On March 31, 2011, the Centers for Medicare & Medicaid Services (CMS) and other Federal agencies issued long anticipated proposed regulations addressing legal issues and other requirements for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program created last year by the health care reform legislation.

The following proposed regulations and documents were issued on March 31, 2011:

Centers for Medicare & Medicaid Services (CMS)

CMS issued a proposed rule that would implement Section 3022 of the Affordable Care Act related to Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program. Under the provisions in Section 3022 for ACOs, providers of services and suppliers can continue to receive traditional Medicare fee-for-service payments under Part A and B, and be eligible for additional payments based on meeting specified quality and savings requirements.

The CMS proposed rule for ACOs is available online at the CMS web site here

CMS and Office of Inspector General

CMS and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) jointly issued a notice with comment period outlining proposals for waivers of the Stark Law, the Federal Anti-kickback statute, and certain provisions of the civil monetary penalty law to specified arrangements involving Accountable Care Organizations (ACOs) in the new Medicare Shared Savings Program. CMS and OIG also solicited public comments on Section 3021 of the Affordable Care Act, which authorizes HHS to waive the same fraud and abuse laws as necessary solely for the purposes of carrying out Section 1115A of the ACA regarding the testing of certain innovative payment and services delivery models by the Centers for Medicare and Medicaid Innovation.

The CMS and DOJ joint notice with comment period is available online at the electronic inspection desk of the Federal Register here

Federal Trade Commission and Department of Justice

The Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) issued a joint statement about how the agencies will enforce U.S. antitrust laws in regard to ACOs. The joint proposed Policy Statement solicits public comment on the antitrust agencies’ proposed guidance to ensure that newly formed collaborative care organizations, known as ACOs, can be established to provide services to Medicare beneficiaries and patients with private health insurance, without raising competitive concerns. The proposed Policy Statement would create an antitrust “safety zone” for certain ACOs and establish expedited antitrust reviews for others.

The Antitrust Policy Statement by the FTC and DOJ is available online

Internal Revenue Service (IRS)

The Internal Revenue Service (IRS) issued a notice requesting comments regarding the need for guidance on participation by tax-exempt organizations in the Shared Savings Program through ACOs. The IRS notice is available online.