Contributed by Daniel Kracov, Arnold & Porter LLP
The US continues to be a dynamic environment for healthcare providers and medical product manufacturers. In particular, the looming implementation of major healthcare reform in the US will change the landscape for all stakeholders in the healthcare field, both in terms of opportunities and regulatory challenges.
Affordable Care Act
Under the Affordable Care Act (ACA), Medicaid expansion and health insurance Exchanges take effect in 2014, at which time an estimated 14 million uninsured Americans will gain coverage. A series of regulations will shape the coverage available to the newly insured (and ACA’s impact on providers and medical product manufacturers), but the most important are the Essential Health Benefit (EHB) regulations, which define the benefits that must be covered by participants in providing coverage under ACA, including qualified health plans offered on Exchanges and non-grandfathered individual and small group coverage offered by insurers.
ACA has already resulted in transactional activity, including the creation of Accountable Care Organizations (ACOs), which are groups of providers, such as primary care and specialty physicians, hospitals, and suppliers, that share accountability for the quality and cost of care for the Medicare patients that they serve. The ACO model is intended to foster better management of care, while rewarding quality and efficiency by creating a mechanism for ACOs to share in the resulting savings to the Medicare program.
False Claims Act and Related Enforcement
The healthcare industry has seen a huge increase in investigations and settlements, principally under the threat of False Claims Act (FCA) liability. In the 2012 fiscal year, the US Department of Justice secured $4.9 billion in settlements and judgments in civil cases involving healthcare fraud, eclipsing the previous single year record by more than $1.7 billion. That trend is likely to continue, In large part due to “whistleblower” provisions, ever-expanding definitions of what is a false claim, and new enforcement funding. While most of these dollars flow from recoveries against large corporate entities, such as hospital systems or pharmaceutical companies, there has been increasing pressure to hold accountable those individuals in a responsible position vis-à-vis alleged misconduct by excluding executives from federal health care programs or, in the more egregious cases, pursuing criminal prosecution.
One bright spot in the enforcement landscape was the December 3, 2012 landmark ruling in United States v. Caronia, in which the Second Circuit held that construing the Federal Food, Drug, and Cosmetic Act (FDCA) to prohibit pharmaceutical companies from engaging in truthful and non-misleading speech regarding unapproved or “off-label” uses of Food and Drug Administration (FDA)-approved drugs violates the First Amendment. Although the ultimate impact of this ruling will be determined as future cases are litigated, Caronia calls into question the core prosecutorial theory used by the government to bring criminal enforcement actions for off-label promotion under FDA’s “intended use” regulations, and may also limit the ability of the government and private plaintiffs to argue that off-label promotion leads to the submission of false claims.
Sunshine Act Implementation
Another upcoming development for both medical product manufacturers and physicians is the implementation of the physician payment “sunshine” provisions of ACA, under which applicable manufacturers and group purchasing organizations (GPOs) will report annually certain payments or other transfers of value to covered recipients, namely physicians and teaching hospitals.. Those subject to the law must begin to collect the required data on August 1, 2013 and report the data to the Centers for Medicare and Medicaid Services (CMS) by March 31, 2014. CMS will publish the data on a searchable website by September 30, 2014 -- a database that is expected to be fertile ground for scrutiny of industry-physician relationships.
In the antitrust sphere, the Supreme Court in Federal Trade Commission v. Actavis is poised to resolve a long-running debate regarding the legality of “reverse payment” patent settlements. In these settlements, a brand drug company licenses a generic to bring its product to market on a certain date, and also gives the generic company something else of value, be it a cash payment, a license on another product, or fee-for-service business arrangement. In Actavis, the FTC condemns these arrangements as payments for delayed generic entry and advocates for an unprecedented “presumption of illegality” regarding these settlements. Industry counters that this approach would chill innovation, discourage patent challenges and ultimately delay generic entry in the roughly 50% of cases where the brand would prevail in litigation. Whether the Supreme Court adopts the FTC’s presumption, endorses the Eleventh Circuit’s “scope of the patent” test that typically permits these settlements, or creates a different standard, the decision will have significant consequences for brand and generic drug companies and consumers.
Another area that has important implications for both medical product manufacturers and providers is the evolving regulation of certain mobile health applications. While FDA has clarified that it does not intend to regulate smartphones or tablets generally, it will be exercising jurisdiction over mobile apps that meet the statutory definition of a "medical device" based on their intended use. The agency plans to issue a final guidance by September 30, 2013 that will clarify FDA's regulatory approach to such mobile health apps and provide examples of the types of apps that FDA does not plan to regulate.
