Healthcare: District of Columbia

THE FIRM This firm is one the strongest in the state for lobbying and healthcare legislation and policy initiatives. Its impressive roster of clients is drawn from every sector of the healthcare industry and includes large corporations, hospitals and pharmaceutical companies. Fraud, abuse, and antitrust are the team's forte, but it has greatly expanded its expertise in the Food and Drug Administration (FDA) area. Clients are quick to praise the group's unfailing responsiveness.

Sources say: "It is clear that this firm hires very skilled and talented individuals; it is undoubtedly a strong firm in this area."

KEY INDIVIDUALS Litigator Robert Salcido is widely respected for his expertise in healthcare fraud and abuse issues. Clients benefit from his "professionalism, responsiveness and practical advice." He recently defended a skilled nursing facility in a False Claims Act action brought by the government. John Jacob is praised for his "thoroughness and attention to detail." He has represented a group of California-based hospitals in appeals relating to changes to Medicaid. Practice head Jorge Lopez is characterized by clients as "available, personable and knowledgeable." He advises a broad clientele on policy, regulatory and compliance matters before Congress and federal regulatory agencies. Former King & Spalding attorneys Christopher Keough and Stephanie Webster are new to the team. Keough has "made a name for himself in the provider reimbursement arena." Sources are particularly quick to point out his strength in Medicare and Medicaid matters. One client enthuses: "He is a very talented man. He always takes my concerns seriously and offers me great advice." Webster is best known for her work in the field of Medicare and Medicaid reimbursement. Sources report: "Stephanie is excellent. She is very smart, pleasant to work with, and very strong technically."

THE FIRM  This firm is praised for successfully building up its strength in Washington, DC. The team is noted for its expertise in fraud, FDA and abuse-related matters, in addition to handling other litigation and transactional work in the sector. Key clients include Inova Health System and Novartis Vaccines and Diagnostics.

Sources say: "This firm has a strong healthcare practice, and provides the full range of expertise."

KEY INDIVIDUALS Lisa Estrada is the firm's first port of call for health law in DC.

THE FIRM Arnold & Porter is recommended for its strength in FDA matters. The team is commended for assisting large drug and device companies on litigation, regulatory, anticompetition and employment matters, among others. In more general matters, the group displays particular strength in handling fraud and abuse, reimbursement and pharmaceutical pricing mandates. Major clients include NovaMed, Arizant and AstraZeneca.

Sources say: "The lawyers are extremely talented and very well qualified. They work to understand my company's legal and business objectives, and then develop appropriate strategic and tactical approaches." 

KEY INDIVIDUALS Alan Reider is "an excellent choice for regulatory matters and issues relating to Medicaid." He recently represented NovaMed in an investigation by the Department of Justice relating to surgical claims at Ambulatory Surgical Centers. Allison Shuren is "a very bright attorney." Peers credit her with having "done a lot to diversify the firm's healthcare group." She recently acted on behalf of numerous medical device and pharmaceutical manufacturers in developing reimbursement strategies for emerging technology. Daniel Kracovis described as "quite exceptional on FDA regulatory matters." He is skilled in carrying out both internal and external reviews for large clients, who praise his "excellent combination of IQ and emotional intelligence."

THE FIRM This group continues to impress commentators with one of the strongest FDA groups in the state. In addition to its established senior stars, it continues to nurture a talented pool of younger attorneys. Covington & Burling LLP provides regulatory advice to a number of the world’s top pharmaceutical, medical device, biotechnology, nutrition and vaccine companies.

Sources say: "This is the go-to firm for any FDA regulatory matter."

KEY INDIVIDUALS Peter Safir is one of the state's most prominent FDA lawyers. "He is experienced in everything – there is not one matter he doesn’t know about when I call," enthuses one source. IP litigation and the Hatch-Waxman Act are among Safir's main fortes. Richard Kingham continues to represent PhRMA in various matters including FDA regulatory, international IP, and state legislative matters. He is praised by commentators as "a high-quality practitioner and an excellent strategist." Sources describe cochair Ellen Flannery as "extremely bright and one heck of a lawyer." She is best known for her medical devices and human pharmaceuticals practice. She recently advised Quest Diagnostics regarding FDA premarket and postmarket regulatory requirements for medical devices and laboratory-developed tests. Michael Labson is increasingly active in government investigations and in litigation. Observers note his "impressive technical skills and sharp mind." One client enthuses: "He is my leading FDA lawyer – he is excellent." Scott Cunningham receives impressive feedback for his "positive approach to dealing with clients," and for his "competency and depth of experience." Peter Barton Hutt is described as "the dean of the FDA Bar." He regularly provides expert advice and reports in private lawsuits involving medical device regulation by the FDA.

