(a) General. Collaborative care arrangements must meet all of the following:
(1) Be in writing, signed by both parties, and contain the effective date of the arrangement.
(2) Be exclusively between the ASM participant and the primary care practice with whom the ASM participant shares at least one established patient who is an ASM beneficiary.
(3) The collaborative care arrangement must be entered into for the purpose of either of the following:
(i) Furthering the ASM participant's performance in the improvement activities ASM performance category at § 512.735.
(ii) Advancing the clinical goals of ASM as described in paragraph (b) of this section.
(4) Participation in a collaborative care arrangement must be voluntary and without penalty for nonparticipation.
(5) Both parties to the collaborative care arrangement must comply with all applicable statutes, regulations, and guidance, including without limitation the following:
(i) Federal criminal laws.
(ii) The False Claims Act (31 U.S.C. 3729 et seq.).
(iii) The anti-kickback statute (42 U.S.C. 1320a-7b(b)).
(iv) The civil monetary penalties law (42 U.S.C. 1320a-7a).
(v) The physician self-referral law (42 U.S.C. 1395nn).
(6) The opportunity to enter into a collaborative care arrangement, and the amount of any payment under a collaborative care arrangement, must not be conditioned directly or indirectly on the volume or value of past or anticipated referrals or business generated by, between, or among the parties to the collaborative care arrangement or any other person.
(7) Any payment between the parties set forth in a collaborative care arrangement must not exceed the sum total of the payment adjustments made to an ASM participant's claims for a given ASM performance year as a result of the application of the ASM payment adjustment factor to the ASM participant's Medicare Part B payments for covered professional services during an ASM payment year.
(8) Any payment or other remuneration set forth in the collaborative care arrangement must be solely between the parties to the arrangements. Any payment between the parties must be made by check, electronic funds transfer, or another traceable cash transaction.
(9) Both parties to the collaborative care arrangement must retain the ability to make decisions in the best interests of ASM beneficiaries, including the selection of clinicians, devices, supplies, and treatments.
(10) The collaborative care arrangement must not do either of the following:
(i) Induce any party to reduce or limit medically necessary services to any Medicare beneficiary.
(ii) Reward the provision of items and services that are medically unnecessary.
(11) ASM participants must maintain contemporaneous documentation, in accordance with § 512.135, regarding all collaborative care arrangements entered into, including the following:
(i) The relevant written agreements.
(ii) The date and amount of any payments between the parties.
(iii) A description of the methodology and accounting formula for determining the amount of any payments between the parties.
(12) The collaborative care arrangement must stipulate that any non-ASM participant party is considered a downstream recipient for CMS data sharing purposes, and must require the non-ASM participant party to comply with applicable data sharing requirements at § 512.760.
(13) Any non-ASM participant party to a collaborative care arrangement must be a downstream participant subject to the standard provisions for Innovation Center models specified in subpart A of this part 512.
(b) Clinical goals of ASM. The following are the clinical goals of ASM, which may be advanced through collaborative care arrangements:
(1) Promoting preventive care through improved management of ASM targeted chronic conditions.
(2) Empowering patients to actively participate and be accountable for quality and whole health outcomes.
(3) Facilitating meaningful and efficient coordination between specialists and primary care providers to increase independent physician participation in value-based payment programs.
(c) Collaborative care arrangement exclusions. An ASM participant may not enter into a collaborative care arrangement with a party that is excluded from participation in any Federal health care programs by the Inspector General.