Title 42—Public Health--Volume 1
PART 512—STANDARD PROVISIONS FOR MANDATORY INNOVATION CENTER MODELS AND SPECIFIC PROVISIONS FOR THE RADIATION ONCOLOGY MODEL AND THE END-STAGE RENAL DISEASE TREATMENT CHOICES MODEL
§ 512.570   Downstream distribution arrangements.
(a) General. (1) An ACO participant that is a PGP, NPPGP, or TGP and that has entered into a distribution arrangement with a TEAM collaborator that is an ACO, may distribute all or a portion of any distribution payment it receives from the TEAM collaborator only in accordance with a downstream distribution arrangement.
(2) All downstream distribution arrangements must comply with the provisions of this section and all applicable laws and regulations, including the fraud and abuse laws.
(b) Requirements. (1) All downstream distribution arrangements must be in writing and signed by the parties, contain the effective date of the agreement, and be entered into before care is furnished to TEAM beneficiaries under the downstream distribution arrangement.
(2) Participation in a downstream distribution arrangement must be voluntary and without penalty for nonparticipation.
(3) The downstream distribution arrangement must require the downstream collaboration agent to comply with all applicable laws and regulations.
(4) The opportunity to make or receive a downstream distribution payment must not be conditioned directly or indirectly on the volume or value of past or anticipated referrals or business otherwise generated by, between or among the TEAM participant, any TEAM collaborator, any collaboration agent, any downstream collaboration agent, or any individual or entity affiliated with a TEAM participant, TEAM collaborator, collaboration agent, or downstream collaboration agent.
(5) The amount of any downstream distribution payments from an NPPGP to an NPPGP member or from a TGP to a TGP member must be determined in accordance with a methodology that is solely based on quality of care and the provision of TEAM activities and that may take into account the amount of such TEAM activities provided by a downstream collaboration agent relative to other downstream collaboration agents.
(6) The amount of any downstream distribution payments from a PGP must be determined in accordance with a methodology that is solely based on quality of care and the provision of TEAM activities and that may take into account the amount of such TEAM activities provided by a downstream collaboration agent relative to other downstream collaboration agents.
(7) A downstream collaboration agent is eligible to receive a downstream distribution payment only if the downstream collaboration agent furnished an item or service to a TEAM beneficiary during an episode that is attributed to the same performance year for which the TEAM participant accrued the internal cost savings or earned the reconciliation payment amount that comprises the gainsharing payment from which the ACO made the distribution payment to the PGP, NPPGP, or TGP that is an ACO participant.
(8) The total amount of all downstream distribution payments made to downstream collaboration agents must not exceed the amount of the distribution payment received by the PGP, NPPGP, or TGP from the ACO.
(9) All downstream distribution payments must be made by check, electronic funds transfer, or another traceable cash transaction.
(10) The downstream collaboration agent must retain his or her ability to make decisions in the best interests of the beneficiary, including the selection of devices, supplies, and treatments.
(11) The downstream distribution arrangement must not—
(i) Induce the downstream collaboration agent to reduce or limit medically necessary services to any Medicare beneficiary; or
(ii) Reward the provision of items and services that are medically unnecessary.
(12) The PGP, NPPGP, or TGP must maintain contemporaneous documentation regarding downstream distribution arrangements in accordance with § 512.586, including the following:
(i) The relevant written agreements.
(ii) The date and amount of any downstream distribution payment.
(iii) The identity of each downstream collaboration agent that received a downstream distribution payment.
(iv) A description of the methodology and accounting formula for determining the amount of any downstream distribution payment.
(13) The PGP, NPPGP, or TGP may not enter into a downstream distribution arrangement with any PGP member, NPPGP member, or TGP member who has—
(i) A sharing arrangement with a TEAM participant.
(ii) A distribution arrangement with the ACO that the PGP, NPPGP, or TGP is a participant in.
(14) The PGP, NPPGP, or TGP must retain and provide access to, and must require downstream collaboration agents to retain and provide access to, the required documentation in accordance with § 512.586.
§ 512.575   TEAM beneficiary incentives.
(a) General. TEAM participants may choose to provide in-kind patient engagement incentives including but not limited to items of technology to TEAM beneficiaries in an episode, subject to the following conditions:
(1) The incentive must be provided directly by the TEAM participant or by an agent of the TEAM participant under the TEAM participant's direction and control to the TEAM beneficiary during an episode.
(2) The item or service provided must be reasonably connected to medical care provided to a TEAM beneficiary during an episode.
(3) The item or service must be a preventive care item or service or an item or service that advances a clinical goal, as listed in paragraph (c) of this section, for a TEAM beneficiary in an episode by engaging the TEAM beneficiary in better managing his or her own health.
(4) The item or service must not be tied to the receipt of items or services outside the episode.
(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 a TEAM beneficiary may be made aware of the availability of the items or services at the time the TEAM 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.