THE FIRM This group is best known for its extensive work on behalf of insurers. It is a popular choice with health systems and medical device companies, and with individual health providers. It is particularly strong in matters relating to managed care, fraud and abuse, antitrust, FDA, and privacy and information security.

Sources say: "They have a very good understanding of federal regulations, particularly those involving Medicare and Medicaid. It really shows that they pay a lot of attention to new developments in the area."

KEY INDIVIDUALS Sources applaud Arthur Lerner's thriving practice and regulatory skill. Commentators note: "He has encyclopedic knowledge of the area; there is nothing he hasn't seen." He is also highly regarded in managed care and antitrust cases. John Brennan draws on over 30 years of experience in the field, and is "very highly regarded in the fraud and abuse arena." He recently defended Good Samaritan Hospital in a kickback investigation.

THE FIRM This group is acknowledged for its strength in transactional matters, and is regularly involved in some of the state's largest healthcare deals, restructurings and joint ventures. The team also handles healthcare litigation and healthcare IT mandates.

KEY INDIVIDUALS T J Sullivan's "extensive and terrific tax exempt practice" is recognized across the state. He advises tax-exempt organizations on complex regulatory and transactional issues. He advised a major client on structuring a complex joint venture, including tax aspects.

THE FIRM The Washington, DC group of this healthcare powerhouse lives up to its national reputation. Clients praise its broad pool of expertise, and the team's efficiency and responsiveness. It advises both insurers and healthcare providers, including large hospitals, long-term care facilities, and ambulatory care facilities. Major clients include Riverside Health System and The Blackstone Group.   

Sources say: "I think that this team is one of the best – healthcare law is the firm's main focus, and it shows."

KEY INDIVIDUALS Douglas Hastings is "one of the top healthcare attorneys in the country; highly respected by all sides in the industry." He is an expert in accountable care organizations, and payment and delivery system reform. He continues to represent Medical Faculty Associates, the largest academic medical group in the Washington, DC area. David Matyas is best known for his work on complex regulatory matters and fraud and abuse. Sources report: "He is extraordinarily responsive and practical, and provides sound advice with no grey areas. He goes above and beyond what's required of him." Steven Epstein is known as one of the nation's healthcare law pioneers. He handles a broad range of issues for healthcare clients, and is praised for his strategic approach. Carrie Valiant is regarded as being particularly strong in fraud and abuse cases. Market observers note: "She's incredibly thorough and knowledgeable," adding that "she is also excellent in Medicare advantage compliance." Lynn Shapiro Snyder has "broad knowledge of interrelated health programs," and "a highly client-centered approach." Her practice covers Medicare, Medicaid, TRICARE, compliance and managed care issues. Mark Lutes is a "seasoned and commercial practitioner." He handles healthcare acquisitions and diligence, and operations work. "He really knows when and how to scale back, but also when to bring on the big guns," says one observer. Bradley Merrill Thompson is the group's big hitter in FDA regulatory matters. He has recently been involved in matters relating to healthcare IT innovations and how they affect the FDA system.  

THE FIRM The DC office of Fulbright & Jaworski is noted for its strength in both litigious and regulatory healthcare work. It serves a range of clients, and proves particularly popular with the pharmaceutical sector. The group successfully represented Universal Health Services in criminal and civil investigations by the Department of Justice into its financial arrangements with physicians.

Sources say: "The firm has a depth of expertise that is difficult to find."

KEY INDIVIDUALS Frederick Robinson is a "very skilled litigator" with impressive knowledge of government investigations and the False Claims Act. One source enthuses: "Not only does he display excellent technical ability, but he tries to understand the business environment and strategies as well. He is also very practical and I give him great credit for that." Thomas Dowdell is applauded as "an excellent lawyer – thoughtful, precise and practical. He is very strong in technical payment issues." His practice covers areas ranging from Medicare and Medicaid program certification to various compliance matters.

THE FIRM Following the merger, this firm now houses an immensely strong and diverse healthcare group in Washington, DC. In general healthcare matters it offers regulatory, transactional and advice on contentious matters. It also houses a top-drawer FDA regulatory group that handles everything from biotechnology to pharmaceutical and medical device matters.

Sources say: "They have an enormous breadth of experience – all of my questions are answered by experts. The lawyers are also very pragmatic, business savvy, and work in line with our business objectives."

