Pharma Companies Feeling the Heat From the Sunshine Act
Last week marked the release of the initial data from the Sunshine Act law of the Affordable Care Act, which had been dreaded by many health care professionals and pharmaceutical and medical device executives.
So, for the past few years, pharma and medical device leaders have feared that thought leaders might shy away from working with their companies because of the data disclosures. Health care professionals have warned that keeping track of their payments would be clunky and time-consuming.
In fact, a Medical Affairs director, interviewed for a recent project on Medical Science Liaisons (MSLs) and the work they do, confirmed this fear. “I worry that as institutions change policy, and with the Sunshine Act, sensitivity is increasing and will impact MSLs,” he said. He went on to discuss his fear that channels may be shut down altogether, and his hopes that this can be avoided as they can provide key information for the benefit of health care.
From the work we do at Best Practices, LLC, there is little doubt that some doctors no longer serve as thought leaders, as 38% of the pharma companies in our study said it was a high risk that institutions would limit interactions with MSLs and other pharma field-based staff.
“Pharmaceutical companies are very concerned about losing touch with key scientific minds and physicians who are in the industry,” said Cameron Tew, head of research services at Best Practices. “Sometimes it is helpful to get the researcher or doctor away from work to speak about an investigator trial they might have going on or an upcoming Congress. That becomes more difficult to do when the hospitals restrict meetings, or doctors become scared about having to report a lunch via the Sunshine Act.”
Under the Sunshine Act, nearly all “transfers of value”—including gifts, consulting and speaking fees, and meals worth more than $10—from industry to physicians and teaching hospitals must be reported and then be disclosed in the public database.
All of this may be true, but pharma and medical device companies and their trade associations are not going to see thought leaders go away anytime soon; the recently released data showed $3.5 billion was spent on industry ties to doctors and hospitals. (Please note that the database does not put the expenditures in context as they may be to fund investigator initiated trials or to start a program at a hospital.)
Yes, more doctors likely will stop serving as thought leaders because the law mandates that every pharmaceutical and medical device company must annually disclose payments by amount, form, and date to doctors and teaching hospitals. Still, it is just as likely that pharma and medical device companies are struggling with the key questions of how to properly document these distributions as well as what a fair market value is for the services such opinion leaders provide.
In addition to launching a study to determine fair market value for thought leaders in the healthcare industry, Best Practices continues to work with companies medical affairs functions to outline ways that their companies can better serve physicians and other health care professionals as well as improving their own processes and checks and balances in regards to the Sunshine Act.
So what can health care organizations do to a) make sure that they are in compliance with the details of the Sunshine Act law and b) continue to have physicians willing to serve as thought leaders?
- Develop strict SOPs: Many companies have implemented Standard Operating Procedures that speak to what their MSLs can and cannot do. This can help leaders to avoid any pitfalls and ensure that MSLs adhere to proper procedures.
- Refine reporting technology: By refining the technology used to disseminate the data, they can work more closely with HCPs to ensure that reported HCP payments are correct and that physician activities are properly accounted for.
- Maintain clear lines of communication with physicians and KOLs: By continuously identifying what activities are reportable and what are exempt, companies can maintain good working relationships with KOLs and can help allay fears about misreported data.