(b) Unless it has in force and effect a valid license issued pursuant to article 11 of the Insurance Law or a certificate of authority issued pursuant to article 44 of the Public Health Law, an ACO or a participant may not enter into any arrangement that constitutes doing an insurance business under section 1101 of the Insurance Law, including an arrangement that provides for full or partial capitation, shared losses or any other arrangement in which the ACO or the provider contractually assumes the liability for the delivery of specified health care services except:

1. (1) an ACO or an ACO participant may enter into such an arrangement when the ACO contracts with a managed care organization certified pursuant to article 44 of the Public Health Law, an insurer authorized pursuant to the Insurance Law to write accident and health insurance in New York, or a corporation licensed pursuant to article 43 of the Insurance Law; or
2. (2) a Medicare-only ACO that contracts with CMS may enter into an arrangement that provides for shared losses provided that, if the shared losses may exceed 10 percent of the benchmark, the ACO meets all of the requirements of sections 1003.5, 1003.6, 1003.11, 1003.12, 1003.13 and 1003.14 of this Part.