KEY INDIVIDUALS Thomas Bulleit is "certainly one of the leading names in the state," and is particularly strong on Medicare and Medicaid reimbursement. His recent work has included representing Wake Forest University in combining its medical school with North Carolina Baptist Hospital under a combined corporation. Robert Leibenluft is another established name in the marketplace. Commentators applaud his antitrust practice on behalf of health, medical device and pharmaceutical clients. Ann Morgan Vickery is best known for her work on regulatory matters relating to the Medicare and Medicaid programs. One source reports: "She is a tremendous attorney – whenever I have a question, she is the first person I will call." Helen Trilling is praised as a "terrific reimbursement lawyer." She also handles fraud and abuse matters for medical device and pharmaceutical companies, and various healthcare providers. Robert Brady is a key player in FDA matters. Delighted commentators note: "He is remarkable – one of the best lawyers I have ever worked with." He handles both day-to-day counseling and complex mandates for some of the biggest names in the industry. Sources report that David Fox's practice "is rapidly growing in stature." He provides regulatory advice to companies in the process of developing new drugs and biological products, and is particularly noted for his technical strength. Clients value his "pragmatic approach and ability to find solutions." Jonathan Kahan has "an impressive medical device practice." He serves as regulatory counsel for Biomet and Boston Scientific, and also represents many clients in administrative hearings and trials. Meredith Manning is particularly skilled in handling the issues surrounding clinical trials, drug and biologic drug approval standards, and FDA compliance.

THE FIRM This FDA boutique is particularly noted for its medical device and generic drug work. Alongside its core FDA work, it advises on new drug development, controlled substances, advertising and healthcare law.

Sources say: "The best FDA boutique in the state."

KEY INDIVIDUALS Paul Hyman and James Phelps are key points of contact.

THE FIRM This firm is well known for its experience in contentious matters and a variety of federal regulatory areas. The team also has a strong transactional practice. It has been involved in a number of M&A matters in the past year, including the acquisition of Novexel by AstraZeneca.

Sources say: "In addition to having exceptional lawyers, it is one of the most responsive groups I've dealt with."

KEY INDIVIDUALS Toby Singer is "absolutely one of the top antitrust people in the state – just brilliant." She represented Blue Cross Blue Shield of Michigan in an investigation by the antitrust division of the Department of Justice regarding its proposed acquisition of a competing health plan.

THE FIRM This firm's 11-strong healthcare group is particularly noted for its strength in the area of Medicaid reimbursement litigation. It is also a key player in the field of healthcare IT and hospital-physician integration strategies and transactions. On the FDA side, clients benefit from the group's strong medical device regulatory practice. Major clients include Adventist Health System and the University of Michigan.

Sources say: "Their experience is head and shoulders above that of many other firms; they continuously work to improve their offering."

KEY INDIVIDUALS Practice head Dennis Barry impresses observers with his "outstanding regulatory compliance practice," largely focused on regulatory compliance. Clients report: "His knowledge and client service are without comparison."  Seth Lundy has a broad practice, including corporate compliance, Stark Law advice, and Medicare and Medicaid reimbursement. Observers describe him as "a great attorney and an increasingly important player." Edward Basile is lauded for his first-class FDA regulatory work. "He is a fantastic lawyer – there is no question about his knowledge and ability." Donna Kalani Thiel is a new recruit from Baker Donelson. She is known for her "phenomenal regulatory practice," particularly in Medicare and Medicaid matters. Interviewees note: "She has a calming presence, really knows her stuff, and conveys complex ideas and arguments in a way we can understand."

THE FIRM This compact FDA boutique handles a wide range of matters facing medical device and pharmaceutical companies. The team is particularly highly regarded for its work in the regulatory arena and is also active in litigious matters, particularly at the federal level.

KEY INDIVIDUALS Managing partner Thomas Henteleff is highly regarded for his regulatory work regarding human drugs and medical devices companies. He is also a popular choice for contentious matters and enforcement proceedings.

THE FIRM This strongly integrated health and life sciences group is noted for its proficiency in corporate matters, particularly with regard to financings. The team is also lauded for its command of fraud and abuse-related matters. Its clients range from clinical laboratories and dialysis facilities to drug and device manufacturers. On the FDA side, the group is increasingly engaged in more complex and sophisticated matters.

Sources say: "They have achieved excellent results in every instance we have used them."

KEY INDIVIDUALS Roger Goldman is a praised as a "strong and respected litigator." His recent work highlights include successfully representing Tenet Healthcare in qui tam litigation at the 5th Circuit Court of Appeals. Stuart Kurlander provides a wide range of services, including regulatory, reimbursement, fraud and abuse, corporate and litigation counsel to a diverse group of healthcare industry clients. He represented a major hospital network in litigation with a Medicare reimbursement consultant valued at tens of millions of dollars. John Manthei is the firm's key player on the FDA side. One source reports: "He has a talent for understanding the nuances of engaging the FDA or policy makers in a constructive way rather than confrontational." He recently provided FDA regulatory and strategic counsel to a leading global medical device company.

