Copyright © Feldesman Tucker Leifer Fidell LLP Pennsylvania Association of Community Health Centers June 23, 2009 Beyond the Basics...Establishing Successful Community Health Center & Hospital Collaborative Models – Legal Considerations Presented by: Marcie H. Zakheim

Copyright © Feldesman Tucker Leifer Fidell LLP Today’s Presentation … Topics for today’s presentation Topics for today’s presentation –Reasons to collaborate –Health center – hospital collaborative opportunities –“Hot” trends in health center - hospital partnerships –Legal considerations –Key planning and negotiation steps

Copyright © Feldesman Tucker Leifer Fidell LLP Reasons to Collaborate

Copyright © Feldesman Tucker Leifer Fidell LLP Reasons to Collaborate: HRSA Expectations Section 330 legislation, as well as HRSA, encourage coordination, collaboration and integration with other provider(s) located in health center’s service area Section 330 legislation, as well as HRSA, encourage coordination, collaboration and integration with other provider(s) located in health center’s service area –Federal, State and local health and social services delivery projects/programs (including other HRSA grantees, Section 330 grantees and FQHC look-alike entities) –Providers of ancillary, secondary and tertiary care

Copyright © Feldesman Tucker Leifer Fidell LLP Reasons to Collaborate: Mission Maintain / enhance amount, level and type of services available to health center patients Maintain / enhance amount, level and type of services available to health center patients –Initiate new or enhance existing programs –Bring “in-scope” services currently provided by referral only –Bring “in-house” services currently provided off- site

Copyright © Feldesman Tucker Leifer Fidell LLP Reasons to Collaborate: Mission Facilitate / improve continuum of care Facilitate / improve continuum of care –Secure access to specialty / ancillary /tertiary services and other necessary services not provided by health center –Provide follow-up care indicated by referral arrangements (and vice versa) Ensure appropriate level of care on timely basis through Ensure appropriate level of care on timely basis through –Emergency room diversion programs –Residency training arrangements

Copyright © Feldesman Tucker Leifer Fidell LLP Reasons to Collaborate: Good Business Expand access locations and patient bases Expand access locations and patient bases Increase market share Increase market share Enhance and improve clinical, administrative and managerial capacities, resources, expertise and systems Enhance and improve clinical, administrative and managerial capacities, resources, expertise and systems Minimize risks and reduce operational costs Minimize risks and reduce operational costs Increase capital and financial support, revenue, and other resources Increase capital and financial support, revenue, and other resources Provide opportunities for health center to participate in programs in which it cannot do on its own Provide opportunities for health center to participate in programs in which it cannot do on its own Increase integration with the medical community Increase integration with the medical community

Copyright © Feldesman Tucker Leifer Fidell LLP Health Center – Hospital Collaborative Opportunities

Copyright © Feldesman Tucker Leifer Fidell LLP What are the Structural Options? Formal Referral Arrangements Formal Referral Arrangements –Note: Informal referral arrangements CANNOT be used to provide required services or any other “in-scope” services Separate Contractual Arrangements Separate Contractual Arrangements Umbrella Affiliation Arrangements Umbrella Affiliation Arrangements Integrated Programs/Services Integrated Programs/Services

Copyright © Feldesman Tucker Leifer Fidell LLP Formal Referral Arrangements Hospital agrees to furnish services to all health center patients who are referred to it by the health center regardless of ability to pay (subject to capacity limitations) Hospital agrees to furnish services to all health center patients who are referred to it by the health center regardless of ability to pay (subject to capacity limitations) –Health center ensures that its patients have access to services it does not (and/or cannot) provide –Hospital is financially, clinically and legally responsible and is solely liable for damages related to services –Hospital bills and collects payment for the services

Copyright © Feldesman Tucker Leifer Fidell LLP Formal Referral Arrangements Hospital agrees to Hospital agrees to –Provide services consistent with, at a minimum, the prevailing standards of care –Provide assurances regarding professional qualifications, licensure, eligibility to participate in federal programs –Refer patients back to the health center for clinically appropriate care –Share medical notes/records/feedback regarding diagnosis and treatment to assist follow-up care by health center

