Healthcare Industry

Overview

At a time of rapid change and tremendous uncertainty within the healthcare industry, the BakerHostetler Healthcare Industry team has the national presence and depth to help our clients strategically navigate challenges and respond nimbly to change.

Our clients come from a broad range of healthcare organizations, including:

  • Hospital and health systems
  • Physician practices
  • Suppliers and pharmaceutical companies
  • Long-term and post-acute care providers
  • Home health, hospice and specialized niche providers
  • Venture capital funds and private equity entities operating in the healthcare sector

We have counseled many of our clients for decades, including some of the nation’s leading medical facilities. We provide responsive and creative solutions for navigating the multitude of legal and regulatory issues involved in this heavily regulated industry.

More »

We routinely assist our healthcare industry clients to assist with or address matters and issues of concern and relevance, including:

Transactional

  • Mergers and acquisitions and divestitures
  • Private equity, venture capital funds investment in healthcare entities
  • Affiliations, joint ventures and strategic alignments
  • Portfolio company acquisition and disposal
  • Liquidity and realization events
  • Management buyouts
  • Senior, mezzanine and warrant financings
  • Strategic alignment
  • Enforcement and Corporate Governance
  • Internal investigations and corporate oversight
  • False Claims Act litigation and investigations
  • Civil investigative demands and subpoenas
  • Civil and criminal healthcare enforcement matters

Reimbursement

  • Medicare and Medicaid coding and billing reviews
  • Government and commercial pre‑payment and post-payment audits and appeals
  • Payment suspensions
  • Managed care payment disputes
  • Audits and proceedings initiated by fiscal intermediaries, program integrity contractors, and federal and state governmental authorities

Regulatory

  • Regulatory and compliance advice
  • Anti-Kickback and Stark laws
  • False Claims Act
  • Health Insurance Portability and Accountability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH)
  • Emergency Medical Treatment & Labor Act (EMTALA)
  • Licensing and certification matters
  • Occupational Safety and Health Administration (OSHA)
  • Compliance program development
  • Clinical research program development

Privacy

  • Federal and state privacy law compliance
  • Data breach response, including crisis management and investigations or audits

Policy

  • Legislative and regulatory proposals involving healthcare issues
  • Communication with Capitol Hill and administration policymakers, administrative agencies and enforcement officials

Our services

We provide a full range of services to clients who need help in many different areas and matters affecting their businesses and operations. Our attorneys routinely work with clients to form new entities and ventures and assist them with the negotiation and implementation of strategic transactions. We help clients respond to data breaches and other privacy matters, identify and advise on specific fraud and abuse risk areas, support their defense against enforcement investigations and proceedings, and develop and execute legislative and regulatory strategies, among many other tasks.

We help hospitals, health systems, academic medical centers and other medical providers grow through many different avenues, including facility acquisitions and leasing, financing arrangements, management contracts, affiliate agreements and the creation of new relationships with relevant partners.  Additionally, we counsel them on the full range of operational matters. We work with physician groups of all sizes to structure joint ventures and other relationships among physicians, physician groups, hospitals, specialty healthcare service providers and others in the industry.

Our Healthcare Privacy team excels at addressing HIPAA issues and has provided timely and discreet advice to clients through more than 500 data breach responses, including responses to the three largest U.S. healthcare data breaches ever reported. We counsel healthcare providers and other covered entities on HIPAA and state privacy law compliance, breach response, crisis management, and regulatory investigations and audits. In this period of aggressive regulatory enforcement, our enforcement and compliance attorneys help keep our clients out of the headlines by proactively identifying and providing advice on their specific risk areas, including those related to the Anti-Kickback and Stark laws, the False Claims Act, HIPAA and HITECH, EMTALA, licensing and certification matters, OSHA, and a wide range of coding and billing issues. Our team has substantial experience defending providers in all facets of audits and proceedings initiated by fiscal intermediaries, program integrity contractors, and federal and state governmental authorities, among many others.

We have specialized healthcare reimbursement experience in Medicare and Medicaid program payment matters, having handled major reimbursement disputes in both Medicare and Medicaid graduate medical education (GME) and disproportionate share hospital (DSH) issues. We assist with a wide range of Medicare and Medicaid appeals and audits. We also represent hospitals and physicians in managed care negotiations and contracting and payment disputes, and we are experienced in Medicare and Medicaid managed care law and regulations. We work to manage enrollment, changes in ownership and certification issues, licensing and Joint Commission responses, and corrective action issues. We have lawyers skilled in cost report reimbursement, appeals and financial payment concerns arising out of state and federal government payors as well as commercial payors.

