On August 27, 2018, the Department of Health and Human Services Office of the Inspector General published a request for information seeking public comments on what new or modified safe harbors to the Anti-Kickback Statute or exceptions to the beneficiary inducements prohibition in the Civil Monetary Penalty Law should be considered in order to reduce barriers for arrangements that promote care coordination, while also preventing the risk of fraud and abuse. Comments are due by October 26, 2018.

The RFI is HHS’s latest step in its “Regulatory Sprint to Coordinate Care,” an HHS initiative focused on decreasing regulatory barriers to coordinated care. Earlier this year, as discussed in a previous Alert, the Centers for Medicare & Medicaid Services released a similar request for information, seeking public feedback on how to ease the regulatory burden on providers related to compliance with the Stark Law, specifically focusing on care coordination.

The OIG RFI addresses a wide variety of different topics – alternative payment models, beneficiary incentives to improve adherence to care plans, Accountable Care Organizations, telehealth technologies for home dialysis services, and the intersection of the Stark Law and the AKS. Providers, suppliers, and other stakeholders should take advantage of this excellent opportunity to engage with the OIG and help shape the structure of AKS safe harbors and exceptions to the beneficiary inducements prohibition in the CMP Law related to arrangements that foster care coordination.

The RFI seeks public input on the topics summarized below.

Promoting Care Coordination and Value-Based Care

  • Potential arrangements that the industry is interested in pursuing, such as care coordination, value-based arrangements, alternative payment models, arrangements involving innovative technology, and other novel financial arrangements that may implicate the AKS or beneficiary inducements prohibition of the CMP Law;
  • How potential arrangements promote care coordination or value-based care;
  • How potential arrangements prevent potential harms, such as increased costs, inappropriate utilization, poor quality of care, and distorted decision-making;
  • Additional or modified AKS safe harbors or exceptions to the CMP Law’s definition of remuneration; and
  • Definitions of critical terminology (e.g. alternative payment model, coordinated care, gainsharing, value-based care, etc.).

Beneficiary Incentives

  • The types of beneficiary incentives that providers and suppliers are interested in providing to beneficiaries;
  • How those incentives would contribute or improve quality of care, care coordination, and adherence to care plans;
  • What restrictions OIG should place on beneficiary incentives that could reduce the risk of fraud and abuse;
  • Any disclosures that the offeror should be required to make to beneficiaries regarding an incentive (e.g. the source of the incentive)
  • Whether the OIG should amend its “Office of Inspector General Policy Statement Regarding Gifts of Nominal Value To Medicare and Medicaid Beneficiaries” to increase the definition of “nominal value” from no more than $15 per item or $75 in the aggregate per patient on an annual basis; and
  • Whether the OIG should have a similar policy on gifts of nominal value under the AKS.

Cost-Sharing Obligations

  • Patient care scenarios in which cost-sharing obligations are particularly problematic;
  • The financial impact to providers and suppliers and the fraud and abuse risks if cost-sharing obligations could be waived for participants in a care coordination and value-based care arrangements; and
  • Any risks to beneficiaries and federal health care programs if cost-sharing obligations could be waived or reduced.

Current Fraud and Abuse Waivers Related to ACOs

  • Feedback on current waivers developed for testing models by the Center for Medicare and Medicaid Innovation and carrying out the Medicare Shared Savings Program, specifically from parties who are using or eligible to use those waivers;
  • Whether stakeholders have found compliance with the waiver conditions challenging; and
  • Whether the ACO governing body concept is working to reduce the risk of fraud and abuse related to the MSSP, the Next Generation ACO Model, and the Pioneer ACO Model.

Cyber-Security Related Items and Services

  • Types of cybersecurity-related items or services that entities wish to donate or subsidize; and
  • How existing fraud and abuse laws may pose barriers to such arrangements.

Intersection of the Stark Law and the AKS

  • Circumstances when Stark Law exceptions and AKS safe harbors should align to improve care coordination or value-based care; and
  • Circumstances when Stark Law exceptions in furtherance of care coordination or value-based care should not have a corresponding AKS safe harbor.

AKS Safe Harbor for ACO Beneficiary Incentive Program

In addition, the RFI seeks feedback related to two statutory exceptions under the Bipartisan Budget Act of 2018 (Budget Act). First, the Budget Act added a statutory exception to the AKS for incentive payments made to Medicare fee-for-service beneficiaries enrolled in an ACO under an ACO Beneficiary Incentive Program. The OIG is seeking comments on what conditions this safe harbor should include as protections or safeguards.

CMP Law Exception for Telehealth Technologies for Home Dialysis

Second, the Budget Act created a new exception to the definition of “remuneration” in the CMP Law, which applies to “telehealth technologies” provided by renal dialysis facilities to individuals with ESRD receiving home dialysis reimbursed under Medicare Part B, subject to certain conditions. The OIG is seeking input on how “telehealth technologies” should be defined, including examples of the types of technologies that may be provided, and whether the OIG should include protections or safeguards for this exception.

The OIG’s RFI presents an important and unique opportunity for providers, suppliers, trade organizations, patient groups, and other stakeholders to engage the OIG and discuss changes to the AKS and CMP Law that could help foster innovation in a number of areas that benefit patients and reduce costs. Stakeholders who have struggled to develop successful innovative coordinated care arrangements due to the regulatory hurdles currently posed by the AKS and CMP Law should strongly consider providing comments to OIG in response to the RFI. Arent Fox assisted clients in submitting comments in response to CMS’s recent RFI; the OIG will accept comments in response to its RFI up to October 26, 2018.