Awardee: Meridian Hospitals Corporation d/b/a Jersey Shore University Medical Center

Transcription

1 Bundled Payments for Care Improvement Model 4 Bundled Payments for Care Improvement Model 4 Awardee Agreement Awardee: Meridian Hospitals Corporation d/b/a Jersey Shore University Medical Center This packet contains the required documents to participate in the Bundled Payments for Care Improvement Initiative. The purpose of this document is to provide awardees with a complete agreement package for review and completion.

2 Table of Contents Model 4 Awardee Agreement Attachment A: Model Payment Policies Attachment B: Implementation Protocol - Pending Attachment C: Awardee Profile Attachment D: Evaluation and Monitoring Plan Attachment E: Request for Application (RFA) Attachment F: Gainsharing List - Pending Attachment G: Secondary Repayment Sources (SRS) Agreement Not Applicable Attachment H: Episode Initiator Signatures Not Applicable Attachment I: Discount Rate Table

3 Model 4 Awardee Agreement

4 BUNDLED PAYMENTS FOR CARE IMPROVEMENT MODEL 4 AGREEMENT I. INTRODUCTION A. Purpose 1. Parties. Meridian Hospitals Corporation d/b/a Jersey Shore University Medical Center ( Model 4 Awardee or Awardee ) and the Centers for Medicare & Medicaid Services (CMS), (collectively, the Parties ), hereby enter into this Bundled Payments for Care Improvement (BPCI) Model 4 Agreement (the Agreement ) under Section 1115A of the Social Security Act (the Act ). This Agreement sets forth the Parties respective duties and responsibilities under BPCI Model 4 ( Model 4 ). 2. Goals and Objectives. Under Section 1115A of the Act, the Center for Medicare and Medicaid Innovation (Innovation Center) is authorized to test innovative payment and service delivery models that have the potential to reduce Medicare, Medicaid, or Children s Health Insurance Program (CHIP) expenditures while maintaining or improving the quality of care for beneficiaries. Through the BPCI initiative described in the Request for Application (RFA), the Innovation Center will test Model 4 to incentivize Care Redesign; protect beneficiaries; and learn and diffuse best practices, in order to inform potential changes to the Medicare fee-for-service (FFS) program. 3. Entire Agreement. This Agreement, including all Attachments hereto, each of which is incorporated by reference, constitutes the entire agreement between the Parties. B. Legal Authority 1. CMS s Authority. Section 1115A(b) of the Act authorizes CMS, through the Innovation Center, to enter into this Agreement. 2. Model 4 Awardee Authority. Awardee represents and warrants that it has the legal authority to enter into this Agreement. (a) Awardee represents and warrants that it has the legal authority to act on behalf of each Episode Initiator, Episode-Integrated Provider ( EIP ), and BPCI Entity, in order to comply with the terms of this Agreement. Awardee represents and warrants that it will enter into a binding written agreement ( Participant Agreement ) with each Episode Initiator identified in Attachment C (Awardee Profile) within 30 calendar days of the Effective Date. Awardee also represents and warrants that it will enter into a Participant Agreement with each EIP and BPCI Entity identified in Attachment F (Gainsharing List), as updated in accordance with Section III.A.1(d)(i), following the confirmation by CMS of the eligibility of the 1

5 EIP or BPCI Entity to participate in gainsharing, as described in Section III.A.1.(d)(iii). The Participant Agreements shall obligate Episode Initiators, EIPs, and BPCI Entities to comply with the applicable terms and conditions of this Agreement and to be subject to all submissions related to BPCI Model 4, including without limitation the Implementation Protocol (Attachment B) that Awardee submits to CMS or its designee(s) pursuant to this Agreement or upon request. Awardee further represents and warrants that it shall require each EIP to enter into a written gainsharing agreement with each Gainsharer that obligates the Gainsharer to comply with the applicable terms and conditions of this Agreement and to be subject to all submissions, including without limitation the Implementation Protocol (Attachment B), related to BPCI Model 4 that Awardee submits to CMS or its designee(s) pursuant to this Agreement or upon request. Awardee further represents and warrants that all new, renewed or materially modified Participant Agreements between Awardee and an Episode Initiator, EIP or BPCI Entity shall require such individuals and entities to comply with the applicable terms and conditions of this Agreement and to be subject to all submissions, including without limitation the Implementation Protocol (Attachment B) related to BPCI Model 4 that the Awardee submits to CMS or its designee(s) pursuant to this Agreement or upon request. C. Term and Duration of Agreement 1. Effective Date. The effective date of this Agreement ( Effective Date ) shall be the date on which the final signatory executes this Agreement. 2. Effective Period. This Agreement will remain in effect from the Effective Date until 180 calendar days after the final settlement following the end of the final Performance Year, unless terminated earlier in accordance with Section VI. of this Agreement ( Effective Period ). II. DEFINITIONS The following terms have the meanings set forth below: A. Administrative Services means services that are directly related to the administration of a Gainsharing Arrangement under this Model 4 Agreement. B. Awardee Convener means the Model 4 Awardee which is financially liable for all Excess Spending Amounts, Readmissions Amounts, and Opt-out Physicians Amounts owed to CMS for Episodes of Care generated at all Episode Initiators listed in Attachment C (Awardee Profile). The term Designated Awardee Convener was used in the BPCI Model 4 Application to describe the role of the Awardee Convener. The roles of a Designated Awardee Convener and an Awardee Convener are identical, and thus for purposes of simplicity within this Agreement, the term Awardee Convener will be used exclusively. 2

6 C. BPCI Discount means the percent discount used in the calculation of the Prospective Model 4 Payment, which is 3 percent for Clinical Episodes that do not include MS-DRGs that were included in the ACE Demonstration, and 3.25 percent for Clinical Episodes that include MS-DRGs that were included in the ACE Demonstration. The applicable BPCI Discount for each Clinical Episode is set forth in Attachment I ( Discount Rate Table ). D. BPCI Entity means an entity that is identified by the Model 4 Awardee on Attachment F (Gainsharing List) and approved by CMS pursuant to Section III.A. 1(d)(iii), has entered into a Participant Agreement with the Awardee, and is (1) legally authorized to bind EIPs to the terms of this Agreement and to receive and distribute Incentive Payments on their behalf, (2) legally authorized to receive and distribute Incentive Payments on behalf of an EIP pursuant to an EIP s written designation, and/or (3) legally authorized to receive and distribute Incentive Payments and retain them solely for Administrative Services actually furnished by the BPCI Entity. E. BPCI Savings Pool means a collection of funds that consists solely of contributions from EIPs (as defined below) of Internal Cost Savings (collectively, BPCI Savings ) that are made available to distribute as Incentive Payments pursuant to Section III.C of this Agreement. F. Care Redesign means the specific planned interventions and changes to the Awardee s current health care model(s) that are described herein and set forth with particularity in the attached Implementation Protocol (Attachment B), including the specific planned interventions and changes to the current health care model(s) of Episode Initiators, EIPs, and Gainsharers that are also set forth with particularity in Attachment B. The Awardee determines the Care Redesign, which must encompass the participation and coordination of Episode Initiators, EIPs, and Gainsharers. Care Redesign elements may include, but are not limited to, the following: 1. Interventions and changes to improve quality of care, beneficiary outcomes, and beneficiary experience of care that are intended to result in Internal Cost Savings; and 2. Quality performance measures and targets. G. Clinical Episode means a family of related MS-DRGs for a clinical condition to be tested through an Episode of Care under Model 4. All Clinical Episodes that will be subject to the terms and conditions of this Agreement will be identified in the Awardee Profile (Attachment C) for each Episode Initiator. The Clinical Episodes will include, without limitation, the family of related MS-DRGs for the clinical condition to be tested and a set of exclusions based on MS-DRGs and International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes, which is referred to in Attachment A. 3

7 H. Descriptive BPCI Materials and Activities include, but are not limited to, general audience materials such as brochures, advertisements, outreach events, letters to beneficiaries, web pages, mailings, social media, or other activities conducted by or on behalf of the Awardee, an Episode Initiator, EIP, Gainsharer, and/or BPCI Entity, when used to educate, notify, or contact Medicare beneficiaries regarding Model 4. The following beneficiary communications are not Descriptive BPCI Materials and Activities: beneficiary communications that do not reference Model 4 (for example, information about care coordination generally would not be considered Descriptive BPCI Materials and Activities), and the following as long as they do not reference BPCI: materials that cover beneficiary-specific billing and claims issues, and educational information on specific medical conditions, referrals for health care items and services, and any other materials that are not within the definition of marketing under the HIPAA Privacy Rule. I. Episode Anchor Hospitalization means a Model 4 Beneficiary s first inpatient stay for a Clinical Episode at an Episode Initiator during an Episode of Care. J. Episode of Care means the Episode Anchor Hospitalization and the 30-day period immediately following a Model 4 Beneficiary s discharge from the Episode Anchor Hospitalization (the 30-day Post-Discharge Period ). The Episode of Care includes Medicare Part A and Part B covered services as described in Attachment A (Model 4 Payment Policies) included in a Clinical Episode and furnished to the Model 4 Beneficiary during (1) the Episode Anchor Hospitalization; and (2) readmissions to the Episode Initiator or any other hospital (as described in Attachment A) during the 30-day Post-Discharge Period, unless the readmission is specifically excluded by the Clinical Episode. Such services may be furnished by the Episode Initiator, an EIP that is a physician, nonphysician practitioner or physician group practice, a Gainsharer, and/or a Third Party Provider. K. Episode Initiator means an acute care hospital identified in Attachment C that triggers an Episode of Care. The Episode Initiator will be paid the Prospective Model 4 Payment, instead of the Inpatient Prospective Payment System (IPPS) payment, for a Model 4 Beneficiary for an Episode of Care, as specified in Section V. L. Episode-Integrated Provider ( EIP ) means a Medicare provider or supplier, including but not limited to an Episode Initiator, that is (1) participating in Care Redesign through a Gainsharing Arrangement that is set forth in a Participant Agreement with the Awardee (or is the Awardee itself); and (2) listed in Attachment F (Gainsharing List). M. Excess Spending Amount means the dollar amount by which the Post-Episode Spending Calculation exceeds the benchmark beyond the Risk Threshold, as may be adjusted in accordance with Section V. of this Agreement. N. Gainsharer means a physician (as defined in Section1861(r) of the Act), a nonphysician practitioner (as described in Section 1842(b)(18)(C) of the Act), or a physician group practice who/which: (1) is participating in Care Redesign, (2) is 4

8 identified in Attachment F, and (3) as specified in Section III.D., has entered into a written gainsharing agreement with an EIP that binds the Gainsharer to all applicable terms and conditions of this Agreement. Where the Gainsharer is a physician group practice, the Awardee must identify in Attachment F all physicians and nonphysician practitioners within the physician group practice who are participating in Care Redesign and eligible to receive a gainsharing payment from the Gainsharer. The Awardee must require those EIPs that have a gainsharing agreement with a physician group practice to ensure that all of the physicians and nonphysician practitioners within such physician group practice who are participating in Care Redesign and eligible to receive a gainsharing payment from the Gainsharer and identified on Attachment F are required, through written agreements with such physician group practice, to comply with all applicable terms and conditions of this Agreement and to be subject to all submissions related to BPCI Model 4, including without limitation the Implementation Protocol. O. Gainsharing Arrangement means the arrangement, memorialized in a Participant Agreement between the Awardee and the participating EIP or BPCI Entity, as appropriate, for (i) the generation of Internal Cost Savings attributable to Care Redesign of EIPs; (ii) the collection of Internal Cost Savings amounts to be contributed to the BPCI Savings Pool from EIPs; and (iii) the distribution of Incentive Payments from the BPCI Savings Pool to the Awardee, EIPs, and/or BPCI Entities. The Gainsharing Arrangement, as memorialized by the Participant Agreement, shall also include means by which the Awardee and EIP or BPCI Entity shall ensure full compliance by all Gainsharers with all applicable requirements of this Agreement, including all requirements of the Gainsharing Arrangement. P. Government means the federal executive, legislative, and judicial branches of the United States of America. Q. Incentive Payment means (i) a payment made directly or indirectly from the BPCI Savings Pool to an Awardee or EIP, pursuant to a Gainsharing Arrangement set forth in a Participant Agreement, (ii) a payment of a portion of BPCI Savings from an EIP to a Gainsharer, pursuant to a written gainsharing agreement between the EIP and Gainsharer, or (iii) a payment made directly or indirectly from the BPCI Savings Pool to a BPCI Entity for Administrative Services actually furnished by the BPCI Entity pursuant to a Gainsharing Arrangement. R. Internal Cost Savings means, for each EIP, the measurable, actual, and verifiable cost savings realized by the EIP resulting from Care Redesign undertaken by the EIP in connection with providing items and services to Model 4 Beneficiaries within specific Episodes of Care. Internal Cost Savings does not include savings realized by any individual or entity that is not an EIP. S. Medically Necessary means reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member. 5