Copyright © Feldesman Tucker Leifer Fidell LLP Formal Referral Arrangements PIN # : “In-scope” referral arrangements PIN # : “In-scope” referral arrangements –If the hospital provides/bills for service, the service itself is not in scope –However, the formal referral arrangement and follow- up care provided by health center will be in-scope if the health center: Executes a formal, written agreement, including Executes a formal, written agreement, including –How the referral will be made and managed –Process for referring patient back to health center for follow-up care Maintains responsibility for the treatment plan Maintains responsibility for the treatment plan Provides, pays for, bills for the follow-up care Provides, pays for, bills for the follow-up care

Copyright © Feldesman Tucker Leifer Fidell LLP Separate Contractual Agreements Contracts for specific health care services Contracts for specific health care services Leases for space, equipment, personnel Leases for space, equipment, personnel Management/administrative services contracts Management/administrative services contracts Contracts to co-locate services or programs (e.g., primary care on hospital site; residency training at the health center site) Contracts to co-locate services or programs (e.g., primary care on hospital site; residency training at the health center site) Shared service contracts and joint purchasing arrangements Shared service contracts and joint purchasing arrangements Community Benefit Grant Community Benefit Grant

Copyright © Feldesman Tucker Leifer Fidell LLP Separate Contractual Agreements: Lease of Personnel Health center contracts with the hospital to furnish services to health center’s patients on behalf of health center Health center contracts with the hospital to furnish services to health center’s patients on behalf of health center –May be used to procure clinical, administrative and/or managerial expertise and experience that health center cannot obtain directly but wants to include in-scope –Health center is financially, clinically and legally responsible for the services purchased (but the hospital may agree to support the costs of care) –The patients receiving services from the hospital and/or its personnel are considered health center patients

Copyright © Feldesman Tucker Leifer Fidell LLP Separate Contractual Agreements: Lease of Personnel Hospital assures that hospital and its contracted personnel will Hospital assures that hospital and its contracted personnel will –Provide services in accordance with the health center ’ s Section 330 grant and applicable rules and policies –Provide services consistent with applicable health care and personnel policies, procedures, standards, protocols –Satisfy the health center ’ s licensure, credentialing and other professional qualifications –Prepare medical records consistent with the health center ’ s protocols –Develop and furnish programmatic and/or financial records required by the health center

Copyright © Feldesman Tucker Leifer Fidell LLP Separate Contractual Agreements: Lease of Personnel Health center retains the right to Health center retains the right to –Monitor and evaluate whether contracted staff is complying with all qualifications, policies, procedures, standards and protocols, and whether they are performing satisfactorily –Terminate the contract or request/require removal, suspension and/or replacement of any contracted professional who fails to meet qualifications, is non- complaint, performs unsatisfactorily, and/or provides sub-standard care –Bill and collect from third party payors/patients, and retain all revenue, for services provided by the hospital and it personnel

Copyright © Feldesman Tucker Leifer Fidell LLP Separate Contractual Agreements: Community Benefit Grant Defrays a portion of the costs of providing otherwise uncompensated care to the health center’s patients Defrays a portion of the costs of providing otherwise uncompensated care to the health center’s patients –“Bona fide” charitable donation to assist the community –Furthers the charitable missions of the parties –Presents a minimal risk of abuse of federal health care programs –Does not limit or restrict patient’s freedom of choice or the provider’s professional judgment –Terms are narrowly tailored to accomplish stated purpose only –Arrangement contains certain safeguards to protect against prohibited referrals or generation of business

Copyright © Feldesman Tucker Leifer Fidell LLP Umbrella “Affiliation” Agreements Joint planning process and planning body Joint planning process and planning body Priorities and associated time frames Priorities and associated time frames Nature of joint control and management of collaborative activities “outside” of Section 330 scope Nature of joint control and management of collaborative activities “outside” of Section 330 scope Extent of preferred relationship, if any Extent of preferred relationship, if any Each party’s financial expectations and commitments Each party’s financial expectations and commitments Right to change the collaboration over time Right to change the collaboration over time Right to terminate the agreement if the other party affiliates with a mission-incompatible entity or a competitor Right to terminate the agreement if the other party affiliates with a mission-incompatible entity or a competitor

