3D printing is quite possibly the next greatest chapter in the industrial revolution, and the technology is moving rapidly. 3D printing, or “additive manufacturing,” has been around since the 1980s. In the past few years, however, the technology has developed at an unprecedented rate, resulting in 3D printing becoming a significant industry with tremendous innovative potential for many applications - from dental and medical, to automotive, aerospace, military, fashion, food, eyewear, and construction.

Forecasters predict that 3D printing will democratize manufacturing, allowing every individual with the means to buy a printer to become a manufacturer and market his or her products to others. As such, 3D printing presents myriad of legal challenges, and our 3D printing focused lawyers are poised to assist.

One of the most powerful tools used by the federal and state governments to identify fraud and recover overpayments in government programs is the federal False Claims Act, 31 U.S.C. section 3729 et seq. (“FCA”), and corollary state false claims acts. We are experienced in responding to Inspector General (“IG”), Assistant United States Attorney (“AUSA”) and Department of Justice (“DOJ”) Civil Investigative Demands; subpoenas; successfully resolving FCA investigations; and defending clients in FCA actions and qui tam litigation filed by FCA relators and the DOJ. Our FCA and qui tam experience includes:

• Providing compliance and related guidance to minimize potential exposure
• Negotiating Corporate Integrity Agreements/Certification of Compliance Agreements
• Conducting internal investigations of potential compliance issues and preparing voluntary or mandatory disclosures
• Utilizing extensive in-house document collection and production capabilities to economically respond to subpoenas and document requests

Regulated industries give rise to unique antitrust problems. Any legal strategy, whether developed for litigation or ongoing business transactions, must take into account not only tenets of antitrust law, but also the interplay of antitrust principles with the legal and operational framework of the industry. Our antitrust lawyers have significant experience working with health care clients, like you, to navigate their highly-regulated industry.

Our team includes lawyers who focus on the application of the antitrust laws to health care providers and other entities in the health care industry. The continuing interest of enforcement agencies in health care, coupled with economic pressures that providers face in an increasingly competitive market, have placed many providers and health insurers in a difficult and uncertain position. While industry responses, such as joint ventures, managed care networks and group purchasing arrangements, are increasingly appealing, the antitrust implications of participation can be complex.

Our antitrust practitioners are experienced in the problems that confront health insurers, hospitals, and other health care entities. We can represent you in a range of antitrust matters, including hospital mergers, the creation of provider networks such as physician-hospital organizations and independent practice associations, the development of a variety of joint ventures, staff privileges cases, exclusive contracting, and the formation of and participation in managed care organizations (MCOs), preferred provider organizations (PPOs) and health maintenance organizations (HMOs).

Our team has extensive experience helping health care businesses like yours 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.

At Reed Smith, we 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 can also provide you with substantial counseling in CON and licensure matters relating to business transactions, principally acquisitions and divestitures, corporate reorganizations, joint ventures and financing agreements.

Our lawyers can represent you in administrative and judicial proceedings in numerous states that involve various aspects of CON and licensure processes, including initial applications, request for site changes and comparative hearings.

We closely follow state insurance law developments pertaining to the health care industry, often advising providers, managed care companies and health insurers on the application of insurance law principles to their activities. We have even assisted a client in obtaining state health maintenance organization (HMO) licensure and complying with HMO licensure requirements.

Allegations of fraud and abuse can instantly threaten your business and destroy the good will you’ve taken years to build. Our team helps structure operations to prevent violations and avoid perceived violations.

We, at Reed Smith, advise virtually every type of health care entity on federal and state anti-kickback laws; physician self-referral restrictions, including the “Stark Law’s” prohibitions and exceptions; restrictions on beneficiary inducements; the federal False Claims Act; and other civil and criminal laws.

Our coordinated team seamlessly conducts legal audits of existing contracts and operations, and develops tailored, comprehensive compliance programs. We can also provide you with counsel regarding regulatory and legislative developments and regularly submit requests for advisory opinions from federal regulators.

In the competitive and ever-changing environment in which health care providers find themselves, having experienced insurance counsel is paramount.  We understand your risks and risk management options, including third party insurance and captive programs.  We can help you analyze your coverage gaps and work with your brokers on the best options to fill them.  You spend substantial amounts on managing risks of all kinds; you should know that what you spend on insurance is spent wisely and that when claims come in, you have the best lawyers to assist you in preparing, negotiating and, if need be, litigating to get the coverage you paid for.  

As one of the largest and fastest-growing segments of the private equity market, the health care industry is ripe with opportunity for private equity funds that are able to navigate the complex regulatory issues involved with these types of investments.

As one of the world’s leading law firms with a historic practice in health care and life sciences, we can guide clients through deals of varying sizes and complexity and through each phase of the investment life cycle with a keen understanding of the complex, dated, or underdeveloped regulatory frameworks affecting each sector of the industry. We bring together market-leading private equity and subject-matter health care teams to assist our private equity clients and their portfolio companies with their most strategic transactions around the world. This has allowed our team to be at the forefront of developing innovative partnerships, structures, and transactions that align with the future of the health care industry and help our clients achieve their strategic and financial goals.

Our team counsels providers and suppliers on reimbursement, coverage, and third-party payment issues. We apply our experience of working with Medicare, Medicaid, and other payors to achieve creative solutions for you through local, national, administrative and Congressional pathways.

Our lawyers assist on every aspect of Medicare and Medicaid reimbursement and coverage, including:

• Local and national Medicare coverage and utilization restrictions, including private payer coverage
• Proposed changes impacting capitation, fee schedules and per-diem payments
• Regulatory processes governing waivers and Medicaid managed-care programs
• Provider survey and certification requirements

We, at Reed Smith, can also counsel you concerning reimbursement from private insurers and managed care plans, including health maintenance organizations (HMOs). In connection, we have structured agreements that include capitation payments and other creative financial risk-sharing mechanisms for your benefit.

In an ever-evolving health-care landscape, our managed care clients remain focused on delivering high-quality, cost-effective care to their members. Reed Smith helps our clients achieve this by providing legal services designed to help them capitalize on the opportunities and confront the challenges of the healthcare market.

With more than 60 attorneys who devote their practice exclusively to managed care, the Reed Smith team has a deep-seated and comprehensive understanding of the issues that managed care organizations face. Our attorneys work to build and maintain a culture of collaboration and trust that is based on a familiarity with the client’s business. This is evidenced not only by the number of long-term clients but also by the depth of those relationships.