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Bridgette A. Keller

Of Counsel

[email protected]

+1.212.692.6735

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Bridgette advises clients in the health insurance industry, including managed care organizations, PBMs, and integrated delivery systems, ACOs, and providers on a variety of regulatory, fraud and abuse, and business planning matters. Her practice centers on compliance with federal health care program regulatory requirements, with a focus on reimbursement issues and value-based contracting.

Bridgette regularly counsels clients regarding risk-adjusted reimbursement programs and the practices that support them, including Medicare Advantage Organizations (MAOs) and ACOs participating in the Medicare Shared Savings Program (MSSP). Bridgette has experience conducting and defending investigations regarding fraud and abuse issues, including billing compliance related to Medicare, Medicaid, and TRICARE. She also works closely with discount medical plans (DMPOs) and other clients in the health care industry on matters relating to compliance with state regulations.

Bridgette is interested in value-based healthcare. She works closely with payors, providers, and ACOs, on a variety of innovative collaborations and has experience negotiating and papering these relationships.

With a background in health care operations, Bridgette is able to provide clients with practical insight that includes a focus on the business implications of health care regulatory and compliance, internal investigations, and fraud and abuse analyses of proposed new procedures. Bridgette applies her experience in health system administration and ethics in health care to her health law practice.  Prior to practicing law, she worked as a health care ethicist at the Department of Veterans Affairs National Center for Ethics in Health Care (NCEHC) and held other health system operations positions within VHA.

Most recently, Bridgette began hosting Health Law Diagnosed, Mintz’s health law podcast and she is a frequent author on Mintz’s Health Law Viewpoints.

Experience

  • Counsels clients regarding Medicare Advantage risk adjustment compliance, including responses to OIG and CMS RADV audits.
  • Assists with communication and advocacy with federal health care program regulators, including CMS and the HHS OIG.
  • Drafts and negotiates complex services agreements between health plans and PBMs.  
  • Monitors changes and developments in state laws that impact the PBM industry and other related stakeholders.
  • Conducts internal investigations into potential fraud and abuse matters and manage multiple key stakeholders.
  • Develops and implements compliance reviews to recommend and identify compliance best practices.
  • Assisted with the defense and settlement of a five-year False Claims Act investigation conducted by multiple U.S. Attorney’s Offices and DOJ’s Civil Division on behalf of a national health care provider. We successfully convinced the Office of Inspector General for the Department of Health and Human Services not to pursue a Corporate Integrity Agreement.
  • Represented a national health care provider in a False Claims Act investigation conducted by the U.S. Attorney’s Office for the Southern District of New York. The government ultimately declined to intervene, and the relator chose to voluntarily dismiss the case.
  • Assisted with the defense of a diagnostics company in a national criminal and civil investigation involving multiple US Attorneys’ Offices and state Attorneys' General Offices. The investigation involved alleged kickback issues and billing violations.
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viewpoints

References to Operation Warp Speed (OWS) have been present throughout our coverage of the ethical questions related to the development and distribution of a COVID-19 vaccine. In fact, OWS is part of a broader public-private effort to accelerate COVID-19 countermeasures, such as the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. OWS has ambitious goals. It intends to deliver 300 million doses of a safe and effective vaccine for COVID-19 by January 19, 2021. Here, we provide a brief overview of OWS, its current progress, and relevant ethical considerations.
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As we noted in our previous post, the Johns Hopkins University Center for Health Security (Center) has been hard at work studying and providing thought leadership regarding the COVID-19 pandemic from a variety of angles. The Center, in conjunction with Texas State University and the Working Group on Readying Populations for COVID-19 Vaccine, recently released a report exploring the public’s role in COVID-19 vaccination (Report). The Report provides recommendations to U.S. policymakers, practitioners, and other stakeholders about how to advance public understanding of, access to, and acceptance of vaccines that protect against COVID-19.
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As you know, the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) was released earlier this week, and we are highlighting its major sections as stakeholders prepare to submit comments by Friday, September 4th. Building on the lessons learned from past allocation frameworks, this post highlights the key provisions of the Draft Framework.
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Continuing with our review of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”), this post highlights a number of uncertainties that will be faced in implementing the proposed allocation. For additional background on the Draft Framework, please see our earlier posts in the Bioethics in a Pandemic series. The final chapter of the committee’s discussion draft identifies specific uncertainties that could present obstacles to the proposed allocation plan’s implementation. Ultimately, a vaccine allocation framework must remain flexible and adaptive when faced with updated scientific evidence and developments like those listed above. These considerations, as well as the public comments, will continue to be inform the development of the framework.
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The Johns Hopkins University Center for Health Security (the “Center”) has been providing thought leadership related to the novel coronavirus and the COVID-19 pandemic since the beginning of the year. Two of the Center’s recent reports relate directly to our discussion on vaccine distribution.  The first is an interim framework for COVID-19 vaccine allocation and distribution (the “Report”), and the second focuses on the public’s role in COVID-19 vaccination. Here, we provide a high-level overview of the first report. We’ll dive into the second report in a separate blog post.
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Bioethics in a Pandemic: Learning from the Past

