Whether we are guiding providers or manufacturers through government investigations and False Claims Act litigation, defending pharmacies on matters of pharmaceutical pricing and drug reimbursement in qui tam and administrative litigation, helping health care providers navigate the privacy and political concerns around providing reproductive or gender-affirming care, or counseling hospitals on joint ventures to create ambulatory surgery centers (ASCs), we help health care clients chart a clear course through a complex system.
We pride ourselves on not only providing top-notch counsel, but on helping clients implement our legal advice into their systems, processes, and technologies. Our clients tell us they appreciate that our legal advice is closely tailored to their unique operations, enterprise capabilities, and risk tolerances.
We regularly advise clients on:
Conflicts of interest (fraud and abuse law)
In the health care space, most business arrangements are subject to broad laws intended to avoid conflicts of interest. We help our clients navigate these federal and state health care fraud and abuse laws, including the Anti-Kickback Statute; physician self-referral (Stark Law) restrictions; the Civil Monetary Penalties Law; beneficiary inducement prohibitions; fee-splitting and similar licensure restrictions; and other civil and criminal laws. We are fluent in the new value-based exceptions and safe harbors that provide greater flexibility to health care entities and systems in developing novel patient care coordination and shared risk models.
Leveraging our deep knowledge and experience in this area, our lawyers structure compliant contractual arrangements between and among health care entities, including joint ventures, discount and bundling arrangements, employer/employee relationships, clinically integrated networks, group purchasing organizations, accountable care organizations, and integrated delivery systems.
When the need arises, we assist clients who are subject to civil and criminal investigations and actions brought by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and the Department of Justice (DOJ) for alleged violations of the anti-kickback laws, the federal False Claims Act, and other statutes. We also help clients with conducting their own internal investigations, considering proactive self-disclosures to government agencies, and preparing and submitting advisory opinion requests to the OIG. We have also negotiated numerous corporate integrity agreements with the OIG and managed the resulting contractual arrangements and related advisors and monitors.
Compliance
We are frequently asked to analyze and stress test our clients’ key strategic initiatives and advise on legal compliance and risk management, as well as to advise on the soundness of the business strategies themselves and the operational and compliance infrastructures in place to support the business initiatives. As strategic legal advisors, we not only help scope the opportunity, but also help mitigate the risks of innovating and operating in a highly regulated and competitive industry.
Building on the Federal Sentencing Guidelines and relevant compliance program guidance from the OIG, as well as industry best practices, we have assisted nearly every type of entity operating in the health care space with compliance program issues. In these engagements, we leverage our market-leading experience to defend health care clients in government investigations, proactively mitigate risk in scrutinized arrangements, and maximize defenses when scrutiny arises. Additionally, we frequently develop innovative “compliance lawyer hotlines,” enabling our clients to obtain ongoing compliance advice for a flat monthly fee.
Billing, coverage, and reimbursement
We have counseled virtually every type of provider, manufacturer, and supplier on billing, coverage, reimbursement, and other payment issues. Our work includes assisting clients in working with the Centers for Medicare & Medicaid Services (CMS) and other payers on payment issues, and developing and appealing coverage determinations. To effectively assist our health care clients, we closely monitor federal and state developments in the Medicare and Medicaid areas, and often are called upon to provide advocacy on behalf of our clients before administrative and legislative bodies on these subjects.
Our practice involves extensive counseling on current reimbursement policies (i.e., regulatory and manual requirements), proposed methodological changes impacting capitation, fee schedules, or per diem payments, and proposed coverage or utilization restrictions. We regularly advise clients on the regulatory processes governing waivers and Medicaid managed care programs, and the design and implementation of such programs. Our attorneys offer in-depth knowledge of many specific reimbursement issues, including the Clinical Laboratory Improvement Amendments (CLIA) and survey and certification requirements for providers. We regularly support our provider clients with reimbursement considerations and disputes related to pharmacy benefit managers (PBMs) and other payors. We also advise providers on compliance with the federal No Surprises Act, including development of policies and defenses against CMS investigations, and analogous state payment transparency laws.
