CMS has published proposed rules for its implementation of the Physician Payment Sunshine Act (SUNSHINE ACT or Act), which was enacted by Congress as part of the 2010 Patient Protection and Affordable Care Act. In short, the SUNSHINE ACT requires life science companies to report annually to CMS their conferral of anything of value, whether it be payment for services or a dinner, in connection with a particular product of the paying company. By requiring CMS to post the information on its website, the Act seeks to ensure that interested patients become aware of physicians’ conflicts of interest that could affect their prescription of a branded drug or choice of a specific medical device.
The SUNSHINE ACT represents another example of the transparency movement, which has had varying degrees of success in either changing the behavior of the parties subject to disclosure, and/or enabling consumers to make better decisions based upon their access to the disclosed information. It is likely that the SUNSHINE ACT will impact physicians and manufacturers’ behavior more than it will enlighten consumers about conflicts of interest. Some physicians will simply conclude that accepting certain gifts or benefits from pharmaceutical or medical device companies isn’t worth having their names on the CMS website. Some companies have already discovered that they haven’t necessarily reaped the value of the costs of gifting many physicians, or that the cost of recording certain activities simply isn’t worth the return on investment. Unquestionably, certain transactions will continue to be valuable to both physician and company, and will continue.
Imagine yourself in front of your computer, looking up information about a drug prescribed by your doctor. Your Internet search tells you that there is a cheaper, maybe even a generic version available, but you have just paid top dollar for the brand name drug. You also learn that another treatment may be safer than the prescription you just filled. Now imagine you discover that your doctor gets paid by the manufacturer to promote the drug to other doctors.
There are various words for this sort of financial transaction, when, say, a radio disk jockey is paid by a recording studio to play a song or a broker is paid to tout a stock — both of which, by the way, are illegal. In medicine it’s called a financial conflict of interest, although “pharmapayola” is in some ways more accurate. It’s perfectly legal, and it’s rampant. In a survey published in the Archives of Internal Medicine in 2010, 28% of physicians reported that they received some kind of payment from a drug company to serve on a speaker’s board, as a consultant, or on an advisory board. Other bennies handed out by companies included free drug samples, tickets to sporting events, meals at five-star restaurants and all-expenses paid trips to medical meetings in nice locales.
As of this year, doctors who accept gifts and payments from drug and device makers will see their names on the web, the result of the 2010 Physician Payment Sunshine Act, one of the most controversial provisions in the health care reform law. Companies will be required to report any gift or payment to a doctor or academic researcher over $10, whether it’s in the form of stock options, speaking fees, box seat tickets, knickknacks for the doctor’s office or travel to a medical conference. Doctors will also be required to disclose payments and gifts.
Monday’s WSJ (online now) features an exceptionally important and courageous op-ed by Harvard professor (and frequent co-author of mine, although not in this case) Tom Stossel, discussing a rule within recently enacted healthcare legislation with the Orwellian title, “The Physician Payment Sunshine Act,” focused on physician/industry relationships.
Taking its name from the assertion that “sunshine is the best disinfectant,” the Act apparently aims to help disinfect physicians who might be contaminated by industry contact, an interaction the Act seems to assume is intrinsically corrupting — in stark contrast, one suspects, to the many other activities in which physicians engage, and the many other factors in their environment that might influence their behavior, as Stossel and I previously discussed here and here; see here and here as well.
To restore physicians to their baseline state of virginal professional purity, the Act mandates a stultifying series of reporting requirements, impacting amounts as little as $10. While such reports may be a Pharmascold’s wet dream, they are a logistical nightmare for the physicians involved, and serve to create an enormous compliance bureaucracy for everyone.
My recent experience at an innovation symposium at Duke University, as well as my frequent informal conversations with academic physicians at other leading institutes, suggest the increasing bureaucratic hurdles confronting university physicians seeking to strengthen the essential translational relationship between academia and industry are a particularly unfortunate problem, and are having the presumably intended effect of stifling these interactions. Young physicians worry that the burdensome requirements are overwhelming, while senior leaders seek desperately to avoid the inevitable media takedowns predictably led by the NYT, public radio, and the rest of the usual suspects. (Not infrequently, these stories seem to originate with material selectively provided to a sympathetic journalist by a plantiff attorney — but of course, nothing cozy or sketchy here….)