Antitrust Division 2011 – Federal Register Recent Federal Regulation Documents

The FTC and DOJ (the ``Agencies'') are issuing the final Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (the ``Policy Statement'') in conjunction with the final rule issued today by the Centers for Medicare and Medicaid Services (``CMS'') under Section 3022 of the Affordable Care Act (the Patient Protection and Affordable Care Act, Public Law 111-48, 124 Stat. 119 (2010), and the Health Care and Education Reconciliation Act of 2010, Public Law 111- 52, 124 Stat. 1029 (2010)). The final Policy Statement differs from the proposed Policy Statement issued earlier this year, 76 FR 21,894 (Apr. 19, 2011), in two significant respects. First, the entire final Policy Statement with the exception of the voluntary expedited antitrust reviewapplies to all collaborations among otherwise independent providers and provider groups that are eligible and intend, or have been approved, to participate in the Medicare Shared Savings Program (the ``Shared Savings Program''); its applicability is no longer limited to those collaborations formed after March 23, 2010, the date on which the Patient Protection and Affordable Care Act was enacted. Second, because the Shared Savings Program final rule will no longer require a mandatory antitrust review for certain collaborations as a condition of entry into the Shared Savings Program, the final Policy Statement no longer contains provisions relating to mandatory antitrust review. However, as discussed in the final rule, the Agencies will continue to protect competition in markets served by accountable care organizations (``ACOs'') that participate in the Shared Savings Program, aided by data and information from CMS that will assist the Agencies in monitoring the competitive effects of ACOs. Specifically, CMS will provide the Agencies with aggregate claims data regarding allowed charges and fee-for-service payments for all ACOs accepted into the Shared Savings Program and also with copies of all of the applications to the Shared Savings Program of ACOs formed after March 23, 2010. The Agencies will vigilantly monitor complaints about an ACO's formation or conduct and take whatever enforcement action may be appropriate. Additionally, upon request, the Agencies will provide an expedited 90 day review for newly formed ACOs that wish to obtain additional antitrust guidance.