In this edition of the Mintz IRA Update, we cover the status of the negotiations underway between CMS and manufacturers pursuant to the Medicare Drug Price Negotiation Program and current legal challenges to the program, other drug pricing–related IRA initiatives, the IRA’s small biotech exemption, implications associated with removing the average manufacturer price cap on Medicaid rebates, and the Biden administration’s proposed draft guidance on patent “march-in” rights.

Read about how the removal of the average manufacturer price (AMP) cap on Medicaid rebates prompted manufacturers to cut insulin prices to avoid significant payments to Medicaid.

Mintz recently launched a new series of Health Law Diagnosed titled Women Leaders in Health Care. This new series highlights women leaders in the health care industry and includes discussions on key issues in the health care industry, women leaders’ reflections on their career, and the impact of mentorship. In our inaugural episode, Leah Pollema, Vice President and General Counsel at InhibRx, and Serene Katranji, Chief Operating Officer, Chief Compliance Officer, and Corporate Counsel at Orchard Laboratories, join host Bridgette Keller to share personal stories about their experiences as both mentees and mentors, shedding light on the invaluable impact mentorship has had on their professional journeys.

Mintz’s PBM & Pharmacy practice is proud to present the Mintz IRA Update, a regular publication that delves into the spectrum of developments under the Inflation Reduction Act of 2022 (“IRA”) impacting the health care industry.

Bipartisan legislative activity related to pharmacy benefit manager oversight is at an all-time high in both the House and Senate. As we noted last week, several bills that address PBM activities are moving through the Senate and House committees with what appear to be high approval rates. There has also been an uptick in general investigations into PBM business practices. This post, which is the second of a two-part series, highlights recent House and federal agency activity targeting the PBM industry.

In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower prescription drug costs. Several bills that address PBM reporting requirements, including increased transparency as it relates to a PBM’s use of spread pricing and the retention of certain rebates and administrative fees, are moving through Senate and House committees. Further, last month the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) proposed a rule to increase transparency related to spread pricing in Medicaid-managed care contracts with PBMs, and recently, the Federal Trade Commission (FTC) expanded its ongoing investigation into PBM practices to include information requests from two group purchasing organizations.

This blog post highlights recent Senate activity as well as a proposed bipartisan Senate and House bill that would impact PBM activity in the Medicaid-managed care space. This blog post is the first in a series of two posts detailing recent federal activities aimed at increasing oversight of the PBM industry.

On April 25, 2023, the Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders and Ranking Member Bill Cassidy introduced a package of legislation aimed at lowering prescription drug prices. The package includes four bills, each proposing changes that would address a different piece of the pharmaceutical supply chain. This post focuses on the Pharmacy Benefit Manager Reform Act (PBM Reform Act), which proposes to increase oversight of entities providing pharmacy benefit manager (PBM) services to group health plans and health insurance issuers (i.e., employer-based health insurance coverage).

Though the flurry of state PBM-focused legislation slowed down with the summer recess, there has still been plenty of noteworthy PBM news. This roundup focuses on state Medicaid enforcement activities involving Centene and provides a brief overview of recent legislative activity.

MintzRx is a regular newsletter providing you with everything you need to know to stay abreast of the legal, regulatory, and industry developments across the pharmaceutical supply chain.

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 Reconciliation Bill includes a revised drug pricing reform package that Democrats had approved last month. In this post, we review what passing the long-awaited drug pricing reforms means for Medicare recipients and for drug prices in the United States.