September 1, 2020 | Blog | By Bridgette Keller, David Friedman

As we continue to discuss the ethical considerations related to the distribution of a safe and effective coronavirus vaccine, it is important to consider lessons learned from other pandemics. Though the particular facts of past pandemics of course differ from those of COVID-19, the goal of public health has always been to promote and protect the health and well-being of a population. Similarly, the ethical distribution of resources amid any pandemic is supported by the balance and tension among the four ethics principles: autonomy, justice, beneficence, and nonmaleficence. Here, we look at lessens learned from the poliovirus, ebolavirus, and 2009 H1N1 pandemics, as well as the National Pandemic Strategy related to vaccine distribution.
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Earlier today, the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released preliminary guidelines on the allocation of initial and limited supplies of a forthcoming COVID-19 vaccine. Once finalized, this framework will inform how policymakers and health professionals should initially prioritize vaccine recipients, taking into account factors such as mitigating community spread, maximizing public health benefits, and ensuring equitable vaccine access for underserved communities.

Though the turnaround time is short, there are two ways for interested stakeholders and member of the public to submit feedback regarding the draft plan:
1. Speak at TOMORROW’s Public Listening Session (September 2, 12 PM EDT). Speakers must adhere to a strict 5-minute time limit and submit their interest in speaking in advance.
2. Submit Written Comment by September 4 at 11:59 PM EDT. Comments and uploaded materials will be made available in the Committee’s Public Access File and should be submitted at this link.
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Bioethics in a Pandemic: The Basics

August 26, 2020 | Blog | By Bridgette Keller, David Friedman

Before we continue our Bioethics in a Pandemic series, we thought it would be helpful to provide a quick overview of the various principles that inform ethical decision-making in the health care setting.

As you might imagine, providing health care to individuals with diverse background and values presents ethical choices for health care professionals every day, throughout the entire health care system – providers, administrators, policymakers, insurers, employers, and even the health care lawyers! Well-recognized bioethics scholars Tom Beauchamp and James Childress offer a principle-based approach to guide ethical decision-making in health care. The four principles are (1) Respect for Autonomy, (2) Nonmaleficence, (3) Beneficence, and (4) Justice.
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News & Press

Press Release Thumbnail Mintz

NEW YORK – Mintz is pleased to announce that 18 attorneys have been named New York Metro Super Lawyers and 11 attorneys have been named New York Metro Rising Stars by Super Lawyers for 2023.

Press Release Thumbnail Mintz

17 Mintz attorneys have been named New York Metro Super Lawyers and nine Mintz attorneys have been named New York Metro Rising Stars by Super Lawyers for 2022.

Press Release Thumbnail Mintz
Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Kindred Healthcare, Inc. The definitive agreement totals approximately $4.1 billion in cash including the assumption or repayment of net debt.
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Recognition & Awards

  • Included on the New York Super Lawyers Rising Star: Health Care list (2020-2023)

  • ABA-BNA Award for Excellence in the Study of Health Law

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Involvement

  • Member, American Health Lawyers Association (AHLA)
  • Member, American Bar Association (ABA)
  • Member, American College of Healthcare Executives (ACHE)
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