When the Red Heifer restaurant opened its doors in upscale Bethesda, Maryland, some years back, the owners offered a steakhouse menu they thought customers would like, but they pinned their biggest hopes for profits on a room in the back of the restaurant complete with video screens and comfortable chairs. That room was designed specifically for drug companies to entertain doctors over juicy steaks and drinks and update the physicians on the firms’ latest drugs and devices.
But a few months after the restaurant opened, Maryland enacted a law limiting corporate meal expenses for physicians to $25 per doctor in a certain period—hardly enough for the profits the Red Heifer envisioned. Within a few years, the restaurant closed.
If you’ve ever wondered if your doctor is one of those who’s received payments, meals, trips, speaker or travel fees, or research money from a large pharmaceutical or medical device company, you’ll be glad to hear it’s going to get much easier to find out: The Centers for Medicare and Medicaid Services (CMS) just released final rules for the so-called Sunshine Act, part of the Affordable Care Act that requires manufacturers of drugs, devices, biological products, and medical supplies who are reimbursed by Medicare—as many physicians, and perhaps even most, are—to report information to CMS each year on payments, ownership, investment interests, and any other items of value the companies give to doctors and teaching hospitals.
Companies will have to begin compiling data August 1, 2013, and filing reports starting in March 2014, though some firms have already been reporting that information for several years under the terms of lawsuit settlements.
For many health and consumer advocacy groups, the new rules are very good news. Over the years, some doctors have been accused—and some found guilty— of taking money or gifts from companies and then pushing patients, sometimes inappropriately, toward that firm’s products.
Sometimes, though, the relationship between the physician and a company is much more subtle. For decades, drug companies, for example, dispatched representatives who hosted weekly pizza parties at medical schools, and handed out pens, pads, and even more expensive schwag with the company’s logo to students and physicians. The aim: to be at the front of a doctor’s mind when it was time to prescribe a drug or choose a device. And drug company reps have long dropped off samples at doctors’ offices with the hope of directly influencing which medications a doctor prescribed.
But while the new rules should make it much easier for patients to see if their doctor is receiving any payments (or anything that could be construed as a kickback) from a device or drug company, the new Act also has the potential to shut down research and cut back on doctors’ post-medical school learning, since the medical community has relied on the same firms to provide many of those classes and training for decades.
“[Under The Sunshine Act] some connections with industry may decline that were useful, as opposed to just marketing that used doctors as shills for the company’s products,” says Arthur Caplan, Ph.D., head of the division of bioethics at New York University Langone Medical Center, in New York City, and a respected medical ethicist. “There are some continuing medical education and research activities that will suffer because the disclosures may appear to look bad, even if they’re not bad.”
Caplan says that while there has been enormous abuse “with wine and cruises and sports events,” used by medical companies to draw doctors to attend the programs they hosted, those events also often included critical information, such as the results of clinical trials and training on new equipment that doctors need in their practices. The events “did serve some role and there hasn’t been a system developed to replace the distorted one that is now evaporating,” he explains, adding that professional medical societies may now need to take that role. Those events,” he says, “will take place in a modest hotel instead of the Caribbean.”
Which is not to say that it bothers all patients that their doc is getting paid by or receiving gifts from big pharma or other healthcare companies. Reporting by ProPublica, a nonprofit investigative journalism site, found that some patients think that if their doctor is linked to a healthcare firm, that physician is important and knowledgeable. Caplan says patients are also “surprisingly trusting of their doctors.”
Until the new rules go into effect and it’s easy to log on to see what, if anything, your doctor has to do with healthcare companies, you can use ProPublica “Dollars for Docs” tool, which lets consumers enter a doctor’s name to see whether that physician received corporate funding.
Caplan, who has himself consulted with pharmaceutical companies, always discloses any financial relationships and thinks the new rules shouldn’t necessarily shut down all funding doctors might accept from companies. As a sign of the changing times, these days many articles in scientific and medical journals financial connections that researchers might have that pertain to their study. And medical advisory committees, including those that advise the FDA, must report any conflicts of interest.
And while The Sunshine Act will do a good job of highlighting doctor/corporate relationships, Caplan says that under the Affordable Care Act, doctors actually will have less power to influence medical purchasing than they did prior to the Act. “Now, government is going to play a much bigger role in deciding what gets paid for, so industry will shift their attention to lobbyists,” he explains. “You will see shifts away from how to influence sales of drugs and devices to how do we influence government to pay for things?”
Consumers may have more power than they used to, too: Drug and device companies may do more direct-to-consumer advertising, hoping to see profits from patients who pay privately and are able to have more of a say in what drug or device their doctor chooses.