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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

As the spread of the Delta variant of COVID-19 and the reality of inconsistent vaccine uptake lead to growing case numbers across the country, many of us are wondering, how did we get here and what’s next?
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One main principle among public health measures is to use the least restrictive method necessary to protect the population, or to do the greatest good. From the public health perspective, requiring COVID status credentials (“Credentials”) makes sense because it allows people who present a low risk to others to not be subject to unnecessary restrictions. However, implementation and use of Credentials will require careful consideration of individual privacy concerns, as well as the ethical questions related to access and additional privilege.
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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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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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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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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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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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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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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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News & Press

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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.

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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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podcasts

Host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is joined by Member Deb Daccord, Of Counsel Cassie Paolillo, and Of Counsel Kate Stewart, who share their insights on the law’s far-reaching implications.

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Host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of Members, Of Counsel, and Associates as they share their perspectives on what’s coming up over the horizon.

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Host Of Counsel Bridgette Keller is joined by Alex Hecht, ML Strategies Executive Vice President & Director of Operations, Washington, DC, as they dive into potential health care policy changes on the horizon following the 2024 election and what stakeholders can expect in 2025.

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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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