Researcher Susan Chimonas, PhD, posed the question to focus groups of 42 physicians in the wake of passage of the Physician Payments Sunshine Act: How would they react if a patient asked whether the gifts they got from pharmaceutical companies influenced their prescribed course of treatment?
Responses ranged from mild to extreme. Some were suspicious of the law; others felt the law undermined public trust. A small number of the physicians even said they would drop the patient who challenged them.
That was not an intended outcome of the Sunshine Act, said Chimonas, a sociologist at the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York City and an expert on transparency in medicine.
The goal behind the legislation was that making public the gifts and payments to physicians from pharmaceutical companies and medical device firms would expose potential undue influence and conflicts of interest (COI), arm patients with information about their doctors and, ultimately, reduce the amount and number of those payments.
While the Sunshine Act succeeded in making the payment information public and searchable, there is little evidence that it has significantly affected either payments or patients' relationships with their doctors. In fact, the total value of payments reported rose from 2014-19, though the number of records reported declined.
Table. Payments Reported Under the Physician Payments Sunshine Act
|Year||Total Payment Value||Records Reported|
|2019||$10.03 billion||10.98 million|
|2018||$9.72 billion||11.5 million|
|2017||$9.2 billion||12.07 million|
|2016||$9.13 billion||12.48 million|
|2015||$9.07 billion||12.51 million|
|2014||$8.61 billion||12.12 million|
Source: Centers for Medicare & Medicaid Services
"It's been a little disappointing if you think clarity is enough to change the behavior at the heart of this," Chimonas said.
Many Physicians Feel Immune to These Influences
The Sunshine Act, which was passed in 2010 after a long legislative struggle, was born out of a concern that pharmaceutical companies and medical device firms were influencing physician prescribing through such gifts as speaking honoraria, trips, consulting fees, even freebies as minor as pizza lunches for staff.
Despite numerous studies showing that Pharma gifts do affect prescribing behavior, most doctors insist they are immune to any untoward influence.
For example, in Medscape's 2020 Ethics Report , physicians were asked if they could be a paid speaker at pharmaceutical dinners or accept lunches from drug reps without it influencing their prescribing habits. Nearly two thirds (63%) of respondents said yes, 26% said no, and 11% said it depends. A similarly worded question in a 2012 survey found that 72% of respondents said they could accept free lunches without influence while 20% said no with 8% reserving judgement.
Sen. Chuck Grassley (R-Iowa) was the main sponsor of the Sunshine Act. In a 2014 newspaper editorial, he wrote: "From day one, the Physician Payments Sunshine Act database will be helpful in shining light on a part of medicine most people haven't had the time or opportunity to consider. Eventually, the database will become a valuable resource for all of us with a stake in our country's healthcare system — individual consumers, insurance companies, and taxpayers who pay for Medicare and Medicaid."
So why hasn't the legislation had more of an impact?
There are a number of possible explanations. Studies have shown that relatively few patients are aware of the reporting requirements or that the data is available online. Of those patients who do know, many probably do not regard it as important enough to investigate. Patient trust in physicians remains high and even those who are aware of COIs and the influence of donations might think their personal doctors are beyond reproach.
"I think most patients are completely unaware of it," said Stephen R. Smith, MD, a retired professor of family medicine at Brown University, Providence, Rhode Island, who has helped develop medical school curriculums.
Even if patients are aware and concerned about their doctors' relationships with pharmaceutical companies and medical device firms, they might not be in a position to do anything about it, said Judith Garber, MPP, a fellow at the Lown Institute, a healthcare think tank. Many patients are assigned to physicians by insurers, particularly in the case of specialist care, and don't have the freedom to switch.
And never mind waiting for a physician to voluntarily disclose contributions or discuss COIs, Garber said: "There is no doctor who's going to say, 'I was given this money from a company and that's why I prescribed those drugs.' "
"The Sunshine Act is important for doing research and writing papers," she said. "It doesn't seem like it's causing change in the behavior of payments to physicians."
Less of a Lightning Rod
That lack of impact could be why the physician Open Payments program, though opposed at the time of passage by many physicians as unfair, obtrusive, and unnecessary, seems not to be a major priority for many professional medical organizations. A spokesperson for the American College of Physicians said the group has not surveyed members or issued any statements on the act recently.
