Healthcare: District of Columbia

THE FIRM This firm's Washington, DC office houses a growing team of preeminent healthcare attorneys who are widely acclaimed for their commitment to all aspects of the industry. The group is a strong choice for hospital reimbursement litigation and fraud and abuse matters. It also offers strong counsel on health policy and legislation, bolstered by a significant bench of former government officials. Recent highlights include defending Golden Living in an antikickback False Claims Act matter worth over $20 million which has thus far resulted in two important victories for the client. The team's renowned regulatory capacity includes work on FDA matters for clients such as Amphastar Pharmaceuticals and Pfizer.

Sources say: "They understand us and are exceptionally flexible, smart and strategic."

KEY INDIVIDUALS Peers attest that "few people know as much about Medicare Part A reimbursement as" Christopher Keough. His practice has continued to garner praise since his recent move to the firm from King & Spalding. He represents over 700 hospitals across the USA in litigation concerning Medicare reimbursement. One client enthuses: "He is the best attorney we have ever worked with, with a keen sense of strategy and of how to get to the end point."

Robert Salcido is "thoughtful, efficient and extremely easy to work with on both litigation and general advice," sources reveal. He is recognized as a leading force in False Claims Act matters, and recently successfully defended a management company against a qui tam case worth over $7.5 million.

Jorge Lopez brings significant experience in compliance and public policy matters to his role as head of the practice group. Clients describe him as someone who "thinks outside of the box and provides prompt, on-point and realistic advice," and praise him as "outstanding, with a real subject matter expertise."

Peers hold John Jacob in high regard for his Medicare reimbursement practice, while clients praise his "common sense and well thought-out approach." He recently represented 17 hospitals in their appeal to the Provider Reimbursement Review Board in a case regarding Medicare-Medicaid dual-eligibles.

Stephanie Webster brings experience at the Department of Health & Human Services to her reimbursement counseling and litigation practice. She recently joined the firm from King & Spalding together with Keough. Clients note that "she is very easy to work with and has a good ability to keep things simple."

THE FIRM This 12-strong team of dedicated healthcare attorneys is acclaimed for its experience in government investigations and regulatory compliance. Its FDA practice places a strong emphasis on the pharmaceutical industry, as is showcased by work done for clients such as Teva. Its recent representation of Broward Health draws on its Stark Law expertise and it also advises Sunrise Senior Living on transactional matters, including acquisitions.

Sources say: "They are very familiar with the healthcare industry and have great resources."

KEY INDIVIDUALS Lisa Estrada leads the firm's nationwide healthcare practice group, and is also the key contact in the Washington, DC office.

THE FIRM The integrated FDA and healthcare team at Arnold & Porter garners praise for its strength in regulatory matters. It remains a force in the medical device and pharmaceutical industries, and is extending its provider expertise with work for hospital systems, among others. The team is highly regarded for its strength in government investigations related to the False Claims Act and regulatory due diligence work. It is able to offer both litigation representation and counseling support to a range of major clients.

Sources say: "They hire extremely smart and approachable attorneys and excel in being of value to clients." "They proactively come back to us with new, creative solutions all the time."

KEY INDIVIDUALS Peers respect Alan Reider for his strength in regulatory and transactional matters. Sources applaud him as a "number-one attorney in the provider sector," and his expertise extends to cover False Claims Act investigations, acquisitions and joint ventures.

Clients praise practice group head Daniel Kracov as being "very insightful into the inner workings of the FDA." His practice incorporates a strong focus on responding to government investigations and undertaking compliance audits. Sources praise his ability to "offer pragmatic advice and look at the whole picture."

Allison Shuren is lauded by clients as "having really good instincts on the business side of things," and is characterized as being "thorough, confident, knowledgeable and personable." She is noted for her expertise in fraud and abuse matters, and works with clients from the provider side and pharmaceutical companies.

Kirk Ogrosky debuts in the table and brings significant DOJ experience to his highly regarded fraud and abuse practice. Impressed clients reveal: "He really helps companies, whether pharmaceutical, medical device or hospitals, relate to regulatory and criminal issues."

