Health Care

Overview

Today’s health care environment is defined by dramatic change, extraordinary competition and rising regulatory complexity. In this dynamic marketplace, the efficient delivery of legal services is essential. Arent Fox combines lawyers from several practice areas to provide coordinated and cost-effective representation in all aspects of health care law.

We provide counseling to every segment of the health care marketplace, including hospitals, health systems and academic medical centers, skilled nursing facilities, assisted living facilities, home health agencies, hospices, dialysis facilities, clinical laboratories, diagnostic testing facilities, ambulatory surgery centers, physicians/group practices, drug manufacturers and wholesalers, medical device manufacturers, suppliers and distributors, therapy companies, physician group practices and management companies.

Our attorneys have experience working in key government policy-making and enforcement agencies, including the US Department of Health and Human Services (HHS), the Centers for Medicare and Medicaid Services (CMS), HHS Office of Inspector General (OIG), the Food and Drug Administration (FDA), the US Department of Justice, the US Securities and Exchange Commission and key congressional committees, including the US Senate Committee on Health, Education, Labor and Pensions and the US House Government Reform Committee.

We have experience in the following areas:

Accreditation

CMS increasingly relies on accrediting bodies in many health care industries. Arent Fox lawyers have experience representing health care providers and suppliers before these various entities. We have advised health care providers on The Joint Commission (TJC) accreditation and assist clients in preparing for surveys, answering Requirements for Improvement and challenging adverse recommendations. We have successfully represented hospitals in overturning Preliminary Denial of Accreditation recommendations in appeal hearings. We have also drafted comments to proposed TJC Standards and Elements of Performance to ensure that TJC creates rules that address health care industry concerns.

Clinical Trials and Research

Arent Fox represents sponsors, contract research organizations, site management organizations and clinical trial sites, including academic medical centers, in clinical trial contracting and compliance. As enforcement actions increase, we offer our clients the benefit of broad-based experience and knowledge in this area to help clients avoid problems, ensure they are appropriately protected when problems arise and resolve or defend enforcement actions.

Compliance Program Development and Counseling

Internal compliance programs are health care companies’ first line of defense in preventing misconduct. Government enforcement actions, revisions to the U.S. Sentencing Guidelines, a series of compliance program guidelines issued by OIG and mandatory compliance programs issued by some state Medicaid programs should prompt providers to review and update their current compliance programs. Arent Fox assists health care providers and manufacturers in navigating this complex, ever-changing world of government regulation and enforcement. Our services include:

• Compliance Program Development
• Ongoing Compliance Counseling and Program Assessment
• Compliance Training
• Internal Reviews and Audits
• Investigation Defense
• Corporate Integrity Agreements
• Voluntary Disclosures

Congressional Investigations and Inquiries

Our firm is based in Washington, D.C., making us a preferred law firm for clients needing Washington experience and expertise. Congressional investigations of health care providers, suppliers and manufacturers are becoming commonplace. Bringing together experienced advisers from our health care, government relations and white collar practices, Arent Fox has helped clients to weather the storm in these matters.

Contract Negotiations

Contracts are everywhere in the health care industry. We have broad-based experience negotiating, drafting and reviewing contracts that arise in the context of health care transactions, vendor arrangements, physician employment and independent contractor arrangements, managed care, joint ventures and many other areas. Our goal is to understand and help our clients reach their business goals while remaining sensitive to compliance with federal fraud and abuse laws, Medicare conditions of participation and state licensing requirements. For our pharmaceutical and medical device clients, we also handle contracting and other interactions with wholesales, managed care organizations, pharmacy benefits managers, Medicare and Medicare Part D plans and patient assistance foundations.

Corporate Governance

Arent Fox provides advice to companies and their officers, boards of directors, board committees and individual directors in creating and maintaining corporate compliance and governance programs, conducting internal investigations and responding to allegations of criminal and civil misconduct. We have particular experience in advising non-profit hospital boards.

False Claims Act

Arent Fox attorneys routinely advise clients on the federal False Claims Act (FCA), including the qui tam or whistleblower provision and various state false claims acts.

Arent Fox handles all phases of FCA litigation, including pre-litigation efforts aimed at the government’s intervention decision, motions practice to dismiss non-intervened whistleblower actions, and, when necessary, FCA discovery and trial work. We are among a select group of law firms that have been involved in litigating health care FCA cases prosecuted by DOJ. We also frequently counsel our clients regarding strategies for minimizing FCA risk and dealing with whistleblowers within their organizations.

