Barriers to Effective ACO Implementation Due to the relatively unique composition of ACOs and partnerships they create to achieve more highly integrated care, questions arise about their legal viability. The Accountable Care Act (ACA) and subsequent regulations seek to ensure that ACOs are able to accomplish their mission by shielding them from undue interference with legal and regulatory barriers. •
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Antitrust and ACOs o The Federal Trade Commission (FTC) and the Department of Justice (DOJ) issued a joint Policy Statement on ACOs and antitrust concerns § What ACOs will be affected § When the FTC and DOJ will apply particular antitrust analyses to those ACOs § An antitrust safety zone for certain ACOs § The CMS-­‐mandated antitrust review process for certain other ACOs § Options for ACOs to gain additional antitrust clarity if they fall outside the safety zone but below the CMS-­‐mandated antitrust threshold CMS issued a rule that includes waivers for ACOs and the Medicare Shared Savings Program (MSSP) under the federal physician self-­‐referral, anti-­‐kickback and civil monetary penalty laws Anti-­‐Kickback Statute o The anti-­‐kickback statute and garnishing portion of the civil monetary penalty laws are waived for financial relationships among the ACO and its participants and providers/suppliers if the ACO is a participant in good standing in the MSSP o The financial relationship must also be reasonably related to the purposes of the MSSP and fully complies with an exception under the physician self-­‐referral law Stark Law o Waived with respect to a start-­‐up arrangement that predates an ACO’s participation agreement, provided certain conditions are met o The Stark Law can also be waived with respect to any ACO arrangement, so long as a separate set of requirements are met Tax Exemption o Tax-­‐exempt organizations may participate in an ACO, but must ensure that they continue to meet IRS tax exemption requirements to avoid any adverse tax implications Barriers to Effective ACO Implementation • August 2012
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Barriers to Effective ACO Implementation Sources Federal Trade Commission. FTC, DOJ Seek Public Comment on Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations. 31 March 2011, at http://ftc.gov/opa/2011/03/aco.shtm. Taft Law. CMS Releases the Final Accountable Care Organization Rule and Related Waivers. 21 October 2011, at http://www.taftlaw.com/news/publications/detail/873-­‐cms-­‐releases-­‐the-­‐final-­‐accountable-­‐
care-­‐organization-­‐rule-­‐and-­‐estimated-­‐waivers. Vorys, Sater, Seymour, and Pease LLP. Health Care Alert: CMS Releases Interim Final Rule for ACO Fraud & Abuse Waiver Provisions. 3 November 2011, at http://www.vorys.com/publications-­‐491.html. Withum, Smith & Brown’s Healthcare Services Group. ACOs and Tax Exempt Organizations. 4 April 2012, at https://www.withum.com/pdf/Healthcare_news/Tip/ACOs_april2012.pdf. Barriers to Effective ACO Implementation • August 2012
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