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42 U.S.C. 1302, 1315a, and 1395hh.
85 FR 61362, Sept. 29, 2020, unless otherwise noted.
89 FR 69914, Aug. 28, 2024, unless otherwise noted.
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(a) Beneficiary freedom of choice.
(1) A TEAM participant, TEAM collaborators, collaboration agents, downstream collaboration agent and downstream participants must not restrict Medicare beneficiaries' ability to choose to receive care from any provider or supplier.
(2) The TEAM participant and its downstream participants must not commit any act or omission, nor adopt any policy that inhibits beneficiaries from exercising their freedom to choose to receive care from any provider or supplier or from any health care provider who has opted out of Medicare. The TEAM participant and its downstream participants may communicate to TEAM beneficiaries the benefits of receiving care with the TEAM participant, if otherwise consistent with the requirements of this part and applicable law.
(3) As part of discharge planning and referral, TEAM participants must provide a complete list of HHAs, SNFs, IRFs, or LTCHs that are participating in the Medicare program, and that serve the geographic area (as defined by the HHA) in which the patient resides, or in the case of a SNF, IRF, or LTCH, in the geographic area requested by the patient.
(i) This list must be presented to TEAM beneficiaries for whom home health care, SNF, IRF, or LTCH services are medically necessary.
(ii) TEAM participants must specify on the list those post-acute care providers on the list with whom they have a sharing arrangement.
(iii) TEAM participants may recommend preferred providers and suppliers, consistent with applicable statutes and regulations.
(iv) TEAM participants may not limit beneficiary choice to any list of providers or suppliers in any manner other than as permitted under applicable statutes and regulations.
(v) TEAM participants must take into account patient and family preferences for choice of provider and supplier when they are expressed.
(4) TEAM participants may not charge any TEAM collaborator a fee to be included on any list of preferred providers or suppliers, nor may the TEAM participant accept such payments.
(b) Required beneficiary notification —
(1) TEAM participant beneficiary notification —
(i) Notification to beneficiaries. Each TEAM participant must provide written notification to any TEAM beneficiary that meets the criteria in § 512.535 of his or her inclusion in the TEAM model.
(ii) Timing of notification. Prior to discharge from the anchor hospitalization, or prior to discharge from the anchor procedure, as applicable, the TEAM participant must provide the TEAM beneficiary with a beneficiary notification as described in paragraph (b)(1)(iv) of this section.
(iii) List of beneficiaries who have received a notification. The TEAM participant must be able to generate a list of all beneficiaries who have received such notification, including the date on which the notification was provided to the beneficiary, to CMS or its designee upon request.
(iv) Content of notification. The beneficiary notification must contain all of the following:
(A) A detailed explanation of TEAM and how it might be expected to affect the beneficiary's care.
(B) Notification that the beneficiary retains freedom of choice to choose providers and services.
(C) Explanation of how patients can access care records and claims data through an available patient portal, if applicable, and how they can share access to their Blue Button® electronic health information with caregivers.
(D) Explanation of the type of beneficiary-identifiable claims data the TEAM participant may receive.
(E) A statement that all existing Medicare beneficiary protections continue to be available to the TEAM beneficiary. These include the ability to report concerns of substandard care to Quality Improvement Organizations or the 1-800-MEDICARE helpline.
(F) A list of the providers, suppliers, and ACOs with whom the TEAM participant has a sharing arrangement. This requirement may be fulfilled by the TEAM participant including in the detailed notification a Web address where beneficiaries may access the list.
(2) TEAM collaborator notice. A TEAM participant must require every TEAM collaborator to provide written notice to applicable TEAM beneficiaries of TEAM, including information on the quality and payment incentives under TEAM, and the existence of its sharing arrangement with the TEAM participant.
(i) With the exception of ACOs, PGPs, NPPGPs, and TGPs, a TEAM participant must require every TEAM collaborator that furnishes an item or service to a TEAM beneficiary during an episode to provide written notice to the beneficiary of TEAM, including basic information on the quality and payment incentives under TEAM, and the existence of the TEAM collaborator's sharing arrangement.
(A) The notice must be provided no later than the time at which the beneficiary first receives an item or service from the TEAM collaborator during an episode. In circumstances where, due to the patient's condition, it is not feasible to provide notification at such time, the notification must be provided to the beneficiary or his or her representative as soon as is reasonably practicable.