9 T. Model 4 Activities are, for all Performance Years, activities related to the overall care of Model 4 Beneficiaries during an Episode of Care, including, but not limited to, all Care Redesign under BPCI Model 4, direct patient care to Model 4 Beneficiaries, reporting on quality and cost measures included in this Agreement, and tracking and measuring Internal Cost Savings. U. Model 4 Beneficiary means a Medicare FFS beneficiary who is eligible for Part A and enrolled in Part B, and receives inpatient hospital care at an Episode Initiator for a Clinical Episode during a Performance Year. On the day of admission to the Episode Anchor Hospitalization, the beneficiary must have either one lifetime reserve day or one day of utilization that is also a day of entitlement remaining. The following beneficiary eligibility criteria must also be met: i) the beneficiary must not have End Stage Renal Disease; ii) the beneficiary must not be enrolled in any managed care plan (for example, Medicare Advantage, Health Care Prepayment Plans, cost-based health maintenance organizations); iii) the beneficiary must not be covered under United Mine Workers; and iv) Medicare must be the primary payer. The beneficiary will be considered a Model 4 Beneficiary for the duration of the Episode of Care. V. Model 4 Coinsurance Amount means the coinsurance amount that is equal to 20% of the Part B portion of the Prospective Model 4 Payment as described in Attachment A. The Model 4 Coinsurance Amount will be applied to and collected from the Model 4 Beneficiaries regardless of physician service utilization within their Episodes of Care. W. Other Coinsurance Amount means the coinsurance amounts that are collected from a Model 4 Beneficiary for services furnished by physicians or nonphysician practitioners who have opted out of the Model 4 payment methodology, as described in Attachment A. X. NPI means National Provider Identifier. Y. Performance Year is specified for each Clinical Episode as listed in Attachment C. The Awardee will test each Clinical Episode for three Performance Years. Z. Post-Episode Spending Calculation means the financial analysis performed by CMS to ensure that aggregate Medicare Part A and Part B spending for Model 4 Beneficiaries does not increase during the Post-Discharge Spending Monitoring Period due to cost shifting or other reasons. AA. Post-Discharge Spending Monitoring Period means the 30-day period following a Model 4 Beneficiary s discharge from the Episode Anchor Hospitalization during which CMS will monitor for cost shifting of Part A and Part B Medicare spending. Data obtained from this period is used in the Post-Episode Spending Calculation. BB. Prospective Model 4 Payment means the amount paid to an Episode Initiator for an Episode of Care, as described in Section V. and Attachment A. 6

10 CC. Readmissions Amount means the aggregate Medicare Fee-for-Service expenditures for Part A and Part B covered services furnished during a readmission of a Model 4 Beneficiary at a hospital other than the Episode Initiator during the 30-day Post- Discharge Period of an Episode of Care. DD. Opt-out Physicians Amount means the aggregate Medicare Fee-for-Service expenditures for Part B covered services furnished during the Episode Anchor Hospitalization or a readmission of a Model 4 Beneficiary during the 30-day Post- Discharge Period of an Episode of Care, by physicians and nonphysician practitioners who use the claims opt out process described in Section V. and Attachment A. EE. RFA means the BPCI Request for Applications (Attachment E). FF. Risk Threshold means the upper limit of the confidence interval (described in Attachment A) that surrounds the calculated benchmark in the Post-Discharge Spending Monitoring Period. GG. Third Party Provider ( TPP ) means a Medicare provider or supplier that furnishes items or services covered under Medicare Part A or Part B to a Model 4 Beneficiary during an Episode of Care, but is not an Episode Initiator, EIP, BPCI Entity, or Gainsharer. HH. TIN means a federal taxpayer identification number, which in some cases may be a Social Security Number. III. DUTIES AND RESPONSIBILITIES OF THE MODEL 4 AWARDEE Model 4 Awardee shall fulfill the following duties and responsibilities during the Effective Period: A. Implementation of Care Redesign. Awardee, along with all Episode Initiators, EIPs, and Gainsharers identified on Attachments C and F, respectively, shall implement the Care Redesign under BPCI Model 4 starting with the first Performance Year as listed in Attachment C. 1. Implementation Protocol. Within 30 calendar days from the Effective Date, Awardee shall submit in writing an implementation protocol, which is a multipart document set forth as Attachment B that outlines processes to implement Care Redesign under BPCI Model 4 ( Implementation Protocol ). Awardee shall be responsible for ensuring implementation of the processes described in the Implementation Protocol by the Awardee, Episode Initiators, EIPs, Gainsharers, and BPCI Entities, as appropriate. The Implementation Protocol must include, but is not limited to, details for the following: (a) A Care Redesign plan applied to Episode Initiators, EIPs, and Gainsharers, as applicable that describes how success will be measured; 7

11 (b) Management and staffing information, including type of personnel or contactors that will be primarily responsible for carrying out changes to the care model for all Episode Initiators and EIPs; (c) A description of the features of the Gainsharing Arrangement(s) for all EIPs and BPCI Entities, and associated quality performance targets for Gainsharers. The description must include, but is not limited to: (i) A specific methodology and accounting formula for calculating and verifying the Internal Cost Savings generated by each EIP participating in a Gainsharing Arrangement based on the Care Redesign elements specifically associated with the individual EIP. Each Gainsharing Arrangement must include specific methodologies for accruing and calculating Internal Cost Savings for each EIP that are transparent, measurable, and verifiable in accordance with Generally Accepted Accounting Principles (GAAP) and Government Auditing Standards (The Yellow Book). The methodology must set out the specific Care Redesign elements to be undertaken by the EIP and pursuant to the written gainsharing agreements between the EIP and Gainsharers, and relate the calculation of Internal Cost Savings to the actual, verifiable cost savings attributed to such Care Redesign element; (ii) A description of the methodology, accounting formula and frequency of contributions made by the Awardee and each EIP to the BPCI Savings Pool from Internal Cost Savings. (iii) A description of the methodology, frequency of distribution, and accounting formula for distributing and verifying any and all Incentive Payments. (d) Gainsharing List (Attachment F). Awardee must provide a list of all EIPs, BPCI Entities, and Gainsharers in the template provided. (i) Awardee shall provide this Gainsharing List to CMS at least 30 calendar days prior to the beginning of each Performance Year or 30 days prior to the first quarter the Awardee will enter into a Gainsharing Arrangement and update the Gainsharing List quarterly as necessary during each Performance Year; (ii) Awardee shall identify, verify and report the TIN/NPI/ other identifier as specified in the Attachment F of every EIP, BPCI Entity (if applicable), and Gainsharer on the Gainsharing List. For BPCI Entities that do not possess an NPI, Awardee must provide the BPCI Entity s TIN; 8

12 (iii) For each Performance Year, CMS will review the information provided by the Awardee pertaining to EIPs, Gainsharers, and BPCI Entities, confirm whether the EIPs, Gainsharers, and BPCI Entities listed on the Gainsharing List maintain valid and active TINs/NPIs/other identifiers as specified in the Attachment F, and respond within 60 days of receipt of the Gainsharing List (or updated Gainsharing List, as applicable) to provide written notice to Awardee confirming the eligibility of the individuals and entities on the Gainsharing List to participate in gainsharing. (iv) No individual or entity can make a contribution of Internal Cost Savings to the BPCI Savings Pool or receive an Incentive Payment unless such individual or entity is identified on the Gainsharing List and CMS has confirmed their eligibility to participate in gainsharing. (v) EIPs that are on the Gainsharing List and confirmed by CMS to participate in gainsharing may contribute Internal Cost Savings to the BPCI Savings Pool which are derived from the performance of Care Redesign that begins on the Effective Date of this Agreement. (vi) EIPs, BPCI Entities and Gainsharers that are on the Gainsharing List and confirmed by CMS to participate in gainsharing may receive Incentive Payments which are derived from the performance of Care Redesign that begins on the Effective Date of this Agreement. (vii) The eligibility determinations described herein shall not preclude CMS or any other government authority from enforcing any and all applicable laws, rules and regulations. Such eligibility determinations also do not relieve Awardee, Episode Initiators, EIPs, Gainsharers, and BPCI Entities of the obligation to comply with the terms of this Agreement and all applicable statutes, regulations and guidance. (e) Information on Organization Readiness. Awardee shall provide CMS with the following information within 10 calendar days of a request by CMS: (i) Information confirming the organizational readiness of the Awardee for the measurement of clinical quality and effectiveness for all Episode Initiators, EIPs and Gainsharers; 9

13 (ii) Information confirming the organizational readiness of the Awardee to measure and track Internal Cost Savings and Administrative Services; (iii) Plan to track Internal Cost Savings and Administrative Services. (iv) Information on the accounting systems used to track Internal Cost Savings and provide feedback to all Episode Initiators, EIPs, BPCI Entities, and Gainsharers; (v) Other information to verify and confirm Awardee s and all Episode Initiators, EIPs, and Gainsharers readiness for and implementation of the Care Redesign; (vi) Other information as requested by CMS to verify, confirm, monitor, or evaluate performance of the Implementation Protocol as carried out by Awardee and all Episode Initiators, EIPs, Gainsharers, and BPCI Entities. (vii) A description of current health information technology (HIT), including systems to track quality measures, and Internal Cost Savings; (viii) Process for determining and verifying the eligibility of Episode Initiators, EIPs, and Gainsharers to participate in Medicare; (ix) Model 4 Beneficiary Notification Plans. Plan for ensuring that each Model 4 Beneficiary is informed in writing of: (1) the existence and purpose of BPCI Model 4; (2) Model 4 coinsurance implications; (3) the Model 4 Beneficiary s right of access to Medically Necessary services; and (4) the Model 4 Beneficiary s right to choose any provider or supplier of items or services; (x) Physician and Nonphysician Practitioner Notification Plans. Plan for ensuring that each physician and nonphysician practitioner who has medical staff privileges at an Episode Initiator and who furnishes services to a Model 4 Beneficiary is informed in writing of: (1) the existence and purpose of BPCI Model 4; (2) the financial implications of the Model 4 payment methodology described in Attachment A; and (3) the physician and nonphysician practitioner opt-out process described in Attachment A; (xi) Plan for tracking payments made by an Episode Initiator to physicians and nonphysician practitioners who furnish Part B 10

14 covered services to a Model 4 Beneficiary during an Episode of Care. (xii) Plan for tracking physicians and nonphysician practitioners who opt-out of the Model 4 payment methodology as described in Attachment A. (xiii) Plan for tracking and recouping payments made by an Episode Initiator to physicians/nonphysician practitioners who furnish Part B covered services to a Model 4 Beneficiary during an Episode of Care where a physician/nonphysician practitioner is also paid by Medicare through the opt-out process described in Attachment A. (xiv) Plan for tracking, maintaining records, and notifying CMS of repayment of Other Coinsurance Amounts. (xv) Plan for approving and tracking all Model 4 Beneficiary protections, including those set out in Section III.H.2 of this Agreement, as well as all items and services furnished to Model 4 Beneficiaries during Episodes of Care. (xvi) Requests for Additional Information. Should CMS determine, at its sole discretion, that any of the immediately preceding information is insufficient or incomplete, CMS reserves the right to request additional information from Awardee, or any Episode Initiator, EIP, Gainsharer or BPCI Entity, at any time. Awardee shall provide CMS with the requested information within 10 calendar days of CMS s request. 2. Awardee shall provide prior written notice to CMS of any modifications the Awardee needs to make to its Implementation Protocol by submitting amendments, which are subject to CMS review. If accepted by CMS, such amendments will become part of the Awardee s Implementation Protocol and be incorporated into this Agreement. Awardee shall ensure that copies of such amendments are provided to all EIPs, Gainsharers, and BPCI Entities. B. Gainsharing Arrangements. The Gainsharing Arrangement shall be set forth in the Participant Agreement between the Awardee and the EIP or BPCI Entity that will be participating in the Gainsharing Arrangement. The Participant Agreement must obligate the parties to comply, and must obligate the EIP to require any of its Gainsharers to comply, during the Effective Period with all relevant terms of this Agreement including, without limitation, the following: 1. Awardee must ensure, and must require all EIPs and BPCI Entities to ensure, that an individual or entity s participation in the Gainsharing Arrangement or in 11

15 any written gainsharing agreement with an EIP is voluntary and without penalty for nonparticipation. 2. Incentive Payments may be made only (i) to Awardees, and (ii) EIPs, BPCI Entities, and Gainsharers that have been confirmed by CMS pursuant to Section III.A.1(d) of this Agreement, and may be made only if the relevant quality conditions specified in Section III.C have been satisfied. 3. EIPs and Gainsharers must be in compliance with all Medicare provider enrollment requirements at 42 C.F.R et seq., including having a valid and active TIN/NPI/other identifier as specified in the Attachment F, as applicable. 4. The BPCI Savings Pool must meet the requirements set forth in Section III. of this Agreement and be administered by the Awardee in accordance with GAAP. Each contribution within the BCPI Savings Pool must be clearly and separately identifiable as to the EIP from which it originated. Internal Cost Savings must be clearly and separately identifiable and independently verifiable. In no event may the BPCI Savings Pool include, nor be used to distribute, any amounts that are not Internal Cost Savings as defined in this Agreement. The BPCI Savings Pool must be administered by the Awardee and must not be comingled with the Awardee s operating funds or any other accounts or funds. All contributions to the BPCI Savings Pool must reflect actual, Internal Cost Savings achieved by the EIP making the contribution through implementation of Care Redesign elements identified in the Implementation Protocol and cannot reflect paper savings from accounting conventions or past investment in fixed costs. 5. The Participant Agreement must obligate the EIPs and BPCI Entities to provide Awardee and CMS access to the records, information, and data of EIPs, Gainsharers and BPCI Entities for purposes of monitoring and reporting and any other lawful purpose. Records, information, and data demonstrating compliance with the Gainsharing Arrangement must have sufficient detail to verify compliance with all material terms of the arrangement and be fully substantiated and documented, both as to statements and numbers. 6. Episode Initiators, EIPs, Gainsharers and BPCI Entities must be required to comply with any Corrective Action Plan instituted pursuant to Section VI.E.6 of this Agreement. C. Incentive Payment Conditions and Restrictions. Awardee further agrees to the following conditions and restrictions concerning Incentive Payments: 1. Neither the Awardee, nor any EIP, BPCI Entity, or Gainsharer shall condition the opportunity to receive Incentive Payments on the volume or value of past or anticipated referrals or other business generated to, from, or among the Awardee, any EIP, BPCI Entity, or Gainsharer. 12