Fraud and Abuse Compliance

Arent Fox has extensive experience structuring arrangements to minimize the risk presented by the wide variety of applicable federal and state fraud and abuse laws, including anti-kickback statutes, self-referral (Stark) laws, false claims acts, beneficiary inducement prohibitions, civil monetary penalties, fee splitting and corporate practice of medicine laws.

Government Investigations

Arent Fox’s health care and white collar litigators have assisted clients from many different industry sectors in responding to and defending against government investigations. We counsel clients under investigation by DOJ – both Main Justice and US Attorneys’ offices – the FBI, the OIG, Fiscal Intermediaries, Recovery Audit Contractors, Medicaid Fraud Control Units and State Attorney General Offices. These investigations have involved allegations of billing for medically unnecessary services, kickbacks, violations of the Stark self-referral law, wrongdoing during clinical research and violations of the Prescription Drug Marketing Act. Many of these investigations have both a civil and criminal component, span multiple years and require the review and production of hundreds of thousands of documents. We have resolved other investigations early in the process through a cooperative effort leading to favorable settlements or, in some cases, no liability.

HIPAA / Health Privacy and Security

Arent Fox began advising clients in matters involving the privacy and security of health information long before the final promulgation of the Privacy and Security Standards under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In fact, we represented clients before Congress and HHS throughout the negotiations of the Administrative Simplifications Provisions of HIPAA and the crafting of the final regulations. We also developed a comprehensive model HIPAA compliance program that enables health care providers to implement the Federal Privacy Standards in a systematic and efficient manner. Given the depth of our HIPAA experience, we are uniquely positioned to provide our clients with a comprehensive, cost-effective means to incorporate new HIPAA and HITECH requirements into existing compliance programs, assess their obligations under the new data breach notification requirements and unravel the complex HIPAA issues that frequently arise in the context of clinical research. Clients facing a HIPAA enforcement action can turn to Arent Fox with confidence knowing that one of our attorneys was involved in the resolution of the largest HIPAA enforcement case to date.

Licensure, Certificates of Need and Certifications

Arent Fox lawyers have been involved in a wide array of health facility and provider licensure and CON issues across the United States. We have analyzed the applicability of licensure and CON requirements to particular transactions, sought CON requirement clarifications from the responsible agencies, submitted applications, made arguments and conducted hearings both in support of and in opposition to CON applications, defended licenses in revocation actions, and represented parties in challenging or attempting to uphold agency decisions.

Litigation and Alternative Dispute Resolution

Our health care litigators represent clients before administrative and judicial forums dealing with survey and certification appeals, coverage and reimbursement appeals, individual and institutional licensure hearings. We also litigate a broad range of business disputes for our health care clients, including contract disputes, actions to enforce non-competition agreements and employment actions. Arent Fox litigators are skilled in the arts of advocacy and informal dispute resolution, and our team of trial lawyers has won verdicts in state and federal courts throughout the country. We also have an active appellate practice and have successfully argued cases before state and federal appellate courts and the United States Supreme Court.

Arent Fox has a multidisciplinary taskforce to help clients navigate all phases of electronic discovery while minimizing risk and cost. Our attorneys work with clients to design and implement comprehensive litigation response plans that include: pre-litigation risk assessments; preparation and implementation of litigation holds and protocols designed to control the costs associated with identification, collection and storage of data; implementation of methods for the efficient identification and preservation of evidence; supervision of crisp data collection, review and production procedures; and strategies to protect the attorney-client privilege.

Managed Care

We are regularly engaged to represent providers and suppliers on matters related to managed care contracting. Arent Fox attorneys assist clients in negotiating issues such as withhold pools, filing grievances regarding “slow pay” and “down-coding” allegations against commercial payers with state insurance departments, and developing shared risk agreements with physician-hospital organizations and others. We also represent providers in coverage disputes with commercial payers.

Medical Staff and Peer Review Law

As a result of shifting legal and accreditation standards, medical staffs have been given more responsibility, and are more accountable for peer review and other important medical functions at the hospital. Arent Fox attorneys are known for their broad experience in advising hospital medical staffs. We have advised on medical staff organization, governance and leadership, bylaws, peer review, investigations, corrective action and appeals, practitioner well being and behavior, allied health professionals, The Joint Commission standards and the various other issues. We have extensive experience in handling physician disciplinary hearings and have been counsel of record or otherwise participated in a number of precedent-setting appellate court decisions. Our expertise and background allow us to educate medical staffs in understanding their own rights and responsibilities, and to assist them in reaching their goals.

