Bridgette Keller

Bridgette Keller

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Trump Sends Letters to Manufacturers Regarding Most-Favored-Nation Executive Order Requirements

In follow-up to the May 12th “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” Executive Order, President Trump issued letters to seventeen manufacturers (Letters), reiterating the mandate for...more

8/11/2025  /  Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Drug Pricing , Executive Orders , Federal Trade Commission (FTC) , Manufacturers , Medicaid , Most-Favored Nations , Pharmaceutical Industry , Trump Administration

PBM Legislation in the Reconciliation Bill is Far From Sweeping PBM Reform

Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these...more

5/29/2025  /  Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Medicaid , Medicare Part D , New Legislation , Pharmacy Benefit Manager (PBM) , Proposed Legislation , Regulatory Reform , Reporting Requirements , Transparency

CMS Announces Sweeping Changes to RADV Audits

On May 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced significant changes in its risk adjustment data validation (RADV) audits. The changes focus on speed, the volume of targeted contracts, and...more

5/23/2025  /  Audits , Centers for Medicare & Medicaid Services (CMS) , Government Agencies , Health Insurance , Healthcare Reform , Medicaid , Medicare , Medicare Advantage , Regulatory Requirements

Trump Signs Most-Favored-Nation Executive Order - Potential Impact on Drug Supply Chain

After significant fanfare and anticipation, President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week. The Executive Order seeks to...more

5/15/2025  /  Department of Health and Human Services (HHS) , Drug Pricing , Enforcement , Executive Orders , Manufacturers , Medicaid , Medicare , Pharmaceutical Industry , Supply Chain , Trump Administration

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

Massachusetts Aligns with National Trends and Enacts Sweeping Legislation to Regulate Pharmaceutical Benefit Managers

On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more

1/27/2025  /  Drug Pricing , Health Insurance , Healthcare , Medicaid , New Legislation , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Regulatory Requirements , Reporting Requirements , Transparency

[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

Mintz IRA Update — Removal of AMP-Cap on Medicaid Rebates Causes Insulin Price Decrease

Insulin costs lowered to $35 dollars per month for many patients this year as three major insulin manufacturers — Sanofi, Novo Nordisk, and Eli Lilly — began offering price caps or savings programs.[1] This strategy was...more

3/18/2024  /  American Rescue Plan Act of 2021 , Drug Pricing , Medicaid , Price Inflation , Rebates

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

PBM Regulatory Roundup (Fall 2022): State Medicaid Enforcement Efforts Continue As Legislative Activity Slows Down

Though the flurry of state PBM-focused legislation slowed down with the summer recess, there has still been plenty of noteworthy PBM news. This roundup focuses on state Medicaid enforcement activities involving Centene and...more

11/15/2022  /  Enforcement , False Claims Act (FCA) , Fraud , Medicaid , Pharmacy Benefit Manager (PBM)

PBM Regulatory Roundup (Summer 2022): States Continue PBM Oversight Activities

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...more

8/2/2022  /  Breach of Contract , Louisiana , Medicaid , Pharmacy Benefit Manager (PBM) , Regulatory Oversight , Reimbursements , Unfair or Deceptive Trade Practices

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 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

OIG Says Proposed MCO Incentive Program Protected by AKS Safe Harbor

In its favorable Advisory Opinion 18-11, the OIG explains how a managed care organization’s proposed incentive program to pay network providers to increase the amount of Early and Periodic Screening, Diagnostic, and Treatment...more

11/20/2018  /  Advisory Opinions , Anti-Kickback Statute , Beneficiaries , Health Care Providers , Incentives , Managed Care Contracts , MCOs , Medicaid , OIG , Safe Harbors

CMS Focuses on a Modern Medicare

Earlier this month, CMS proposed changes to the Medicare Physician Fee Schedule and Quality Payment Program with the goal of “modernizing Medicare and restoring the doctor-patient relationship.” The proposed changes achieve...more

