Jane’s practice focuses primarily on health care enforcement defense. Jane defends laboratories, physicians, and other clients facing government investigations and qui tam litigation arising from alleged violations of the federal False Claims Act (FCA), the Stark Law, and alleged criminal and civil violations of the anti-kickback statute. Jane assists clients with negotiation and structuring of global settlements with the US Department of Justice and its US Attorneys’ Offices and state Attorneys' General Offices as well as corporate integrity agreements with the Department of Health and Human Services Office of Inspector General. Jane also defends clients in consumer protection and unfair or deceptive trade practices investigations initiated by the Federal Trade Commission or state Attorneys’ General Offices. Jane also advises clients regarding cannabis licensing, compliance, and regulatory matters.
Recent victories to which Jane has contributed include:
- Successfully defended a national laboratory against a whistleblower’s qui tam complaint.
- Defense verdicts on summary judgment in multi-jurisdictional product liability disputes involving FDA-approved pharmaceutical drugs and assay test development.
- Defense verdict on partial summary judgment in a bet-the-company case involving a dispute between the majority owner of a multi-billion dollar company and private equity investors.
Jane also maintains an active pro bono practice, succeeding on an appeal before an administrative law judge and securing social security benefits for her client. Jane has also appeared in family and probate court on behalf of her clients in guardianship and custody matters. Most recently, Jane’s pro bono practice has focused on social justice efforts, including participating in CORI sealing clinics and conducting research specific to assisting individuals with criminal records in understanding their public housing options. Jane also participates in the Lawyers Clearinghouse Legal Clinic for the Homeless, through which Mintz attorneys provide legal representation to residents of Boston-area homeless shelters.
While attending law school at night and working full time for the State Auditor’s Office, Jane was the winner of the National Moot Court New England Regional Competition and the two-time winner of the Tom C. Clark Appellate Advocacy Competition. She also served as Comment Editor of the Suffolk University Law Review. She graduated first in her class from Suffolk Law’s evening program.
viewpoints
COVID-19 Relief Programs: Mitigating and Responding To Enforcement Risk
June 22, 2020 | Blog | By Brian Dunphy, Jane Haviland, Nicole Henry, Karen Lovitch
Since the early days of the pandemic, Mintz’s COVID-19 Compliance & Enforcement Defense Task Force has closely monitored and advised clients on the evolving COVID-19 relief programs, including those created by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The CARES Act provided for over $2 trillion in relief funds, which is the largest emergency assistance package in American history. The numerous CARES Act programs have continued to develop through, among other things, the passage of the Paycheck Protection Program and Health Care Enhancement Act, the Paycheck Protection Program Flexibility Act of 2020, and rapidly changing regulatory guidance and FAQs. As one example, the government recently wrestled with whether to make public the list of about 4.6 million entities that received more than $500 billion from the Paycheck Protection Program (PPP) under the CARES Act. After initially refusing to disclose PPP loan recipients, the Small Business Administration and Treasury Department decided to make public the names of entities that received loans larger than $150,000, as well as the dollar range of each loan.
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CMS Allows Pharmacies and Other Suppliers to Bill Medicare for COVID-19 Testing
May 15, 2020 | Blog | By Karen Lovitch , Jane Haviland
In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they may temporarily enroll as independent clinical diagnostic laboratories during the COVID-19 public health emergency (PHE) so that they may bill Medicare for COVID-19 testing.
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FCC Chairman Proposes Plan to Implement CARES Act Funding for Telehealth Program
March 31, 2020 | Blog | By Jane Haviland, Ellen Janos
On Monday, FCC Chairman Ajit Pai circulated a plan to his fellow Commissioners detailing how the $200 million the agency will receive via the CARES Act should be deployed for a telehealth program to combat COVID-19. The telehealth program will enable eligible healthcare providers to purchase telecommunications, broadband connectivity and information services, and devices necessary to provide telehealth services to beneficiaries. The increased access to the tools needed to provide care via telehealth will allow COVID-19 patients to receive care and providers to give it, while reducing opportunities for further exposure.
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CMS Offers Unprecedented Flexibility in Medicare Enrollment Requirements in Light of the COVID-19 Pandemic
March 25, 2020 | Blog | By Karen Lovitch , Jane Haviland
As authorized by Section 1135 of the Social Security Act, the Centers for Medicare & Medicaid Services (CMS) has announced that it will extend temporary Medicare billing privileges to physicians and non-physician practitioners via telephone and that it will expedite pending enrollment applications submitted by all other providers and suppliers, including DMEPOS. CMS made the announcement on March 13th and followed up with the publication of FAQs related to enrollment relief earlier this week.