Copyright © Feldesman Tucker Leifer Fidell LLP Integrated Services/Programs If operated in the health center’s scope of project If operated in the health center’s scope of project –Integrated services/programs are operated as under the health center umbrella –Health center must assume operational and financial authority for the services/programs –The hospital clinicians are either integrated into the health center’s workforce or purchased by the health center through a Lease of Clinical Capacity –May require “Transition Agreement” –Must ensure that the integration does not impact the health center board’s Compliance with Section 330 size, composition and selection requirements Compliance with Section 330 size, composition and selection requirements Autonomous and independent decision-making Autonomous and independent decision-making

Copyright © Feldesman Tucker Leifer Fidell LLP “Hot” Trends in Health Center – Hospital Partnerships

Copyright © Feldesman Tucker Leifer Fidell LLP What are the “Hot” Trends in Partnerships? Residency training arrangements Residency training arrangements ER diversion programs ER diversion programs Leveraging the safe harbor for Section 330 grantees Leveraging the safe harbor for Section 330 grantees Leveraging ARRA funding Leveraging ARRA funding

Copyright © Feldesman Tucker Leifer Fidell LLP Residency Training Arrangements Core Principles Core Principles –Hospital maintains control over, and responsibility for the costs of teaching activities performed at the health center, which are provided in accordance with the hospital’s policies and procedures Classroom teaching, undergraduate programs, and orientation programs Classroom teaching, undergraduate programs, and orientation programs Curriculum development and faculty meetings Curriculum development and faculty meetings Resident recruitment, selection, placement and evaluation, and setting of schedules Resident recruitment, selection, placement and evaluation, and setting of schedules Program administration and evaluation Program administration and evaluation

Copyright © Feldesman Tucker Leifer Fidell LLP Residency Training Arrangements Core Principles (cont.) Core Principles (cont.) –Hospital retains general responsibility for salaries and benefits (including malpractice insurance) of hospital faculty and residents and other costs but health center pays for clinical time of faculty for which it bills (need to avoid “double billing” of Medicare/Medicaid and Federal grants) –Hospital provides FMV payment to the health center for the time spent by health center clinicians and support staff in providing (as well as equipment and space used for) teaching activities

Copyright © Feldesman Tucker Leifer Fidell LLP Residency Training Arrangements Core Principles (cont.) Core Principles (cont.) –Health center maintains responsibility and authority over activities related to direct patient care services Scope, location and scheduling of services Scope, location and scheduling of services Right to approve/require removal, suspension, replacement of hospital faculty/residents providing clinical services to health center patients Right to approve/require removal, suspension, replacement of hospital faculty/residents providing clinical services to health center patients Diagnosis and treatment-related activities Diagnosis and treatment-related activities Billing third parties for clinical services provided Billing third parties for clinical services provided

Copyright © Feldesman Tucker Leifer Fidell LLP ER Diversion Programs CMS guidance pertaining to ER Diversion grants: overall impact on health center CMS guidance pertaining to ER Diversion grants: overall impact on health center –Provides opportunity for initiating or increasing health center- local hospital collaborative activities that recognize health centers as appropriate alternate non-emergency services providers –Establishes legal principle that, after an appropriate EMTALA screening and non-emergency determination, the patient can choose whether to receive care from the hospital or from an alternative provider

Copyright © Feldesman Tucker Leifer Fidell LLP ER Diversion Programs Potential Models: Potential Models: –Hospital refers patients who present with non- emergent/urgent conditions to the health center’s existing site(s), possibly with transportation linkage –Health center places personnel in hospital for purposes of intake, registration, making appointments for patients who present with non-emergent/urgent conditions –Health center assumes operator status for hospital- owned ambulatory clinic or new health center site located on or near hospital campus to provide alternate non-emergency services