16 2. EIPs and Gainsharers that fail to meet the gainsharing quality performance targets described in Section II.D. of the RFA and set forth with particularity in the Implementation Protocol (Attachment B) and the quality specifications in the Evaluation and Monitoring Plan (Attachment D) will not be eligible to receive Incentive Payments either directly or indirectly. 3. Incentive Payments must not induce EIPs, BPCI Entities, and/or Gainsharers to reduce or limit Medically Necessary services to any Medicare beneficiary. 4. Individual physicians and nonphysician practitioners must retain their ability to make decisions in the best interests of the patient, including the selection of devices, supplies, and treatments. 5. Gainsharing methodologies for calculating Incentive Payments must not directly account for volume or value of referrals, or business otherwise generated, between or among Awardee, EIPs, BPCI Entities, and/or Gainsharers. 6. Incentive Payments must be derived solely from the BPCI Savings contained in the BPCI Savings Pool. 7. BPCI Entities may receive and retain Incentive Payments solely for the provision of Administrative Services actually furnished by the BPCI Entity, as provided in the BPCI Entity s Participant Agreement with the Awardee and this Agreement. 8. A BPCI Entity may receive and distribute Incentive Payments to other BPCI Entities or to EIPs pursuant to the terms of the BPCI Entity s Participant Agreement with the Awardee and this Agreement. 9. An EIP may distribute Incentive Payments to Gainsharers pursuant to the terms of (1) a written gainsharing agreement between the EIP and the Gainsharer as specified in Section III.D., and (2) this Agreement. 10. The total amount of Incentive Payments for a Performance Year paid to an EIP that is a physician or nonphysician practitioner or to a Gainsharer must not exceed a cap which is determined by taking 50 percent of the total Medicare expenditures paid under the Physician Fee Schedule to all EIPs that are physicians or nonphysician practitioners and Gainsharers for furnishing services to Model 4 Beneficiaries by Clinical Episode during that Performance Year divided by the total number of EIPs that are physicians or nonphysician practitioners and Gainsharers furnishing services to Model 4 Beneficiaries by Clinical Episode during that Performance Year. 11. Awardee, EIPs, BPCI Entities and Gainsharers may earn Incentive Payments only when the conditions specified in Section III.C. of this Agreement are met. 13

17 D. Gainsharing Agreement between EIP and Gainsharer 1. The gainsharing agreement between an EIP and a Gainsharer must be set forth in writing and must require the Gainsharer, as well as any physicians/nonphysician practitioners who are participating in Care Redesign and eligible to receive a gainsharing payment from the Gainsharer, to comply with (1) all applicable Medicare laws, rules, and regulations; and (2) all applicable terms and conditions of this Agreement; 2. The gainsharing agreement between an EIP and a Gainsharer must require the EIP to share with the Gainsharer a copy of both the EIP s Participant Agreement with the Awardee and this Agreement. E. Prohibitions on Gainsharing 1. On a quarterly basis, if CMS determines that any TIN/NPI/other identifier as specified in the Attachment F associated with an Awardee, EIP, Gainsharer or BPCI Entity identified in the Gainsharing List is no longer valid or active, CMS will notify the Awardee in writing within 21 calendar days of discovery that the EIP, Gainsharer or BPCI Entity is no longer eligible, as of the date of the written notification, to contribute Internal Cost Savings to the BPCI Savings Pool, or accept, distribute, or retain Incentive Payments, as applicable. (a) Upon receipt of this notification, Awardee must immediately suspend the distribution of all Incentive Payments to affected parties. Where CMS has determined that a Gainsharer s TIN/NPI/other identifier as specified in the Attachment F is no longer valid or active, Awardee must require that the EIP immediately cease the distribution of Incentive Payments to the Gainsharer. (b) If Awardee believes CMS has reached its eligibility determination in error, Awardee may respond to CMS in writing within 14 calendar days for the sole purpose of providing any missing information, or correcting information previously submitted, that addresses whether the affected EIP, Gainsharer, or BPCI Entity maintains a valid and active TIN/NPI/other identifier as specified in the Attachment F. (i) CMS will make reasonable efforts to communicate its decision in writing to the Awardee within 21 calendar days from receipt of Awardee s information submission as set forth in subsection (ii) above. Should CMS in its sole discretion determine that the affected EIP, Gainsharer, or BPCI Entity is in possession of a valid and active TIN/NPI/other identifier as specified in the Attachment F, 14

18 F. Monitoring and Enforcement CMS will permit Awardee to resume issuing Incentive Payments to the affected EIP, Gainsharer, or BPCI Entity. (ii) Awardee, EIP, and BPCI Entities shall not issue or distribute retroactive Incentive Payments to the affected EIP, Gainsharer, or BPCI Entity attributable to the period during which the affected party was prohibited from receiving such payments, unless CMS concludes that CMS s determination of ineligibility was made as a result of a clerical error on the part of CMS. (iii)the affected EIP or BPCI Entity Awardee may not make retroactive contributions of Internal Cost Savings to the BPCI Savings Pool attributable to the period during which the affected party was prohibited from making such contributions, unless CMS concludes that CMS s determination of ineligibility was made as a result of a clerical error on the part of CMS. (iv) Where CMS has determined that a Gainsharer s TIN/NPI/other identifier as specified in the Attachment F is no longer valid or active, the EIP may not make retroactive contributions of Internal Cost Savings that are pursuant to a written gainsharing agreement attributable to the efforts of the affected Gainsharer, unless CMS concludes that CMS s determination of ineligibility was made as a result of a clerical error on the part of CMS. 1. Awardee is responsible for monitoring and enforcing the payment provisions in Section V, the quality provisions in Section III.G, and the gainsharing provisions in Sections III.B through E. Awardee must ensure that it has sufficient access to all necessary records, data, and information of Episode Initiators, EIPs, Gainsharers and BPCI Entities, as applicable, to enable it to carry out this responsibility. (a) Awardee and Episode Initiators agree to monitor and maintain records of the recoupment of payments made by the Episode Initiator to physicians/nonphysician practitioners who furnish Part B covered services to a Model 4 Beneficiary during an Episode of Care where a physician/nonphysician practitioner is also paid by Medicare through the opt-out process described in Attachment A. Awardee agrees to report all such recoupments to CMS on a quarterly basis. (b) Awardee and Episode Initiators agree to monitor and maintain records of repayments of Other Coinsurance Amounts. Awardee agrees to report all such repayments to CMS on a quarterly basis. 15

19 G. Quality Improvements. 1. During the Effective Period, Awardee must adhere, and must ensure that Episode Initiators, EIPs, and Gainsharers, as applicable, adhere to all quality safeguards described in Sections II.D., II.G., II.J., and Appendix B of the RFA and set forth with particularity in the Implementation Protocol (Attachment B) and described in the Evaluation and Monitoring Plan (Attachment D). (a) Overall Institutional Quality. (b) Quality Care (i) Awardee must participate, and must ensure that all Episode Initiators, EIPs, and Gainsharers as a condition for participation in Model 4, participate in all applicable CMS quality reporting initiatives authorized under current or future law, including without limitation: the Hospital Inpatient Quality Reporting (IQR) Program, the Hospital Outpatient Quality Reporting (OQR) Program, and the Physician Quality Reporting System (PQRS). (ii) The aggregate participation rate in PQRS by EIPs who are physicians or nonphysician practitioners and Gainsharers must be maintained or improved annually as compared to the previous year. (i) Awardee must provide, and must ensure that all Episode Initiators, EIPs, and Gainsharers provide, all required quality reporting data that CMS determines necessary, as described in the Evaluation and Monitoring Plan (Attachment D), to monitor and evaluate the quality of care in Model 4 during the Effective Period. Specifically, Awardee shall collect, secure, provide to CMS or its designee, and certify data necessary for the implementation, monitoring, and evaluation of Awardee s Care Redesign under Model 4, including, without limitation, clinical quality performance measures, B- CARE data, Episode Initiator internal cost reports, and all other data elements as described in Section III.H.7. Awardee is responsible for ensuring quality of care that includes the domains of care coordination, evidence based process of care, morbidity and mortality outcomes, and resource adequacy related to staffing. (ii) Awardee is responsible for ensuring that its participation and the participation of all Episode Initiators, EIPs, and Gainsharers in Model 4 does not result in an increase in 16

20 undesirable, unintended consequences, including but not limited to, patient selection, care stinting, and costshifting. Awardee understands and agrees that CMS will monitor for evidence of unintended consequences, including examining trends and patterns with shifts in mix of beneficiaries, utilization rates, and an analysis of resources expended on patient care and cost efficiency. (iii)awardee and Episode Initiators are responsible for applying appropriateness criteria for patients as a first step prior to the initiation of Episodes of Care to help ensure that Episodes of Care are Medically Necessary and clinically appropriate. (c) EIPs and Gainsharers are subject to the gainsharing quality performance targets as specified under Section III.C.2. H. Maintenance of BPCI Eligibility 1. Eligibility Requirements. During the Effective Period, Awardee shall comply with the conditions of participation for BPCI Model 4 as specified in the RFA under Section III, and shall notify CMS in writing of any changes or deficiencies related to the RFA requirements or this Agreement s terms within 15 calendar days of discovery. (a) Notice of Corporate Name Change or Change of Ownership. Awardee shall notify CMS within 30 days of any change in its corporate name or ownership and any change in the corporate names or change of ownership of any Episode Initiator, EIP, or BPCI Entity. 2. Model 4 Beneficiary Protections (a) Beneficiary Choice. Consistent with Section 1802(a) of the Act, the Awardee, Episode Initiators, EIPs, Gainsharers and BPCI Entities shall not commit any act or omission, nor adopt any policy, that inhibits Model 4 Beneficiaries from exercising their freedom of choice to obtain health services from other health care providers and entities that are not Awardees, Episode Initiators, BPCI Entities, Gainsharers or EIPs. Notwithstanding the foregoing, Awardee, Episode Initiators, EIPs, Gainsharers and BPCI Entities may communicate to Model 4 Beneficiaries the benefits of receiving care from a Medicare provider or supplier participating in Model 4. (b) Awardee, Episode Initiators, EIPs, Gainsharers and BPCI Entities are prohibited from providing gifts or other remuneration to Model 4 Beneficiaries as inducements for receiving items or services from 17

21 Awardee, an Episode Initiator, an EIP, a Gainsharer, a BPCI Entity, or any Third Party Provider unless otherwise specified in the Implementation Protocol. (c) Availability of all Medicare Covered Services. Awardee shall, and shall require Episode Initiators, EIPs, Gainsharers and BPCI Entities to, make Medically Necessary services available to Model 4 Beneficiaries in accordance with applicable laws, regulations and guidance. Model 4 Beneficiaries and their assignees retain their right to appeal claims in accordance with 42 CFR 405, Subpart I. (d) Model 4 Beneficiary Notification. Upon admission to an Episode Initiator, Awardee shall ensure that each Model 4 Beneficiary is informed in writing of: (1) the existence and purpose of BPCI Model 4; (2) Model 4 coinsurance implications; (3) the Model 4 Beneficiary s right of access to Medically Necessary services; and (4) the Model 4 Beneficiary s right to choose any provider or supplier of items or services. 3. Physician and Nonphysician Practitioner Notification. Each Episode Initiator shall inform in writing each physician and nonphysician practitioner who has medical staff privileges at the Episode Initiator and who furnishes services to a Model 4 Beneficiary of: (1) the existence and purpose of BPCI Model 4; (2) the financial implications of the Model 4 payment methodology described in Attachment A; (3) the physician and nonphysician practitioner opt-out process described in Attachment A. Awardee shall ensure that each Episode Initiator provides such notification in accordance with this paragraph. 4. Descriptive BPCI Materials and Activities. Any Descriptive BPCI Materials or Activities, including those pertaining to the Model 4 Beneficiary notification described in Section III.H.2.(d), may not be used until reviewed and deemed approved by CMS. Any material changes to CMS-approved Descriptive BPCI Materials or Activities must also be reviewed and deemed approved by CMS before use. Any Descriptive BPCI Materials or Activities, or material changes to same, received but not expressly disapproved in writing by CMS within 30 calendar days after submission will be deemed approved. The Awardee must retain copies of all written and electronic Descriptive BPCI Materials and Activities and appropriate records for all other Descriptive BPCI Materials and Activities provided to Model 4 Beneficiaries in a manner consistent with Section III.I HIPAA Requirements. All data sharing within the Awardee and communications to and from the Awardee, Episode Initiators, EIPs, Gainsharers, and BPCI Entities that are for BPCI purposes must comply with the HIPAA Privacy and Security Rules and all relevant HIPAA Privacy 18

