BY Kianna L. Sitarski, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.
Many recent additions to the healthcare regulatory framework have largely been aimed at adding much needed transparency for patients. One such addition with this objective is the Physician Payments Sunshine Act, colloquially known as the “Sunshine Act” or “Open Payments Act”, which seeks to require certain industry players to disclose certain financial interactions and relationships with physicians and other Covered Recipients.
Enacted as part of the Affordable Care Act, the Sunshine Act requires certain Reporting Entities to report to the Centers 
for Medicare & Medicaid Services (“CMS”) any financial relationships with, or transfers of value to, covered recipients. Put generally, the goal of these required disclosures is to “discourage conflicts of interest that could compromise treatment decisions, medical research, or increase healthcare costs billed to federal health programs.”[1]
Required Reports: Who, What, and When
WHO:
There are two primary groups that fall within the definition of a Reporting Entity: (i) medical device, drug, biological, and/or medical supply manufacturers operating in the United States and (ii) Group Purchasing Organizations. The Sunshine Act requires that these Reporting Entities submit annual reports to CMS outlining all (i) payments and transfers of value to Covered Recipients, or to a third party as the request of, or on behalf of, the Covered Recipient and (ii) ownership and investment interests in the Reporting Entity held by Covered Recipients, or the immediate family members of Covered Recipients.
Though the Sunshine Act originally defined Covered Recipients to include physicians (MDs, DOs, dentists, optometrists, chiropractors, and podiatrists) and teaching hospitals, the SUPPORT Act (effective January 1, 2021) expanded the definition of Covered Recipients to include additional healthcare providers including physician assistants, nurse practitioners, and more. Importantly, the Sunshine Act is applicable to all Covered Recipients, regardless of the Covered Recipient’s enrollment status with any Medicare, Medicaid, or CHIP program.
WHAT:
Required reports must include both Reporting Entity and Covered Recipient identifiers and include specific details and context regarding certain categories of payments, transfers of value, and ownership and investment interests. Though there is significant nuance to whether payments, transfers of value, and ownership and investment interests are reportable, one more widely applicable exception is for payments and transfers of value considered to be below the reportable threshold. Specifically, for the 2025 calendar year, if a payment or transfer of value is worth less than $13.46, it is excluded from the reporting requirements under the Sunshine Act. However, if all payments and transfers of value from the Reporting Entity to the Covered Recipient are worth more than $134.54 in the aggregate over the calendar year (even if each falls below the $13.46 threshold), the Reporting Entity must submit a detailed disclosure such all payments and transfers of value.
WHEN:
Though the onus of Sunshine Act compliance (and related penalties for noncompliance) falls widely on the Reporting Entities, Covered Recipients are afforded the opportunity to correct any erroneous reports and data submitted to CMS pursuant to the Sunshine Act. Specifically, Reporting Entities are required to submit the required reports to CMS between February 1 and March 31 of each year and include the required data for the prior calendar year. Beginning in April 1 of each year, Covered Recipients are able to access and review their reported data. To the extent that any Covered Recipient identifies an issue with the accuracy of the reported data, the Covered Recipient must initiate a dispute of such data no later than 45 days following the release of the reported data. From there, CMS, the Reporting Entity, and the Covered Recipient have a 15-day window to resolve the dispute. Regardless of whether a dispute is raised, the reported data will be published to OpenPaymentsData.CMS.gov, a public, searchable database (the “Open Payments Database”) by June 30. To the extent that any dispute is still pending, the Open Payments Database will include the disputed data but indicate that it is under dispute. The Open Payments Database allows any member to review their healthcare provider’s affiliations, relationships, and interests with Reporting Entities, and is designed to enable potential patients to make informed decisions about their healthcare providers.
Intersection with Other Regulations
As previously stated, the purpose of the Sunshine Act is to promote transparency to the public for conflicts of interest that might improperly influence, or compromise treatment decisions or healthcare costs billed to federal programs. This purpose closely aligns with that of the federal Stark Law and federal Anti-Kickback Statute (which, broadly, prohibit remuneration, in cash or in kind, for the referral of health care services reimbursable by federal healthcare programs). Though CMS and the United States Office of the Inspector General (“OIG”) have not explicitly noted their reference to the Open Payments Database as a basis for enforcement action of the Stark Law or Anti-Kickback Statute, it is reasonable to assume that both CMS and OIG might utilize this publicly available platform to as evidence of a health care provider’s compliance, or non-compliance, with these federal statutes. Therefore, Covered Recipients should closely monitor the Open Payments Database, and with the assistance of regulatory counsel, review their relationships with Reporting Entities to best mitigate the risk of violating the Sunshine Act, the Stark Law, and federal Anti-Kickback Statute.
[1] See The Physician Payments Sunshine Act – Compliance in a Nutshell