Tara Dwyer on Medicare

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

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

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 – 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

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

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 — Second Edition: Q1 2024

Mintz’s PBMs & Pharmacies practice is pleased to present the second edition of our Mintz IRA Update, a regular publication that delves into developments under the Inflation Reduction Act of 2022 (“IRA”) impacting the health...more

3/14/2024 / Drug Pricing , Healthcare , Inflation Reduction Act (IRA) , Medicare , Prescription Drugs

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

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

Revised Draft 2018 Medicare Marketing Guidelines Open For Comment

Last week, CMS published the Revised Draft 2018 Medicare Marketing Guidelines and requested feedback from all interested parties. The draft includes many small changes to the Marketing Guidelines, including but not...more

1/26/2017 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Electronic Communications , Health Plan Sponsors , Medicare , Section 1557

2017 OIG Work Plan: For Medicare Plans

Last week, the OIG posted its Work Plan for 2017. In it, the OIG announced many goals touching on programs including, but not limited to, Medicare, Medicaid, Insurance Marketplace (Health Exchanges), Indian Health Service,...more

11/16/2016 / Drug Pricing , Medicare , Medicare Advantage , Medicare Part B , Medicare Part D , OIG , Risk Adjustment Formula

2017 MA and Part D Audit Protocols and Data Requests are Open for Comment

CMS issued its Audit Protocols and Data Requests for Medicare Advantage and Part D plans on November 4, 2016 (the “Protocols”). The Protocols have been updated based on the over 500 comments CMS received in response to the...more

11/14/2016 / Centers for Medicare & Medicaid Services (CMS) , Medicare , Medicare Advantage , Medicare Part D

Part D Woes, According to the OIG

On June 23, 2015, the OIG issued two reports focusing on fraud, waste, and abuse in the Part D program, the first “Ensuring the Integrity of Medicare Part D” and the second “Questionable Billing Practices and Geographic...more

7/2/2015 / Centers for Medicare & Medicaid Services (CMS) , Fraud Alerts , Healthcare , Medicare , Medicare Part D , OIG , Prescription Drug Coverage , Prescription Drugs

CMS Changes Medicare Prescriber Enrollment Requirements

On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs. Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date,...more

5/15/2015 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Healthcare , Medicare , Medicare Part D , Prescription Drugs , Proposed Regulation

MA Risk Adjustment in the 2016 Call Letter and … in Health Care Fraud Charges

In past Call Letters, CMS has proposed and finalized significant changes to the Medicare Advantage risk adjustment system including, recalibrations, deletions and additions of diagnoses codes, and questioning of the value of...more

3/6/2015 / Centers for Medicare & Medicaid Services (CMS) , Coding , Healthcare , Healthcare Fraud , Medicare , Medicare Advantage

CMS Releases 2016 Draft Call Letter

Last week, the Centers for Medicare & Medicaid (CMS) released its 2016 Advance Rate Notice and draft Call Letter (2016 Call Letter) for the Medicare Advantage (MA) and Medicare Part D programs. The 2016 Call Letter outlines...more

2/27/2015 / Centers for Medicare & Medicaid Services (CMS) , Medicare , Medicare Advantage , Medicare Part D , Pharmaceutical Industry , Pharmacies , Physician Medicare Reimbursements

Supplemental Excepted Benefits? “It depends.”

Last week, HHS, along with the Department of Labor and the Treasury, provided long overdue guidance regarding the third category of supplemental “excepted benefits” as defined by Section 2791 of the Public Health Services...more

2/20/2015 / Affordable Care Act , Department of Health and Human Services (HHS) , Department of Labor (DOL) , Employee Retirement Income Security Act (ERISA) , Health Insurance , IRS , Medicare , Public Health Service Act , Supplemental Benefits , TRICARE

CMS Continues to Struggle with How to Provide High Quality Care to Dual Eligibles

Last week CMS announced that it would not execute its option to terminate its 2015 contracts with Medicare Advantage Plans and Part D plans that had scored three stars or less for three consecutive years. ...more

9/22/2014 / Centers for Medicare & Medicaid Services (CMS) , Healthcare , Medicare , Medicare Advantage , Medicare Part D

Tara Dwyer

Mintz

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