Health Care Practice

The health care field continues to grow rapidly due to changing demographics, a shifting regulatory environment and the explosion of technological advances. Employment and spending are up. So too are regulation and oversight. Companies in the health care industry—whether hospitals and health care systems, professionals, ancillary service providers, insurers, device or drug manufacturers, or staffing or data companies—need a law firm with a deep and broad bench of advisors who focus on this fast-moving area.

Alston & Bird has built a large team of lawyers and policy advisors with a distinct set of skills and experience so that we can creatively solve increasingly critical business and legal issues for our health care clients. Nearly 100 lawyers based in Atlanta, Charlotte and Washington, D.C. practice exclusively in the area of health care, one of the largest practice groups of its kind in the country. Our lawyers concentrate their practices in the areas of corporate, regulatory, policy, FDA, and investigations and litigation. The breadth, depth and focus of our practice enables us to solve complex client problems quickly and efficiently.

Comprehensive Industry Coverage

� Academic medical centers

� Accountable care organizations

� Alternate-site health care providers

� Ambulatory surgery centers

� Behavioral health services

� Biotechnology companies

� CME providers

� Consumer products manufacturers and distributors

� Dental/orthodontics

� Dialysis providers

� Financial institutions and specialty lenders

� Group purchasing organizations

� Health care REITs

� Health plans and managed care plans

� Home health and hospice

� Hospitals and health systems

� Industry trade associations

� Laboratory services

� Medical app developers and vendors

� Medical billing, coding and clearinghouse companies

� Medical device manufacturers

� Medical information technology and e-health companies

� Medical suppliers and distributors

� Outpatient health services

� Pharmaceutical manufacturers and distributors

� Pharmacy benefit managers

� Physician groups

� Post-acute care providers

� Research institutions

� Senior living and long-term care providers

� Skilled nursing facilities

� Urgent care and medical transportation

Alston & Bird’s Health Care Group

� We are one of the country’s largest groups of corporate finance and M&A attorneys dedicated to the health care industry and bring unmatched bench strength.

� Our significant experience in health care securities offerings, M&A and corporate governance includes public and private company debt and equity financing, mergers, tender offers, asset and stock acquisitions, recapitalizations, network formation, joint ventures, roll-ups and spinoffs.

� Our understanding of the regulatory environment adds significant value and provides a competitive advantage to our clients. We help our clients take balanced risks and provide certainty of execution.

� Our strong relationships with key investment banks and private equity firms have been valuable to our clients.

� Our experience with nonprofit health care transactions, including member substitutions, management agreements, affiliations and integrations in the hospital consolidation arena, is unrivaled.

Team � Mark Ray is co-chair of the firm’s Health Care Group and concentrates his practice on public and private company M&A and

corporate financing transactions.

� Steve Pottle is a founding member of the firm’s Corporate Health Care practice area. He has counseled multibillion-dollar international companies and Fortune 100 corporations.

� Sarah Ernst has been named one of Law360 ’s “Top Attorneys Under 40.”

� Mark Kelly works with private equity firms and their portfolio companies in equity and debt financings, leveraged buyouts and exit transactions, including mergers with public companies.

� Rosemarie Thurston represents REITs and real estate funds investing in health care real estate, as well as health care real estate developers and asset managers, on public and private securities offerings, mergers and acquisitions, joint ventures and ongoing securities and corporate governance law compliance.

� Rick Blumen‘s experience in leveraged capital ranges from asset-based lending to investment grade, and from high-net worth individuals to major airline carriers to portfolio companies.

“They’re extremely effective and can leverage their experience and relationships to move our issues forward in a very strategic way.” – Health care client in Chambers USA 2015

Corporate

We take a substantive, policy-driven, nonpartisan approach to our client work. As one of the nation’s largest, most experienced, full-service regulatory and legislative public policy teams, we offer a wide range of services, including:

� Crafting innovative policy options and solutions to address client priorities.

� Continuously monitoring legislative and regulatory activity, educating clients on policy trends and opportunities or threats and providing strategic advice.

� Implementing legislative and administrative strategies to influence congressional and Executive Branch action, including passage of laws and issuance of regulatory rules and policies.

� Advocating policy solutions, including Medicare/Medicaid reimbursement policy, with members of Congress and Administration officials and their respective staff.

Team � Hon. Bob Dole (R-KS) is the former Senate Majority Leader and Finance Committee chair.

� Jennifer Butler is co-chair of the firm’s Health Care Group and has served as Sen. Dole’s chief health care counsel for the last decade.

� Michael Park is a former counsel to then-Finance Committee chair and Ranking Member Charles Grassley (R-IA).

� Hon. Earl Pomeroy (D-ND) is a former nine-term U.S. Representative and Ways and Means Committee member.

