Safe Harbor Arrangements under the Anti-Kickback Law
AKS Safe Harbor Nursing Coordination Agreements protect in-kind benefits exchanged between qualified EBV participants under a values-based agreement associated with the coordination and management of care for the target patient population.10 Under this safe harbour, each offer of in-kind remuneration between EBV participants must be analysed separately to verify compliance with the security. A key element of this safe harbor is the requirement for the recipient to pay 15% of (i) the supplier`s cost or (ii) the fair market value of the compensation in kind. Comment: Other commentators expressed concern about potential fraud and abuse, with several stating that value-based safe havens would foster an environment conducive to fraud and anti-competitive effects. Commentators had a variety of reasons for their position, including, for example, that existing shelters would be sufficient to conduct value-based models; An assessment was warranted prior to the completion of these shelters; And the focus on coordinating the provision of value-based safe harbors would lead to further industry consolidation. A state health ministry has generally claimed that the proposals are not detailed enough and, if finalized, would cause problems with implementation. This commenter requested that we include more detail in our rule-making, rather than through sub-regulatory guidance, to help the state develop comprehensive guidelines to support the rule. Comment: In response to our request for comment on whether the term “value” should be defined, we received various comments. Some commentators supported our suggestion to use the term in a non-technical way, with one arguing that the term “value” was not a uniform concept of art. Others suggested that we refer – in the final definitions or otherwise – to financial arrangements under alternative advanced payment models (APMs) to clarify that value-based agreements would be protected in CMS-sponsored programs under value-based security safeguards. Comment: Many commentators expressed support for our values-based framework.
For example, one commentator explained that the OIG has struck an appropriate balance between flexibility for beneficial innovation and protections to protect patients and federal health programs from the risks of fraud and abuse. Others commended the OIG for welcoming the transition from risk-free to financial to downside risk as a central element of the value-based framework. In particular, commentators supported the OIG`s Safe Harbor Care Coordination proposal to protect value-based agreements where the parties had not yet taken a financial risk of deterioration. Comment: One commenter asserted that the proposed definitions of “value-based entity”, “value-based agreement”, “value-based activity” and “EBV participant” apply only to safe harbor procurement coordination agreements, and not to the “safe harbor” presenting a significant downside financial risk or the total “safe harbor” for financial risk. A: As further explained in Section III.A.1 of this Preamble, we are committed to reducing the burden on suppliers and other industry stakeholders, and have worked to align value-based terminology and safe harbor terms with those adopted by CMS as part of the regulatory sprint to the extent possible. However, full alignment is not possible due to fundamental differences in legal structures and sanctions between the two laws, as well as differences in how Safe Harbor laws operate against bribery laws and exemptions to the self-referral law for physicians. For example, the physician self-referral legislation applies to certain designated health services, while the anti-bribery legislation applies to referrals of individuals from a federal health program. The inclusion of an exemption from the law on self-referral for physicians is mandatory, while the use of Safe Harbors is voluntary. In designing our liability exemptions, we have included conditions to ensure that protected agreements are not disguised bribery schemes, and we recognize that for the purposes of these agreements, which relate to both the Physician Self-Referral Act and the federal Anti-Bribery Act, value-based exemptions may therefore protect a narrower range of agreements than CMS exemptions.
Maria Zakharova: We disagree with commentators who have said that our definitions are too narrow or prescriptive, and that proposed value-based safe havens are not bold enough because they would impose limits on the types of protected agreements. In addition, many of the requirements of the final Safe Harbour provisions and exemptions are consistent, particularly in the areas of cybersecurity and electronic health records.