As mentioned in the September 17th post below, the FTC, CMS and OIG (the “Agencies”) published a notice (the “Notice”) in the Federal Register announcing a public workshop regarding Accountable Care Organizations (ACOs) to be held on October 5th at the CMS Headquarters. In addition to setting forth the workshop format and discussion topics, the Notice solicits comments concerning the types of contractual and financial relationships under various ACO business models that might trigger or implicate the antitrust laws, the physician self-referral prohibition (the "Stark Law") and/or the anti-kickback statute, as well as payment arrangements that might implicate the civil monetary penalties law.
Further, the Notice requests comments relating to how current Stark Law exceptions and anti-kickback statute safe harbors might be inadequate to address the types of financial arrangements that will be created by ACOs and ways existing exceptions and safe harbors might be tailored to further address integration. The Notice also solicits recommendations for how a "new meaningful exception and safe harbor for incentive payments related to the newly created ACOs could be crafted."
Citing a May 2010 Policy Brief entitled, "Implementing Accountable Care Organizations," the Notice recognizes the complexity associated with integrating health care delivery among independent providers. The Notice states that because of the "substantial commitment of health care providers' resources and time," providers may be "more likely to integrate their care delivery Medicare and Medicaid beneficiaries if they also use the same delivery system for patients covered by health care insurance in the private market. The potential for ACOs to operate in both public and private markets further supports the need to explore the application to ACOs of these laws and regulations, as well as the Agencies' enforcement responsibilities."
There are a substantial number of potential ACO models under development at present. The opportunity to submit questions prior to the issuance of draft regulations for ACOs may be the best time to influence the direction that the regulations will take.
The Notice sets out certain requirements for written comments. Written comments or statements should not include any sensitive personal information, such as an individual’s Social Security number; date of birth; driver’s license number or other State identification number or foreign country equivalent; passport number; financial account number; or credit or debit card number. Comments also should not include any sensitive health information, such as medical records and other individually identifiable health information. Written comments or statements will be accepted and considered for discussion at the workshop if they are received by the September 27th deadline.
I will be attending the workshop in person. If you would like to provide me with a copy of your comments to the Agencies in advance of the workshop or if you are interested in additional information regarding any specific topics relating to the workshop, please feel free to contact me at the email address below. I can assume no responsibility for assisting in the advancement your comments, but it would be helpful for my preparation for the meeting and future posts regarding the workshop. You may send comments to me by email at VBPBlog@gmail.com.