(B) The TEAM collaborator must be able to provide a list of all beneficiaries who received such a notice, including the date on which the notice was provided to the beneficiary, to CMS upon request.
(ii) A TEAM participant must require every PGP, NPPGP, or TGP that is a TEAM collaborator where a member of the PGP, member of the NPPGP, or member of the TGP furnishes an item or service to a TEAM beneficiary during an episode to provide written notice to the beneficiary of TEAM, including basic information on the quality and payment incentives under TEAM, and the existence of the entity's sharing arrangement.
(A)
(1) The notice must be provided no later than the time at which the beneficiary first receives an item or service from any member of the PGP, member of the NPPGP, or member of the TGP, and the required PGP, NPPGP, or TGP notice may be provided by that member respectively.
(2) In circumstances where, due to the patient's condition, it is not feasible to provide notice at such times, the notice must be provided to the beneficiary or his or her representative as soon as is reasonably practicable.
(B) The PGP, NPPGP, or TGP must be able to provide a list of all beneficiaries who received such a notice, including the date on which the notice was provided to the beneficiary, to CMS upon request.
(iii) A TEAM participant must require every ACO that is a TEAM collaborator where an ACO participant or ACO provider/supplier furnishes an item or service to a TEAM beneficiary during an episode to provide written notice to the beneficiary of TEAM, including basic information on the quality and payment incentives under TEAM, and the existence of the entity's sharing arrangement.
(A)
(1) The notice must be provided no later than the time at which the beneficiary first receives an item or service from any ACO participant or ACO provider/supplier and the required ACO notice may be provided by that ACO participant or ACO provider/supplier respectively.
(2) In circumstances where, due to the patient's condition, it is not feasible to provide notice at such times, the notice must be provided to the beneficiary or his or her representative as soon as is reasonably practicable.
(B) The ACO must be able to provide a list of all beneficiaries who received such a notice, including the date on which the notice was provided to the beneficiary, to CMS upon request.
(3) Discharge planning notice. A TEAM participant must provide the beneficiary with a written notice of any potential financial liability associated with non-covered services recommended or presented as an option as part of discharge planning, no later than the time that the beneficiary discusses a particular post-acute care option or at the time the beneficiary is discharged from an anchor procedure or anchor hospitalization, whichever occurs earlier.
(i) If the TEAM participant knows or should have known that the beneficiary is considering or has decided to receive a non-covered post-acute care service or other non-covered associated service or supply, the TEAM participant must notify the beneficiary in writing that the service would not be covered by Medicare.
(ii) If the TEAM participant is discharging a beneficiary to a SNF after an inpatient hospital stay, and the beneficiary is being transferred to or is considering a SNF that would not qualify under the SNF 3-day waiver in § 512.580, the TEAM participant must notify the beneficiary in accordance with paragraph (b)(3)(i) of this section that the beneficiary will be responsible for payment for the services furnished by the SNF during that stay, except those services that would be covered by Medicare Part B during a non-covered inpatient SNF stay.
(4) Access to records and retention. Lists of beneficiaries that receive notifications or notices must be retained, and access provided to CMS, or its designees, in accordance with § 512.586.
(c) Availability of services.
(1) The TEAM participant and its downstream participants must continue to make medically necessary covered services available to beneficiaries to the extent required by applicable law. TEAM beneficiaries and their assignees retain their rights to appeal claims in accordance with part 405, subpart I of this chapter.
(2) The TEAM participant and its downstream participants must not take any action to select or avoid treating certain Medicare beneficiaries based on their income levels or based on factors that would render the beneficiary an “at-risk beneficiary” as defined at § 425.20 of this chapter.
(3) The TEAM participant and its downstream participants must not take any action to selectively target or engage beneficiaries who are relatively healthy or otherwise expected to improve the TEAM participant's or downstream participant's financial or quality performance.
(d) Descriptive TEAM materials and activities.
(1) The TEAM participant and its downstream participants must not use or distribute descriptive TEAM materials and activities that are materially inaccurate or misleading.
(2) The TEAM participant and its downstream participants must include the following statement on all descriptive TEAM materials and activities: “The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of the Centers for Medicare & Medicaid Services (CMS). The authors assume responsibility for the accuracy and completeness of the information contained in this document.”
