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
The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several...more
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
The PBM regulatory landscape continues to evolve rapidly 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. Our team actively...more
The PBM regulatory landscape continues to evolve rapidly 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. Our team actively...more
The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which aims to lower drug prices by enabling the federal government to negotiate prices for some of the costliest Medicare Part D...more
On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”). In...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
In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...more
As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers...more
In a significant development with far-reaching implications for health plans and pharmacy benefit managers (PBMs), Judge John D. Bates of the U.S. District Court for the District of Columbia has recently struck down a federal...more
Governor Gavin Newsom signed 997 bills into law in 2022, including a substantial number relating to health care. In Part II of our legislative update, we summarize many of the laws relevant to health facilities, a number of...more
12/21/2022
/ CDPH ,
Governor Newsom ,
Healthcare Facilities ,
Hospice ,
Hospitals ,
Licensing Rules ,
Long Term Care Facilities ,
Mental Health ,
New Legislation ,
Pharmacies ,
Skilled Nursing Facility ,
Substance Abuse
On March 17, the same day we wrote about proposed legislation in Connecticut to cap drug price increases, Governor Charlie Baker of Massachusetts included a similar proposal in his proposed budget. Similar to the Connecticut...more
4/22/2022
/ Affordable Care Act ,
Drug Pricing ,
Governor Baker ,
Medicaid ,
Medicare ,
Medicare Part D ,
Penalties ,
Pharmacy Benefit Manager (PBM) ,
PHRMA ,
Price Inflation ,
Proposed Legislation ,
State Budgets
On March 15, 2022, a drug pricing bill proposed by Connecticut Governor Ned Lamont’s (S.B. 13) was referred to the state legislature’s nonpartisan legal counsel responsible for drafting and processing official legislation....more
Continuing our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed Rule), this post focuses on a few...more
The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing. Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the...more
Today's post is the last in our series on the 10-year anniversary of the Affordable Care Act (ACA). While the Congress that passed the ACA recognized that health care delivery reform was necessary, the law included few...more
This post is the third installment in our blog series looking back the Affordable Care Act (ACA) and the 10 years since it was passed. We will cover the ACA's market reforms, including the establishment of essential health...more
Two weeks ago marked the tenth anniversary of the enactment of the Affordable Care Act (ACA). Given the ongoing COVID-19 pandemic, which Mintz has been closely monitoring, it is understandable why the anniversary has largely...more
This post is the second installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA) and will examine Medicaid expansion under the ACA. Medicaid is joint federal-state program that...more
4/9/2020
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Budget Office ,
Department of Health and Human Services (HHS) ,
Federal Health Insurance Exchanges ,
Federal Poverty Line ,
Health Insurance ,
Medicaid Expansion ,
Medicaid Work Requirements ,
Medicare ,
Social Security Act ,
Spending Clause ,
State and Local Government
This post is the first installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA). The most controversial of the ACA's reforms has been the individual mandate, which requires that...more
4/8/2020
/ Affordable Care Act ,
American Health Care Act (AHCA) ,
Commerce Clause ,
Health Insurance ,
Health Insurance Exchanges ,
Individual Mandate ,
Minimum Essential Coverage ,
Preexisting Conditions ,
Repeal ,
SCOTUS ,
Tax Penalties
On December 31, 2019, the Tenth Circuit Court of Appeals upheld the Department of Health & Human Services’ Affordable Care Act (ACA) risk adjustment methodology in New Mexico Health Connections v. HHS, No. 18-2186 (10th Cir....more
The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic Care Rx LLC d/b/a Patient Care America (PCA), private equity firm Riordan, Lewis & Haden...more
9/23/2019
/ Amended Complaints ,
Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Drug Compounding ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud and Abuse ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Portfolio Companies ,
Private Equity Firms ,
TRICARE
CMS recently proposed several important changes for the Medicare Advantage ("MA") program that relate to payment, benefit design, and new actions to combat the opioid crisis. These changes, among others, were proposed in...more
2/7/2019
/ Advance Notice ,
Bipartisan Budget Act ,
Call Letter ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Healthcare ,
Medicare Advantage ,
Medicare Part D ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Risk Adjustment Formula
On October 19, 2018, a New Mexico district judge rejected a request from HHS to reconsider a February decision that had briefly led to the suspension of the ACA’s risk adjustment program. In February, District Judge James...more