Jeffrey Handwerker is praised as being "exceptionally knowledgeable in his area both on the law and industry practice - he is solution-oriented." He joins this year's rankings on the back of strong praise for his pricing and fraud and abuse practice. He works with clients from the medical device and pharmaceutical industries, among others.

THE FIRM This highly regarded team maintains its position as a leading choice for FDA matters, and continues to be active across the board in regulated industries. Market sources commend its sophisticated pharmaceutical and medical device expertise, and its broad clientele includes Microsoft and Procter & Gamble. Its recent work includes acting as lead counsel for Genentech in a unique FDA hearing regarding accelerated approval of cancer treatment drug Avastin.

Sources say: "They have a very good, consistently high level of performance, they know the whole process very well and they are great for client service."

KEY INDIVIDUALS Richard Kingham is praised for his international pharmaceutical and biotechnology practice, and brings extensive experience to his FDA work. Peers applaud him as a leading choice in the field, and he has worked with clients such as Merck.

Peter Safir is "a very strategic lawyer who understands the way the regulator works - he is thoughtful, responsive and very effective." He is held in very high esteem by peers for his regulatory work within the pharmaceutical industry, and is praised as "an extraordinarily talented Hatch-Waxman lawyer." He recently secured five years' exclusivity for Shire's product Vyvanse.

Ellen Flannery is highly respected by sources for her medical device practice. She advises clients such as Procter & Gamble on regulatory matters and her FDA expertise also extends to the software arena. She recently counseled a medical device company on regulatory matters related to product pre-marketing and post-marketing strategies and compliance. 

Sources consider Michael Labson to be "a very capable food and drug lawyer," and praise his "very broad industry perspective." His work with clients such as Genentech draws on his regulatory and litigation experience. He recently worked on an FDA Citizen Petition for a specialty pharmaceutical company.

Former FDA chief counsel Gerald Masoudi joined the firm in 2009 and debuts in the table this year having earned praise for his strength in pharmaceutical and medical device matters. His recent work includes serving as lead counsel for McNeil in the negotiation of a consent decree. Sources applaud him as "an excellent lawyer, very knowledgeable about food and drug law and also very practical."

Peter Barton Hutt wins accolades for his long-standing presence in the arena, and is lauded as a preeminent expert in food and drug law. His practice has a particular focus on government policy matters, medical devices and human pharmaceuticals.

Scott Cunningham continues to be noted for his strong pharmaceutical practice and FDA expertise. He works with clients from a range of industry sectors, with his focus extending to compliance work with medical device companies, enforcement and Hatch-Waxman matters.

THE FIRM This respected team maintains a strong position in the market and is commended for its litigation, regulatory and transactional practice. It counsels clients from various industry sectors in government investigations and criminal trials, and recently represented Fletcher Allen Health Care in antitrust matters related to an acquisition. The group's practice also encompasses advising clients such as Coventry Health on the impact of healthcare reform.

Sources say: "They run the gamut of antitrust, regulatory, compliance and litigation matters - they are very prompt, give good practical advice and work with you to find a solution."

KEY INDIVIDUALS Peers view John Brennan as a leading choice in fraud and abuse matters. He represents clients such as hospital systems in False Claims Act investigations, and brought his regulatory expertise to bear when assisting on the sale of the Center for Pain Management to Provident Bank.

Arthur Lerner's antitrust expertise draws praise from peers, and clients such as Humana benefit from his extensive managed care background. He is "top-notch - he is flexible and tries to find a solution for you. I call him with a problem and he will look into it; he is my one-stop shop," enthuses one client.  

THE FIRM This prominent firm houses an expanding team of respected health and life science attorneys, incorporating both a significant global footprint and extensive former government experience into its broad practice. It is a recognized force in regulatory matters such as fraud and abuse counseling and product pricing issues. Sources additionally note the team's strong litigation practice, and its ability to work with clients from a range of industries on policy reform. Recent work includes representing Geisinger Health System in disclosing issues related to device billing that resulted in keeping over $3 million in reimbursement.

