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    Medicare and Medicaid Fraud and Abuse Statutes and Regulations

    Stark Anti-Referral Laws and Regulations
    Anti-Kickback Statutes and Regulations
    Comparison Chart of Exceptions and Safe Harbors

    The Stark Anti-Referral Laws and Regulations


    The Stark Statute
    42 U.S.C. 1395nn. Includes the statutory changes mandated by the Affordable Care Act.

    For information on a small, but important, clarification regarding compliance with certain Stark Law exceptions that require a signature, see our September 13, 2018 article Important clarification regarding compliance with certain Stark Law exceptions


     THE STARK REGULATIONS: Section-by-Section

    Please note that CMS has finalized new definitions and exceptions to the Stark law. These changes became effective on January 1, 2016. The amended and added sections are noted below with links to the comparison charts and further links to the revised language. You also can read about the regulations in this Bricker & Eckler bulletin of November 10, 2015.

    411.350 Scope -- No change

    411.351 Definitions -- As amended January 2016

    411.352 Group Practice -- No change

    411.353 Prohibition on Certain Referrals by Physicians and Limitations on Billing -- With January 2016 amendments

    411.354 Financial Relationship, Compensation, and Ownership or Investment Interest -- With January 2016 amendments

    411.355 General Exceptions to Referral Prohibitions Related to Both Ownership/Investment and Compensation
    411.355(a) Physician Services
    411.355(b) In-Office Ancillary Services
    411.355(c) Services Furnished by an Organization to Enrollees
    411.355(e) Academic Medical Centers
    411.355(f) Implants Furnished in an ASC
    411.355(g) EPO and Other Dialysis-Related Drugs
    411.355(h) Preventive Screening Tests, Immunizations and Vaccines
    411.355(i) Eyeglasses and Contact Lenses Following Cataract Surgery
    411.355(i) Intra-Family Rural Referrals
    411.356 Exceptions to Referral Prohibitions Related to Ownership or Investment Interests
    411.356(a) Publicly-Traded Securities -- With January 2016 amendments
    411.356(b) Mutual Funds
    411.356(c)(1) Rural Providers
    411.356(c)(2) Hospitals in Puerto Rico
    411.356(c)(3) Hospital Ownership or Investment -- With January 2016 amendments
    411.357 Exceptions to Referral Prohibitions Related to Compensation Arrangements
    411.357(a) Rental Of Office Space -- With January 2016 amendments
    411.357(b) Rental Of Equipment -- With January 2016 amendments
    411.357(c) Bona Fide Employment Relationship -- With January 2016 amendments
    411.357(d) Personal Services Arrangements -- With January 2016 amendments
    411.357(e) Physician Recruitment -- With January 2016 amendments
    411.357(f) Isolated Transactions -- With January 2016 amendments
    411.357(g) Certain Arrangements With Hospitals -- No Change
    411.357(h) Group Practice Arrangements With a Hospital -- No Change
    411.357(i) Payments by a Physician -- No Change
    411.357(j) Charitable Donations By a Physician -- No Change
    411.357(k) Nonmonetary Compensation -- No Change
    411.357(l) Fair Market Value Compensation-- With January 2016 amendments
    411.357(m) Medical Staff Incidental Benefits -- With January 2016 amendments
    411.357(n) Risk Sharing Arrangements -- No Change
    411.357(o) Compliance Training -- No Change
    411.357(p) Indirect Compensation Arrangements -- With January 2016 amendments
    411.357(q) Referral Services -- No Change
    411.357(r) Obstetrical Malpractice Insurance Subsidies -- With January 2016 amendments
    411.357(s) Professional Courtesy-- With January 2016 amendments
    411.357(t) Retention Payments in Underserved Areas-- With January 2016 amendments
    411.357(u) Community-Wide Health Information Systems -- No Change
    411.357(v) Electronic Prescribing Items and Services -- No Change
    411.357(w) Electronic Health Records Items and Services -- No Change
    411.357(x) Assistance to Compensate a Nonphysician Practitioner -- Added January 2016
    411.357(y) Timeshare Arrangements -- Added January 2016


    411.358 Reserved

    411.359 Reserved

    411.360 Group Practice Attestation

    411.360 Reporting Requirements

    411.362 Additional Requirements Concerning Physician Ownership and Investment in Hospitals -- As amended January 2016


    Anti-Kickback Statutes and Regulations

    The Anti-Kickback Statute
    42 U.S.C. 1320a-7b

    The Anti-Kickback Safe Harbors
    Federal regulations at 42 C.F.R. 1001.952

    Comparison Chart

    Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors
    Current as of July 2015 (January 2016 amendments not yet included)