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(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(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(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