US healthcare

US Health Care Practice Client Desk Reference

MEET THE DENTONS HEALTH CARE PRACTICE. Whether you are new to Dentons or have worked together with us for years, we hope you find this desk reference a useful source of information about our health care team and the many different areas where our lawyers and professionals have capabilities and experience. That way, you know us before you need us. Dentons' US Health Care practice has both depth and breadth of experience in virtually every area relating to your business. We look forward to working together and growing our partnership with you. 22 • dentons.com

Contents Dentons by the numbers ....................................................... 5 Hospital operations .............................................................. 24 Subject matter resources Integrated delivery systems ...............................................25 Academic medical centers.................................................... 9 Joint ventures and partnerships.........................................25 Accountable care...................................................................... 9 Legislative advocacy and strategy.................................... 27 Antitrust and unfair competition ...................................... 10 Licensing, accreditation and Clinical research...................................................................... 10 Medicare enrollment ............................................................ 27 Compliance programs: design, implementation, Medicaid ...................................................................................28 effectiveness reviews and gap analyses ......................... 11 Medicaid managed care...................................................... 29 Contracting............................................................................... 11 Medical cannabis: policies and Distressed health care............................................................12 regulatory compliance ........................................................ 29 Faculty practice plan arrangements..................................13 Medical staff: credentialing and peer review................ 30 Faith-based health care issues ...........................................14 Medicare Advantage ..............................................................31 False Claims Act and white collar litigation.................... 15 Medicare regulatory and reimbursement ......................32 Fraud and abuse: compliance and defense....................15 Medicare secondary payor and coordination Government contracts.......................................................... 16 of benefits.................................................................................33 Graduate Medical Education (GME) .................................16 Mergers and acquisitions ....................................................33 Health care business litigation ............................................17 Nonprofit corporations and governance .......................34 Health care employment and benefits ............................17 Physician integration and Health care finance.................................................................18 clinically integrated networks.............................................34 Health care insurance regulatory..................................... 20 Prescription drugs, including Part D.................................35 Health care intellectual property .................................... 20 Safety net health programs.................................................36 Health care private equity.................................................... 21 Securities offerings and regulatory compliance...........36 Health care real estate ......................................................... 21 State attorneys general ........................................................ 37 Health information technology..........................................22 Tax and tax exemption ......................................................... 37 Health insurance exchanges.............................................. 22 Telehealth ................................................................................ 38 HIPAA compliance, information privacy Leaders in health care......................................................... 40 and data security ...................................................................23 Contacts................................................................................... 41 dentons.com • 3

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Dentons by the numbers US Locations US locations Albany Boston Chicago New York Short Hills San Francisco Denver Kansas City St. Louis Washington, DC Oakland Phoenix Northern Virginia Silicon Valley Atlanta Los Angeles Dallas New Orleans Orange County Houston San Diego Miami Honolulu Hilo 40+ full time health care lawyers and professionals in the US 100+ lawyers and professionals in the US who spend 50% or more of their time on health care matters dentons.com • 5

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• Our team. The US Health Care practice combines lawyers and other professionals who have spent decades in private practice with lawyers and senior policy directors who have served at high levels in the US Department of Health & Human Services, Office of Inspector General, the Centers for Medicare & Medicaid Services, and the criminal and civil divisions of the US Department of Justice. • O ur clients. We represent more than 250 hospitals and health systems in the United States and abroad, as well as the world's largest health insurers, suppliers, pharmaceutical companies, manufacturers, ambulatory providers, and financial institutions on a wide range of strategic and structural regulatory, policy, transactional, and financial matters. • Solutions. In today's health care industry, a genuine solution usually requires both a depth of knowledge of the issue at hand and breadth of experience in related subject matter. With Dentons' global reach, the US Health Care practice counsels companies in the US and worldwide that need assistance with US health care matters. dentons.com • 7

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Academic medical centers We have wide-ranging experience working with academic medical centers (AMCs) and understand the full range of health care legal and structural issues, including the unique relationships among medical centers, schools of medicine and faculty, and the role of clinical research. Dentons’ lawyers have assisted teaching hospital clients with Medicare and Medicaid reimbursement and policy issues involving direct and indirect graduate medical education (GME) payments. Our team has also worked with hospitals to create new GME programs, navigate ACGME issues and deal with PATH (physicians at teaching hospitals) audits by the US Department of Health & Human Services, Office of the Inspector General (HHS-OIG). Accountable care Dentons' lawyers and professionals were actively involved in drafting and negotiating the Affordable Care Act (ACA) and, since its enactment, have counseled providers, payers, employers, state exchanges, prospective and participating accountable care organizations (ACOs), and others in connection with its implementation. Our team members: • Help clients develop and implement strategic business plans relating to the ACA (including preparing applications to participate in the Medicare Shared Savings and Pioneer ACO programs) • Monitor all legislative, judicial, regulatory and sub-regulatory developments relating to the law • A dvocate for our clients in connection with these developments, both formally (through the notice-and- comment and legislative processes) and informally (through our federal and state government contacts) • Our team was instrumental in setting up the first private ACO and handled complex regulatory, transactional and policy issues in connection with that effort. We remain at the forefront of health care reform, assisting clients with applications to participate in the Centers for Medicare & Medicaid Services (CMS) Bundled Payment for Care Improvement Initiative (BPCI), including developing the underlying agreements and necessary disclosures; consulting with work groups to develop care redesign protocols and models; and assessing complex fraud and abuse issues arising from gainsharing, shared cost savings, and similar program activities. dentons.com • 9

