Xavier Hardy on Centers for Medicare & Medicaid Services (CMS)

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

5/13/2025 / Administrative Procedure Act , Appeals , Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Drug Pricing , Inflation Reduction Act (IRA) , Judicial Review , Medicare , Pharmaceutical Industry , Prescription Drugs

CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more

3/25/2025 / Affordable Care Act , Biden Administration , Centers for Medicare & Medicaid Services (CMS) , DACA , Department of Health and Human Services (HHS) , Enrollment , Federal Poverty Line , Gender Identity , Health Insurance , Healthcare Reform , Inflation Reduction Act (IRA) , Insurance Industry , Out-of-Pocket Expenses , Proposed Rules , Regulatory Agenda , Regulatory Reform , Regulatory Requirements

What to Take Away from CMMI’s Early Termination of Four Demonstration Models

On March 12, 2025, in one of the Trump Administration’s first actions with respect to the Center for Medicare and Medicaid Innovation (CMMI), CMMI announced that it would prematurely terminate four alternative payment model...more

3/20/2025 / Alternative Payment Models (APM) , Biden Administration , Centers for Medicare & Medicaid Services (CMS) , CMMI , ESRD , Healthcare Reform , Medicaid , Medicare , MedPAC , Trump Administration , Value-Based Care

Mintz IRA Update — A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges

As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more

2/14/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Chevron Deference , Constitutional Challenges , Loper Bright Enterprises v Raimondo , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , SCOTUS

[Podcast] Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, 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...more

2/4/2025 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Health Insurance , Medicare , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Regulatory Requirements , Value-Based Care

Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, 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....more

2/4/2025 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Healthcare , Pharmacy Benefit Manager (PBM) , Regulatory Requirements , Value-Based Care

Stakeholders Raise 340B Concerns in Medicaid Drug Rebate Program Final Rule; CMS, With Hands Tied, Shrugs

On September 26, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). While not the focus of the agency’s rulemaking, stakeholders...more

10/30/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Manufacturers , Medicaid , Prescription Drugs , Rebates , Section 340B

PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It...more

8/1/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Supply Chain , Telehealth , Transparency

Mintz IRA Update — IRA Litigation Update: Courts Begin to Address Legal Challenges to the Medicare Drug Price Negotiation Program

The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several...more

7/16/2024 / AstraZeneca , Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Dismissals , Drug Pricing , Fifth Amendment , Inflation Reduction Act (IRA) , Infringement , Medicare , Negotiations

The Uncertain Landscape of Medicare Agent/Broker Compensation Rules

In the Proposed Medicare Advantage and Part D Rules for 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to how Medicare Advantage organizations (MAOs) are allowed to contract with and...more

7/11/2024 / Administrative Procedure Act , Agents , Brokers , Centers for Medicare & Medicaid Services (CMS) , Contract Terms , Fees , Medicare , Medicare Advantage , Medicare Advantage Organizations (MAOs) , Medicare Part D

Mintz IRA Update — Legal Challenges to the Medicare Drug Price Negotiation Program Continue

The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which aims to lower drug prices by enabling the federal government to negotiate prices for some of the costliest Medicare Part D...more

3/18/2024 / AARP , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Medicare , Medicare Part D , Negotiations , PHRMA , Preliminary Injunctions

Mintz IRA Update — Demystifying the IRA’s Small Biotech Exception

On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”). In...more

3/18/2024 / Biotechnology , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Negotiations , OMB , Prescription Drugs

Court Strikes Down HHS Rule on Copay Accumulators: Implications for Health Plans and PBMs

In a significant development with far-reaching implications for health plans and pharmacy benefit managers (PBMs), Judge John D. Bates of the U.S. District Court for the District of Columbia has recently struck down a federal...more

10/10/2023 / Centers for Medicare & Medicaid Services (CMS) , Co-payments , Department of Health and Human Services (HHS) , Health and Welfare Plans , Health Care Providers , Healthcare , Out-of-Pocket Expenses , Pharmacy Benefit Manager (PBM)

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

A Review of the Affordable Care Act at 10 Years, Part 4: Alternative Payment and Delivery Models

Today's post is the last in our series on the 10-year anniversary of the Affordable Care Act (ACA). While the Congress that passed the ACA recognized that health care delivery reform was necessary, the law included few...more

4/14/2020 / Affordable Care Act , Antitrust Provisions , Centers for Medicare & Medicaid Services (CMS) , CMMI , Healthcare Reform , Medicare Shared Savings Program , Sherman Act , Waivers

A Review of the Affordable Care Act at 10 Years, Part 2: Medicaid Expansion

This post is the second installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA) and will examine Medicaid expansion under the ACA. Medicaid is joint federal-state program that...more

4/9/2020 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Congressional Budget Office , Department of Health and Human Services (HHS) , Federal Health Insurance Exchanges , Federal Poverty Line , Health Insurance , Medicaid Expansion , Medicaid Work Requirements , Medicare , Social Security Act , Spending Clause , State and Local Government

CMS Proposes Changes to Medicare Advantage Program for CY 2020

CMS recently proposed several important changes for the Medicare Advantage ("MA") program that relate to payment, benefit design, and new actions to combat the opioid crisis. These changes, among others, were proposed in...more

2/7/2019 / Advance Notice , Bipartisan Budget Act , Call Letter , Centers for Medicare & Medicaid Services (CMS) , CMMI , Healthcare , Medicare Advantage , Medicare Part D , Opioid , Pharmaceutical Industry , Prescription Drugs , Risk Adjustment Formula

CMS, In a Reversal, Announces Plans to Continue Funding Risk Adjustment Payments

On Wednesday, August 8, CMS filed a proposed rule clearing the way for the federal government to continue making payments under the ACA’s risk adjustment program for the benefit year 2018. The 2018 proposed rule is...more

8/10/2018 / Affordable Care Act , Arbitrary and Capricious , Centers for Medicare & Medicaid Services (CMS) , Co-Op , Department of Health and Human Services (HHS) , Health Insurance , Healthcare Reform , Proposed Rules , Risk Adjustment Formula

What Lessons Can We Take From The Administration’s Refusal to Allow Idaho to Dismantle the ACA Marketplaces?

In early January, Idaho Governor Butch Otter signed an executive order (EO) directing the state’s Department of Insurance (DOI) to “seek creative options” to expand “access” to health insurance coverage for Idahoans. The EO...more

4/3/2018 / 1115 Waivers , 1332 Waiver , Affordable Care Act , Association Health Plans , Centers for Medicare & Medicaid Services (CMS) , Deregulation , Executive Orders , Health Insurance , Healthcare Reform , Legislative Agendas , Medicaid , Trump Administration

Xavier Hardy

Mintz

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