Each new safe harbor has subtly distinct requirements and limits to the remuneration they cover, ranging from in-kind services to monetary payment, which vary based on the level of financial risk inherent in the relationship.The scale of risk can be summarized for these three new safe harbors found in 42 CFR § 1001.952(ee), (ff), and (gg):Care coordination agreements define coordination and management of care to be the deliberate organization of patient care activities and sharing of information between two or more VBE activities, one or more VBE participants and the VBE, or one or more VBE participants and patients, and which is designed to achieve safer, more effective, or more efficient care to improve the target patient population’s health outcomes. 42 CFR § 1001.952(ee)(14)(i).

If finalized, these concepts will be an important benchmark for measuring stakeholder compliance and for CMS's enforcement capability.Proposed Changes to the AKS and CMP Law RegulationsThe OIG's proposed changes to the AKS regulations include new exceptions to the definition of "remuneration" and amendments to certain existing exceptions. OIG notes that its guiding principles were to (1) "design proposed safe harbors that allow for beneficial innovations in healthcare delivery," (2) "avoid promulgating safe harbors and exceptions that drive such innovation to limited channels that may not reflect up-to-date understandings in medicine, science, and technology," and (3) "design proposed safe harbors useful for a range of entities engaged in the coordination and management of patient care. . ."1. New AKS ExceptionsThe OIG proposed additional safe harbors to the AKS, which would be added to 42 C.F.R. § 1001.952, and provide only prospective protection for relevant arrangements. These include:Value-Based Arrangements.

Even ineligible entities, however, may be able to use other new or modified safe harbors.The Final Rule also codifies an exception to the prohibition of beneficiary inducements under the Civil Monetary Penalties Law (CMPL) for telehealth technologies furnished to certain in-home dialysis patients, and notes that by operation of law any arrangements that fit in the new and modified AKS safe harbors for patient engagement and support and local transportation are also protected under that CMPL provision.The new AKS safe harbors and modifications are:Value-Based ArrangementsThese safe harbors cover remuneration exchanged between or among participants in a value-based arrangement that fosters better coordinated and managed patient care, including:care coordination arrangements to improve quality, health outcomes, and efficiency without requiring the parties to assume risk (42 CFR §1001.952(ee));value-based arrangements with substantial downside financial risk (42 CFR §1001.952(ff)); andvalue-based arrangements with full financial risk (42 CFR §1001.952(gg)).These safe harbors are intended to provide “flexibility for innovation and customization of value-based arrangements to the size, resources, needs, and goals of the parties to them,” including “emerging arrangements that reflect up-to-date understanding in medicine, science, and technology.” All three safe harbors provide protection for in-kind remuneration, but only the two safe harbors with substantial assumption of risk protect monetary remuneration.

OIG would define “VBE” as “the network of individuals and entities that collaborate together to achieve one or more value-based purposes.”The three proposed safe harbors are: The Care Coordination Arrangements Safe Harbor, 42 C.F.R. § 1001.952(ee), which would cover certain in-kind, non-monetary remuneration, including services and infrastructure, exchanged between qualifying VBE participants with value-based arrangements, to be used primarily to engage in value-based activities.This safe harbor does not necessarily require the parties to assume downside financial risk.The Value-Based Arrangements with Substantial Downside Financial Risk Safe Harbor, 42 C.F.R. § 1001.952(ff), which would cover certain in-kind and monetary arrangements where the VBE is at substantial downside financial risk from a payor.

That is significant for providers looking to incorporate fee-for-service Medicare and Medicaid patients into a value-based arrangement, whether or not the provider is participating in the Medicare Shared Savings Program or other government initiatives that come with special fraud and abuse waivers.Beyond these base requirements, the Final Rules adopt a “tiered approach,” with growing flexibility available to the parties as they assume more financial risk for the cost of care.C. AKS and Stark provisions for value-based arrangements without financial risk (42 C.F.R. § 1001.952(ee); 42 C.F.R. § 411.357(aa)(3))The care coordination AKS safe harbor permits (i.e., does not treat as remuneration) certain in-kind benefits that promote care coordination and management, such as the provision of care coordination personnel or technology for the exchange of patient data between VBE Participants. To be protected, the value-based arrangement would need to:Establish at least one legitimate outcome or process measure that the parties reasonably anticipate will advance the coordination and management of care of a target patient population based on clinical evidence or credible medical or health science support.

