March 31, 2011 | 15,692 Comments
Posted by Sharlene Hunt
Today, the Centers for Medicare and Medicaid Services (“CMS”), the U.S. Department of Health and Human Services Office of Inspector General (“OIG”), the Federal Trade Commission and the Department of Justice, and the Internal Revenue Service issued guidance under the Patient Protection and Affordable Care Act (Affordable Care Act) regarding accountable care organizations participating in the Medicare shared savings program.
The Affordable Care Act authorized the Secretary of Health and Human Services to issue waivers under certain laws in order to carry out the Medicare shared savings program. (See our companion blog post from today discussing CMS’ proposed rule for ACOs under the shared savings program). CMS and the OIG issued a joint notice with comment period regarding possible waivers under the Stark law, the federal antikickback law, and the civil monetary penalties law as they might apply to financial arrangements involving accountable care organizations. The same waivers could apply to demonstration projects under the Center for Medicare and Medicaid Innovation. CMS and the OIG are also soliciting public comments on a number of topics, which must be submitted 60 days after the date of publication, which is currently scheduled for the April 7, 2011 Federal Register.
Although the notice is limited to ACOs under the Medicare shared savings program, the agencies are soliciting comments on whether a waiver is necessary to address distributions of payments received by the ACO from a private payor since it seems likely that ACOs operating under the Medicare program will also operate under private payor contracts. Since ACOs participating in the Medicare shared savings program must enter into an agreement to participate, part of that process would be the issuance of waivers, to the extent required under the proposed structure. The waivers would basically address distributions of shared savings and other financial relationships directly related to the ACO’s participation in the program for purposes of the Stark law, the antikickback law, and the section of the civil monetary penalty law that prohibits a hospital from making payments to induce physicians to reduce or limit services to Medicare or Medicaid beneficiaries.
The full text of the notice can be found here: http://www.ofr.gov/(X(1)S(sja4ylt0r21hmotpe3t41a2a))/OFRUpload/OFRData/2011-07884_PI.pdf
The Federal Trade Commission and the Department of Justice issued a joint notice with comment period addressing the application of the antitrust laws to ACOs to the extent they seek to participate in or are approved to participate in the Medicare shared savings program. Public comments under this notice must be received by the agencies on or before May 31, 2011. The notice specifically recognizes that ACOs will most likely treat both Medicare beneficiaries as well as commercially insured patients, and the antitrust analysis is designed to address both. The notice creates a new antitrust policy statement for accountable care organizations under the Medicare shared savings program. It outlines an antitrust safety zone for ACOs, indicates when the agencies will apply rule of reason treatment under the antitrust laws to ACOs, addresses agency review mandated by CMS under the shared savings program for ACOs exceeding a 50% share threshold and outlines options for ACOs to obtain additional guidance if they are outside the safety zone and below the mandatory review threshold. The rule of reason analysis of an arrangement will apply, rather than a per se review, if providers are financially or clinically integrated and the agreement is reasonably necessary to accomplish precompetitive benefits.
The full text of the notice can be found here: http://www.ftc.gov/os/fedreg/2011/03/110331acofrn.pdf
The Internal Revenue Service was slated to issue a notice with comment period regarding the need for guidance for tax-exempt organizations participating in ACOs and the Medicare shared savings program. As of press time of this blog post, the notice has not yet been posted on the IRS website.