� Mark Rayder is a former advisor to three members of Congress and a former associate staff member to the House Commerce, Justice, State and Judiciary Appropriations Subcommittee.

� Bob Siggins is former senior House Democratic chief of staff to Rep. Pomeroy and a health policy specialist.

� Carolyn Smith is a former associate deputy chief of staff of the Congressional Joint Committee on Taxation.

� Peter Swire served as one of five members of President Obama’s Review Group on Intelligence and Communications Technology, and was chief counselor for privacy at the OMB under President Clinton.

� Tim Trysla is the former senior policy advisor to the CMS administrator.

� Marilyn Yager is a former deputy assistant to President Clinton, advising on health and budget issues.

Legislative & Public Policy

We have significant experience in regulatory and compliance matters affecting the health care industry at the state, regional and national levels and in working with the federal and state agencies that oversee health care. Our legal services include:

� Advising on anti-kickback and self-referral issues, including drafting OIG advisory opinion and self-disclosure requests.

� Representing clients in federal and state enforcement actions and administrative proceedings.

� Creating compliance programs and providing related audits and training.

� Advising on Medicare and Medicaid coverage, coding and reimbursement issues.

� Providing clients with structuring advice, including antitrust, joint ventures, physician and supplier relationships, managed care arrangements and attorney general conversions.

� Advising on HIPAA and health information privacy, security and breach notification matters.

� Assisting with credentialing and licensure, change of control, surveys, plans of correction and Medicare terminations.

� Advising on implementation of reimbursement reform programs.

� Developing and implementing clinically integrated networks and accountable care organizations.

Team � Jackie Baratian has served in federal regulatory enforcement, as a chief compliance officer at both a national provider—

while navigating a Corporate Integrity Agreement and Deferred Prosecution Agreement—and for a national health insurer.

� Donna Bergeson’s practice touches health care regulation broadly—from board room to courtroom—focusing on hospitals, academic medical centers and Medicare compliance. She has served as the Health Care Group leader and chair of the firm’s governing board.

� Angie Burnette handles regulatory and litigation matters, including hospital-physician disputes, HIPAA, end-of-life issues and state licensing board investigations. She is the firm’s assistant HIPAA privacy officer.

� Larry Gage founded the National Association of Public Hospitals and Health Systems. He previously served as deputy assistant secretary for health legislation at the Department of Health and Human Services (HHS).

� Peter Kazon is nationally renowned for his extensive knowledge of regulatory, reimbursement and compliance issues affecting laboratories and diagnostic companies.

� Dawnmarie Matlock is the firm’s HIPAA privacy officer. She holds a B.S.N. and practiced as a registered nurse specializing in adult intensive care and ER nursing.

� Rob Stone specializes in fraud and abuse issues, focusing on federal and state anti-kickback statutes, self-referral laws and the False Claims Act. He also has significant experience counseling clients participating in Medicare pilot programs.

� Michelle Williams is a medical technologist and former in-house counsel at University Hospitals of Cleveland. She advises on hospital acquisitions.

Regulatory and Compliance Practice

Alston & Bird has consistently earned recognition as a U.S. law firm providing superior client service, including ranking 6th in the

BTI Consulting Group Power Rankings 2016: The Law Firms with the Best Client Relationships.

� Representing domestic and international makers, marketers and distributors of foods, drugs (branded, generic, over-the-counter, animal), biologics, medical devices, in vitro diagnostics (IVDs), dietary supplements and cosmetics.

� Counseling on regulatory compliance with the Food and Drug Administration (FDA) and related federal and state agency requirements across product categories to minimize and manage regulatory risk exposure.

� Advising on the resolution and remediation of establishment inspection observations, warning letters, product recalls, import alerts, import detentions and other disputes.

� Representing clients in interactions with FDA personnel, including product development and regulatory meetings.

� Advising manufacturers, marketers and distributors on labeling and advertising requirements and restrictions, corporate communications and managing legal and regulatory risks in interactions with customers and health care professionals.

� Representing clients in federal court actions for seizures and injunctions brought by FDA and the Department of Justice (DOJ) and in FDA administrative civil penalty proceedings.

� Defending FDA -regulated clients in state and federal criminal investigations as well as False Claims Act qui tam suits.

� Representing clients in Administrative Procedure Act challenges to FDA actions.

Team � Cathy Burgess, former American Red Cross associate general counsel and trial counsel in U.S. v Barr Laboratories, is a recognized

leader in cGMP regulation.

� Dan Jarcho litigates affirmative challenges to FDA actions and defends clients in FDA-related enforcement actions.

� Marc Scheineson is a former FDA associate commissioner for legislative affairs.

