MEDICARE: Safe Harbor Regulations

Medicare “Safe Harbor” Regulations

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The Medicare Safe Harbor rules were passed in an effort to identify areas of practice that would not lead to a conviction under the anti-fraud statute.  The Safe Harbor regulations provide for eleven areas where providers may practice without violating the anti-fraud statute. 


Areas of safe practice under these regulations are briefly highlighted below:

  • Large Entity Investments – Investment in entities with assets over $50 million. The entity must be registered and traded on national exchanges.
  • Small Entity Investments – Small entity investment entities must abide by the 40-40 rule.  No more than 40% of the investment interests may be held by investors in a position to make referrals. Additionally, no more than 40% of revenues can come through referrals by these investors.
  • Space and Equipment Rentals – Such lease agreements must be in writing and must be for at least a one year term. Furthermore, the terms must be at fair market value.
  • Personal Services and Management Contracts – These contracts are allowable as long as certain rules are followed. Like lease agreements, these personal service and management contracts must be in writing for at least a one-year term, and the services must be valued at fair market value.
  • Sale of a medical practice – There are restrictions if the selling practitioner is in a position to refer patients to the purchasing practitioner.
  • Referral services– Referral services (such as hospital referral services) are allowed. However, such referral services may not discriminate between practitioners who do or do not refer patients.
  • Warranties – There is certain requirements if any item of value is received under a warranty.
  • Discounts – Certain requirements must be met if a buyer receives a discount on the purchase of goods or services that are to be paid for by Medicare or Medicaid.
  • Payments to Bona Fide Employees – Payments made to bona fide employees do not constitute fraud under the Safe Harbor Regulations.
  • Group Purchasing Organizations – Organizations that purchase goods and services for a group of entities or individuals are allowed; provided certain requirements are met.
  • Waiver of Beneficiary Co-Insurance and Deductible – Routine waiver would not come under the safe harbor.

A physician’s actions that come under the Safe Harbor Regulations will not violate the Medicare Fraud and Abuse Statutes.  However, the provider must still abide by the Stark amendments and must also abide by applicable state law.


Your thoughts are appreciated.





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