Arnold & Porter LLP's healthcare attorneys for decades have represented hospitals, hospital systems, and other institutional healthcare providers, including some of the most established and nationally respected hospitals and healthcare systems in the country. We understand that operating a hospital is one of the most complex and regulated enterprises that one may undertake, whether on a for-profit or nonprofit basis. Our team of highly skilled attorneys includes a physician and a nurse practitioner who bring first-hand understanding of the industry. We work with hospitals and health systems on issues ranging from state matters such as licensure and certificate of need, to more global issues such as evolving healthcare delivery, reimbursement, and value-based purchasing models that can materially affect the financial success and even viability of the hospital services provider.
We are extremely familiar with the sensitivities arising from the need to maintain an active medical staff while competing with physician-owned ventures and complying with the Anti-Kickback, self-referral (Stark), and other fraud and abuse laws. Nonprofit tax-exempt hospitals face additional challenges arising out of the need to provide charity care and avoid private inurement issues, and management must report to boards or trustees that may include members who do not have an in-depth understanding of the hospital business. Hospitals must also contend with licensure, certificate of need, accreditation, and quality control issues, especially with the new Medicare hospital acquired condition provisions now in effect. Providing insights developed over years of industry experience and service in high-ranking positions at the Center for Medicare and Medicaid Services (CMS) and the US Food and Drug Administration (FDA), we understand the issues that hospitals and healthcare systems confront, and we have the experience, understanding of the law, and skills to help our hospital clients navigate their daily and long-term challenges.
Our group is complemented by a firm of over 700 litigation, regulatory, and corporate attorneys who work in related practice areas, including antitrust, real estate, mergers and acquisitions, tax, and criminal defense to provide clients with comprehensive service. At other times we are engaged to assist management or other counsel when a particular issue arises that requires the depth of our judgment, knowledge, and legal skills.
The following highlights some of the areas with respect to which we regularly provide advice and other legal services.
Accountable Care Organizations
Arnold & Porter LLP is distinguished as a national leader in providing physicians and health systems counseling and advice for developing Accountable Care Organizations (ACOs). Overcoming potential legal hurdles and business challenges when forming, structuring, and operating ACOs for participation in the Shared Savings Program under the Patient Protection and Affordable Care Act (PPACA) is critical to reducing unnecessary costs while improving quality of care. As new forms of integrated health systems continue to emerge, regulators are forging new pathways for reconciling the existing antitrust laws and referral laws, as well as other legal barriers to sustainability. Arnold & Porter attorneys are at the forefront of this rapidly developing area, and bring practical, innovative and results-driven strategies to physicians and hospitals. We are qualified to assist clients in ACO exploration, development, and operation as we have the necessary experience in the substantive disciplines required for successful ACO development and operation. By working together with our antitrust, regulatory, tax, corporate, and transactional teams, our clients benefit from the full range of knowledge and experience we offer.
Compliance and Fraud and Abuse
Arnold & Porter is a recognized leader in the field of healthcare compliance services. We have designed, helped implement, and provided ongoing advice with respect to compliance programs for hundreds of providers, including teaching and community hospitals, large regional hospital and healthcare systems, professional practices, clinics, and a variety of similar entities. We have performed in-depth and confidential compliance audits to help strengthen existing compliance programs and ensure that they meet the "effectiveness" standard necessary to provide protection for the hospital in case of an investigation or enforcement action. If and when the issue arises, we assist our clients in assessing the need to make a voluntary disclosure where potential problems have been identified, and if a decision to do so is made, we assist in the development and presentation of such disclosures. In connection with the general compliance plans, we also prepare Health Insurance Portability and Accountability Act (HIPAA) compliance plans. We also regularly advise our clients regarding particular compliance matters relating to issues arising out of charging, billing and coding, Anti-Kickback and Stark laws, national correct coding initiative (NCCI) bundling, and patient confidentiality, among many others.
Reimbursement and Billing
We have significant experience in legal, regulatory, and policy issues relating to Medicare, Medicaid, and private payers. We also have in-depth, up-to-date knowledge of hospitals, physicians, and other providers under Medicare and other public and private insurance programs.
