If you are part of the medical manufacturing community, March 31st is a big day for you. Due to the Open Payments law, formally known as the Sunshine Act, reports of your spending from August 1, 2013 through end of December 2013 are due to Centers for Medicare and Medicaid Services (CMS) that day.
With only weeks until the pressing deadline, how much do you truly understand about the Open Payments legislation?Are you clear on which payments or other transfers of value you need to report? All set on the three separate data submission file specs established by CMS? If you had to think about that for a minute, download our Essential Guide to Open Payment Compliance for easy guidelines to ensure you are in line with Open Payments, formally known as the Sunshine Act.
Not sure whether Open Payments, a.k.a. the Sunshine Act applies to you?
You can follow these three steps to determine if Open Payments pertains to your organization.
Step 1: Does your organization operate in the United States, or any territory, possession or commonwealth of the United States?
Step 2: Does your organization do any of the following types of activities?
- Type 1: Engage in the production, preparation, propagation, compounding or conversion of a covered drug, device, biological or medical supply
- Type 2: Under “common ownership” (ownership by the same individuals or entities of 5 percent or more in two entities) with Type 1 AND provides assistance or support with such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale or distribution of a covered drug, device, biological or medical supply.
Step 3: Are any of your organization’s products covered by insurance, such as Medicare, Medicaid or Children’s Health Insurance Program? If so, does the drug or biological require a doctor’s prescription? Or, if they are medical devices and supplies, do they require premarket approval or notification by the FDA?
If your answers are yes to the above questions, then your organization is considered to be an applicable manufacturer for Open Payments, a.k.a. the Sunshine Act. You will need to get all of your reporting in order and submit it by March 31st. The good news is you don’t have to figure it all out on your own.
Check out our Essential Guide to Open Payment Compliance for information on how to report your spending. Our guide simplifies what this new legislation means to the medical manufacturing community and provides easy ways to make sure you are in compliance with Open Payments, also known as The Sunshine Act.