If you are in the pharmaceutical or life science industry, you must be in compliance with the Sunshine Act. Knowing what these regulations are, the aggregate spend tracking and reporting requirements, and the software available to you are very important. There are many details that go into this act and into your company being in compliance with the act. You need to make sure that you are up to date on any and all changes to help avoid issues in the future. If you work with physicians or pharmaceutical companies, here’s what you need to know.

 

What is the Sunshine Act?

In simple terms, this is an accountability program between those in the pharmaceutical industry and the physicians they work with. This act was set in place to keep the relationships between doctors and drug companies transparent to the public. While there may not be any issues there, the perception can be misconstrued that the drug companies have the health industry in their “back pocket”. In this day and age of natural and holistic treatments, the public’s perception can be skewed. By having this act in place to keep relationships transparent, it helps to make sure that everyone is following the rules as they should be.

What Do You Report?

There are several in the industry that have to report their relationships and fundings. Those include various companies in the life science industry and manufacturers that produce the drugs or devices used in the medical and health industry.

How Do You Stay in Compliance?

When it comes to obeying the regulations and reporting, you need to work with a trusted reporting company that can assist you in making sure all details are in order. Companies such as MedPro Systems has a reporting and tracking system already created to make sure you’re in compliance with all Sunshine Act regulations. Some of the items in your dealings with physicians that you will need to report and track include:

  • Name and address of the physician you are working with

  • Date the payment actually took place

  • How the payment was completed such as cash, check, charge, etc.

  • The license number and NPI of the physician you’re dealing with

  • The specialty that the doctor works in, for example, orthopedic medicine or pediatrics

  • The nature of the payment being reported such as was it used for consultation, research, or education

  • Report ownership interest if the person you’re working with or their immediate family is part owner


It is vital that as a manufacturer you stay in complete compliance in regards to these regulations. By making sure that you track everything your company does and have a solid reporting system in place, you can avoid unwanted investigations and fines in the future.

Published by Mary Charli