Tara Dwyer on Medicare Part D

CMS’s 2026 Final Medicare Advantage Rule Focuses on Implementing the IRA and Deregulation

In April, CMS finalized its Contract Year (CY) 2026 Medicare Advantage and Part D Final Rule (Final Rule). With CMS releasing the 2026 Medicare Advantage and Part D Proposed Rule in December under the Biden Administration,...more

5/9/2025 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Final Rules , Inflation Reduction Act (IRA) , Medicare Advantage , Medicare Part D , Prescription Drugs , Proposed Rules , Regulatory Reform , Trump Administration

Mintz IRA Update — Fourth Edition: Q1 2025

Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022...more

2/14/2025 / Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Regulatory Agenda , Regulatory Requirements , Supply Chain

EnforceMintz — Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025

As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more

7/16/2024 / Beneficiaries , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Insurance , Health Plan Sponsors , Inflation Reduction Act (IRA) , Manufacturers , Medicare Part D , Out-of-Pocket Expenses , Reimbursements

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

Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program

As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) finalized a number of regulatory changes relating to how Medicare Advantage (MA) plans offer...more

6/6/2024 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Medicare Advantage , Medicare Advantage Organizations (MAOs) , Medicare Part D , Social Security Act , Supplemental Benefits

Unpacking CMS’s 2025 DSNP Changes: Considerations for Medicare Advantage Organizations

As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) made a number of enrollment changes impacting dual eligible special needs plans (DSNPs). The...more

5/3/2024 / Centers for Medicare & Medicaid Services (CMS) , Enrollment , Final Rules , Medicaid , Medicare Advantage , Medicare Advantage Organizations (MAOs) , Medicare Part D

CMS Publishes Final Rules Implementing Part C and Part D Program Changes

On April 23, 2024, the Centers for Medicare & Medicaid Services (CMS) published final rules setting forth Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024--Remaining...more

4/24/2024 / Agents , Beneficiaries , Brokers , Centers for Medicare & Medicaid Services (CMS) , Consolidated Appropriations Act (CAA) , Final Rules , Health Care Providers , Medicare Advantage , Medicare Advantage Organizations (MAOs) , Medicare Part C , Medicare Part D , Mental Health , Prescription Drugs , Social Security Act

CMS Releases Part Two of Guidance for the Inflation Reduction Act’s Medicare Prescription Payment Plan

On February 15, 2024, the Centers for Medicare and Medicaid Services (CMS) released the Medicare Prescription Payment Plan Draft Part Two Guidance (Part Two Guidance) as part of the Inflation Reduction Act’s (IRA) efforts to...more

2/27/2024 / Centers for Medicare & Medicaid Services (CMS) , Inflation Reduction Act (IRA) , Medicare Part D , Out-of-Pocket Expenses

CMS Releases Draft Part One Guidance on the Maximum Monthly Cap on Cost-Sharing Payments Program to Part D Plans

Most of the recent focus around the implementation of the Inflation Reduction Act (IRA) by the press and the industry has been on the Medicare Drug Price Negotiation Program and its potential impact on manufacturers. But the...more

9/8/2023 / Beneficiaries , Centers for Medicare & Medicaid Services (CMS) , Cost-Sharing , Drug Pricing , Inflation Reduction Act (IRA) , Medicare Part D , Negotiations

CMS Proposes Significant Changes to Medicare Advantage and Part D for 2021 and Beyond

This week, the U.S. Department for Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) released a proposed rule (the Medicare and Medicaid Programs: Contract Year 2021 and 2022 Policy and...more

2/10/2020 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Elder Care , ESRD , Medicare Advantage , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

HHS Proposes to Remove Drug Rebate Protections

On January 31, 2019, the U.S. Department of Health & Human Services (HHS) issued a proposed rule that would amend the discount safe harbor under the Anti-Kickback Statute (AKS) to eliminate protection for certain drug...more

2/5/2019 / Anti-Kickback Statute , Comment Period , Department of Health and Human Services (HHS) , Drug Pricing , Medicare Part D , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Proposed Rules , Public Comment , Safe Harbors

