Bridgette Keller on Proposed Rules

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team...more

2/12/2025 / Compliance , Federal Trade Commission (FTC) , Final Rules , Health Insurance , Healthcare , Legislative Agendas , Medicaid , Medicare , Pharmacy Benefit Manager (PBM) , Proposed Rules , Regulatory Agenda , Regulatory Reform , Regulatory Requirements

[Podcast] Health Law Diagnosed – The 2024 Election and Health Care Policy

In the latest episode of Health Law Diagnosed, host Bridgette Keller dives into potential health care policy changes on the horizon following the November 2024 election. She is joined by Alex Hecht, ML Strategies Executive...more

1/22/2025 / Health Insurance , Healthcare Reform , Legislative Agendas , Medicaid , New Legislation , Pharmacy Benefit Manager (PBM) , Proposed Rules , Regulatory Agenda , Telehealth

Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs

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...more

3/11/2024 / Clinical Laboratories , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Pharmaceutical Industry , Proposed Rules

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

Bipartisan legislative activity related to pharmacy benefit manager (PBM) oversight is at an all-time high in both the House and Senate. As we noted last week, several bills that address PBM activities are moving through the...more

6/16/2023 / Department of Health and Human Services (HHS) , Drug Pricing , Federal Trade Commission (FTC) , FTC Act , Medicaid , Pharmacy Benefit Manager (PBM) , Proposed Rules , Reporting Requirements , Sunshine Act , Transparency

Final Medicare Advantage and Part D Rule will Likely Require Medicare Advantage Plans to Update 2023 Bids under Maximum...

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...more

5/5/2022 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Final Rules , Medicaid , Medicare , Medicare Advantage , Medicare Part D , Out-of-Pocket Expenses , Proposed Rules

CMS Proposes Changes to Medicare Advantage Regulations: Network Adequacy, Beneficiary Access, MLR Reporting, and MOOP

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...more

1/20/2022 / Centers for Medicare & Medicaid Services (CMS) , Medical Loss Ratio , Medicare , Medicare Advantage , Medicare Advantage Organizations (MAOs) , Medicare Part D , Out-of-Pocket Expenses , Proposed Rules , Public Health Emergency

CMS Proposes New Rules for Medicare Advantage and Part D

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...more

1/12/2022 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Durable Medical Equipment , Home Health Care , Medicaid , Medicare Advantage , Medicare Part D , Proposed Rules , Public Health Emergency

Bioethics in a Pandemic: FDA Guidance on Granting EUAs for a COVID-19 Vaccine

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...more

10/29/2020 / Biologics , CARES Act , Centers for Medicare & Medicaid Services (CMS) , Clinical Trials , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Infectious Diseases , Interim Final Rules (IFR) , Investigational New Drug Application (IND) , Proposed Rules , Provider Relief Fund , Public Health Emergency , Vaccinations

GAO Studies Use of PBMs in Medicare Part D

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...more

8/27/2019 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , GAO , Medicare , Medicare Part D , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Proposed Rules

Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a...more

12/6/2017 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Comprehensive Addiction and Recovery Act of 2016 (CARA) , Drug & Alcohol Abuse , Medicare Advantage , Medicare Part D , Opioid , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

Texas Medical Board’s Appeal Must Proceed Under Existing Jurisdiction Arguments

In another procedural defeat for the Texas Medical Board (the “Board”) over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth...more

8/22/2016 / Appeals , Commerce Clause , Proposed Rules , Sherman Act , State Action Immunity , State Medical Board , Statute of Limitations , Telemedicine

Bridgette Keller

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