Healthcare - New York
THE FIRM Epstein's preeminent healthcare and life sciences practice is noted for its depth in a wide range of matters, including regulatory compliance, contracting, joint ventures and litigation. The group wins particular acclaim for its work involving healthcare providers and payors, as well as major names in the life sciences arena. Its enviable client list includes Millennium Pharmaceuticals, Daiichi Sankyo, Montefiore Medical Center and Triple S Management.
Sources say: "The firm has been around for a long time and has a very solid healthcare practice."
KEY INDIVIDUALS Firm cofounder Jeffrey Becker is highlighted by sources for being "very creative and ridiculously smart." He is known for his broad-ranging practice encompassing transactional and regulatory work, and for taking leading roles on behalf of the some of the group's most significant clients, including the Mount Sinai Medical Center and Gold Health Strategies.
The up-and-coming Bethany Hills recently joined the firm from Hodgson Russ LLP. Hills has a practice covering a wide range of healthcare reimbursement and regulatory compliance issues.
THE FIRM Manatt Phelps takes a leading position in the rankings this year due to tremendous market recognition of its expertise in healthcare IT and reform work on behalf of clients such as Montefiore Medical Center, Health Plus and Memorial Sloan-Kettering Cancer Center. The group is also credited for the unique advantage offered by its dedicated Manatt Health Solutions team, a department combining a range of policy, operational, regulatory and strategic counsel for clients.
Sources say: "The practice is very active in healthcare IT matters around the country." "It is very in touch with the latest healthcare issues and has an incredible depth of expertise."
KEY INDIVIDUALS William Bernstein chairs the firm’s healthcare practice group. He is especially recommended for his expertise in healthcare reform issues, and "has been a player in healthcare law for many years." Sources go on to praise him as "highly professional, articulate, accessible and personable."
The immensely experienced Robert Belfort has in-depth expertise in transactional healthcare and regulatory compliance matters, covering the areas of fraud and abuse, HIPAA and privacy, and managed care work. Sources describe him as "extremely knowledgeable, encyclopedic, very careful at detailed work and a really good attorney."
James Lytle is lauded in particular as "a very good regulatory healthcare attorney." He heads the firm's Albany office as well as its New York state legislative lobbying and regulatory practice group.
The up-and-coming Melinda Dutton plays a lead role in the Manatt Health Solutions team. She has a solid healthcare practice advising clients on general business, regulatory and policy issues. Sources say she is "fabulous to work with, very responsive, and has an incredible depth of expertise."
Similarly highlighted as a future star of the sector, Helen Pfister also counsels her clients on a range of regulatory, policy and general business matters.
THE FIRM Proskauer's outstanding healthcare practice has all-encompassing expertise and depth, and includes reimbursement, fraud and abuse, transactions and financing, and regulatory and compliance work. Clients include AthenaHealth, Ascension Health Care Network and Catholic Health Services of Long Island. In recent highlights, the group represented Richmond University Medical Center in the establishment of a clinical affiliation with Mount Sinai Medical Center, and in the discontinuation of its joint venture in the Heart Institute.
Sources say: "The practice has an exceptionally deep understanding of healthcare law in New York."
KEY INDIVIDUALS Edward Kornreich wins tremendous client acclaim, with many describing him as a "very responsive" attorney and "a seasoned practitioner with a top-notch healthcare practice." His recent work includes representing Beth Israel Medical Center in an investigation by the US Attorney for the Southern District of New York.
Richard Zall chairs the firm's healthcare group, and maintains an excellent practice covering a range of regulatory and transactional issues. He is "extremely easy to work with," say sources; "exceptionally bright, very well connected, resourceful and generally a great guy."
THE FIRM This firm's exceptional New York team is highlighted for its deep bench and versatility in the healthcare arena. The group has a strong and longstanding line in representing major healthcare providers, community hospitals and academic medical centers, as well as pharmaceutical, medical device and biotech companies. Its recent highlights include assisting North Shore Long Island Jewish Health System in numerous healthcare concerns, including in relation to DOJ investigations and transactional issues.
Sources say: "They master a broad scope of knowledge and are completely accessible."
KEY INDIVIDUALS Sources are immensely impressed by the leading Stephen Warnke: "He is absolutely the best! He's terrific, very precise and exact, and clear - he leaves no stone unturned." His wide-ranging practice is particularly commended in the areas of regulatory compliance, healthcare reform, and Medicare and Medicaid reimbursement.
THE FIRM Arent Fox's New York-based healthcare group forms an integral part of the firm's increasingly recognized national practice. Its sizable team undertakes all manner of regulatory, compliance, investigation, transactional and litigious assignments on behalf of a broad and enviable list of clients, including Maxim Healthcare Services, Fundamental Long Term Care and the Visiting Nurse Association of Long Island.
Sources say: "I'm impressed with the team's responsiveness, reliability, accessibility, professionalism and quality of work product."
