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Bridgette A. Keller

Associate

[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

Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill

August 10, 2022 | Blog | By Bridgette Keller, Stephnie John

On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the Reconciliation Bill includes a revised drug pricing reform package that Democrats had approved last month. In this post, we review what passing the long-awaited drug pricing reforms means for Medicare recipients and for drug prices in the United States.
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PBM Regulatory Roundup (Summer 2022): States Continue PBM Oversight Activities

August 2, 2022 | Blog | By Bridgette Keller, Hassan Shaikh, Derek Flynn, Shaina Sikka

2022 continues to see a surge in state-led PBM enforcement efforts. This roundup provides a brief summary of Louisiana’s complaint against United Healthcare and OptumRx related to its Medicaid program and recent state legislative actions.
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Bridgette Keller speaks with Kerlann Flowers, Legal Director and Senior Attorney for Hofstra University School of Law’s Medical-Legal Partnership (MLP), and Mintz Associate Jean Krebs about the MLP’s work and how collaboration between medical providers and lawyers can improve outcomes.
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PBMs Continue to Draw Federal Scrutiny: PBM Transparency Act of 2022

June 30, 2022 | Blog | By Bridgette Keller, Hassan Shaikh, Sergey Smirnov, Jewel Duberry-Douglas

As we noted in our last PBM Regulatory Roundup, there has been a wave of state regulation focused on PBM practices in the wake of Rutledge and Webhi. However, PBMs are also facing federal reform efforts. The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 (the Act) was recently proposed in the U.S. Senate and intends to incentivize “fair and transparent” PBM practices, prohibit spread pricing and claw backs of payments to pharmacies, and empower the Federal Trade Commission (“FTC”) and state attorneys general in enforcement actions to stop “unfair and deceptive” PBM business practices.

At the same time, government watchdogs are also taking action: on June 7, 2022, the FTC announced that it would launch an inquiry into vertically integrated PBMs, and the Office of the Inspector General (OIG) for the Department of Health and Human Services expects to release a report in 2022 following completion of its analysis of Medicaid Managed Care Organization (MCO) PBM pricing.
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Telehealth has the potential to counteract historical disparities in access to health care. Listen to hear how Andy Ward, Director of the South Boston Collaborative Center, and Kate Steinle, Chief Clinical Officer of Folx Health, are leveraging telehealth to serve their communities.
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Continuing our series discussing the CY 2023 Medicare Advantage and Part D Final Rule (Final Rule), this post focuses on the D-SNP related provisions under the Final Rule.  As we discussed, the Centers for Medicare & Medicaid Services (CMS) proposed significant modifications to its regulations governing Dual Eligible Special Needs Plans (D-SNPs).  CMS finalized the majority of its proposals with limited modifications.  This blog summarizes some of the key D-SNP provisions, focusing on the modifications from the proposed rule and CMS’ commentary that provides insight into CMS’ priorities and focus areas.  Please refer to our prior post on D-SNPs for a more in-depth overview of the proposals.
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The Centers for Medicare & Medicaid Services (CMS) released its Final Rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (Final Rule) late last week.  We summarized the major provisions of CY 2023 Proposed Rule in a blog series in January, noting that the proposals sought to increase consumer protections and reduce health disparities, with a strong emphasis on policies impacting individuals who are dually eligible for Medicare and Medicaid. This is the first blog post in our series on the Final Rule in which we discuss policy changes to the maximum out-of-pocket (MOOP) rules requiring that all cost-sharing, including cost sharing paid by secondary payors, be included in the calculations for MOOP.
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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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Health Law Diagnosed — Key Takeaways from the 6th Annual Pharmacy & Pharmaceutical Industry Summit

April 7, 2022 | Podcast | By Stephnie John, Bridgette Keller, Hassan Shaikh

The latest episode of Mintz’s Health Law Diagnosed podcast covers key takeaways from our 6th Annual Pharmacy & Pharmaceutical Industry Summit.
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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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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.
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Recognition & Awards

  • Included on the New York Super Lawyers Rising Star: Health Care list (2020-2021)
  • 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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Bridgette A. Keller

Associate

New York