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
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
Last year was a pivotal year for the pharmaceutical industry. Under the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program), the US government negotiated the prices of 10 selected high-expenditure,...more
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
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
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
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
Mintz’s PBM practice is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from July through September that affects the PBM industry....more
11/25/2024
/ Audits ,
CVS ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Pending Litigation ,
Pharmacy Benefit Manager (PBM) ,
PHRMA ,
Policies and Procedures ,
Prescription Drugs ,
Proposed Legislation ,
Rebates ,
Settlement ,
Transparency
Effective immediately, on August 22, 2024, the Office of Health Care Affordability (OHCA) adopted revisions to the cost and market impact review (CMIR) regulations (Revised Regulations), which govern California’s pre-closing...more
8/27/2024
/ Attestation Requirements ,
California ,
Confidentiality Policies ,
Documentation ,
Financial Transactions ,
Healthcare ,
Healthcare Workers ,
Labor Shortage ,
Notice Requirements ,
Regulatory Reform ,
Revenue
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
In our previous Mintz IRA Update, we covered the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the “Act”) to seize pharmaceutical patents if the administration...more
Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure...more
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
States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care...more
Our team’s preparation for the year includes a review of the anticipated impact of the IRA on the health care industry in 2024. Many of the IRA’s key provisions that go into effect this year are centered around two main...more
The Biden administration appears steadfast in its efforts to lower prescription drug costs and continues to explore multiple avenues — even as the Medicare Drug Price Negotiation Program continues to move forward — to tackle...more
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
On October 10, 2023, the Drug Enforcement Administration (DEA) published another temporary rule extending the COVID-era telemedicine flexibilities that allow physicians and other prescribers to prescribe controlled substances...more
10/25/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
Data Collection ,
DEA ,
Department of Health and Human Services (HHS) ,
Mental Health ,
Patients ,
Pharmacies ,
Public Health Emergency ,
Ryan Haight Act ,
Shareholders ,
Telehealth ,
Telemedicine
The Centers for Medicare & Medicaid Services (CMS) announced a new primary care model—the Making Care Primary (MCP) Model—geared towards smaller, independent primary care practices and organizations that want to participate...more
In a resounding unanimous 9-0 decision, the Supreme Court rejected the argument that a defendant’s subjective belief is irrelevant under the False Claims Act (FCA) when evaluating whether a defendant “knowingly” submitted a...more
Nurse and health care professional staffing shortages during the COVID-19 pandemic resulted in a significant increase in the use of temporary health care professional staffing. Lawmakers and health care providers have urged...more
On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the...more
At the end of March 2022, the Centers for Medicare & Medicaid Services (CMS) released guidance to drug manufacturers and states on reporting Medicaid Best Price under value based purchasing (VBP) arrangements (Medicaid Best...more
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION -
FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
2/11/2022
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Nursing Homes ,
Pharmaceutical Industry ,
Pharmacies ,
Qui Tam ,
Telehealth
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