Copyright © Feldesman Tucker Leifer Fidell LLP ER Diversion Programs - Under all potential models, must address -Whether patients are referred to the health center in lieu of treatment of non-emergency condition OR only for follow-up appointment -Separation of EMTALA screening personnel from ER treating clinicians -Documentation of patient choice -Referral protocols -Collaboration between providers and other staff of hospital and of health center -Development, maintenance and sharing of medical records

Copyright © Feldesman Tucker Leifer Fidell LLP Safe Harbor for Section 330 Grantees Health Center Safe Harbor under Federal Anti-Kickback statue: final OIG rule issued October 4, 2007 [42 C.F.R (w)] Health Center Safe Harbor under Federal Anti-Kickback statue: final OIG rule issued October 4, 2007 [42 C.F.R (w)] –Protects certain arrangements between health center grantees and other providers or suppliers of goods, services, donations, loans, etc. Must contribute to the health center’s ability to maintain or increase the availability, or enhance the quality, of services provided to its medically underserved patients Must contribute to the health center’s ability to maintain or increase the availability, or enhance the quality, of services provided to its medically underserved patients

Copyright © Feldesman Tucker Leifer Fidell LLP Safe Harbor for Section 330 Grantees Requirements Requirements –Written agreement signed by both parties that covers and specifies the amount of all goods, items, services, donations, loans, etc. provided to the health center, which may be fixed sum, fixed percentage, or established by a fixed methodology –Goods, items, services, donations, loans, etc., must be medical or clinical in nature or directly relate to any services (not just patient services) provided under the scope of project –Reasonable expectation (and documentation of the basis) that the arrangement will contribute meaningfully to services to the underserved – must re-evaluate at least annually

Copyright © Feldesman Tucker Leifer Fidell LLP Safe Harbor for Section 330 Grantees Requirements (cont.) Requirements (cont.)  Disclosure of the existence and nature of the arrangement to patients who inquire about it  No restriction on referrals (maintenance of provider professional judgment), health center’s ability to contract with others and/or patient freedom of choice  Goods, items, and/or services furnished under the arrangement must be available to all health center patients who clinically qualify for them, regardless of payor status or ability to pay, subject to hospital capacity

Copyright © Feldesman Tucker Leifer Fidell LLP The American Recovery and Reinvestment Act (ARRA) Signed into law on February 17, 2009 Signed into law on February 17, 2009 Includes $2 billion in grants to health centers to Includes $2 billion in grants to health centers to –Support comprehensive primary and preventive health care to an increasing number of patients –Create or retain thousands of health center jobs –Support pressing capital improvement needs, such as construction, repair, renovation, and equipment purchases (including health information technology – HIT – systems) HHS has already distributed HHS has already distributed –$155 million to establish 126 new health center sites –$338 million to support care to an increasing number of patients and to create or retain jobs at all existing health centers

Copyright © Feldesman Tucker Leifer Fidell LLP The American Recovery and Reinvestment Act (ARRA) Still to come Still to come –Capital Improvement Program (CIP) grants - $862.5 million appropriated to support infrastructure needs, such as construction, repair, renovation, and equipment purchases (including health information technology systems) –Health Information Technology (HIT) Systems/Networks grants - $125 million appropriated to support Electronic Health Record (HER) and HIT systems for health centers –Facility Investment Program (FIP) grants - $512.5 million appropriated to fund an estimated 100 significant facility projects (major facility investments in health centers including construction, repair, renovation, and equipment purchase)

Copyright © Feldesman Tucker Leifer Fidell LLP The American Recovery and Reinvestment Act (ARRA) ARRA offers great opportunities for expansion but also presents a high level of responsibility ARRA offers great opportunities for expansion but also presents a high level of responsibility –Transparency and accountability are critical elements of ARRA –Health centers should anticipate a high level of scrutiny in their use of these funds Funds can be used in conjunction with other funding as necessary to complete projects, but must be tracked and reported separately Funds can be used in conjunction with other funding as necessary to complete projects, but must be tracked and reported separately –Separate Notice of Grant Award, Payment Management System Account –Internal tracking – examples include time and effort reports, cost centers, ledgers, etc.

