There is public concern about financial relationships between doctors and medical product manufacturers. While these relationships can yield benefits, they can also skew doctors’ decisions in terms of patient treatment. This concern took legal shape as the initial Sunshine Protection Act.
The Sunshine Act requires that medical device companies report fiscal relationships with physicians. The same holds for group purchase organizations.
These relationships range from direct payments to ownership in a company. Starting in 2022, the Sunshine Act expands requirements to include advanced practice nurses and PAs.
Keep reading for an overview of the Open Payment system and the Sunshine Act Expansion
What Is Open Payments?
Open payments is the system the government put into place to act as a data clearinghouse for the Sunshine Protection Act. All of the required reporting data ultimately goes to this system.
Once there, the information is available to the public. While mainly a resource for researchers, lawyers, and journalists, anyone can search the database.
Let’s say that someone gets a prescription from their doctor. They do some research on their prescription. It looks like their doctor ignored an option that research claims is more effective.
That patient can visit the Open Payments system and search for their doctor. If that doctor stands to make a profit on the medication or device, Sunshine Act reporting should expose the relationship.
Similarly, what if a doctor on staff at a teaching hospital pushes for the hospital to adopt a particular device? Administrators can perform a similar search to see if the doctor will benefit financially. The system offers another layer of public and professional accountability.
Sunshine Act Expansion
The Sunshine Act expansion addresses a meaningful change in who gives prescriptions. Specifically, it deals with the fact that advanced practice nurses and physician assistants write prescriptions far more often than they once did.
Some of this expanded responsibility stems from the advanced training people receive in these fields. Most advanced practice nurses and PAs hold master’s degrees.
The new rules require reporting for the following categories of medical professionals:
- Physician Assistant
- Nurse Practioner
- Clinical Nurse Specialist
- Certified Registered Nurse Anesthetists
- Certified Nurse Midwives
The expansion addresses the prescribing power these professionals hold. It also deals with the relationships they might hold with medical device manufacturers. We’ll explore this issue more fully in the next section.
Why Is There an Expansion?
In raw numbers, there are more physicians in the US now there than were ten years ago. Yet, there is a growing shortage of physicians in the US. The number of active physicians simply cannot meet the overall need.
This shortage comes at a particularly bad time as the Baby Boomer generation is now retiring and will retire in droves in the near future. As they retire, they will move into a period of life with greater medical care demands.
The need for people with prescribing power will only grow. This helps explain why advanced practice nurses and PAs now enjoy some prescribing power.
This also means that advanced practice nurses and PAs will find end up filling in for doctors more often. They’ll also hand out more prescriptions.
As that duty grows, PAs and advanced practice nurses will find themselves dealing more with medical device companies. Device companies will court them in a similar fashion as they court doctors.
That creates a situation where unreported relationships could lead to abuse.
There is one major challenge involved with this expansion in reporting financial relationships. There is general agreement on credentials issued to physicians, based on their specialties. Whether you live in Seattle, Chicago, or rural Tennessee, a cardiologist is always called a cardiologist.
The same applies to neurologists, anesthesiologists, and general surgeons. The requirements for taking up these specialties are largely standardized.
Unfortunately, the same does not apply to advanced practice nurses and PAs. State-to-state credential variations number in the hundreds for advanced practice nurses and PAs.
That puts the burden on the companies charged with reporting financial relationships. The companies must somehow find a way to identify them across all the variations.
Failure in this respect can lead to fines as high as $100,000 for every lapse.
Addressing the Challenge
It’s not all bad news for these device manufacturers. They can use resources like this solution that already do a lot of legwork in identifying these variations. Companies can lean into these resources in meeting reporting requirements.
Even so, companies and group purchase organizations will still need a number of internal initiatives. At the very least, they will need updated data collection policies. The last thing any company needs is a pile of fines for failing to report relationships in their CMS reports.
The key issue is making sure that your company doesn’t treat the changes lightly.
The government may offer a short grace period for companies to get their reporting in order. Companies shouldn’t expect that grace period to last for very long. After that, expect a harsh crackdown for reporting failures.
Hospitals will need to enact new training for advanced practice nurses and physician assistants. Specifically, they will need training on conflict of interest.
Sunshine Act Expansion and Your Organization
The Sunshine Act expansion will create new challenges for hospitals, medical device manufacturers, and group purchase organizations. These are not insurmountable challenges.
Hospitals can institute conflict of interest training that keeps staff on the right foot. New data collection policies will help ensure that companies meet reporting requirements.
Companies can also use resources that already collect information on PAs and advanced practice nurses.
Looking for more health care-related news and articles. Take a look in our Health Care section on this site.