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Milestones In AHLA and Health Law Interviews

Below is a repository of interviews of Past Presidents and Fellows, with both an audio file and written transcripts.

Evolution of Government Antitrust Enforcement in Healthcare 

The Antitrust Work Group completed the following recordings:

While today antitrust enforcement in the health care sector is very active and a key consideration throughout the industry, this has not always been the case.  Indeed, prior to the late 1970s, there was very little antitrust scrutiny of health care, and to the extent there was antitrust litigation, there were serious questions as to whether special rules should be applied to health care professionals and non-profit hospitals. These issues are now largely settled, and the health care sector is the largest enforcement priority of federal and state antitrust enforcers.

Our two-part program brought together five individuals who were involved in many of the leading health care antitrust matters over the past 40 years, both as government enforcers and in private practice.

The first program began by setting the stage, discussing how the Federal Trade Commission (FTC), U.S. Department of Justice Antirust Division (DOJ) and State Attorneys General have staffed and exercised their antitrust initiatives, and how that has changed over time.  We then took a deep dive in reviewing the evolution of antitrust enforcement involving physicians and other professionals.  The panel noted that, in the 1980s and 1990s, a key focus was on alleged price-fixing and boycotts by physicians aimed at managed care companies who were aggressively reducing reimbursement rates for providers who wished to participate in their networks.  Some of the key developments during this period included criminal cases brought by DOJ; efforts in Congress to enact an antitrust exemption for physicians covering their negotiations with health plans; and the issuance of the DOJ/FTC Statements of Antitrust Enforcement in Health Care in 1996 which first discussed clinical integration, and which are still in effect; and more recent agency policy statements on ACOs.  Among our speakers were the government enforcers who had taken leading roles in all of these matters.  We also discussed the process for obtaining the advisory opinions and business review letters that are periodically issued by the FTC and DOJ; our speakers had collectively authored a large share of these over the past 3 decades.

Our second program focused primarily on mergers.  We began with a review of some of the more significant hospital merger challenges, explaining how both the agencies and the courts have evolved over the years with respect to both their approaches in assessing mergers, and the results.  For example, early cases questioned whether non-profit hospital mergers should be assessed differently from mergers involving for-profits.  In the 1990s, courts gave particular attention to patient flow under the so-called Elzinga-Hogarty test; this led to a string have been employing more sophisticated economic tools, and now have a string of victories and are becoming increasingly stringent in their review of hospital mergers.  The speakers also addressed government enforcement involving health plans, including mergers and certain health plan contracting practices, such as most-favored nation (MFN) clauses and “anti-steering” and “anti-tiering” provisions.

The second program concluded with a discussion of what lessons could be learned from considering this past experience.  The panelists noted that the government antitrust focus on health care has continued – and even grown – through over the last 40 years.  Some of the tools that enforcers and courts use, especially economic modeling, is now much more sophisticated.  Understanding how these tools have changed can help practitioners better address government concerns.  Of course, in other ways, enforcement involves the same concerns that have been around since the 1970s – whether providers and payers are accruing or exercising excessive market power which can increase costs, reduce quality, or inhibit innovation.  Accordingly, the panel concluded that in many ways, the more things change, the more they stay the same!

Members of the workgroup included: Bob Leibenluft, Hogan Lovells LLP, Washington, DC; Jeff Miles, Baker Donelson, Washington, DC; Bob Bloch, Mayer Brown LLP, Washington, DC; Gail Kursh, US Department of Justice, Washington, DC; Dave Narrow, Retired; Abigail Kaericher, Hall Render Killian Heath & Lyman PC, Washington, DC; and Jonathan Elsasser, Hogan Lovells LLP, Washington, DC.

Use and Rise of the FCA and Healthcare Fraud Enforcement

False Claims Act Work Group completed the following recordings:

  • Part 1 with Richard Shackelford, Kevin McAnaney, and Dan Anderson, recorded on 10.2.19
  • Part 2 with Richard Shackelford, Michael Granston, Laura Laemmle-Weidenfeld, and Marc Raspanti, recorded on 10.29.19
  • Part 3 with Richard Shackelford, Laurie Oberembt, and Jonathan Diesenhaus, recorded on 11.14.19

This three-part program brought together some of the country’s leading legal experts on the federal False Claims Act (FCA or Act) to discuss the history of the FCA’s use by government enforcement officials and private whistleblower plaintiffs (relators) to investigate healthcare fraud and to bring recovery actions under the Act’s civil damages and penalty provisions.  The healthcare enforcement approaches under the FCA and its interpretations by both the government and the judiciary have evolved over time and raised numerous issues of considerable complexity.  All lawyers and consultants who seek to represent clients on government healthcare payment regulation and fraud issues need a basic knowledge of this history to draw upon in addressing the numerous current issues of enforcement and interpretation that have evolved from this complex history.

Part One of this program addresses the early enforcement activities that occurred after the substantial legislative amendments to the FCA in 1986 which strengthened the Act’s recovery provisions and further incentivized whistleblowers to pursue “qui tam” lawsuits under the Act.  Part One summarizes (1) some early large settlements of healthcare FCA cases, (2) certain government-led national enforcement initiatives in the mid-to-late 90’s, (3) the important influence of the passage of HIPAA in 1996 on the coordination of government enforcement efforts, and (4) the expansion of state false claims act legislation due to the incentives created by the Deficit Reduction Act of 2005.

