ACO REACH STANDARDS

1.1.          Participant Provider Agreement.  All terms and conditions below apply to that certain Participant Provider Agreement by and between Provider and the ACO (the “Participant Provider Agreement”).  Provider agrees to comply with all terms and conditions of the Participant Provider Agreement and those set forth in these Provider ACO REACH Model Requirements.  Capitalized terms used below that are not defined below have the meaning given to them in the Participant Provider Agreement, unless otherwise specified below.

1.2.          General.

(a)            Provider is required to be a Medicare-enrolled provider (as defined at 42 CFR § 400.202) or supplier (as defined at 42 CFR § 400.202) by the time that Provider is added to ACO’s Participant Provider List, or such other later date as may be specified by CMS, that bills for items and services it furnishes to Beneficiaries under a Medicare billing number assigned to a TIN in accordance with applicable Medicare regulations.  Provider is not a Preferred Provider or a Prohibited Participant, as defined in the Participation Agreement.

(b)            Provider agrees to participate in the ACO REACH Model, to engage in ACO Activities, to comply with the applicable terms of the ACO REACH Model as set forth in the Participation Agreement, including any provisions regarding the following: participant exclusivity; Voluntary Alignment Activities; Marketing Activities; Beneficiary freedom of choice; participation in evaluation, shared learning, monitoring, and oversight activities; ACO compliance plan; and audit and record retention requirements.  Provider agrees to comply with all applicable laws and regulations, as further outlined below and in the Participation Agreement.  Provider acknowledges and agrees that ACO has provided Provider with a copy of the Participation Agreement and shall provide Provider with copies of any amendments thereto and the ACO Model Participation Agreement, and that a copy of such documents shall be made available to Provider Clinicians.

1.3.          Availability of Services.  Provider is required to make Medically Necessary Covered Services available to Beneficiaries in accordance with applicable laws, regulations and guidance.  Beneficiaries and their assignees retain their right to appeal claims determinations in accordance with 42 CFR Part 405, Subpart I.  Provider shall not take any action to avoid treating At-Risk Beneficiaries or to target certain Beneficiaries for services for the purpose of trying to affect the population of Beneficiaries aligned to ACO for a subsequent Performance Year.

1.4.          Prohibition on Influencing or Attempting to Influence the Beneficiary. 

(a)            Provider shall not directly or indirectly, commit any act or omission, nor adopt any policy, that coerces or otherwise influences a Beneficiary’s decision to complete or not complete a Voluntary Alignment Form or a MyMedicare.gov designation, including but not limited to the following:

(i)            Completing a Voluntary Alignment Form on behalf of the Beneficiary;

(ii)          Designating a primary clinician on MyMedicare.gov on behalf of the Beneficiary;

(iii)        Including the Voluntary Alignment Form and instructions with any other materials or forms, including but not limited to materials requiring the signature of the Beneficiary; and

(iv)        Withholding or threatening to withhold medical services or limiting or threatening to limit access to care.

(b)            The Provider may answer questions from Beneficiaries regarding Voluntary Alignment, but is prohibited from completing a Voluntary Alignment Form or designating a clinician on MyMedicare.gov on behalf of the Beneficiary. 

(c)            Provider shall instruct Beneficiaries to call ACO for questions about how to make changes to a Voluntary Alignment Form or how to designate a primary clinician on MyMedicare.gov.

1.5.          Beneficiary Freedom of Choice.  Provider shall not commit any act or omission, nor adopt any policy, that inhibits Beneficiaries from exercising their freedom to obtain health services from providers and suppliers who are not Participant Providers or Preferred Providers.  This prohibition shall not apply to referrals made by employees or contractors who are operating within the scope of their employment or contractual arrangement with the employer or contracting entity, provided that the employees and contractors remain free to make referrals without restriction or limitation if a Beneficiary expresses a preference for a different provider or supplier, or the referral is not in the Beneficiary’s best medical interests in the judgment of the referring party.  For the avoidance of doubt, ACO is prohibited from requiring prior authorization for services furnished to Beneficiaries.

1.6.          Prohibition on Beneficiary Inducements.  Provider shall not provide gifts or other remuneration to Beneficiaries to induce them to receive items or services from the ACO, Provider, or ACO Participant or Preferred Providers or to induce them to continue to receive items or services from ACO, Provider, or ACO Participant or Preferred Providers.

