- The Senate has voted overwhelmingly in favor of an opioid bill that will make drugmakers and medical device manufacturers report payments to a wider range of healthcare professionals. President Donald Trump is expected to sign the bill into law.
- The opioid bill will expand the so-called Sunshine Act reporting requirements beyond physicians and teaching hospitals to include payments to nurses.
- Device trade group AdvaMed criticized the expansion ahead of the final vote but failed to persuade senators to change it before they sent the bill to Trump.
When the House began debating a bill intended to curb the opioid epidemic earlier this year, the text made no mention of changes to the Sunshine Act. The act mandates public reporting of payments by makers of drugs, biologics, medical devices and supplies to physicians if they are covered by Medicare, Medicaid, or the Children's Health Insurance Program.
As the bill was debated in Congress, where it enjoyed a rare level of bipartisan support, lawmakers tweaked the text. The modifications included the addition of a new selection titled “Fighting The Opioid Epidemic With Sunshine.”
In the new section, lawmakers proposed including additional practitioners under Sunshine reporting rules. Specifically, the bill seeks to make companies report payments to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.
The requirements will ensure that manufacturers of opioids have to disclose payments to nurses. However, the expanded reporting requirements will also apply to manufacturers of drugs and devices that have nothing to do with opioids or pain medications more generally.
That set alarm bells ringing at AdvaMed, which said it did "not believe this provision will provide the public with helpful information and therefore will force an unnecessary compliance burden on companies." AdvaMed issued that statement late last month when the House voted in favor of the then-latest version of the text, which included the Sunshine section. Despite AdvaMed’s intervention, the Senate then passed the bill by a margin of 99 to 1.
Assuming Trump signs the bill, the changes to the Sunshine Act will pass into law. The bill gives companies some time to prepare for the changes, though. The amendments will apply on or after Jan. 1, 2022.