Today the federal government released final rules for the formation and operation of Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program. The regulations initially proposed in March 2011 generated considerable attention and comment as ACOs represent a key component of the Affordable Care Act, the healthcare reform legislation enacted in 2010.
The Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) jointly issued a final rule implementing section 3022 of the Affordable Care Act. The regulations take effect 60 days after the date of publication in the Federal Register.
CMS and the HHS Office of the Inspector General jointly released an interim final rule establishing waivers of certain federal laws, including the Stark (physician self-referral) law, the federal anti-kickback statute, and certain provisions of the civil monetary penalty (CMP) law with respect to financial relationships among parties operating as ACOs. The interim final rule is effective on the date of publication in the Federal Register, and public comments have been solicited and are due 60 days after publication in the Federal Register.
The Federal Trade Commission (FTC) and the Department of Justice (DOJ) issued a final policy statement on antitrust enforcement regarding ACOs participating in the Medicare Shared Savings Program.
Additionally, the Internal Revenue Service issued a Fact Sheet confirming that IRS Notice 2011-20, issued in April 2011, "continues to reflect IRS expectations regarding the Shared Savings Program and ACOs, and provides additional information for charitable organizations that may wish to participate in the Shared Savings Program."
CMS has published a side-by-side comparison of the proposed rule versus the final rule. Waller Lansden will provide additional information relating to the ACO rules and regulations released today and will continue to monitor developments regarding ACOs. For more information regarding ACOs, please contact David Head, Nora Liggett, Kim Harvey Looney, James Bowden, Brent Bowman, Trenton Poynter or any member of Waller Lansden's Healthcare Department at 800-487-6380.