Changes in administrations can create significant changes to the manner in which healthcare can be delivered and Medicare and Medicaid may be funded. Our Healthcare Public Policy team closely monitors emerging policies, advancing our clients’ interests on Capitol Hill with relevant healthcare agencies and with the then current administration. We routinely assist clients in developing legislative and regulatory proposals and legislative language to help them effectively communicate; advocate on their behalf; develop strategies for advancing their goals; and manage the adverse impacts that healthcare legislation and regulation may have on their organizations. We also work with trade associations in partnering to advance their message.

Select Experience

  • Served as team leader in a major integration of an academic medical center's faculty practice plans, including the transition of 450 physicians and more than 20 separate non-profit and for-profit entities. Established a plan for a new entity to function as the sole multi-specialty practice plan. Resolved governance, organizational, tax and regulatory issues.
  • Counseled a regional healthcare system in the wake of improper employee access to over 100,000 patients' records. Coordinated the internal investigation and led the response on several fronts, including crisis management, notification of affected patients, resolution of patient complaints, regulatory investigations and defense in a class action alleging failure to safeguard confidential personal information and notify class members of the incident in a timely manner. We combined our healthcare, privacy and class action litigation experience for a full-service strategic defense of the matter.
  • We provide the Children’s Hospital Association—which includes more than 200 children’s hospitals in this country—with national Medicaid policy advice. We helped to develop a particular program for children with chronic and complex conditions, develop a risk-based payment mechanism in Medicaid tied to the creation of a pediatric medical home and analyzed Medicaid claims data and whether a coordinated care model can provide scoreable savings for Congress. We are directly involved in both the continued development of the policy, as well as with strategic advocacy in Congress, with CMS and the administration, identifying champions, preparing and supporting the policy, developing the legislative language and providing substantive legal and policy support for the concept.
More »

Professionals

Name Title Office Email
Partner Columbus
Partner Dallas
Partner Washington, D.C.
Partner Atlanta
Partner Atlanta
Partner Washington, D.C.
Partner Los Angeles
Partner Columbus
Partner Atlanta
Partner Atlanta
Partner Atlanta
Counsel Atlanta
Partner Atlanta
Partner Houston
Partner New York
Associate Atlanta
Partner Dallas
Partner Atlanta
Partner Atlanta
Partner Atlanta
Counsel Atlanta
Partner Atlanta
Counsel Cleveland
Partner Atlanta
Partner San Francisco
Partner Columbus
Partner Atlanta
Partner Washington, D.C.
Partner Orlando
Partner Columbus
Partner New York
Partner Atlanta
Of Counsel Washington, D.C.
Partner Atlanta
Counsel Atlanta
Partner Dallas
Partner Houston
Partner Orlando
Associate Atlanta
Associate Atlanta
Partner Cincinnati
Partner Atlanta
Partner Columbus
Senior Advisor for Government Relations
Senior Advisor for Government Relations Columbus
Partner Cleveland
Partner Cleveland
Partner Chicago
Senior Advisor Washington, D.C.
Partner Atlanta
Partner Los Angeles
Counsel New York
Counsel Atlanta
Partner Washington, D.C.
Partner Cleveland
Partner New York
Partner Washington, D.C.
Partner Atlanta
Partner Cleveland
Partner Atlanta
Regulatory Analyst Atlanta
Partner Atlanta
Partner Atlanta
Partner Cleveland
Partner Cincinnati
Partner Houston
Associate Atlanta
Partner Columbus
Partner Seattle
Partner Orlando
Partner Philadelphia
Of Counsel Washington, D.C.
Partner Washington, D.C.
Partner Washington, D.C.
Partner Cleveland
Partner New York
Partner Dallas
Partner Washington, D.C.
Partner New York
Partner Atlanta
Counsel Atlanta
Partner Columbus
Partner Houston
Partner Houston
Partner Washington, D.C.
Partner Columbus
Counsel Philadelphia
Of Counsel Atlanta
Partner Cleveland
Associate Atlanta
Senior Advisor Washington, D.C.
Partner New York
Partner Cleveland
Partner Columbus
Associate Washington, D.C.
Partner Cleveland
Regulatory Analyst Atlanta
Partner Columbus
Partner Houston