President Trump Delivers Much Anticipated Drug Pricing Speech

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more

5/14/2018 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Health Care Providers , Manufacturers , Medicaid , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Public Comment , REMS , Section 340B , Trump Administration

CMS Releases 2019 MA and Part D Final Rules and Call Letter

Earlier this week, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. CMS also released fact sheets for the Final Rule and the Call Letter. The Final...more

4/5/2018 / Call Letter , Centers for Medicare & Medicaid Services (CMS) , Final Rules , Healthcare , Medicare , Medicare Advantage , Medicare Part D , Pharmacies , Prescription Drugs , Rebates

CMS’s Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic

CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their...more

3/5/2018 / Advance Notice , Call Letter , Centers for Medicare & Medicaid Services (CMS) , Healthcare , Medicare , Medicare Advantage , Medicare Part D , New Guidance , Opioid , Pharmaceutical Industry , Pharmacies , Prescription Drugs

CMS Releases Advance Notice and Call Letter for Medicare Advantage and Part D

Late last week, CMS released the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter (Advance Notice...more

2/7/2018 / Call Letter , Centers for Medicare & Medicaid Services (CMS) , Civil Monetary Penalty , Medicare Access and CHIP Reauthorization (MACRA) , Medicare Advantage , Medicare Part D , Risk Adjustment Formula

In Proposed Regulations CMS Requests Information on Changes to Part D Negotiated Prices

Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In...more

1/16/2018 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Drug Pricing , Manufacturers , Medicare , Medicare Part D , Negotiations , Pharmaceutical Industry , Pharmacies , Point of Sale Terminals , Prescription Drugs , Proposed Regulation , Remuneration

Azar’s Nomination Hearing Highlights Medicare Negotiation of Part B Drug Prices

On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served...more

1/11/2018 / Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Drug Pricing , Healthcare Reform , Medicaid , Medicare , Medicare Part D , Presidential Nominations , Secretary of HHS , Section 340B , Trump Administration

Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes Aim at Drug Prices

The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid...more

11/28/2017 / Benefit Plan Sponsors , Centers for Medicare & Medicaid Services (CMS) , Cost-Sharing , Drug Pricing , Medicaid , Medicare , Medicare Advantage , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Proposed Rules , Public Health Service Act

CMS Releases CY 2019 Proposed Rule for Medicare Advantage and Part D

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the...more

11/21/2017 / Centers for Medicare & Medicaid Services (CMS) , Comprehensive Addiction and Recovery Act of 2016 (CARA) , Generic Drugs , Medicaid , Medicare , Medicare Advantage , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

CMS Completes Final Medicare Part D Reconciliation for 2016

CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017....more

10/12/2017 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Plan Sponsors , Medicare Part D , Pharmacies , Prescription Drugs , Remuneration , Reporting Requirements

CMS Releases the Final Medicare Part D DIR Reporting Requirements for 2016

On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of...more

6/26/2017 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Medicare Part D , Pharmacies , Proposed Regulation , Provider Payments , Remuneration , Reporting Requirements

CMS Releases the Proposed Part D DIR Reporting Requirements for 2016

Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline....more

5/18/2017 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Medicare Part D , Proposed Regulation , Provider Payments , Remuneration , Reporting Requirements

C-THRU’s Proposed Changes to Negotiated Prices – A Demonstration of the Part D Program’s Complexities and Misunderstandings

As described in last week’s post, Senator Wyden has introduced the C-THRU Act that seeks to require public disclosure of PBM rebate amounts, establish a minimum rebate percentage that PBMs must pass on to Part D and Exchange...more

3/31/2017 / Drug Pricing , Health Insurance Exchanges , Medicare Part D , Prescription Drugs , Proposed Legislation , Public Disclosure , Rebates

Wyden’s C-THRU Act – Publicizing PBM Rebate Data

Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.” As its name suggests, it seeks to require parties (e.g., PBMs)...more

3/22/2017 / Department of Health and Human Services (HHS) , Disclosure , Drug Pricing , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Proposed Legislation , Rebates , Sensitive Business Information , State Health Insurance Exchanges , Transparency

Tara Dwyer

Mintz

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