Each of the value-based arrangement Safe Harbors is described, in turn, below. Care Coordination Arrangements to Improve Quality, Health Outcomes, and Efficiency without Requiring the Parties to Assume Risk (42 C.F.R. § 1001.952(ee)): OIG finalized this Safe Harbor for in-kind remuneration exchanged between qualifying VBE participants that do not assume any risk or assume less than substantial downside risk. The requirements for this Safe Harbor include commercial reasonableness, written documentation, record retention, and the establishment and monitoring of legitimate outcome or process measures that the parties reasonably anticipate will advance the “coordination and management of care for the target patient population based on clinical evidence or credible medical or health science support.”

This “tiered” structure attempts to take into account the assumption that arrangements involving greater amounts of downside risk inherently limit incentives to order medically unnecessary or overly costly items or services.Care Coordination Arrangements to Improve Quality, Health Outcomes and Efficiency (42 CFR § 1001.952(ee))The OIG’s first proposed new value-based safe harbor covers “care coordination arrangements.” The safe harbor would protect from AKS liability in-kind remuneration between VBE participants intended to facilitate coordination and management of care.The safe harbor would require the VBE to establish specific, evidence-based outcome measures against which the recipient of the remuneration will be measured.

Or, as Secretary Azar put it, to revise regulations “that have stood in the way of creativity and innovation by American health care providers for far too long.”To that end, the cornerstone of the final rules is the creation of new regulations to address value-based arrangements which may involve the assumption of financial risk by providers. The new regulatory safe harbors to the Anti-Kickback Statute address value-based care arrangements in which providers assume no risk (42 C.F.R. §1001.952(ee)), substantial downside financial risk (42 C.F.R. §1001.952(ff)), and full financial risk (42 C.F.R. §1001.952(gg)). The new regulatory exceptions to the Stark Law similarly involve arrangements in which providers assume no financial risk (42 C.F.R. §411.357(aa)(3)), meaningful downside financial risk (42 C.F.R. §411.357(aa)(2)), and full financial risk (42 C.F.R. §411.357(aa)(1)).

OIG’s final rule also codifies one new exception under the CMP Law.New AKS Safe HarborsIn finalizing these new AKS safe harbors, OIG reiterated that failure to satisfy a statutory safe harbor does not indicate that a financial arrangement is in violation of AKS; rather, each arrangement is analyzed according to the totality of the circumstances. Notably, these new safe harbors only offer prospective protection for applicable arrangements.A. Value-Based Compensation ArrangementsSimilar to the Stark Law exceptions for value-based compensation arrangements, OIG finalized its proposal to include three similar value-based safe harbors at 42 C.F.R. § 1001.952. The first protects care coordination arrangements designed to improve quality, health outcomes, and efficiency.

“Limited technology participant” means a VBE participant that exchanges digital health technology with another VBE participant or a VBE and that is either (i) a manufacturer of a device or medical supply (but not including a physician-owned distributorship), or (ii) an entity or individual that sells or rents durable medical equipment, prosthetics, orthotics, or supplies covered by a federal health care program (other than a pharmacy or a physician, provider, or other entity that primarily furnishes services).Care Coordination Safe HarborThe new safe harbor for care coordination arrangements to improve quality, health outcomes, and efficiency, 42 CFR 1001.952(ee) (the “Care Coordination” safe harbor), protects in-kind remuneration exchanged between a VBE and VBE participant, or between VBE participants, regardless of whether the entities assume any financial risk. The remuneration exchanged pursuant to the value-based arrangement must be used predominantly to engage in value-based activities that are directly connected to the coordination and management of care for the target patient population.