Patient Safety Organizations

Arent Fox advises large institutional providers on the formation of captive Patient Safety Organizations that permit the providers to analyze clinical and adverse events data and utilize it to improve quality outcomes while protecting the data from disclosure to third-parties in litigation.

Pharmaceutical and Device Compliance

The pharmaceutical and device industries increasingly find themselves the subject of intense government scrutiny. Arent Fox helps these companies to navigate the rough waters by providing fraud and abuse risk assessments related to the sales and marketing of prescription drugs and devices, as well as compliance program development, monitoring, auditing and training tailored for the drug and device arena. We also track state law developments relating to price reporting, reporting of advertising and marketing costs, registering of clinical trials and reporting of trial results, limitations on prescription data-mining, and licensing or other oversight of field sales representations.

Physician Compensation and Financial Arrangements

Arent Fox is a national leader in advising clients on the complex legal requirements that apply to relationships between providers and physicians. Our lawyers are nationally recognized for their expertise in federal and state anti-kickback statutes and the Stark Law restrictions applicable to hospital contracts with physicians, including various types of joint ventures. Our team draws on the experience of seasoned health care lawyers who have been deeply involved – from both inside and outside the government – in the formulation of the Anti-Kickback Act Safe Harbors and the Stark Law regulations. We also have substantial experience in the regulatory, tax, employment law and other issues that may impact these arrangements.

Prescription Drug Pricing and Government Price Reporting

Arent Fox is one of only a handful of firms that can provide sophisticated counsel to prescription drug industry players on the full range of complex pricing issues they face, including AWP and WAC reporting to the compendia, ASP reporting to Medicare, AMP and Best Price reporting to Medicaid, ceiling and sub-ceiling price reporting to support the Public Health Service 340B program and non-FAMP and FCP reporting to FA/FSS. Our advice reflects experience gained from supervising government pricing systems audits, handling restatements and voluntary disclosures with CMS, the Office of Pharmacy Affairs at HRSA and the VA, and representing clients facing enforcement actions tied to their price reporting obligations.

Product Coverage and Payment

The successful launch and sale of a health care product or service depends largely on the availability of adequate Medicare, Medicaid and third-party payer coverage and reimbursement. Whether a product or service is a state-of-the-art emerging technology or considered an established standard of care, Arent Fox attorneys have the experience to develop and implement local and national strategies to champion new reimbursement and to address existing coverage and payment inequities. We work with clients to ensure that clinical trials are designed to collect data critical to address the safety and efficacy standards for FDA approval as well as the medical necessity standards of payers. We also assist clients determining the most advantageous regulatory approval strategy to position a product for third-party reimbursement.

Regulatory Due Diligence

Arent Fox conducts health care regulatory due diligence for merger, acquisition and financing transactions. For acquiring companies, venture capital firms, lenders and underwriters, we put our regulatory knowledge and extensive investigative experience to work in assessing target companies in a health care context. We look at issues such as licensure, certification, coverage and reimbursement, billing and coding, marketing and financial relationships with physicians and other referral sources (anti-kickback and Stark law compliance) to evaluate a target’s compliance with applicable laws, rules and regulations. We identify and assess a target’s regulatory risks and communicate them to clients.

Telemedicine and E-health

The use and sharing of electronic medical records, the transmission of health care information by electronic communications, and e-health are some of the hottest issues in health care today. With the enactment of the HITECH Act on the federal side and numerous initiatives at the state level, all health care providers will need to use electronic medical records over the next few years. Arent Fox has a long history as a leader in this area, frequently assisting clients in licensing, contracting, advertising, fraud and abuse, reimbursement and privacy issues that arise in the E-health world.

Transactions

Our attorneys have significant experience in the structuring and closing of complex corporate transactions in the healthcare industry. In recent years, we have completed several hundred M&A transactions with multi-state providers of healthcare services.

Arent Fox provides a multidisciplinary team-approach to address all aspects of a transaction including tax, antitrust, bond financing, labor and employment, benefits, regulatory compliance government approvals and real estate. Our experience enables us to quickly identify key business and regulatory issues and facilitate the development of appropriate legal structures for a targeted transaction or relationship. We represent numerous health care entities in mergers, acquisitions, divestitures and joint ventures. We have vast experience advising clients on how to structure these arrangements to comply with the Anti-kickback Statute, the Stark Law, the False Claims Act and other federal and state laws governing relationships among health care providers.