(3) The TEAM participant and its downstream participants must retain copies of all written and electronic descriptive TEAM materials and activities and appropriate records for all other descriptive TEAM materials and activities in a manner consistent with § 512.135(c).
(4) CMS reserves the right to review, or have a designee review, descriptive TEAM materials and activities to determine whether or not the content is materially inaccurate or misleading. This review takes place at a time and in a manner specified by CMS once the descriptive TEAM materials and activities are in use by the TEAM participant.
The TEAM participant and its TEAM collaborators must comply with the requirements of § 403.1110(b) of this chapter and must otherwise cooperate with CMS' TEAM evaluation and monitoring activities as may be necessary to enable CMS to evaluate TEAM in accordance with section 1115A(b)(4) of the Act and to conduct monitoring activities under § 512.590, including producing such data as may be required by CMS to evaluate or monitor TEAM, which may include protected health information as defined in 45 CFR 160.103 and other individually-identifiable data.
(a) Right to audit. The Federal government, including CMS, HHS, and the Comptroller General, or their designees, has the right to audit, inspect, investigate, and evaluate any documents and other evidence regarding implementation of TEAM.
(b) Access to records. The TEAM participant and its TEAM collaborators must maintain and give the Federal government, including CMS, HHS, and the Comptroller General, or their designees, access to all such documents and other evidence sufficient to enable the audit, evaluation, inspection, or investigation of the implementation of TEAM, including without limitation, documents and other evidence regarding all of the following:
(1) The TEAM participant's and its downstream participants' compliance with the terms of TEAM.
(2) The accuracy of TEAM reconciliation payment amounts and repayment amounts.
(3) The TEAM participant's payment of amounts owed to CMS under TEAM.
(4) Quality measure information and the quality of services performed under the terms of TEAM.
(5) Utilization of items and services furnished under TEAM.
(6) The ability of the TEAM participant to bear the risk of potential losses and to repay any losses to CMS, as applicable.
(7) Patient safety.
(8) Other program integrity issues.
(c) Record retention.
(1) The TEAM participant and its downstream participants must maintain the documents and other evidence described in paragraph (b) of this section and other evidence for a period of 6 years from the last payment determination for the TEAM participant under TEAM or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—
(i) CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies the TEAM participant at least 30 days before the normal disposition date; or
(ii) There has been a termination, dispute, or allegation of fraud or similar fault against the TEAM participant or its downstream participants, in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the termination, dispute, or allegation of fraud or similar fault.
(2) If CMS notifies the TEAM participant of the special need to retain records in accordance with paragraph (c)(1)(i) of this section or there has been a termination, dispute, or allegation of fraud or similar fault against the TEAM participant or its downstream participants described in paragraph (c)(1)(ii) of this section, the TEAM participant must notify its downstream participants of this need to retain records for the additional period specified by CMS.
(a) CMS may—
(1) Use any data obtained under §§ 512.584, 512.586, or 512.590 to evaluate and monitor TEAM; and
(2) Disseminate quantitative and qualitative results and successful care management techniques, including factors associated with performance, to other providers and suppliers and to the public. Data disseminated may include patient—
(i) De-identified results of patient experience of care and quality of life surveys, and patient; and
(ii) De-identified measure results calculated based upon claims, medical records, and other data sources.
(b) Notwithstanding any other provision of this part, for all data that CMS confirms to be proprietary trade secret information and technology of the TEAM participant or its downstream participants, CMS or its designee(s) will not release this data without the express written consent of the TEAM participant or its downstream participant, unless such release is required by law.
(c) If the TEAM participant or its downstream participant wishes to protect any proprietary or confidential information that it submits to CMS or its designee, the TEAM participant or its downstream participant must label or otherwise identify the information as proprietary or confidential. Such assertions are subject to review and confirmation by CMS prior to CMS' acting upon such assertions.
(a) Compliance with laws. The TEAM participant and each of its downstream participants must comply with all applicable laws and regulations.
(b) CMS monitoring and compliance activities.
