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Medicare and Medicaid Fraud and Abuse Statutes and Regulations
Please note that this resource does not yet reflect the changes to the Stark Law or Anti-Kickback Statute that were made final in November 2020. You can review these changes in our recent publication. If you have questions about how these final changes impact your organization, please contact Beth Kastner or Shannon DeBra.
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, 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(c) Services Furnished by an Organization to Enrollees
411.355(h) Preventive Screening Tests, Immunizations and Vaccines
411.355(i) Eyeglasses and Contact Lenses Following Cataract Surgery
411.356 Exceptions to Referral Prohibitions Related to Ownership or Investment Interests
411.356(a) Publicly-Traded Securities -- With January 2016 amendments
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(j) Charitable Donations By a Physician -- 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(p) Indirect Compensation Arrangements -- With January 2016 amendments
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)
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