We also represent private equity funds and other sources of equity to the health care industry, as well as lenders to public and private businesses that operate skilled nursing, assisted living, continuing care, retirement and independent living facilities. We represent buyers and sellers of nursing homes, assisted living and independent living facilities, and a variety of ancillary service businesses in hundreds of transactions throughout the country. Our attorneys have years of experience in starting, financing and growing early stage, venture-backed health care companies. We also advise clients on the regulatory and transactional legal issues faced by companies during accelerating growth.

White Collar Criminal Defense

Arent Fox represents clients facing allegations of business-related and other criminal conduct. Arent Fox’s White Collar litigators have specific experience with health care investigations and are sensitive to the impact government investigations have on corporate clients. Our litigators have represented business entities, corporate executives and employees who are under criminal investigation or criminally charged. We represent individuals before a grand jury, respond to grand jury and administrative subpoenas and civil investigative demands, prepare voluntary disclosures and negotiate criminal and civil settlements with both federal and state prosecutors. Our White Collar team also works closely with our health care government investigations team to handle parallel criminal and civil proceedings involving the False Claims Act.

Related Practice Areas

Antitrust and Competition

We are involved in every aspect of antitrust practice, from rulemaking proceedings, administrative and federal court litigation to complicated compliance matters. We assist clients in establishing and operating physician organizations, negotiating with third party payors, PPOs, HMOs, and other managed care plans, reviewing exclusive provider arrangements, and developing specialty PPOs. We have counseled health care providers in developing joint ventures, as well as in undertaking mergers and acquisitions. We have developed and evaluated exclusive contracts for services, assisted hospitals in the areas of credentialing and peer review matters, including staff privilege disputes, and have advised clients in connection with enforcement of non-compete provisions in employment agreements. In addition, our attorneys have advised health care clients regarding information dissemination and advertising claims, two areas in which government enforcement activities are increasing.

Bankruptcy / Business Restructuring / Reorganization

Arent Fox has an active and versatile national bankruptcy and financial restructuring practice. We handle financial restructurings, recapitalizations and bankruptcy-related and strategic litigation as well as distressed asset and corporate acquisitions throughout the country. We have participated on behalf of debtors, creditors’ committees and other clients in the Chapter 11 cases of numerous major health care organizations. Our healthcare bankruptcy proceedings have included nursing homes, hospitals, manufacturers, medical equipment suppliers, home and alternate site health care services and radiology centers.

Government Relations

Arent Fox’s health care and government relations attorneys work together to provide strategic advice relating to legislative developments, assist in the formation of coalitions to achieve legislative objectives, participate in Congressional hearings and work actively with Congressional representatives in supporting or opposing legislation of interest to our clients. We frequently employ combined Congressional and executive branch lobbying strategies to achieve Medicare reimbursement objectives for our clients.

Our government relations team includes lawyers and policy professionals with experience in Republican and Democratic politics and government service, including two former US Senators, a former US House member, as well as attorneys and professionals with extensive and recent experience in senior positions on Capitol Hill, in the Executive branch and in the political arena.

Intellectual Property

Arent Fox offers a broad range of services related to the acquisition, enforcement and commercial exploitation of IP rights and assets. With extensive experience prosecuting and defending against infringement claims in state and federal courts throughout the United States, Arent Fox is one of the nation’s preeminent IP litigation firms. We have brought and defended numerous lawsuits and proceedings in federal district and appellate courts, the US Supreme Court, the US Patent And Trademark Office’s Board of Appeals and Interferences and Trademark Trial and Appeal Board as well as before The International Trade Commission. Further, Arent Fox has extensive experience and knowledge in patent and trademark prosecution for both large and small patent and trademark portfolios with respect to the US Patent and Trademark Office.

Labor and Employment

Arent Fox regularly represents clients in labor, employment, employment discrimination and occupational health and safety compliance matters. Our attorneys have handled administrative proceedings before the Equal Employment Opportunity Commission, National Labor Relations Board, Department of Labor and State Attorney General’s offices. Our work with regard to traditional labor matters includes union negotiations, elections, arbitrations, unfair labor practice charges and union avoidance. We are also involved in health care cost containment issues such as managed care programs. We work closely with our transactional attorneys to deal with and resolve employee benefit and labor and employment law issues that arise during mergers and acquisitions, such as the National Labor Relations Act, ERISA, the Internal Revenue Code and the Worker Adjustment and Retraining Notification Act. In corporate reorganizations, we assist employers in designing and carrying out reductions in force, advising early retirement programs, exit incentives, and severance pay plans.