7/23/2018  /  Alternative Payment Models (APM) , Centers for Medicare & Medicaid Services (CMS) , Comment Period , Health Care Providers , Medicaid , Medicare , Medicare Part B , MIPS , Physician Fee Schedule , Physicians , Proposed Regulation

Opioids Have Our Attention

The government is focusing on opioids. Whether it be program policies, enforcement, or legislation, combating the opioid epidemic continues to be a major focus for government officials. It is also a major piece of the...more

6/22/2018  /  Alternative Payment Models (APM) , Electronic Medical Records , Health Care Providers , Healthcare Reform , HELP , Legislative Agendas , Legislative Committees , Medicaid , Medicare Part C , Medicare Part D , Opioid , Prescription Drugs , Substance Abuse

Future of the Affordable Care Act and the American Health Care Act

This week, in their “Future of the Affordable Care Act” series on our Employment Matters blog, my colleagues Alden Bianchi and Edward Lenz provided an analysis of the major provisions of the American Health Care Act...more

3/24/2017  /  Affordable Care Act , Medicaid , Proposed Legislation , Repeal , Trump Administration

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: March 2017

Trends & Analysis - ..This issue looks at 18 health care–related qui tam cases that were unsealed in whole or in part in late October through November 2016. ..The cases identified were filed in federal district courts...more

3/20/2017  /  Anti-Kickback Statute , False Claims Act (FCA) , Medicaid , Medicare , Personal Care Assistants , Qui Tam , Traumatic Brain Injuries

Mintz Levin Health Care Qui Tam Update: Recently Unsealed Whistleblower Cases

Featured Unsealed Cases United States ex rel. Thomas v. Best Choice Home Health Care Agency, Inc., No. 2:13-cv-02209 (D. Kan.) - Complaint Filed: May 6, 2013 - Complaint Unsealed: October 24, 2016...more

3/17/2017  /  Anti-Retaliation Provisions , Civil Penalty Fund , Co-Conspirators , Corporate Integrity Agreement , Criminal Penalties , Dismissals , False Billing , False Claims Act (FCA) , False-Certification of Conformance , Former Employee , Guilty Pleas , Home Health Care , Intervenors , Kickbacks , Medicaid , Medicare , Qui Tam , Relators , Stark Law , State False Claims Acts , Whistleblowers

Making the Sausage: Medicaid Block Grants in the 115th Congress

Republicans have been talking about remodeling the Medicaid program through block grants or per capita caps for years. Both block grants and per capita caps are designed to limit federal spending by providing a state with a...more

11/28/2016  /  Community Development Block Grants , Department of Health and Human Services (HHS) , Healthcare Reform , Medicaid

Groundbreaking Multi-Payer Alignment on Core Measures for Quality-Based Payments

For too long, health industry stakeholders have bandied about massive amounts of information that could not be used in a comparative sense. Both public and private payers had their own proprietary reporting metrics,...more

2/24/2016  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Medicaid , Proprietary Information , Provider Payments , Quality of Care Standards

HRSA Takes its First Steps on 340B Rules

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more

6/23/2015  /  Centers for Medicare & Medicaid Services (CMS) , Civil Monetary Penalty , Drug Pricing , HRSA , Medicaid , Pharmaceutical Industry , Prescription Drugs , Section 340B

Over a Decade in the Making: CMS Releases Long-Awaited Medicaid Managed Care Rule

On May 27, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a 653-page proposed rule affecting the thirty-nine states (plus the District of Columbia) that use managed care organizations (“MCOs”) to...more

6/8/2015  /  Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Managed Care Contracts , Medicaid

3 Key Take Aways from AHLA’s Institute on Medicare and Medicaid Payment Issues

Last week I attended the American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues in Baltimore, Maryland. Taking a comprehensive approach to reimbursement issues, the program offered a variety of...more

4/3/2015  /  Data Collection , Healthcare , Healthcare Fraud , Medicaid , Medicare , Professional Conferences
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