Sunshine Act Brings Some Transparency but Little Change

Those expecting that the federal “Sunshine Act” would diminish industry efforts to buy influence with physicians will be disappointed by a pair of studies published Tuesday in JAMA.

After the Centers for Medicare & Medicaid Services implemented the national disclosing database Open Payments in 2013, the number of providers receiving industry payments declined 14% by 2018, according to a research letter published in JAMA — but the total dollar value of such payments fell only 6% in inflation-adjusted dollars.

Median payments were virtually identical at $215 in 2014 versus $216 in 2018, while the average payment rose 9%, reported Deborah C. Marshall, MD, MAS, of the Icahn School of Medicine at Mount Sinai in New York, and colleagues.

Over this period, annual payment values decreased for physicians receiving payments of $50,000 or less, but physicians receiving upwards of $50,000 continued to receive similar or greater amounts from industry, the group found.

Doctors receiving more than $50,000 accounted for just 3.4% of the cohort, yet they received 82% of industry dollars. Overall, physicians received 49.8 million payments totalling $9.3 billion across the study period.

The findings suggest the push for transparency in the Open Payments program, also known as the Physicians Payments Sunshine Act, is not in fact leading to a “huge decline in industry payments,” Marshall said.

“Transparency is important, but as a profession in the U.S., more is needed to address this issue,” Marshall told MedPage Today. “The number of payments we are looking at and the dollar amounts are substantial.”

In another JAMA study, researchers looked at the connection between industry payments and implantable cardioverter-defibrillator (ICD) placements. Among 145,900 patients who received one of four ICD brands from 4,435 physicians during 2016-2018, 94% of doctors took payments from device manufacturers.

Physicians in the study were most likely to use the ICD brand from the manufacturer that gave them the most money. Providers who received the highest payments from “manufacturer A,” for example, were about 6-fold more likely to use its product than they were to use an ICD from companies that did not pay them (odds ratio 6.07, 95% CI 4.37-8.44), reported Jeptha P. Curtis, MD, of Yale School of Medicine in New Haven, Connecticut, and colleagues.

“Manufacturer D” (Curtis and colleagues did not identify the companies) appeared to do even better at rewarding physicians who used its ICDs. Physicians receiving the highest total payments from this device maker were 17-fold more likely to place its ICDs versus those from other firms (OR 17.0, 95% CI 10.99-26.29), Curtis reported.

Overall, 38.5%-54.7% of patients received devices from a manufacturer that had provided physicians with the largest payments, the authors noted.

Neither study could look at differences in types of payments such as consulting fees versus food and beverage payments, which is a limitation, the authors noted. Also, both analyses are limited to general payments recorded in Open Payments, rather than research or ownership fees.

But Curtis told MedPage Today that his group isn’t suggesting that manufacturers are trying to “buy off” physicians; that would be “extremely unlikely” since it’s both unethical and illegal.

“Instead, I think it represents a softer type of influence,” Curtis said in an email. “If I have a choice of devices from different manufacturers, and I have financial entanglements with one of them, it stands to reason that I will be more likely, consciously or not, to select that manufacturer, particularly if I do not think that there is a difference in device performance.”

Several laws are in place to discourage industry influence in healthcare. In addition to the Sunshine Act, the Anti-Kickback Statute prohibits physicians from trading payment for referrals, and the Stark Law prohibits doctors from referring publicly insured patients to entities or practitioners with which he or she has financial relationships.

However, payments like those in Curtis’ study “often avoid triggering Anti-Kickback Statute liability because they may be nominally intended to cover speakers’ fees or travel costs,” commented Carmel Shachar, JD, MPH, of Harvard Law School in Boston, Massachusetts, and Gregory Curfman, MD, deputy editor of JAMA, in an editorial accompanying both studies.

Some may argue that industry payments are irrelevant so long as they do not affect patient care.

In Curtis’ study, there was no association between the amount physicians received for a respective device and postprocedural complications or death.

In fact, eligible patients were significantly more likely to get a cardiac resynchronization therapy defibrillator (CRT-D) if their providers received at least $10,000 annually in industry payments rather than if their providers received less than $100 annually (OR 2.33, 95% CI 1.89-2.87), Curtis reported. Patients of higher-paid physicians were also more likely to receive guideline recommended medications at discharge compared to patients of lower-paid physicians.

Still, industry payments have the potential to impact patients financially or otherwise, Shachar and Curfman noted. In the end, payments “were funded by ICD sales, and these devices would be less expensive without these payments,” they wrote.

“Furthermore, these payments may undermine the reputation and trust of the medical profession, potentially damaging the complex relationship between patients and physicians,” Shachar and Curfman wrote. “Therefore, it is problematic that the Anti-Kickback Statute does not explicitly address these payments.”

Curtis agreed that the concerning aspect of industry payments boiled down to optics and public trust. One recent study found providers were unaware or unconvinced that industry payments influenced their practice patterns, yet mounting evidence suggests they do.

“Patients need to know that decisions regarding their care have been made on the basis of fact and science, not how much money their physician received from a device company,” Curtis told MedPage Today.