Pharmaceutical and medical device manufacturers have the same need and right to advertise their products as any other businesses, and doctors have the need and right to be advised of new products potentially beneficial to their patients. In the United States, direct marketing to physicians is therefore legal. However, in an industry with stakes as high as those in health care, transparency and proper protocol are paramount. Patients need to know their doctors are simply being updated, not being incentivized by manufacturers to prescribe one medication or procedure over another.
In 2010, the Affordable Care Act (ACA) enacted regulations on business transactions between medical providers and medical product manufacturers. Known as the Physician Payment Sunshine Act (Sunshine Act), this section of the federal ACA law differentiates between allowable and illegal business practices in the doctor/pharma relationship. Furthermore, it requires details of any financial relationship to be made public in the Open Payments database.
The Sunshine Act stipulates the federal rules, and patients benefit from familiarity with these general guidelines. But individual states also have their own additions to the federal law, and knowing their special criteria helps residents make the best choices in their state. Below are just a few additions your local legislation may contain.
Vermont Takes The Lead
The opioid crisis that erupted at the turn of the 21st century did not occur in a vacuum. Many factors intensified the problem, including pharma companies paying 67% of physicians to prescribe their products. The federal Sunshine Act came about largely because of the system failures illuminated by the opioid sale debacle.
Vermont led the charge before the federal Sunshine Act even passed. In 2009, Vermont virtually banned pharma companies from offering incentives to doctors. The few exceptions must be reported to the attorney general. The Green Mountain State now has only 19.5% of doctors receiving payments from pharma companies, which is less than a third of the national average.
Truly Informed Consent
To decide if they are comfortable with their provider’s actions, patients must be aware of them. California requires physicians to share the Open Payments database with all patients, both individually and in prominent positions in their office and website. Patients across the country can easily type in their providers and follow the money in this database, but California law does not leave room for any doubt the patients are informed.
Wider Scope Of Practice
In some states, sunshine laws impact more types of practitioners than in others. Washington, DC even includes registered dieticians and licensed nutritionists in its rules, even though these professionals cannot prescribe medication. It also maintains exceptionally low limits on allowable payments for activities such as business dinners. To maintain unbiased treatment protocols, these laws maintain a wide distance between all sellers and potential buyers, making it more difficult to engage in any questionable transactions.
Making Use Of Sunshine Laws
Regardless of opinions on any regulations, it behooves patients to become educated about the laws and how their chosen practitioners are working within them. Next time you go to the doctor, you can arrive armed with more facts about your medical team and be more aware of any potential conflicts of interest. The best defense against medical misbehavior is knowledge, and we have never had more of it at our fingertips.