When the Physician Payments Sunshine Act went into effect in 2013, it was called a “watershed moment” that would “usher in a new era of transparency regarding the financial relationships between doctors and the makers of drugs and devices.”
Under the law, drug and medical device companies had to, for the first time, disclose to the public all payments over $10 made to physicians for such things as consulting and speaking fees, research funding, meals and gifts.
As the CMS website makes clear, the amount of money U.S. physicians receive from the drug and medical device industry is staggering. In 2015, more than 618,000 physicians and more than 1,100 teaching hospitals received 11.9 million payments totaling $7.52 billion. Of that money, $3.9 billion was for research; the remaining $3.6 billion was for consulting and speaking fees, as well as for gifts of one kind or another.
So, has the Sunshine Act been effective in its primary goal: to reduce industry influence in health care in the United States? More specifically, has it made doctors less likely to accept payments from drug and medical device companies? And, if they do accept those payments, are the doctors less likely to prescribe brand name drugs when generics are available? Or, when they put medical devices into their patients, are they less likely to use only the device of the company from which they have received payments? Also, has the act led to more patients questioning their doctors?
Unfortunately, the early evidence suggests that the Sunshine Act is making only a small dent in protecting the health-care system — or, more importantly, patients — from undue industry influence, as an article published last week in the BMJ makes depressingly clear.
“Although the full effects of the Physician Payments Sunshine Act are not yet known, there has been no sudden reduction in the problems the act was intended to solve,” writes Jeanne Lenzer, an independent journalist and associate editor at BMJ. “Indeed evidence suggests transparency is having paradoxical effects: physicians who openly acknowledge their ties tend to make even more extravagant claims about product safety and efficacy, and patients tend to view doctors who declare their ties as particularly ‘honest.’”
One major problem with the Sunshine Act is that it still contains loopholes. As Lenzer notes, 12 types of payments are exempt from the reporting requirement, including “payments for specific types of continuing medical education, receipt of product samples, and discounts and rebates.”
The law has other serious gaps, as Lenzer explains:
The act requires reporting of physician owned distributorships (surgeons who use or implant medical devices sometimes own distributorships of those devices, creating a conflict of interest when they sell the devices to their hospitals or directly to their patients). However, a Senate investigation found that such interests are rarely reported in the database.
[In addition,] physician ownership of imaging facilities, specialty clinics, or hospitals does not have to be reported, even though evidence from several studies shows that doctors who have financial interests in imaging facilities order substantially more imaging procedures than their peers and refer well insured patients to their own facilities.
It’s also unclear whether the Sunshine Act has encouraged many doctors to turn down industry gifts and payments.
The percentage of practicing doctors with one or more financial ties to industry has certainly declined, from 94 percent in 2004 to 83.8 percent in 2009 to 73 percent in 2015.
“However,” writes Lenzer, “it is hard to say whether the Sunshine Act has affected the proportion of doctors with industry ties because the rules of data collection for the 2004 and 2009 surveys were different from the CMS rules.”
For example, data about the receipt of drug samples, reported by 78 percent of doctors in 2004 and 63.8 percent in 2009, were excluded from the 2015 survey.
(Research has shown that physicians in clinics that receive free drug samples are much more likely to prescribe those drugs than those in clinics that do not receive the free samples.)
“It is equally unclear whether transparency has led to a substantive change in biased prescribing practices,” Lenzer adds. “A study of physician prescribing habits in four states (Maine, Massachusetts, Minnesota, and Vermont) that adopted Sunshine rules before the act, found no statistically significant decline in prescribing of expensive branded statins when compared with doctors in states without such rules.”
Asking patients to do the heavy lifting
And what about patients? Are they using the Sunshine Act and the CMS Open Payments website to ask their doctors more questions?
That’s also unclear. Furthermore, expecting patients to do this kind of checking up on their doctors is unfair, argues Lenzer:
Putting the onus on patients to navigate physicians’ conflicts of interest may not be realistic because most US doctors have financial ties to industry. Nor can the public readily decipher the meaning of a physician’s tie to a particular company because drug companies have multiple and complex marketing, distribution, and licensing ties to other companies.
Another problem is that tracking which companies have paid a doctor might not be enough. The classic study by Stelfox and colleagues found that doctors with industry ties were not only more likely to favor their sponsor’s calcium channel blocker, they were also more likely to favor an expensive branded drug over a generic formulation if they received any industry funding.
‘It’s up to doctors’
So what needs to be done to give the Sunshine Act more “teeth”?
“A growing number of doctors, including Jerome R. Hoffman, emeritus professor of medicine at University of California, Los Angeles, say that influence has to be removed through public funding of genuinely independent research and medical education,” writes Lenzer.
“Hoffman says that the industry’s responsibility is to shareholders — not to patients or the public,” she adds. “It’s up to doctors, he says, to put patients’ needs first. But, he says they can’t do that if they ‘voluntarily create a conflict of interest for themselves by taking industry funding with one hand while writing prescriptions with the other. If a judge took money from a prosecuting attorney it would be considered a bribe … The same should be true for doctors.’”
FMI: You’ll find Lenzer’s article on the BMJ website.