Government investigations
Our experience with health care-related investigative and enforcement activity is broad and deep. We engage on a regular basis with state and federal enforcement agencies – DOJ, OIG, FDA, Department of Veterans Affairs, Department of Defense, state Medicaid Fraud Control Units, state attorneys general – as well as with private litigants in the qui tam context. Our reputation for defending False Claims Act allegations in particular has made us the “go-to” firm for health care and life sciences companies as the government continues to use the False Claims Act as one of its primary enforcement tools, and we have recently seen record highs in cases brought by whistleblowers pursuing claims on behalf of the government.
For more information, please visit our Health Care & Life Sciences Investigations page.
Payment transparency
We have in-depth knowledge of U.S. transparency requirements, including the Open Payments (aka Sunshine) Law and similar state laws. We analyze these laws’ applicability to clients’ operations, develop and implement related policies and procedures, and provide training. We regularly advise regarding the reportability and proper characterization of payments and transfers of value (or ownership interests). Such analyses are often conducted in conjunction with fraud and abuse analyses, and we have assisted companies in developing dynamic compliance dashboards utilizing Sunshine and other business data. We also commonly consider transparency issues in the context of due diligence. Given the range of clients we represent, we have strong benchmarking capabilities when it comes to considering unique issues and questions.
Certification, accreditation, and licensure
We have extensive experience in health planning and licensure issues, including the application of state certificate of need (CON) laws, state health care facility licensure laws, and physician and other professional licensure laws. Our attorneys routinely provide advice to health care clients of all types concerning whether the proposed establishment, modification, replacement, or expansion of a health care service or facility is subject to CON or licensure approval by a state.
We also provide substantial client counseling in CON and licensure matters relating to business transactions, principally acquisitions and divestitures, corporate reorganizations, joint ventures, and financing agreements. We have represented health care clients in administrative and judicial proceedings in numerous states that involve various aspects of CON and licensure processes, including initial applications, requests for site changes, and comparative hearings.
State licensing and compliance services
We support clients’ state licensing needs, including assisting with filings, responding to licensing board requests and compliance communications, and providing strategic licensing analysis and risk mitigation advice in the context of complex distribution networks (including the use of third-party logistics providers in addition to wholesale distributors). We regularly support clients in the preparation of new applications, as well as managing renewals and change of ownership/personnel applications, leveraging highly experienced paraprofessionals to provide efficient and practical approaches with the oversight of our attorneys. We also assist with National Association of Boards of Pharmacy Verified-Accredited Wholesale Distributor (VAWD) accreditation matters. Additionally, we handle disputes with boards of pharmacy for major pharmacy chains, including defending against administrative actions brought by these boards and citations of non-compliance.
Administrative appeals and disputes
We have extensive experience defending clients in administrative state and federal litigation, including litigation involving the Administrative Procedure Act. We have handled numerous payment appeals, administrative findings, and other disputes through the administrative appeal process through to federal court challenges. These appeals are broad in topic and range, from quality bonus payments and ratings to findings of potential fraud by Unified Program Integrity Contractors (UPICs).
Regulatory due diligence
In addition to our experience handling the corporate aspects of health care and life sciences transactions – including structuring transactions, forming entities, and negotiating contractual arrangements – Reed Smith shines in its ability to provide specialized FDA and health care regulatory due diligence in transactions involving nearly every type of health care organization.
For more information, please visit our Health Care & Life Sciences Transactions page.
Regulatory and legislative counseling and advocacy
Our practice involves regulatory and legislative monitoring and lobbying on behalf of all types of health care entities and industry associations. The firm assists clients in complying with regulatory and legislative requirements, as well as challenging major regulatory actions through negotiations with federal agencies, such as CMS, and state agencies throughout the country, and pursuing litigation where appropriate.
For more information, please visit our Health Care & Life Sciences Governmental Monitoring and Advocacy page.
HIPAA, data privacy and security, and digital health
We have a well-established, sophisticated team of data privacy and security lawyers dedicated to counseling clients on health information privacy and security issues, including data breaches. This team is comprised of attorneys with a unique combination of privacy, security, and health care industry experience, allowing them to pragmatically counsel clients through the complex and evolving digital health care space. The group focuses on counseling entities doing business in the health care field, including providers (covered entities) and their vendors.
For more information, please visit our Health Care & Life Sciences Privacy, Data Protection, and Cybersecurity page and our Digital Health & AI page.
