On December 29, 2016, CMS and OIG issued a Notice of Amended Waivers of Certain Fraud and Abuse Laws in Connection with the Next Generation ACO Model (the 2016 Notice). The 2016 Notice does not change or limit arrangements protected by the waivers in the Notice of Waiver of Certain Fraud and Abuse Laws in Connection with the Next Generation ACO Model dated December 9, 2015 (the 2015 Notice). Arrangements protected under the 2015 Notice do not need any new action to remain protected under the 2016 Notice, provided that they continue to meet all of the conditions of a waiver. Rather, the 2016 Notice includes two provisions that protect additional arrangements.
First, the 2016 Notice adds to the Compliance with the Physician Self-referral Law Waiver protection for financial relationships between or among the Next Generation ACO and providers that are categorized as “Preferred Providers.” This waiver previously only protected financial relationships with Next Generation ACO Participants.
Second, the 2016 Notice adds a new “All-Inclusive Population-Based Payment” (AIPBP) Arrangement Waiver that applies to AIPBP Payment Arrangements. Under the Next Generation ACO participation agreement, providers reimbursed under AIPBP Payment Arrangements agree to accept reimbursement for services from the ACO rather than from CMS. AIPBP Payment Arrangements must meet certain conditions, such as good-faith negotiation and fair market value compensation.
The new AIPBP Payment Arrangement Waiver waives compliance with the Stark Law and the Anti-Kickback Statute with respect to an AIPBP Payment Arrangement if all of the following conditions are met:
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as with the other Next Generation ACO waivers, the Next Generation ACO has entered into a Participation Agreement and remains in good standing;
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the Next Generation ACO has entered into an AIPBP Payment Arrangement with the AIPBP-participating Next Generation Participant or Preferred Provider that establishes how the Next Generation ACO will make payments for Covered Services;
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in establishing the terms of, implementing, and performing under, the AIPBP Payment Arrangement, neither party gives or receives remuneration in return for or to induce business other than Covered Services covered by the AIPBP Payment Arrangement;
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upon request, the parties to an AIPBP Payment Arrangement must provide the government with access to records regarding the AIPBP Payment Arrangement that are required to be maintained in accordance with the Participation Agreement; and
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the Participation Agreement does not provide that this waiver is inapplicable.
The Next Generation ACO Participation Waiver, Shared Savings Distribution Waiver, and Waiver for Patient Engagement Incentives remain unchanged from the 2015 Notice. The 2016 Notice is available here, and the 2015 Notice is available here. Notably, the 2016 Notice supersedes the 2015 Notice as of December 29, 2016.
The 2016 Notice follows CMS’s December 15, 2016 announcement of the third application round for the Next Generation ACO Model, with a January 2018 start date. ACOs that start on January 1, 2018 will have an initial agreement term of one year with two option years that would end on December 31, 2020. Interested applicants must submit a non-binding Letter of Intent, which CMS expects to open in February 2017. CMS expects that the application portal will open in March 2017 and that applications will be due in May 2017. Click here for more information regarding the 2018 application round.