Experience

  • Served as team leader in a major integration of an academic medical center's faculty practice plans, including the transition of 450 physicians and more than 20 separate non-profit and for-profit entities. Established a plan for a new entity to function as the sole multi-specialty practice plan. Resolved governance, organizational, tax and regulatory issues.
  • Counseled a regional healthcare system in the wake of improper employee access to over 100,000 patients' records. Coordinated the internal investigation and led the response on several fronts, including crisis management, notification of affected patients, resolution of patient complaints, regulatory investigations and defense in a class action alleging failure to safeguard confidential personal information and notify class members of the incident in a timely manner. We combined our healthcare, privacy and class action litigation experience for a full-service strategic defense of the matter.
  • We provide the Children’s Hospital Association—which includes more than 200 children’s hospitals in this country—with national Medicaid policy advice. We helped to develop a particular program for children with chronic and complex conditions, develop a risk-based payment mechanism in Medicaid tied to the creation of a pediatric medical home and analyzed Medicaid claims data and whether a coordinated care model can provide scoreable savings for Congress. We are directly involved in both the continued development of the policy, as well as with strategic advocacy in Congress, with CMS and the administration, identifying champions, preparing and supporting the policy, developing the legislative language and providing substantive legal and policy support for the concept.
  • Representing major children’s hospitals in Texas and Washington state in challenging a CMS interpretation of the DSH hospital specific limit (HSL) reimbursement relative to the calculation of Medicaid shortfall. Similar determinations affect all seven freestanding children’s hospitals in Texas for a total potential loss of as much as $70 million in Medicaid program reimbursement and approximately $15 million to Washington children’s hospitals. Representation involves meeting with CMS officials, convincing the State of Texas to support a compromise approach, developing federal legislative bill language and support of the Texas and Washington delegation and filing a temporary restraining order in state court.

Recognition

  • Chambers USA: Healthcare
    • Nationwide: Highly Regarded (2022)
      • Band 1
    • Georgia (2015 to 2022)
      • Band 2
    • Ohio (2011 to 2022)
      • Band 3
    • Texas (2009 to 2022)
      • Band 5
  • Chambers USA: Healthcare: Pharmaceutical/Medical Products Regulatory
    • District of Columbia (2021 to 2022)
      • Band 4
  • Chambers Global: Privacy & Data Security: Healthcare Spotlight Table – Nationwide (2021 to 2022)

News

News

Press Releases

Publications

Alerts

Articles

Blog Posts

Key Contacts

Blog

In The Blogs

Previous Next
Antitrust Advocate
Are Hospital Acquisitions with COPA Authorization Exempt from HSR Pre-Merger Notification?
By Marc G. Schildkraut
May 1, 2023
The Federal Trade Commission (FTC or the Commission) has experienced multiple recent setbacks with respect to its regulatory authority. Now a new dispute raises questions about whether hospital acquisitions with Certificate of Public...
Read More ->
Health Law Update
Supreme Court Orders That Mifepristone Remain Widely Available Pending Appeal in Fifth Circuit
By Amy E. Fouts, Scott P. Robertson
April 25, 2023
On Friday, April 7, the Northern District of Texas issued a decision blocking the prescribing and dispensing of mifepristone nationwide. The court held that plaintiffs had a substantial likelihood of success on the merits regarding their...
Read More ->
Health Law Update
Challenge to the FDA's Approval of Abortion Medication
By Claire M. Bass, Amy E. Fouts
April 17, 2023
On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the FDA approval of the abortion drug mifepristone. The Texas decision blocks prescribing and dispensing of...
Read More ->
Data Counsel
Washington State's New Shield Law, Part of Washington's ‘Choice-Defending Agenda,' Modifies Obligations Related to Other States' Criminal and Civil Process
By Andreas T. Kaltsounis
April 17, 2023
Entities that receive criminal process (such as subpoenas or search warrants) in Washington state should review Washington’s new Shield Law, which the legislature just passed as part of its post-Dobbs “choice-defending agenda.” The law...
Read More ->
Health Law Update
Cybersecurity in Medical Devices
By Laura E. Macherelli, Lee H. Rosebush, Lynn Sessions
April 10, 2023
The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. The nonbinding guidance, titled “Cybersecurity in Medical Devices...
Read More ->