Healthcare Law: the inside view from the experts at Waller
Since the enactment of Medicare in 1965 and through the ongoing implementation of the Affordable Care Act, service to the healthcare industry has been the cornerstone of Waller’s legal practice. From a single physician-owned hospital in Nashville, Waller helped HCA Inc. grow into the world’s largest investor-owned operator of healthcare facilities. We continue to represent investor-owned and not-for-profit hospitals and health systems throughout the United States, and over the past 50 years our healthcare practice has evolved with the industry itself. Today we also represent clients focused on outpatient healthcare services, post-acute care, behavioral health, life sciences and healthcare information technology. Our experience extends across virtually every segment of the healthcare industry.
For more than a decade Waller has been recognized among the nation’s 10 largest healthcare law firms by Modern Healthcare, and we are top-ranked in the South for membership in the Health Law Section of the American Bar Association (ABA). We are recognized annually among the nation's largest healthcare law firms by American Health Lawyers Association (AHLA) for our continued commitment to the advancement of professional development in healthcare law. Additionally, our healthcare practice has earned a top ranking from Chambers USA. Waller attorneys are frequently quoted on healthcare topics in Modern Healthcare, The Wall Street Journal, The New York Times and myriad other industry publications. Our healthcare attorneys serve in key leadership positions in the AHLA and the ABA Health Law Section, and they are also highly sought-after speakers at healthcare industry and professional conferences held throughout the country. In addition, many leading healthcare companies and organizations are now led by former Waller attorneys who fill C-Suite, General Counsel, Compliance, Operational and other key roles across the healthcare industry.
“Waller stands out for the quality of services in the corporate arena. Aimed at the middle market, the team operates on a national level.” — Chambers USA
Waller’s multidisciplinary healthcare department comprises more than 100 attorneys across our four offices in Austin, Birmingham, Memphis and Nashville. Waller has earned a national reputation for our experience in high-profile healthcare transactions, having provided counsel in healthcare mergers, acquisitions, joint ventures and divestitures with a combined value of more than $14 billion since 2010. As Chambers USA noted: “Waller stands out for the quality of services in the corporate arena. Aimed at the middle market, the team operates on a national level.” Our capabilities in corporate transaction are complemented by attorneys with specialized experience across the full spectrum of healthcare legal services, including:
- Regulatory compliance and operations
- Government investigations, False Claims Act matters and qui tam litigation
- Commercial finance and securities
- Real estate
- Environmental law
- Labor and employment
- Intellectual property
- Software licensing and IT outsourcing
- Data security and patient privacy
Healthcare Compliance and Government Enforcement Defense
For healthcare providers and investors, the counsel provided by Waller’s Healthcare Compliance and Government Enforcement Defense team is now more critical than ever. Scrutiny from government enforcement agencies continues to escalate, and financial recoveries in the form of penalties and settlements from healthcare organizations remain at historic levels. In the wake of recent high profile cases, businesses and individuals in the healthcare industry increasingly find themselves the subject of government investigations and enforcement. Waller’s expanding Healthcare Compliance and Government Enforcement Defense Team focuses on healthcare compliance, government enforcement, internal and external investigations, and white collar defense and includes attorneys with experience gained in-house, at other top-ranked law firms, and in various U.S. Attorneys’ Offices.
This complex regulatory overlay creates the need for highly specialized attorneys who are experienced with the technical aspects of federal and state laws, rules and regulations. Equally critical is the need for attorneys who understand healthcare regulatory law as it applies to a wide range of facilities and service providers. The expansion of Waller’s Healthcare Compliance and Government Enforcement Defense Team comes in response to the increased government enforcement actions brought against healthcare providers since the creation of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) - a joint effort between the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS). HHS and the Centers for Medicare & Medicaid Services (CMS) are increasingly focused on developing approaches to monitor, limit and remediate such payments, all of which makes compliance more complex for providers.
Healthcare organizations turn to Waller every day for assistance with navigating the federal and state regulations that impact both their day-to-day operations and their long-term objectives. Our goal is to provide peace of mind as we guide them through a virtual regulatory minefield. Their confidence is based on our more than 50 years of experience with healthcare regulatory law and the fact that many of the solutions to complex problems we have developed are now models used throughout the healthcare industry.
