Commencing October 2024, CMS will start off-cycle revalidations of all Skilled Nursing Facilities (SNFs).  As part of the revalidation process, SNFs must disclose the additional information required under CMS’ final rule, “Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities,” which was  released November 17, 2023 (“Final SNF Disclosure Rule”).  

In ‘Third Edition: Q2 2024’ of the Mintz IRA Update, we cover updates to the Medicare Drug Price Negotiation Program being considered by CMS, developments in litigation challenging the program, the consequences and costs of redesigning the Part D program, opposition to the use of march-in rights to lower drug prices, and the growing use of state prescription drug affordability boards.

Read about the 2025 redesign of the Medicare Part D program pursuant to the Inflation Reduction Act of 2022 and how those changes impact Medicare Part D plan sponsors, beneficiaries, and manufacturers.

As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) made a number of enrollment changes impacting dual eligible special needs plans (DSNPs). The goal of these changes is to promote integration of Medicaid and Medicare services for full benefit dually eligible (FBDE) individuals. While stakeholders support the overall goal of better integration, the new policies are complex and may discourage Medicare Advantage Organizations (MAOs) from participating in Medicaid managed care programs in certain regions. They also highlight how a federal DSNP regulation that is tied to how a state contracts with entities that offer Medicaid benefits can result in different impacts in different states.

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. 

Lawyers for Good Government, in partnership with the American College of Obstetricians and Gynecologists, initiated a vital project known as The Policy Resource Hub in 2022.

As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

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.

The Centers for Medicare & Medicaid Services recently released the first 10 drugs included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. Mintz Member Theresa Carnegie and Of Counsel Lauren Moldawer discuss the program, implications for drug manufacturers, and early lawsuits brought by drugmakers.