Sources say: "They bring intimate knowledge of federal state laws and are very pragmatic in their approach - they are very flexible and accommodating in their approach to client service."

KEY INDIVIDUALS Bruce Fried is praised as "an expert in dealing with the federal government in Medicare matters," and brings his significant industry and government experience to his respected healthcare policy practice. His recent work includes advising physician groups and hospitals on Accountable Care Organizations, and clients enthuse that "he will take your call anytime, anywhere and give very practical advice."

Practice group chair Holley Thames Lutz continues to be held in high regard by peers and clients alike, and is considered "an exceptionally good analyst with exceptionally broad knowledge of complex rules and regulations." Her practice has a strong focus on both regulatory matters related to Medicare and Medicaid and on clinical research. 

McCarty Thornton is commended for his strength in fraud and abuse matters, and brings his prior experience as chief counsel to the Inspector General of the Department of Health to his enforcement practice. Sources praise his expertise in counseling clients on issues related to government regulations.

The "outstanding" Gadi Weinreich "is a deep strategic thinker who is results-focused and client-centered." He is widely acclaimed for his strong fraud and abuse capabilities, and for his regulatory compliance expertise. He works with clients such as Abbott Laboratories and K-V Pharmaceutical, and is characterized by sources as "a real strategist in terms of putting pieces together to make the whole situation work out favorably."

Thomas Hyatt is a new addition to the table this year, and is praised as "an expert on the tax law of healthcare organizations and board governance." His strength lies in counseling nonprofit groups on a range of matters, and he recently secured tax-exempt status for private entity Partnership for a Healthier America.

THE FIRM This well-established team maintains its position in the market, and is respected for the breadth of its practice. It particularly displays merit in complex transactions that draw on its creativity, and can also provide advice on regulatory compliance matters.

Sources say: "They are very solid and committed to healthcare." 

KEY INDIVIDUALS T J Sullivan is widely acclaimed by peers as outstanding in matters related to tax-exempt entities such as hospitals and clinics. His practice encompasses transactions such as joint ventures and acquisitions, and he brings significant regulatory expertise to his work.

Jesse Witten is a new addition to the table this year. He is highly praised for his fraud and abuse work and focuses on representing clients in government investigations and providing advice on matters such as Medicaid and Medicare reimbursement.

THE FIRM This expanding team continues to impress observers with its very strong foothold in the market. Its preeminent practice spans all areas of the industry, and has a strong focus on civil and criminal litigation. Its expertise also encompasses transactional and regulatory compliance counsel, and it works with a range of clients such as Northwestern Medical Faculty Foundation and Radius Ventures. The group recently provided counsel to GTCR on transactions such as the $675 million acquisition of Sterigenics International.

Sources say: "They are experts in the healthcare regulatory world without peer. They are very plugged into what is going on, they have seen everything and are balanced in their assessment of issues."

KEY INDIVIDUALS Lynn Shapiro Snyder is praised for her ability to be "strategic in thinking and responsive," and is highly respected by peers for her extensive practice. She focuses on Medicare reimbursement matters, but also offers strength in the fraud and abuse arena. Her regulatory expertise was recently brought to bear when counseling a private equity client on a $233 million acquisition of a healthcare provider.

Firm chair Douglas Hastings is considered a leading force in the market who "is really paying attention to what is going on around the country, so he is a national expert in accountable care." He continues to win accolades for his expertise in reform of the payment system in addition to maintaining a strong transactional practice. He works with a range of clients, including Palmetto Health and George Washington University Medical Faculty Associates.

Mark Lutes is noted as being "particularly good at building the right team to answer the question" and is valued for his ability to "interpret what the client actually needs." He brings significant regulatory expertise to his work counseling clients in transactions such as acquisitions, and is also noted for his strength in antitrust matters. Recent highlights include working with Apax Partners on the $6.3 billion acquisition of Kinetic Concepts, and on its $1.2 billion sale of Qualitest Pharmaceuticals.