Healthcare organizations require assistance with navigating the federal and state regulations that impact both their day-to-day operations and their long-term objectives. To be successful, healthcare associates need to be both highly technical and detail oriented to align client objectives with the constantly changing regulatory environment. Healthcare compliance attorneys work closely with clients to understand their objectives and then develop creative approaches to achieve those goals. Typical areas in which healthcare compliance associates will be involved include:
- Medicare enrollment and reimbursement, Stark, state and federal anti-kickback compliance, along with the Emergency Medical Treatment and Active Labor Act, Joint Commission standards and numerous other regulations
- Structuring mergers, acquisitions and joint ventures to ensure compliance with federal and state regulations
- Innovative models for hospitals and physicians to work together, e.g., through clinical co-management agreements and foundation models, within Physician-Hospital Organizations and Accountable Care Organizations, and through joint venture arrangements
- State survey and certification issues, including Certificate of Need applications
- HIPAA patient privacy/security regulations, the electronic storage and transfer of medical records and electronic payment systems, security programs under the HITECH Act and security breaches
- Regulatory investigations, audits and appeals involving Medicare reimbursement, including Zone Program Integrity Contracts (ZPIC), Recovery Audit Contractors (RACs) and Medicare Administrative Contractors (MACs)
Government Enforcement and Defense
Healthcare businesses today face an environment in which regulatory issues can quickly turn into government investigations or enforcement actions. Waller's attorneys help clients navigate this dynamic environment to prevent otherwise simple regulatory issues from morphing into something far more damaging and costly. We understand what to expect and how to respond to a government investigation because many of our attorneys actually investigated allegations of fraud and abuse for the government. When faced with a government investigation or enforcement action, our attorneys help clients respond appropriately with strategies aimed at minimizing – or completely avoiding – penalties, negative publicity and disruptions to core business operations.
'For attorneys with the ability to navigate the technical regulatory interplay governing the healthcare industry [...] significant career opportunities are available in both private practice and in-house legal roles.'
In fiscal year 2015, the United States Department of Justice obtained $1.9 billion in healthcare fraud settlements and judgments from False Claims Act cases for a total of $16.5 billion recovered in healthcare cases since January 2009. These settlements underscore both the federal government’s continuing commitment to pursuing healthcare fraud and abuse cases and the increasingly important roles played by compliance attorneys and government enforcement defense attorneys. False Claims Act cases known as qui tam actions can also be filed by private citizen whistleblowers on behalf of the government. In actions in which the government prevails, the whistleblower is eligible to receive up to 30 percent of the amount recovered in the form of fines, penalties, and/or settlements. Until 1992, the majority of new healthcare-related matters opened each year were classified as non-qui tam matters by the DOJ. Since 1992, however, the percentage of qui tam actions has skyrocketed. In 2013, 500 new healthcare matters were classified as qui tam actions compared to a mere 15 non-qui tam matters. In the healthcare context, a significant percentage of False Claims Act enforcement actions center on alleged violations of the Stark Law or the Anti-kickback Statute.
Even for a healthcare organization with an effective compliance program and plan overseen by strong internal counsel and a compliance officer, there are still instances when it is necessary to involve outside counsel. Such instances include:
- Any contact, subpoena, or inquiry from a governmental entity such as the DOJ or the OIG
- Credible allegations of criminal conduct
- Senior management or board members directly involved in a complaint or investigation
- A nuanced analysis when the hospital or health system needs an outside written opinion
- An overtaxed or understaffed compliance department, which is unable to conduct a thorough internal investigation
- A matter when maintaining legal privilege is particularly important and where third parties may need to be hired for investigation or review purposes
- A potential settlement with a governmental agency or relator is being negotiated
- External validation of the compliance department’s effectiveness is needed
The complex and constantly changing nature of federal and state healthcare regulations and the government’s aggressive enforcement of False Claims Act cases have combined to create a high demand for healthcare compliance and enforcement defense attorneys. To be successful, these attorneys will need critical thinking skills and a commitment to mastering a highly specialized area of the law. For attorneys with the ability to navigate the technical regulatory interplay governing the healthcare industry, however, significant career opportunities are available in both private practice and in-house legal roles.