Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid package passed last week.  As we've previously reported, the Fighting the Opioid Epidemic with Sunshine Act, will require manufacturers to report payments made to advance practice nurses and physician assistants in addition to physicians and teaching hospitals.  The change is effective for payments reported in 2022, so manufacturers will have some time to prepare. 

Manufacturers subject to the Sunshine Act (also known as the Open Payments system) will need to update the way they track payments and transfers of value to ensure that they capture payments to the newly covered practitioner types. Additionally, manufacturers will need to update their training for sales and other staff responsible for making payments to ensure that they are aware of the changes and know which payments to track and report. 

Notably, the expansion of the federal reporting requirements will also have implications for separate state law reporting obligations. The Sunshine Act, which was included as part of the Affordable Care Act in 2010, includes a preemption provision that provides that the federal reporting obligations preempt any state reporting obligations for recipients covered by the federal law (originally physicians and teaching hospitals). Several jurisdictions, including Massachusetts, Minnesota and the District of Columbia, have laws that require the reporting of payments to physicians and other providers.  Although the physician reporting obligations were preempted by federal law, those states continue to require the reporting of payments to other provider types.  Once the revamped federal Sunshine Act goes into effect, state law reporting obligations for the newly covered provider types will be preempted as well. 

Additionally, the Fight the Opioid Epidemic with Sunshine Act will sunset a provision of the Sunshine Act that prohibited CMS from publishing the NPI of covered recipients in the final, publicly available reports of payments. That provision will no longer be applicable beginning with information reported in 2022. 

We anticipate that CMS will issue updated regulations in the coming months to address these changes.  Stay tuned for more.