New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XII - Innovative Delivery Models › Part 1003 - Accountable Care Organizations › Section 1003.14 - Legal Protections; State Action Immunity

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
(1) An
				ACO certified pursuant to this Part shall not be considered to be in violation
				of Article 22 of the General Business Law relating to contracts or agreement in
				restraint of trade if the ACO's actions qualify for the safety zone, subject to
				the antitrust analysis set forth in the
Statement of Antitrust
				Enforcement Policy Regarding Accountable Care Organizations Participating in
				the Medicare Shared Savings Program
issued by the Federal Trade
				Commission and U.S. Department of Justice and published in the Federal Register
				on October 28, 2011. For ACOs that do not participate in one of the CMS
				Accountable Care Organization shared savings programs, certification under this
				Part will be considered equivalent to participation with CMS.
(2) As part of its application for a
				certificate of authority under this Part, an ACO may request that the state
				provide state action immunity from federal and state antitrust laws. An ACO
				requesting review shall submit, in addition to the application materials
				required by this Part, any additional materials or information requested by the
				Department to make a state action immunity determination. The factors to be
				considered in evaluating requests for state action immunity pursuant to this
				Part shall include, but shall not be limited to:
(i) the potential benefits of the ACO's
				collaborative activities, including but not limited to the likelihood that one
				or more of the following may result from such activities:
(a) Preservation of needed health care
				services in the relevant primary service area that would be at risk of
				elimination in the absence of the ACO's collaborative activities
(b) Improvement in the nature or distribution
				of health care services in the primary service area, including expansion of
				needed health care services or elimination of unnecessary health care
				services;
(c) Enhancement of the
				quality of health care provided by the ACO and its participants;
(d) Expansion of access to care by
				medically-underserved populations;
(e) Lower costs and improved efficiency of
				delivering health care services; including reductions in administrative and
				capital costs and improvements in the utilization of health care provider
				resources and equipment; or
(f)
				Implementation of payment methodologies that control excess utilization and
				costs, while improving outcomes;
(ii) the health care provider landscape of
				the relevant primary service area, including the availability of suitable and
				accessible health care services and the level of competition in the primary
				service area, the likelihood that other health care providers will enter or
				exit the primary service area, the health care workforce and the existence of
				unique challenges such as difficulties in recruiting and retaining health care
				professionals;
(iii) the potential
				disadvantages of the ACO's collaborative activities;
(iv) the availability of arrangements that
				are less restrictive to competition and achieve the same benefits or a more
				favorable balance of benefits over disadvantages attributable to any reduction
				in competition;
(v) other benefits
				or disadvantages identified in the course of review; and
(vi) the extent to which active supervision
				is likely to mitigate any disadvantages.
In determining whether to provide state action immunity, the
				  Department may impose such conditions as necessary to ensure that the
				  activities of the ACO are consistent with the purposes of Article 29-E and/or
				  are necessary to ameliorate any potential disadvantages.
If the Department determines to provide state action
				  immunity, such determination shall be reflected on the certificate of authority
				  or in an amendment thereto. In such case, the State shall provide active state
				  supervision and the ACO shall provide such materials or information as is
				  requested by the Department for such
				  purpose.