Antitrust and unfair competition • Dentons’ antitrust lawyers have extensive experience representing providers, payers and other health care organizations in antitrust and unfair competition matters, including civil and criminal government investigations and litigation, private party litigation, regulatory proceedings, day-to-day compliance counseling and audit services, and negotiating and setting up ventures, collaborations, joint operating arrangements and mergers and acquisitions. Our team works with providers, payers and other health care organizations on issues relating to: • The competitive consequences of mergers, acquisitions, joint ventures and other forms of integration • Compliance issues and business strategies, including joint pricing and marketing, joint purchasing, exchanges of business information, price discrimination and exclusive dealing • Hearings and related regulatory proceedings of the Federal Trade Commission (FTC) and other state and federal government agencies Clinical research We counsel research institutions, academic medical centers (AMCs), hospitals, manufacturers, clinical trial sponsors, institutional review boards (IRBs) and other life science organizations with respect to clinical research programs (structuring and implementation), human subject protections, scientific misconduct, Sunshine Act compliance, conflicts of interest, research billing issues, research-related injuries, Medicare secondary payer (MSP) reporting, budgeting, confidential disclosure agreements (CDAs), clinical trial agreements (drafting and negotiation), collaborative agreement preparation, optimization of clinical trial operations, research privacy and security issues, and intellectual property (protection and enforcement). We also defend against audits and investigations by the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Office for Human Research Protection (OHRP), the Office of Research Integrity (ORI), and the US Department of Health & Human Services, Office of Inspector General (HHS–OIG). 10 • dentons.com

Compliance programs: design, implementation, effectiveness reviews and gap analyses We routinely assist clients in developing and enhancing corporate compliance programs tailored to industry-specific risks and demands. For Medicare Advantage and Part D plan sponsors, for instance, we have conducted numerous compliance program effectiveness reviews and gap analyses based on our deep understanding of the relevant programs, risk areas and evolving Centers for Medicare & Medicaid Services (CMS) expectations. Working closely with clients, we analyze and assess the strengths and weaknesses of their processes and make practical recommendations for improvement. We offer broad support in connection with our clients' compliance programs and initiatives, including: • Collaborating in the creation of risk assessments, compliance work plans, codes of conduct and policies and procedures • Delivering general and specific training on compliance and fraud, waste and abuse issues • Conducting internal investigations into compliance-related concerns • Assisting with CMS audit preparation and documentation • Providing counsel regarding negotiation and implementation of corporate integrity Contracting We routinely represent clients in connection with a host of contracting matters critical to their day-to-day operations, including relating to mission support, professional services, physician recruitment, medical research, ancillary services, clinical management, graduate medical education, consulting, leases, supply chain, intellectual property, health information technology, licensing, data use/nondisclosure/confidentiality and human resources. dentons.com • 11

Distressed health care Our restructuring, insolvency and bankruptcy team has worked on a wide variety of matters across the nation relating to troubled or distressed situations in the health care industry. Working closely with our health care, capital markets and lending, corporate, real estate, employment and labor and other teams, Dentons has amassed significant experience in: • Chapter 11 reorganization • R eceiverships and conservatorships, including interactions with regulatory authorities • Bankruptcy administration • Licensure and certification, including certificates of • Government benefit overpayments need (CONs), and related issues • Purchases and sales of distressed assets in and outside • Hospital and outpatient clinic closures of bankruptcy proceedings • Health care financing, including through the sale of • E nforcement of non-competition and medical receivables non-solicitation agreements • Restructurings, including negotiating covenant amendments, waivers and forbearance agreements 12 • dentons.com

Faculty practice plan arrangements Dentons has extensive experience counseling faculty practice plans (FPPs), including those organized as a completely integrated academic medical center (AMC), in which the university, hospital, and school of medicine or teaching and physician components operate as divisions of a single entity, as parts of several combined entities, or those in which the faculty practice plan is a stand-alone operating as a single entity, or through multiple department- or specialty-based entities. Our work for FPPs includes: • D ay-to-day regulatory and compliance counseling relating to insurance coverage, billing and reimbursement, compliance with federal and state self-referral and anti-kickback laws, antitrust, clinical research and tax-exempt status issues • Assistance with strategic initiatives, including restructuring, affiliations, joint operating agreements, joint ventures, hospital-FPP service and mission support agreements, payer contracting, manufacturer-physician consulting and research arrangements, Medicaid supplemental payment initiatives and physician recruitment and retention dentons.com • 13

Faith-based health care issues Dentons has considerable experience representing faith-based health care organizations, so we understand the added dimension of mission and sponsorship, and how these can affect governance and operations. We also understand how issues of theology, church policy and religious law often intersect with civil law and regulations and have experience finding a balance between the religious and secular, including what institutions and individuals may need to be consulted or from whom approvals may be required. Our experience in this area includes: • Creating and restructuring the governance of faith-based health care organizations, including complex multi-hospital health systems • Presenting options for sponsorship and governance relationships • Harmonizing civil law with relevant theology, church policy and religious law • Thorough familiarity with Catholic Canon Law and the Ethical and Religious Directives (ERDs) for Catholic Health Care Services • Development of mixed religious and secular health systems \"They are responsive and intuitive, and give concise business answers.\" - Chambers USA 14 • dentons.com

False Claims Act and white collar litigation False Claims Act (FCA) litigation is growing, and reputational and financial risks for health insurers and providers are rising. Dentons' lawyers have successfully represented life sciences and health care companies and carriers across the full spectrum of federal and state enforcement matters, from internal investigations to jury trials, including: • False Claims Act litigation, including a full range of cases spanning a wide variety of possible claims • Investigations by federal and state regulators into alleged violations of anti-kickback, physician self-referral and beneficiary inducement laws • Coding, billing and payment/overpayment enforcement actions by federal and state authorities Health care organizations under attack need skilled and experienced counsel who understand the legal issues, the industry, and (most important) how the government evaluates a whistleblower action. Dentons' lawyers have obtained early dismissals on legal grounds, convinced the federal government to decline intervention in FCA cases, and, where voluntary or court-ordered dismissals have not been possible, obtained negotiated settlements on terms acceptable to our clients. Fraud and abuse: compliance and defense Dentons has one of the most prominent and experienced health care fraud and abuse practices in the United States. Our team includes former enforcement officials with the US Department of Health & Human Services, Office of Inspector General (HHS–OIG) and Department of Justice Health Care Fraud Unit, as well as lawyers and professionals with decades of private practice experience, who regularly help providers to: • Ensure that their various arrangements, • Respond to congressional inquiries, and administrative, initiatives and strategies comply with federal civil and criminal audits, investigations and litigation and state coverage, billing, reimbursement, anti-kickback, physician self-referral (Stark • Implement and resolve voluntary disclosures and law), beneficiary inducement and gainsharing other \"report and return\" strategies laws and regulations, among others • Develop and implement state-of-the-art • C onduct internal investigations, medical compliance programs documentation and coding reviews and audits, and other risk assessments dentons.com • 15

