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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 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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Earlier this week, a committee of the National Academies sponsored by the CDC and NIH released its Draft Framework for Equitable Allocation of COVID-19 Vaccine. This Draft Framework builds on the successes and challenges of past vaccine allocation frameworks, as well as current frameworks for allocating scarce COVID-19 resources. This blog reviews these past frameworks that laid the foundation for the committee to develop its decision-making 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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Bioethics in a Pandemic: Vaccine Distribution

August 19, 2020 | Blog | By Bridgette Keller, David Friedman

After months of stay-at-home orders, quarantine protocols, social distancing, and back-to-school planning, the ever- present question on everyone’s mind is, When will we get back to business as usual?  For many, the answer involves discussion of a safe and effective vaccine, including when it will be available and who will be able to get it. Even though a vaccine likely won’t be available until 2021 at the earliest, experts are already thinking about how to distribute it.  This post is the first in a blog series that will consider the various bioethics issues and principles related to the COVID-19 pandemic.
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GAO recently released a report analyzing the use of pharmacy benefit managers (“PBMs”) and efforts to manage drug spending and use in the Medicare Part D program. Importantly, the report found that use of PBMs reduced Part D spending in 2016 by 20%, from $145 billion to $116 billon, through drug price rebates.
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Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription drug prices and builds off the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and arrive on the heels of CMS publishing a rule requiring the disclosure of drug prices in TV ads. Below we’ve provided a brief overview of the major provisions in the final rule, noting changes from the proposed rule that was issued in November 2018.
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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.

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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.
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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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