Preparing for DSRIP: Legal and Strategic Issues for Long-Term Care Providers LeadingAge New York Webinar November 10, 2014 Tracy E. Miller, Esq. Health Care Group Bond, Schoeneck & King, PLLC Delivery System Reform Incentive Payment Program Primary Goals Reduce preventable hospital admissions by 25%. Fundamentally restructure the health care delivery system. Other Goals Over the course of 5 years, shift Medicaid from FFS to capitation and pay for performance. Move towards large integrated delivery systems in the State that cut across the continuum of care. Manage population health. Use data and metrics to drive performance. 2 1
Key DSRIP Dates September 29 Draft DSRIP Project Plan application released. November 14 DOH releases final application. November 24 Final participant lists for attribution submitted to DOH. December 16 Final applications due. December 18 Applications posted for public comment. Early February, 2015 Assessor recommendations made public. Early March, 2015 DSRIP Project Awards announced. April 1, 2015 DSRIP Year One begins. 3 Funding Related To DSRIP 4 Pre-implementation Interim Access Assurance Fund ($500 million) temporary funding for safety net providers. Design Grants awarded to Emerging PPS entities ($21.6 million). DSRIP Implementation ($6.42 billion) April 1 Year One starts Capital Restructuring Grants (up to $1.2 billion) To support capital projects that promote health system transformation and align with DSRIP goals. RFA released this fall. Eligible applicants--providers with certificates issued by DOH, OMH, OASAS, OPWDD. Other Medicaid Redesign Purposes ($1.08 billion) To support home health development, investments in long-term care workforce and behavioral health services. 2
DSRIP Funding Criteria Lead Performing Provider Systems (PPS) entities and entities that will receive most of the DSRIP funding must meet the definition of safety net providers unless participating as part of a state-designated health home. Other entities eligible for funding, but at a maximum of 5% of DSRIP funding for each project, unless approved as a vital access provider. Funding will be allocated to each PPS lead based on a formula with the following components: Project index score (to a maximum of 60) Number of projects proposed by the PPS Plan application score as set by DOH Number of Medicaid beneficiaries attributed to the PPS. Within parameters set by safety net definition, PPS entities must develop budget and plan for distributing funds to participants. Pay for reporting/pay for performance. 5 DSRIP Funding Application Scoring Project Score (70%) and Organizational Score (30%) Score for Organization Governance (25%) Community Needs Assessment (25%) Workforce Strategy (20%) Data Sharing, Rapid Cycle Evaluation and Confidentiality (5%) Cultural Competence (15%) Financial Sustainability (10%) Pass/Fail Sections Describe how the PPS will evolve into a highly effective integrated delivery system. Present budget and plan to allocate DSRIP funding among participating providers. 6 3
Projects and Domains PPS must include in the Project Plan Application at least 5 but no more than 11 projects chosen from the following four domains: Domain 1: Implementation of PPS Project Plan Example: Establish system for data sharing. Domain 2: System Transformation Projects Example: Create an integrated delivery system. Domain 3: Clinical Improvement Projects Example: Palliative care or behavioral intervention programs in nursing homes Domain 4: Population-wide Projects Example: Increase access to high quality disease management. 7 Workforce Strategy Each PPS must identify workforce issues and submit a plan/strategies to: 1. Address how existing workforce strengths will be leveraged in the new delivery system; 2. Address the impact of DSRIP goals on the workforce; 3. Identify workforce issues including but not limited to: Identify impact on employment levels, wages, benefits, and distribution of skills and new hires anticipated by category; How workers will be trained and deployed to meet patient needs; Strategy to minimize negative impact on workforce; Categories of workers who will be most affected; and Role of unions in retraining. Workers and representatives of workers (unions) must be included in planning and implementing the Workforce Strategy. 8 4
Participation Agreements Anticipated that PPS entities will enter into contractual agreements with participating providers and vendors that will establish the rights and obligations of the PPS and PPS participants in areas such as: Funding distribution Obligations to implement clinical protocols Clinical and financial reporting Data sharing Obligations of PPS Participants to comply with PPS policies and procedures, e.g., compliance, health literacy, HIPAA security. Process to sanction poor performing providers. 9 Project Agreements Project specific agreements are also likely between the PPS and Participants and between PPS participants. Examples of Arrangements: Arrangements for sharing personnel and equipment Revising transfer and affiliation agreements Shared clinical outcomes data Shared clinical care protocols and pathways Workforce education and training. 10 5
