Everything you need to know about the Sunshine Act
BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4704 (Published 26 July 2013) Cite this as: BMJ 2013;347:f4704
If you are a physician working in the United States, 1 August marks a watershed moment. This is when the Physician Payments Sunshine Act, which is part of the Affordable Care Act, goes into effect and is eventually expected to usher in a new era of transparency regarding the financial relationships between doctors and the makers of drugs and devices.1
The law is an outgrowth of a controversy over undisclosed payments made to physicians for things such as consulting and speaking fees, meals, gifts, and research funding. The widely debated topic prompted a US Senate probe in response to concerns that such financial dealings could unduly influence medical practice and research. Even small financial ties have been shown in various studies to bias physicians.
And so, drug and device makers must now collect and disclose payments exceeding $10 (£6.5; €7.6) to physicians and teaching hospitals and, starting in September 2014, the data will be posted on a publicly accessible website that will be administered by the Centers for Medicare & Medicaid Services. The data must also include all ownership or investment interests held by a doctor or family member.
For physicians, much is at stake. For the first time, patients will now be able to see what, if any, financial ties their own doctor has with a drug or device maker. As American Medical Association president Ardis Hoven notes, this affects “all physicians with a current medical licence.” To what extent this knowledge will sway patient decisions remains unknown, but the public database is predicted to generate a level of scrutiny that has never before been a part of the sacrosanct relationship between physicians and their patients.
“There are reputational issues,” says Mary Bennett, a registered pharmacist and vice president of the ethical leadership group at Navex Global, a compliance consulting firm. “Let’s put it this way: imagine someone looking at your tax return. You can’t hide anymore. It’s sort of like that. So if it’s published on a site, the information may be one more place people will look.
“And people do a lot more research than ever before when choosing a provider. While I don’t think in the first year it will necessarily have an effect [on patient decisions], I do think this will gather steam over time,” she continues. “There’s so much out there on the web now that it will work its way into the list of items that people put on their page about their provider.”
Physicians also need to be mindful that the government will be watching. For instance, increasing attention has been paid to physicians who write an inordinate number of prescriptions for drugs that are listed as controlled substances. The database will provide federal and state officials with a new tool for reviewing prescribing habits and match this information with financial dealings with manufacturers.
“Once the database goes live, law enforcement agencies can look up physicians and see who’s getting money from industry. And it’s not going to take much for government to come up with a kickback case,” says Brian French, a partner at the Nixon Peabody law firm, where he is deputy group leader in the government investigations and white collar practice and a member of the life sciences group.
“Right now, the topic may be confined to embarrassing news stories, but this will give a state attorney general, for instance, the opportunity to go after doctors to see the kinds of incentives they may be getting for writing a lot of prescriptions The government is concerned about (doctors) prescribing (costlier) brand name drugs when generics are out there. So this becomes a new risk for doctors.”
Yet as recently as this past spring, many physicians were unfamiliar with the Sunshine Act.2 A survey of 186 board certified, primary care physicians found that 38% were not at all familiar with the rules and requirements. Nearly half, or 49%, confessed that they were only somewhat familiar and just 13% claimed to have been very familiar with the ins and outs of the act.
Whatever your degree of familiarity, there are some important details and reminders to help you prepare and navigate what is now a regular feature of your professional life (box, based on recommendations from the Federal Register and American Medical Association).
Key changes of the Sunshine Act
1) Now is the time to update any financial or conflict of interest disclosure information required by employers, advisory boards, and institutions that provide research funding, and continue to do so on a regular basis. You should also make sure that your National Provider Identifier is accurate and kept current in order to limit the possibility that you are incorrectly identified.
2) In a similar vein, if you have industry contacts, you should regularly request notice of what is reported to the government so that you can review and, if need be, correct the information. The American Medical Association’s Hoven notes that “it is best to correct any errors before they are publicly reported,” and the organization also suggests reviewing anything received from another party, such as funding, that may have originated with a drug or device maker and whether that must be reported.
3) What must be reported to the government? Food, gifts, entertainment, travel expenses, royalties or licenses, charitable contributions, education, honoraria, consulting fees, compensation for other types of services, grants, research, investment interests, and any direct compensation for serving as faculty or speaker for a medical education program.
4) Various things are exempt from reporting. Exemptions include certified and accredited continuing medical education, buffet meals and snacks that are generally available to everyone at a large scale event, product samples not intended for sale, educational material for patients, the loan of a device for a trial period of less than 90 days, in-kind items used for charity care, and dividends in a publicly traded security or fund.
5) What happens if you receive something worth less than $10? Again, that is not reportable, but you need to keep track of such things. The reason is that if you receive enough items and their aggregated value exceeds $100, then these must be reported.
6) Physicians should regularly review the information collected and posted. By law, physicians are provided at least 45 days to review their own transparency reports through an online portal that the Centers for Medicare & Medicaid Services are creating and make any corrections before the information is posted to the public website.
7) If a dispute cannot be resolved, physicians and manufacturers are given another 15 days before a report is made public to find a solution. If no resolution is found, the Centers for Medicare & Medicaid Services will note this on the site. There is a two year window in which to dispute any information, even after reports are posted.
8) Do not forget to sign up with the Centers for Medicare & Medicaid Services to receive direct notice when reports are made public.
9) What should physicians do if patients have questions? Most experts say that this is increasingly likely to occur, so candor is recommended. Discuss your work and why it is done. In fact, this may be an opportunity to underscore that the work is designed to advance medical research and how these undertakings may yield needed evidence and improve outcomes for patients.
10) What are the key dates to track? Between 1 August and 31 December 2013, drug and device makers must start collecting and tracking payment and ownership information, after which they are required to report the data for each full calendar year. The American Medical Association expects the Centers for Medicare & Medicaid Services to launch its physician portal in January 2014 and allow physicians to receive notice when reports are available for review. By March 2014, drug and device makers are expected to report 2013 data to the Centers for Medicare & Medicaid Services; by June 2014, the Centers for Medicare & Medicaid Services are expected to provide physicians access to individualized and consolidated reports for 2013. Going forward, Hoven notes that, each June, reports for the prior year are supposed to be available. By September 2014, the Centers for Medicare & Medicaid Services are expected to release the data on the public website.
Source: Federal Register and American Medical Association.
An act to help physicians
At the end of the day, the database may help physicians with their practices by allowing them to better understand the interplay between key opinion leaders and manufacturers, according to Paul Thacker, a former US Senate Finance committee investigator who worked for US Senator Chuck Grassley (Republican party, Iowa) and drafted the original Sunshine bill.
“I don’t think most doctors realize the extent to which their profession has been compromised by industry. They’re in the dark. The overwhelming majority [of doctors] are just trying to do their jobs—run a practice and think about patients—and they’re not completely aware of the extent this has been going on. This will shed some light on that,” says Thacker, who is now a fellow at the Harvard University Edmund J Safra Center for Ethics.
He continues: “It’s going to allow them to make smarter decisions when it comes to determining who to believe and what type of research to believe. Even if you’re conscientious, it’s been impossible to do this because you wouldn’t know how prominent physicians were being paid. It’s also true for articles in journals. It was virtually impossible for conscientious doctors to know this because that’s not their job.”
Notes
Cite this as: BMJ 2013;347:f4704
Footnotes
Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.
Provenance and peer review: Commissioned; not externally peer reviewed.