Updated: Jan 6
On December 31, 2019, TAF submitted comments on the proposed rule issued by HHS-OIG in October 2019 (“Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements”). The letter expresses our concern that any changes to the AKS or additional proposed safe harbors protect, rather than undermine, the interests of honest patients and providers, and of the taxpaying public.
A brief summary of our arguments:
“Value-Based Activity” and “Value-Based Arrangement”
It is unclear from the Proposed Rule what specific arrangements these safe harbors are intended to protect, and its lack of precision may invite bad actors to attempt to conceal a variety of harmful and presently illegal practices behind the VBA façade. This will lead to an increase in the harms the AKS was intended to prevent, including overutilization of healthcare services and increased costs to Government healthcare programs, and will severely impede AKS enforcement.
OIG and DOJ will be forced to find and consider the legality of a wide spectrum of complex arrangements on a case-by-case basis.
The Proposed Rule’s deference to healthcare entities’ intentions and reasonable beliefs may preclude the Government from addressing remuneration-for-referral arrangements that the Government believes are abusive.
The uncertainty created by the breadth and vagueness of the Proposed Rule may make it prohibitively difficult, as a practical matter, to demonstrate knowledge of wrongdoing under the FCA.
The Proposed Rule’s VBE and VBA provisions do not satisfy the AKS’s requirements for new safe harbors. These proposed safe harbors exceed the Secretary’s discretion under the statute, which allows him to propose safe harbors specifying acceptable payment practices under the AKS. Instead, the proposed changes sanction non-specified payment practices that may open the door to abuses the statute was designed to prevent.
Personal Services and Management
Many of the proposed modifications to this safe harbor are not specific enough to prevent fraud and abuse. The proposal to eliminate the requirement to set aggregate compensation in advance and replace it with identification of “methodology” for determining compensation could allow entities to structure agreements that appear acceptable on their face, but actually take into account the volume and value of referrals. The addition of an “outcomes-based” safe harbor for personal services arrangements, without any indication of how improvement can be measured or what specific outcomes are covered, invites arrangements that disguise payments in exchange for maintaining the status quo and encourage sham arrangements.
To prevent fraud and abuse, we have suggested that as a safe harbor allows increased flexibility as to the method of offering incentives to the healthcare system’s gatekeepers, it should be coupled with requirements for increased structure and enhanced documentation.
TAF does not oppose the modifications proposed to the warranty safe harbor, subject to the inclusion of several proposed safeguards to protect against fraud and abuse.
Cybersecurity Technology and Related Services
Similarly, TAF does not oppose the addition of a safe harbor for cybersecurity technology, subject to the inclusion of several proposed safeguards to protect against fraud and abuse.
Patient engagement and support to improve quality, health outcomes, and efficiency
TAF supports the limitations OIG has included to in-kind remuneration and would oppose the removal of the gift card, cash, and cash equivalent prohibitions and any additional broadening of this safe harbor to include the use of such incentives to promote patient “adherence.”
Thank you to Steve Hasegawa, Jennifer Verkamp, Shelley Slade, Sarah Frazier, Nick Mendoza, Marlan Wilbanks, and Ed Baker for their invaluable assistance working through the issues presented by the proposed rule changes and drafting our comments.
You can read the full comments below.