22 and Security guidance applicable to the use and disclosure of protected health information by covered entities. 6. Requirement to Comply with Evaluation and Monitoring. CMS or its designee(s) reserves the right to monitor for changes in the care and treatment of Model 4 Beneficiaries, such as avoidance of difficult to treat patients, care stinting, inappropriate cost shifting, inappropriate increases in utilization, and inappropriate steering of beneficiaries. CMS or its designee(s) will monitor and evaluate the performance of Awardee, Episode Initiators, EIPs, Gainsharers and BPCI Entities, including, but not limited to, compliance with this Agreement. 7. Evaluation and Monitoring Plan. The evaluation and monitoring plan that sets forth the data elements that Awardees must capture and report to CMS or its designees and the frequency and method of providing such reports ( Evaluation and Monitoring Plan ) is attached as Attachment D. CMS or its designee(s) may change the Evaluation and Monitoring Plan upon written notice to Awardee. 8. Data Sources for Evaluation and Monitoring. (a) Regular Monitoring Progress Reports. Awardee shall capture the following data elements and information and report them to CMS or its designee in regular monitoring progress reports in accordance with the Evaluation and Monitoring Plan. These data elements and information are described further in the Evaluation and Monitoring Plan and include, but are not limited to: (i) Care redesign interventions (including, but not limited to, planned and completed quality improvement projects); (ii) Structural changes (including but not limited to HIT use, key staff changes); (iii) Quality indicators (including, but not limited to, Hospital IQR data, Hospital OQR data, PQRS data, LTCH quality data, IRF quality data, Minimum Data Set data from SNFs (Nursing Home Compare), Home Health Consumer Assessment of Healthcare Providers and Systems data (HHCAHPS) and Hospital Consumer Assessment of Healthcare Providers and Systems, Outcome and Assessment Information Set data (OASIS), and inpatient mortality data); (iv) Internal hospital-level cost data that is consistent with cost report principles, which includes the average cost per case in a reference year (which is the year preceding the current performance year), including, but not limited to, costs by 19

23 hospital department, services provided, labor costs; savings achieved per admission; (v) Internal provider and supplier-level cost data for EIPs (as applicable); and (vi) Information on Gainsharing Arrangements, as well as any written gainsharing agreements between EIPs and Gainsharers. (b) BPCI-Adapted Continuity Assessment Record and Evaluation (B- CARE). Awardee will capture beneficiary data through the B- CARE tool for Model 4 Beneficiaries as specified by CMS. Awardee will submit these data to CMS or its designee(s) as specified in the Evaluation and Monitoring Plan. (c) Miscellaneous Reporting. CMS may require Awardee to submit additional data elements or information at a time and in a manner specified in the Monitoring and Evaluation Plan, as amended from time to time. Nothing in the Evaluation and Monitoring Plan shall limit CMS s ability to conduct evaluation and monitoring activities pursuant to Section III.H.7.(e) or CMS s right to audit set forth in Section III.I.4 of this Agreement. (d) Other Data Sources. Awardee acknowledges that in conducting evaluation and monitoring activities, CMS or its designee(s) may use data or information not submitted by Awardees, including, but not limited to, all Medicare claims submitted for items and services furnished to Model 4 Beneficiaries, Awardee or Episode Initiator Medicare cost reports, and any related information or documentation deemed necessary. (e) Activities Conducted by CMS or its Designees. Awardee acknowledges and will require all parties to Participant Agreements to acknowledge that CMS may conduct evaluation and monitoring activities to, among other things, review and assess episode-based payments, the Gainsharing Arrangement, any written gainsharing agreement between an EIP and a Gainsharer, the distribution, receipt and retention of Incentive Payments, patient-level clinical outcomes, patient-centeredness criteria, the achievement of changes in spending, quality performance, as well as the compliance of any Awardee, Episode Initiators, EIPs, Gainsharers and/or BPCI Entities with the terms of this Agreement. Such evaluation and monitoring activities may include, but are not limited to, the following: 20

24 (i) Interviews with Model 4 Beneficiaries and their caregivers; (ii) Interviews with Awardee, Episode Initiators, EIPs, Gainsharers and/or BPCI Entities; (iii) Audits of charts, medical records, and other data from Awardee, Episode Initiators, EIPs, Gainsharers and/or BPCI Entities; (iv) Site visits in accordance with the Evaluation and Monitoring Plan and Section III.H Quality Improvements. Awardee acknowledges that CMS will assess the quality performance of Awardee, Episode Initiators, EIPs, and Gainsharers during the Effective Period in accordance with Section III.G of this Agreement. 10. Evaluation. Awardee acknowledges that CMS may use data collected through monitoring activities to evaluate BPCI Model 4. The results of its evaluations will be made available to the public in accordance with Section 1115A(b)(4)(B) of the Act. CMS may use evaluation and monitoring activities and data elements to assess whether BPCI Model 4 should be expanded pursuant to Section 1115A(c) of the Act. I. Compliance 1. Oversight Committee. Awardee shall identify a committee to manage the operation of BPCI Model 4 and conduct oversight to ensure that Model 4 Awardee, Episode Initiators, EIPs, Gainsharers and BPCI Entities are in compliance with the terms and conditions of this Agreement. 2. Compliance Plan. Awardee shall have in place, and maintain during the Effective Period, a compliance plan that addresses the prevention, detection, and correction of fraud, abuse, and noncompliance with BPCI Model 4 requirements, including the requirements of this Agreement. Awardee may share, use, or modify its existing compliance programs and/or the existing compliance programs of Episode Initiators, BPCI Entities, Gainsharers, and EIPs, to meet this requirement. The compliance plan should include sufficient elements to be effective and must include at least the following elements: (a) A designated compliance official or individual who is not legal counsel to the Awardee, Episode Initiators, EIPs, Gainsharers, or BPCI Entities; (b) Mechanisms for identifying and addressing compliance problems related to Awardee s operations and performance and the 21

25 operations and performance of Episode Initiators, EIPs, Gainsharers, and BPCI Entities; (c) A method for anonymous reporting, such as a number, or anonymous message drop box, to the compliance official or individual of suspected problems related to the BPCI Model 4; (d) Regular compliance training for individuals and entities engaged in Model 4 Activities, including contractors and employees of Awardee, Episode Initiators, EIPs, Gainsharers and BPCI Entities, addressing compliance with the BPCI requirements, including the requirements of this Agreement; (e) A requirement for Awardee, Episode Initiators, EIPs, Gainsharers and/or BPCI Entities to report probable violations of law to an appropriate law enforcement agency; and (f) Awardee must submit annually to CMS within 30 calendar days after each Performance Year a written certification that it satisfies, and will continue to satisfy, this requirement to have in place and maintain a Compliance Plan during the Effective Period. 3. Additional Compliance Requirements. Awardee agrees, and shall require all Episode Initiators, EIPs, Gainsharers and BPCI Entities to agree, to comply with all applicable laws including, but not limited to, the following: (a) Federal criminal law. (b) The False Claims Act (31 U.S.C et seq.). (c) The Anti-Kickback statute (42 U.S.C. 1320a 7b(b)). (d) The Civil Monetary Penalties law (42 U.S.C. 1320a 7a). (e) The Physician Self-referral law (42 U.S.C. 1395nn). 4. Audits and Record Retention. (a) Right to Audit. Awardee agrees, and shall require Episode Initiators, EIPs, Gainsharers and BPCI Entities to agree, that HHS- CMS, HHS-OIG, and the Comptroller General or their designee(s) have the right to audit, inspect, investigate, and evaluate any books, contracts, records, documents and other evidence of Awardee, Episode Initiators, EIPs, Gainsharers and BPCI Entities, that pertain to any of the following: 22

26 (i) (ii) Awardee s compliance with this Agreement, as well as the compliance of Episode Initiators, EIPs, Gainsharers and BPCI Entities; The quality of services furnished by Awardee, Episode Initiators, EIPs, Gainsharers and BPCI Entities; (iii) Determination of Excess Spending Amounts; (iv) Calculation, allocation, and distribution of Incentive Payments from the BPCI Savings Pool; (v) Calculation, allocation, and distribution of any payments comprised in whole or in part of BPCI Savings to any individual or entity; (vi) Allocation and contribution of Internal Cost Savings into the BPCI Savings Pool; (vii) Administration of the BPCI Savings Pool; (viii) Calculation of Internal Cost Savings; (ix) Patient safety; and (x) Medicare Part A and B billings during an Episode of Care. 5. Maintenance of records. Awardee agrees, and must require Episode Initiators, EIPs, Gainsharers and BPCI Entities to agree, to the following: (a) To maintain and give HHS-CMS, HHS-OIG, and the Comptroller General or their designee(s) scheduled and unscheduled access to all books, contracts, records, documents, and other evidence (including data related to utilization and costs, quality performance measures, billings, and financial arrangements related to Model 4 Activities) sufficient to enable the audit, evaluation, inspection, or investigation of Awardee s, Episode Initiators, EIPs, Gainsharers and BPCI Entities compliance with BPCI requirements, this Agreement, the Participant Agreement, any written gainsharing agreement between an EIP and a Gainsharer, the quality of services furnished, the obligation to repay any Excess Spending Amounts, Readmissions Amounts, or Opt-out Physicians Amounts owed to CMS, and/or the calculation, distribution, or recoupment of Incentive Payments or any portion of BPCI Savings. 23

27 (b) To maintain such books, contracts, records, documents, and other evidence for a period of 10 years from the expiration or termination of this Agreement 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 Awardee at least 30 calendar days before the normal disposition date; or (ii) There has been a termination, dispute, or allegation of fraud or similar fault against Awardee, Episode Initiator(s), EIP(s), Gainsharer(s), and/or BPCI Entity(s), in which case the records shall 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. 6. Responsibility of Awardee. Notwithstanding any arrangements between or among Awardee, Episode Initiator(s), EIP(s), Gainsharer(s), and BPCI Entity (s), Awardee agrees it shall have ultimate responsibility for adhering to and otherwise fully complying with all terms and conditions of this Agreement. 7. Office of Inspector General of the Department of Health and Human Services (OIG) Authority. None of the provisions of this Agreement limits or restricts any of OIG s authorities including the authority to audit, evaluate, investigate, or inspect Awardee, Episode Initiator(s), EIP(s), Gainsharer(s) and/or BPCI Entity(s) or any other person or entity or their records, data, or information, without limitation. 8. Other Government Authority. None of the provisions of this Agreement limits or restricts any other government authority permitted by law to audit, evaluate, investigate, or inspect Awardee, Episode Initiator(s), EIP(s), Gainsharer(s), and/or BPCI Entity(s), or any other person or entity or their records, data, or information, without limitation. 9. Financial Guarantees. (a) State Recognition. During the Effective Period, Awardee must be in compliance with state laws applicable to risk-bearing entities, unless it has provided a written attestation to CMS within 30 days of the Effective Date that it is exempt from such licensure or other related licensure requirements. (b) Secondary Repayment Source. (i) Awardee Conveners shall submit to CMS, by 45 days after the Effective Date, executed documents establishing a 24

28 secondary repayment source that complies with the criteria set forth in Attachment G and guarantees the Awardee Convener s ability to pay on demand amounts owed to CMS under this Agreement up to the amount specified in Attachment G. (ii) The Awardee Convener shall ensure that the secondary repayment source becomes effective no later than 45 days after the Effective Date and remains in effect until at least 18 months after the conclusion of the Effective Period. The Awardee shall remain liable for any amount owed to CMS in excess of the amount specified in Attachment G. (iii)the amount guaranteed by the secondary repayment source shall be calculated by CMS in accordance with the methodology specified in Attachment G. 10. Public Release of Information. Awardee shall obtain prior approval from CMS during the Effective Period and for six months thereafter for the publication or release of any press release, external report or statistical/analytical material that references its participation in BPCI Model 4 or Awardee s financial arrangement with CMS. External reports and statistical/analytical material may include papers, articles, professional publications, speeches, and testimony. Awardee agrees to include the following statement on the first page of all external reports and statistical/analytical material that are subject to this Section: 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. Any material submitted to CMS for prior approval that is not disapproved in writing by CMS within 30 calendar days after receipt by CMS will be deemed approved. (a) In the course of Awardee s participation in BPCI Model 4, Awardee will apprise CMS of any unanticipated results related to BPCI Model 4, Awardee or its Model 4 Beneficiaries, before dissemination to the general public. 11. Rights in Data and Intellectual Property. (a) Property of Awardee. Notwithstanding any other provision in this Agreement, all proprietary information and technology of Awardee are and shall remain the sole property of Awardee, and, to the extent allowed by Federal law, shall not be released by CMS without the express written consent of Awardee. 48 CFR , Rights in Data-General (no alternate) is hereby incorporated by reference into this Agreement. CMS does not 25

