CMS’ Proposed Regulations Include Significant Antitrust Implications For Entities Interested In Forming ACOs

The Centers for Medicare & Medicaid Services (CMS) released proposed regulations to clarify and build on current regulatory requirements for Accountable Care Organizations (ACOs) that participate in the Medicare Shared Savings Program (MSSP).  Among the changes is one addressing when an ACO must be formed as an independent legal entity, separate from any of its multiple participants.  According to CMS, this proposed change is designed to clarify existing regulations and to ensure that ACO decision-making is governed by individuals with fiduciary duties to the ACO alone.

Existing CMS regulations require an ACO formed by two or more "otherwise independent," prospective ACO participants to be a separate, independent legal entity.  According to CMS, in the approximately two years since this requirement went into effect,  prospective participants have raised valid questions as to the exact meaning of "otherwise independent" and the specific parameters of when a