Copyright © Feldesman Tucker Leifer Fidell LLP Legal Considerations

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Scope of Project PIN # : Scope of Project Policy PIN # : Scope of Project Policy –All health centers must request and obtain prior approval from BPHC to implement significant changes in the federally-approved scope of project Add or delete services Add or delete services Increase, decrease or relocate service sites Increase, decrease or relocate service sites –Examples of changes that do not require prior approval Adding a service to a site already within scope as long as the service is already provided in scope at another site Adding a service to a site already within scope as long as the service is already provided in scope at another site Changing type of providers furnishing an in-scope service Changing type of providers furnishing an in-scope service Changing hours of operation of in-scope site Changing hours of operation of in-scope site

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Scope of Project In general, a request to change the approved scope of project will be approved if it In general, a request to change the approved scope of project will be approved if it –Does not require any additional 330 funding –Does not shift resources from the current target population –Furthers the health center’s mission by increasing / maintaining access and quality of care –Is consistent with Section 330 and Program Expectations –Provides credentialing / privileging of providers

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Scope of Project Approval factors (cont.) Approval factors (cont.) –Does not eliminate or reduce access to a required services –Does not result in diminution of the level or quality of services provided to current target population –As applicable, continues to serve an MUA/MUP –Board minutes document approval by the health center’s board –Does not significantly affect the current operation of another health center located in same or adjacent service area

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Scope of Project Additional considerations for new services Additional considerations for new services –All required services must be provided within the approved scope of project Either directly or through established written purchase agreement or formal referral arrangement Either directly or through established written purchase agreement or formal referral arrangement Regardless of how they are furnished, all in-scope services must be Regardless of how they are furnished, all in-scope services must be –Readily available and reasonably accessible to all patients equally regardless of ability to pay –Offered on a sliding fee / discount schedule –Can provide non-required services in-scope or out-of-scope

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Scope of Project Additional considerations for new sites Additional considerations for new sites –To include a new site, the following conditions must be met: Face-to-face encounters between the health center’s patient and provider are generated Face-to-face encounters between the health center’s patient and provider are generated Provider exercises independent professional judgment in furnishing services Provider exercises independent professional judgment in furnishing services Services are provided directly or on behalf of the health center, whose board retains control and authority over the services Services are provided directly or on behalf of the health center, whose board retains control and authority over the services Services are provided on a regularly scheduled basis Services are provided on a regularly scheduled basis –Includes “contracted” sites if all criteria are met

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Scope of Project Format and Timing for Change in Scope Request Format and Timing for Change in Scope Request –All requests must be prepared as described in the PIN and must be electronically through the Electronic Hand Book (EHB) separate from the continuation grant application –BPHC expects to indicate a final decision within 60 days of submission but could take longer –Effective date of an approved change No earlier than the date that BPHC receives a complete request No earlier than the date that BPHC receives a complete request No later than 120 days from NGA No later than 120 days from NGA No retroactive coverage for changes that are implemented prior to receipt of the request No retroactive coverage for changes that are implemented prior to receipt of the request

Copyright © Feldesman Tucker Leifer Fidell LLP Scope of Project: Adding Specialty Services PIN # – 12/18/08 PIN # – 12/18/08 Factors for approval – in addition to all general factors from PIN Factors for approval – in addition to all general factors from PIN –Necessary for the adequate support of primary care – demonstrate that the proposed service Is a logical extension of required primary care services already provided; and/or Is a logical extension of required primary care services already provided; and/or Complements required primary care services Complements required primary care services –Demonstrate and document target population’s need for the proposed services – describe unmet needs in narrative and with data –Demonstrate ability to maintain level and quality of required primary health services

