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Samantha Kingsbury is an Associate in the firm’s Boston office. Samantha’s practice focuses on health care enforcement defense matters, often involving criminal and administrative actions brought against health care providers and companies by state and federal governmental and regulatory agencies. She has experience preparing self-disclosures and other reports relating to such enforcement matters, as well as developing internal compliance programs. In addition, Samantha handles licensure and regulatory filings for a variety of health care clients, with a focus on hospitals and clinical laboratories. She has worked on several large transactions in Massachusetts involving the change of ownership of major hospital systems, and has assisted national clinical laboratories with respect to licensure and reimbursement issues.

Last week, Mintz Levin’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 60 health care-related False Claims Act qui tam cases unsealed in December 2017 and January 2018 and the trends they reflect:

  • The government intervened in 14% of those unsealed cases (a figure that is consistent with the longer-term trends we have seen over the prior twelve months).
  • Of the 60 unsealed cases, only 28 were being litigated (at least initially). The remaining 32 cases were docketed as closed or dismissed.
  • The 60 unsealed cases were filed in 38 different courts. Jurisdictions with the most unsealed cases included:
    • The Central District of California (which includes Los Angeles) with six cases;
    • The Middle District of Florida (which includes Jacksonville, Orlando, and Tampa) with 4 cases; and
    • The District of Connecticut and Eastern District of Louisiana (New Orleans), each with 3 cases.
  • The most frequently targeted types of defendants included:
    • Pharmaceutical companies, hospitals, and healthcare systems, with each accounting for 9 of the 60 unsealed cases.
    • Physicians and physician group practices, which were targeted in 7 cases.
    • Home health and hospice providers, which were the subject of 6 cases.
    • Outpatient clinics, which were defendants in 5 cases.
  • Former employees were again the most frequent relator type, accounting for 23 of the 60 unsealed cases. Expert witnesses brought 7 cases and current employees brought 2 cases.
  • Only one of the cases was unsealed within the 60-day period specified by statute. That case was under seal for 55 days.
  • The longest time a case was under seal was almost eight-and-a-half years. Average time under seal for this cohort was 700 days, though half of these cases were unsealed in 16 months or less, and 23 of these 60 cases were unsealed in less than a year.

Continue Reading Mintz Levin’s Health Care Enforcement Defense Group Publishes New Qui Tam Update

The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending – at least in the Fifth Circuit.  Although the Fifth Circuit Court of Appeals remanded the case, Family Rehabilitation, Inc. v. Azar, back to the district court and thus it is still too soon to tell the ultimate outcome, it reversed the district court and held that there is jurisdiction for a district court to enjoin CMS recoupment during the administrative appeals process.  This decision is a big win for companies navigating the difficult and seemingly one-sided process of Medicare recoupment actions. Continue Reading Fifth Circuit Decision is Rare Victory Permitting District Court to Enjoin Recoupment Before Provider Exhausts Administrative Remedies

Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had violated the False Claims Act by purchasing lavish meals for physicians to induce them to use heart pumps manufactured by the Company.

The government’s allegations are not particularly novel, but do serve as an important reminder to health care providers and suppliers that it is important to institute, and remain vigilant about, sound compliance practices across all areas of their business.  These allegations also make clear that the government continues to be focused on providers’ and suppliers’ sales and marketing practices. Continue Reading Recent FCA Settlement Shows That What’s Old Is New in Health Care Fraud Enforcement

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices.  Earlier this month, the Department of Justice (DOJ) announced that a Michigan physician, Dr. Rodney Moret, was sentenced to 75 months in prison for his role in conspiracies to distribute prescription pills illegally and to defraud Medicare. The conduct alleged against Dr. Moret is particularly extreme, but nevertheless reflects the government’s commitment to ferreting out opioid-related misconduct. Continue Reading Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

In both civil and criminal enforcement proceedings, 2017 was perhaps most notable for the cases brought against individual health care providers and small physician practice owners.  Among the factors that may have resulted in the uptick in cases against individuals are the Yates Memo issued in late 2015, improved and increased reliance on sophisticated data analytics, and the aggressive focus on opioid addiction and its causes. Continue Reading Health Care Enforcement Review and 2018 Outlook: Criminal and Civil Enforcement Trends

Earlier this week, Mintz Levin’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update. This Update covers 34 health care-related qui tam cases that were unsealed in July 2017.