Government contracts Almost all US health care providers and many health plans are government contractors. Dentons has an extensive Government Contracts group that includes authorities on federally funded health care programs. For example, the Dentons Government Contracts practice has: • Litigated all manner of health care-related bid • Represented pharmaceutical and life sciences protests involving the US Department of Health clients on Public Readiness and Emergency & Human Services (HHS), the US Department Preparedness (PREP) Act issues of Veterans Affairs (VA), and the Centers for Medicare & Medicaid Services (CMS) • Secured interim Patient Safety Organization (PSO) certifications from HHS • Conducted compliance reviews and risk assessments for Medicaid carriers and • Counseled clients on structuring contracts intermediaries and also Medicaid managed with the federal government and maximizing care entities reimbursements under these contracts • Represented pharmaceutical and life • Advised on drug pricing and VA supply sciences clients in all manner of dealings schedule contract issues with the Biomedical Advanced Research and Development Authority (BARDA) Graduate Medical Education (GME) We offer breadth and depth of experience in all areas of medical and dental residency education, including Medicare and Medicaid reimbursement, affiliation and other contractual agreements, accreditation and policy issues, merger and acquisition considerations, and fraud and abuse concerns. We understand the legal and structural issues related to graduate medical education (GME), including navigating the unique relationships among hospitals, academic medical centers, non-hospital training sites, schools of medicine, and faculty, as well as the role of clinical research. Our GME team combines regulatory, compliance and transactional attorneys with a number of senior advisors, including a former regulator from the Centers for Medicare & Medicaid Services (CMS), a former executive director at the Accreditation Council for Graduate Medical Education (ACGME) and a former designated institutional official (DIO) of a major academic medical center. 16 • dentons.com

Health care business litigation Dentons' lawyers have handled all aspects of litigation in the health care sector including “one-off” cases in state courts known to be notoriously difficult for defendants; complex class actions claiming damages for personal injury and/or economic loss and sometimes punitive damages; and massive national product litigation, both as local and national counsel. Our experience in Medicare secondary payer issues is particularly deep, having served as special counsel on such issues in a number of large class action matters. Regarding product liability suits, whether the claims involve product defects, labeling defects, a recalled drug or medical device, an off-label promotion, or allegations of economic loss due to a product defect, we have the experience to help you manage your risks and resolve your cases, ideally through creative and early case assessment and settlement, but if necessary, through trial and appeal. Health care employment and benefits Dentons’ Pensions, Benefits and Executive Compensation practice is one of the most well-established and respected in the United States. Our lawyers and professionals, many of whom are nationally recognized as leading practitioners in the field, are strategically located throughout the country in Chicago, Dallas, Kansas City, New York, and Washington, DC. The team assists some of the largest and most well-known health care employers in the nation in designing, implementing and maintaining a variety of employee benefit programs and compensation incentive arrangements. dentons.com • 17

Health care finance Dentons' health care finance team has experience with capital and financing structures as varied as the industry it serves. Dentons' health care sector clients include hospitals and health systems, senior living and other health care service providers, pharmaceutical and medical device companies, commercial and investment banks, and private equity funds. We regularly prepare and negotiate financing documents, so we understand what's market and can provide our clients with a range of options and alternatives to achieve their objectives. Our finance team can assist your organization with: • Tax-exempt and taxable bond financing, including preparation and review of offering and disclosure documents, securities, tax and bond compliance, diligence reviews and disclosure matters; we have assisted some of the nation’s largest health systems and senior living providers on such matters • Private equity investments and financing, including acquisitions, dispositions and regulatory matters involving portfolio companies • Receivables finance structuring and documentation, including true sale opinions • Secured and unsecured loans, lines of credit, private placements, swaps and other financing instruments. \"I don't think there is an issue they can't address. Their depth is impressive\". - Chambers USA 18 • dentons.com

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Health care insurance regulatory With nearly two dozen insurance regulatory lawyers across the US, Dentons has one of the largest insurance teams— and one of the sector's few truly multifaceted, 360-degree practices—including strong litigation, transactional and regulatory capabilities. Our lawyers—a combination of seasoned litigators, former insurance regulators, and in- house counsel for insurance industry leaders—relentlessly advocate for our clients' interests. Through their frequent interactions with regulators, they are able to apprise clients of the positions they are likely to take and of issues not yet on the horizon. Our insurance regulatory practice focuses on: • Corporate and complex transactional matters for insurance and managed care entities, including mergers, acquisitions, reorganizations, risk transfers and joint ventures • Regulatory and governmental investigations, examinations and inquiries, risk management issues regarding significant insurance, and reinsurance matters • Development, contract drafting and negotiations, and licensing matters Health care intellectual property With more than 100 IP lawyers and advisors in the US (more than 15 of whom hold PhDs), we provide comprehensive legal services to develop, manage and protect our clients' IP portfolios. Our services include all aspects of strategic IP portfolio management, including: • Trademark • Patent interferences • Copyright • Patent reissues and reexaminations • Patent prosecution and appeals • Inter partes reviews (IPR) • Counseling and due diligence opinions • Licensing and risk management Additionally, our seasoned patent litigators regularly try cases involving pharmaceutical, biotechnology and life sciences patents before US district courts and the International Trade Commission. 20 • dentons.com

