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.


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Preventing and Reducing Improper Medicare and Medicaid Expenditures Act

demBy Dr. David Edward Marcinko MBA

This Act was introduced into congress in 2013 and contains a number of provisions that would increase rewards and incentives for those who uncover healthcare fraud, as well as heighten penalties for those who commit it.


The PRIME Act would enact stronger penalties for Medicare and Medicaid fraud; curb improper or mistaken payments made by Medicare and Medicaid; establish stronger fraud and waste prevention strategies with Medicare and Medicaid to help phase out the practice of “pay and chase” (i.e., recouping monies already erroneously paid to providers instead of detecting problems on the front end); curb the theft of physician identities; expand the fraud identification and reporting work of the Senior Medicare patrol; take steps to help states identify and prevent Medicaid overpayments; and improve the sharing of fraud data across state and federal agencies and programs.



The law directs the Secretary to develop a plan to revise the incentive program under HIPAA for the reporting of fraud and abuse to encourage greater participation by individuals reporting Medicare fraud and abuse.

And, it also requires the plan to include certain recommendations for ways to enhance rewards for individuals reporting and an extension of the incentive program to the Medicaid program.

MORE: Ten Ways to Prevent Fraud [Consumer]


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