THE FIRM The depth and diversity of knowledge in this leading healthcare group makes it a popular choice for leading organizations not just in Washington, DC, but also at the national level. In addition to the team's broad knowledge base, clients benefit from the fact that a number of its attorneys have prior federal government experience in their areas of expertise. It has recently been involved in transactional work relating to physician-hospital alignment, as well as a range of matters for Medicare clients. 

Sources say: "They are excellent in every area we use them – their ability and expertise are unparalleled."

KEY INDIVIDUALS Practice head Joel Michaels is applauded for his "exceptional level of client focus." He wins praise for advising insurers on how to comply with new regulations and requirements facing the industry. Satisfied clients enthuse: "I think that he is one of the leading healthcare lawyers in the country. He has tremendous subject matter expertise and keeps current with the latest developments." Guy Collier is a "first-rate lawyer with an impressive list of clients." He recently served as lead counsel for a mid-Atlantic US academic medical center in its acquisition of a pediatric specialty hospital. Commentators report: "He is very personable and knowledgeable." Eric Zimmerman is best known for his Medicare reimbursement expertise. He advises clients on navigating legislative and regulatory processes in the area between healthcare, life sciences and government strategies. Reed Stephens is "an impressive litigator" who also handles drug pricing issues and various regulatory matters for clients in the healthcare and life sciences industries.

THE FIRM This firm is best known for its work on behalf of healthcare providers, including hospitals and clinical laboratories. The team represents healthcare insurers, in addition to investors in the sector. The group handles a broad range of work, from regulatory compliance to government investigations and litigation.

Sources say: "They bring a high level of competence and expertise; I regularly recommend them."

KEY INDIVIDUALS Hope Foster draws on over 30 years of experience in the field, and is praised as a first-rate litigator. Clients report: "We have total faith and trust in her work; she is both business savvy and very familiar with the rules and regulations. She makes us feel completely comfortable."

THE FIRM This firm successfully integrated a 12-strong group from SNR Denton, resulting in a significantly strengthened general healthcare practice. The team is particularly noted for its fraud and abuse expertise, and for its well-established FDA practice. The group acted for Covenant Medical Center in a federal False Claims Act investigation, achieving a favorable $4.5 million settlement.

Sources say: "This group is a force to be reckoned with."

KEY INDIVIDUALS Howard Young "has a very good reputation and a great practice." His forte is compliance and fraud and abuse work. Sources note that he is increasingly involved in individual liability-related matters. Kathleen Sanzo is "a terrific, solid FDA attorney." She is active in matters involving drug safety and biosimilars, and has also assisted multiple companies considering the use of new social media for pharmaceutical promotion. 

THE FIRM Ober Kaler Grimes & Shriver is noted for its healthcare work on the East Coast and is a solid presence there. The Washington, DC office is well established and respected for its strength in antitrust work, fraud and abuse, and Stark Law-related matters. The team was recently involved in a number of merger investigations by the Trade Commission.  

Sources say: "A very strong firm of talented lawyers."

KEY INDIVIDUALS John Miles is universally acknowledged as a top-drawer antitrust lawyer. Sources say: "He is exceptionally knowledgeable; he has worked in the sector for a long time and seen all the issues." Peers describe Patrick O'Hare as "a terrific attorney." He is well known for assisting healthcare providers with a range of transactional work including M&A, affiliations and joint ventures.

THE FIRM This firm has a 25-strong group dedicated to healthcare law. It is well recognized for its Medicare reimbursement practice, but also houses strength in fraud and abuse, and transactional work. The team wins praise for its recent M&A work, particularly in relation to large company acquisitions and work relating to physician-hospital integration.  

Sources say: "The firm has an excellent reputation and everyone we deal with is an expert in their field."

KEY INDIVIDUALS Mark Fitzgerald is lauded for his fraud and abuse, and anti-kickback work. Clients say: "He is an excellent communicator, trustworthy, smart, and does a great job." He is a popular choice in mandates relating to academic health systems, including compliance and work relating to investigation. Joel Hamme is a recognized force in the long-term care arena. He is best known for his practice in Medicare and Medicaid reimbursement, provider licensure and certification, and litigation. Mary Susan Philp is a "very solid lawyer," praised for her extensive knowledge in the area of Medicare. One client enthuses: "She is extremely thorough and has done a great job for our company." Robert Saner is noted for his expertise in handling issues involving physician organizations and related issues. He is well regarded for fraud and abuse cases, Medicare reimbursement, and corporate compliance.

