Sunshine brings transparency – that was the idea behind the “Physician Payments Sunshine Act”, more formally known as “Section 6002 of the Affordable Care Act (ACA) of 2010”. The legislation, which went into effect on August 1, 2013, mandates that the Centers for Medicare & Medicaid Services (CMS) collect information about payments physicians and teaching hospitals receive from drug and medical device manufacturers and publicize this information in the Open Payment Database (1).
In this blog we take a look at the status of the Sunshine Act, now in its eighth year, discuss recent changes, benefits, challenges, and unintended consequences.
The foremost goal of the Sunshine Act was to give patients an easy tool to look up whether their healthcare provider receives money from industry and if so, how much, from which company, and for what. If a physician (or one of their family members) receive “payments and transfers of value” of more than $10, or $100 combined per year, from one manufacturer they have to report those payments which will then be captured and published in the Open Payments Database.
The payments fall into three categories:
- Research payments – any payments that are associated with research, e.g. grants and funding for pre-clinical research or for clinical studies
- General payments – everything else, from consulting or speaker fees to lunch, educational materials or travel
- Value of ownership – captures any ownership or investment interest a physician might have in a company
Figure 1 provides an overview of just how much money we are talking about (2019 numbers) and how the overall amount breaks down between the different categories.
Fig 1: 2019 Open Payment Data Overview
The total amount of payments reported has gone up from $8.58 B in 2014 (first full year of reporting) to $10.03 B in 2018, an overall increase of just under 17%.
The temptation is great to dive into the data and start analyzing it and CMS makes this possible by providing online analysis tools (2). Alternatively, those with enough computing power can download the data, all 10.4 million rows and 75 columns of it in 2019 alone and start crunching it.
The justification for this massive data collection effort was straight-forward: the transparency the Sunshine Act brings would discourage conflicts of interest by healthcare providers (HCPs) and thereby lower healthcare costs. The idea was to remove incentives for HCPs to prescribe expensive branded products over generics, if the former came with gifts. If patients could easily find out what value their physicians received, doctors would be careful to avoid the impression of bias.
To find out whether the Sunshine Act lives up to its promise, let’s first have a look at the underlying premise, namely that gifts influence people, in this case physicians, in their behavior. A PubMed search turns up a number of studies that show that physicians, as a group, are just like everybody else and tend to react positively to gifts.
Here are some of the findings:
- A physician-industry financial relationship was associated with increased odds of prescribing costly brand-name drugs of uncertain medical benefit (3)
- Gifts of any size had an effect and larger gifts elicited a larger impact on prescribing behaviors (4)
- Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted (5).
While a relationship between industry payments and prescription patterns has been shown in these and numerous other studies, data showing that increased transparency reverses these patterns, leads to lower healthcare cost and increases “rational use of medicines” (definition see reference 6) are much harder to find.
In fact, there is a curious absence of reports, analyses or statements by the CMS or others speaking to savings that can be attributed to the Sunshine Act. The most relevant study (7) predates the Sunshine Act and looks at the effect disclosure requirements had in Maine and West Virginia, two states which had implemented sunshine laws before 2013. For this study, the researchers compared prescribing patterns of two classes of drugs (statins and SSRIs) “in which marketing plays an important role because the therapies within each class are pharmacologically and clinically highly substitutable” in Maine and West Virginia with the prescribing patterns in states that did not have reporting requirements at the time. Overall, they found the effects of the sunshine laws “negligible to small”.
A possible explanation the authors offer is, that neither Maine nor West Virginia required public disclosure, just reporting to state agencies.
The critical question now is: does public disclosure required by the Sunshine Act increase the small observed effect on prescribing patterns?
Criticism and Unintended Consequences
The answer seems to be: we don’t know! This is in part because - albeit published and publicly available - hardly any patients look at the data: a study found that only 3% of the population searches their physicians’ financial ties to the healthcare industry (8).
Several possible reasons come to mind for this lack of interest:
- Accessing and making sense of the raw data is not trivial and requires time and effort
- Many people don’t know that the data is collected
- Patients don’t know what to do with the information once they have it.
That latter argument is especially powerful and remains valid even if awareness and access issues would be addressed. What can or should a patient do when they find out that their endocrinologist had a lunch paid by a pharmaceutical company? Change doctors? Question their doctor’s prescribing habits? Demand that they never have another lunch paid by the company? Of all the players in the complex healthcare ecosystem, the patients seem to be the least able to bring about meaningful change, even if they suspect their physician of bias due to industry payments.
The other area of criticism is related to an unintended consequence: instead of increasing trust in the system, researchers have observed that added transparency has had the opposite effect: it led to an erosion of patients’ trust in all healthcare providers, whether they accept payments or not. A study published in JAMA (9) found a 2.7% decline in trust associated with the public disclosure system. The reason, the study authors speculate, might be due to the extensive media coverage of the overall large amount of money the industry spends and the large payments a small minority of HCPs receive.
Expanding the Sunshine Act
Despite these criticisms, the Sunshine Act is about to be expanded: originally it applied to physicians and teaching hospitals only, but the US opioid crisis prompted a push for its expansion. On October 3, 2018 the US congress passed the “SUPPORT Act” which - starting on January 1, 2022 - extends the reporting requirements to physician assistants, nurse practitioners, clinical nurse specialists, nurse anaesthetists, and nurse midwives.
The reason for this expansion lies in headline-grabbing stories like that of Heather Alfonso. The nurse practitioner doubled her annual income by accepting a total of $82,000 in kickbacks from Insys Therapeutics for prescribing the company’s pain-killer. Alfonos was single-handedly responsible for writing $2.7 million in prescriptions which made her the highest prescriber in Connecticut of these potent narcotics with a high potential for addiction and abuse (10). The lawmakers believe that extending the Sunshine Act to all medical professionals with prescribing authority will help curb abuse and promote accountability especially surrounding prescription of controlled substances.
Open Payment data can bolster expert mapping
The intended beneficiaries of the Open Payments database, the patients, might not use the information nearly as enthusiastically as anticipated, however, for life science companies the database contains rich information they can’t afford to ignore.
General trends, e.g. total research funding over the years, are fairly easy to obtain, and a number of scientific papers have been published that analyze the data for specific groups or therapeutic areas (11).
For medical affairs departments charged with market landscaping and identifying external experts the Open Payment database can be a valuable resource for qualifying or excluding experts.
To find out how medical affairs professionals use Open Payment data in concert with Monocl Monocl Professional please read or blog “5 Ways Industry Payment Data Can Inform External Expert Selection” or talk to one of our specialists directly.
- Association between industry payments and prescribing costly medications: an observational study using open payments and medicare part D data, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880069/
- Influence of pharmaceutical marketing on Medicare prescriptions in the District of Columbia, https://www.ncbi.nlm.nih.gov/pubmed/29069085
- Pharmaceutical Industry-Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries, https://www.ncbi.nlm.nih.gov/pubmed/27322350
- Definition: “Patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community.” (WHO, 1985).
- http://c-hit.org/2015/06/23/high-prescribing-nurse-charged-with-accepting-drug-company-kickbacks/ and https://www.bloomberg.com/news/articles/2019-02-12/opioid-nurse-sold-out-patients-for-82-000-in-insys-kickbacks
- Examples: physician-editors: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6366761/, thoracic surgeons: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6294877/, neurologists: https://www.ncbi.nlm.nih.gov/pubmed/29728521