News/Blogs
Pharmacy Benefit Compliance Updates: Q3 2024
Below are significant compliance and pharmacy benefit updates that occurred during the third quarter of 2024. While many new regulations target the “Big 3” PBMs and their insurance company owners (known as BUCAHs), independent PBMs like Serve You Rx continue to put clients first. As a privately held PBM focused on flexibility and transparency, we remain committed to your goals rather than shareholder interests. These updates include new regulatory actions at both federal and state levels, court rulings, and ongoing legal challenges affecting pharmacy benefit managers and prescription drug pricing.
Laws, Regulations, and Guidance:
- The Departments of Labor, Health and Human Services, and the Treasury issued a final rule requiring mental health coverage under terms comparable to medical and surgical benefits.
- The U.S. Department of Labor (DOL) published Compliance Assistance Release No. 2024-01. It clarifies that cybersecurity guidance applies to all employee benefit plans, including health and welfare plans.
- More than 30 state laws affecting pharmacy benefits managers were passed. California Governor Newsom vetoed a bill requiring PBMs to be licensed and regulated by the state’s insurance department, among other requirements. The ERISA Industry Committee applauded the veto.
- The Department of Health and Human Services (“HHS”) issued guidance on annual out-of-pocket expense limits for non-grandfathered group health plans for plan years beginning in 2026.
- HHS also published the Annual Notice of Benefit and Payment Parameters proposed rule for 2026, indicating that future rules will address the applicability of drug manufacturer support to the annual cost-sharing limitation.
Events and Litigation:
- The House Committee on Oversight and Accountability published a report on PBMs. Shortly after, executives from CVS Caremark, Express Scripts, and Optum Rx testified at the committee’s hearing on July 23, 2024.
- The House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust held a hearing on the role of PBMs. The hearing featured healthcare academics from multiple institutions.
- The Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing titled, “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?”
- The FTC’s interim report found PBM consolidation and complex contracts have led to widespread independent pharmacy closures, particularly in rural areas. Express Scripts filed a lawsuit seeking retraction, while Compass Lexicon released a study challenging the FTC’s evidence.
- The FTC also filed an administrative complaint against the three largest PBMs — Caremark Rx, Express Scripts, and OptumRx — and their group purchasing organizations (GPOs). The complaint claims their rebate practices artificially inflated insulin prices.
- State insulin cases were halted in favor of certain PBMs, including dismissal in Hawaii.
- Several lawsuits alleging antitrust violations have been filed. These include one by Vermont’s Attorney General against two PBMs asserting claims under the Vermont Consumer Protection Act.
- The Texas Attorney General filed a complaint against HHS and the Office for Civil Rights (OCR) challenging rules addressing the protection of health information (PHI) related to reproductive health.
- The U.S. Supreme Court sought input from the Solicitor General on a petition for certiorari in the Mulready case, questioning whether Oklahoma’s PBM law is preempted by federal ERISA law.
By the Serve You Rx Compliance Department.
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About Serve You Rx®
Serve You Rx is a full-service pharmacy benefit manager (PBM) with unquestionable flexibility and an unwavering commitment to doing what's best for its clients. With a fervent focus on those it serves, including insurance brokers, consultants, third-party administrators, and their clients, Serve You Rx delivers exceptional service and tailored, cost-effective benefit solutions. Independent and privately held for nearly 40 years, Serve You Rx can implement new groups in 30 days or less and say "yes" to a wide variety of viable solutions. Known for its adaptability, quality, and client-centricity, Serve You Rx aims to be a benchmark for better client service.