(1) CMS staff, or its approved designee, may conduct monitoring activities to ensure compliance by the TEAM participant and each of its downstream participants with the terms of TEAM under this subpart to—
(i) Understand TEAM participants' use of TEAM payments; and
(ii) Promote the safety of beneficiaries and the integrity of TEAM.
(2) Monitoring activities may include, without limitation, all of the following:
(i) Documentation requests sent to the TEAM participant and its downstream participants, including surveys and questionnaires.
(ii) Audits of claims data, quality measures, medical records, and other data from the TEAM participant and its downstream participants.
(iii) Interviews with members of the staff and leadership of the TEAM participant and its downstream participants.
(iv) Interviews with beneficiaries and their caregivers.
(v) Site visits to the TEAM participant and its downstream participants, performed in a manner consistent with paragraph (c) of this section.
(vi) Monitoring quality outcomes and clinical data, if applicable.
(vii) Tracking patient complaints and appeals.
(3) In conducting monitoring and oversight activities, CMS or its designees may use any relevant data or information including without limitation all Medicare claims submitted for items or services furnished to TEAM beneficiaries.
(c) Site visits.
(1) In a manner consistent with § 512.584, the TEAM participant and its downstream participants must cooperate in periodic site visits performed by CMS or its designees in order to facilitate the evaluation of TEAM and the monitoring of the TEAM participant's compliance with the terms of TEAM.
(2) CMS or its designee provides, to the extent practicable, the TEAM participant or downstream participant with no less than 15 days advance notice of any site visit. CMS—
(i) Attempts, to the extent practicable, to accommodate a request for particular dates in scheduling site visits; and
(ii) Does not accept a date request from a TEAM participant or downstream participant that is more than 60 days after the date of the CMS initial site visit notice.
(3) The TEAM participant and its downstream participants must ensure that personnel with the appropriate responsibilities and knowledge associated with the purpose of the site visit are available during all site visits.
(4) CMS may perform unannounced site visits at the office of the TEAM participant and any of its downstream participants at any time to investigate concerns about the health or safety of beneficiaries or other patients or other program integrity issues.
(5) Nothing in this part shall be construed to limit or otherwise prevent CMS from performing site visits permitted or required by applicable law.
(d) Reopening of payment determinations.
(1) CMS may reopen a TEAM payment determination on its own motion or at the request of a TEAM participant, within 4 years from the date of the determination, for good cause (as defined at § 405.986 of this chapter).
(2) CMS may reopen a TEAM payment determination at any time if there exists reliable evidence (as defined in § 405.902 of this chapter) that the determination was procured by fraud or similar fault (as defined in § 405.902 of this chapter).
(3) CMS's decision regarding whether to reopen a TEAM payment determination is binding and not subject to appeal.
(e) OIG authority. Nothing contained in the terms of TEAM limits or restricts the authority of the HHS Office of Inspector General or any other Federal government authority, including its authority to audit, evaluate, investigate, or inspect the TEAM participant or its downstream participants for violations of any Federal statutes, rules, or regulations.
(a) Grounds for remedial action. CMS may take one or more remedial actions described in paragraph (b) of this section if CMS determines that the TEAM participant or a downstream participant:
(1) Has failed to comply with any of the terms of TEAM, included in this subpart.
(2) Has failed to comply with any applicable Medicare program requirement, rule, or regulation.
(3) Has taken any action that threatens the health or safety of a beneficiary or other patient.
(4) Has submitted false data or made false representations, warranties, or certifications in connection with any aspect of TEAM.
(5) Has undergone a change in control that presents a program integrity risk.
(6) Is subject to any sanctions of an accrediting organization or a Federal, State, or local government agency.
(7) Is subject to investigation or action by HHS (including the HHS Office of Inspector General and CMS) or the Department of Justice due to an allegation of fraud or significant misconduct, including any of the following:
(i) Being subject to the filing of a complaint or filing of a criminal charge.
(ii) Being subject to an indictment.
(iii) Being named as a defendant in a False Claims Act qui tam matter in which the Federal government has intervened, or similar action.
(8) Has failed to demonstrate improved performance following any remedial action imposed under this section.
(9) Has misused or disclosed 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 TEAM data sharing agreement.
(b) Remedial actions. If CMS determines that one or more grounds for remedial action described in paragraph (a) of this section has taken place, CMS may take one or more of the following remedial actions:
(1) Notify the TEAM participant and, if appropriate, require the TEAM participant to notify its downstream participants of the violation.
