HHS Finalizes New AKS Safe Harbors for Patient Engagement and CMS-Sponsored Arrangements

In Short 

The Situation: As health care providers transition to value-based care models, they have often been forced to rely on safe harbors under the Anti-Kickback Statute, or AKS, that were never designed with value-based payment arrangements in mind. Some of these arrangements involve activities approved by the Centers for Medicare & Medicaid Services ("CMS") under the Medicare Shared Savings Program ("MSSP") and other CMS models. These arrangements also may include engagement tools and support services provided to patients to facilitate and manage their health care.  

The Action: On November 20, 2020, as part of the Regulatory Sprint to Coordinated Care initiative by the U.S. Department of Health and Human Services ("HHS") to remove regulatory barriers to care coordination, the HHS Office of Inspector General ("OIG") issued final rules that, among other things, establish protections under the AKS for the CMS-approved activities and patient engagement tools and support.  

Looking Ahead: The OIG expects that the new AKS safe harbors will alleviate concerns that CMS-approved activities may violate the AKS and encourage health care providers to engage patients with tools and support to improve the quality, outcomes, and efficiency of their health care. However, when engaging in such CMS-approved activities or furnishing patients with tools and services, MSSP Accountable Care Organizations ("ACOs") may prefer to seek protection through existing OIG Fraud and Abuse waivers.

The AKS prohibits offering, paying, soliciting, or receiving remuneration (e.g., kickbacks, bribes, or rebates) to induce or reward the referral of business reimbursable under any federal health care program. On November 20, 2020, the HHS OIG issued final rules modifying the AKS regulations. These rules create new safe harbors under the AKS that protect provider initiatives for patient engagement and encourage value-based arrangements sponsored by CMS. Our Commentary, "New Stark Law, Anti-Kickback Statute Exceptions and Safe Harbors for Value-Based Arrangements," provides a summary of new exceptions and safe harbors for value-based arrangements ("VBA") under the AKS and the Stark Law. 

Arrangements for Patient Engagement and Support to Improve Quality, Health Outcomes, and Efficiency 

This safe harbor protects patient engagement tools and support furnished by value-based enterprise ("VBE") participants or their "eligible agents" to patients in the target population in order to improve quality, health outcomes, and efficiency. The tools and support must meet all of the conditions of the safe harbor, including: 

  1. The VBE participant is not one of the listed prohibited entities or individuals (see list below);
  2. The tools or support are furnished directly to the patient by a VBE participant or eligible agent;
  3. The tools or support meet enumerated criteria (in-kind, etc.);
  4. The tools or support are not funded or contributed by a non-VBE participant or a prohibited entity or individual;
  5. The aggregate retail value of the tools or support on an annual basis does not exceed $500;
  6. The tools or support are not exchanged or used to market other reimbursable items or services or for patient recruitment purposes;
  7. The VBE participant satisfies the record access requirement; and
  8. The availability of tools or support do not take into account type of insurance coverage. 

In contrast to the VBA safe harbors, this safe harbor does not protect remuneration in the form of cash or cash-equivalents. However, the OIG has confirmed that, while most gift cards would not be protected under this safe harbor, limited-use gift cards exclusively designated for items or services that meet the above-listed conditions (e.g., gas cards or ride-share vouchers) could be considered in-kind remuneration.  

As noted above, the safe harbor expressly excludes several entities and individuals from being a VBE participant or an eligible agent. Prohibited entities and individuals include, for example, pharmaceutical manufacturers, distributors, and wholesalers; laboratory companies; pharmacy benefit managers; certain compound pharmacies; certain manufacturers of devices or medical supplies (unless the tool or support is digital health technology); and durable medical equipment suppliers. The OIG believes these entities and individuals could misuse the safe harbor to market their products and services instead of advancing the goal of improving the coordination and management of patient care. 

The OIG further notes that, by operation of law, arrangements that fit under this safe harbor are also protected under the beneficiary inducement Civil Monetary Penalty Law.  

CMS-Sponsored Model Arrangements and CMS-Sponsored Model Patient Incentives 

This safe harbor protects an exchange of anything of value between or among CMS-sponsored model parties under a CMS-sponsored model arrangement where CMS has determined that the safe harbor is applicable. Each of this safe harbor's conditions must be met, including that: 

  1. The model parties must reasonably determine that the arrangement advances goals of the model;
  2. The exchange of value does not induce the furnishing of medically unnecessary items or services or reduce or limit medically necessary items or services;
  3. The parties do not offer, pay, solicit, or receive remuneration in return for, or to induce or reward, federal health care business referrals or business generated outside the model;
  4. The parties have a prior or contemporaneously signed writing with the enumerated description of the arrangement;
  5. The parties meet the record access requirements; and
  6. The parties satisfy programmatic requirements imposed by CMS in connection with the safe harbor. 

ACO Beneficiary Incentive Program  

This safe harbor protects an incentive payment made by an MSSP ACO under a beneficiary incentive program ("BIP"). Under the MSSP regulations, ACOs participating in certain two-sided models may apply to establish and operate a BIP to encourage assigned beneficiaries to obtain medically necessary primary care services.

Four Key Takeaways

  1. As with the VBA safe harbors, the safe harbors for patient engagement and support, CMS-sponsored models, and ACO BIPs provide flexibility under the AKS for the health care industry to continue engaging patients with tools, supports, and other incentives to improve the quality, outcomes, and efficiency of health care. 
  2. Like any traditional AKS safe harbor, any arrangement must meet the requirements that each safe harbor imposes in order to benefit from the protection and flexibility of such safe harbor.
  3. The safe harbors offer protection only with respect to prosecution and enforcement under the AKS. Participants must continue accounting for and complying with a variety of other laws implicated by an arrangement under these safe harbors, including the Stark Law, state Stark Law and AKS analogues, medical practice/licensure requirements, tax matters, insurance laws, and antitrust issues. 
  4. While the OIG believes that the safe harbor for CMS-sponsored models largely supplants the need for the aforementioned ACO waivers, the final rule does not modify the waivers themselves. The waivers continue in effect, and likely provide applicable participants greater flexibility than do the AKS safe harbors.
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