Industries & Practices

Compliance, Fraud & Abuse

    Proposed Changes to the Stark Law and Anti-Kickback Statute Regulations

    On October 9, 2019, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services Office of Inspector General issued long-awaited proposed changes “to modernize and clarify the regulations that interpret” the Physician Self-Referral Law (Stark Law) and the federal Anti-Kickback Statute. The series of publications below contains updates and analysis of the proposed changes to the regulations.

    Each proposed rule is lengthy. However, both CMS and OIG issued fact sheets along with their proposed rules to highlight the changes being proposed. Read more >>

    Key Stark Law definitions
    CMS’ proposed changes to the regulations interpreting the Stark Law include bright-line rules to clarify several key terms used in the Stark Law exceptions. Specifically, CMS proposes changes to the terms “commercial reasonableness,” “takes into account the volume or value of referrals or other business generated,” and “fair market value.” Read more >>

    Scope and application of Stark Law regulations
    CMS is proposing to recalibrate the scope and application of the Stark Law regulations. These clarifications provide helpful insight into how CMS interprets the Stark Law and, in some instances, proposes to modify the existing regulations. Read more >>

    Profit shares for group practices
    This publication covers proposed changes to the special rules for profit shares and productivity bonuses paid by group practices to physicians. Read more >>

    Donation of EHR and cybersecurity technology/services
    OIG and CMS have proposed modifications to the existing AKS safe harbor and Stark Law exception for the donation of electronic health records (EHR) items and services. The agencies have also proposed a new safe harbor and new exception for donations of cybersecurity technology and services. Read more >>

    Value-based care exceptions
    CMS has proposed three new compensation exceptions for direct and indirect value-based arrangements: full financial risk exception, meaningful downside financial risk exception and value-based arrangements exception. OIG also has proposed three new safe harbors: full financial risk safe harbor, substantial downside financial risk safe harbor and care coordination safe harbor. Read more >>

    Correcting administrative and operational errors
    CMS has proposed clarifications addressing whether mistaken payments of excess or insufficient compensation that differ from the amount written indicated in the written agreement result in noncompliance. It has also clarified how certain administrative and operational mistakes can be resolved.  Read more >>

    Anti-Kickback Statute safe harbors
    OIG has proposed changes to the Anti-Kickback Statute's regulatory safe harbors, including the personal services and management contracts safe harbor, warranty safe harbor and local transportation safe harbor. Read more >>

    Limited remuneration to a physician
    CMS has proposed a new exception for limited remuneration to a physician. This exception is designed to offer protection for certain non-abusive arrangements that cannot satisfy existing Stark Law exceptions due to reasons including the dollar limit, documentation, signature and/or the “set in advance” requirement. Read more >>