(2) Require the TEAM participant to provide additional information to CMS or its designees.
(3) Subject the TEAM participant to additional monitoring, auditing, or both.
(4) Prohibit the TEAM participant from distributing TEAM payments, as applicable.
(5) Require the TEAM participant to terminate, immediately or by a deadline specified by CMS, its agreement with a downstream participant with respect to TEAM.
(6) Require the TEAM participant to submit a corrective action plan in a form and manner and by a date specified by CMS.
(7) Discontinue the provision of data sharing and reports to the TEAM participant.
(8) Recoup TEAM payments.
(9) Reduce or eliminate a TEAM payment otherwise owed to the TEAM participant.
(10) Such other action as may be permitted under the terms of this part.
There is no administrative or judicial review under sections 1869 or 1878 of the Act or otherwise for all of the following:
(a) The selection of models for testing or expansion under section 1115A of the Act.
(b) The selection of organizations, sites, or participants to test TEAM, including a decision by CMS to remove a TEAM participant or to require a TEAM participant to remove a downstream participant from TEAM.
(c) The elements, parameters, scope, and duration of testing or dissemination, including without limitation the following:
(1) The selection of quality performance standards for TEAM by CMS.
(2) The methodology used by CMS to assess the quality of care furnished by the TEAM participant.
(3) The methodology used by CMS to attribute TEAM beneficiaries to the TEAM participant, if applicable.
(d) Determinations regarding budget neutrality under section 1115A(b)(3) of the Act.
(e) The termination or modification of the design and implementation of TEAM under section 1115A(b)(3)(B) of the Act.
(f) Determinations about expansion of the duration and scope of TEAM under section 1115A(c) of the Act, including the determination that TEAM is not expected to meet criteria described in paragraph (a) or (b) of this section.
(a) Notice of bankruptcy. If the TEAM participant has filed a bankruptcy petition, whether voluntary or involuntary, the TEAM participant must provide written notice of the bankruptcy to CMS and to the U.S. Attorney's Office in the district where the bankruptcy was filed, unless final payment has been made by either CMS or the TEAM participant under the terms of TEAM and all administrative or judicial review proceedings relating to any TEAM payments have been fully and finally resolved.
(1) The notice of bankruptcy must be sent by certified mail no later than 5 days after the petition has been filed and must contain a copy of the filed bankruptcy petition (including its docket number).
(2) The notice to CMS must be addressed to the CMS Office of Financial Management at 7500 Security Boulevard, Mailstop C3-01-24, Baltimore, MD 21244 or such other address as may be specified on the CMS website for purposes of receiving such notices.
(b) Notice of legal name change. A TEAM participant must furnish written notice to CMS within 30 days of any change in its legal name becomes effective. The notice of legal name change must meet all of the following:
(1) Be in a form and manner specified by CMS.
(2) Include a copy of the legal document effecting the name change, which must be authenticated by the appropriate State official.
(c) Notice of change in control.
(1) A TEAM participant must furnish written notice to CMS in a form and manner specified by CMS at least 90 days before any change in control becomes effective.
(2) If CMS determines, in accordance with § 512.592(a)(5), that a TEAM participant's change in control would present a program integrity risk, CMS may—
(i) Take remedial action against the TEAM participant under § 512.160(b).
(ii) Require immediate reconciliation and payment of all monies owed to CMS by a TEAM participant that is subject to a change in control.
(a) Termination of TEAM.
(1) CMS may terminate TEAM for reasons including, but not limited to, the following:
(i) CMS determines that it no longer has the funds to support TEAM.
(ii) CMS terminates TEAM in accordance with section 1115A(b)(3)(B) of the Act.
(2) If CMS terminates TEAM, CMS provides written notice to the TEAM participant specifying the grounds for termination and the effective date of such termination.
(b) Notice of a TEAM participant's termination from TEAM. If a TEAM participant receives notification that it has been terminated from TEAM and wishes to dispute the termination, it must provide a written notice to CMS requesting review of the termination within 10 calendar days of the notice.
(1) CMS has 30 days to respond to the TEAM participant's request for review.
(2) If the TEAM participant fails to notify CMS, the termination is deemed final.