Steven Epstein is one of the founding partners of the firm, and is venerated for his ongoing contribution to the development of concepts such as managed care. He leads relationships with clients such as Warburg Pincus and General Atlantic.

Peers attest to David Matyas's expertise in fraud and abuse, and his knowledge of how regulatory issues impact transactions. His recent work includes counseling the University of Oklahoma School of Medicine on the growth of a cancer institute.

Carrie Valiant is held in high regard for her regulatory compliance expertise and fraud and abuse practice. She works with clients from across the industry in False Claims Act investigations and advises on the compliance-related impact of healthcare reform.

The team also houses Bradley Merrill Thompson, whose FDA expertise extends to cutting-edge mobile health and medical device work. He recently advised client Beckman Coulter on the recall of three products, and aided it in responding to unexpected FDA inspections.

THE FIRM The seven-strong group based in this firm's Washington, DC office is praised for its considerable breadth in the arena. Clients such as Spectra Medical Devices are able to draw on its FDA expertise, and it represented CVS/Caremark in a case related to the employment of a pharmacist who had been excluded. The team has also in the last year been involved in a $500 million False Claims Act action, and its work with Audax Health Solutions saw the setting up of a new healthcare social networking entity.

Sources say: "Their advice is practical and not just theoretical - they come to us with a very good fundamental understanding of business."

KEY INDIVIDUALS One of the group's key contacts in Washington, DC is Donald Romano.

THE FIRM This prominent group continues to be well regarded in the market, and is particularly noted for its strength in fraud and abuse litigation. Its expertise also extends to transactional and regulatory matters, and it works with clients from across the industry. The team recently represented Universal Health Services and Boston Scientific in False Claims Act actions related to Medicaid payment and medical device off-label promotion.

KEY INDIVIDUALS Practice head Frederick Robinson is recognized as a leading choice in the fraud and abuse litigation arena, and is seen as having "a very comprehensive and strong regulatory practice." He represented Walgreens in a False Claims Act qui tam action regarding Medicare reimbursement, achieving a successful outcome on behalf of the client.  

Sources consider Thomas Dowdell outstanding for his sophisticated regulatory practice, and he is praised as having "great interpersonal skills." Recent work on behalf of client BJC Healthcare draws on his Medicare and Medicaid reimbursement expertise.

THE FIRM This broad-based group is acclaimed as being a leading force in both the traditional healthcare and FDA regulatory arenas. Its client base highlights the scope of its practice, with medical device companies, pharmaceutical and biotechnology companies, payors and providers on its roster. The group's extensive practice covers False Claims Act litigation and counseling, transactions, and approval matters related to the lifecycle of a product or device. It recently advised Laboratory Corporation of America on the $925 million acquisition of Genzyme Genetics, and also worked with Graceway Pharmaceuticals on FDA matters.

Sources say: "I had a very good experience working with them - they are very confident, pragmatic and very accessible. Their strengths are the quality and immediacy of their responses."

KEY INDIVIDUALS Thomas Bulleit garners praise from commentators as being a first choice in the arena. His widely acclaimed practice has a strong focus on fraud and abuse matters, and his regulatory work with client Stryker has drawn on his reimbursement expertise.

Robert Leibenluft is characterized by sources as "a very fine attorney whose judgment I respect," and he is commended for his antitrust expertise. Recent highlights include representing the State University of New York in acquisitions of Long Island College Hospital and Community General Hospital, two deals with a total value of $450 million.

Ann Morgan Vickery is lauded as a leading name in regulatory matters, noted particularly for her Medicare work relating to drug manufacturers. Her practice incorporates expertise in the impact of healthcare reform on clients from across the industry.

Clients enthuse that David Fox "brings this common-sense solution-driven approach which has been great for us." His product approval practice draws on his experience of working for the FDA and focuses on drugs, combination and biological products. His technical abilities are highly praised, and sources add that "we would never turn to any other person or firm on regulatory matters."