Copyright © Feldesman Tucker Leifer Fidell LLP Scope of Project: Adding Specialty Services Factors for approval (cont.) Factors for approval (cont.) –Demonstrate the additional service will generate adequate revenue to cover its costs –Provide assurance that Service will be accessible and equally available to all patients of the center regardless of ability to pay and on a sliding fee scale (as necessary) Service will be accessible and equally available to all patients of the center regardless of ability to pay and on a sliding fee scale (as necessary) Center will be able to maintain control over service delivery Center will be able to maintain control over service delivery Service will be provided at a site or location that is presently in approved scope or eligible to be included according to scope definitions Service will be provided at a site or location that is presently in approved scope or eligible to be included according to scope definitions

Copyright © Feldesman Tucker Leifer Fidell LLP Scope of Project: Adding Specialty Services Examples of potentially “acceptable” specialty services Examples of potentially “acceptable” specialty services –Pulmonary consultations/exams –Cardiology screenings/diagnoses –Minor podiatry outpatient procedures/exams –Psychiatric consultations/exams –Periodontic services –Colonoscopies –Oncological care

Copyright © Feldesman Tucker Leifer Fidell LLP Scope of Project: Changing Target Population PIN # – 3/23/09 PIN # – 3/23/09 –Applies solely to health centers receiving only special population funding (no 330(e) funding) that want to add a new target population beyond the one for which the health center was funded Factors for approval – in addition to all general factors from PIN , the health center must Factors for approval – in addition to all general factors from PIN , the health center must –Document unmet need of new population –Document support and/or cooperation from any neighboring health center(s) in the form of a Board- endorsed letter, or an explanation why such letter cannot be obtained

Copyright © Feldesman Tucker Leifer Fidell LLP Scope of Project: Changing Target Population Factors for approval (cont.) Factors for approval (cont.) –Maintain, to the extent possible, existing level of services for current target population for which it was originally funded Demonstrate compliance with any and all applicable requirements (e.g., no governance waivers, services available to all residents of the service are) –Demonstrate that the center can generate sufficient revenue from the new population to cover direct costs and a reasonable share of overhead costs –Provide a reasonable projection of grant funds and patients allocated between appropriate 330 sub-parts Must propose an amount of current 330 grant to be reallocated to the new population Must propose an amount of current 330 grant to be reallocated to the new population

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Affiliation Policies HRSA Affiliation PIN #97-27: HRSA Affiliation PIN #97-27: –Purpose: to protect the autonomy and integrity of health center project by limiting third party involvement in the structure, governance and operation of health center Corporate Structure Corporate Structure –No parent/subsidiary or similar structures (e.g., Sole Member) unless Health center retains all Board selection and composition requirements, and exercises all prescribed authorities and Health center retains all Board selection and composition requirements, and exercises all prescribed authorities and The structure is specifically approved by HRSA The structure is specifically approved by HRSA

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Affiliation Policies Governance: under all affiliation arrangements, board must remain compliant with all Section 330- related selection and composition requirements and retain all prescribed authorities Governance: under all affiliation arrangements, board must remain compliant with all Section 330- related selection and composition requirements and retain all prescribed authorities –No other entity or appointed individual may Select the majority of health center board members, non-consumer members, or members of the Executive Committee, or function as board chair Select the majority of health center board members, non-consumer members, or members of the Executive Committee, or function as board chair Preclude the selection, or require the dismissal, of board members not appointed by that party Preclude the selection, or require the dismissal, of board members not appointed by that party Have overriding approval authority, veto authority or “dual majority” authority Have overriding approval authority, veto authority or “dual majority” authority

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Affiliation Policies Management and Finance Management and Finance –No other entity can employ Executive Director/CEO –No other entity can employ CFO and/or CMO, subject to good cause exception (PIN #98-24) Health Services/Clinical Operations Health Services/Clinical Operations –No other entity can employ the majority of health center’s PCPs, subject to good cause exception (PIN #98-24) –Non-exclusivity: no other entity can control health center’s relationships with other providers unless control will not impact health center’s ability to collaborate and coordinate with other local providers

