The Physician Payment Sunshine Act requires wholesale distributors, repackagers, relabelers and kitters of drugs, devices, and biological or medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report payment or values of transfer made to their physician and teaching hospital customers.
In general, suppliers must report on any payment over $10, and if the annual payments to the covered provider are greater than $100, then all payments, even those less than $10 must be reported. Reportable gifts include cash, food and beverage, consulting fees and honoraria, and many other kinds of gifts.
The federal law, passed in 2010, does not preempt states from passing more stringent gift disclosure laws and several states have their own regulations.
What Member Need to Know
Covered devices are those requiring premarket (510k) or pre-notification approval from FDA. Covered drugs are those requiring a prescription.
Covered products are those for which a payment is available under Medicare, Medicaid, or Children’s Health Insurance Program (CHIP), and which require a prescription or premarket approval.
Those who are not in compliance with the Physician Payment Sunshine Act may be subject to fines up to $100,000. HIDA continues to monitor state legislation to clarify the role of distributors and prevent over-regulation.
Sunshine Act Gift Disclosure Distributor Checklist (PDF)
FAQ: Sunshine Act Gift Disclosure Final Rule (PDF)
2-1-2013 | Physician Gift Disclosure Final Rule Released by CMS