On October 9, HHS released two proposed rules aimed at modernizing the Stark Law and Anti-kickback Statute (AKS), particularly as they apply to value-based arrangements. These proposed rules are part of HHS’ Regulatory Sprint to Coordinated Care.
The AKS proposed rule, among other things, would add new AKS safe harbors:
- Care Coordination Arrangements to Improve Quality, Health Outcomes, and Efficiency (§ 1001.952(ee));
- Value-Based Arrangements With Substantial Downside Financial Risk (§ 1001.952(ff));
- Value-Based Arrangements With Full Financial Risk (§ 1001.952(gg));
- Certain tools and supports furnished under patient engagement and support arrangements to improve quality, health outcomes, and efficiency (1001.952(hh));
- Certain remuneration provided in connection with a CMS-sponsored model (§ 1001.952(ii)); and,
- Cybersecurity Technology and Services (§ 1001.952(jj)
The Stark Law proposed rule, would provide new exceptions to the Stark Law, including for compensation arrangements that facilitate value-based health care delivery and payment in a value-based enterprise (§411.357(aa)), arrangements involving the donation of cybersecurity technology and related services (§411.357(bb)), and limited remuneration to a physician (§411.357(z)).