Governance Each PPS application must include a detailed governance description. DOH seeking governance that is representative, effective (small boards and committees preferable) with strong project central control. Governance Domains o Financial o Clinical o Information Technology and Data o Compliance and Governance Oversight 11 Project Advisory Committee (PAC) May be advisory or more direct role in governance. Each PPS partner with more than 50 employees must select representatives to the PAC one managerial representative and one representative of workers. PPS partners with fewer than 50 employees have the option of selecting a worker and managerial representative. Advise on planning and implementation throughout DSRIP. PAC can have a governing committee and subcommittees. Must be representative. Include subject matter experts. 12 6
Governance Plans submitted to DOH must describe: Corporate structure for life of the program; Powers granted to the corporate entity by participating providers; How governance will evolve over the five years to a highly effective Integrated Delivery System; and How the PPS will address poor performing providers. Three basic models Collaborative Contracting Delegated Model New legal entity created to govern/operate the PPS PPS as single legal, integrated entity. One size does not fit all. 13 Governance What Does it Mean for Your Organization? Choice of corporate structure LLC or not-for-profit corporation. How are governing body members chosen? By the lead entity as the corporate member of a not-for-profit or members of an LLC? Will the PAC chose members of the governing body? Will PPS participants be represented on the governing body? By what criteria? o Capital contribution o Attributed patients o Regional representatives o Type of provider o Projects undertaken What is the role/status of your organization? o Governance Partner beneficiary attribution; governance role o Participating Partner beneficiary attribution; no governance role o Affiliate no beneficiary attribution; participate in the PPS. 14 7
DSRIP Governance What powers are granted to the governing body in relation to participating providers? Which governing body committees will be formed? On what basis will members be chosen? How will projects be run? By centralized staff? What are the rights of participating providers in relation to the PPS? What information will participating providers receive about PPS governing body decisions? PPS financial and clinical performance? Will your organization s performance data be shared with other PPS participants? What are the rights of participating providers if sanctioned as a poor performing provider? 15 Regulatory Waivers DOH, OMH, OASAS, and OPWDD will waive some New York State regulations to advance care coordination, system integration, and project implementation. PPS organizations must apply for waivers. Waiver requests must be project-specific and specific to individual providers. May not be used to create dual systems or different tiers of care: must apply to all patients not just Medicaid. Regulatory agencies may impose conditions on waiver approval (e.g., policies, staff training, monitoring, evaluation). Waivers may be revoked. State waivers cannot override federal law. 16 8
Examples of Waivers PPS Formation (Antitrust: Certificate of Public Advantage (COPA) proposed regulation; corporate practice of medicine). Integrated Services (Allowing primary care and behavioral health to operate under a single license) Shared Space (OASAS, OMH, and Article 28 providers) CON (Waiver for construction, new programs, need methodology) Expanded Services Areas (CHHAs, LHCSAs, and hospices) Ownership /Management (Active parent, Management contracts) Operating Standards (Admission/discharge, Transfer and affiliation agreements, LTC patient assessments, Credentialing, Telehealth) Information Sharing (HIPAA) Workforce Flexibility (Home care orders, EMS) 17 Waivers Relevant for Nursing Homes Waiver of CON approval for general hospitals, nursing homes, clinics, CHHAs and hospices to, for example: (i) renovate facilities; (ii) add or delete services; (iii) acquire major medical equipment; and (iv) change ownership. Transfer and affiliation agreements Assessment of long-term care residents, contingent upon policies and procedures to assure appropriate assessment and discharge Information sharing to overcome the need for separate consent as patients move between care settings DOH to develop model form. 18 9
