Arnold & Porter LLP healthcare attorneys have extensive experience representing physicians, physician practices, hospital medical staffs, as well as healthcare-related ventures owned in whole or in part by physicians. Our physician clients include large multispecialty and single specialty physician practices, smaller physician groups, and individual physician practices. Additionally, we represent a number of medical societies and professional associations.
We understand the issues important to physicians based, in part, on our extensive experience representing hospitals, health systems, and other healthcare provider clients. Our healthcare practice includes a physician and a nurse practitioner; in addition, several members of our practice served as high ranking officials at the Center for Medicare and Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA), and other federal and state agencies.
In short, we understand the challenges that physicians face in their practices and health-related investments and businesses, and we have the experience, understanding of the law, and skills to help them attain their goals and objectives. The following highlights some of the areas with respect to which we regularly provide advice and other legal services.
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 client 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 self-referral (Stark) laws, national correct coding initiative (NCCI) bundling, and patient confidentiality, among many others.
We have significant experience in legal, regulatory, and policy issues relating to Medicare, Medicaid, and private payers. We have successfully represented physicians in hundreds of reimbursement appeals, including those arising from Recovery Audit Contractor and Zone Program Integrity Contractor audits, through the administrative law judge hearing process.
Government Investigations and Enforcement
Our attorneys have successfully defended and advised individual physicians as well as large physician practices 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 experienced in defending our physician clients in court or through administrative proceedings. In addition, our attorneys have negotiated and provided advice to our clients relating to numerous Corporate Integrity Agreements and Individual Integrity Agreements.
Practice Group Formation
Arnold & Porter's healthcare attorneys have worked extensively with physicians in establishing, structuring, or restructuring physicians practice groups, both large and small. While our principal goal is assuring compliance with applicable laws and regulations, we also recognize the business realities of operating a medical practice and work with our clients to pursue both regulatory compliance and business success.
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 Accountable Care Organizations 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, referral laws, as well as other legal barriers to sustainability. Arnold & Porter LLP attorneys are at the forefront of this rapidly developing area, and bring practical and innovative 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 wide range of knowledge and experience we offer.
Arnold & Porter's healthcare transactional attorneys combine drafting, negotiation, and strategic planning skills with an in-depth understanding of the legal and business challenges in the healthcare industry in general, and physicians and physician groups in particular. We have successfully completed transactions on behalf of physicians and physician groups, including mergers, acquisitions, dispositions, real property purchases, sales and leases, financing arrangements, joint ventures with other healthcare providers, equipment and technology leases and licenses, vendor arrangements, and other sophisticated contracts. The firm's multidisciplinary approach ensures that we can cover virtually all aspects of a healthcare transaction, including labor, antitrust and employment, government approvals, regulatory compliance, real estate, and tax.
Credentialing, Peer Review, and Professional Conduct Matters
We represent our physician clients in connection with credentialing disputes, loss of privileges issues, and peer review matters with hospitals, insurers, and government agencies. In addition, we have successfully assisted physicians in administrative and court licensure or professional misconduct proceedings.
Managed Care Contracting
Arnold & Porter attorneys have experience in a broad range of managed care matters. Our work includes managed care contracting, coverage, and slow-pay disputes with commercial payers, and shared-risk agreements with hospital organizations.
Government Approvals, Licenses and Certificates of Need
With respect to physician-related ventures that require state approvals, permits, and licenses, including Certificates of Need, we assist in the preparation and submission of applications and related documents and forms, interface with the applicable governmental authorities charged with granting or denying such approvals, and appeal challenges to the grant or continuance of such approvals.
We have extensive experience in advising clinical investigators on their regulatory obligations, drafting and reviewing agreements with research sponsors and clinical research organizations, and navigating issues associated with FDA and Institutional Review Board clearance of research protocols. We also regularly represent investigators in responding to FDA inspections, investigations and warning letters, scientific misconduct proceedings, and Notices of Initiation of Disqualification Proceeding and Opportunity to Explain.
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 IPAs, preferred provider organizations, and other forms of physician collaborative structures. In addition, our attorneys regularly provide counsel to physicians and physician practices in the development of joint ventures, as well as in undertaking mergers and acquisitions.
Our litigators have represented physicians and other health care providers in commercial litigation matters including shareholder or vendor disputes, employment terminations, contract breaches and claims, and enforcement of restrictive covenants.