Health care private equity Dentons’ US private equity team has more than 25 years of experience in US and global private equity markets. In health care, we represent private equity firms, financial institutions, portfolio companies and health care providers in matters ranging from regulatory diligence and analysis of a sponsor's portfolio company acquisition to advising a health care system managing its alternative investments. What our clients appreciate most is that we're a one-stop shop, providing coordinated advice across a range of legal disciplines, delivered by lawyers with particular experience handling private equity transactions in the health care space. Health care real estate The breadth and depth of our real estate practice—we have nearly 100 US real estate lawyers advising a broad spectrum of clients on some of the most complex development, acquisition, disposition and debt and equity financing transactions in today's market—make us a logical choice for health care-related real estate transactions. We represent commercial real estate lenders, real estate investors, including REITs, pension funds, private equity firms and insurance and mortgage companies, developers, and land and building owners and leaseholders, including health care systems and academic medical centers, in connection with their real estate needs, including medical office space and medical specialty spaces such as cancer centers, ambulatory facilities and outpatient care facilities. dentons.com • 21

Health information technology Our health care team, which includes lawyers and professionals knowledgeable in both the health care and information technology industries, has substantial regulatory, transactional and litigation capabilities in the area of health information technology (HIT). Our experience includes: • Advocating on behalf of providers when Congress and the executive branch develop and implement new policies to accelerate the use of HIT to improve medical care, reduce medical errors and make health care administration more efficient • Counseling clients regarding IT outsourcing strategy, including drafting and negotiating third-party vendor agreements • Handling a wide variety of HIT industry-related transactions, such as arranging venture capital financing for a health care transaction processing technology and services provider, as well as various other deals, including mergers, acquisitions and spinoffs • Advising clients on eligibility and meaningful use of the Centers for Medicare & Medicaid Services' Electronic Health Record (EHR) incentive programs Health insurance exchanges Dentons' lawyers and professionals have provided legal and strategic counsel to state health insurance exchanges since their inception. After advising them on formation issues, we have continued to provide counsel to ensure their continued viability and adherence to the ever-changing health reform landscape. Our experience includes: • Helping shape the state legislation and regulations governing one of the largest health insurance exchanges • Counseling two health insurance exchanges regarding evolving public policy developments and guiding them in congressional oversight investigations • Advising health insurance exchanges on the complex interplay of HIPAA and state privacy laws • Advising employers, insurers and service providers on their relations with health insurance exchanges • Advising a major exchange on permissible data sharing and antitrust issues 22 • dentons.com

HIPAA compliance, information privacy and data security The health care group, working closely with lawyers and professionals in other practice groups as needed, has accrued significant experience counseling hospital systems and other health care providers on the full gamut of information privacy, data security, and transaction and code set requirements governing the collection, use and disclosure of patient, employee and other confidential information, including under the Health Insurance Portability and Accountability Act (HIPAA), Health Information Technology for Economic and Clinical Health Act (HITECH) and Gramm- Leach-Bliley Act (GLBA). Our team addresses such issues as: • Internal governance and compliance programs to ensure adherence with all relevant federal and state laws and regulations • Health industry security and data breach compliance, including the requirements of the Food and Drug Administration and various state laws • Risk assessments and gap analyses regarding compliance with federal and state privacy regimes • Breach management assistance, including internal investigation, risk assessment, mitigation and reporting • Response to multijurisdictional regulatory investigations following breaches or suspected breaches \"They are my go-to health law firm. They have an exceptional group of attorneys.\" - Chambers USA dentons.com • 23

Hospital operations Dentons serves as principal outside counsel on Medicare/Medicaid fraud and abuse and other operational risk and compliance management issues for a major hospital company in the United States. Lawyers across all our US offices work on a daily basis with hospitals and other health care providers, from ambulatory surgical centers to large physician groups, to help them achieve their business objectives. This includes representing clients in connection with: • Government and internal investigations • Recruitment of physicians and practices and audits • Emergency Medical Treatment & Labor • Government enforcement actions Act (EMTALA) compliance • Mergers, acquisitions and restructurings • Clinical integration initiatives • Joint ventures, including between tax- • Graduate medical education (GME) and indirect exempt and for-profit entities medical education (IME) programs • Contractual arrangements for • Medicare and Medicaid coverage and ancillary services reimbursement projects • Telemedicine initiatives Hospital systems view us as their strategic partner, routinely seeking our counsel on new ventures and other major undertakings. 24 • dentons.com

Integrated delivery systems Dentons has extensive experience counseling hospitals as well as other providers across the spectrum of health care delivery regarding the formation of integrated delivery systems and integrated delivery networks. We have advised on all types of collaborations, from negotiating and documenting loose affiliations between small and medium-sized hospitals or between hospitals and physician groups, to advising on the development and implementation of accountable care organizations (ACOs). Integrated delivery system arrangements are a heavily regulated area, and our lawyers have written and spoken extensively on the subject, including conducting numerous compliance training sessions covering the federal Stark law and Anti-Kickback Statute, state and federal tax exempt status requirements, federal and state antitrust and unfair competition laws, and other laws implicated by the bundling of health care services. Joint ventures and partnerships Our team works with hospitals and health systems, academic medical centers (AMCs), physician groups, and other entities and individuals in connection with joint ventures, partnerships, joint operating arrangements—including ACOs—and other strategic alliances. On more significant transactions, our engagement will include working with banks, investors, financial advisors and others to help clients obtain cost-effective financing. In addition to our work in connection with the formation of such entities or arrangements, including advising on structure, market terms and conditions, regulatory risks and challenges, and licensure and approvals, we provide ongoing advice on the entities' day-to-day operations, including employee benefits, labor law, intellectual property, corporate formalities, business contracts, regulatory compliance, risk management and expansion-related issues such as antitrust. dentons.com • 25