29 acquire by license or otherwise, whether express or implied, any intellectual property right or other rights to Awardee s proprietary information or technology. (b) Indemnity. Awardee shall indemnify the Government and its officers, agents, and employees acting for the Government against any liability, including costs and expenses, incurred as the result of a violation by Awardee, Episode Initiator(s), EIP(s), Gainsharers, and/or BPCI Entity(s), of trade secrets, copyrights, or right of privacy or publicity, arising out of the creation, delivery, publication, or use of any data furnished under this Agreement; or any libelous or other unlawful matter contained in such data. The provisions of this paragraph do not apply unless the Government provides notice to Awardee as soon as practicable of any third party claim or suit, affords Awardee an opportunity under applicable laws, rules, or regulations to participate in the defense thereof, and obtains Awardee s consent to the settlement of any suit or claim other than as required by final decree of a court of competent jurisdiction. 12. Participation in Shared Learning Activities. Awardee, Episode Initiator(s), and EIP(s) shall participate in reasonable learning activities designed to strengthen results and share learning that emerges from participation in BPCI Model 4. CMS will also organize additional activities, such as live case visits to all BPCI Model 4 Awardees, that Awardee will be encouraged to host and/or attend. IV. CMS OBLIGATIONS A. Implementation Protocol. CMS will make reasonable efforts to accept the Implementation Protocol in writing within 60 calendar days from the Effective Date. Upon written acceptance from CMS, the Implementation Protocol will be attached at Attachment B and incorporated herein. CMS will review any written amendments to the Implementation Protocol submitted by the Awardee and make reasonable efforts to respond or provide notice of an extension of the review period to Awardee within 30 calendar days of receipt. Should CMS accept an amendment to the Awardee s Implementation Protocol, such amendment will become part of the Implementation Protocol and incorporated to this Agreement. CMS s acceptance of an Awardee s Implementation Protocol shall not preclude CMS or any other government authority from enforcing any and all applicable laws, rules and regulations. Such acceptance also does not relieve Awardee, Episode Initiators, EIPs, Gainsharers, and BPCI Entities of the obligation to comply with the terms of this Agreement and all applicable statutes, regulations and guidance, as set forth in Section VIII.A. of this Agreement. 26

30 B. Data Sharing. Subject to this Agreement and in accordance with applicable law, CMS will provide, at a minimum, the following categories of data to Awardee during the Effective Period: 1. Beneficiary-level claims data. CMS shall make available on a monthly basis an Awardee s Model 4 beneficiary-level claims dataset. 2. Part B report. CMS shall provide to each Episode Initiator on a weekly basis a report of the Part B claims that are associated with the Episode Initiator s Episodes of Care, as specified in Attachment A. 3. Reconciliation Report. CMS will make reasonable efforts to quarterly furnish a report that includes the Readmissions Amount and Opt-out Physicians Amount, as described in Section V. 4. Post-Episode Spending Calculation. CMS shall furnish a report for each Performance Year that includes the Post-Episode Spending Calculation, as described in Section V. C. Evaluation and Monitoring 1. Feedback Monitoring. CMS or its designees shall provide Awardee with periodic feedback reports to assist Awardee in identifying areas for ongoing improvement ( Feedback Monitoring Reports ), as specified in the Evaluation and Monitoring Plan. CMS or its designee(s) shall capture and summarize relevant data, including, but not limited to, select Medicare payments during and around the Episode of Care, key quality indicators, case mix and demographic information. The sources for the Feedback Monitoring Reports may include but are not limited to: Medicare claims data, data reported or obtained from BPCI Model 4 Awardees in accordance with Section III.H.8 of this Agreement and the Evaluation and Monitoring Plan. D. Learning and Diffusion Activities. CMS or its designees shall provide BPCI Model 4 Awardees with learning activities to assist in understanding the information contained in the Feedback Monitoring Reports and in identifying best practices to further continuous quality improvement. E. Notification of Changes in Evaluation and Monitoring Plan. CMS or its designee(s) may change the Evaluation and Monitoring Plan at any time and will notify Awardee when doing so. To the extent that CMS is requiring Awardee to capture and submit new metrics, CMS will provide at least 30 calendar days written notice to Awardee. Any amendments to the Evaluation and Monitoring Plan shall be incorporated into this Agreement. F. Notification of Site Visits. CMS or its designee(s) shall provide Awardee no less than 15 calendar days advance notice of any site visits related to BPCI Model 4. Notwithstanding the foregoing, CMS or its designee(s) may perform unannounced site visits at any time to investigate concerns about the health or safety of patients, or 27

31 other program integrity issues. Nothing in this Section shall be construed to limit or otherwise prevent CMS or other government authority from performing site visits for purposes unrelated to BPCI as permitted by applicable law or regulations. G. Development of Metrics. CMS shall establish metrics for assessing Awardee s performance during the Effective Period. CMS shall primarily rely on the following sources for the relevant data: Medicare claims data and data reported by BPCI Model 4 Awardees as described in the Evaluation and Monitoring Plan and described above in Section III.H.6 of this Agreement. CMS will monitor to ensure that BPCI Model 4 Awardees maintain or improve overall quality performance, as well as aggregate levels of participation in the quality reporting systems set forth in Section III.G. of this Agreement. V. PAYMENT A. Payment Process. Attachment A contains a general description of the payment policies for Model 4 ( Model 4 Payment Policies ). Awardee and Episode Initiators understand and agree that the Model 4 Payment Policies and the terms of this Agreement will apply to services furnished during an Episode of Care. All of the Medicare conditions of participation, coverage, and payment, as well as other laws and policies, that would otherwise apply to the services that are furnished during an Episode of Care will continue to apply, unless expressly waived in writing under section 1115A(d)(1) of the Act. B. Prospective Model 4 Payment. Awardee and Episode Initiators understand and agree that under this Agreement and subject to the reconciliation process set forth in section V.G, CMS will pay the Prospective Model 4 Payment to an Episode Initiator, which will include the services that are furnished by the Episode Initiator, EIPs, Gainsharers, and/or Third Party Providers during an Episode of Care, as described in Attachment A. 1. Notwithstanding the Readmissions Amount and Opt-out Physicians Amount, the Prospective Model 4 Payment will be considered the total payment for all of the services that are furnished to a Model 4 Beneficiary during an Episode of Care. Awardee understands and agrees, and shall ensure through written agreements that Episode Initiators, EIPs who are physicians or nonphysician practitioners, and Gainsharers understand and agree, that the Prospective Model 4 Payment will be considered payment in full for services they furnish to a Model 4 Beneficiary during an Episode of Care, and that claims for such services will not be paid under the applicable Medicare Fee-for-Service payment rules, unless an EIP, Gainsharer, or Third Party Provider has opted out of the Model 4 payment methodology in accordance with the process described in Attachment A. 2. Awardee and Episode Initiators understand and agree that each Episode Initiator will pay each physician and nonphysician practitioner who furnishes 28

32 services to a Model 4 Beneficiary during an Episode Anchor Hospitalization or a readmission to the Episode Initiator during the 30-day Post-Discharge Period (regardless of whether the physician or nonphysician practitioner is an EIP, a Gainsharer, or a Third Party Provider) at a rate that is equivalent to the amount that would otherwise apply under the Physician Fee Schedule, unless a different amount has been agreed to in writing by the Episode Initiator and the physician/nonphysician practitioner, or the physician/nonphysician practitioner has opted out of the Model 4 payment methodology in accordance with the process described in Attachment A. Awardee and Episode Initiators understand and agree that payment to physicians and nonphysician practitioners must comply with all applicable laws unless those laws are expressly waived in writing under section 1115A(d)(1) of the Act. C. Model 4 Coinsurance Amount. Awardee and Episode Initiators understand and agree that under this Agreement, each Episode Initiator will collect the Model 4 Coinsurance Amount from each Model 4 Beneficiary. Notwithstanding Other Coinsurance Amounts, Awardee understands and agrees, and shall ensure through written agreements that Episode Initiators, EIPs who are physicians or nonphysician practitioners, and Gainsharers understand and agree, that the Model 4 Coinsurance Amount will be considered the full coinsurance amount owed by a Model 4 Beneficiary for services furnished during an Episode of Care, and that Episode Initiators, EIPs who are physicians or nonphysician practitioners, and Gainsharers shall not collect additional coinsurance amounts from a Model 4 Beneficiary for services furnished during the Episode Anchor Hospitalization or readmissions to the Episode Initiator during the 30-day Post-Discharge Period unless an EIP or a Gainsharer has opted out of the Model 4 payment methodology in accordance with the process described in Attachment A. D. Readmissions Amount. Awardee and Episode Initiators understand and agree that under this Agreement, CMS will perform a quarterly reconciliation to identify readmissions of a Model 4 Beneficiary at hospitals other than the Episode Initiator. Awardee understands and agrees that the Awardee will pay to CMS the Readmissions Amounts calculated. E. Opt-out Physicians Amount. Awardee and Episode Initiators understand and agree that under this Agreement, CMS will perform a quarterly reconciliation to identify Medicare paid claims submitted by physicians or nonphysician practitioners who opt out of the Model 4 payment methodology as described in Attachment A, for services furnished to a Model 4 Beneficiary during an Episode of Care. Awardee understands and agrees that the Awardee will pay to CMS the Opt-out Physicians Amounts calculated. Each Episode Initiator agrees to recoup the payments made by the Episode Initiator to a physician/nonphysician practitioner for Part B covered services furnished to a Model 4 Beneficiary during an Episode of Care where the physician/nonphysician practitioner is also paid by Medicare for those services through the opt-out process described in Attachment A. Awardee shall ensure that each Episode Initiator shall recoup such amounts. 29

33 F. Repayment of Other Coinsurance Amounts. Awardee and Episode Initiators understand and agree that under this Agreement, each Episode Initiator will repay Other Coinsurance Amounts, subject to a ceiling equal to the Model 4 Coinsurance Amount collected from the Model 4 Beneficiary, to the Model 4 Beneficiary or secondary insurer, as applicable, within 30 calendar days of receiving notification, through the weekly Part B report (as described in Attachment A), of claims associated with physicians and nonphysician practitioners who have opted out of the Model 4 payment methodology, as described in Attachment A. G. Reconciliation Process. CMS shall determine Prospective Model 4 Payments for the Clinical Episodes using the methodology described in Attachment A. On a quarterly basis, CMS shall institute a reconciliation process as described in Attachment A. 1. Reconciliation Report. On a quarterly basis, and subject to the evaluation and monitoring data collected in Section III.H.8 of this Agreement, CMS will issue a Reconciliation Report to the Awardee. The Reconciliation Report will specify any Readmissions Amount and any Opt-out Physicians Amount that has been calculated. CMS reserves the right, in its sole discretion, to make redeterminations of the Readmissions Amount and Opt-out Physicians Amount in subsequent periods based on the availability of updated Medicare administrative data. The Readmissions Amount and the Opt-out Physicians Amount calculation may include adjustments as necessary to account for redeterminations of Readmissions Amounts and Opt-out Physicians Amounts that were specified in earlier Reconciliation Reports. 2. Calculation Error. Awardee shall have 30 calendar days from the date the Reconciliation Report is issued to provide written notice of an error in the calculation of the Readmissions Amount and the Opt-out Physicians Amount. Unless Awardee provides such notice within such 30-day period, the calculation shall be deemed final as of 30 calendar days after it is issued. If CMS receives a timely notice of an error in the calculation, CMS shall respond in writing within 30 calendar days to either confirm or refute the calculation error, although CMS reserves the right to an extension upon written notice to Awardee. If CMS does not respond within 30 calendar days (or the extended time period, as applicable) of receiving the notice of error, the calculation error shall be deemed valid and the Readmissions Amount and the Opt-out Physicians Amount shall be adjusted accordingly and reflected in a revised Reconciliation Report. 3. Determination Letter. CMS shall make reasonable efforts to issue a determination letter specifying the Readmissions Amount and the Opt-out Physicians Amount to Awardee within 5 calendar days after the Reconciliation Report is deemed final by CMS. 30

34 4. Repayment of Readmissions Amount and Opt-out Physicians Amount. If the determination letter indicates a Readmissions Amount and/or Opt-out Physicians Amount, Awardee shall issue an electronic funds transfer for that amount to CMS within 30 calendar days after issuance of the determination letter. 5. Non-Repayment of Readmissions Amount and Opt-out Physicians Amount. If the Awardee does not pay the Readmissions Amount and/or Opt-out Physicians Amount owed within 30 calendar days after issuance of the determination letter, CMS will issue a demand letter indicating the amount owed by Awardee. Awardee shall pay CMS the full amount specified in the demand letter by the date indicated in the demand letter. If Awardee fails to pay CMS the amount owed by the date indicated in the demand letter, CMS will either recoup owed monies from Awardee s present and future Medicare payments, or invoke its rights under the secondary repayment source provided pursuant to Section III.I.9(b) of this Agreement to collect all monies due to CMS. Awardee understands and agrees that Awardee is solely liable for the repayment of the Readmissions Amount and Opt-out Physicians Amount to CMS. H. Post-Episode Spending Calculation 1. Post-Episode Spending Calculation Report. For each Performance Year and upon the earlier termination of this Agreement, CMS will issue a Post-Episode Spending Calculation Report to Awardee, which will specify any Excess Spending Amount. 2. Calculation Error. Awardee shall have 30 calendar days from the date the Post-Episode Spending Calculation Report is issued to provide written notice of an error in the calculation. Unless Awardee provides such notice within such 30-day period, the calculation shall be deemed final as of 30 calendar days after it is issued. If CMS receives a timely notice of an error in the calculation, CMS shall respond in writing within 30 calendar days to either confirm or refute the calculation error, although CMS reserves the right to an extension upon written notice to Awardee. If CMS does not respond within 30 calendar days (or the extended time period, as applicable) of receiving the notice of error, the calculation error shall be deemed valid and the Excess Spending Amount shall be adjusted accordingly and reflected in a revised Post-Episode Spending Calculation Report. 3. Determination Letter. CMS shall make reasonable efforts to issue a determination letter specifying the Excess Spending Amount to Awardee within 5 calendar days after the Post-Episode Spending Calculation Report is deemed final by CMS. 4. Repayment of Excess Spending Amount. If a determination letter is issued indicating an Excess Spending Amount, Awardee shall issue an electronic 31

