On Friday, February 6, 2023, the Division of Justice (DOJ) introduced the withdrawal of the 2011 Assertion of Antitrust Enforcement Coverage Concerning Accountable Care Organizations Taking part within the Medicare Shared Financial Savings Program (2011 ACO Assertion) along with two different well-being care antitrust coverage statements.
The 2011 ACO Assertion was collectively issued by the DOJ and the Federal Commerce Fee (FTC). The DOJ has characterized the withdrawn statements as “outdated” and as now not “totally replicate[ing] market realities.” Withdrawal by the DOJ is in line with the Biden administration’s pronouncements that will probably be taking an extra aggressive antitrust enforcement method, which features a focus well-being care. The FTC, nevertheless, has not but withdrawn the statements.
For context, the antitrust legal guidelines usually preclude suppliers and supplier organizations from participating in joint negotiations with payers. Nevertheless, long-standing DOJ-FTC antitrust coverage statements present steerage on how clinically or financially built-in supplier networks that meet sure standards could interact in sure joint actions and keep away from per se condemnation beneath Part 1 of the Sherman Act, which prohibits contracts, mixtures, and conspiracies “in restraint of commerce or commerce.”
Medical integration amongst suppliers in some ways might be tough to ascertain and, equally, to display. In distinction, monetary integration amongst suppliers has developed into in some ways extra possible than when the 2011 ACO Assertion was adopted for quite a lot of causes, together with payer product choices, a transfer away from fee-for-service funds, development capital companions, and regional components.
The withdrawn 2011 ACO Assertion, amongst different issues, specified that the DOJ and FTC won’t routinely deal with as presumptively illegal joint negotiations with payers by accountable care organizations (ACOs) if the negotiations are fairly essential to an ACO’s main function of bettering well being care supply and the ACO meets the Facilities of Medicare and Medicaid Companies (CMS) eligibility standards and “makes use of the identical governance and management constructions and medical and administrative processes it makes use of within the Shared Financial savings Program to serve sufferers in business markets.”
- The 2011 ACO Assertion utilized to collaborations amongst unbiased suppliers and teams that have been eligible and supposed to, or had been permitted, to take part within the Medicare Shared Financial savings Program (MSSP).
- The 2011 ACO Assertion maintained that antitrust company scrutiny wouldn’t comply with sure “ACOs that meet the CMS eligibility standards for and intend, or have been permitted, to take part within the Shared Financial savings Program and are extremely unlikely to lift important aggressive considerations.”
- To qualify as extremely unlikely to lift aggressive considerations and keep away from antitrust scrutiny, the DOJ and FTC introduced a security zone during which the mixed share of companies in knowledgeable companies settlement (PSA) for the ACOs have to be 30 % or much less of every frequent service in a PSA. Hospitals and ambulatory surgical procedure facilities have to be non-exclusive to the ACO to fall throughout the security zone, no matter PSA share.
- Even for the ACOs that don’t fall throughout the security zone, the 2011 ACO Assertion established that joint negotiations with personal payers wouldn’t be per se violations of the Sherman Act and as a substitute evaluated beneath a “rule of motive” evaluation in the event that they glad CMS eligibility standards and the settlement in all fairness essential to perform the procompetitive advantages of the combination.
Recognizing that worth, many supplier networks and different supplier collaborations have relied on participation within the MSSP as an ACO as a stepping stone to display medical integration. Since 2011, monetary integration has been more and more accessible to quite a lot of supplier sorts. Monetary integration usually facilities on downside danger preparations. In distinction, medical integration focuses on structuring the entity as a built-in medical apply and highlighting how taking part or member suppliers function with a excessive diploma of interdependence and cooperation to ship price management and guarantee high quality.
The DOJ’s withdrawal of the 2011 ACO Assertion indicators potentially elevated antitrust scrutiny of ACOs and different supplier networks and danger-bearing organizations. Persevering to depend on the withdrawn steerage by the DOJ that the FTC has but to withdraw presents some danger. Within the absence of the 2011 ACO Assertion, it’s necessary for these entities to work with their counsel to judge medical and monetary integration practices and the place they might fall on the continuum of antitrust danger whereas we wait to be taught extra from DOJ and, probably, the FTC.
Foley is right here that will help you deal with the short- and long-term impacts within the wake of regulatory adjustments. We have now the sources that will help you navigate these and different necessary authorized issues associated to enterprise operations and industry-specific points. Please attain out to the authors, your Foley relationship accomplice, or to our Well being Care Observe Group with any questions.