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Legislative advocacy and strategy Dentons' advocacy and government affairs team works in tandem with our Health Care group to advance and convey to government policymakers at the local, state and federal levels the insights and objectives of health care industry leaders. The team also keeps our clients well informed on any legislative or political developments that could impact their business, and engages in direct legislative lobbying, administrative advocacy and comprehensive issue-monitoring in Congress and the executive branch and in state legislatures and statehouses. Dentons’ substantive knowledge of federal and state public policy, tax and appropriations matters includes not only matters directly pertaining to the health care sector, but also industries important to the sector, such as financial services and energy. Clients summoned to appear before a House oversight committee or subpoenaed to testify before a Senate panel in a criminal investigation or who are themselves the target of an investigation, turn to Dentons for help in such a unique or high-stake situation. We offer comprehensive, integrated legal, political and public relations services. Licensing, accreditation and Medicare enrollment Dentons has assisted numerous health care systems, home health agencies, hospice providers, skilled nursing facilities, individual practitioners, and providers of ancillary products and services with a wide variety of licensure, accreditation and Medicare/Medicaid enrollment issues. Our experience ranges from providing advice with respect to specific licensure and enrollment issues to coordinating, preparing and filing federal and state notification forms and change-of-ownership applications in connection with transactions, often requiring extensive interaction with the Centers for Medicare & Medicaid Services (CMS) and state regulatory agencies. dentons.com • 27

Medicaid Dentons has one of the nation's premier Medicaid practices, with a team that includes not only nationally known authorities on government reimbursement and financing, but also a former federal and state Medicaid official. Dentons regularly assists state governments, providers, insurance carriers, HMOs, pharmacy benefits managers (PBMs) and other payers, and medical device manufacturers and other suppliers of medical goods in navigating the complex federal and state issues that riddle this massive government program. Our extensive Medicaid-specific experience is enhanced by Dentons' significant state and federal legislative practice. Our experience includes: • Creating and protecting Medicaid supplemental payment arrangements that have generated hundreds of millions of dollars for providers • Supporting state government entities in appeals before the Centers for Medicare & Medicaid Services' (CMS) Departmental Appeals Board (DAB) • Providing health plans and providers with insight into government regulatory policy and practice as it relates to Medicaid to ensure compliance with existing managed care rules and guidance, and assisting with the submission of comments on proposed rules • Advising clients regarding Medicaid provider taxes, intergovernmental transfers and certified public expenditures • Advocating before state Medicaid agencies to obtain favorable reimbursement rates for manufacturers and providers • Developing and shepherding through CMS and state Medicaid agencies, Medicaid waiver proposals, including delivery system reform incentive payment (DSRIP) programs 28 • dentons.com

Medicaid managed care More than half of all Medicaid beneficiaries nationally receive most or all of their care from risk-based managed care organizations (MCOs) that contract with state Medicaid programs to deliver health care services to enrollees. Although not all state Medicaid programs contract with MCOs, a large and growing number do, and states are including more medically complex beneficiaries, delivering more long-term services and support and—with the help of financial incentives provided to states under the Affordable Care Act (ACA)—serving millions of newly eligible low-income adults. Dentons has a strong history of advising insurers, hospitals and health systems, and other organizations on all aspects of Medicaid managed care regulation. Our deep bench includes individuals who have served in state and federal government agencies with responsibility for policy-making and program administration, as well as other highly experienced lawyers who are thought leaders in the field. Our team has extensive experience negotiating managed care contracts between providers and MCOs, including in connection with the capitated financial alignment demonstration programs. Medical cannabis: policies and regulatory compliance Dentons' lawyers understand the broad range of legal and financial challenges facing the medical cannabis industry, including the impacts on health care providers, physicians and other employers. Few industries in the United States are grappling with legal issues as complex as those facing the medical cannabis industry, due to the conflict of law between the federal government and states with cannabis programs. A multidisciplinary team provides the following services: • Federal and state regulatory compliance advice and advocacy • Evaluation, assessment and development of health care provider policies to address state medical cannabis programs • Advice regarding the rights, duties and obligations of physicians with respect to participation in state medical cannabis programs • Analysis with respect to employment law issues affecting health care providers operating in states with medical cannabis programs dentons.com • 29

Medical staff: credentialing and peer review Dentons' lawyers have substantial experience providing hospitals and other providers and practitioners guidance on issues relating to medical staff credentialing and peer review. Our services include: • Counseling hospitals in properly executing their duties and responsibilities under their medical staff bylaws, particularly during the appointment, reappointment, corrective action and hearing-and-review processes • Helping hospitals ensure that such processes qualify for state peer review privilege, and that both the entity and staff qualify for federal and state peer review immunity • A dvising hospitals regarding malpractice insurance subsidies, peer review activities, the National Practitioner Data Bank (NPDB), disciplinary actions, and a wide range of related staff membership issues • Working closely with hospitals in managing risks associated with extraordinary events, such as the suspension of a medical staff member 30 • dentons.com

Medicare Advantage Currently, about a third of all Medicare beneficiaries are enrolled in Medicare Advantage (MA) plans. Dentons has, for many years, advised Medicare managed care plan sponsors and other organizations on all aspects of this program and its predecessors. To this historical perspective, we add a keen eye for the challenges and opportunities of today, as well as a vision of where the program is heading. Our services include providing assistance with: • Day-to-day regulatory issues (e.g., involving • Advocacy before CMS in contract-related marketing and broker compensation, enforcement actions, including reward and incentive programs, network challenges to the imposition of civil adequacy and risk adjustment) monetary penalties • Provider network development • Acquisitions of MA organizations, and credentialing including due diligence, change of ownership filings and novation requests • Centers for Medicare & Medicaid Services (CMS) program audits • Compliance effectiveness reviews • Initial and expanded service area • Dispositions of blocks of MA business applications and appeals • Plan sponsor fraud, waste and abuse • Upstream, downstream and related- prevention and detection programs entity oversight • False Claims Act investigations • Medicare secondary payer (MSP) and other benefits coordination matters • Supplemental benefit providers (e.g., vision, behavioral health) dentons.com • 31

