(a) Accountability for beneficiaries. As part of its application and participation agreement, the ACO must certify that the ACO, its ACO participants, and its ACO providers/suppliers have agreed to become accountable for the quality, cost, and overall care of the Medicare fee-for-service beneficiaries assigned to the ACO.
(b) Disclosure of prior participation. (1) The ACO must disclose to CMS whether the ACO, its ACO participants, or its ACO providers/suppliers have participated in the Medicare Shared Savings Program under the same or a different name, or is related to or has an affiliation with another Shared Savings Program ACO.
(1) The ACO must disclose to CMS whether the ACO, its ACO participants, or its ACO providers/suppliers have participated in the Medicare Shared Savings Program under the same or a different name, or is related to or has an affiliation with another Shared Savings Program ACO.
(2) The ACO must specify whether the related participation agreement is currently active or has been terminated. If it has been terminated, the ACO must specify whether the termination was voluntary or involuntary.
(3) If the ACO, ACO participant, or ACO provider/supplier was previously terminated from the Shared Savings Program, the ACO must identify the cause of termination and what safeguards are now in place to enable the ACO, ACO participant, or ACO provider/supplier to participate in the program for the full term of the participation agreement.
(c) Eligibility. (1) As part of its application, and upon request thereafter, an ACO must submit to CMS the following supporting materials to demonstrate that the ACO satisfies the requirements set forth in this part:
(1) As part of its application, and upon request thereafter, an ACO must submit to CMS the following supporting materials to demonstrate that the ACO satisfies the requirements set forth in this part:
(i) Documents (for example, ACO participant agreements, agreements with ACO providers/suppliers, employment contracts, and operating policies) sufficient to describe the ACO participants' and ACO providers'/suppliers' rights and obligations in and representation by the ACO, and how the opportunity to receive shared savings or other financial arrangements will encourage ACO participants and ACO providers/suppliers to adhere to the quality assurance and improvement program and evidence-based clinical guidelines.
(ii) A description, or documents sufficient to describe, how the ACO will implement the required processes and patient-centeredness criteria under Sec. 425.112, including descriptions of the remedial processes and penalties (including the potential for expulsion) that will apply if an ACO participant or an ACO provider/supplier fails to comply with and implement these processes.
(iii) Materials documenting the ACO's organization and management structure, including an organizational chart, a list of committees (including names of committee members) and their structures, and job descriptions for senior administrative and clinical leaders specifically noted in Sec. 425.108 and Sec. 425.112(a)(2).
(iv) Evidence that the governing body--
(A) Is an identifiable body;
(B) Represents a mechanism for shared governance for ACO participants;
(C) Is composed of representatives of its ACO participants; and
(D) Is at least 75 percent controlled by its ACO participants.
(v) Evidence that the governing body includes a Medicare beneficiary representative(s) served by the ACO who does not have a conflict of interest with the ACO, and who has no immediate family member with conflict of interest with the ACO.
(vi) A copy of the ACO's compliance plan or documentation describing the plan that will be put in place at the time the participation agreement with CMS becomes effective.
(2) Upon request, the ACO must provide copies of all documents effectuating the ACO's formation and operation, including, without limitation the following:
(i) Charters.
(ii) By-laws.
(iii) Articles of incorporation.
(iv) Partnership agreement.
(v) Joint venture agreement.
(vi) Management or asset purchase agreements.
(vii) Financial statements and records.
(viii) Resumes and other documentation required for leaders of the ACO.
(3) If an ACO requests an exception to the governing body requirement in Sec. 425.106(c)(2) or (c)(3), the ACO must describe--
(i) Why it seeks to differ from the requirement; and
(ii) If seeking an exception to (c)(2), how the ACO will provide meaningful representation in ACO governance by Medicare beneficiaries.
(iii) If seeking an exception to the requirement at (c)(3), why the ACO is unable to meet the requirement and how it will involve ACO participants in innovative ways in ACO governance.
(4)(i) An ACO must certify that it is recognized as a legal entity in the State, Federal or Tribal area in which it was established and that it is authorized to conduct business in each State or Tribal area in which it operates.
(i) An ACO must certify that it is recognized as a legal entity in the State, Federal or Tribal area in which it was established and that it is authorized to conduct business in each State or Tribal area in which it operates.
(ii) An ACO formed among two or more ACO participants must provide evidence in its application that it is a legal entity separate from any of the ACO participants.
(5) The ACO must provide CMS with such information regarding its ACO participants and its ACO providers/suppliers participating in the program as is necessary to implement the program.
(i) The ACO must submit a list of all ACO participants and ACO providers/suppliers in accordance with Sec. 425.118.
(ii) ACOs must also submit any other specific identifying information as required by CMS in the application process.
(iii) If the ACO includes an FQHC or RHC as an ACO participant, it must also do the following:
(A) Indicate the TINs, organizational NPIs, and other identifying information for its participant FQHCs or RHCs or both, as well as NPIs and other identifying information for the physicians that directly provide primary care services in the participant FQHCs or RHCs or both.
(B) Submit any other specific identifying information for its participant FQHCs or RHCs or both as required by CMS in the application process.