� Julie Tibbets has been a Washington, D.C. Super Lawyers “Rising Star” in the area of food and drug practice since 2013.

Food, Drug and Device Practice

� Advising and representing clients in state and federal civil and criminal inquiries, trials and settlements and Corporate Integrity Agreements negotiations across the country, and work closely with our health care policy advisors to respond to parallel congressional inquiries and hearings.

� Served as an independent review organization and outside reviewer under a Corporate Integrity Agreement.

� Conducting internal investigations for clients.

� Representative clients include hospitals, hospital systems, physician groups, third-party billing companies, pharmaceutical companies, dialysis providers, DME companies and device manufacturers.

Team � Bill Jordan was formerly at the DOJ, where he served as senior counsel to the assistant attorney general for the Civil Division and

as senior counsel to the associate U.S. attorney general.

� Mitch Mitchelson serves as co-chair of the Southeast Subcommittee of the ABA Committee on White Collar Crime. He is a former assistant U.S. attorney for the Middle District of Florida, Criminal Division.

� Leslie Overton previously held senior leadership roles in DOJ’s Antitrust Division in two presidential administrations, including her recent tenure as deputy assistant attorney general for civil enforcement.

� Frank Sheeder is past president (2015) of HCCA and has defended clients against civil and criminal fraud allegations brought by federal and state government agencies and other hostile third-party litigants—especially whistleblowers—for more than 28 years.

� Ted Kang is a former federal prosecutor in the DOJ’s Criminal Division and at the U.S. Attorney’s Office for the District of Connecticut.

� Mark Calloway served as the U.S. attorney for the Western District of North Carolina.

� Wade Miller is co-chair of the Health Care Compliance Association Southeast Regional Conference and is certified in health care compliance.

� Kim Peretti is a former senior litigator for the DOJ’s Computer Crime and Intellectual Property Section.

� Adam Biegel, head of the firm’s D.C. antitrust team, counsels and represents health care clients before federal and state authorities, and has been in the leadership of the ABA Antitrust Law Section since 2002.

“They do a very good job for us, they have a lot of inside knowledge and they have also done a very good job on our regulatory investigations. They handle matters in an efficient manner and have a lot of good contacts.” – Health care client, quoted in Chambers USA 2014

Investigations and Litigation

“They provide excellent competencies in all areas of law, particularly health care law. They’re very practical and

reasonable in terms of their approach.” – Health care client, quoted in Chambers USA 2014

� Chambers USA: America’s Leading Lawyers for Business 2016 ranked our health care practice among the best in its national rankings, along with eight other Alston & Bird practices.

� Chambers USA 2016 ranked our Georgia health care team in Band 1 and noted our D.C. team as well.

� Our Privacy & Data Security Group is recognized by both Chambers Global 2017 and Chambers USA 2016 as one of the leading privacy practices in the U.S.

� U.S. News—Best Lawyers “Best Law Firms” ranked the firm nationally in 43 different practice categories in 2017. In addition, the firm was extensively featured on the regional list, ranking in 110 categories.

� Alston & Bird ranks No. 6 among a small group of firms that in-house counsel consider the best in building and retaining deep client relationships in BTI Consulting Group’s “Power Rankings 2016: The Law Firms with the Best Client Relationships.”

� For the sixth consecutive year, general counsel have identified Alston & Bird as a firm that they are willing to bet their reputation on and recommend to their peers, as reported by BTI Consulting Group in its 2016 study Most Recommended Law Firms.

� FORTUNE’s “100 Best Companies to Work For” list has ranked Alston & Bird for 18 consecutive years, including in the top 25 for eight consecutive years, four of which were in the top 10.

� CTA Intelligence – Alston & Bird was a 2017 finalist for the CTA Intelligence Services Awards in the categories of “Best Law Firm - Overall” and “Best Law Firm - Client Service,” an honor bestowed on the firm in 2016.

� Mergermarket – Alston & Bird ranked #8 in the category “U.S. Legal Advisors (South) M&A” and #11 for “Canada Legal Advisors M&A,” both based on deal value for the first three quarters of 2016.

Accolades

Chambers USA 2015 says, “Deep bench of experienced practitioners with strength

across wide-ranging transactional, policy and litigation matters. Houses notable

regulatory expertise, regularly advising on Stark, ACA and FDA issues. Hospitals and

academic medical centers form a key part of its varied client base.”“They are very proactive, creative thinkers with strong analytical capabilities.” – Health care client in Chambers USA 2015

“They have the breadth and depth to handle almost any legal matter we have

experienced.” – Health care client in Chambers USA 2015

“They have a very practical approach to legal matters and are able to advise

us on practical strategies for our business needs.” – Health care client in

Chambers USA 2015

What Clients Are Saying

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