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Bridgette A. Keller

Associate

[email protected]

+1.212.692.6735

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Bridgette applies her experience in health system administration and ethics in health care to her health law practice. Bridgette advises health care providers, ACOs, health plans, PBMs, and laboratories on a variety of regulatory, fraud and abuse, and business planning matters.

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 enforcement defense activities, internal investigations, regulatory compliance, and fraud and abuse analyses of proposed new procedures.

Bridgette's work also includes a focus on ethics in health care principles. As a health care ethicist with the Department of Veterans Affairs National Center for Ethics in Health Care (NCEHC), Bridgette provided technical guidance on health care ethics problems to VA stakeholders, VA Central Office staff, and field-based consultants. She also collaborated on the development of an ethics consultation program and educational materials. Prior to her appointment at the NCEHC, Bridgette served as the Outpatient Clinic Coordinator at the Manhattan Campus of the VA New York Harbor Healthcare System and completed the Graduate Health Administration Training Program at the Washington DC VA Medical Center. Her health care management experience includes outpatient clinical operations, customer service, performance improvement, program development and implementation, data analysis, and supervision of staff.

Bridgette is trained in Lean/Six Sigma thinking and as an examiner for the Baldrige Criteria for Performance Excellence.

Education

  • Seton Hall University (JD)
  • Georgetown University (MS)
  • Villanova University (BS)

Recognition & Awards

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

Involvement

  • Member, American Health Lawyers Association (AHLA)
  • Member, American Bar Association (ABA)
  • Member, American College of Healthcare Executives (ACHE)
  • Member, American Society of Bioethics and Humanities (ASBH)

Recent Insights

News & Press

Events

Viewpoints

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Health Law Diagnosed — Bioethical Considerations in a Pandemic

January 7, 2021 | Podcast | By Nili Yolin, Bridgette Keller

Mounting anxiety over how to control the spread of infectious disease outbreaks encourages public and political discourse of bioethics.
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As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations, which go into effect January 19, 2021. Today, we are taking a look at changes to existing AKS safe harbors and Stark Law exceptions, and, an extra add-on: a new Stark Exception for Limited Remuneration to a Physician. Mintz is also hosting a webinar during which we will review the key provisions from the final rules and provide practical examples of how the industry can take advantage of these significant changes. We hope you can join us.
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Bioethics in a Pandemic: FDA Guidance on Granting EUAs for a COVID-19 Vaccine

October 29, 2020 | Blog | By Bridgette Keller, Benjamin Zegarelli

Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational vaccines for COVID-19. This guidance was the subject of intense political debate among the White House, FDA, and other public health officials given the urgent need for a safe and effective vaccine.
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As the COVID-19 pandemic continues to upend our daily lives, the promise of a vaccine offers hope that life may, in the not-too-distant future, return to some version of normalcy. The path to getting a safe, accessible vaccine to market, however, presents a variety of its own challenges. As we’ve been exploring in our Bioethics in a Pandemic blog series, the pandemic has presented a host of bioethics issues pertinent to the vaccine development and distribution process. Mintz's Bridgette Keller recently shared her insights into how bioethics can (and should!) influence research and development at the M2D2 Challenge Awards. A video of her presentation is now available to view online.
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Bioethics in a Pandemic: Final Framework for Equitable Allocation of a COVID-19 Vaccine

October 20, 2020 | Blog | By Bridgette Keller, David Friedman

Earlier this month, the National Academies Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released its Final Framework to guide US distribution and administration of a COVID-19 vaccine, once available. The nuts and bolts of the Final Framework remain largely the same as the Draft Framework we covered previously in our Bioethics Blog Series. After a quick review of the Allocation Phases here, we explore a few areas in the Final Framework the Committee expanded on and responded to stakeholder comments.
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Bioethics in a Pandemic: Operation Warp Speed

September 23, 2020 | Blog | By Bridgette Keller, Elizabeth Conti

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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Bioethics in a Pandemic: Vaccine Research and Clinical Trials

September 16, 2020 | Blog | By Bridgette Keller, Benjamin Zegarelli

After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine development process, including clinical trials. As a first step, we provide a very brief introduction on how vaccines are developed and tested prior to approval and release.
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Bioethics in a Pandemic: The Public’s Role in COVID-19 Vaccination

September 9, 2020 | Blog | By Bridgette Keller, Michelle Caton

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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Bioethics in a Pandemic: Uncertainties in Applying the Draft Framework

September 4, 2020 | Blog | By Bridgette Keller, David Friedman

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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Bioethics in a Pandemic: Draft Framework for Equitable Allocation of COVID-19 Vaccine

September 4, 2020 | Blog | By Bridgette Keller, David Friedman

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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News & Press

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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.