1.7.          Marketing. 

(a)            Provider is prohibited from conducting Marketing Activities, as defined in the Participation Agreement, before the Start Date or such other date specified by CMS.  In conducting Marketing Activities, Provider shall not:

(i)            Conduct Marketing Activities outside the ACO Service Area, as defined in the Participation Agreement;

(ii)          Conduct communication or activities related to Medicare Advantage or any other Medicare managed care plan targeted to Beneficiaries;

(iii)        Discriminate or selectively target Beneficiaries based on race, ethnicity, national origin, religion, gender, sex, age, mental or physical disability, health status, receipt of health care, claims experience, medical history, genetic information, evidence of insurability, geographic location, or income;

(iv)        Use Marketing Materials or engage in Marketing Activities until such Marketing Materials and Marketing Activities are reviewed and approved by CMS;

(v)          Engage in activities that could mislead or confuse a Beneficiary regarding the ACO REACH Model, Medicare benefits, or ACO;

(vi)        Claim ACO is recommended or otherwise endorsed by CMS or that CMS recommends that the Beneficiary select Provider as his or her main doctor, main provider, and/or the main place the Beneficiary receives care;

(vii)       Expressly state or imply that selecting Provider as the Beneficiary’s main doctor, main provider, and/or the main place the Beneficiary receives care removes a Beneficiary’s freedom to choose to obtain health services from providers and suppliers who are not a ACO Participant Provider or Preferred Provider;

(viii)     Use Marketing Materials or conduct Marketing Activities through the use of door-to-door solicitation, including leaving information such as a leaflet or flyer at a residence, approaching Beneficiaries in common areas, such as parking lots, hallways, lobbies, sidewalks, or using telephonic solicitation, including text messages and leaving voicemail messages.  This restriction does not apply to solicitation in common areas of a health care setting, which is subject to the limitations as set forth in the Participation Agreement;

(ix)        Conduct Marketing Activities in restricted areas of a health care setting.  Restricted areas of a health care setting include, but are not limited to, exam rooms, hospital patient rooms, treatment areas (where patients interact with a health care provider and his/her clinical team and receive treatment, including dialysis treatment facilities), and pharmacy counter areas (where patients interact with pharmacy providers and obtain medications). 

(b)            Provider shall promptly discontinue the use of any Marketing Materials and Marketing Activities reviewed and disapproved by CMS.  Any material changes to CMS-approved Marketing Materials and Marketing Activities must be submitted to CMS and approved by CMS, or deemed approved in accordance with the Participation Agreement before use.

(c)            `Provider is able to conduct Marketing Activities through unsolicited direct contact with Beneficiaries using conventional mail and other print media or email, provided that the Beneficiaries are given an opportunity to opt-out of subsequent such contacts.

1.8.          Provision of Certain Claims Data and Beneficiary Reports.  Provider acknowledges and agrees, and shall cause each Provider Clinician to agree, that data disclosed to Provider pursuant to the HIPAA-Covered Disclosure Request Attestation and Data Specification Worksheet may be retained by the Provider until the expiration or termination of the Participation Agreement.  Provider is permitted to retain any individually identifiable health information from such data files or derivative data files after the expiration or termination of the Participation Agreement if the Provider is a HIPAA covered entity, and the data has been incorporated into the subject Beneficiaries’ medical records that are part of a designated record set under HIPAA. Furthermore, any HIPAA covered entity to whom the Provider provides such data in the course of carrying out the ACO REACH Model may also retain such data if the recipient entity is a HIPAA covered entity or business associate and the data is incorporated into the subject Beneficiaries’ medical records that are part of a designated record set under HIPAA. The Provider shall destroy all other data and send written certification of the destruction of the data files and/or any derivative data files to CMS within thirty (30) days following the expiration or termination of the Participation Agreement, except as CMS shall authorize in writing or as otherwise required by law.  Except for disclosures for treatment purposes, Provider and any downstream recipients, shall abide by these terms and conditions as a condition of disclosing such data to downstream entities and permitting them to retain such records under the Participation Agreement. 

1.9.          Patient Centered Care. Provider acknowledges that ACO shall define, establish, implement, and periodically update processes for delivery of care to Beneficiaries in a patient-centered manner.  Provider shall comply with and shall require Provider Clinicians to comply with such patient-centered care processes of ACO, including:

(a)            Promotion of evidence-based medicine, such as through the establishment and implementation of evidence-based guidelines.

