In the life sciences sector, a program's success is contingent on its compliance. That's why it's imperative that professionals involved in medical device and pharmaceutical meetings stay informed of pertinent regulations. For those in the United States, 2022 will bring about new changes in reporting, therefore, updated processes should be established by the start of 2021. In this article, we explain how your teams can begin preparing for the upcoming changes to Open Payments.
How to Prepare Life Sciences Programs
for SUPPORT ACT of 2018 Changes
It’s been nearly two years since the SUPPORT Act of 2018 was passed in the US. However, the transparency around reporting changes it mandates under the Physician Payments Sunshine Act (PPSA) are only now coming into focus. In particular, these changes will affect the transfer-of-value data, which life sciences organizations will report to Centers for Medicare & Medicaid Services (CMS) in 2022. And although it may seem like there's ample time, the work to collect this information must begin long before then. In fact, life sciences organizations are urged to begin looking at the changes they will need to incorporate into their processes now, so they are ready to collect the correct data beginning on January 1, 2021.
What has changed?
The most significant change, and the one that will have the biggest impact for our clients, is the reportable entities. Previously, reportable entities included almost exclusively high-level prescribers (MD, DDS, DPM, OD, DO and DC) and teaching hospitals. Now, CMS has ruled that in response to the statutory changes included in the SUPPORT Act (Pub. Law No. 115-271), the definition of a “covered recipient” is expanded to include five additional provider types.
The added provider types are:
- Physician assistants (PA-C)
- Nurse practitioners (NP)
- Clinical nurse specialists (CNS)
- Certified registered nurse anesthetists (CRNA)
- Certified nurse midwives
Nature of Payment Categories
In addition, there are three new nature of payment categories: debt forgiveness, long term medical supply or device loan and acquisitions. Conversely, two different categories were merged into one. Now accredited/certified and unaccredited/non-certified continuing education programs will simply become “medical education programs” for the purposes of CMS reporting.
Finally, where medical devices are concerned, a device identifier will be required for devices and medical supplies.
What can you do to prepare?
Applicable Manufacturers will need to audit the data they are currently collecting to determine where there are gaps between what they collect and what they will need. They will also need to do a thorough review of the transparency reporting templates for provider types, license numbers, options listed for nature of payments, and device identifiers to name a few. This may take time and resources, so it is best to undertake this process now.
When it comes to collecting the appropriate new data, consider whether you will need to add or customize new fields into your meetings management tool or CRM.
Likewise, consider how you will obtain the newly required data. One way to gather this information could include collecting it during the consulting agreement contract period and storing it in a CRM. Alternatively, you could require all meeting registration websites be configured to make this level of detail mandatory. The information can then be merged into any transfer of value reporting forms, tools or databases.
While these changes are not seismic, it is important to be prepared. With a little forethought and preparation, the SUPPORT Act changes can be seamlessly implemented.