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42 U.S.C. 1302, 1315a, and 1395hh.
85 FR 61362, Sept. 29, 2020, unless otherwise noted.
90 FR 50022, Nov. 5, 2025, unless otherwise noted.
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(a) General. CMS shares certain beneficiary-identifiable data as described in paragraphs (b), (c), and (e) of this section and certain aggregate data as described in paragraph (d) of this section with ASM participants regarding ASM beneficiaries and performance under the model.
(b) Beneficiary-identifiable data. CMS shares beneficiary-identifiable data with ASM participants as follows:
(1) CMS makes available certain beneficiary-identifiable data described in paragraph (b)(5) of this section for ASM participants to request for purposes of conducting health care operations work that falls within the first or second paragraph of the definition of health care operations at 45 CFR 164.501 on behalf of their patients who are ASM beneficiaries.
(2) An ASM participant that wishes to receive beneficiary-identifiable data for its ASM beneficiaries must do all of the following:
(i) Submit a formal request for the data, on at least an annual basis in a manner and form and by a date specified by CMS, which identifies the data being requested and attests that—
(A) The ASM participant is requesting this beneficiary-identifiable data as part of a covered entity, as defined at 45 CFR 160.103;
(B) The ASM participant's request reflects the minimum data necessary, as set forth in paragraph (c) of this section, for the ASM participant to conduct activities described in the first or second paragraph of the definition of health care operations at 45 CFR 164.501; and
(C) The ASM participant's use of beneficiary-identifiable data is limited to developing processes and engaging in appropriate activities related to coordinating care, improving the quality and efficiency of care, and conducting population-based activities relating to improving health or reducing health care costs that are applied uniformly to all ASM beneficiaries under the care of the ASM participant, and that these data are not to be used to reduce, limit or restrict care for specific Medicare beneficiaries.
(ii) To the extent practicable, limit the request to ASM beneficiaries whose claims were used to determine the requesting ASM participant's eligibility for ASM participation or to whom the requesting ASM participant provided care during an applicable ASM performance year.
(iii) Sign and submit a data sharing agreement with CMS as set forth in paragraph (e)(1) of this section.
(3) CMS shares beneficiary-identifiable data with an ASM participant on the condition that the ASM participant and other individuals or entities performing functions or services related to the ASM participant's activities, including but not limited to non-ASM participant parties in collaborative care arrangements with ASM participants, comply with all appliable laws addressing the appropriate use of data and the confidentiality and privacy of individually identifiable health information and the terms of the data sharing agreement described in paragraph (e)(1) of this section.
(4) CMS omits from the beneficiary-identifiable data any information that is subject to the regulations in 42 CFR part 2 governing the confidentiality of substance use disorder patient records.
(5) The beneficiary-identifiable data includes, when available, the following information:
(i) Unrefined (raw) Medicare Parts A, B, and D beneficiary-identifiable claims data used to determine ASM participant eligibility for an applicable ASM performance year; and
(ii) Unrefined (raw) Medicare Parts A, B, and D beneficiary-identifiable claims data for ASM beneficiaries who trigger an applicable EBCM episode with the ASM participant during the applicable ASM performance year.
(c) Minimum necessary data. The ASM participant must limit its request for beneficiary-identifiable data under paragraph (b) of this section to the minimum necessary to accomplish the permitted use of the data. The minimum necessary Medicare Parts A, B, and D data elements may include, but are not limited to the following:
(1) Medicare beneficiary identifier (ID).
(2) Procedure code.
(3) Sex.
(4) Diagnosis code.
(5) Claim ID.
(6) The from and through dates of service.
(7) The provider or supplier ID.
(8) The claim payment type.
(9) Date of birth and death, if applicable.
(10) Tax identification number.
(11) National provider identifier.
(d) Aggregated data feedback. CMS shares aggregated data on one or more select indicators of the ASM participant's performance, de-identified in accordance with 45 CFR 164.514(b), in a form and manner to be specified by CMS, when available, with ASM participants.
(e) ASM data sharing agreement.
(1) To retrieve the beneficiary-identifiable data specified in paragraphs (b) and (c) of this section, the ASM participant must complete and submit, on at least an annual basis, a signed ASM data sharing agreement, to be provided in a form and manner and by a date specified by CMS, under which the ASM participant agrees, at a minimum to do all of the following:
(i) Comply with the requirements for use and disclosure of this beneficiary identifiable data that are imposed on covered entities by the HIPAA regulations, including but not limited to 45 CFR part 164, subparts A and E, and the requirements of ASM set forth in this part.
(ii) Comply with additional privacy, security, breach notification, and data retention requirements specified by CMS in the ASM data sharing agreement.