KEY INDIVIDUALS The tremendously experienced Connie Raffa is the founding member of the firm's healthcare group in New York. Interviewees describe her as “very adept at understanding the scope of the problem, and designing and revising strategies to address issues." She wins accolades across a number of areas, including Medicare and hospice and palliative care.
The "very talented" Michael Blass has a solid practice handling general business transactions, corporate matters and regulatory issues in the healthcare space. He is a go-to adviser for many of the firm's most significant healthcare clients, including Maxim Healthcare Services, who he advises on a range of corporate, finance and regulatory matters.
THE FIRM Greenberg Traurig's superb healthcare practice group counsels clients across a range of transactional and regulatory issues, and brings a particular advantage to the table in the form of its government affairs and legislative lobbying strength. In recent highlights, the group provided regulatory advice to Amerigroup on its purchase of Health Plus, one of the largest Medicaid managed care companies in New York. Other major clients include MVP HealthCare, UnitedHealthcare, Affinity Health Plan and Jewish Home Lifecare.
Sources say: "The team does a lot of work in the New York healthcare market, and offers its clients a complete package, including counseling, advice and litigation."
KEY INDIVIDUALS The "collaborative and results-oriented" Harold Iselin is managing partner of the firm's Albany office. A preeminent practitioner in the healthcare arena and a former DOJ trial attorney, he wins particular acclaim for his expertise in healthcare plans and reimbursement, and undertakes a range of governmental affairs and regulatory issues, among other matters.
The tremendously experienced Francis Serbaroli has a respected and broad-ranging healthcare practice. His highlights include recently representing EmblemHealth in a significant contract negotiation with ExpressScripts in relation to the outsourcing of prescriptions for the former's members.
THE FIRM Mintz Levin's increasingly recognized New York healthcare group forms a key part of the firm's superb East Coast practice. The team is praised for its depth across a range of transactional and regulatory matters, including litigation and healthcare IT issues. Particular areas of expertise also include cross-border assignments and physician residency programs. Key clients include HealthpointCapital, Fidelis Care New York, the Wartburg Adult Care Community and North Shore-Long Island Jewish Health System.
Sources say: "The practice has very good people with a deep knowledge of the New York healthcare environment, as well as with deep expertise in M&A work."
KEY INDIVIDUALS Brian Platton is lauded as "knowledgeable, thorough, thoughtful" and "highly collaborative." Clients praise not just his in-depth healthcare expertise but also his capabilities in M&A work.
Backed by more than 30 years' experience in the field, Andrew Roth has all-encompassing healthcare expertise. Clients appreciate that "he is always available" for them, and "provides great-quality work."
THE FIRM Nixon Peabody maintains a sterling, deep and broad-based healthcare practice group in New York. The team handles all manner of corporate, regulatory, reimbursement, medical staff and compliance issues, among other types of matter. Its clientele includes a range of healthcare providers, integrated delivery systems, pharmaceutical companies and physicians groups.
Sources say: "The team has excellent communication skills, knowledge, adaptability to client needs and great contacts in peer institutions."
KEY INDIVIDUALS Peter Millock is considered a go-to attorney in regulatory and policy issues in the healthcare space. He is tremendously experienced in the field, and has in the past served as general counsel at the New York State Department of Health.
The "very talented" Susan Robfogel, chair of the firm's life sciences practice group, occupies a strong niche in handling complex labor and employment matters involving the healthcare and life science sectors.
James Fabian is "very purposeful, logical and a good strategist," say sources. Backed by more than 30 years of experience, he has a strong practice acting on behalf of healthcare providers, academic medical centers and teaching hospitals, among others.
Michele Masucci leads the firm's health services practice group. She is an expert in acting for healthcare providers, particularly in relation to reform legislation, regulatory issues and M&A-related compliance matters. Sources also highlight her excellence with physician issues.
A new entry in this year's rankings, Peter Egan comes highly recommended as a future star of the sector. "He is an excellent attorney," say sources; "well versed in all aspects of healthcare law, state and federal regulations, business law and contract negotiation."
THE FIRM Cadwalader's established New York team offers a broad array of healthcare advice, and is particularly highlighted for its in-depth expertise in issues relating to long-term care. As such, it is considered a go-to group for the likes of Leading Age Care, who the team regularly advises across a range of regulatory, policy, tax and corporate issues, among other types of matter. Other notable representations include its enviable role as general corporate counsel to CenterLight Health System.
Sources say: "The team is formed by consummate professionals who are a pleasure to deal with."
KEY INDIVIDUALS Brian McGovern is highly active in enforcement and regulatory issues, and is highlighted in particular for his expertise in compliance issues relating to long-term care. He recently represented Brownsville Multi-Service Family Health Center in issues concerning an audit and administrative hearing relating to alleged Medicaid overpayments.