Medicare regulatory and reimbursement Dentons' health care group includes lawyers and professionals with a deep understanding of Medicare reimbursement rules, including how they have evolved over time, and how they are currently being applied to provider entities, individual practitioners and suppliers of medical goods and services. Our services have included: • Advising hospitals and health systems on a wide range of reimbursement-related issues, including Medicare financing of graduate medical education (GME) and particularly the Centers for Medicare & Medicaid Services' (CMS) ever-changing formula for determining disproportionate share hospital (DSH) payments; provider-based status determinations; change of ownership guidelines; legislative changes to the three-day payment window; and contractor difficulties applying the two-midnight rule in making payment determinations and reviewing claims • Counseling Medicare Advantage (MA) organizations, Part D sponsors, providers and other entities concerning the regulatory regime applicable to the MA and Part D programs, including with respect to payment • Assisting clients in challenging the reimbursement decisions made by Medicare administrative contractors and provider audit contractors (RACs, ZPICs, MICs and others), including before the Provider Reimbursement Review Board (PRRB) • Helping clients meet certification and/or classification requirements relating to prospective payment system (PPS)-exempt units or hospitals, “hospital-within-a-hospital” arrangements, and “under arrangement” relationships that involve the provision of services to Medicare beneficiaries, and in other specific areas 32 • dentons.com

Medicare secondary payer and coordination of benefits Health care insurers and third-party administrators of group health plans face significant risks, including the Centers for Medicaid & Medicare Services (CMS) recovery activities and civil money penalties for failure to report. Our lawyers offer solutions to complicated Medicare secondary payer (MSP) issues, providing practical, experience-based regulatory advice, training, consulting services and compliance reviews, and counseling companies that operate Part D plans regarding their coordination of benefits and obligations under the Part D program. Mergers and acquisitions Dentons has represented a comprehensive array of health care organizations in merger, acquisition, divestiture and other change-of-control transactions of all sizes and types. Our professionals have played lead roles in executing transactions for virtually every segment of the health care sector: providers (including health systems, hospitals, specialty providers, home health, hospice and physician organizations of all sizes), insurers, health maintenance organizations (HMOs) and health plans, device makers, durable medical equipment manufacturers and suppliers and many others. We have an intimate understanding of the business of health care and the markets and market participants applicable to health care M&A transactions. Our deep bench of health care legal, regulatory, operational and advocacy lawyers provide ample resources for the varied issues that often arise in complex health care transactions, such as providing counsel regarding the local and national reimbursement and regulatory climate facing target companies. Our lead professionals advise strategically and tactically, not just in pure legal terms. Dentons' deal experience includes some of the largest nonprofit health system mergers and reorganizations, mixed public and private transactions, as well as investor-driven (private equity, venture capital and other financial buyers). We have particular skills in large-scale, unique and highly complex transactions that require creativity and a balanced approach to win-win outcomes. dentons.com • 33

Nonprofit corporations and governance Dentons' lawyers have substantial experience working with the governing boards, administration and faculty of nonprofit health care organizations to identify and implement best governance practices and eliminate obstacles to effective governance. Our team: • Provides governing boards strategic counseling, facilitation, dispute resolution and education services • Works with governing boards to develop bylaws, policies and procedures that will ensure legal compliance, effective governance and fair process • Helps governing boards develop successful practices for determining leadership compensation that will pass muster with key stakeholders Physician integration and clinically integrated networks Dentons routinely works with hospitals, health systems and academic medical centers across the country on clinical integration projects designed to improve health and the patient care experience (quality, access and reliability) and reduce cost. Based on the goals of the institutions involved, these projects can cover a wide range of activities, including working with the institutions and physicians to enhance outcomes, consistency, quality and alignment, on the formation of clinical integration networks and on the formation and operation of accountable care organizations (ACOs). 34 • dentons.com

Prescription drugs, including Part D The US Medicare program provides health care coverage, including prescription drug coverage, to more than 55 million enrollees, including individuals age 65 and over and persons with disabilities or end-stage renal disease. The prescription drug portion of the Medicare program is complex, with different rules applying to Medicare fee-for- service coverage and the Medicare managed care and Part D prescription drug programs. Dentons' lawyers and professionals have vast experience counseling the following entities concerning the Medicare program rules applicable to prescription drugs: • Hospitals • Pharmacy chains • Health systems • Pharmacy benefit managers • Large physician practices • Drug manufacturers • Health plans We provide a full range of services to our clients, including regulatory and fraud and abuse counseling, compliance assistance, defense against the Centers for Medicare & Medicaid Services (CMS) enforcement actions or litigation (including False Claims Act cases), and assistance in understanding innovative new programs affecting Medicare beneficiaries, including the capitated financial alignment demonstration program. dentons.com • 35

Safety net health programs Dentons has extensive experience in dealing with programs designed to support the health care safety net, including the 340B drug pricing program, the Medicare and Medicaid disproportionate share hospital (DSH) programs and the federally qualified health center (FQHC) program. Some of our projects have included: • Advising 340B-covered entities regarding compliance with the program’s requirements, including eligibility, registration, contract pharmacy arrangements, and assisting them in responding to audits by, and requests for information from, the Health Resources Services Administration (HRSA) and manufacturers • Assisting hospitals in responding to audits seeking to ascertain that Medicaid DSH payments did not exceed the hospital-specific limit, and negotiating issues with state Medicaid agencies and the Centers for Medicare & Medicaid Services (CMS) • Assessing and developing strategies for responding to legislative, regulatory and case law developments in the Medicare DSH program, including the redistributions mandated by the Accountable Care Act (ACA) • D eveloping and revising governance models for FQHCs that comply with applicable HRSA guidance Securities offerings and regulatory compliance Dentons counsels companies and underwriters operating in the health care space in connection with public and private offerings of equity and debt securities, corporate governance, compliance with securities laws and the disclosure and filing requirements of the US Securities and Exchange Commission, NASDAQ, the New York Stock Exchange and other global exchanges and financial oversight bodies. Our clients range in size from middle-market companies to Fortune 100 corporations. Several of our lawyers have held posts at the SEC prior to entering private practice, enhancing our ability to navigate that agency's complex regulatory framework. We have advised biotechnology companies, pharmaceutical companies and health care services management companies on multimillion dollar initial public offerings. Our experience representing parties on all sides of securities transactions enhances our ability to provide holistic counsel that takes our clients’ risk tolerance and business objectives into full account. 36 • dentons.com