Waivers Relevant for Home Care Regulatory Waivers 1. LHCSA extension of service area. 2. CHHA and hospice extension of service area. 3. Waiver allowing hospitals and diagnostic and treatment centers to provide home care to chronically ill patients. Potential Proposed Legislative/Regulatory Changes 1. Allow physician assistants in LHCSAs to issue orders for home care services. 2. Facilitate nurse driven protocols by expanding prescribing authority of nurse practitioners and role of nurses to implement treatment. 3. Allow advanced home health aides to administer medication. 19 Quality Collaboration DSRIP imposes numerous requirements for care coordination, quality, and data sharing. Coordinate care across the continuum to reduce cost, improve quality, and manage population health: Develop and carry out process metrics and goals to achieve system transformation. Set standards, processes, benchmarks, and metrics for care delivery. Manage implementation of evidence-based clinical protocols and best practices to achieve project goals. Collect performance metrics in uniform, valid manner from all PPS participants. Implement process for rapid cycle evaluation to enable PPS evaluation of participant and system progress and drive change. Report progress on goals with metrics to DOH. 20 10
Legal Implications of Quality Mandates Affiliation agreements or transfer/care coordination agreements. Data sharing agreements. Credentialing--possibility of shared credentialing standards and review. Medical Staff Bylaws o Require use of quality data and reporting o Responsibility of Medical Staff Quality Committee o Require adherence to clinical protocols Medical Director Role o Job description and contract Physician Contracts Pay-for-Performance Aligning payment to physicians with payment to the facility. 21 Implications for Quality Program and Capacity Governance--Essential Role in Overseeing Quality Understand quality improvement and use of measures Mounting relationship between quality and financial sustainability New care delivery models and policy initiatives, including DSRIP Set tone, priorities, monitor performance. CMS Guidance for Quality Assurance and Performance Improvement Leadership culture of quality Use of data to advance improvement collect data, analyze findings, develop interventions, and monitor progress. Importance of performance improvement projects--focus on identified goals. 22 11
Reducing Preventable Hospital Admissions Certain conditions associated with high rates of preventable readmission, e.g., pneumonia, urinary tract infections, congestive heart failure. (D. Grabowski et al, Health Affairs (2007) End of life care and discussions Health Care Proxy and effective implementation of Family Health Care Decisions Act. 23 Relevant Fraud and Abuse Laws Federal and State Anti-Kickback Laws (AKS) Prohibit knowingly offering, paying, soliciting, or receiving remuneration of any kind to induce or in exchange for referrals for goods and services paid for by Medicare, Medicaid, or other federal programs. Civil and criminal penalties. AKS safe harbors can apply and possibility of waiver from state AKS law. False Claims Act Imposes liability on persons/entities who knowingly submit false claims to Medicare or Medicaid. Claims can be false for numerous reasons, e.g., for services not delivered, or if claim is based on an underlying kickback. Penalties can be up to $11,000 per claim and three times amount of the claim. 24 12
Relevant Fraud and Abuse Laws Stark Law Prohibits a financial relationship, including compensation arrangements, between a physician (or immediate family member) and an entity with which the physician (or immediate family member) refers patients for designated health services, e.g., labs, physical and occupational therapy, home health services, unless an exception applies. Waiver may be available from application of the state Stark Law. Federal Civil Monetary Penalties Law Prohibits a hospital or a critical access hospital from knowingly making a payment, directly or indirectly, to a physician as an inducement to reduce or limit services provided to Medicare or Medicaid beneficiaries. 25 Data Reporting and Sharing; HIPAA Flow of Information NYSDOH PPS Participants Participants PPS DOH Participants PPS Other Participants Other Participants 26 13
Types of Information Protected Health Information (PHI) Medicaid Analytics Performance Portal (MAPP) Data De-identified Patient Information Clinical performance and outcome data provider and PPS performance Entity QA reviews Credentialing Information Proprietary Information Financial Information about PPS and provider performance 27 Legal Considerations Confidential Medicaid Data HIPAA NYS Patient Confidentiality Laws Substance Use HIV Mental Health Privilege/Confidentiality of QA and Peer Review 28 14
Ensuring the Flow of Information Data Exchange and Application Agreement to gain access to the Medicaid portal (data needed for community assessment and analysis) Business Associate Agreements Data Sharing Agreements Limited Data Use Agreements Patient Consents (Opt in/opt out) Secure systems for exchanging and storing data Interoperability between EHR and data systems Policies and procedures for data sharing and IT systems PPS Audit Capability 29 Questions? Tracy E. Miller, Esq. tmiller@bsk.com 646-253-2308 30 15