(b) Technology provided to a TEAM beneficiary. TEAM beneficiary engagement incentives involving technology are subject to the following additional conditions:
(1) Items or services involving technology provided to a TEAM beneficiary may not exceed $1,000 in retail value for any one TEAM beneficiary during any one episode.
(2) Items or services involving technology provided to a TEAM beneficiary must be the minimum necessary to advance a clinical goal, as listed in paragraph (c) of this section, for a beneficiary in an episode.
(3) Items of technology exceeding $75 in retail value must—
(i) Remain the property of the TEAM participant; and
(ii) Be retrieved from the TEAM beneficiary at the end of the episode, with documentation of the ultimate date of retrieval. The TEAM participant must document all retrieval attempts. In cases when the item of technology is not able to be retrieved, the TEAM participant must determine why the item was not retrievable. If it was determined that the item was misappropriated (if it were sold, for example), the TEAM participant must take steps to prevent future beneficiary incentives for that TEAM beneficiary. Following this process, documented, diligent, good faith attempts to retrieve items of technology will be deemed to meet the retrieval requirement.
(c) Clinical goals of TEAM. The following are the clinical goals of TEAM, which may be advanced through TEAM beneficiary incentives:
(1) Beneficiary adherence to drug regimens.
(2) Beneficiary adherence to a care plan.
(3) Reduction of readmissions and complications following an episode.
(4) Management of chronic diseases and conditions that may be affected by the TEAM procedure.
(d) Documentation of TEAM beneficiary incentives. (1) TEAM participants must maintain documentation of items and services furnished as beneficiary incentives that exceed $25 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 TEAM 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)(3) of this section.
(4) The TEAM participant must retain and provide access to the required documentation in accordance with § 512.586.
§ 512.576   Application of the CMS-sponsored model arrangements and patient incentives safe harbor.
(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 (42 CFR 1001.952(ii)(1)) is available to protect remuneration furnished in TEAM in the form of the sharing arrangement's gainsharing payments and alignment payments, the distribution arrangement's distribution payments, and the downstream distribution arrangement's distribution payments that meet all safe harbor requirements set forth in 42 CFR 1001.952(ii), and §§ 512.565, 512.568, 512.570.
(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 (42 CFR 1001.952(ii)(2)) is available to protect TEAM beneficiary incentives that meet all safe harbor requirements set forth in 42 CFR 1001.952(ii) and § 512.575.
§ 512.580   TEAM Medicare Program Waivers
(a) 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 episodes being tested in TEAM solely for services that—
(i) May be furnished via telehealth under existing Medicare program requirements; and
(ii) Are included in the episode in accordance with § 512.525(e).
(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)I(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 included in the episode in accordance with § 512.525(e).
(3) Waiver of selected payment provisions. (i) CMS waives the payment requirements under section 1834(m)(2)(A) 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) CMS waives the payment requirements under section 1834(m)(2)(B) of the Act to allow the distant site payment for telehealth home visit HCPCS codes unique to TEAM.
(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.
(b) Waiver of the SNF 3-day rule —(1) Episodes initiated by an anchor hospitalization. CMS waives the SNF 3-day rule for coverage of a SNF stay within 30 days of the date of discharge from the anchor hospitalization for a beneficiary who is a TEAM beneficiary on the date of discharge from the anchor hospitalization if the SNF is identified on the applicable calendar quarter list of qualified SNFs at the time of the TEAM beneficiary's admission to the SNF.
(2) Episodes initiated by an anchor procedure. CMS waives the SNF 3-day rule for coverage of a SNF stay within 30 days of the date of service of the anchor procedure for a beneficiary who is a TEAM beneficiary on the date of service of the anchor procedure if the SNF is identified on the applicable calendar quarter list of qualified SNFs at the time of the TEAM beneficiary's admission to the SNF.
(3) Determination of qualified SNFs. CMS determines the qualified SNFs for each calendar quarter based on a review of the most recent rolling 12 months of overall star ratings on the Five-Star Quality Rating System for SNFs on the Nursing Home Compare website. Qualified SNFs are rated an overall of 3 stars or better for at least 7 of the 12 months.
(4) Posting of qualified SNFs. CMS posts to the CMS website the list of qualified SNFs in advance of the calendar quarter.
(5) Financial liability for non-covered SNF services. If CMS determines that the waiver requirements specified in paragraph (b) of this section were not met, the following apply:
(i) CMS makes no payment to a SNF for SNF services if the SNF admits a TEAM beneficiary who has not had a qualifying anchor hospitalization or anchor procedure.
(ii) In the event that CMS makes no payment for SNF services furnished by a SNF as a result of paragraph (b)(5)(i) of this section, the beneficiary protections specified in paragraph (b)(5)(iii) of this section apply, unless the TEAM participant has provided the beneficiary with a discharge planning notice in accordance with § 512.582(b)(3).