THE FIRM This group has impressive depth and breadth of experience, having represented both healthcare providers and suppliers over the past 40 years. Its work spans a number of areas including transactional, antitrust and regulatory matters. The team assisted Omnicare in the acquisition of Walgreens' long-term care pharmacy business in exchange for Omnicare's home infusion business.

Sources say: "Reed Smith has a great reputation and a very talented team in DC."

KEY INDIVIDUALS Elizabeth Carder-Thompson is regarded as "a leader in the field." She is particularly noted for her skill in prescription drugs law. She is an expert in the regulatory and fraud and abuse fields, and regularly represents clients ranging from hospitals and individual physicians to drug manufacturers and nursing homes. Clients single out Thomas Fox as "an adept long-term care lawyer and a go-to attorney for regulatory advice." His experience also includes litigation and various government investigations, in which he represents both public and private healthcare providers. Carol Loepere is another key player in the team. She recently represented a leading global pharmaceutical manufacturer in a range of regulatory matters.

THE FIRM Ropes & Gray houses a strong group of attorneys known for their deep legislative knowledge and understanding of policy issues. On the FDA side, the team is lauded for its strength in government investigations and False Claims Act matters. The general healthcare group is commended for its representation of hospitals and academic medical centers. Clients benefit from its sophisticated Medicaid expertise and strength in various areas of reimbursement. Clients include Johnson & Johnson and Morgan Stanley.

Sources say: "They are extremely responsive and very helpful; top-notch customer service."

KEY INDIVIDUALS Alan Bennett's "impressive reputation and seniority" make him a popular choice for high-end mandates and particularly sensitive matters. He has nearly 40 years of experience advising on issues surrounding the regulation of pharmaceutical advertising, promotion and compliance. Gregory Levine is particularly experienced in counseling companies facing potential FDA enforcement actions, including those involving product safety standards, advertising and promotion. Larry Gage is a "very well-known and respected attorney in public healthcare matters." His expertise covers hospital governance, healthcare for the uninsured, Medicaid policy, medical school affiliation agreements, managed care and international health.

THE FIRM This sizable team handles statewide and national mandates for clients at all levels of the healthcare and life sciences industries. The group is particularly noted for its strength in the public policy and government affairs arenas. Clients also benefit from the fact that many of its attorneys are experienced in both FDA and healthcare law.

Sources say: "They are extremely knowledgeable and they can always execute any plan we put together."

KEY INDIVIDUALS Practice head Paul Kalb is best known for his work in healthcare-related criminal, civil and administrative enforcement actions and related litigation. Sources praise his "fantastic practice." Sources describe William Sarraille as "an intellectual heavyweight. He is hugely professional on every issue." His practice includes complex enforcement cases and antikickback matters. The head of the FDA regulatory group, Coleen Klasmeier has "tremendous knowledge of FDA rules, regulations and contacts." Satisfied clients report: "She gives pragmatic advice, and is always attentive to our business needs." Raymond Bonner has an acclaimed FDA enforcement practice, and is often involved in FDA-related litigation. A recent highlight saw him represent a large multinational pharmaceutical company in a major qui tam whistleblower lawsuit involving 20 states.

THE FIRM Sources report that SNR Denton benefits from an enlarged global healthcare practice. The Washington, DC group is particularly applauded for its lobbying efforts on behalf of clients on Capitol Hill, for its strong litigation capacity, and for its expertise in the area of fraud and abuse. It also assists healthcare sector clients with nonhealthcare-related matters, including tax, employment and corporate governance.

Sources say: "Amazing responsiveness, professionalism and integrity. They are unflappable."

KEY INDIVIDUALS Holley Thames Lutz was recently appointed chair of the group, and is widely respected in the healthcare sphere. She is well regarded for her work in Medicare regulatory compliance, coverage and reimbursement issues, in addition to Medicaid matters. She is also increasingly noted in the fraud and abuse arena. McCarty Thornton is recognized as "a real force in the marketplace." Commentators note that he is increasingly active in government enforcement matters. Gadi Weinreich is a "very bright attorney who always sees the big picture." He is best known for his work in fraud and enforcement matters, and successfully represented University of Arizona Health Care in a highly complex whistleblower matter. Bruce Merlin Fried is commended for his "deep knowledge of the regulatory market in Washington, DC." He represents a wide range of health industry clients with regard to Medicare, Medicaid, the Healthcare Insurance Portability and Accountability Act and other federal healthcare programs and policies.