(iii) Contractually bind any and all downstream recipients of this beneficiary identifiable data, such as other individuals or entities performing functions or services related to the ASM participant's data sharing activities, including those that meet the definition of a business associate as defined at 45 CFR 160.103 and non-ASM participant parties to collaborative care arrangements described at § 512.771, to the same terms and conditions to which the ASM participant is itself bound in its data sharing agreement with CMS as a condition of the business associate's or non-ASM participant parties' receipt of the beneficiary-identifiable data obtained by the ASM participant.
(iv) That if the ASM participant or any downstream recipient misuses or discloses the beneficiary-identifiable data in a manner that violates any applicable statutory or regulatory requirements or that is otherwise non-compliant with the provisions of the data sharing agreement, CMS may do any or all of the following:
(A) Deem the ASM participant ineligible to obtain the beneficiary-identifiable data under paragraph (b) of this section for any amount of time.
(B) Subject the ASM participant to additional sanctions and penalties available under applicable law.
(v) An ASM participant must comply with all applicable laws and the terms of the data sharing agreement to obtain beneficiary-identifiable data.
(2) CMS shares beneficiary-identifiable data with an ASM participant on the condition that the ASM participant and other individuals or entities performing functions or services related to the ASM participant's data sharing activities, including business associates as defined at 45 CFR 160.103 of the ASM participant and non-ASM participant parties to collaborative care arrangements described at § 512.771, comply with all relevant laws governing the use of data and the privacy and security of individually identifiable health information and the terms of the data sharing agreement described in paragraph (e)(1) of this section.
(f) Data custodian. An ASM participant must designate and provide the contact information for, in a form and manner identified by CMS, a data custodian who is responsible for ensuring compliance with privacy and security requirements, including all applicable laws and terms of the ASM data sharing agreement, and for notifying CMS of any incidents relating to unauthorized disclosures of beneficiary-identifiable data.
(a) Application of the CMS-sponsored model arrangements safe harbor. CMS has determined that the Federal anti-kickback statute safe harbor for CMS-sponsored model arrangements (§ 1001.952(ii)(1)) is available to protect remuneration furnished in accordance with the collaborative care arrangements that meet all safe harbor requirements set forth in §§ 1001.952(ii) and 512.771.
(b) Application of the CMS-sponsored model patient incentives safe harbor. CMS has determined that the Federal anti-kickback statute safe harbor for CMS-sponsored model patient incentives (§ 1001.952(ii)(2)) is available to protect remuneration furnished in ASM in the form of ASM beneficiary engagement incentives that meet all safe harbor requirements set forth in §§ 1001.952(ii) and 512.770.
(a) ASM beneficiary incentives. ASM participants may choose to provide in-kind patient engagement incentives, including but not limited to items of technology or services, to ASM beneficiaries, subject to the following conditions:
(1) Provision of incentive.
(i) The incentive must be provided directly by the ASM participant or by an agent of the ASM participant under the ASM participant's direction and control to an ASM beneficiary who is an established patient of the ASM participant.
(ii) The ASM participant must be solely responsible for any costs associated with the provision of the incentive, including but not limited to, the retail value of the item or services offered as the ASM beneficiary incentive.
(2) The item or service provided must be reasonably connected to medical care provided by the ASM participant to an ASM beneficiary for an ASM targeted chronic condition.
(3) The item or service must be a preventive care item or service or an item or service that advances a clinical goal, as specified in paragraph (d) of this section, for an ASM beneficiary by engaging the ASM beneficiary in better managing an ASM targeted chronic condition.
(4) The item or service must not be tied to the receipt of items or services outside the services furnished by the ASM participant to the ASM beneficiary.
(5) The item or service must not be tied to the receipt of items or services from a particular provider or supplier.
(6) The availability of the items or services must not be advertised or promoted, except that an ASM beneficiary may be made aware of the availability of the items or services at the time the ASM beneficiary could reasonably benefit from them.
(7) The cost of the items or services must not be shifted to any Federal health care program, as defined at section 1128B(f) of the Act.
(8) The totality of items or services, including technology as described at paragraph (b) of this section, provided to an ASM beneficiary may not exceed $1,000 in retail value for any one ASM beneficiary.
(b) Technology provided to an ASM beneficiary. ASM beneficiary incentives involving technology are subject to the following additional conditions:
(1) Items or services involving technology provided to an ASM beneficiary must be the minimum necessary to advance a clinical goal, as listed in paragraph (d) of this section, for an ASM beneficiary.
(2) Items of technology exceeding $75 in retail value must—
(i) Remain the property of the ASM participant; and
(ii) Be retrieved from the ASM beneficiary—
(A) Upon the end of their care relationship with the ASM participant, with documentation of the ultimate date of retrieval. The ASM participant must document all retrieval attempts.
(1) In cases when the item of technology is not able to be retrieved, the ASM participant must determine why the item was not retrievable.
