Sunshine Reporting Season Has Begun: Are You Meeting the Requirements?

By Mark Gardner and Lisa Damhof

Medical products manufacturers should be deep into reporting season planning. The federal Physician Payments Sunshine Act and Open Payments Program deadline is March 31, 2026, and it covers transfers of value made during calendar year 2025. CMS uses Open Payments to promote transparency in financial relationships between industry and U.S. healthcare providers. CMS and state authorities have increasingly emphasized audits, data integrity, and enforcement.

Federal reporting is only part of the story. A growing patchwork of state, municipal, and international transparency and marketing compliance requirements can create separate registration, certification, recordkeeping, and reporting obligations, often with different thresholds, deadlines, and covered recipient definitions.

What is due March 31, 2026?

By March 31, 2026, applicable manufacturers and applicable group purchasing organizations must submit complete and accurate Open Payments data reflecting reportable transfers of value to covered recipients in 2025. Transfers include, among other things, consulting fees, meals, travel, honoraria, speaker payments, research-related payments, and certain ownership or investment interests.

Even companies that view themselves as small or early stage can be surprised by reporting triggers, particularly where there are U.S. affiliates, distribution partners, contract sales organizations, or research and education activities that involve interactions with healthcare professionals.

Covered recipients now includes many advanced practice providers

Many compliance programs were built around physician and teaching hospital reporting. The SUPPORT for Patients and Communities Act expanded the Sunshine Act’s scope by adding advanced practice providers to the definition of covered recipient, including:

• Physician assistants
• Nurse practitioners
• Clinical nurse specialists
• Certified registered nurse anesthetists
• Certified nurse-midwives

Companies should ensure their policies, training, data capture, and systems reflect this expanded scope, especially for meals, travel, speaker programs, and consulting arrangements that routinely involve these professionals.

Do not stop at federal: state and municipal requirements can be separate

A common pitfall is treating Open Payments as the only transparency obligation. In reality, many jurisdictions impose additional obligations, including gift bans or limits, marketing disclosures, manufacturer or sales representative licensing and registration, compliance program attestations, and other information that must be produced.

Examples of commonly encountered requirements include:

• Massachusetts: annual marketing disclosure reporting and a separate manufacturer registration or renewal filing and fee window during the summer
• Connecticut: annual reporting applicable to payments to APRNs, plus requirements to maintain sales and marketing policies and a compliance program consistent with industry codes and OIG guidance
• District of Columbia and Chicago: sales representative licensing or registration and related obligations
• Miami–Dade County, Florida: sales representative registration and annual expenditure reporting
• Minnesota: annual reporting of certain practitioner payments
• Nevada: compliance filings and other disclosures, plus additional drug-specific reporting in certain contexts
• Vermont: strict rules that include gift ban restrictions and state reporting obligations
• California: Requires manufacturers to publish specified compliance information on their company website annually

Additional transparency, marketing conduct, gift limitation, registration, or reporting requirements may apply in other jurisdictions, including Colorado, New Jersey, Louisiana, Maine, New York, and various other states that regulate interactions with healthcare professionals or state employees.

These requirements vary by jurisdiction, including thresholds, scope, and recordkeeping expectations. Enforcement is not theoretical. Some prosecutors have pursued settlements and penalties.

International transparency obligations are expanding

For companies with activity outside the U.S., or U.S. companies interacting with foreign healthcare professionals or organizations, transparency reporting may be required or expected under industry codes in multiple countries. Requirements differ materially by jurisdiction and may include public disclosures of sponsorships, speaker fees, consulting, and support for attendance at meetings and educational events.

Practical steps as the deadline approaches

As March 31 approaches, manufacturers should, at a minimum:

• Confirm reporting status and responsible entities, including affiliates and GPO considerations
• Validate data capture across finance, compliance, sales and marketing, medical affairs, and any third-party vendors
• Reconcile 2025 transactions and ensure data is clean, including identifiers, addresses, nature of payment categories, and assumptions documentation
• Allocate time for internal review and attestation before submission and avoid last-day portal congestion
• Assess state and municipal exposure, including registration, certification, licensing, and reporting, and ensure all deadlines are calendared and monitored, as certain January 1 obligations may already be overdue
• Systematize transparency reporting in compliance infrastructure, including through a quality management system or comparable controls, to reduce the risk of missed deadlines

Enforcement risk

CMS may impose civil monetary penalties for failures to timely, accurately, or completely report required information. Transparency issues can also become easier add-ons in broader enforcement matters, including Anti-Kickback Statute and False Claims Act investigations. Inaccurate or inconsistent reporting can increase scrutiny, disputes, and audit exposure. Certain states have likewise been active in enforcing their transparency and marketing compliance laws.

How Gardner Law can help

Gardner Law supports clients across the full transparency lifecycle, from applicability assessments and policy updates to data validation and submission support. For clients who want to conserve internal resources or reduce reporting risk, we can also perform registration and reporting on an outsourced basis, including coordination of data collection, review, documentation of assumptions, submission support, and readiness for disputes and audits.

If you have questions regarding your transfers of value, ownership or investment interests, applicable manufacturer or GPO status, or the impact of federal, state, municipal, and international transparency requirements on your organization, please contact us.