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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

Last month, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a report finding that Medicare Part D, and Medicare beneficiaries, could reduce spending with increased use of biosimilars. Specifically, OIG recommends that the Centers for Medicare & Medicaid Services (CMS) (1) encourage Part D plan sponsors to increase access to and use of biosimilars, and (2) monitor biosimilar formulary coverage to identify concerning trends. This blog unpacks the OIG’s report.

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As states move forward with their 2022 legislative sessions in earnest, we have been examining whether the Wehbi decision has had any initial effects on PBM-focused legislation. This roundup provides a brief recap of the significance of Wehbi, summarizes the Eighth Circuit’s opinion and holding, and highlights some state measures that have been proposed or passed during the flurry of PBM-focused legislation we have already seen in 2022.

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Removing Barriers to Second Chances

January 24, 2022 | Article

Mintz initiated many pro bono projects to combat systemic racism after the murder of George Floyd, including organizing Massachusetts Criminal Offender Record Information sealing clinics with the Lawyers Clearinghouse and conducting research for a Boston-based nonprofit into how housing authorities around the country evaluate applicants with open criminal charges.
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Continuing our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed Rule), this post focuses on a few items that are specific to Medicare Advantage (MA) Plans. Here, we discuss CMS’ proposals to (1) require initial and expanded services area applicants to submit their proposed contracted networks during the application process, (2) clarify that beneficiary access requirements during disasters and emergencies apply when there is a “disruption in access to health care,” (3) return to medical loss ratio (MLR) reporting requirements from 2014 – 2017, and (4) an adjustment to how the maximum out-of-pocket (MOOP) limit is calculated for dually-eligible beneficiaries.
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Last week, CMS announced proposed rules seeking to increase consumer protections and reduce health care disparities in Medicare Advantage (MA) and Part D, with a strong emphasis on individuals who are dually eligible for Medicare and Medicaid. Over the next few weeks, the Mintz team will provide an in-depth review and analysis of the proposed rules here on our blog. In the meantime, here is summary of the proposed changes.
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As our colleagues predicted, the Supreme Court’s decision in Rutledge v. Pharmaceutical Care Management Association (PCMA) encouraged state efforts to expand regulation of pharmacy benefit managers (PBM) and related practices. And as expected, this year has already seen an aggressive round of state legislation that aims to expand regulation in this area.
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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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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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podcasts

Of Counsel Bridgette Keller is joined by Joanne Hawana, Ben Zegarelli, and John Daley, as they offer advice for navigating communications with the FDA.

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Host, Bridgette Keller is joined by Associate, David Gilboa to break down the highlights from our Spring 2025 PBM Policy and Legislative Update. In just five minutes, we cover the most impactful federal and state developments shaping the PBM landscape this season.

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Host Bridgette Keller is joined by Members Deb Daccord and Dan Cody to discuses the evolving legislative and regulatory landscape impacting healthcare transactions, particularly for private equities and hedge funds.

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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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Host Bridgette Keller, joined by Lauren Edgerton, Healthcare Director at Piper Sandler, and Kathryne Cooper, Partner at Jumpstart Nova leads a conversation around investing in women's health.

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In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, host Bridgette Keller leads a conversation around the emerging role of artificial intelligence (AI) in health care.

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In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs).

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As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

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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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