(b)            Beneficiary/caregiver engagement, and the use of shared decision making processes that take into account Beneficiaries’ unique needs, preferences, values, and priorities.  Measures for promoting Beneficiary engagement include, but are not limited to, the use of decision support tools and shared decision making methods with which the Beneficiary can assess the merits of various treatment options in the context of his or her values and convictions.  Beneficiary engagement also includes methods for fostering what might be termed “health literacy” in Beneficiaries and their families or caregivers.

(c)            Coordination of Beneficiaries’ care and care transitions (e.g., sharing of electronic summary records across health care providers, telehealth, remote Beneficiary monitoring, and other enabling technologies).

(d)            Providing Beneficiaries access to their own medical records and to clinical knowledge so that they may make informed choices about their care.

(e)            Ensuring individualized care for Beneficiaries, such as through personalized care plans.

(f)             Routine assessment of Beneficiary and caregiver and/or family experience of care and seek to improve where possible.

(g)            Providing care that is integrated with the community resources Beneficiaries require.  

ACO shall institute remedial processes and penalties, as appropriate, if Provider fails to comply with or implement a required process or protocol.

1.10.   Evaluation Requirements.  Provider is required to participate and cooperate in any such independent evaluation activities, including monitoring and oversight requests and activities, conducted by or on behalf of CMS.

1.11.   Release of Information.  Provider agrees it shall obtain prior approval from CMS during the term of the Participation Agreement and for one (1) year thereafter for the publication or release of any press release, external report or statistical/analytical material that materially and substantially references ACO’s participation in the ACO REACH Model.  External reports and statistical/analytical material may include, but are not limited to, papers, articles, professional publications, speeches, and testimony.  All external reports and statistical/analytical material that are subject to this requirement must include the following statement on the first page: “The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS.  The authors assume responsibility for the accuracy and completeness of the information contained in this document.”

1.12.   Maintenance of Records.  Provider shall maintain, and give the government access to, all books, contracts, records, documents, and other evidence (including data related to Medicare utilization and costs, quality performance measures, and financial arrangements) sufficient to enable the audit, evaluation, inspection, or investigation of the ACO REACH Model, including the subjects identified in the Participation Agreement.  Provider is required to maintain, such books, contracts, records, documents, and other evidence for a period of ten (10) years from the expiration or termination of the Participant Provider Agreement or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless:

(a)            CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies ACO at least thirty (30) calendar days before the normal disposition date; or

(b)            There has been a termination, dispute, or allegation of fraud or similar fault against ACO or Provider related to ACO Activities, in which case the records shall be maintained for an additional six (6) years from the date of any resulting final resolution of the termination, dispute, or allegation of fraud or similar fault.

1.13.   Electronic Health Records Software.  If the Participant Provider Agreement involves the provision of electronic health records software to Provider, such software shall be interoperable (as defined in 42 C.F.R. § 411.351) or satisfy 42 C.F.R. § 411.357(w)(2) (related to interoperability) at the time it is provided to Provider.

1.14.   Material Breach.  Provider’s, or any Provider Clinician’s, non-compliance with any provision set forth herein shall constitute a breach of a material term of the Participant Provider Agreement.

1.15.   Compliance with Laws.

(a)            Provider shall comply with, and cause Provider Clinicians to comply with, all applicable federal and state laws, regulations, and other legal authorities, including: (i) federal criminal law; (ii) the federal False Claims Act (31 U.S.C. § 3729 et seq.); (iii) the federal anti-kickback statute (42 U.S.C. § 1320a-7b(b)); (iv) the federal civil monetary penalties law (42 U.S.C. § 1320a-7a); (v) the federal physician self-referral law (42 U.S.C. § 1395nn); (vi) the federal Antitrust laws (including, without limitation, 15 U.S.C. §§ 1-7 and 15 U.S.C. § 18, respectively the Sherman Act and Section 7 of the Clayton Act); and (vii) all federal and state laws and regulations governing the confidentiality and disclosure of patient records and personal information, including, the Health Insurance Portability and Accountability Act, the Health Information Technology for Economic and Clinical Health Act, and the regulations promulgated thereunder, as amended (collectively “HIPAA”).  The Parties agree to the terms and conditions set forth in the Business Associate Addendum.  The Participation Agreement does not waive any obligation of Provider to comply with the terms of any other CMS contract, agreement, model, or demonstration.  Provider and its providers and personnel shall cooperate with ACO in its efforts to ensure compliance with all applicable laws as interpreted and implemented by regulations, rulings, case law and applicable governmental agency guidance.  In particular, and without limiting the broad application of the preceding sentences, Provider agrees to, and shall cause its providers and personnel to, support and comply with financial risk sharing terms and conditions, clinical integration policies and procedures, contracting process requirements, and any related compliance measures that ACO takes to promote and facilitate compliance with applicable laws, including without limitation ACO’s Compliance Program, as amended from time to time. 