35 funds transfer for that amount to CMS within 30 calendar days after issuance of the determination letter. 5. Non-Payment of Excess Spending Amount. If the Awardee does not pay the Excess Spending Amount owed within 30 calendar days after issuance of the determination letter, CMS will issue a demand letter indicating the amount owed by Awardee. Awardee shall pay CMS the full amount specified in the demand letter by the date indicated in the demand letter. If Awardee fails to pay CMS the amount owed by the date indicated in the demand letter, CMS will either recoup owed monies from Awardee s present and future Medicare payments, or invoke its rights under the secondary repayment source provided pursuant to Section III.I.9.(b) of this Agreement to collect all monies due to CMS. Awardee understands and agrees that Awardee is solely liable for the repayment of the Excess Spending Amount to CMS. I. Recoupment from Awardee s Present and Future Medicare Payments. If CMS is owed funds by an Awardee or Awardee Convener that is not required to provide a secondary repayment source pursuant to section III.I.9(b), CMS shall recoup the funds owed from Medicare payments otherwise due and owing to the Awardee or to the Awardee Convener s wholly owned Episode Initiators that triggered the Episodes of Care that resulted in funds being owed to CMS. J. Interaction with a Shared Savings Program. BPCI Model 4 does not involve shared savings for purposes of Section 1899(b)(4) of the Act. Notwithstanding the foregoing, Awardee agrees that CMS may, in its sole discretion, make adjustments through the Reconciliation Process and as specified in Attachment A and as otherwise necessary to avoid duplicative accounting for, and payment of, savings achieved by a provider or supplier that is participating in any other existing or future Medicare program, demonstration or model that involves shared savings. VI. TERMINATION AND REMEDIATION A. Termination by Awardee. Awardee may terminate this Agreement at any time for any reason upon advance written notice as specified in Section VI.D. B. Termination by CMS. CMS may immediately or with advance notice terminate this Agreement, or require Awardee to terminate the noncompliant individual or entity s participation in BPCI Model 4, if: 1. CMS determines that it no longer has the funds to support BPCI Model 4; 2. CMS terminates the BPCI Model 4 pursuant to Section 1115A(b)(3)(B) of the Act; 3. CMS does not accept, for any reason, the Awardee s Implementation Protocol or any amendments thereto; or 32

36 4. An Awardee, Episode Initiator, EIP, Gainsharer or BPCI Entity: (a) Fails to comply with any applicable term of this Agreement, or any other Medicare program requirement, rule, or regulation; (b) Takes any action that threatens the health or safety of patients; avoids at-risk Medicare beneficiaries, as this term is defined in 42 C.F.R ; or avoids patients on the basis of payor status; (c) Is subject to sanctions or final actions of an accrediting organization, or Federal, State or local government agency that could lead to the inability to comply with this Agreement; (d) Takes or fails to take any action that CMS determines for program integrity reasons is not in the best interests of the BPCI Model 4 initiative; or (e) Is subject to action by HHS (including OIG and CMS) or the Department of Justice to redress an allegation of fraud or significant misconduct, including intervening in a False Claims Act qui tam matter, issuing a pre-demand or demand letter under a civil sanction authority, or similar actions. 5. Upon CMS s termination of the Agreement for any of the reasons listed in Section VI.B of the Agreement, Awardee shall immediately cease the distribution of funds from the BPCI Savings Pool. C. Termination by Mutual Consent. The Parties may terminate this Agreement at any time by mutual written consent. D. Notice of Termination. 1. Notice of Termination by Awardee. If the termination is intended to take effect after the start of the first Performance Year, Awardee shall provide CMS with at least 60 calendar days prior written notice of the effective date of the termination of this Agreement by Awardee. 2. Notice of Termination by CMS. CMS shall issue written notice ( Notice of Termination ) specifying its grounds for termination of this Agreement and the effective date of such termination. 3. Notice of Termination to Third Parties. If the termination is intended to take effect after the start of the first Performance Year, Awardee shall notify all Episode Initiators, EIPs, and BPCI Entities at least 60 calendar days before the termination of this Agreement by either party. If the Agreement is terminated by mutual written consent effective prior to the start of the first Performance Year, no notice to Episode Initiators, EIPs, and BPCI Entities is required. 33

37 E. Remedial Actions. If CMS determines that there may be grounds for terminating this Agreement, CMS, in its sole discretion, may take any or all of the following actions: 1. Notify Awardee of the specific performance problem. 2. Require Awardee to provide additional data to CMS or its designees. 3. Require Awardee to stop distributing Incentive Payments to an Episode Initiator, EIP, and/or BPCI Entity. 4. Require Awardee to prohibit an EIP from distributing Incentive Payments to a Gainsharer. 5. Require Awardee to prevent contributions of an Episode Initiator s and/or EIP s Internal Cost Savings into the BPCI Savings Pool. 6. Request a corrective action plan from the Awardee. If CMS requests a corrective action plan, then the following requirements apply: (a) Awardee must submit a corrective action plan for CMS approval by the deadline established by CMS. (b) The corrective action plan must address what actions Awardee will take within a specified time period to ensure that Awardee, Episode Initiator(s), EIP(s), Gainsharers, and/or BPCI Entities will correct all deficiencies and remain in compliance with this Agreement. (c) If Awardee, Episode Initiator(s), EIP(s), Gainsharers, and/or BPCI Entities do not comply with the corrective action plan within the specified time period, CMS may terminate this Agreement or require Awardee to terminate the noncompliant individual or entity s participation in BPCI Model 4. F. Financial Settlement upon Termination. Awardee shall be liable for all Readmissions Amounts, Opt-out Physicians Amounts, and Excess Spending Amounts owed to CMS for Episodes of Care that occurred prior to the effective date of termination of the Agreement for any reason. Upon termination of this Agreement, Awardee shall pay all outstanding Readmissions Amounts, Opt-out Physicians Amounts, and Excess Spending Amounts owed to Medicare, in accordance with Section V.B-H of this Agreement, no later than 30 calendar days after the issuance of a determination letter pursuant to Section V.G.3 or Section V.H.3, as applicable. Awardee shall not distribute or otherwise remove any monies from the BPCI Savings Pool unless and until CMS has issued a written notice informing the Awardee that all outstanding Readmissions Amounts, Optout Physicians Amounts, and Excess Spending Amounts owed to CMS for Episodes of Care that occurred prior to the effective date of termination of the 34

38 Agreement have been settled to CMS s satisfaction. With regard to any Post- Episode Spending Calculation that occurs after the effective date of termination for Episodes of Care that occurred prior to the effective date of termination, Awardee shall pay the Excess Spending Amount within 30 calendar days after receiving notice of such Excess Spending Amount. This Section shall survive any termination of this Agreement. VII. DISPUTE RESOLUTION. A. Limitations on Review. Awardee acknowledges that notwithstanding any other provision of this Agreement, there is no administrative or judicial review under Sections 1869 or 1878 of the Act or otherwise for the following: 1. The selection of models for testing or expansion under Section 1115A of the Act; 2. The selection of organizations, sites, or participants to test those models selected; 3. The elements, parameters, scope, and duration of such models for testing or dissemination; 4. Determinations regarding budget neutrality under subsection 1115A(b)(3); 5. The termination or modification of the design and implementation of a model under subsection 1115A(b)(3)(B); 6. Decisions about expansion of the duration and scope of a model under subsection 1115A(c), including the determination that a model is not expected to meet criteria described in paragraph (1) or (2) of such subsection. B. Matters Subject to Dispute Resolution. The dispute resolution process for BPCI Model 4 is limited solely to Awardee contesting the Readmissions Amounts, Optout Physicians Amounts, and Excess Spending Amounts on the grounds that CMS or its representative has made an error in calculating such amounts. Awardee and CMS agree that no other disputes or appeals will be considered for any other matters, including the following payment related matters: (1) methodology used to determine the Readmissions Amounts, Opt-out Physicians Amounts, and Excess Spending Amounts; (2) methodology and/or definition of the intervention and comparison groups; (3) the approved quality measures and application of these measures for each Performance Year; and (4) claims that dispute financial or quality results based on Awardee's inability to use or apply CMS data provided during the Performance Year. 35

39 C. Dispute Resolution Process. 1. If the Awardee is dissatisfied with CMS s response to the Awardee s notice of calculation error submitted in accordance with Section V.G.2 or V.H.2, the Awardee may request a reconsideration review by a CMS reconsideration official. The reconsideration review request shall be submitted in a form and manner and to an individual or office specified by CMS. The reconsideration review request shall provide a detailed explanation of the basis for the dispute and include supporting documentation for the Awardee s assertion that CMS or its representatives did not accurately calculate the Readmissions Amounts, Opt-out Physicians Amounts, and Excess Spending Amounts in accordance with this Agreement. 2. Within 15 calendar days of receiving the Awardee s reconsideration review request, the CMS reconsideration official shall make reasonable efforts to notify the Parties in writing of the date, time, and location of the review, the issues in dispute, the review procedures, and the procedures (including format and deadlines) for submission of evidence (the Scheduling Notice ). The CMS reconsideration official shall make reasonable efforts to schedule the review to occur no later than 30 days after the date of the Scheduling Notice. 3. The provisions at 42 CFR (a)(2) and (b)-(e) (as in effect on the Effective Date of this Agreement) shall apply to reviews conducted pursuant to this Agreement. 4. The CMS reconsideration official shall make reasonable efforts to issue a written determination within 30 days of the review. The determination shall be final, binding, and not subject to any further administrative or judicial review. 5. Awardee shall proceed diligently with performance of this Agreement, pending final resolution of any dispute arising under the Agreement prior to termination. VIII. APPLICATION OF OTHER LAWS GOVERNING FEDERAL HEALTH CARE PROGRAMS A. Agreement to Comply. Awardee agrees, and shall require Episode Initiators, EIPs, Gainsharers, and BPCI Entities to agree, to comply with the terms of this Agreement and all applicable statutes, regulations, and guidance. B. Reservation of Rights. Nothing contained in this Agreement is intended or shall be construed as a waiver by the United States Department of Justice, the Internal Revenue Service, the Federal Trade Commission, HHS Office of the Inspector General, or CMS of any right to institute any proceeding or action against defendants for violations of any statutes, rules or regulations administered by the Government, or to prevent or limit the rights of the Government to obtain relief 36

40 under any other federal statutes or regulations, or on account of any violation of this Agreement or any other provision of law. This Agreement shall not be construed to bind any Government agency except CMS, and this Agreement binds CMS only to the extent provided herein. The failure by CMS to require performance of any provision shall not affect CMS s right to require performance at any time thereafter, nor shall a waiver of any breach or default of this Agreement constitute a waiver of any subsequent breach or default or a waiver of the provision itself. C. Agency Notifications and Submission of Reports. Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this Agreement shall be submitted to the following entities: CMS: Model 4 Bundled Payments for Care Improvement Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mailstop: WB-06-05, Baltimore, MD BundledM234@cms.hhs.gov Model 4 Awardee: Meridian Hospitals Corporation d/b/a Jersey Shore University Medical Center 1945 Route 33 Neptune, NJ IX. MISCELLANEOUS PROVISIONS A. Notice of Bankruptcy. In the event Awardee enters into proceedings relating to bankruptcy, whether voluntary or involuntary, Awardee agrees to furnish, by certified mail, written notification of the bankruptcy to CMS. This notification shall be furnished within 5 calendar days of the initiation of the proceedings relating to bankruptcy filing. This notification shall include the date on which the bankruptcy petition was filed, the identity of the court in which the bankruptcy petition was filed, and a listing of Government contracts, project agreements, contract officers, and project officers for all Government contracts and project agreements against which final payment has not been made. This obligation remains in effect until the expiration or termination of this Agreement and final payment under this Agreement has been made. B. Certification. The Awardee executive signing this Agreement on behalf of Awardee certifies to the best of his or her knowledge, information, and belief that the information contained in this Agreement (inclusive of Attachments), is accurate, complete, and truthful and that he or she is authorized by Awardee to execute this Agreement and to legally bind Awardee to its terms and conditions. 37

41 C. Severability. In the event that any one or more of the provisions contained herein shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provisions of this Agreement, but this Agreement shall be construed as if such invalid, illegal or unenforceable provisions had never been contained herein, unless the deletion of such provision or provisions would result in such a material change so as to cause completion of the transactions contemplated herein to be unreasonable. D. Survival. Termination of this Agreement by either Party shall not affect the rights and obligations of the Parties accrued prior to the effective date of the termination or expiration of this Agreement. E. Execution in Counterpart. This Agreement and any amendments thereto may be executed in counterparts, each of which shall be deemed to be an original, but all of which, taken together, shall constitute one and the same agreement. In the event that any signature is delivered by facsimile transmission or by delivery of a.pdf format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or.pdf signature page were an original thereof. F. Amendment. The Parties may amend this Agreement or any Attachment hereto at any time by mutual written agreement; provided, however, CMS may unilaterally amend this Agreement or any Attachment hereto for good cause or as necessary to comply with applicable federal or state law, regulatory requirements, accreditation standards or licensing guidelines or rules. To the extent practicable, CMS shall provide Awardee with 30 calendar days advance written notice of any such unilateral amendment, which notice will specify the amendment s effective date G. Precedence. If any provision of this Agreement conflicts with a provision of any document incorporated herein by reference, the provision of this Agreement will prevail. If any provision of the RFA conflicts with the Implementation Protocol, the provision of the Implementation Protocol will prevail. 38

