The HHS OIG Safe Harbor Regulations
The HHS OIG Safe Harbor Regulations define the circumstances in which the offer, solicitation, payment, or receipt of remuneration in exchange for items or services billable to a Federal healthcare program is not regarded as a violation of the Anti-Kickback Statute. It is important for healthcare providers to be aware of these regulations in order to avoid inadvertent violations of anti-fraud laws.
In 1972, Congress added an Anti-Kickback Statute to the Social Security Act §1128B which penalizes individuals found to have intentionally offered, solicited, or received anything of value in return for referrals for goods or services billable to a Federal Healthcare program. At the time, the broad nature of the Statute raised concerns that healthcare providers participating in beneficial commercial arrangements were technically covered by the statute and at risk of criminal prosecution.
It was not until the passage of the Medicare and Medicaid Patient and Program Protection Act of 1987 that the law was changed to allow the HHS Office of Inspector General (OIG) to promulgate regulations specifying what arrangements were exempted from the Anti-Kickback Statute. The Act also gave HHS OIG the authority to exclude individuals and organizations from participation in Federal health programs as an alternative to a criminal conviction (the “HHS OIG Exclusions List”).
First HHS OIG Safe Harbor Regulations Published
The first ten HHS OIG Safe Harbor Regulations plus an exemption for hospitals that waived Medicare coinsurance and deductible amounts to attract patients (provided the waivers were not claimed back from Medicare) were published in 1991. The regulations only applied if all the standards in each regulation were complied with; however, as the number of standards in each regulation has subsequently increased, it is now only necessary to comply with all applicable standards.
HHS OIG Exclusions List
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Further HHS OIG Safe Harbor Regulations were published in 1996 and 1999, and then at irregular intervals until 2016. However, in 2020, in addition to adding two new Safe Harbors, HHS OIG also attempted to remove an existing Safe Harbor related to discounted prescription drug prices. The removal of this Safe Harbor was challenged in court by the pharmaceutical industry and its implementation was initially delayed until 2023. It has subsequently been delayed until 2032.
Since the legal challenge, HHS OIG has not published any new Safe Harbor Regulations nor attempted to remove existing Safe Harbors. Other than a Final Rule published in December 2020 that modified existing Safe Harbors to account for changes in the delivery of, and payment for, health care items and services, the thirty-seven HHS OIG Safe Harbor Regulations have remained unchanged for four years. The Regulations and the standards that apply to each can be found in 42 CFR §1001.952.
Why It Is Important to be Aware of Safe Harbor Exceptions
It is important to be aware of the Safe Harbors and the standards that apply to each in order to avoid inadvertent violations of the HHS OIG anti-kickback regulations. Violations of the HHS OIG anti-kickback regulations can often result in parallel violations of the False Claims Act and/or the Stark Law, which are then combined to maximize the penalties for fraud, waste, and misconduct against Federal healthcare programs. (Note: separate Safe Harbor Exceptions apply to the Stark Law).
Individuals and organizations unsure about how to assess whether their commercial agreements qualify for a Safe Harbor exception can read more about the Anti-Kickback Statute, the False Claims Act, and the Stark Law in the HHS OIG’s General Compliance Program Guidance. However, for scenario-specific information, it will be more beneficial to seek compliance advice from a legal professional with experience in federal healthcare law.
