The comprehensive, nationwide effort that the Physician Payment Sunshine Act represents is desperately needed, says Steven Nissen, MD, of the Cleveland Clinic. Others, however, have concerns about privacy, accuracy in reporting, and patients' ability to understand reported information.
"Secrecy in a democracy is never a good thing,” says the chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the institution. “In a democracy, transparency is the best policy.”
The Sunshine Act, he adds, is about fairness to patients as well. “If I prescribe an expensive, branded drug to treat your cholesterol, you should know whether or not I have a financial relationship with the company that makes that drug.”
Nissen was one of five prominent physicians who sent a letter to then-White House Chief of Staff Jacob Lew in January pressing for an end to the delay in release of the final rule. The Affordable Care Act had required that reporting procedures be established by October 2011, with information collection beginning in January 2012 and data submitted to the Department of Health and Human Services by the end of March 2013. The Centers for Medicare and Medicaid Services (CMS) ultimately published the proposed rule in December 2011, however, and accepted comments until February 2012. In November, CMS submitted a preliminary version of the final rule to the Office of Management and Budget for review by the Office of Information and Regulatory Affairs.
The voices of these physicians joined a chorus of other organizations representing doctors, including the American Medical Association and National Physicians Alliance, calling for release of the final rule, although the proposed act also prompted opposition from those who thought the requirements unnecessary or who were concerned about the burdens of reporting, government involvement, or a possible chilling effect on productive collaborations. Even some groups supporting the overall goal of the act expressed misgivings-for instance, about whether physicians would be adequately protected if disputes occurred. Some corporations tired of waiting to put into effect their advance compliance efforts.
Reaction to final rule
The final rule was published in February, and Nissen does not agree with its critics.
The Sunshine Act is “very reasonable,” he says. “It doesn’t say that physicians can’t have relationships; it simply says that they should be a matter of public disclosure.”
American Medical Association President Jeremy Lazarus, MD, agrees. “Physicians’ relationships with the pharmaceutical industry should be transparent and focused on benefits to patients,” he says. “Our feedback during this rulemaking process was aimed at ensuring the new registry will provide a meaningful picture of physician-industry interactions and give physicians an easy way to correct any inaccuracies.”
The American Academy of Family Physicians says that CMS addressed some but not all of its concerns before releasing the final rule, ultimately exempting speaker fees for accredited and certified continuing medical education programs.
CMS also agreed with some but not all of the suggestions made by the American College of Physicians, ultimately declining to provide links to professional organizations’ relevant ethics/professionalism materials, for instance, and deciding not to distinguish between direct and indirect research payments.
Effect on doctors, patients
CMS expects 224,425 physicians and 1,100 teaching hospitals to be affected in the first year of the program and 168,319 physicians and 1,100 teaching hospitals to be affected in subsequent years.
Physicians acting ethically should have nothing to fear, Nissen says, and doctors who do not want their names appearing in the database can refuse funding from drug and device manufacturer. But “anybody who says [physicians are] not influenced is simply not being realistic. Studies have shown over and over and over again that physicians are influenced,” he says. (See www.MedicalEconomics.com/SunshineStudies for examples of recent research on this topic.)
When Forbes Insights conducted a survey for Deloitte Touche Tohmatsu in early 2012, 68% of physicians said they were in favor of a public, searchable database of physician-industry relationships, and 27% said they were not, citing privacy concerns. A worry expressed by 54% of those in favor of a database was that patients would not understand how to interpret the data.
But Nissen scoffs at the notion that patients may have difficulty interpreting the reported information.
“Patients are much more educated than they’ve ever been before,” he says. “Most of the patients who come to see me have looked me up on the Web. They know my history. They’ve looked at my Wikipedia page about me. They’ve looked at Web sites...that have patients who grade physicians.”
In such instances, Nissen says, consumers are applying in the healthcare arena the techniques they use when making other important decisions.
“Before I go out and buy a major appliance, I check Consumer Reports, and I see this as no different,” he says “Before you see a physician, you may want to know whether that physician has relationships that you think might influence their care of you. It’s a basic right for patients to have that information.”
CMS expects about 1,150 manufacturers and 420 group purchasing organizations to be required to submit information. They face penalties for noncompliance ranging from $1,000 to $100,000 for each payment reported, with a maximum of $1 million per annual filing.
The Coalition for Healthcare Communication, which has members from organizations and industry united to “prevent interference with the conduct of continuing healthcare education,” says it may petition the government to reconsider or clarify parts of the rule and says that further interpretation is needed regarding the definition of education, how to quantify educational transfers of value in promotional settings, how to calculate the per-meal costs at educational programs, and where publication supplements and single-sponsor medical journals fall on the spectrum of covered and noncovered materials.
As the rule contains no reporting requirements or noncompliance penalties for physicians, however, the main issue facing doctors, in addition to ensuring that patients understand reported information, is to ensure that the information released is accurate to begin with. Nissen says the affected drug and device manufacturers with which he is familiar plan to share the information with potentially affected physicians before disclosing it to the government, so that any inaccurate information can be corrected before submission. (See the “More tips” sidebar at the end of the article here.)
Prior to the Sunshine Act’s finalization, members of the public had other resources to consult to learn whether physicians have received payments from drug or device manufacturers.
ProPublic’s Dollars for Doctors Web site (http://projects.propublica.org/docdollars/), for instance, uses public information, some of it disclosed due to legal settlements, to compile a database of payments from 12 pharmaceutical companies to physicians. Searchable by doctor, affiliated institution, and state, the database currently lists $761 million in payments made by the companies.
And some individual institutions have publicly disclosed physician payments from drug and device makers for several years. The Cleveland Clinic announced its reporting policy in 2008.
“This has caused no problems,” Nissen says. “It hasn’t caused problems for patients, and it hasn’t caused problems for physicians.”
The database resulting from the Sunshine Act will be another tool available to help patients make informed decisions, Nissen says.
“I feel strongly about it. I believe, and have believed for many years, that patients have a right to know what monies their physicians are receiving from commercial entities,” he says.