(b)            Provider shall also comply with, and cause Provider Clinicians to comply with, any applicable Data Use Agreement between ACO and CMS, if so required, and with any other applicable data use and privacy restrictions imposed on ACO by CMS.

(c)            The Parties to the Participant Provider Agreement acknowledge their obligation to comply with Section 1861(v)(1)(I) of the Social Security Act, as amended, and written regulations promulgated thereunder.  Accordingly, the Parties agree to comply with the following statutory requirements governing the maintenance of documentation to verify the cost of any goods provided or services rendered pursuant to the Participant Provider Agreement: (i) until the expiration of four (4) years after the furnishing of any goods or services pursuant to the Participant Provider Agreement, each Party will make available, upon written request of the Secretary of the Department of Health and Human Services, the Comptroller General of the United States, or any of their duly authorized representatives, copies of the Participant Provider Agreement and any books, documents, records, or other data of such Party that are necessary to certify the nature and extent of costs incurred for such goods or services; and (ii) if a Party carries out any of its duties under the Participant Provider Agreement through a subcontract with a related organization involving a value or cost of Ten Thousand Dollars ($10,000) or more over a twelve (12)-month period, such Party will cause each such subcontract to contain a clause to the effect that, until the expiration of four (4) years after the furnishing of any goods or services pursuant to such subcontract, the related organization will make available, upon written request of the Secretary of the Department of Health and Human Services, the Comptroller General of the United States, or any of their duly authorized representatives, copies of such subcontract and any books, documents, records or other data of such related organization that are necessary to certify the nature and extent of such costs.

1.16.   Maintenance and Updating of Identification Data.  Provider shall provide ACO with all Participant Provider locations, TINs and National Provider Identifiers (“NPIs”) used by Provider, Provider Clinicians, and all other individuals or entities who bill CMS for services under Provider’s Medicare-enrolled TIN.  Such locations, TINs, and NPIs shall be listed in Exhibit 1 of the Participant Provider Agreement.  Provider shall update its Medicare enrollment information, including the addition or deletion of individuals or entities that bill CMS for services under Provider’s TIN, on a timely basis, in accordance with CMS program requirements, including, but not limited to, 42 CFR 424.516, and shall notify ACO of any such changes along with all other pertinent information to be included on Exhibit 1 of the Participant Provider Agreement within thirty (30) days after the change (a “Provider Addition/Deletion”).  Not in limitation of the foregoing, Provider shall notify ACO within fifteen (15) days of any change to the locations, TINs, or NPIs used by Provider, Provider Clinicians, or other individuals or entities who bill CMS for services under Provider’s Medicare-enrolled TIN, whether or not such locations, TINs or NPIs were previously reported on Exhibit 1 of the Participant Provider Agreement.  As promptly as reasonably practicable following receipt of notice of a Provider Addition/Deletion, ACO shall (i) update Exhibit 1 of the Participant Provider Agreement (which updated Exhibit may be separately maintained by ACO and need not be attached to the Participant Provider Agreement) to reflect such Provider Addition/Deletion (provided that ACO, in its reasonable discretion, may elect not to include any newly added individual as a Provider Clinician hereunder, in which event such individual will not be reflected on Exhibit 1 of the Participant Provider Agreement), and (ii) notify Provider (and, if applicable, such newly added Provider Clinician) of such update prior to submission thereof to CMS.  For the avoidance of doubt, a Participant Provider that is added to the Participant Provider List during a Performance Year is prohibited from participating in ACO’s selected ACO Capitation Payment Mechanism (i.e., PCC Payment) and the APO (if applicable) for the Performance Year in which the Participant Provider is so added. 

1.17.       Use of CEHRT.  During the Term of the Participant Provider Agreement, Provider shall ensure that each Provider Clinician that is an eligible clinician shall use certified electronic health record technology to document and communicate clinical care to their patients or other health care providers.  For the purpose of this paragraph, the terms “eligible clinician” and “certified electronic health record technology” have the definitions provided at 42 C.F.R. § 414.1305.  Provider shall also ensure that Provider and all Provider Clinicians comply with the forthcoming final rule, if adopted, on Interoperability and Patient Access.

Last revised May 30, 2023