42

43 ATTACHMENTS Attachment A Model 4 Payment Policies Attachment B Implementation Protocol Attachment C Awardee Profile Attachment D Evaluation and Monitoring Plan Attachment E Request For Application (RFA) Attachment F Gainsharing List Attachment G Secondary Repayment Sources Agreement Attachment H Episode Initiator Signatures Attachment I Discount Rate Table 40

44 Attachment A: Model 4 Payment Policies

45 Version 2, July 22, 2013 Bundled Payments for Care Improvement Model 4 Awardee Agreement: Attachment A Model 4 Payment Policies This Attachment A contains a general description of the payment policies for Model 4. Capitalized terms used in Attachment A have the same meaning as in the Agreement unless otherwise indicated. The Clinical Episodes are defined by anchor MS-DRGs and the Part A and B exclusions lists posted on the following website: Performance Quarter Attribution A Performance Quarter will include all Episodes of Care that meet the following criteria: 1) the end date of the Episode occurs no later than 30 days following the end of a three calendar month period that defines the Performance Quarter; 2) the Episode of Care was not assigned to a prior Performance Quarter; 3) the Episode of Care did not begin prior to the first Performance Year; and 4) the Episode of Care does not end after the final Performance Year. CMS will issue a Reconciliation Report to the Awardee within a reasonable period of time after the end of each Performance Quarter indicating the Readmissions Amount and the Opt-out Physicians Amount that has been calculated and is owed to CMS. Eligible beneficiaries Methodology for Calculation of Prospective Model 4 Payment Model 4 Beneficiaries are defined as Medicare FFS beneficiaries who are eligible for Part A and enrolled in Part B and receive inpatient hospital care at an Episode Initiator for a Clinical Episode during a Performance Year. On the day of admission to the Episode Anchor Hospitalization, the beneficiary must have either one lifetime reserve day or one day of utilization that is also a day of entitlement remaining. Beneficiaries who are covered under the United Mine Workers, managed care plans (for example, Medicare Advantage, Health Care Prepayment Plans, cost-based health maintenance organizations), or for whom Medicare is not the primary payer, as well as beneficiaries with End-Stage Renal Disease (ESRD), are excluded. Baseline calculation Baseline prices are calculated for each Episode Initiator using three years of historical data for the period of July 1, 2009-June 30, All cases are trended to 2012 using national episode-specific growth rates. For Clinical Episodes with volumes in excess of the established minimum volume to produce a credible estimate, benchmarks for each MS-DRG within the Clinical Episode are calculated using the Awardee s Clinical Episode base weight and the relative weight of mean episode payments for each MS-DRG developed from a national sample. For Clinical Episodes with volumes below the established minimum volume to produce a credible estimate, mean episode payments are first adjusted using the Empirical Bayes method of estimation, which derives a weighted average of the Awardee s mean episode payments 1

46 Version 2, July 22, 2013 and the state s mean episode payment, which is adjusted for wage-index. Following this adjustment benchmarks for each MS-DRG are calculated as for Clinical Episodes exceeding the minimum volume. Prospective Model 4 Payment Calculation The Prospective Model 4 Payment will be updated by applying market basket updates to the baseline prices and then applying the BPCI Discount. Direct adjustments for Medicare payment policies that differentially affect the Awardee will be applied. The Prospective Model 4 Payment will be updated at the time the payment policies described above are applied. Post-Episode Spending Calculation The baseline for each Clinical Episode at each Episode Initiator will be calculated in the same manner for the Post-Episode Spending Calculation as for the Prospective Model 4 Payment. The post-episode benchmark is calculated by applying the national Clinical Episode growth rate to the baseline. The Post- Episode Spending Calculation will be performed by CMS on an annual basis. A calculation will be performed separately for each Clinical Episode and for each Episode Initiator. If the total dollar amount of Medicare Fee-for-Service (FFS) expenditures for services furnished by the Awardee, the Episode Initiator, EIPs, or Third Party Providers, during the 30-day Post-Discharge Spending Monitoring Period exceeds the Risk Threshold, which is the upper end of a 99% two-tailed confidence interval surrounding the estimated benchmark, the result would be an Excess Spending Amount that must be repaid to CMS. Claims Processing Methodology under Model 4 The following claims processing and billing policies will apply under Model 4. These policies may be subject to change in order to ensure the payment policies of Model 4 are implemented appropriately. Educational activities will precede the implementation of Model 4 to ensure that Model 4 Awardees, Episode Initiators, physicians and nonphysician practitioners, and beneficiaries are aware of these policies. Notice of Admission (NOA) Submission When a beneficiary is admitted to an Episode Initiator and is anticipated to group into a BPCI anchor MS- DRG, the hospital must submit a Notice of Admission to CMS. The purpose of the NOA is to provide advance notice of the beneficiary s expected status as a Model 4 Beneficiary such that Part B claims will not be paid during the Episode Anchor Hospitalization or readmissions to the Episode Initiator. The NOA shall be created and submitted via direct data entry or hard copy. After CMS receives the NOA, the Episode Initiator will receive a $500 payment, which will later be deducted from the Prospective Model 4 Payment. Submission of this NOA is required. If the NOA is not submitted, it will jeopardize the ability of CMS to timely provide the Episode Initiator with information on unpaid Part B claims related to Model 4. If the NOA is submitted and then the patient does not group into an anchor MS-DRG, the Part B claims that were originally processed as no-pay claims will be reprocessed and paid as usual. 2

47 Version 2, July 22, 2013 Episode Initiator Final Discharge Billing When the final hospital claim for the Model 4 Beneficiary s Episode Anchor Hospitalization is received by Medicare, the Episode Initiator will be paid the Prospective Model 4 Payment (minus the $500 NOA payment, if applicable). The Episode Initiator will also be paid IME, DSH, outlier, and capital payments as usual under Fee-for-Service. Physician and Nonphyisician Practitioner Billing Physicians and nonphysician practitioners who are paid under the Medicare Physician Fee Schedule should submit claims to Medicare as usual. Medicare will not pay those claims if they are for services furnished during the Model 4 Beneficiary s Episode Anchor Hospitalization or related readmissions to the Episode Initiator. These no-pay claims do not need to be submitted any differently than Part B claims are typically submitted. They will appear the same to the submitting practitioner. If a Part B claim is paid by CMS, and then later it is determined that the patient in question is a Model 4 Beneficiary, that claim will be reprocessed automatically and payment will be recouped. No action will need to be taken by either the Episode Initiator or the physician or nonphysician practitioner in order for this reprocessing to take place. Episode Initiators will receive a report each week of all the no-pay Part B claims for a week that are associated with Model 4. The Episode Initiator can then use this weekly Part B report as a guide to pay the physicians and nonphysician practitioners. Episode Initiators must pay each physician and nonphysician practitioner who furnishes services during an Episode Anchor Hospitalization or a readmission to the Episode Initiator during the 30-day Post-Discharge Period at a rate that is equivalent to the amount that the physician or nonphysician practitioner would have been paid for those services under the Physician Fee Schedule unless a different amount has been agreed to in writing by the Episode Initiator and the physician/nonphysician practitioner, or the physician/nonphysician practitioner has opted out of the Model 4 payment methodology as described below. This Physician Fee Schedule amount will be included on the weekly Part B report. If claims related to Model 4 are reprocessed (either from Model 4 to regular fee-for-service, or from regular fee-for-service to Model 4), they will appear on the report for the week they are reprocessed, with an indicator to signal the change made to payment. Physicians and nonphysician practitioners must continue to bill for their services. While claims related to Model 4 will not be paid by CMS, the claims will be reflected in the weekly Part B report that is sent to Episode Initiators. Submission of these claims will also ensure that the various incentive programs for physicians and other professionals under Medicare Fee-for-Service can effectively calculate payments. For purposes of such incentive programs, physicians and other eligible professionals will be credited with the amount they would typically receive for the service under the Physician Fee Schedule (even if the professional receives a different amount for the service from the Episode Initiator). Unassigned Part B Claims Unassigned Part B claims will be excluded from Model 4. Unassigned Part B claims will be processed as usual in accordance with the regular Fee-for-Service payment rules. 3

48 Version 2, July 22, 2013 Physician Opt Out Procedures To be implemented no sooner than January 2014 In the event that a physician or nonphysician practitioner would prefer to opt out of the Model 4 payment methodology described above, they can indicate this on a regularly submitted claim using a HCPCS modifier, and that claim will be paid in accordance with the regular Fee-for-Service payment rules. If a physician or nonphysician practitioner submits a claim without the HCPCS modifier, they may later resubmit that claim with the modifier in accordance with the regular Fee-for-Service billing processes and receive payment as usual under Fee-for-Service. If a claim is submitted for the first time or resubmitted after the physician or nonphysician practitioner has already been paid by the Episode Initiator for that service under Model 4, the Episode Initiator will be required to recoup the payment made to that physician or nonphysician practitioner for that service such that only one payment is made (either by CMS or by the Episode Initiator). CMS will notify the Episode Initiators of claims associated with physicians and nonphysician practitioners who have opted out of Model 4 through the weekly Part B report. The amounts paid to physicians and nonphysician practitioners who use the claims opt out process described above ( Opt-out Physicians Amounts ) will be recouped from the Model 4 Awardee through a quarterly payment reconciliation process, as they were already included in the Prospective Model 4 Payment that was paid to the Episode Initiator. The opt out procedure described above will be implemented no sooner than January In the event that a physician or nonphysician practitioner would like to opt out of the Model 4 payment methodology for services rendered prior to opt out procedure implementation, there are two ways to accomplish this: 1. The physician or nonphysician practitioner will be able to indicate the HCPCS modifier on the claim when they submit that claim for payment, even if submission occurs before the date on which the opt out procedure described above is implemented. After the opt out procedure has been implemented, physicians and nonphysician practitioners who have already submitted claims with the modifier will then be able to request that the Medicare Administrative Contractor (MAC) reprocess all of their Model 4 no-pay claims that have been submitted with the modifier for dates of service prior to the date of implementation of the opt out procedure. 2. The physician or nonphysician practitioner can revise and resubmit the claim with the modifier, in accordance with the regular Fee-for-Service billing processes, after the date of implementation of the opt out procedure. All claims that are resubmitted with the modifier after the date of implementation of the opt out procedure will be processed according to the opt out procedure. Readmissions When a Model 4 Beneficiary is readmitted to the Episode Initiator for a related MS-DRG (one that is not listed on the Part A exclusion list which defines the Clinical Episode) with a date of admission that is within 30 days of discharge from the Episode Anchor Hospitalization, the Part A claim for this readmission will not be paid. However, CMS will pay IME, DSH, outlier, and capital payments associated with the readmission under the regular Fee-for-Service rules. Part B claims for services furnished by physicians and nonphysician practitioners during the readmission will not be paid, and they will appear on the weekly Part B report. 4

49 Version 2, July 22, 2013 When a Model 4 Beneficiary is readmitted to a hospital (including acute care IPPS hospitals, Maryland hospitals, critical access hospitals, cancer hospitals, children s hospitals, and inpatient psychiatric facilities) other than the Episode Initiator for a related MS-DRG within 30 days of discharge from the Episode Anchor Hospitalization, all Part A and Part B claims associated with the readmission will be paid by Medicare as usual. The amounts paid for such claims ( Readmissions Amounts ) will be recouped from the Episode Initiator or the Awardee during the quarterly payment reconciliation process, as those amounts were reflected in the Prospective Model 4 Payment. Claims Crossover Secondary payers who are currently participating in the file-based claims crossover process in conjunction with the Coordination of Benefit Contractor (COBC) will receive Model 4 claims as they normally receive Part A claims through the claims crossover process. This will allow secondary payers to process claims and pay beneficiary liability amounts or other amounts owed based on the Model 4 claims. No-pay physician claims will not cross over. Beneficiary Coinsurance and Deductibles Model 4 Beneficiaries will continue to be subject to Part A and Part B deductibles (per the regular Feefor-Service payment rules) if they have not yet met them upon initiation of an Episode of Care. Because all Part B services furnished during the inpatient stay are included in the Prospective Model 4 Payment, it will not be feasible to apply Medicare fee-for-service Part B coinsurance per service during the Model 4 Performance Years. As such, Model 4 Beneficiaries will be subject to a Model 4 Coinsurance Amount that is equal to 20% of the Part B portion of the Model 4 Prospective Payment (which is the same portion for all Model 4 Beneficiaries who initiate an Episode of Care at a given Model 4 Episode Initiator). This amount will be applied to Model 4 Beneficiaries regardless of service utilization within their Episode of Care. It will be billed on the Model 4 claim, which is a Part A claim, and it will be collectible by the Model 4 Episode Initiator. As this amount will be standardized across Model 4 Beneficiaries within a given MS-DRG at an Episode Initiator, it may be higher or lower than the amount the particular beneficiary would normally have paid based on the clinical condition for which they were admitted. The Model 4 Coinsurance Amount is intended to be equal, on average, to cost sharing experienced by a typical beneficiary for each condition for each Episode Initiator, less the appropriate BPCI Discount. However, it will be impossible to know this for a given Model 4 Beneficiary as Model 4 may influence both the quality and volume of the Part B services that Model 4 Beneficiary experiences during their Episode of Care. Model 4 Beneficiaries will receive notification of the effect of Model 4 on payments that they may owe to providers and suppliers through the Medicare Summary Notice (MSN), which they regularly receive whenever Medicare-covered services are furnished. New MSN messages will be applied to Model 4 services when they appear on the MSNs, which will inform Model 4 Beneficiaries of the Model 4 Prospective Payment for both Part A and Part B services, and will breakdown the existing column titled Maximum You May Be Billed into separate dollar amounts for the Part A deductible, Part B deductible, Part A coinsurance and/or lifetime reserve coinsurance, and the Model 4 Coinsurance Amount. If a physician or nonphysician practitioner chooses to opt out of the Model 4 payment methodology (as described above) and receive payment in accordance with the regular Fee-for-Service payment rules, they 5