State attorneys general Dentons has one of the most sophisticated State Attorneys General practices in the nation. Lawyers in the full-service, nationwide practice advise and assist clients in dealing with state AGs and their staffs on a host of matters. A stand-out feature of the practice is the bipartisan leadership provided by four former state AGs, who are supported by a former deputy AG, a former assistant AG and former chiefs of staff from some of the most active attorneys general offices in the nation, and a number of top-notch litigators experienced in defending companies and individuals in investigations and lawsuits brought by state AGs, including consumer protection investigations and litigation, antitrust investigations and litigation, data privacy and data breach investigations, and state False Claims Act and Medicaid fraud litigation. Tax and tax exemptions Lawyers in Dentons' Tax practice, working closely with the Health Care group, counsel hospitals, health care systems, academic medical centers and other health care organizations in connection with: • Mergers, acquisitions, dispositions • Outsourcing arrangements and reorganizations • Bankruptcy and workouts • State and local tax strategies • Taxable and tax-exempt financings • Excess benefit transactions • Lobbying at the federal and state levels • Partnerships, joint operating agreements and other joint ventures on tax issues • Tax-exempt status determinations We also have extensive experience representing health care organizations in tax controversies, including tax litigation in state courts, the US Tax Court and various appellate courts. dentons.com • 37

Telehealth We have extensive experience assisting companies in the telehealth industry on regulatory and transactional matters. Our experience has involved working closely with health care providers and the telecommunications entities to meet providers' business needs, including qualifying for telehealth reimbursement, and to ensure compliance with the requirements of the Centers for Medicare & Medicaid Services (CMS), the Federal Communications Commission (FCC) and/or state-level governments in connection with funding opportunities. Our experience has included helping clients take advantage of government funding programs to improve telehealth services by assisting clients in forming application development partnerships, assisting clients in responding to government and industry RFPs for goods and services, and working with providers and telehealth businesses to put cutting-edge telecommunications systems for the transmission of video, voice and data to work in the health care marketplace. 38 • dentons.com

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Leaders in health care For many years and in a wide variety of forums, Dentons' Health Care practice and its lawyers have been recognized as leaders in the field. For example: • Chambers USA. For more than a decade, our health care lawyers have consistently received top rankings in Chambers USA: America's Leading Lawyers for Business. A recent edition states that our team \"frequently advises high-caliber industry clients including health systems and global medical manufacturers, as well as offering significant experience in representing hospitals. The team is highly knowledgeable, very thoughtful and responsive.\" • BTI-Fortune 1000. In recognition of his truly outstanding client service, Gadi Weinreich received BTI/Fortune 1000's prestigious Client Service All-Star Award in 2011, 2013 and 2014. • US News & World Report-Best Lawyers. Since 2006, a large number of Dentons' health care lawyers have been recognized in the US News-Best Lawyers directory, and our Health Care and Biotechnology practices currently hold top national rankings in the US News-Best Law Firms directory. • L egal 500 US. For years Dentons' Health Care group has consistently received top rankings. \"Dentons is singled out for its ‘incredible service and response times’ and ‘deep understanding of its client base.’\" • Shortlisted for the Chambers USA Awards 2017 \"Healthcare Team of the Year.\" This distinction comes from notable achievements over the past 12 months, including outstanding client work, impressive strategic growth and excellence in client service. 40 • dentons.com

Contacts Sean Cenawood Partner, New York HEALTH CARE D +1 212 398 4867 [email protected] Kathryn Ashton Partner, Chicago Allison M. Cohen D +1 312 876 3157 Managing Associate, Washington, DC [email protected] D +1 202 408 7927 [email protected] Susan Banks Partner, Denver Ausra Deluard D +1 303 634 4329 Counsel, San Francisco/Oakland [email protected] D +1 415 267 4131 [email protected] Eric Berlin Partner, Chicago Edward Dougherty D +1 312 876 2515 Principal, Washington, DC [email protected] D +1 202 408 6412 [email protected] Claire Bornstein Managing Associate Linda Famiglio New York Senior Advisor, Washington, DC D +1 212 768 5371 D +1 202 496 7500 [email protected] [email protected] Joanne Caceres Ramy Fayed Managing Associate, Chicago Partner, Washington, DC D +1 312 876 2862 D +1 202 408 6193 [email protected] [email protected] Lauren Carboni dentons.com • 41 Managing Associate, Denver D +1 303 634 4312 [email protected]

Jasmine Fisher Dan Higgins Managing Associate, Washington, DC Partner, San Francisco D +1 808 441 6125 D +1 415 882 0130 [email protected] [email protected] Rosemarie Fisher, MD Thomas K. Hyatt Senior Advisor, New York Partner, Washington, DC D +1 212 398 5834 D +1 202 408 3947 [email protected] [email protected] Bruce M. Fried Christopher Janney Partner, Washington, DC Partner, Washington, DC D +1 202 408 9159 D +1 202 408 9151 [email protected] [email protected] John T. Gilbertson Michelle Stark Kaufman Senior Counsel, Los Angeles Partner, Kansas City D +1 213 892 2913 D +1 816 460 2442 [email protected] [email protected] Samantha Groden Kimberly Kerry Managing Associate, San Fran- Partner, San Francisco cisco D +1 415 882 0147 D +1 415 882 5056 [email protected] [email protected] Ed (Edward) T. Laborde, Jr. Robert Guenthner Partner, Houston Special Counsel, Chicago D +1 713 658 4641 D +1 312 876 8961 [email protected] [email protected] Marci Rose Levine Tzvi M. Hefter Partner, Washington, DC Senior Advisor, Washington, DC D +1 202 408 6456 D +1 202 408 6386 [email protected] [email protected] 42 • dentons.com