Since the reporting responsibility lies with the pharmaceutical companies and medical device makers, the law has had little impact on physicians, said Mollie Gelburd, JD, assistant director of government affairs for the Medical Group Management Association.
"It's not something that comes up very often," Gelburd said, adding that she hasn't heard of any medical practices that have changed their policies on accepting gifts as a result of reporting.
The trade group Pharmaceutical Research and Manufacturers of America issued the following statement: "Communication and collaboration between researchers developing medicines and the physicians prescribing those medicines are critical to promoting the health and well-being of patients. We support the goal of transparency that is reflected in the Sunshine Act, and we're committed to seeing that the law is successful in achieving this important goal."
Though patients might not be poring over the records, that doesn't mean no one is.
The payment data is available to all on the Centers for Medicare & Medicaid Services Open Payments website. Journalists have used the records to explore COI and improper ties between physicians and contributors. Malpractice attorneys have mined it for evidence of improper influence. Other users are pharmaceutical companies and physicians checking if the information reported about them is accurate. Compliance officers for healthcare systems and organizations with rules about payments also check the records.
Not even CMS, which is responsible for collecting and maintaining the payment data, as well as ensuring compliance with reporting requirements, can speak to the program's impact. The agency has not conducted an analysis of the program and whether it has affected payments. It does not release data on compliance with or enforcement of reporting requirements. And while CMS reports the database receives tens of thousands of visits a month, it has no way of determining how many are from patients researching their physicians' records.
In the years since its passage, the Sunshine Act has been tweaked to close loopholes. For example, in response to increased Pharma targeting of nonphysician prescribers, beginning this year the reporting requirements have been extended to nurse practitioners, physician assistants, and other clinicians. That data will be available in 2022.
Despite that, opponents of gifts or perks to physicians say disclosure has failed as a deterrent.
"[Disclosure] is a smokescreen; it's a distraction," said Adam Urato, MD, chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Massachusetts.
Urato says he does not accept any corporate gifts and rejects the arguments for them as rationalizations.
"All the things that have been dragged up over the years and used as excuses are absurd," he said. "There is a fundamental misunderstanding about the natures of the two industries. One is to help patients and the public good; the other is to make money for the corporation and shareholders."
Sometimes, those motivations align, Urato said, but often they don't. He cited the devastating opioid crisis as evidence that gifts can influence physicians into behaving unethically to the detriment of their patients and the country.
Some say the fact that corporate giving records are now public has had the unintended effect of "sanitizing" it, making it easier for physicians to accept gifts with the rationalization that it's all public.
Smith said a public relations campaign to publicize the database and the influence of corporate donations might lead to more people researching the data and, perhaps, more doctors declining to take gifts. The best policy is a ban, he said.
That's what a number of states, including Minnesota, Vermont and Massachusetts, have done. More medical schools also are banning gifts, which could include speaker fees, consulting fees, meals, travel, or other perks.
Whether it's the Sunshine Act or changing attitudes, there is evidence that some practices are changing behavior. A recent study in the Journal of the American Board of Family Medicine compared surveys of family practice residency policies from 2008 and 2013 with 2019.
The survey found that 81% of responding residencies did not allow food or gifts; 86% did not allow drug samples; 84% did not allow industry to interact with medical students or residents; and 81% did not allow industry-sponsored residency activities. These numbers were statistically significantly higher than those of both 2008 and 2013.
In 2019, 64% of responding programs were entirely pharma-free, compared with 26% in 2008% and 49% in 2013. University-based family medicine programs were more likely to be pharma-free. Factors cited for decreasing interaction included institutional policy, ethical concerns, faculty input, and local response to national legislation.
Critics say the changes aren't coming fast enough. "Disclosure is not the answer to this," Urato said. "We're not solving the problem. It's a relationship that's broken."
James F. Sweeney is a freelance healthcare writer based in Cleveland, Ohio. He has disclosed no relevant financial relationships.
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Cite this: Few Patients Know or Care About Doc Payments From Industry - Medscape - Feb 10, 2021.