On August 27, 2018, the Department of Health and Human Services Office of Inspector General (HHS-OIG) published a request for information (“RFI”) pertaining to possible changes to the federal Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties (“CMP”) for beneficiary inducements.
In the RFI, HHS-OIG outlines broad goals to contribute to transforming healthcare in the U.S. by promoting the establishment of value-based payment systems. The RFI acknowledges HHS’s position that a key to establishing such value-based care is the promotion of care coordination, and the current state of AKS and CMP regulations may hinder and prevent certain arrangements that would foster more care coordination. Accordingly, through the RFI, HHS-OIG is seeking to identify potential ways to modify or add new safe harbors to the AKS. The RFI is also seeking information regarding new or modified exceptions to CMS’s definition of remuneration. Some of the specific areas of interest outlined by the request are:
- Promotion of Care Coordination: The RFI seeks input regarding creating or modifying safe harbors to the AKS or exceptions to the CMP definition of remuneration that are needed to promote care coordination and valued-based care. Commenters are encouraged to provide information regarding alternative payment models, innovative technology, or other financial arrangements that need to be addressed in the regulations so that the AKS and CMP regulatory schemes would still prevent potential harms but not at the expense of care coordination.
- Beneficiary Incentives: The RFI seeks information about the types of incentives providers, suppliers, and others would like to provide to beneficiaries, and how such incentives would contribute to or improve quality of care, care coordination, and patient engagement, including adherence to care plans.
- Cost-Sharing Obligations: The RFI seeks information related to relieving or eliminating beneficiary cost-sharing obligations for the purpose of improving care delivery, enhancing value-based arrangements, and promoting the quality of care.
- The Stark Law: The RFI seeks input that could be used in examining whether there should be more alignment of exceptions to the Stark Law with safe harbors to the AKS.
- Fraud and Abuse Waivers: The RFI seeks feedback on the test model fraud and abuse waivers currently available to Accountable Care Organizations (“ACOs”). Specifically, the RFI is interested in whether stakeholders have found compliance with the waivers to be challenging, whether specific waiver requirements are unduly burdensome, what waiver structures or conditions work well, and what pros and cons exist for fraud and abuse protections that are uniform across different CMS models, initiatives, and programs.
- Cybersecurity: The RFI seeks information regarding the 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.
- Telehealth: The RFI seeks information on how to define the new “telehealth technologies” exception in the beneficiary inducements CMP, whether the definition should also include services, and examples of those services.
HHS-OIG will accept comments until October 26, 2018. After the comment period closes, HHS-OIG will consider the feedback from stakeholders and then may eventually publish new proposed rules for the AKS and/or CMP. Such proposed new rules would then go through the notice and comment process in which HHS could choose to alter or withdraw various potential changes before finalizing the rule. Thus, it is impossible to know when or if any changes will ever go into effect. Chilivis Grubman will continue to monitor developments and update this alert as appropriate.
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