E. John Steren, Member of the Firm in the Health Care & Life Sciences and Litigation & Business Disputes practices, in the firm’s Washington, DC, office, was interviewed in the Advisory Board’s Law Review Q&A, “Reconsidering Participation in MSSP? Don’t Overlook Antitrust Compliance.”
Following is an excerpt:
Change is afoot in the world of ACOs. At the end of 2018, CMS proposed an overhaul of the current Medicare Shared Savings Program (MSSP), which underscores their intention to accelerate ACOs’ transition towards downside risk. Now, current MSSP participants are evaluating whether they are ready to take on more financial accountability for cost and quality outcomes or whether they’re better off exiting the program. And those that are ready may even double down on the model by expanding into more commercial markets.
While anyone would agree that providers’ decision to stay or leave MSSP should be based on a multitude of factors (e.g., existing management infrastructure, system margin performance), it’s important to not overlook the legal implications of that decision, particularly with regard to clinical integration and antitrust compliance. To learn more about what that might entail, we connected with John Steren of Epstein Becker Green who provided his take on the decision that providers face and offered some key points to keep in mind moving forward.
Question: Before we get into strategy, I want to set the stage. How do ACOs currently fit into the antitrust regulatory landscape?
John Steren: In describing how an ACO fits into the antitrust regulatory landscape, and the significance, from an antitrust perspective of an ACO’s participation in the MSSP, it may be best to start by describing what a clinically integrated network (CIN) is, and the benefits of clinical integration.
A CIN is a moniker placed on a network of independent providers (including physicians and hospitals) that join together for the primary purpose of improving care and reducing costs through clinical integration. Providers in a network are deemed to be clinically integrated if they implement a program to modify practice patterns and create interdependence among the providers to control cost and ensure quality. A successful clinical integration program consists of many elements including: (1) protocols to monitor and control utilization; (2) selectively choosing network participants and assuring adherence to established protocols through education, and if necessary termination for non-compliance; and (3) investment by the network participants of both human and financial capital in the network.
Significantly, if these independent providers are deemed to be clinically integrated, they can undertake certain joint actions, including jointly negotiating payer contracts on behalf of the network, without concern that their joint conduct will be deemed unlawful per se under the antitrust laws.
ACOs and CINs are related, but not synonymous, terms. The ACO is a creature of the Affordable Care Act designed to serve a patient population under the MSSP. ACOs, like CINs, are networks comprised of independent providers. However, while an ACO was intended to improve quality and control cost, many ACOs have not implemented all of the required elements to achieve clinical integration. Nevertheless, because of the similarities between CMS’ eligibility criteria and the enforcement agencies definition of clinical integration, and CMS’ monitoring of ACO results, the federal enforcement agencies have indicated that they will treat all ACOs that participate in MSSP as clinically integrated.