(iii) If the TEAM participant does not provide the beneficiary with a discharge planning notice in accordance with § 512.582(b)(3)—
(A) The SNF must not charge the beneficiary for the expenses incurred for such services;
(B) The SNF must return to the beneficiary any monies collected for such services; and
(C) The TEAM participant is financially liable for the expenses incurred for such services.
(6) Coverage of SNF services and discharge planning notification. If the TEAM participant provided a discharge planning notice to the beneficiary in accordance with § 512.582(b)(3), then normal SNF coverage requirements apply, and the beneficiary may be financially liable for non-covered SNF services.
(c) Other requirements. All other Medicare rules for coverage and payment of Part A-covered services continue to apply except as otherwise waived in this part.
§ 512.582   Beneficiary protections.
(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.
§ 512.584   Cooperation in model evaluation and monitoring.
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.
§ 512.586   Audits and record retention.
(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.
§ 512.588   Rights in data and intellectual property.
(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.
§ 512.590   Monitoring and compliance.
(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.
§ 512.592   Remedial action.
(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.
§ 512.594   Limitations on review.
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.
§ 512.595   Bankruptcy and other notifications.
(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.
§ 512.596   Termination of TEAM or TEAM participant from model by CMS.
(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.
§ 512.598   Decarbonization and resilience initiative.
(a) Voluntary reporting. A TEAM participant may elect to respond to questions and report metrics related to the TEAM participant's, or the TEAM participant's corporate affiliate's, emissions to CMS on an annual basis following each performance period. Voluntary reporting includes the following metrics:
(1) Organizational questions, which are a set of questions about the TEAM participants' sustainability team and sustainability activities.
(2) Building energy metrics, which are a set of metrics related to measuring and reporting GHG emissions related to energy use at TEAM participant facilities.
(i) Building energy metrics are based on the ENERGY STAR® Portfolio Manager® guidelines for the time of submission. TEAM participants reporting these metrics must submit using ENERGY STAR Portfolio Manager in the manner described in paragraph (b) of this section.
(ii) Metrics to be collected include all of the following:
(A) ENERGY STAR® Score for Hospitals as defined in the ENERGY STAR® Portfolio Manager® as well as supporting data which may include energy use intensity, electricity, natural gas, and other source emissions and normalizing factors such as building size, number of full-time equivalent workers, number of staffed beds, number of magnetic resonance imaging machines, zip codes, and heating and cooling days, as specified in the ENERGY STAR® Portfolio Manager®.
(B) Energy cost, to capture total energy costs, as specified in the ENERGY STAR® Portfolio Manager®.
(C) Total, direct, and indirect GHG emissions and emissions intensity as specified in the ENERGY STAR® Portfolio Manager®.
(3) Anesthetic gas metrics, which are a set of metrics related to measuring and managing emissions from anesthetic gas which include all of the following:
(i) Total greenhouse gas emissions from inhaled anesthetics based on purchase records.
(ii) Normalization factors that may include information on anesthetic hours, operating rooms, or MAC-hour equivalents.
(iii) Assessment questions based on key actions recommended for reducing emissions for anesthetic gases.
(4) Transportation metrics, which are a set metrics that focus on greenhouse gases related to leased or owned vehicles and may include any of the following:
(i) Gallons for owned and leased vehicles.
(ii) Normalization factors that may include patient encounter volume and the number of full-time equivalent (FTE) employees.
(iii) Assessment questions on key actions to reduce transportation emissions.
(b) Manner and timing of reporting. (1) If the TEAM participant elects to report the metrics in paragraph (b) of this section to CMS, such information must be reported to CMS in a form and manner specified by CMS for each performance year, including the use of ENERGY STAR® Portfolio Manager® for the building energy metrics at paragraph (a)(2) of this section and a survey and questionnaire for questions and metrics at paragraphs (a)(1), (3), and (4) of this section.
(2) If the TEAM participant chooses to participate, the TEAM participant must report the information to CMS—
(i) No later than 120 days in the year following the performance year; or
(ii) A later date as specified by CMS.
(c) Individualized feedback reports; recognition. If a TEAM participant elects to report all the metrics specified in paragraph (a) of this section to CMS, in the manner specified in paragraph (b) of this section, CMS annually provides the TEAM participant with the following:
(1) Individualized feedback reports, which may summarize facilities' emissions metrics and may include benchmarks, as feasible, for normalized metrics to compare facilities, in aggregate, to other TEAM participants in the Decarbonization and Resilience Initiative. A TEAM participant that receives individualized feedback reports from CMS must request approval from CMS in writing and receive written approval from CMS prior to publication or public disclosure of data or information contained in the individualized feedback reports.
(2) Publicly reported hospital recognition for the TEAM participant's commitment to decarbonization through a hospital recognition badge publicly reported on a CMS website, which may include recognition of the TEAM participant's corporate affiliates when such data has been submitted as specified in paragraph (a) of this section.