As we have written several times over the past few weeks, the Centers for Medicare and Medicaid Services (CMS) recently issued proposed regulations to implement the Physician Payments Sunshine Act. Consequently, a recent editorial in the Wall Street Journal, written by Harvard Medical School Professor Thomas Stossel, MD, noted that the Sunshine Act is a “toxic rule,” which requires all companies that manufacture medical products purchased by the government to disclose on a public website anything they give physicians valued above $10.
In addition to this article, a recent post from David Shaywitz on Forbes noted that, “While such payment 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.” Stossel and Shaywitz have discussed the Sunshine act previously here and here; see here and here as well.
Stossel noted how CMS justifies this legislation by citing “conflicts of interests that may influence research, education and clinical decision-making in ways that compromise clinical integrity and patient care, and may lead to increased health care costs.” However, CMS readily admits that it has no empirical basis for estimating the frequency of such problems (inappropriate use), the likelihood that transparent reporting will reduce them, or the likely resulting effects on reducing the costs of medical care.
As a result, Stossel asserted that CMS’ “reasoning inverts reality.” He noted how “Medical care is incomparably better today than when he received his M.D. degree in 1967—due primarily to the availability of products developed by industry in unencumbered collaboration with physicians, and to industry’s commitment to teach physicians how to use them.”
He recognized that because of “this collaboration, longevity has increased by a decade, and in his specialty, hematology, treatments for anemia, blood-clotting disorders and malignancies of the blood have improved spectacularly.”
Stossel further asserted that, “Evidence that collaborations “compromise clinical integrity and patient care” is practically nonexistent. He pointed to “a voluminous 2009 Institute of Medicine report on “Conflict of Interest in Medical Research, Education, and Practice,” and noted how the report “was unable to find evidence that relationships adversely affect what really counts—patient outcomes.”
Accordingly, Stossel assessed who the winners and losers are of the Sunshine regulations. He explained that the “Sunshine Act” is a stimulus plan for critics of the pharmaceutical and medical-device industries, who are the “winners.” Having failed to detect substantive corruption due to physician-industry relationships over a quarter century, they will spend taxpayer-provided grant money promising to find it by trolling the “Sunshine” database.
He noted how the media—such as ProPublica—already exploit disclosures—some made to pre-empt this law, some mandated by states—to demean physicians compensated by royalties from useful inventions that they license to companies, or who were paid consulting fees for advice concerning the optimal use of products, or for educating other physicians about products.
Additionally, Stossel recognized that, “The Sunshine Act is a boondoggle for accountants, compliance bureaucrats and the legions of lawyers whom companies will hire to interpret and manage the regulations. They will muddle through endless complexities such as which entity of a global company actually pays physicians and must report the payments. There will be the questions of how to identify which physicians are being paid for what—such as how to account for $25 worth of bagels brought into a group-practice office when it’s unclear who actually ate the bagels.”
Who doesn’t care? Consumers. Stossel maintained that, “Few patients have the time, interest or competence to interpret the disclosures. Even if they did, most survey data indicate that patients have few concerns about physicians’ industry relationships.” Consequently, he recognized that patients are also the losers of the Sunshine regulations. Why?
Stossel explained that, the complexity of medical innovation makes it almost impossible for physicians to keep up with. Keeping physicians up to date is extremely expensive. Yet if the act is implemented, Stossel recognized that “hundreds of millions of dollars better applied to innovation and education will shift to “Sunshine” management. And this regulatory burden disproportionately compromises small companies at the cutting edge of innovation.
The resource diversion does not stop there. Stossel noted how, “Prior to public disclosure, physicians are supposed to review payments ascribed to them, including royalties, fees for research consulting, and reimbursements for legitimate expenses associated with these activities. And they had better check the paperwork closely, because reporting of this magnitude and granularity will contain inaccuracies.” These inaccuracies could assist plaintiffs lawyers and federal and state prosecutors pursue investigations and legal claims into Stark Law violations, anti-kickbacks, and general fraud and abuse laws. This reporting will also put physicians and their institutions reputations at risk due to the appearance of impropriety that publication of the payments may create.
Ultimately, Stossel asked patients to think about what they want from health care reform and the health care system. “Do you want your doctor pilloried for eating a corporate bagel while getting useful product information that might benefit you? Do you want your hospital hiring compliance officers instead of nurses or laboratory technicians? Do you want medical researchers censured for being paid by industry for discoveries that might save your life?”
Stossel concluded by noting that the Sunshine Act “is the poster child for what President Obama characterized as rules that are “just plain dumb.” No matter what happens to the health-care reform law as a whole, Congress should junk the “Sunshine Act” before it burns us all.”
Interestingly, Shaywtiz pointed out his recent experience at an innovation symposium at Duke University, as well as his frequent informal conversations with academic physicians at other leading institutes. He noted that these experiences have suggested that 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.
Shaywitz maintained that, “young physician’s worry that the burdensome requirements are overwhelming, while senior leaders seek desperately to avoid the inevitable media takedowns.” In the end, while transparency is a noble goal, there needs to be “common sense,” and beyond that, “an environment that seeks to balance appropriate and genuinely useful compliance regulation with an understanding and belief that university/industry interactions are vitally important for the translation of knowledge. Researchers and clinicians seeking to strengthen these relationships deserve to be celebrated, not demonized.”
Can you imagine if servicemen – especially high ranking officers – were feeding on “corporate bagels” while serving in the military?
(yes this happens all the time)
I suppose the same arguments used by Dr. Stossel could be used to justify the “benefits.”
(The benefit to patient care are overwelming, without innovation nothing happens, think statins, HIV medication, stents, diabetes medication, cancer treatments….. Do you think it is because of luck and diet that we live 20 years longer today than 50 years ago)
Does Harvard`have the greatest share of this financial industry-academic pie?
(no Harvard does not recieve the greatest share of the industry-academic pie)