Payment Reporting for Clinical Trials under Sunshine Act

Author: Mukesh Kumar
The kind of payments that should be reported in clinical trials are: consulting fees, compensation for services other than consulting, honoraria, gift, entertainment, food and beverage, travel and lodging, education (Conference attendance, payment for CME courses), direct compensation for serving as faculty for a medical education program. Want to learn what are the payments that do not require reporting, what is clinical trial payment to clinical sites and more? This article will provide you the answer for all your queries on reporting for clinical trials under the Sunshine Act.
Payments that do not Require Reporting
Here are a few things which do not require reporting, OTC drugs and Class I and II Medical Devices, less than $10 each time, total less than $100 per year, direct payments to patients (patient incentives for participating in trials), payments to staff, items supplied for care of patients.
Other things that Need to be Reported
Here are a few other entities which does not need reporting, covered recipient name, covered recipient address, physician covered recipient specialty and NPI, amount of payment, date of payment, form of payment, nature of payment, name of drug, device, biological, or medical supply associated with payment (if applicable).
Clinical Trial Payments to Clinical Sites
Clinical Trial Payments to Clinical Sites are Complex. Only a fraction of the payment goes to the physician, Payment to institution, Payment to staff, Payment to vendors (labs, imaging, etc). Only direct payment to physicians are reportable, not that to support staff. It also includes cost of time plus consultancy.
Financial Disclosure under 21 CFR 54
Financial disclosure under 21 CFR 54 is required at the time of marketing approval application, payments above and beyond the cost of clinical trial conduct, compensation affected by outcome, equity and ownership, payments above $25,000 excluding cost of clinical trial conduct.
Tracking Payments to Clinical Sites
Tracking payments to clinical sites could be done by itemizing the payments, tracking all payments (monthly, quarterly, yearly, overall, etc), transparent and auditable payments, financial reporting to sponsors, timely and accurate CMS reporting.

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