Government Investigations and Enforcement
Our attorneys have successfully defended and advised some of the most substantial healthcare providers in the nation with respect to investigations and proposed enforcement actions pertaining to the False Claims Act, the Anti-Kickback law, the Stark law, and other federal and state fraud and abuse laws by the Office of Inspector General (OIG), the Department of Justice (DOJ), and state enforcement agencies. While we attempt to resolve these issues informally with the applicable agencies, we are well experienced in defending our clients in court or through administrative proceedings. In addition, our attorneys have negotiated and provided advice to our healthcare clients relating to numerous Corporate Integrity Agreements.
White Collar Criminal Defense
Arnold & Porter's attorneys have a wealth of experience representing providers and suppliers in criminal and civil enforcement proceedings. For those accused of cost report fraud, kickbacks, money laundering, mail fraud, wire fraud, healthcare fraud, and questions of medical necessity, our attorneys have successfully handled some of the most complex and challenging investigations, cases, and trials in the country. We have the experience to effectively deal with search warrants, grand jury subpoenas, civil investigative demands, administrative demands/subpoenas, injunction actions, bond hearings, and trials. Our attorneys include former federal and state prosecutors from the US Department of Justice as well as US Attorney's Offices around the country.
Arnold & Porter's healthcare transactional attorneys combine drafting, negotiation, and strategic planning skills with an in-depth understanding of the legal and business constraints that are particular to the healthcare industry in general, and hospital/healthcare systems in particular. Accordingly, we have been able to close many substantial transactions on behalf of our healthcare industry clients, including mergers, acquisitions, dispositions, real property purchases, sales, leases, financing arrangements (including asset-backed loans, tax-exempt financings and mortgages), joint ventures with other healthcare providers, equipment and technology leases and licenses, institutional pharmacy contracts, vendor arrangements, and other sophisticated contracts. The firm's multidisciplinary approach further ensures that we can cover virtually all aspects of a corporate healthcare transaction, including labor and employment, government approvals, regulatory compliance, real estate, and tax.
Physician Contracting and Relations
In addition to the more general transactional work referred to above, we have extensive experience with respect to matters involving physician contracts (including employment and under arrangement matters) and joint ventures with hospitals and other healthcare facilities. This includes, for example, federal and state Anti-Kickback restrictions on hospital contracts with physicians, anti-self-referral provisions, fee split, and other state fraud and abuse restrictions as they apply to compensation agreements, practice acquisitions and divestitures, and joint ventures involving hospitals and physicians.
Managed Care Contracting
Arnold & Porter has long been involved in issues relating to managed care in its many aspects. Our work includes managed care contracting, coverage and slow-pay disputes with commercial payers, and shared-risk agreements with hospital organizations.
We have extensive experience in advising hospitals and academic medical centers on research-related regulatory requirements, drafting and reviewing agreements with research sponsors, clinical research organizations and investigators, and navigating issues associated with FDA and Institutional Review Board (IRB) clearance of research protocols. We have also assisted institutions in auditing their research operations for compliance with good clinical practice and related research issues. Arnold & Porter regularly represents institutions, IRBs, and individual clinical investigators in handling FDA inspections, investigations, and Warning Letters, scientific misconduct proceedings, research-related safety issues, Notices of Initiation of Disqualification Proceeding and Opportunity to Explain, and National Institutes of Health grant and Cooperative Research and Development Agreements matters.
Licensure and Certificate of Need
We frequently assist our healthcare clients in obtaining and maintaining state approvals, permits, and licenses, including Certificates of Need. This representation includes helping with preparation and submission of applications and related documents and forms, interfacing with the applicable governmental authorities charged with granting or denying such approvals, and appealing challenges to the grant or continuance of such approvals. In addition, approval issues often arise in connection with sales of healthcare industry businesses or other changes of control, including management arrangements.
Arnold & Porter's tax attorneys represent clients that qualify or attempt to qualify for federal and state tax-exempt status. These attorneys have an in-depth understanding of the issues relating to qualification for tax-exempt status, including debt-financed property, joint ventures with for-profit entities, executive compensation arrangements, corporate governance issues, tax-exempt bond financing, and other tax-exempt financing matters. As part of their practice, they often advise clients on private inurement issues. Moreover, they represent many foundations and intimately understand the grant-making process.
Arnold & Porter's antitrust practice is among the most prominent in the country and our antitrust attorneys advise our healthcare clients with respect to negotiating with third-party payors, exclusive provider arrangements, and developing specialty Preferred Provider Organizations. In addition, our attorneys have counseled healthcare providers in developing joint ventures, as well as in undertaking mergers and acquisitions.