Real Estate

Arent Fox boasts one of the most prominent real estate practices in the United States. The Firm regularly represents owners, investors, developers, managers and operators of hospitals, health systems, medical office buildings and other health-related centers in complex real estate, corporate and finance transactions, including acquisitions, dispositions, leases, construction services, bond financing and loans. We counsel venture partners on the structuring of sales of portfolios of healthcare facilities, draft master leases on behalf of owners of medical office buildings and secure financing for the development of new urgent-care centers and the acquisition of hospital equipment. Whether negotiating design and construction agreements and coordinating bond or other types of financing on behalf of hospitals for their expansion projects or negotiating employment arrangements with physician groups, Arent Fox attorneys handle every facet of each deal, combining their real estate, corporate, finance, tax, licensing and regulatory expertise to best serve clients in the healthcare industry. Arent Fox also offers one of the leading long-term care and senior living practices in the nation, handling some of the largest and most sophisticated purchases, sales, equity structuring and financings for owners, investors, developers and managers of senior and assisted living facilities. For more information on Arent Fox’s particular expertise in the long-term care and senior living field, please see www.arentfox.com/practices/longtermcare.

Tax

Arent Fox has a significant and well-respected exempt organizations tax practice. Our attorneys are experienced in the areas of private inurement, private benefit and intermediate sanctions. We regularly advise our health care clients regarding unrelated business income, executive compensation and tax exempt financing matters. We have experience in all areas of federal and state tax law and bring practical business judgment and strong advocacy skills in representing taxpayers before the Internal Revenue Service, New York tax authorities and all courts having jurisdiction over federal tax disputes.

Rankings

CHAMBERS 2011
HEALTHCARE: DISTRICT OF COLUMBIA

This firm is praised for successfully building up its strength in Washington, DC. The team is noted for its expertise in fraud, FDA and abuse-related matters, in addition to handling other litigation and transactional work in the sector. Key clients include Inova Health System and Novartis Vaccines and Diagnostics. Sources say: "This firm has a strong healthcare practice, and provides the full range of expertise." Lisa Estrada is the firm's first port of call for health law in DC.

HEALTHCARE: NEW YORK

This strong group primarily advises healthcare providers, and is particularly noted for its work for long-term care providers. It covers areas from transactional work to litigation, and has been increasingly involved in compliance and enforcement work. The team often works on large multistate projects together with attorneys from its DC and Los Angeles offices. Sources say: "I think the healthcare group is outstanding - the firm as a whole has a reputation for recruiting and retaining strong attorneys." Connie Raffa can draw on over 30 years' experience in the industry, and is an expert on end-of-life care. Clients are full of praise for her, one noting her "passion about getting good healthcare to the right people at the right time." Michael Blass has a strong corporate transactional practice and has also been involved in regulatory matters.

LEGAL 500 2011

“Although it is primarily known as a Washington DC practice, in fact half of Arent Fox LLP’s 28 healthcare attorneys are based in New York and Los Angeles, giving the firm a good range of coverage. The firm’s managed care clients say the ‘healthcare team possesses incomparable depth of knowledge’. Los Angeles-based practice chair Lowell Brown has worked to broaden the firm’s healthcare coverage beyond its traditional regulatory expertise. In the same office, Thomas Jeffry’s arrival from Davis Wright Tremaine LLP in 2009 significantly deepened expertise in compliance and corporate transactions. The firm represents many health systems, hospitals, hospices, and long-term care facilities, and also handles litigation for manufacturers. The California group handles Medicare and Medicaid issues and staffing matters for St Joseph Health System and advises Kaiser Permanente – an integrated health system spanning 26 hospitals and 3,000 physicians – on regulatory compliance, ethics, and labor litigation. Its Washington DC team continues to represent Fresenius in false claims and related litigation and investigations, and advises Teva North America on compliance and pricing issues. The New York team’s recent work includes advising Dialysis Corporation of America during its $110m acquisition by US Renal Care, a deal creating an entity with 84 dialysis centers nationwide. Clients recommend Connie Raffa and litigator David Wynn as being ‘adept at understanding the scope of the problem, and in designing and revising strategies to address the problems at hand’. Raffa is ‘very knowledgeable on all areas of federal and state laws pertaining to hospices’, and provides ‘superb analysis and sound advice’.”