Jonathan Kahan draws on 35 years of experience in FDA law, and is particularly noted for his work with medical device companies. He counsels clients such as Siemens Healthcare on regulatory matters related to clearance and approval of devices. His expertise extends to issues such as the proposed changes to the 510(k) process.

Helen Trilling is applauded as being "just outstanding - she is extremely knowledgeable about healthcare compliance and is an outstanding problem solver." Her practice incorporates compliance and fraud and abuse matters, and she has been increasingly active in health information technology innovations, acting for clients such as GE Healthcare.

Clients applaud Meredith Manning as "fantastic - she is always accessible." She is recognized for her strength in FDA approval and review of drugs and biologics, and her practice also covers enforcement litigation and product promotion.

Robert Brady is praised for his ability to "understand regulatory problems from how the government sees things, and give excellent advice." His long-standing expertise in FDA matters sees him work with a range of clients on product development, approval and promotion.

THE FIRM This dedicated FDA firm wins accolades for its proficiency in all aspects of food and drug law, and is seen as a market expert in this field. Its practice extends to cover fraud and abuse counseling and litigation, and its strength in medical devices and drug development is particularly highlighted.

Sources say: "They are extremely talented and have the right balance. They are cost-effective, deeply involved in the community and know the FDA."

KEY INDIVIDUALS Peers attest to Jeffrey Gibbs's visibility and expertise within the FDA sector, and he comes highly recommended for his strength in the medical device arena.  

THE FIRM This widely acclaimed group maintains its position as a leading force in the market, and offers expertise across the board. Its strength in Medicare and Medicaid matters is highlighted along with its transactional expertise and experience in government investigations. The team's work for client Hoffmann-La Roche involved fraud allegations relating to drug pricing. The group is also praised for its FDA regulatory expertise and boasts an impressive client list including the likes of Montefiore Medical Center and Johnson & Johnson.

Sources say: "The quality of their legal advice is excellent. They think about regulatory issues at a high level and consistently provide advice and solutions which we wouldn't come up with on our own."

KEY INDIVIDUALS FDA and life sciences group chair Edward Basile is praised by sources as being "incredibly knowledgeable. His understanding of the FDA and his relationships with them are key." His recent work includes successfully obtaining a consent decree for a client that resolved government enforcement actions taken against it.

Dennis Barry is considered "one of the gurus in the country as far as Medicare goes," and is also "very easy to work with and extremely knowledgeable." He is characterized by sources as having "unique expertise in reimbursement matters" and is regarded as a first choice in this field. His recent work for a client involved appealing the government's denial of $16 million of Medicare funding for a graduate course.

Clients enthuse that Seth Lundy "knows how to approach things from a business perspective and tries to bring value to the business with his advice." His approach to client service is highly praised, and sources consider him a leader in the manufacturing field. His practice includes a strong focus on regulatory issues related to durable medical equipment suppliers, along with False Claims Act matters.

Sources commend Donna Kalani Thiel for her extensive regulatory practice, and note her particular expertise in advising providers on Medicare and Medicaid payment matters. She is lauded for her ability to "bring a real professional and personal interest in the outcome of her cases," and for her "great capacity to understand really technical areas."

THE FIRM This dedicated FDA firm is commended for its expertise in compliance issues that affect the pharmaceutical and medical device sectors. Its experience in enforcement matters includes recalls, inspections and litigation, and the team is also highly adept at handling product promotion.

KEY INDIVIDUALS Daniel Dwyer is a key contact.

THE FIRM Latham & Watkins's Washington, DC office houses over 40 dedicated healthcare and life sciences lawyers, and continues to garner praise for its strong regulatory capabilities. The group's transactional strength is highlighted in its recent work advising Leonard Green & Partners on the $363 million acquisition of Prospect Medical Holdings. A range of clients including device manufacturers and HCA Healthcare benefit from its litigation experience. It also continues to represent Allergan in compliance matters associated with physician interaction and FDA product promotion. 