50 Version 2, July 22, 2013 may also collect beneficiary coinsurance in accordance with these rules (known collectively as the Other Coinsurance Amount). In order to avoid requiring Model 4 Beneficiaries or their secondary insurers to pay excess coinsurance, the Episode Initiator that collected the Model 4 Coinsurance Amount from the Model 4 Beneficiary or their secondary insurer would be required to repay to that source the Other Coinsurance Amount that would be collectible by a physician who opted out of Model 4, up to a maximum amount equal to the agreed upon Model 4 Coinsurance Amount. If a Model 4 Beneficiary is readmitted to a hospital (including acute care IPPS hospitals, Maryland hospitals, critical access hospitals, cancer hospitals, children s hospitals, and inpatient psychiatric facilities) other than the Episode Initiator for a related MS-DRG within 30 days of discharge from the Episode Anchor Hospitalization, that hospital and any physicians or nonphysician practitioners rendering services during that hospitalization can collect coinsurance and deductible amounts according to the regular Medicare Fee-for-Service payment rules. Such coinsurance amounts will not be repaid by the Episode Initiator to the Model 4 Beneficiary or secondary insurer, as applicable. Interaction with Accountable Care Organizations While providers may participate in only one Medicare program or initiative involving a shared savings component (SSC) at a time, they may participate in an SSC initiative and BPCI, which is not an SSC initiative, or they may care for beneficiaries during a BPCI Episode of Care who are simultaneously aligned with an SSC initiative, which in both cases may result in potential overlap. All BPCI models include a discount off of an estimate of historical payments for an Episode of Care, which should result in overall Medicare savings. With no accounting for overlap between BPCI and SSC initiatives, a portion of the intended Medicare savings generated by a BPCI episode of care may be paid back to the SSC program participants. In the event that an Awardee or Episode Initiator is a participant in a Medicare Shared Savings Program or Pioneer Accountable Care Organization, the Awardee will be liable for any savings paid out to SSC program participants that represent savings intended to accrue to Medicare due to BPCI. This amount will be owed by the Awardee to CMS and recouped through the BPCI reconciliation process described in section V. of the Agreement. Additions and Deletions of Clinical Episodes and Episode Initiators Awardees may add or delete Clinical Episodes and/or Episode Initiators in a process to be specified by CMS by submitting an updated Awardee Profile. Changes to the Awardee Profile must be submitted at least 75 days prior to the Performance Quarter in which the change is to become effective. In the case of deletions, financial settlements will include payments or recoupments associated with Episodes of Care that were initiated prior to the start of the Performance Quarter in which the change becomes effective, regardless of whether or not the Episode of Care extends beyond the start of that Performance Quarter. In the case of additions, financial settlements will include payments and recoupments associated with Episodes of Care that were initiated on or after the start of the Performance Quarter in which the change becomes effective. 6

51 Attachment B: Model 4 Implementation Protocol

52 The page is acting as a placeholder for the Implementation Protocol. The Implementation Protocol will be submitted by the awardee at a later date.

53 Attachment C: Awardee Profile

54 Meridian Hospitals Corporation d/b/a Jersey Shore University Medical Center Awardee Profile Date of submission: October 18, 2013 Version: 1.0

55 Worksheet 1: Risk Track ReadMe Participants must select a Risk Track for each Clinical Episode and Episode Initiator. The Risk Tracks are defined as follows and apply to the calculation of Target Prices and Aggregated Fee-for-Service Payments: A- Individual Episodes of Care will be Winsorized at the 1st and 99th percentile of national wage-mix adjusted episode payments. For Episodes of Care Winsorized at the 99th percentile, 20% of the difference between the non-winsorized and Winsorized amount will be added to the Winsorized amount to determine the payment for that Episode of Care. B- Individual Episodes of Care will be Winsorized at the 5th and 95th percentile of national wage-mix adjusted episode payments. For Episodes of Care Winsorized at the 95th percentile, 20% of the difference between the non-winsorized and Winsorized amount will be added to the Winsorized amount to determine the payment for that Episode of Care. C- Individual Episodes of Care will be Winsorized at the 5th and 75th percentile of national wage-mix adjusted episode payments. For Episodes of Care Winsorized at the 75th percentile, 20% of the difference between the non-winsorized and Winsorized amount will be added to the Winsorized amount to determine the payment for that Episode of Care.

56 Worksheet 2: Entity List Complete Current BPID Candidate ID # Organization Name Model Role Organization Legal Name Org Type Org Type - Other CCN EIN/TIN NPI Jersey Shore University Medical Center 4 SA Meridian Hospitals Corporation d/b/a Jersey Shore University Medical Center Acute Care Hospital N/A

57 Worksheet 3: Episode List Episode Risk Track (Must Choose Performance Year 1 Performance Year 1 Performance Year 2 Performance Year 2 Performance Year 3 Performance Year 3 BPID Episode Length One: A, B, C) Begins Ends Begins Ends Begins Ends Coronary artery bypass graft 30 N/A January 1, 2014 December 31, 2014 January 1, 2015 December 31, 2015 January 1, 2016 December 31, 2016

58 Attachment D: Model 4 Evaluation and Monitoring Plan

59 Version 1, June 25, 2013 Bundled Payments for Care Improvement Model 4 Innovation Agreement: Attachment D Evaluation and Monitoring Plan Purpose. The purpose of this Evaluation and Monitoring Plan is to set forth the information that the Model 4 Awardee must capture and report to CMS or its designee(s) and the frequency and method of providing such reports. This is in accordance with Section III.H.7 of the Agreement. CMS or its designee(s) may change the Evaluation and Monitoring Plan upon written notice to Model 4 Awardees as specified in Section IV.E of the Agreement. I. Data Sources for Evaluation and Monitoring a. Regular Monitoring Progress Reports. The Model 4 Awardee shall capture data elements and information such as, but not limited to, the following and report them to CMS or its designee in a regular monitoring progress report at the periodicity specified below. Note that in Section III.G of the Agreement, the Awardee must also adhere to other quality requirements as specified in the Agreement. Monitoring Domains Care Redesign Interventions Information Submitted by Awardee Changes to care redesign approaches and aims Frequency of Submission Quarterly (if applicable) Structure Gainsharing Participants Gainsharing Methodology and Distribution Participation in Waivers Related to Beneficiary Incentives Complaint Reporting Quality Indicators for Acute Care Hospitals Key changes to organizational structure and other characteristics (Process improvement, data systems, support infrastructure, and ownership) Changes to the Gainsharing List BPCI Savings Pool determination methodology including actual Internal Cost Savings if applicable, Incentive Payment distribution methodology, Incentive Payments made to each organization or individual participating in a gainsharing arrangement. Changes to the criteria for providing incentives to beneficiaries; Information about incentives distributed to beneficiaries [Name and HICN of beneficiaries who received incentives, name and identification number (e.g., NPI, EIN, TIN, CCN, SSN, NSC, or PTAN, as appropriate) of the entity who furnished the incentive, date it was provided, and what incentive was provided] Date of complaint, original documentation or items received as part of a complaint (including description of alleged activity as applicable) Measure for All Acute Care Episodes: Medication Reconciliation Post-Discharge Quarterly (if applicable) Quarterly Quarterly Quarterly Quarterly Quarterly 1

60 Version 1, June 25, 2013 Monitoring Domains Quality Indicators for Acute Care Hospitals Quality Indicators for Acute Care Hospitals Information Submitted by Awardee Episode-specific measures for Cardiovascular Disorders, Surgical 1 : STS CABG Composite (Mortality and Morbidity Subset) Episode-specific measures for Infectious and Inflammatory Disorders 2 : Severe Sepsis and Septic Shock: Management Bundle Frequency of Submission Quarterly Quarterly b. BPCI-Adapted Version of the Continuity Assessment Record and Evaluation (B-CARE). The Model 4 Awardee will complete the BPCI-adapted version of the Continuity Assessment Record and Evaluation (B-CARE) Tool on all Medicare beneficiaries treated within the Model 4 BPCI episodes. In Model 4, B-CARE information will be collected immediately prior to at discharge from the hospital. The Model 4 Awardee will transmit this data to CMS or its designee on an ongoing basis with the allowed time between discharge and finalization to be determined. c. CMS or its designee will update this Evaluation and Monitoring Plan in accordance with Section IV.E of the Agreement to specify the data elements to be collected through the B- CARE Tool, expectations for permissible levels of missing data including beneficiaries not receiving a completed B-CARE Tool assessment or missing elements within the B-CARE Tool, the periodicity with which the Model 4 Awardee must submit these data, the method by which the Model 4 Awardee will submit these data, and other pertinent information. d. Miscellaneous Reporting. CMS may require the Model 4 Awardee to submit additional data elements or information. CMS or its designee(s) may update this Evaluation and Monitoring Plan in accordance with Section IV.E of the Agreement to specify the nature of this miscellaneous reporting. e. Activities Conducted by CMS or Its Designees. Model 4 Awardee acknowledges that CMS may conduct miscellaneous evaluation and monitoring activities. CMS or its designee(s) may update this Evaluation and Monitoring Plan in accordance with Section IV.E of the Agreement to specify the nature of these activities. Such evaluation and monitoring activities may include, but are not limited to, the following: i. Interviews, surveys, and focus groups with Model 4 Awardee Beneficiaries, beneficiary proxies, family members and/or caregivers; ii. Interviews, surveys, and focus groups with Model 4 Awardee, Episode Initiators, Episode-Integrated Providers, Gainsharers, and Model 4 Awardee Employees or Subcontractors; 1 BPCI episodes related to Cardiovascular Disorders, Surgical, include the following MS-DRGs: : Coronary artery bypass graft surgery (CABG); : Cardiac valve; : Major cardiovascular procedure; and : Other vascular surgery. 2 BPCI episodes related to Infectious and Inflammatory Disorders, include the following MS-DRGs: : Esophagitis, gastroenteritis and other digestive disorders; : Sepsis; : Urinary Tract Infection (UTI); : Cellulitis; and , : Simple pneumonia and Respiratory infections. 2

61 Version 1, June 25, 2013 II. Method of Reporting iii. Review and abstractions of charts, medical records, and other data from the Model 4 Awardee, Episode Initiators, Episode-Integrated Providers, Gainsharers, and Model 4 Awardee Employees or Subcontractors; and iv. Site visits in accordance with this Evaluation and Monitoring Plan and Section IV.E of the Agreement. CMS or its designee(s) will update this Evaluation and Monitoring Plan in accordance with Section IV.E of the Agreement to specify the method of reporting the information described in Sections III.H III. Quality Metrics Model 4 Awardee acknowledges that CMS shall assess the Model 4 Awardee s quality performance during the Effective Period in accordance with Section III.H.7 and Section III.F of the Agreement. CMS intends to measure quality metric domains, including structural and organizational characteristics; patient case-mix; clinical care and patient safety; patient experience; and utilization and cost. These domains will be measured through multiple sources including, the provider submitted quality indicators listed above in Section I.A of this attachment, and existing secondary data sources such as claims. CMS or its designee(s) will update this Evaluation and Monitoring Plan in accordance with Section IV.E of the Agreement to specify the methodology of this assessment. 3

62 Attachment E: Request for Application (RFA)

63 Bundled Payments for Care Improvement Initiative Request for Application Table of Contents I. Background... 2 A. Goals and Objectives... 2 B. General Approach of the Bundled Payments for Care Improvement Initiative... 5 C. Application Submission Process... 7 iii. Participation in Multiple Models... 9 D. Requests to Withdraw a Pending Application or a Provider... 9 II. Description of Model Components A. Principles and Summary of the Models B. Length of Agreement C. Budget Impact D. Gainsharing Arrangements E. Shared Learning Network Activities i. Learning Networks for Potential Applicants ii. Learning Networks for Awardees F. Participation of Other Payers G. Program Monitoring H. Beneficiary Protections I. Termination of Bundled Payments for Care Improvement Agreements J. Evaluation III. Conditions of Participation A. Eligible Applicants B. Beneficiary Eligibility C. Risk Bearing Capability IV. Application Submission, Review Process, and Selection Criteria A. Application & Selection Process Appendix A: Glossary Appendix B: Model 1 Mandatory Minimum Quality Measures /22/11