Sidney Lindenberg Lori Mihalich-Levin Senior Advisor, Washington, DC Partner, Washington, DC D +1 202 408 6425 D +1 202 408 6942 [email protected] [email protected] Talia Linneman Michael Montgomery Associate, Washington, DC Associate, San Francisco D +1 202 496 7117 D + 1 +1 415 882 0375 [email protected] [email protected] Charles A. Luband Shelly Nuss Partner, New York Senior Advisor, Atlanta D +1 212 768 6942 D +1 404 527 4000 [email protected] [email protected] Holley Thames Lutz Stephanie Posek Partner, Washington, DC Associate, San Francisco/Oakland D +1 202 408 6836 D +1 415 267 4068 [email protected] [email protected] Summer Martin Caroline E. Reigart Partner, Atlanta Managing Associate, Washington, DC D +1 404 527 4910 D +1 202 408 6440 [email protected] [email protected] Kaitlyn Halesworth McKendry Tisha Schestopol Senior Managing Associate, New York Counsel, Washington, DC D +1 212 768 5333 D +1 202 496 7165 [email protected] [email protected] Rebecca Merrill Robin E. Schneider Senior Managing Associate, Senior Counsel, Washington, DC Atlanta D +1 202 408 6814 D +1 404 527 8569 [email protected] [email protected] dentons.com • 43

Raymond Sczudlo Mary G. Wilson Senior Counsel, Washington, DC Partner, Chicago D +1 202 496 7929 D +1 312 876 8936 [email protected] [email protected] Patricia Surdyk, PhD Clay Wortham Senior Advisor, Chicago Counsel, Chicago D +1 312 876 8000 D +1 312 876 3437 [email protected] [email protected] Gadi Weinreich Janice H. Ziegler Partner, Washington, DC Partner, Washington, DC D +1 202 408 9166 D +1 202 408 9158 [email protected] [email protected] Tesch West Dianne Winter Brookins Associate, New York Partner, Honolulu D +1 212 768 5364 D +1 808 441 6124 [email protected] [email protected] BANKRUPTCY AND RESTRUCTURING Samuel R. Maizel Partner, Los Angeles Sam J. Alberts D +1 213 892 2910 Partner, Washington, DC [email protected] D +1 202 408 7004 [email protected] 44 • dentons.com

CORPORATE AND FINANCE Michael M. Froy Partner, Chicago Mitchell E. Albert D + 1 312 876 8222 Partner, Kansas City [email protected] D + 1 816 460 2618 [email protected] Phillip Bradley Senior Counsel, San Diego Kristina Beirne D +1 619 595 8025 Partner, New York [email protected] D +1 212 632 8321 [email protected] Ross Docksey Partner, Chicago Thomas K. Vandiver D +1 312 876 8171 Partner, Los Angeles [email protected] D + 1 213 892 2829 [email protected] Samuel Fifer Partner, Chicago INSURANCE REGULATORY D + 1 312 876 3114 [email protected] Bruce E. Baty Partner, Kansas City D +1 816 460 2495 [email protected] INTELLECTUAL PROPERTY AND TECHNOLOGY Joel N. Bock Partner, New York D + 1 212 398 8484 [email protected] dentons.com • 45

LITIGATION AND DISPUTE RESOLUTION Sandy Hauser Partner, New York Bonnie Lau D +1 212 768 6802 Partner, San Francisco [email protected] D +1 415 882 5083 [email protected] Ronald Hedges Senior Counsel, New York Steven D. Libowsky D +1 212 768 5387 Partner, Chicago [email protected] D +1 312 876 2529 [email protected] Stephen Hill Partner, Kansas City Susan M. Walker D +1 816 460 2494 Partner, Los Angeles [email protected] D + 1 213 892 5039 [email protected] Martin J. Moderson Partner, Kansas City PENSIONS, BENEFITS AND EXECUTIVE COMPENSATION D + 1 816 460 2617 [email protected] Katharina E. Babich Partner, Kansas City Todd Daubert D +1 816 460 2612 Partner, Washington, DC [email protected] D +1 202 408 6458 [email protected] PUBLIC POLICY AND REGULATION John Russell Thurbert Baker Principal, Washington, DC Partner, Atlanta D +1 202 408 6392 D +1 404 527 8480 [email protected] [email protected] Bill McCollum Partner, Washington, DC D +1 202 408 9145 [email protected] 46 • dentons.com

REAL ESTATE Troy Housman Managing Associate, San Diego D +1 619 699 2547 [email protected] TAX Bruce Davison Kelli Wikoff Partner, Kansas City Partner, Kansas City D +1 816 460 2514 D +1 816 460 2480 [email protected] [email protected] VENTURE TECHNOLOGY Jeffrey Baumel Partner, New York D +1 212 768 5374 [email protected] dentons.com • 47

ABOUT DENTONS Dentons is the world's largest law firm, delivering quality and value to clients around the globe. Dentons is a leader on the Acritas Global Elite Brand Index, a BTI Client Service 30 Award winner and recognized by prominent business and legal publications for its innovations in client service, including founding Nextlaw Labs and the Nextlaw Global Referral Network. Dentons' polycentric approach and world-class talent challenge the status quo to advance client interests in the communities in which we live and work. dentons.com © 2019 Dentons. Dentons is a global legal practice providing client services worldwide through its member firms and affiliates. This publication is not designed to provide legal or other advice and you should not take, or refrain from taking, action based on its content. Please see dentons.com for Legal Notices. CSBrand-105 US healthcare handbook-v27 — 12/06/2019 48 • dentons.com