N.Y. Comp. Codes R. & Regs. tit. 10 § 1003.14

Current through Register Vol. 46, No. 51, December 18, 2024

Section 1003.14 - Legal Protections; State Action Immunity

(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.

(b) An ACO certified pursuant to this Part shall not be considered to be in violation of Article 131-A of the Education Law relating to fee splitting in the following circumstances:

(1) When as a function or activity of the ACO, the ACO enters into contracts or arrangements reasonably related to and necessary for operations of the ACO; or

(2) The shared savings are:

(i) Distributed to and among individuals or entities who were ACO participants during the year in which the shared savings were earned; or

(ii) Used for activities that are reasonably related to the purposes of the ACO.

(c) Health care providers, as defined in Title 2-D of Article 2 of the Public Health Law, who participate in or contract with an ACO certified pursuant to this Part, and who make referrals to other health care providers within the scope of the ACO's functions, activities and services, shall not be considered to be in violation of Title 2-D of Article 2 of the Public Health Law relating to health care practitioner referrals.

(d) A medical assistance provider, as defined in section 366-d of the Social Services Law, that enters into arrangements with an ACO certified pursuant to this Part, one or more of its ACO participants, or a combination thereof, shall not be in violation of section 366-d of the Social Services Law.

(e) In order to obtain the protections under subdivisions (b), (c), (d) and (e) of this section, contracts or arrangements shall be authorized as reasonably related to the purposes of the ACO and contemporaneously documented by the governing body of the ACO and a description of the contract or arrangement shall be publicly disclosed;

(1) The documentation must be made available to the appropriate governmental agencies upon request and include the following:

(i) A description of the contract or arrangement including all parties to the arrangement;

(ii) The date and purpose of the contract or arrangement;

(iii) The items, services, facilities, and/or goods covered by the contract or arrangement (including non-medical items, services, facilities or goods);

(iv) The financial or economic terms of the arrangement; and

(v) The date and manner of the governing body's authorization of the contract or arrangement including the basis that the contract or arrangement is reasonably related to the purposes of the ACO.

(2) The public disclosure shall be posted on the ACO's website within 60 days of the governing body's authorization and shall not contain the financial or economic terms of the contract or arrangement. Other proprietary or confidential business terms may also be omitted. The website posting must be such that generally used internet search engines will produce results listing the ACO's required disclosure.

(f) The provision of health care services directly or indirectly by an ACO certified pursuant to this Part shall not be considered the practice of a profession under Title 8 of the Education Law.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 1003.14

Adopted, New York State Register December 31, 2014/Volume XXXVI, Issue 52, eff.12/31/2014