Paul Mourning continues to garner acclaim for his corporate governance and transactional expertise, particularly on behalf of nonprofit organizations and long-term care providers. He has played a lead role in the group's activities on behalf of CenterLight.
THE FIRM This highly respected and longstanding healthcare boutique firm is noted for its representation of a major proportion of the state's most significant healthcare providers. The group undertakes a full array of issues for its clients, ranging from regulatory counsel to corporate transactions.
Sources say: "An enormous breadth of practice."
KEY INDIVIDUALS Firm founder and chairman Robert Wild is renowned for his all-encompassing expertise in representing hospitals in New York state. One peer notes: "He is fantastic! I have the highest respect for him!"
THE FIRM Hodgson Russ is known for the breadth of the excellent work it undertakes on behalf of healthcare clients, including healthcare and long-term care providers, academic medical centers, hospitals and pharmaceutical companies. In recent highlights, the group represented Kaleida Health in an appeal against two Medicaid reimbursement-related issues.
Sources say: "The practice offers responsiveness and a great depth of resources."
KEY INDIVIDUALS Ellen Weissman leads the firm's healthcare practice group, and was recently appointed chair of the Health Law Section of the New York State Bar Association. As such, she is an esteemed figure in the sector, particularly in relation to regulatory and reimbursement issues, with many describing her as "very bright and very persistent" as well as "extremely personable."
THE FIRM Hogan Lovells is able to provide in-depth and wide-ranging healthcare advice thanks to the firm's extensive reach and resources. The team in New York represents all manner of healthcare, medical device and pharmaceutical entities. Key clients include the State University of New York, Jefferson Regional Medical Center and the American Board of Neurological Surgery.
Sources say: "The practice has deep expertise in a variety of complex healthcare matters."
KEY INDIVIDUALS The preeminent Jeffrey Schneider is "an absolute pleasure to work with," say clients; "he is extremely responsive and knowledgeable." Peers also praise him as one of the most talented healthcare attorneys in the state across a range of transactional and regulatory matters.
THE FIRM Katten Muchin's small but highly effective New York healthcare team handles an array of regulatory, transactional and reimbursement matters, and is highlighted in particular for its excellence in litigation assignments. Its clients include the New York City Health & Hospitals Corporation, Greater New York Hospital Association and Catholic Health Services of Long Island.
Sources say: "The group is very knowledgeable."
KEY INDIVIDUALS Of counsel Peter Nadel is a highly respected and experienced authority in the sector. He focuses on healthcare matters, undertaking litigation, transactional and regulatory work on behalf of healthcare providers.
With more than 30 years of experience in the healthcare sector, Joseph Willey comes recommended as an excellent choice for Medicare and Medicaid reimbursement work. One client mentioned that "he is a good litigator, and also a very pleasant person to deal with."
Jeffrey Ruggiero is a partner in the firm's FDA and healthcare practice group of Arnold & Porter LLP. He continues to receive acclaim as an "effective and direct communicator, a good strategic thinker, and a good resource in helping to resolve issues and develop effective solutions."
Wendy Goldstein recently joined Cooley LLP from Epstein Becker & Green PC. She is renowned for her expertise in pharmaceutical and life science issues. One peer said: "She is a superstar in the pharmaceutical area and I would love to have her at my firm, she is that good."
Charles Luband joined the healthcare group at Dentons from Ropes & Gray in January 2012. He is best known for his Medicaid reimbursement expertise. His recent highlights include representing the University of North Carolina Health Care System in relation to Medicaid supplemental payment issues.
Jeff Thrope of Foley & Lardner LLP is highlighted by sources as a "very smart regulatory guy" and an expert in range of healthcare issues on behalf of providers. His key clients include Medisys Health Network and Nassau Health Care.
The "very smart" Robert Iseman of Iseman Cunningham Riester & Hyde LLP is an immensely experienced healthcare attorney, with more than 35 years of experience in the sector. He has a broad-ranging practice acting on behalf of insurers and healthcare providers.
David Ivill is partner-in-charge of the New York healthcare practice group at McDermott Will & Emery LLP. He takes the lead in a significant proportion of the firm's healthcare matters, and is a regular adviser to clients like TeamHealth.
Robert Greene of Phillips Lytle LLP is known for his tremendous experience across a wide variety of healthcare law matters, including corporate governance, regulatory and reimbursement issues.
Paul Schnell of Skadden, Arps, Slate, Meagher & Flom LLP & Affiliates has a broad-based transactional practice encompassing corporate, M&A, private equity and healthcare matters. He is renowned as "a great transactional lawyer who does really big deals."
Joel Hodes is a founding partner of Whiteman Osterman & Hanna LLP. With a strong and wide-ranging healthcare practice, he enters this year's rankings on the back of tremendous client praise. "He is thoughtful and considerate in all issues, a good listener and assesses things well," say sources.