(iv) The ACO must certify the accuracy of this information.
(6) As part of the application process and upon request by CMS, the ACO must submit documents demonstrating that its ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to ACO activities are required to comply with the requirements of the Shared Savings Program. The evidence to be submitted must include, without limitation, sample or form agreements and, in the case of ACO participant agreements, the first and signature page(s) of each executed ACO participant agreement. CMS may request all pages of an executed ACO participant agreement to confirm that it conforms to the sample form agreement submitted by the ACO. The ACO must certify that all of its ACO participant agreements comply with the requirements of this part.
(d) Distribution of savings. As part of its application to participate in the Shared Savings Program, an ACO must describe the following:
(1) How it plans to use shared savings payments, including the criteria it plans to employ for distributing shared savings among its ACO participants and ACO providers/suppliers.
(2) How the proposed plan will achieve the specific goals of the Shared Savings Program.
(3) How the proposed plan will achieve the general aims of better care for individuals, better health for populations, and lower growth in expenditures.
(e) Selection of track and option for interim payment calculation. (1) As part of its application, an ACO must specify the Track for which it is applying (as described in Sec. 425.600).
(1) As part of its application, an ACO must specify the Track for which it is applying (as described in Sec. 425.600).
(2)(i) An ACO applying to participate in the program with a start date of April 1, 2012 or July 1, 2012, has the option of requesting an interim payment calculation based on the financial performance for its first 12 months of program participation and quality performance for CY 2012.
(i) An ACO applying to participate in the program with a start date of April 1, 2012 or July 1, 2012, has the option of requesting an interim payment calculation based on the financial performance for its first 12 months of program participation and quality performance for CY 2012.
(ii) An ACO must request interim payment calculation as part of its application to participate in the Shared Savings Program.
(f) Assurance of ability to repay. (1) An ACO must have the ability to repay all shared losses for which it may be liable under a two-sided model.
(1) An ACO must have the ability to repay all shared losses for which it may be liable under a two-sided model.
(i) As part of the application or participation agreement renewal process, an ACO that is seeking to participate under a two-sided model of the Shared Savings Program must submit for CMS approval documentation that it is capable of repaying shared losses that it may incur during the agreement period.
(ii) The documentation specified in paragraph (f)(1)(i) of this section must include details supporting the adequacy of the mechanism for repaying shared losses equal to at least 1 percent of the ACO's total per capita Medicare parts A and B fee-for-service expenditures for its assigned beneficiaries based on expenditures used to calculate the benchmark for the applicable agreement period, as estimated by CMS at the time of application or participation agreement renewal.
(2) An ACO may demonstrate its ability to repay shared losses by placing funds in escrow, obtaining a surety bond, establishing a line of credit (as evidenced by a letter of credit that the Medicare program can draw upon), or establishing a combination of such repayment mechanisms, that will ensure its ability to repay the Medicare program.
(3) An ACO participating under a two-sided model must demonstrate the adequacy of this repayment mechanism prior to the start of each agreement period in which it takes risk, and upon request thereafter. After the repayment mechanism has been used to repay any portion of shared losses owed to CMS, the ACO must replenish the amount of funds available through the repayment mechanism within 90 days.
(4) The repayment mechanism must be in effect for a sufficient period of time after the conclusion of the agreement period to permit CMS to calculate the amount of shared losses owed and to collect this amount from the ACO.
(g) Consideration of claims billed under merged and acquired Medicare-enrolled TINs. An ACO may request that CMS consider, for purposes of beneficiary assignment and establishing the ACO's benchmark under Sec. 425.602, claims billed by Medicare-enrolled entities' TINs that have been acquired through sale or merger by an ACO participant.
(1) The ACO may include an acquired Medicare-enrolled entity's TIN on its ACO participant list under the following circumstances:
(i) The ACO participant has subsumed the acquired entity's TIN in its entirety, including all of the providers and suppliers that reassigned their right to receive Medicare payment to the acquired entity's Medicare-enrolled TIN.
(ii) Each provider or supplier that previously reassigned his or her right to receive Medicare payment to the acquired entity's TIN has reassigned his or her right to receive Medicare payment to the TIN of the acquiring ACO participant and has been added to the ACO provider/supplier list under paragraph (c)(5) of the section.
(iii) The acquired entity's TIN is no longer used to bill Medicare.
(2) The ACO must submit the following supporting documentation in the form and manner specified by CMS.
(i) An attestation that--
(A) Identifies by Medicare-enrolled TIN both the acquired entity and the ACO participant that acquired it;
(B) Specifies that all the providers and suppliers that previously reassigned their right to receive Medicare payment to the acquired entity's TIN have reassigned such right to the TIN of the identified ACO participant and have been added to the ACO provider/supplier list under paragraph (c)(5) of this section; and
(C) Specifies that the acquired entity's TIN is no longer used to bill Medicare.
(ii) Documentation sufficient to demonstrate that the acquired entity's TIN was merged with or purchased by the ACO participant. [76 FR 67973, Nov. 2, 2011, as amended at 80 FR 32837, June 9, 2015]