Pharmacy Benefit Compliance: Q1 2024 Updates 

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As a trusted benefits advisor, staying informed about the latest developments in pharmacy benefit compliance is crucial for providing proactive guidance. Above all, these updates help your clients navigate the complex legal and regulatory landscape. By keeping abreast of regulatory changes, new laws, and ongoing litigation, you can effectively mitigate risks and empower your clients to make informed decisions. This article highlights the key developments in pharmacy benefit compliance during the first quarter of 2024. We help ensure you have the knowledge and insights to deliver exceptional value to your clients.

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Key Developments: 

  • More than 25 state laws applicable to PBMs and/or self-funded plans were enacted between January and March. These laws primarily focus on utilization management, pharmacy network requirements, and transparency. 
  • The FDA authorized Florida’s drug importation program.  
  • CMS published updated Prescription Drug Data Collection (RxDC) reporting instructions for the reporting deadline. The deadline recently occurred on June 1, 2024. 
  • The federal government released an FAQ about the upcoming requirement for plans to post prescription drug machine-readable files. Technical requirements and an implementation timeline will be released soon. 
  • Another FAQ indicated the federal government’s intent to propose rulemaking on the applicability of a policy in the final 2025 NBPP. Specifically, this policy discusses whether prescription drugs beyond a state’s essential health benefits (EHB) benchmark plan are considered EHB for prohibiting lifetime and annual limits and the annual cost-sharing limitation under the PHS Act. 

Litigation Highlights: 

  • Copay Assistance: Advocacy groups urged insurance commissioners to act on a federal court ruling. The ruling struck down an HHS rule permitting insurers and group health plans to exclude manufacturer copay assistance from out-of-pocket costs. As a result, HHS will likely issue a new rule soon. 
  • Employee Retirement Income Security Act (ERISA): Oklahoma seeks Supreme Court review of a ruling that ERISA preempts state law regulating employers’ pharmacy networks. 
  • Fiduciary Duties: A class action lawsuit was filed against Johnson & Johnson for alleged ERISA violations in PBM selection and monitoring. 
  • Preventive Care Mandate: A federal appeals panel heard arguments on the constitutionality of a mandate requiring coverage of preventive health services. 
  • Mifepristone: The Supreme Court heard arguments challenging the FDA’s approval of a medication abortion drug. 

Next Steps

We expect the rapid pace of changes in pharmacy benefits to continue. We are committed to navigating these developments with expertise and transparency. Stay tuned for an update on the developments occurring in the second quarter.

By the Serve You Rx Compliance Department.

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 over 37 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.

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