Part Two addresses several key judicial decisions regarding the FCA and important legislative amendments to the Act from the last 15 years.  Specifically, after several federal courts issued decisions limiting the reach of the Act, Congress passed legislation in response expanding the scope of the Act—the Fraud Enforcement and Recovery Act of 2009 (FERA) and certain provisions of the Affordable Care Act in 2010.  Part Two also summarizes key judicial decisions regarding complex interpretation issues under the Act including (1) express versus implied certification, (2) the application of kickback concepts to healthcare fraud enforcement, (3) off-label promotion issues involving pharmaceutical companies, (4) and the consideration of materiality by the Supreme Court in its 2016 Escobar decision.

Part Three addresses how FCA enforcement officials and whistleblowers have sought to extend the reach of the Act into a broader range of healthcare issues, including various types of kickback claims, the Stark Law, enforcement actions against medical device companies, medical necessity and quality of care.  Part Three also includes observations on how large FCA settlements, especially some of the off-label cases against pharmaceutical companies, led to the rise of a professional relator bar with the resources and expertise to handle large, complex FCA actions.  Part Three closes with some observations on the importance of the FCA today and its likely expansion into other segments of the healthcare industry such as managed care.

Members of the workgroup included: Richard Shackelford, King & Spalding LLP (Ret.), Atlanta, GA; Kevin McAnaney, Law Offices of Kevin McAnaney, Princeton, NJ; Dan Anderson, US Department of Justice (Ret.), Washington, DC; Jennifer Lewin, King & Spalding LLP, Atlanta, GA; Lee Nutini, King & Spalding LLP, Atlanta, GA; Laura Laemmle-Weidenfeld, Jones Day, Washington, DC; Marc Raspanti, Pietragallo Gordon Alfano Bosick & Raspanti LLP, Philadelphia, PA; Michael Granston, US Department of Justice, Washington, DC; Jonathan Diesenhaus, Hogan Lovells LLP, Washington, DC; Carol Lam, former United States Attorney for the Southern District of California, San Diego, CA; Laurie Oberembt, US Department of Justice, Washington, DC; and Sally Strauss, Mount Sinai Hospital, New York, NY.

Evolution of the Appeals Process

Medicare Reimbursement Appeals Work Group completed the following recordings:

From the beginning of the Medicare Program in the mid-1960's to the current time, those Medicare providers, suppliers, and beneficiaries dissatisfied with the Program's payment and coverage decisions have sought to challenge those decisions through the administrative channels and the courts. These challenges have been far from static. The Medicare payment and coverage rules have changed dramatically over time as have the rules regarding challenges to those rules. Issues that once seemed subject to challenge are now considered off limits, while other issues once considered off limits are now considered to be appropriate for challenge. The Medicare appeals podcast explores this shifting landscape and explains the evolution of the appeals process, notable regulations and case law that have addressed the appeals process, and how to pursue appeals in today's environment.

We have assembled numerous experts to address this topic. J.D. Epstein and Thomas Coons have been leaders in the field since the Medicare appeals process was first instituted. Ken Marcus and Both Roth, similarly have spent decades litigating Medicare reimbursement appeals, as has Greg Etzel. And Matt Horton is an emerging leader in the reimbursement bar, focusing on reimbursement issues and appeals. Providing balance to the podcast and, at times, a different perspective, are Susan Lyons, Depute Chief Counsel for Litigation in the CMS Division of HHS's Office of the General Counsel, and Suzanne Cochran, who spent a number of years as the Chair of HHS's Provider Reimbursement Review Board (PRRB) and before that was in private practice and the Government. Through these speakers, we have been able to provide a comprehensive and balanced review of the Medicare appeals process and the issues presented.

Our presenters discuss the evolution of the appeals process, from its beginnings prior to the establishment of the PRRB through today. The presenters further discuss the requirements for PRRB jurisdiction and how that has evolved. We discuss early and more recent Medicare jurisdictional decisions and key rulings from the Supreme Court as well as certain Courts of Appeals addressing Medicare reimbursement issues and the appropriate standard of review under the Medicare statute and the APA noting, again how the courts' view of those standards and their application has changed over time. We address the statutory and regulatory limits to PRRB review, including the expedited judicial review process and certain statutory restrictions to obtaining administrative and judicial review, as well as the extent to which providers may challenge in current years certain facts from fiscal years that are closed and no longer to subject appeal (so-called "predicate facts"). Additionally, we discuss the current rules and processes in place to perfect Medicare appeals through the current PRRB process. Then, we summarize discussions with an overview of how the reimbursement and appeals process has changed and is likely to continue to change.

Every beginning reimbursement lawyer, as well as reimbursement veterans, should listen to these recordings. In roughly two hours, the presenters tie together the critical trends, critical issues and developments that have taken place over the last 50 years in the area of Medicare reimbursement and appeals. It is not to be missed.

Members of the workgroup included:  Chair, Thomas W. Coons, Baker Donelson Bearman Caldwell & Berkowitz PC, Baltimore, MD; J.D. Epstein, Greer Herz & Adams LLP, Galveston, TX; Ken Marcus, Honigman Miller Schwartz and Cohn LLP, Detroit, MI; Greg Etzel, Morgan Lewis & Bockius LLP, Houston, TX; Bob Roth, Hooper Lundy & Bookman PC, Washington, DC; Matt Horton, King & Spalding LLP, Washington, DC; Suzanne Cochran, Akin Gump Strauss Hauer & Feld, Washington, DC; and Susan Lyons, Office of the General Counsel, CMS Division, Washington, DC.

Additional Interviews

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