Here are some of the highlights:

– Of the 34 cases unsealed in July 2017, the government intervened (in whole or in part) in six cases and declined to intervene in 28.

– These 34 unsealed cases were filed in 21 different courts, including:

  • Five in the Southern District of Ohio;
  • Three in the District of Arizona; and
  • Three in the Western District of Virginia.

Continue Reading Mintz’s Health Care Enforcement Defense Group Publishes New Qui Tam Update

Earlier this week we released a Health Care Enforcement Advisory about a recent decision from the U.S. Court of Appeals for the Fifth Circuit that may have a significant impact on the element of “materiality” in False Claims Act (FCA) cases.  A panel of judges on the Fifth Circuit overturned a district court decision after a jury found the defendant, Trinity Industries, Inc. (Trinity), liable under the FCA for changing its highway guardrail design without disclosing such changes to the Federal Highway Administration (“FHWA”).  The Fifth Circuit decided as a matter of law that the case lacked the element of “materiality” required in FCA cases. Continue Reading Fifth Circuit Limits FCA Liability Due to Lack of “Materiality” in Highway Guardrails Case

On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and U.S. Food and Drug Commissioner Dr. Scott Gottlieb will give the keynote addresses. Part of the goal of the workshop is to identify obstacles to competition and discuss policy steps that can increase the availability of generic drugs to consumers.

The Hatch-Waxman Act (the Act), which Congress passed over 30 years ago, provides a regulatory and judicial framework to expedite generic entry into U.S. prescription drug markets. For many drugs, the Act has helped reduce patent-related barriers to generic drug entry, which, in turn, has increased competition that has led to lower drug prices. In 2010, Congress created a similar framework for biosimilar drug development under the Biologics Price Competition and Innovation Act. Continue Reading Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market

Last week, Mintz Levin’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 21 health care-related False Claims Act qui tam cases unsealed in May 2017, and the findings include:

  • long delays in unsealing remain the norm;
  • relators overwhelmingly consisted of current and former employees (and physicians); and
  • the most common alleged violation was billing fraud (which was claimed in two-thirds of the 21 unsealed cases).

Also of note in this Update:

  • The targeted entities in these 21 cases included outpatient medical and psychological providers, laboratory testing companies, inpatient hospitals, and home health care providers.
  • Of the 21 cases, the government intervened, in whole or in part, in seven cases and declined to intervene in 10.  (Intervention status could not be determined from the docket in four cases.)
  • The cases were filed in 17 different courts (including the Central District of California, the District of South Carolina, the Eastern District of Michigan, and the Northern District of California).

This Update provides in-depth analysis of three of the unsealed cases, which involve allegations regarding (1) “up coding” by a hospital that allegedly billed routine transport as emergency transport, which was reimbursed at a higher rate; (2) billing for medically unnecessary tests that purported to identify susceptibility to opioid addiction and engaging in a kickback scheme; and (3) processing prior authorization requests for MCOs using automated procedures to expedite processing and circumvent medical necessity determinations, resulting in submission of false claims.

Earlier this week, my colleagues Bruce Sokler, Robert Kidwell, Dionne Lomax, and Farrah Short published an alert about the federal district court for the Eastern District of Michigan’s recent decision to deny both the government’s and defendant hospital’s respective motions for summary judgment in a suit filed by the Department of Justice and the Michigan Attorney General in 2015 against W.A. Foote Memorial Hospital, d/b/a Allegiance Health (“Allegiance”), Hillsdale Community Health Center (“HCHC”), Community Health Center of Branch County (“Branch”), and ProMedica Health System, Inc. (“ProMedica”).  In this case, the government alleged that HCHC orchestrated agreements among the hospitals not to advertise or otherwise market in each other’s territories for competing health care services in violation of the Sherman Act.  (You can read Dionne’s previous alert on the Allegiance complaint here.)  HCHC, Branch and ProMedica have each settled, leaving Allegiance as the sole defendant. Continue Reading Antitrust Suit Against Michigan Hospital Moves Forward After Federal District Court Denies Both Sides’ Motions for Summary Judgment