(2) If it was determined that the item was misappropriated, then the ASM participant must take steps to prevent future beneficiary incentives for that ASM beneficiary.
(3) Following this process, documented, diligent, good faith attempts to retrieve items of technology is deemed to meet the retrieval requirement; or
(B) If the provided technology breaks or is otherwise rendered unusable for its intended purposes, with documentation of the ultimate date of retrieval. The ASM participant may replace the unusable unit with the same or similar technology, to the extent practicable, that meets the requirements of paragraphs (a) and (b) of this section.
(c) Documentation of ASM beneficiary incentives. In addition to requirements at § 512.135 of this part ASM participants must do all of the following:
(1) Maintain documentation of items and services furnished as beneficiary incentives that exceed $75 in retail value.
(2) The documentation must be established contemporaneously with the provision of the items and services with a record established and maintained to include at least the following:
(i) The date the incentive is provided.
(ii) The identity of the ASM beneficiary to whom the item or service was provided.
(3) The documentation regarding items of technology exceeding $75 in retail value must also include contemporaneous documentation of any attempt to retrieve technology at the end of an episode, or why the items were not retrievable, as described in paragraph (b)(2)(ii) of this section.
(4) The ASM participant must retain and provide access to the required documentation.
(d) Clinical goals of ASM. The following are the clinical goals of ASM, which may be advanced through ASM beneficiary incentives:
(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.
(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.
(a) Medicare payment waivers. Unless otherwise specified in § 512.710(a)(2), CMS waives the requirements of section 1848(q) of the Act, and its implementing regulations, for an ASM participant for each ASM performance year that the ASM participant meets the ASM eligibility criteria set forth in § 512.710(b).
(b) Waiver of certain telehealth requirements —
(1) Waiver of the geographic site requirements. Except for the geographic site requirements for a face-to-face encounter for home health certification, CMS waives the geographic site requirements of section 1834(m)(4)(C)(i)(I) through (III) of the Act for ASM participants and ASM beneficiaries solely for services that—
(i) May be furnished via telehealth under existing Medicare program requirements; and
(ii) Are medically appropriate for treatment of an ASM targeted chronic condition.
(2) Waiver of the originating site requirements. Except for the originating site requirements for a face-to-face encounter for home health certification, CMS waives the originating site requirements under section 1834(m)(4)(C)(ii)(I) through (VIII) of the Act for episodes to permit a telehealth visit to originate in the beneficiary's home or place of residence solely for services that—
(i) May be furnished via telehealth under existing Medicare program requirements; and
(ii) Are medically appropriate for treatment of an ASM targeted chronic condition.
(3) Waiver of selected payment provisions. CMS waives payment requirements as follows:
(i) Under section 1834(m)(2)(B) of the Act so that the facility fee normally paid by Medicare to an originating site for a telehealth service is not paid if the service is originated in the beneficiary's home or place of residence.
(ii) Under section 1834(m)(2)(A) of the Act to allow the distant site payment for telehealth home visit HCPCS codes unique to ASM.
(4) Other requirements. All other requirements for Medicare coverage and payment of telehealth services continue to apply, including the list of specific services approved to be furnished by telehealth.
[90 FR 50022, Nov. 5, 2025; 91 FR 12082, Mar. 12, 2026]
(a) General rule. Except as specified in paragraph (b) of this section, CMS—
(1) Applies determinations made under the Quality Payment Program for whether an extreme and uncontrollable circumstance has occurred and the affected area during the ASM performance year; and
(2) Has sole discretion to determine the period during which an extreme and uncontrollable circumstance occurred.
(b) Additional criteria.
(1) CMS has sole discretion to determine, based on information known to the agency prior to the beginning of the relevant ASM payment year, that data for an ASM participant are inaccurate, unusable, or otherwise compromised due to circumstances outside of the control of the clinician and its agents, including third-party intermediaries.
(2) CMS notifies ASM participants of the following:
(i) Its determination that the circumstances described at paragraph (b)(1) of this section exist; and
(ii) The impact of the circumstances described in paragraph (b)(1) of this section upon scoring methodology for affected ASM participants in a form and manner determined by CMS.
(c) Impact on final scores.
(1) Except as described in paragraph (c)(2) of this section, an ASM participant who CMS identified as having been affected by a circumstance described in paragraphs (a) or (b) of this section is exempt from meeting data submission requirements identified at § 512.720 and does not receive a final score, resulting in a neutral payment adjustment for the corresponding ASM payment year.
(2) In the event that an ASM participant who CMS identified as having been affected by a circumstance described in paragraph (a) or (b) of this section submits data in accordance with the data submission requirements at § 512.720, CMS assigns the ASM participant a final score using the methodology described at § 512.745 for the applicable ASM performance year.