Lauren Moldawer on Medicare

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

HHS Restructuring and Workforce Reductions – Key Implications for the Health Care Industry

As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s...more

4/15/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Healthcare Reform , Involuntary Reduction in Force , Layoffs , Medicaid , Medical Devices , Medicare , Pharmaceutical Industry , Regulatory Oversight , Regulatory Reform

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

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

2/14/2025 / Centers for Medicare & Medicaid Services (CMS) , Compliance , Drug Pricing , Inflation Reduction Act (IRA) , Manufacturers , Medicaid , Medicare , Pharmaceutical Industry , Regulatory Requirements , Section 340B

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

CMS Announces Drug List for Inflation Reduction Act Price Negotiations

Today, the Centers for Medicare & Medicaid Services (CMS) released the first 10 drugs (“Listed Drugs”) that will be included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program (“Negotiation Program”)....more

8/31/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Fair Price , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Negotiations , Prescription Drugs

CMS Proposes New Disclosure of Ownership Regulations for Nursing Facilities - Top Five Takeaways for Private Equity Firms and...

Private equity (PE) ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. For...more

2/22/2023 / Business Ownership , Centers for Medicare & Medicaid Services (CMS) , Disclosure Requirements , Medicaid , Medicare , Private Equity Firms , Proposed Rules , REIT , Skilled Nursing Facility

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

Building on the Success of Medicare-Medicaid Plans, CMS Proposes Modifications for D-SNPs

As we noted, Centers for Medicare & Medicaid Services (CMS) recently proposed its Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed...more

1/17/2022 / Centers for Medicare & Medicaid Services (CMS) , HRA , Long-Term Care , Medicaid , Medicare , Medicare Advantage

The OIG Urges CMS to Implement Solutions to Reduce Fraud in Medicare Part C and Part D

Recently, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued its 2019 “Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: Top Unimplemented Recommendations.” The OIG...more

8/5/2019 / Annual Reports , Department of Health and Human Services (HHS) , Fraud Abuse and Waste , Information Reports , Medicare , Medicare Advantage , Medicare Part C , Medicare Part D , OIG , Reporting Requirements

As CMS Lifts HHA Medicare Provider Enrollment Moratorium, States Continue to Limit HHA Licenses

As of January 30, 2019, CMS lifted its temporary provider enrollment moratoria (“Enrollment Moratorium”) for home health agencies (“HHAs”) in Florida, Illinois, Michigan and Texas. The Enrollment Moratorium had prevented new...more

2/13/2019 / Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Enrollment , Health Care Providers , Healthcare , Home Health Agencies , Medicaid , Medicare , Moratorium

The OIG Identifies “Significant Vulnerabilities” in the Medicare Hospice Program: What This Might Mean for Hospice Providers?

Last week, the Department of Health and Human Services – Office of Inspector General (“OIG”) released a portfolio report identifying multiple vulnerabilities in the Medicare Hospice Program (the “Hospice Portfolio Report”),...more

8/9/2018 / Centers for Medicare & Medicaid Services (CMS) , Government Investigations , Health Care Providers , Hospice , Inpatient Billing , Medicare , Medicare Part D , OIG , Physician Medicare Reimbursements , Skilled Nursing Facility

The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move...more

12/19/2016 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Healthcare Reform , Medicare , Medicare Part B , Pharmaceutical Industry

Will Republicans Embrace CMMI’s Authority?

The Affordable Care Act (ACA) and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare & Medicaid Services (CMS) and the newly created Center for Medicare and Medicaid Innovation (CMMI)...more

11/18/2016 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , CMMI , Healthcare , Medicaid , Medicare , Trump Administration

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

CMS Delays Enforcement of Part D Prescriber Enrollment Requirements

Last week, CMS released a Fact Sheet announcing that it is further delaying enforcement of the Medicare Part D Prescriber Enrollment Requirements, with full enforcement to begin on January 1, 2019. Under the Medicare Part D...more

11/8/2016 / Centers for Medicare & Medicaid Services (CMS) , Enrollment , Medicare , Medicare Advantage , Medicare Part D

CMS releases Final Rule Overhauling Long-Term Care Facility Requirements

The Centers for Medicare & Medicaid Services (CMS) recently released its final rule overhauling long-term care (LTC) facility participation requirements for Medicare and Medicaid (“Final Rule”). This much anticipated rule...more

10/10/2016 / Affordable Care Act , Arbitration Agreements , Centers for Medicare & Medicaid Services (CMS) , Compliance , Ethics , Final Rules , Long Term Care Facilities , Medicaid , Medicare , Pharmacies , Physicians

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: August 2016

Since our last issue, we have identified 31 recently unsealed health care-related whistleblower cases. In this Qui Tam Update, we analyze the trends and take an in-depth look at a few noteworthy cases....more

8/5/2016 / Certificates of Compliance , Constructive Trusts , Criminal Prosecution , DEA , False Billing , False Claims Act (FCA) , Intervenors , Kickbacks , Medicare , Qui Tam , Relators , State False Claims Acts , Unjust Enrichment , Whistleblowers

Delays in 340B Mega-Guidance and a Recap of the Latest 340B Updates

Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level. Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the...more

6/8/2016 / Department of Health and Human Services (HHS) , HRSA , Medicare , Omnibus Guidance , Prescription Drug Coverage , Prescription Drugs , Section 340B

The Proposed 340B Guidance: Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

10/8/2015 / Comment Period , Covered Entities , Drug Pricing , Health Care Providers , Healthcare , Hospitals , HRSA , Interpretive Rule , MCOs , Medicaid , Medicare , Omnibus Guidance , Patients , Pharmaceutical Industry , Pharmacies , Proposed Regulation , Section 340B , State Medicaid Programs

Mintz Levin Health Care Qui Tam Update - July 2015

Trends & Analysis - ..We have identified 36 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of these cases, eight were filed within the last year. A number...more

7/19/2015 / Anti-Kickback Statute , False Claims Act (FCA) , Healthcare , Intervenors , Medicare , Qui Tam , Settlement , Stark Law , Whistleblowers

Beyond SGR – MACRA Provides Additional Payment Provisions and Offsets

This is the second post in our continuing series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No: 114-10. In addition to repealing the Sustainable Growth Rate (SGR), which was covered in our April 20th...more

4/22/2015 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Healthcare , Hospitals , Medicare , Medicare Access and CHIP Reauthorization (MACRA) , Physician SGR Formula , Physicians , Repeal

Lauren Moldawer

Mintz

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