Copyright © Feldesman Tucker Leifer Fidell LLP HRSA Affiliation Policies PIN #98-24: Amendment to #97-27 PIN #98-24: Amendment to #97-27 –HRSA prefers that health centers directly employ CFO, CMO, and core staff of primary care providers –HRSA may grant a “good cause” exception Programmatic benefit (e.g., improved or increased access, expertise, quality, capital) Programmatic benefit (e.g., improved or increased access, expertise, quality, capital) Sufficient accountability for operation and direction of grant-approved project and the expenditure of grant funds – should include accountability criteria in written agreements between the parties Sufficient accountability for operation and direction of grant-approved project and the expenditure of grant funds – should include accountability criteria in written agreements between the parties

Copyright © Feldesman Tucker Leifer Fidell LLP Other Legal Considerations Section 330-related laws, regulations, expectations and policies Section 330-related laws, regulations, expectations and policies –Other PINs and Program Assistance Letters (PALs) (including PIN – Program Expectations) –45 CFR Part 74 (or Part 92): Procurement and property standards (incorporating OMB Circulars A-110 and A-122) –HHS Grants Policy Statement –Notice of Grant Award/special terms and conditions –FTCA coverage –Section 340B discount drug pricing Other federal/state law – Medicaid/Medicare, Fraud and Abuse, physician self referral, tax law, antitrust, etc. Other federal/state law – Medicaid/Medicare, Fraud and Abuse, physician self referral, tax law, antitrust, etc.

Copyright © Feldesman Tucker Leifer Fidell LLP Key Planning and Negotiation Steps

Copyright © Feldesman Tucker Leifer Fidell LLP Value Assessment Identify and assess strengths (and weaknesses) of the health center corporation Identify and assess strengths (and weaknesses) of the health center corporation –Clinical and administrative capacity –Infrastructure –Existing relationships with community providers/agencies Identify benefits available to Section 330 grantees and/or FQHC Look-alike entities – for example Identify benefits available to Section 330 grantees and/or FQHC Look-alike entities – for example –Access to grants and loan guarantees –Enhanced Medicaid/Medicare reimbursement –Federal Tort Claims Act coverage –340B Discount Drug Pricing –Anti-kickback safe harbors –National Health Service Corp clinicians

Copyright © Feldesman Tucker Leifer Fidell LLP Preliminary Agreements and Planning Process Execute preliminary agreements Execute preliminary agreements –Confidentiality Agreement –Non-binding Memorandum of Agreement Establish and conduct planning process Establish and conduct planning process –Identify proposed scope of joint activities –Establish timeline for negotiations and planning –Define critical terms of proposed collaboration –Form planning teams to identify and evaluate collaborative opportunities –Engage legal counsel and business consultants as necessary

Copyright © Feldesman Tucker Leifer Fidell LLP Due Diligence Process Timing: after parties reach agreement in principle as to the basic terms of proposed transaction Timing: after parties reach agreement in principle as to the basic terms of proposed transaction Process Process –Parties request relevant operational information from each other –Each party analyzes information to determine the other party’s “fitness” (and, as necessary, requests additional information or clarification) Conclusion: each party summarizes its findings and recommends either to execute, negotiate changes to, or terminate negotiations of the affiliation Conclusion: each party summarizes its findings and recommends either to execute, negotiate changes to, or terminate negotiations of the affiliation

Copyright © Feldesman Tucker Leifer Fidell LLP Regulatory Approvals and Definitive Agreements Prior to executing the definitive documents, the parties must satisfy all relevant regulatory approvals, as necessary - examples Prior to executing the definitive documents, the parties must satisfy all relevant regulatory approvals, as necessary - examples –State requirements: licensure, certificate of need, credentialing –Change in the health center’s approved scope of project –Advance rulings, advisory opinions, other Federal/State regulatory approvals Execute definitive agreements (see prior slides) … AND Execute definitive agreements (see prior slides) … AND Leave room for change! Leave room for change!

Copyright © Feldesman Tucker Leifer Fidell LLP Marcie H. Zakheim: Feldesman Tucker Leifer Fidell LLP 2001 L Street, NW – 2 nd Floor Washington, DC (202)