Sources say: "They are excellent - they bring a lot of knowledge to the table, and do a great job in researching and finding the right people to help us."

KEY INDIVIDUALS Roger Goldman is "a fine litigator who can work well with the government," observers reveal. He is highly regarded for his strength in False Claims Act matters, and recently represented a number of hospitals in a DOJ investigation. One source notes: "He is one of the people I would want to represent me."

Stuart Kurlander is widely acclaimed for the breadth of his regulatory expertise. His practice encompasses matters related to fraud and abuse, transactions and reimbursement. Impressed clients say: "He is thorough, incredibly knowledgeable and willing to present a lot of different options and go through them with us. He always looks at things in terms of what is best for us."  

"Terrific" John Manthei "combines strong substantive knowledge with an excellent sense of how the regulatory authority thinks." He is noted for his FDA regulatory expertise, and recently worked with Beckman Coulter to address a significant enforcement action brought against it.

Daniel Meron is a new addition to the rankings this year, bringing experience as former general counsel at the Department of Health & Human Services to his practice. Sources comment that "his experience representing a broad array of healthcare companies means that he can provide quality, reliable advice in time-sensitive situations." He is particularly commended for his litigation and regulatory expertise.

THE FIRM This national healthcare titan continues to be seen as a first choice in Washington, DC, where the team is applauded for the wide range of expertise it offers across the industry. Sources are particularly quick to commend its strength in hospital work. The group's recent work with Blue Cross and Blue Shield of North Carolina saw it advise on issues associated with the development of patient-centered medical homes. It also recently provided regulatory counsel to Endo Pharmaceuticals in connection with its $900 million private offering of senior notes. Other major clients of the group include Covance and Vanguard Health Systems.

Sources say: "Their healthcare practice is superb - it is very broad and deep and they always have the expertise that we need."

KEY INDIVIDUALS Practice head Joel Michaels maintains his reputation as a leader in the insurance sector. Sources applaud him as "one of the best healthcare lawyers in the country - very responsive and knowledgeable." A recent highlight involved representing a subsidiary of Munich Re in a stock purchase of Windsor Health Group worth $135 million.

Sources characterize Guy Collier as "a seasoned healthcare lawyer who has a lot of knowledge and very good analysis." His practice focuses on working with clients such as health systems and pharmaceutical companies on compliance and transactional matters. His recent work for various academic medical centers drew on his expertise in structuring both funds flow agreements and affiliations.

Eric Zimmerman garners praise for his "very good government relations practice," and is also noted for his experience in Medicare reimbursement matters. His recent work with Congress has seen the development of several favorable legislative provisions on behalf of a range of clients. Commentators note that "it is a pleasure dealing with him as he is knowledgeable, thorough and responsive."

Reed Stephens brings deep experience of working with the DOJ Civil Division to his strong drug pricing practice. He is noted for his government investigation capabilities that draw on both regulatory and litigation expertise. A recent highlight saw him lead a large team representing a significant health system in a large-scale qui tam investigation in Florida.

THE FIRM This 11-strong team is recognized for the breadth of its practice, with clients from across the industry benefiting from its expertise. The group is particularly strong in regulatory compliance matters and litigation, while maintaining its transactional capabilities. Its recent highlights include a range of work for Catalyst Health Solutions which draws on its understanding of pharmacy benefit management and Medicare matters. This work included providing regulatory counsel to Catalyst in the $525 million acquisition of Walgreens Health Initiatives and the $225 million acquisition of FutureScripts.

Sources say: "They have been wonderful - they have very strong expertise and are practical from a business perspective."

KEY INDIVIDUALS Hope Foster upholds her leading position in the fraud and abuse arena. Her practice has a strong focus on government and internal investigations, and she supports a range of clients such as hospitals and clinical laboratories in False Claims Act and self-disclosure matters. Clients enthuse that "she is excellent: a client's advocate, zealous in her passion to serve the people she works with, very hard-working and knows the guidelines inside and out."

