On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-delayed final rule that is intended to implement the Physician Payments Sunshine provisions that were included in the Patient Protection and Affordable Care Act. Under these provisions, which were passed in March 2010 and were originally due to be implemented in 2012, doctors and teaching hospitals will be required to report the payments that they receive from pharmaceutical and device manufacturers, with the stated goal being to shed light on the financial relationships between physicians and the industry.
Notwithstanding the issuance of the final rule, there will still be some further delay in the implementation of the Sunshine provisions. Under the final rule, data collection is to begin by August 1, 2013, and data must be reported to CMS by March 31, 2014. Nonetheless, to those who believe in the importance of the Sunshine provisions and have long supported their mandated disclosures, the approaching implementation provides a new opportunity to tout the achievements they expect to see. For example, in a press release announcing the issuance of the final CMS regulation, Senator Chuck Grassley, who was one of the original authors of the provisions, proclaimed that “[d]disclosure brings about accountability,” and asserted that the provisions will change the “lack of transparency regarding payments made by the pharmaceutical and medical device community to physicians.”
But will the Sunshine provisions actually bring about such transparency? Will the compilation and release of data regarding payments to physicians and teaching hospitals actually clear the haze and give the public meaningful insight into the relationship between physicians on the one hand, and the device and pharmaceutical industries on the other? Or, at the other end of the spectrum, will the statute and accompanying regulations instead cast undue suspicion on relationships that are sometimes ambiguous, often symbiotic, and, in the case of medical research and study, actually beneficial to the public at large?
Preliminary answers to these questions can be found in a brief journey through a database that the investigative entity ProPublica maintains on its website. The ProPublica database, provocatively titled “Dollars for Docs,” was established in 2010, was expanded and updated earlier this month, and is described by its founders as “the first comprehensive look at the money that drug companies spend to enlist doctors as a sales force.” Based on data obtained from 15 pharmaceutical manufacturers, including such major companies as Allergan, AstraZeneca, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis and Pfizer, the “Dollars for Docs” database allows its users to search for all payments that these 15 pharmaceutical companies have made to physicians, medical practices, and hospitals since 2009.
There is no denying that trolling the “Dollars for Docs” database provides its own unique form of fun, and gives users the chance to see if one’s own physicians have landed on what is apparently is intended to be a not-so-subtle wall of shame. Has my internist received funds from drug manufacturers? No – good for her! Has the hospital where I had surgery received any funds? Yes, from at least two pharmaceutical companies, for what is labeled as “research” – wonder what that’s all about? And have any of my friends and relatives who are now physicians ever received funds for food or travel?
But moving beyond such a superficial look into the complex relationships that exist in the medical industry, what is the genuine significance of all of this information? And does data about historical payments really shed any light on a doctor’s professionalism, his or her commitment to patients, and the relationships between physicians, hospitals, and industry?
The answer, at least with respect to Dollars for Docs, appears to be no. In fact, the database raises more questions than it answers. If a doctor has received funds from one of the 15 companies, the website breaks down the nature of the payments into broad categories such as research, speaking, meals, travel, and consulting. But no further light is shed on the nature of these payments. For example, when a physician is shown to have received $10,000 for travel, what was the purpose of the trip? Did he or she go to the British Virgin Islands for a conference in which there was one hour of consulting and otherwise a good deal of snorkeling. Or, was the trip to China for the purpose of helping fix the cleft palates of orphans? The database offers no insight into these critical distinctions. Similarly, when a doctor appears to have received $10,000 for speaking, was this amount paid for 20 separate talks given to clinics in underprivileged areas about the doctor’s experiences treating a certain condition. Or, was the money paid for just one talk in which the doctor attempted to convince other physicians about the benefits of a specific manufacturer’s product? Again, the database does not distinguish between these two very different types of payments. Thus, unless one views every single benefit given to and received by a physician or hospital as part of a cynical effort to influence the independent judgment of physicians, it is impossible to gauge whether any payments in the database are problematic, or instead appear to be reasonable, justified, and even beneficial for society as a whole.
Similarly, what should a patient make of the fact that one of his or her treating physicians appears on the database at all? On the one hand, if my doctor is on the list, does that mean that her medical judgment has been tainted and I should immediately switch physicians? Or does it mean that in fact she is a premier physician, respected by and influential with her peers, and the kind of person who will detect and cure my ailment before those doctors who do not appear on the list? Again, the database offers no way to answer these questions.
And, what does the database reveal about the pharmaceutical companies themselves? If the database shows that certain corporations have given millions of dollars to physicians and hospitals across the country, does that mean that they sell questionable medications, and that these products in turn are prescribed or used only because of funds that pass from the industry to medical professionals? Or, are these companies funding essential research, conducting important studies, and encouraging the valuable exchange of ideas among physicians? Without greater insight and nuance, a database simply cannot answer questions such as these.
Now that the data reporting requirements of the Physician Payments Sunshine provisions are finally on the horizon, one last point merits discussion. As the ProPublica website repeatedly points out, the size and consistency of payments to certain health care providers can be striking, and there may indeed be instances where further scrutiny is warranted. But for those unique instances, there are investigative agencies, subpoenas, and the ability to delve into prescribing practices and histories. There are numerous means of determining, in a careful and rational way, whether industry money is tainting professional judgment. And if it is, there are statutes that can be brought to bear, with elements that the government must meet. With these finely honed tools, reliance upon a blunt instrument like a database of payments to physicians appears unwarranted, and perhaps even risks doing more harm than good.
To read more from Robert Radick, please visit www.maglaw.com