HHS has long admitted that the Anti-Kickback Statute (AKS) and the Stark law have not evolved to keep pace with the transition to value based care.  In June of 2018, HHS issued an RFI seeking additional information and HHS also issued a release on December 12, 2018 seeking input on improving care coordination and reducing the regulatory burdens of the HIPAA rules.

I would suggest that almost everybody else came to that conclusion much earlier than last year.

On October 9, 2019 HHS and OIG released their proposals as part of this “Regulatory Sprint to Coordinated Care”.  Note that OIG is issuing new Safe Harbors applicable to the AKS rules and CMS is issuing proposed changes to the definitions in the Stark Law.

  • AKS prohibits the solicitation or payment of remuneration by anybody for any government health care program.
  • CMS only prohibits physicians from referring Designated Health Services (DHS) to provider entities with which they have financial relationships and, although it is more restricted in scope, it is nevertheless broad enough to impact global health care delivery.

OIG has issued Safe Harbors in the following areas:

  • Care coordination and improved quality, health, and efficiency.
  • Value-based arrangements with substantial downside financial risk covering certain in-kind and monetary arrangements where a value-based enterprise (VBE) accepts substantial downside risk from third party payors.
  • Value-based arrangements with full financial risk.
  • Patient engagement and support arrangements.
  • CMS sponsored model arrangements and model patient incentive.
  • Donations of cybersecurity technology services, accompanied by modifications to the existing EHR Safe Harbor.

CMS is proposing to change definitions with respect to fair market value, as follows:

  • CMS is proposing to alternative definitions for the term commercially reasonable so that it could apply either to arrangements that further legitimate business purposes or arrangements that make commercial sense similar to other existing arrangements.
  • CMS is proposing three definitions of fair market value (FMV) applying to equipment rentals, office space, and FMV in general.
  • CMS is proposing to revise the volume or value based standard so that it will apply only when the formula used to calculate the remuneration actually includes referrals and other business generated.

Following are links to:

  • HHS Press Release


  • OIG Safe Harbors


  • CMS Proposed Stark Law Amendments


All of these documents comprise of hundreds of pages, 650 to be exact, and I will attempt to isolate individual proposals for discussion throughout the end of the year.