THE FIRM This group maintains its solid position in the healthcare and FDA arena. The team's strong regulatory practice enhances its work providing counsel in transactions and supporting clients with government investigations and compliance audits. It recently successfully represented Johnson & Johnson and Cordis in a False Claims Act action declined by the DOJ, and also counseled Pfizer on the negotiation of its Corporate Integrity Agreement.

Sources say: "They have broad experience, with a mixture of FDA regulatory, antitrust and compliance knowledge. They have a good range and breadth of practice."

KEY INDIVIDUALS Kathleen Sanzo heads the practice group, and is highly praised for her ability to "just know the FDA regulatory space inside out." Her increasingly active regulatory and enforcement practice has seen her support medical device and pharmaceutical companies with compliance audits and multisite inspections.

Howard Young is lauded as being "very strong in healthcare enforcement issues." He brings his experience of serving with the Office of Counsel to the Inspector General to his extensive fraud and abuse practice, working with clients such as hospices, hospitals and pharmaceutical companies.

Since publication, Gary Yingling  has joined the firm from K&L Gates. He is a recognized force in the market, bringing extensive experience to his respected FDA regulatory practice. He has a particular focus on pharmaceuticals, with noted expertise in obtaining exclusivity for clients and addressing issues surrounding product recalls.

THE FIRM This prominent group draws on over 30 years of experience in the field and is particularly noted for its antitrust expertise. Sources also hold it in high regard for work with provider clients, drawing on its strong regulatory and transactional capabilities. A recent highlight involved the representation of St. Peter's Hospital, Northeast Health System and Seton Health System in a complex merger investigated by the FTC.

Sources say: "It is one of the most prestigious firms and has a big footprint in healthcare."

KEY INDIVIDUALS John Miles draws praise as "incredibly knowledgeable on antitrust issues," and peers consider him a leading choice in the field. He represented Catholic Health Initiatives, the University of Louisville Medical Center and Jewish Hospital/St. Mary's Healthcare in a recent merger. The FTC decided not to investigate this transaction. 

Patrick O'Hare is recognized for his strong transactional practice, and helps a range of clients including hospitals and nonprofit corporations in work such as acquisitions and joint ventures.

THE FIRM This well-established group brings over 28 years' experience to its provider-focused practice, and maintains its widely acclaimed position in the market. It displays particular strength in regulatory matters at both federal and state level, with noted expertise in Medicare and Medicaid reimbursement. It provides compliance counsel to clients such as academic medical centers, and continues its representation of a range of clients in transactional matters such as acquisitions.

Sources say: "They have strong subject matter expertise, good connections and they know how to find the right information."

KEY INDIVIDUALS Mark Fitzgerald remains a leading choice and is characterized by clients as being "extraordinarily knowledgeable," as well as "clear and able to organize information in a way that makes the complex appear to be simple." His practice maintains a focus on fraud and abuse Medicare matters, and he is noted for his expertise in Stark Law.

Joel Hamme is highly regarded by sources for his strength in reimbursement matters, and is particularly commended for his expertise in long-term care. His practice also encompasses insurance reimbursement and his client base spans the provider sector of the industry.

Mary Susan Philp brings extensive experience to her respected regulatory practice and is considered to be excellent in the arena by clients. Her particular forte lies in Medicaid and Medicare reimbursement matters and she is equally recognized for her strong fraud and abuse expertise.

Robert Saner continues to be commended for his acclaimed physician practice, and works with clients such as academic practices and medical groups. His focus extends to include Medicare payments and fraud and abuse matters, and he brings experience of serving in the Department of Health to his work.

THE FIRM This team wins acclaim for the range of its expertise, and is especially noted for its strong regulatory practice. It serves a broad cross-section of clients that span the industry, including Abbott Laboratories and American Health Care Association. Its recent work for Nycomed drew on its significant litigious capabilities, successfully defeating a motion to withdraw FDA approval of a skin cancer treatment. The group also maintains its prominence in both transactions and government investigations, acting as regulatory counsel in several significant matters this past year. 

