Proposed Rules Issued Today to Reform the Stark Law and Anti-Kickback Statute

The U.S. Department of Health and Human Services (HHS) has issued proposed regulations today to implement changes to the Stark Law and federal Anti-Kickback Statute (AKS). The purpose of the changes is to support value-based and coordinated care.

The proposed rules include new value-based exceptions under the Stark Law based on recognition by CMS that incentives are different in a healthcare system that pays for value rather than the volume of services provided. CMS says that the new exceptions will continue to protect against overutilization and other harms while giving providers added flexibility to improve the quality of care for patients.

Proposed changes to the regulations related to the AKS and the Civil Monetary Penalties Law issued by the OIG today would, if finalized, address a longstanding concern that current regulations unnecessarily limit the ways in which providers can coordinate care for patients. Changes are intended to make it easier for providers to comply with the law by establishing specific safe harbors for these arrangements.

Here are some examples involving coordinated care, value-based care, data sharing and patient engagement activities that may be difficult to fit under existing exceptions or safe harbors, but may be protected by the new rules:
• Home care and hospice providers may share data analytics services with other providers.
• Home care and hospice providers can work with other providers in new ways to coordinate care for patients discharged from hospitals, including the provision of care coordinators to ensure that patients receive appropriate follow up care, data analytics systems to help ensure that patients are achieving better health outcomes, and remote monitoring technology to alert physicians or caregivers when patients need interventions to help prevent unnecessary ER visits and readmissions.
• Home care and hospice providers could provide smart pillboxes to patients without charge to help them remember to take their medication on time. Providers can also teach patients how to use the pillboxes that automatically alert providers and caregivers when patients miss doses of medications so that they can promptly follow up with patients.
• Providers may improve their cybersecurity and the cybersecurity of nearby providers that they work with frequently. In order to do so, providers can donate cybersecurity software for free to other providers that refer patients. The software will help to ensure that hackers cannot attack providers’ computers and helps prevent hackers from spreading attacks to other providers.
• Providers may furnish patients with technology capable of monitoring patients’ health and that allows for two-way, real time interactive communication between patients, physicians and other providers.
• Providers may also furnish other providers with data analytics software to help them monitor patients’ health outcomes.

This is the first in a series of articles about the proposed rules. Stay tuned for much more!

©2019 Elizabeth E. Hogue, Esq. All rights reserved.

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