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    Medicare and Medicaid Fraud and Abuse Statutes and Regulations

    INDEX TO RESOURCES

    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 STATUTE

    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, review this publication

    THE STARK REGULATIONS: Section-by-Section

    411.350 Scope

    411.351 Definitions

    411.352 Group Practice -- Including amendments effective January 1, 2022

    411.353 Prohibition on Certain Referrals by Physicians and Limitations on Billing

    411.354 Financial Relationship, Compensation, and Ownership or Investment Interest

    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(j) Intra-Family Rural Referrals

    411.356 Exceptions to Referral Prohibitions Related to Ownership or Investment Interests

    411.356(a) Publicly-Traded Securities
    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

    411.357 Exceptions to Referral Prohibitions Related to Compensation Arrangements

    411.357(a) Rental Of Office Space
    411.357(b) Rental Of Equipment
    411.357(c) Bona Fide Employment Relationship
    411.357(d) Personal Services Arrangements
    411.357(e) Physician Recruitment
    411.357(f) Isolated Transactions
    411.357(g) Certain Arrangements With Hospitals
    411.357(h) Group Practice Arrangements With a Hospital
    411.357(i) Payments by a Physician
    411.357(j) Charitable Donations By a Physician
    411.357(k) Nonmonetary Compensation
    411.357(l) Fair Market Value Compensation
    411.357(m) Medical Staff Incidental Benefits
    411.357(n) Risk Sharing Arrangements
    411.357(o) Compliance Training
    411.357(p) Indirect Compensation Arrangements
    411.357(q) Referral Services
    411.357(r) Obstetrical Malpractice Insurance Subsidies
    411.357(s) Professional Courtesy
    411.357(t) Retention Payments in Underserved Areas
    411.357(u) Community-Wide Health Information Systems
    411.357(v) Electronic Prescribing Items and Services
    411.357(w) Electronic Health Records Items and Services 
    411.357(x) Assistance to Compensate a Nonphysician Practitioner 
    411.357(y) Timeshare Arrangements
    411.357(z) Limited Remuneration to a Physician -- Added January 2021
    411.357 (aa) Arrangements that Facilitate Value-Based Health Care Delivery and Payment -- Added January 2021

    411.357(aa)(1) Value-Based Arrangements with Full Financial Risk
    411.357(aa)(2) Value-Based Arrangements with Meaningful Downside Financial Risk to the Physician
    411.357(aa)(3) Value-Based Arrangements

    411.357(bb) Cybersecurity -- Added January 2021
     

    411.361 Reporting Requirements

    411.362 Additional Requirements Concerning Physician Ownership and Investment in Hospitals


    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 March 2021

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    Collapsible Group Item #2
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