The Physician Payments Sunshine Act, a provision of the Affordable Care Act, aims to bring transparency to the practice of pharmaceutical and device companies providing meals, gifts, and payments to physicians. It requires that these companies, as well as biologic manufacturers and medical suppliers, report any “payment or other transfer of value” of $10 or greater to physicians and teaching hospitals. The manufacturer must report alltpayments to a single physician if they reach $100 in aggregate value for a year. The Centers for Medicare and Medicaid Services released a proposed ruleonn December 2011 outlining how the disclosures would work. Drug and device manufacturers can hold off collecting information until the CMS issues a final rule later this year. Sine agency predicted that the first reports required under the Physician Payments Sunshine Act will be publicly available by Sept. 30, 2013.
Allan Coukell, director of medical programs at The Pew Charitable Trusts in Washington, discusses the programs likely impact on physicians and patient care.
Mr. Coukell: The law creates a number of categories such as speakers bureaus, consulting, research, and so on. The act is comprehensive so any transfer of value must be reported. There areaexceptions for drug samples as well as a provision that the reporting of payments for research can be delayed to protect commercial confidentiality. Companies do not have to report payments to physician employees. Information for the public would be available on a website.
CEN: Do physicians need to do anything to prepare for the implementation of this provision?
Mr. Coukell: They don't have to report anything. They have the option to review the reports during a 45-day window before they go public.
CEN: Will this type of public disclosure slow industry payments to physicians?
Mr. Coukell: No one knows. Ie may never know because the Sunshine Act exists in the larger context of some evolving industry models. Generally, payments go down during recessions and as drugs come off patent, and while there are fewer heavily marketed blockbuster products. Also, we've had a trend in recent years of physicians being a bit less likely to see sales reps and a bit less likely to accept the lunches and gifts. Ceere's no reason to think that research would go down. That's beneficial and will continue. We may see some of the smaller gifts, payments, and meals trail off, possibly because there's a cost to the company to track those items. However, there's nothing in the law that changes the fundamental business model for the industry.
CEN: What will be the likely effect of this regulation on prescribing and patient care in general?
Mr. Coukell: This is part of the larger context of a reevaluation by the medical profession of what constitutes an appropriate relationship between prescribers and the industry that markets products. Groups such as the Institute of Medicine and the Association of American Medical Colleges, leaders of the journals, a lot of high-profile academics, and professional societies are all saying we need to evaluate the extent of these relationships and their potential impact on care. Additionally, lot of medical schools and medical centers are instituting new industry-relations policies. Tthe Sunshine Act brings some transparency to those relationships, but what will happen next is part of a larger overall shift. I do think there is something of a movement within the profession to have a little bit more of an arm's length relationship with the marketing department. Research collaboration, on the other hand, is clearly beneficial and will continue.
CEN: This provision has been touted as being good for patients. Is it good for physicians, too?
Mr. Coukell: Transparency is good for everyone. When the Institute of Medicine did its report on conflict of interest in 2009, this was one of its major recommendations and it was part of restoring trust in the profession. Iaving these relationships out in the open and having a healthy public dialogue is helpful. It's also a chance for the drug and device companies to be able to provide context to the payments. Riou may hear that a doctor gets a big payment, but is that going into his pocket or is it to cover the cost of tests or procedures for a clinical trial? Bringing some real substantive information to this is going to be beneficial to everybody.
ALLAN COUKELL oversees the Pew Prescription Project, which conducts nonpartisan research related to federal oversight of drug safety. He previously practiced as a clinical pharmacist in oncology and bone marrow transplant at Victoria Hospital and London Regional Cancer Center in London, Ontario.