hand, we don't want to negatively impact some of the many positive benefits that can occur through these interactions in terms of innovation, in terms of important research and education."
CMS is urging doctors to keep track of their industry relationships so they're not blindsided when the information goes public next year. The agency is even working on a mobile app for smartphones to help with that process, hitting the market in July, along with a sample list of questions to ask manufacturers, and things to say to patients on this topic. There's also a wealth of information on the act, at webpages created by both the AMA and CMS, worth perusing.
The act applies to all types of MDs, from osteopathic to dental, but not nurse practitioners and physician assistants, bringing some groans from those in attendance. Kevin Flaherty, M.D., an ophthalmologist in Wausau, Wis., said after the session that those types of clinicians are seeing their scopes of practice expand across the U.S., and should be subject to the same set of rules.
He worries that the act will place more burdens on already swamped physicians. If attending a conference, Flaherty said he doesn't want to have to pull out a mobile app to keep track of every cup of coffee he drinks (though the act does exclude any interactions valued at less than $10).
"I understand that there's been a lot of abuse in this area over the years, and I think there should be some way to track it so that there's not undue influence by drug companies and manufacturers on physicians. That's very appropriate, but I think this seems way overboard," Flaherty said.
What are your thoughts on the National Physician Payment Transparency Program? Will it get rid of the undue influence in the doctor's office, or just create a whole new set of problems? Share your thoughts in the comment section below, and watch for continuing coverage of the AMA House of Delegates meeting on Wednesday and Thursday.