Sunshine Act Reporting Requirements for Companies

The Physician Payments Sunshine Act's purpose is to provide the public with insight into financial relationships between healthcare providers and industry stakeholders.  The law applies to:

• Manufacturers

• Distributors

• Wholesalers, or

• Marketers

Of the following types of products:

• Medical Devices

• Drugs,

• Biologics, or

• Medical Supplies (which includes such things as: some medical devices, durable medical equipment, etc.)

These companies must report payments or other transfers of value made to physicians and teaching hospitals.  This requirement is enforced by the Centers for Medicare & Medicaid Services (CMS).

What Must be Reported?

Reporting requirements include any compensation, gifts, research funding, or other financial relationships that could influence physician decision-making or clinical practices.

Key Considerations:

• Who is a "Physician"? A "physician" under the Sunshine Act includes doctors of medicine, osteopathy, dental surgery, and other healthcare professionals involved in the delivery of care, as well as teaching hospitals affiliated with medical schools.

• What Must Be Reported? Any payment or transfer of value exceeding $10 must be reported. This can include meals, travel, speaking fees, consulting fees, research funding, and other forms of financial compensation provided to physicians or teaching hospitals.

• Reporting Period & Deadline: The reporting period runs from January 1 to December 31, with submissions due by March 31 of the following year. All required data must be reported to the CMS Open Payments system.

• Public Disclosure: Once submitted, the data becomes publicly available through the CMS Open Payments database, which can be accessed by patients, healthcare professionals, and the general public.

What Companies Should Know:

Your company is responsible for ensuring full compliance with the Sunshine Act. Failure to report required payments or transfers of value can result in significant penalties, including fines and reputational harm. To maintain compliance, companies must carefully track all financial interactions with physicians and teaching hospitals and ensure timely submission of data to CMS.

Steps to Ensure Compliance:

• Identify Reportable Relationships: Review all payments, gifts, and transfers of value to physicians and teaching hospitals to determine what must be disclosed.

• Track and Maintain Records: Implement systems to track all relevant transactions throughout the year. Accurate and thorough documentation is critical to meet reporting obligations.

• Submit Accurate Reports: Ensure all required data is submitted to the CMS Open Payments database by the March 31 deadline.

• Stay Informed: Regularly update your policies and practices to stay aligned with any changes to the Sunshine Act regulations or reporting guidelines.

If you need assistance with understanding or meeting your obligations under the Sunshine Act, the Thompson PLLC team is here to help. Contact us for expert guidance tailored to the medical device industry.