On February 15, 2024, the Centers for Medicare and Medicaid Services (CMS) released the Medicare Prescription Payment Plan Draft Part Two Guidance (Part Two Guidance) as part of the Inflation Reduction Act’s (IRA) efforts to tackle high prescription drug costs. The Medicare Prescription Payment Part Plan (the Program), which was previously referred to as the “OOP Smoothing Program”, was established as part of the IRA and requires Part D plans (PDPs) to offer their members an option to pay for out-of-pocket (OOP) prescription drug costs in monthly capped payments, as opposed to all at once, at a pharmacy. Meaning, for members who opt-in to the Program, they will pay $0 at the pharmacy and the PDP must pay the pharmacy the full cost-sharing amount of the drug and then bill the member the amount of the cost-sharing over the remainder of the calendar year. 

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with removing the average manufacturer price cap on Medicaid rebates, and the Biden administration’s proposed draft guidance on patent “march-in” rights.

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.

Most of the recent focus around the implementation of the Inflation Reduction Act (IRA) by the press and the industry has been on the Medicare Drug Price Negotiation Program and its potential impact on manufacturers. But the Centers for Medicare & Medicaid Services (CMS) has been regularly releasing guidance regarding IRA-related changes that Part D plan sponsors had to implement for 2023 and in future years. CMS recently released guidance (Part One Guidance) on the Maximum Monthly Cap on Cost-Sharing Payments Program or the Medicare Prescription Payment Plan Program (previously referred to as the “OOP Smoothing Program”). The Medicare Prescription Payment Plan Program (the Program) will require Part D plans (PDPs) to make significant operational and system changes to meet its requirements. Many questions remain regarding the Program.

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 May 11, 2022, New York Governor Kathy Hochul announced the creation of the Department of Financial Services’ Pharmacy Benefits Bureau. Governor Hochul noted that the Pharmacy Benefits Bureau is the first of its kind in the country. The Pharmacy Benefits Bureau will be tasked with implementing and overseeing new licensing and reporting requirements impacting Pharmacy Benefit Managers (PBMs) in New York.  This blog post provides an analysis of the intended purpose of the Pharmacy Benefits Bureau and an overview of the new PBM guidance from the Department of Financial Services.

Health regulatory diligence has the ability to make or break a deal. Listen to hear about our team’s firsthand experience in the importance of conducting health regulatory diligence and best practices in preparing for a sell-side transaction.

In a recently decided case, Rutledge v. Pharmaceutical Care Management Association, the U.S. Supreme Court held that the Employee Retirement Income Security Act of 1974 (ERISA) does not preempt an Arkansas statute that regulates reimbursement levels paid by Pharmacy Benefit Managers (PBMs) to local pharmacies.

With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy.

As a continuation of our series on the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program (the “Proposed Rule”) released by the Centers for Medicare & Medicaid Services (“CMS”) earlier this month, this blog focuses on CMS’s codification of its recent guidance on supplemental benefits, including guidance on Special Supplemental Benefits for the Chronically Ill (“SSBCI”). It also discusses CMS’s proposed changes to the medical loss ratio (“MLR”) to account for changes in supplemental benefits.