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OIG Advisory Opinion Permits a Pharmaceutical Manufacturer to Provide Financial Assistance to Needy Patients Receiving Risky Cell Therapy
January 30, 2020 | Blog | By Karen Lovitch , Jane Haviland
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial assistance for travel, lodging, and other expenses to certain patients receiving a cell therapy that it offers (the Arrangement). The OIG concluded that the Arrangement could potentially violate the Anti-Kickback Statute as well as the prohibition on beneficiary inducement in the Civil Monetary Penalties Law (the Beneficiary Inducement CMP) but ultimately declined to impose administrative sanctions.
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Health Care Enforcement Year-in-Review and 2020 Outlook: Criminal Case Developments
January 22, 2020 | Blog | By Eoin Beirne, Nicole Henry, Jason Burrell , Jane Haviland
As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the Department of Justice (DOJ), in addition to DOJ's sustained focus on prosecuting individuals and data-driven identification of health care fraud. This post provides an overview of our article, which covers these issues and our expectations for 2020 in detail.
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HHS Proposes Sweeping Changes to AKS and Stark Law, Part 6: Proposed Changes to the AKS Related to Beneficiary Inducement
December 18, 2019 | Blog | By Karen Lovitch , Rachel Yount, Jane Haviland
As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This final post in our blog series focuses on a proposed new safe harbor that would protect patient engagement and support arrangements designed to improve quality, efficiency of care, and health outcomes. The OIG is also proposing modifications to the existing safe harbor for local transportation and a new safe harbor for remuneration provided in connection with certain payment and care delivery models developed by the Centers for Medicare & Medicaid Innovation Center or by the Medicare Shared Savings Program. Lastly, the OIG is codifying an existing statutory safe harbor for Accountable Care Organization (ACO) beneficiary incentives and an existing statutory exception to the Civil Monetary Penalty (CMP) rules on beneficiary inducement for telehealth technology related to in-home dialysis services.
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DOJ Seeks Dismissal of FCA Qui Tam Case to Escape Onerous Discovery Obligations
August 22, 2019 | Blog | By Jane Haviland, Karen Lovitch
On August 20, 2019, the United States exercised its authority under the False Claims Act (FCA) to seek dismissal of a relator’s qui tam suit because of the defendant’s burdensome discovery demands, in Polansky v. Executive Health Resources, Inc. Since the lawsuit’s inception in 2012, the U.S. Department of Justice (DOJ), the U.S. Department of Health and Human Services' (HHS) Centers for Medicare and Medicaid Services (CMS), and other government agencies have attempted to fend off a series of burdensome Touhy requests but failed to do so. Meanwhile, the scope of discovery has ballooned. Collectively, DOJ and HHS have deployed six attorneys to work this case. And, to top it off, DOJ is concerned about relator’s credibility and his ability to prove a FCA violation. DOJ’s dismissal request thus comes as no surprise.
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Third Circuit Dismisses FCA Case Under Pre-ACA Version of Public Disclosure Bar
July 10, 2019 | Blog | By Jane Haviland
The Third Circuit Court of Appeals recently dismissed a relator’s False Claims Act (“FCA”) case under the pre-Affordable Care Act (“ACA”) version of the public disclosure bar. The court decided in U.S. ex rel. Denis v. Medco that to escape the FCA’s public disclosure bar by qualifying as an “original source” under the pre-ACA version of the FCA, a relator must have first-hand, non-derivative knowledge of conduct giving rise to the FCA claim.
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Divided Supreme Court Cuts Back Doctrine of Judicial Auer Deference to Agency Interpretations of Its Own Ambiguous Rules
July 2, 2019 | Blog | By Jane Haviland
On June 26, 2019, a divided Supreme Court in Kisor v. Wilkie issued one of its most important administrative law decisions in decades. The Supreme Court decided to uphold, but dramatically narrow, the doctrine of judicial deference to agency regulations, known as Auer deference, but at the same time unanimously found for petitioner James Kisor in overturning the Federal Circuit’s affirmance of the Board of Veteran’s Appeals decision to deny part of his claim for Vietnam War disability benefits. We discuss below the majority and minority opinions on Auer deference, the narrow unanimous holding of reversal, and the importance of this decision.
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News & Press
Cannabis Ruling Lights Path For Bankruptcy Protection
April 16, 2024
Ruling Casts Shadow On Cannabis Employees' Ch. 13 Relief
February 16, 2023
Associates Jane Haviland, Kathryn Droumbakis, and Rachel Sposato co-authored an article published by Law360 discussing bankruptcy relief for employees in the cannabis industry.
Events & Speaking
Speaker
Speaker
Apr
25
2024
Healthcare Regulatory Considerations for Patient Incentives: AKS and CMPL Compliance, Safe Harbors, Exceptions
Strafford CLE
Virtual Webinar
Jun
24
2022
Enforcement and Data Analytics
ABA 32nd Annual National Institute on Health Care Fraud
Caesars Palace
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