Sources say: "They are outstanding - extremely knowledgeable, responsive and practical."

KEY INDIVIDUALS Elizabeth Carder-Thompson is praised as a first choice in regulatory matters, and sources enthuse that "she has been providing good advice for clients for many years." She is held in particularly high regard for her expertise in the fraud and abuse arena, and is a former president of the American Health Lawyers Association. Her client base spans the industry, but she is especially noted for her compliance work on behalf of pharmaceutical and medical device companies.

Sources enthuse that Thomas Fox's "experience and expertise are invaluable." He is particularly commended for his fraud and abuse practice as well as for his transactional strength, and recently provided regulatory counsel to MedCath on the $200 million plus sale of its subsidiary and two hospitals.

Carol Loepere "really tries to get the client what they want" and is praised as being excellent in the long-term care arena. She recently led the representation of HCR ManorCare in its $6.1 billion sale of 334 facilities to investment trust HCP, work that drew on her extensive regulatory expertise.

THE FIRM This highly regarded firm is considered a significant force due to its broad regulatory expertise which includes advising clients on litigation, transactional and policy matters. Its deep FDA capabilities informed significant First Amendment litigation regarding off-label promotions, and its healthcare group has worked extensively on matters involving the impact of the Affordable Care Act. Major highlights include providing Pfizer with regulatory advice pertaining to issues such as advertising and promotion, and it also recently represented Grady Health System in amending affiliation agreements with the schools of medicine at Emory and Morehouse Universities.

Sources say: "They have been exceptional - they have provided a broad base of knowledge and expertise."

KEY INDIVIDUALS Gregory Levine garners praise for his ability to "listen well and try to understand what the practical need is in a given situation." Sources consider him "a go to-person on medical device issues" and his FDA regulatory expertise extends to include pharmaceuticals. He works with clients such as Stryker and Human Genome Sciences.

Alan Bennett brings "a tremendous amount of knowledge on FDA regulation of promotional and marketing practices" to his long-standing practice. He was part of a team that submitted an amicus brief on behalf of most members of the Medical Information Working Group. He is also particularly noted for his experience in Hatch-Waxman matters. 

THE FIRM This highly respected team is able to offer expertise on regulatory, compliance and enforcement matters that affect clients from across the industry. Its integrated approach is enhanced by a strong bench of former government officials, with a particular focus on supporting clients in all stages of government investigations. The team is also noted for its pricing and reimbursement work for manufacturers. Recent work includes representing GE Healthcare in the $590 million acquisition of Clarient Labs. The team is also part of the Pfizer Legal Alliance.

Sources say: "It has been really rewarding working with them - an excellent firm that is easy to work with and very knowledgable."

KEY INDIVIDUALS Paul Kalb is considered a leader in the fraud and abuse arena. He is widely acclaimed for his work representing device and drug manufacturers in government investigations. His recent work includes favorably resolving a case brought against client Novo Nordisk regarding allegations of illegal promotion activity.

Raymond Bonner is highly regarded within the industry for his expertise in FDA compliance and enforcement matters, and for his experience in the medical device arena. He is increasingly active in good manufacturing practice cases.

Coleen Klasmeier garners praise for her "encyclopedic knowledge of FDA regulatory case law and decisions," and is characterized as being "very client-oriented and focused." Her practice is highly focused on FDA regulatory matters and related litigation, and she advises clients at the highest management levels.

Sources attest to William Sarraille's "incredible breadth of knowledge across the entire healthcare system" and he is particularly noted for his expertise in fraud and abuse and pricing matters. His practice encompasses regulatory issues that affect device and drug manufacturers and his recent highlights include forming part of the lead counsel in a False Claims Act brought against Johnson & Johnson.

Scott Bass debuts in the table this year, and is acclaimed as having "a lot of depth in good manufacturing practices and international law." His practice has a strong focus on FDA regulatory and enforcement matters, and clients praise his ability to look at issues from different angles.