As part of its 2025 Physician Fee Schedule Final Rule (PFS Rule), the Centers for Medicare & Medicaid Services (CMS) finalized two crucial updates to federal Medicare overpayments regulations (sometimes referred to as the “60-Day Rule”) that (1) align the standard for when an overpayment is identified with the applicable standard under the
Affordable Care Act
CMS Revises Process for Reporting Stark Law Violations and Posts New SRDP Forms
On March 28, the Centers for Medicare & Medicaid Services (CMS) revised the procedures and posted new forms for its Voluntary Self-Referral Disclosure Protocol (SRDP). The SRDP is a mechanism established pursuant to the Affordable Care Act for health care providers and suppliers to facilitate settlement of violations of the physician self-referral law (Stark Law).
Under the Stark Law, physicians (or their immediate family members) who have a financial relationship with an entity are prohibited from making referrals to that entity for certain designated health services (DHS) that are payable by Medicare, unless an exception applies. In addition, the entity is prohibited from presenting (or causing to be presented) claims to Medicare, or another individual, entity or third-party payer, for the services referred in violation of the Stark Law. Violations of the Stark Law can result in monetary penalties of $10,957 to $21,916 per claim submitted.
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New Anti-Kickback Safe Harbors and Exceptions to CMP Law
By Robinson+Cole's Health Law Group on
Posted in Fraud and Abuse, Medicare and Medicaid
On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule establishing new Anti-Kickback Statute (AKS) safe harbor protections and codifying regulatory exceptions to the Civil Monetary Penalties Law (CMP).
Local Transportation Safe Harbor
This safe harbor protects local transportation made available by an “Eligible Entity” as long as the following conditions are met. An “Eligible Entity” is any individual or entity, except for individuals or entities (or family members or others acting on their behalf) that primarily supply health care items (for example, durable medical equipment suppliers or pharmaceutical manufacturers).
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