Tara Dwyer on Centers for Medicare & Medicaid Services (CMS)

CMS Proposes New Standards for Bona Fide Service Fees in Average Sales Price Calculations: What Plans, PBMs, and Other Recipients...

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more

7/31/2025 / Centers for Medicare & Medicaid Services (CMS) , Fees , Manufacturers , Medicare , Pharmaceutical Industry , Prescription Drugs , Proposed Rules , Regulatory Requirements , Reporting Requirements

CMS Sheds Light on its Timeline for Expedited RADV Audits

Shortly following its announcement of sweeping changes to RADV audits, CMS shared industry guidance last week regarding upcoming deadlines for the submission of risk adjustment data corrections in advance of RADV sampling....more

6/6/2025 / Audits , Centers for Medicare & Medicaid Services (CMS) , Filing Deadlines , Health Insurance , Medicare , Medicare Advantage , Medicare Advantage Organizations (MAOs) , New Guidance , Reporting Requirements

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

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

[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

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

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 — 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

Health Care: A Clearer Vision in 2020? Don’t Bet On It

As we noted in our previous blog post, there are several legislative priorities in the health care space that could see action this year. There are also a variety of activities beginning this year that could set the stage for...more

1/16/2020 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Federal Food Drug and Cosmetic Act (FFDCA) , Health Care Providers , Healthcare , Healthcare Reform , Legislative Agendas , Pharmaceutical Industry , Prescription Drugs

CMS Finalizes Rule Requiring Disclosure of Drug Prices in TV Ads

Yesterday, May 8, 2019, the Centers for Medicaid & Medicaid Services (“CMS”) released its final rule requiring drug manufacturers to disclose a drug’s wholesale acquisition cost (“WAC”) in direct-to-consumer television...more

5/10/2019 / Advertising , Centers for Medicare & Medicaid Services (CMS) , Direct to Consumer Sales , Drug Pricing , Final Rules , First Amendment , Pharmaceutical Industry , Prescription Drugs , Television Commercials

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

Tara Dwyer

Mintz

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