Last month, the National Academies of Science, Engineering, and Medicine (“NASEM”) issued a report discussing the inclusion of pregnant and lactating people in clinical research and the health impacts of inadequate data from research involving this subpopulation. Titled “Advancing Clinical Research with Pregnant and Lactating Persons: Overcoming Real and Perceived Liability Risks,” the report came as a response to Congress calling upon NASEM to examine the real and perceived prevalence of legal liability resulting from including these research subjects in clinical trials. Overall, the report concluded that legal liability for including pregnant and lactating persons in research is very limited, but that perceptions of potential liability and a lack of explicit guidance for including this population safely have created real barriers to their inclusion.  In response, the report provides recommended actions for Congress, the Food and Drug Administration (“FDA”), the National Institutes of Health (“NIH”), and the Office of Human Research Protections (“OHRP”) to take to enhance the inclusion of this population in clinical trials, thereby enhancing data around the safety and efficacy of approved drug products for pregnant and lactating persons.  Study sponsors and institutions conducting research should continue to monitor developments in this area, including guidance from FDA.

Mintz is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from October through December 2023 that affects the PBM industry and will specifically highlight (i) federal legislative and enforcement updates, (ii) state legislative updates and litigation, (iii) other industry news, and (iv) Inflation Reduction Act (IRA) updates.

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. 

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.

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 the Biden administration’s backing of draft guidance to government agencies weighing the enforcement of march-in rights, which can allow federal agencies to require patent licenses to be given to third parties if a product was developed or conceived with federal funding assistance.

On January 11, 2024, the Office of Civil Rights (OCR) issued its highly anticipated Final Rule regarding conscience protections. The Final Rule clarifies the religious beliefs and moral convictions protections practitioners and entities may assert in their health care practices. The Final Rule, entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes, becomes effective March 11, 2024. 

As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the regulatory environment with modern health care delivery, cutting-edge technologies, and innovative data-sharing techniques. Some of this work has been done in the form of federal agency guidance in which health care organizations will be looking for additional updates and there are also a handful of pending U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) proposals that call for substantial changes to the HIPAA Privacy Rule.