The 2021 Stark Law and Anti-Kickback Statute: Fair Market Value and Commercial Reasonableness (American Health Law Association Publication)

Noteworthy 2021 stark law revisions and modifications: specifically areas impacting provider compensation and transactions valuation.


FMV and Commercial Resaonableness
Download a PDF Version of the Article as Published in AHLA’s 2021 Transactions Resource Guide to Share With Your Team

Fair Market Value and Commercial Reasonableness – 2021 and Beyond

This article was originally published by the American Health Law Association in April 2021 as part of their 2021 Health Care Transactions Resource Guide. The original content piece along with other guide publications can be accessed here.

Looking for help navigating the Stark Law Final Rule? Contact our expert, Neal D. Barker at nbaker@hsgadvisors.com or call (502) 814-1189.

This article is intended to highlight some of the most noteworthy revisions, clarifications, and modifications provided by the Centers for Medicare & Medicaid Services (CMS) through the Stark Law Final Rule and by the Office of Inspector General (OIG) through the Anti-Kickback Statute (AKS) Final Rule. HSG is not a law firm; we are a health care consulting and compensation valuation firm, so this article is not an exhaustive legal interpretation, summary, or review of all of CMS and OIG’s updates, but rather a review of selected areas—particularly those elements and areas we view as having the most impact in the world of physician and advance practice provider (APP) compensation and transactions valuation. This piece concludes with thoughts regarding the COVID-19 pandemic’s effect on the immediate future of physician and APP compensation valuation.

The Stark Law and Anti-Kickback Statute

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) published Final Rules for the Physician Self-Referral Law (Stark Law), the federal AKS, and the Civil Monetary Penalties (CMP) Law. These new rules, which significantly amend the existing laws, are a direct result of HHS’ Regulatory Sprint to Coordinated Care. HHS, through the Regulatory Sprint to Coordinated Care, has a stated goal of reducing regulatory barriers within our nation’s health care system and accelerating “the transformation of the health care system into one that better pays for value and promotes care coordination.” As HHS’ statement indicates, value-based arrangements and transactions are the focus of this episode of Stark Law and AKS revisions, but other areas and central ideas of the Stark Law and AKS are significantly impacted as well.

On December 2, 2020, OIG published its Final Rule, “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Rules Regarding Beneficiary Inducements,” and CMS published its Final Rule, “Modernizing and Clarifying the Physician Self-Referral Regulations” in the Federal Register.

The Stark and AKS Final Rules became effective January 19, 2021, with the exception of certain changes to the definition of a “group practice” that have an effective date of January 1, 2022 to give physician practices time to adjust their compensation methodologies.

The AKS Final Rule creates new safe harbors for entities participating in a “value-based enterprise” (VBE) and amends existing safe harbors. OIG’s proposed new safe harbors are: