News/Blogs

As a trusted benefits advisor, staying informed about the latest pharmacy benefit compliance updates is crucial for providing proactive guidance. 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 second quarter of 2024. 

Key Developments: 

• Federal departments released various new guidance, including: 
  • The Centers for Medicare & Medicaid Services (CMS) released instructions that will impact creditable coverage determinations. Due to enhancements in the Medicare Part D benefit under the Inflation Reduction Act of 2022 (IRA), some group health plans that previously met the creditable coverage standard may lose that status unless certain plan design changes are made. While CMS will continue to permit plans to use the simplified tool to determine creditable or non-creditable status for calendar year 2025, employers should be aware of potential future changes. CMS will reevaluate its position for 2026. This will include whether to continue to use the existing methodology, establish a revised version, or eliminate the option. 
  • The Department of Labor has released FAQ Part 66,indicating its intention to propose new rules for self-insured group health plans regarding prescription drug coverage. These rules would require such plans to treat prescription drugs covered beyond the applicable EHB-benchmark plan as Essential Health Benefits (EHB) for purposes of the prohibition of lifetime and annual limits and the annual limitation on cost-sharing. 
  • CMS updates on gag clause prohibition compliance attestations.
  • IRS inflation adjustments to the applicable dollar limits for HSAs, HDHPs, and excepted benefit HRAs for 2025.
  • Final Rules on reproductive health care privacy and the confidentiality of substance use disorder patient records.
• More than 40 state laws applicable to self-funded plans and pharmacy benefit management were enacted between April and June. Oklahoma, in particular, enacted many laws in this space. 
• The Government Accountability Office released a report on PBMs, outlining state regulatory authority. 
• The Senate Judiciary Committee held a hearing on prescription drug prices, pharma competition, and the patent system. 

Litigation Highlights: 

• State attorneys general urged a Supreme Court review of a ruling that Oklahoma’s law regulating pharmacy networks is preempted under ERISA and Medicare Part D  
• The Supreme Court issued decisions on: 
  • Its decision to preserve the status quo of FDA regulation of Mifepristone 
  • Overruling of the Chevron deference precedent that required courts to defer to federal agencies’ reasonable interpretations of the statute. 
• A federal district court in Texas declared that the OCR overstepped its authority in determining that the use of certain online tracking technologies could violate HIPAA privacy regulations.  
• The Fifth Circuit Court of Appeals issued a decision on an ACA preventive care mandate challenge. 

Next Steps

We are committed to navigating compliance updates with expertise and transparency. Stay tuned for an update on the third quarter’s developments.

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 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.