By Rebecca Fleeman

Over the past two decades a large portion of the public has formed unfavorable feelings towards the pharmaceutical industry¹. With soaring drug prices and the opioid epidemic, many question the financial intentions of not only drug companies, but also the doctors who accept financial kickbacks from pharma. This distrust kindled government action in 2007, with US Senator Charles Grassley proposing the Physician Payments Sunshine Act to shed light on the monetary movements between pharma and health care professionals (HCPs)². While not a total transformation, the promotion of transparency due to the incorporation of the Sunshine Act was a step in the right direction. Highlights below include what the Sunshine Act is, how it affects patients, health care workers, and pharma, and how the Sunshine Act has expanded and evolved -with new updates publishing in just two weeks (June 30, 2022)³!

What is the Sunshine Act?

The Sunshine Act was introduced in 2007 and while given some pushback, was ultimately bundled into the Affordable Care Act (ACA) passed in 2010 under the full name ‘The National Physician Payment Transparency Program: Open Payments’⁴. The Sunshine Act created what the Centers for Medicare and Medicaid Services (CMS) calls the ‘Open Payments Program’⁵ which requires drug manufacturers to report payments made to physicians and teaching hospitals⁶ with the goal of increasing transparency and accountability in healthcare. The idea is that by requiring pharma companies to disclose payments, the published information will deter bribing due to a negative response from the public⁴. Any payment over $10 and individual payments totaling more than $100 annually must be reported to CMS, whether or not they were related to a drug, medical supplies, or medical devices a company offers⁵ (Figure 1). Data collection began in August 2013 and the first reports were published in August 2014⁶.

The ‘Open Payments Program’ puts responsibility on patients, insurance companies, and other public entities to take the time to find this information, and ultimately act on findings⁴. However, many patients are unaware of the publicly available information, and others who are aware of it do not always understand the full story. While pharma once shelled out excessive money to doctors to promote their drugs, payments have decreased with money now more focused on important discussions towards therapeutic research⁷. I spoke with stakeholders on both sides of this equation, a family doctor in North Carolina, as well as a medical science liaison director in Colorado, and got similar responses from both; the Sunshine Act decreased extravagant gifts from pharma to HCPs, but also put constraints on the ability to form new and lasting relationships between the parties.

What is new with the Sunshine Act?

As of 2021, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act expands Open Payments to include physician associates (PAs), nurse practitioners (NPs), clinical nurse specialists, certified nurse-midwives, certified registered nurse anesthetists (CRNAs), and anesthesiologist assistants³. Previously drug, medical supplies, and medical devices companies only had to report payments to licensed medical doctors (MD) and doctors of osteopathy (DO)⁴. This addition comes in the wake of the apparent loophole to shift focus from MDs and DOs to these additional HCPs to circumvent reporting⁴. Other updates that began in 2021 and will ultimately be published later this month include updated payment categories and additional website features³.

How does this impact you as a…

Patient

You are able to search https://openpaymentsdata.cms.gov/ to identify how much money any licensed physician in the US has accepted from drug, medical supply, or medical device company and see the breakdown of which companies that money came from. Equipped with this information, you can make more informed decisions about whether an HCP’s financial ties align with your health goals. Importantly, CMS does not report on the specifics of the financial relationships beyond categorizing transactions into general payments (food and beverage, travel and lodging, consulting, education), research payments, associated research funding, and ownership/investment interest.

Just because meals and travel were provided by a pharma company to a physician, does not mean the physician agreed to use a company’s product or was sold on a product. Accepting payments or offerings also does not mean that the company was using any type of advertising or selling tactics. These scenarios are possible, but equally as likely, the HCP was meeting with an industry representative to talk about safety and efficacy of new drugs in the pipeline, without conflicting interests. Relationships between HCPs and pharma companies are important so that both parties are aware of the best medicines and new data on current and future medicines⁸. Beneficial practices include companies seeking out HCP leaders in the field to consult on disease and treatment expertise, using their vital knowledge of patient experience. Medical science liaisons (MSLs) are critical employees of pharma companies with the key mission to build relationships with HCP leaders to gather insights and also communicate therapeutic directions the company has to offer. Thus, communication between pharma and HCPs, often led by MSLs, is vital for efficient and successful progression of new and improved therapeutics for patients⁸. However, other conflict of interest type relationships can still exist between HCPs and pharma, and this is the key reason that the Sunshine Act was made. It is important to consider the complete picture of these nuanced financial ties beyond a knee-jerk reaction that you do not want your doctor to have a relationship with industry.

Pharma Employee

Pharma employees, like the MSLs mentioned above, must be aware of the reporting they must submit to maintain adherence to the Sunshine Act. When building relationships with key opinion leaders like physicians, it is not uncommon to have discussions like this over a meal. If this occurs, and the expense is over $10, the company must report this transaction to CMS. Other common transfers of value that MSLs must report to CMS are things as simple as sharing a PDF of a research paper that isn’t open access with an HCP (See my previous LTS article on the Open Access conundrum). Although the average patient would not be upset that their doctor is receiving the latest peer-reviewed research, failure to report any payment can result in a penalty of $1,000-$10,000, with the maximum annual penalty of $150,000. If a company knowingly fails to report, charges are raised to $10,000-$100,000 per payment, with a maximum of $1 million⁵.

Health Care Professional (HCP)

The Sunshine Act has impacted HCPs as well as pharma. Worried about their reputation, some doctors now hold fewer meetings with pharma representatives, even if well intentioned for progression of science, to prevent negative light. Other HCPs have changed the way they interact with pharma, declining any free meals or transportation for meetings, but maintaining their relationships with pharma. Doctor organizations and medical schools consistently advise HCPs and future HCPs on the Sunshine act to ensure accurate reporting and awareness of the publicity⁹. One area with huge pushback is pharma-funded clinical research for an HCP or hospital. These thousands or even millions of dollars can take a patient scrolling through ‘Open Payments’ aback if they do not fully understand the intentions of these payments, which were meant to help, not hurt, patients.

Overall, the Sunshine Act has moved a large pendulum, from pharma companies spending excessive money on HCPs, to having increased transparency at the cost of decreased collaboration. Hopefully as the dust settles, we will find the perfect balance of maintaining important HCP-pharma relationships and creating ethical financial ties to promote the most beneficial mix of swift, efficacious, and comprehensive medicine.

Want to learn more? Here are some great resources with more information on the Sunshine Act:

CMS Open Payments Site: https://www.cms.gov/openpayments

CMS Sunshine Act Update: https://www.cms.gov/newsroom/press-releases/affordable-care-act-sunshine-rule-increases-transparency-health-care

TL;DR

• The Sunshine Act requires drug, medical supplies, and medical device companies to report all payments to health care professionals over $10.
• The goal of the Sunshine Act is to increase transparency and accountability in healthcare.