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Insights

Compliance and Industry Update – November 2025

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Empowering Your Pharmacy Benefit Decisions

At ClearScript, we are committed to keeping you informed and prepared for the evolving landscape of Pharmacy Benefit Management (PBM). This update highlights key regulatory changes, industry updates, and ClearScript’s proactive strategies.

REGULATORY UPDATES

Consolidated Appropriations Act (CAA): Prescription Drug Cost Reporting

  • Annual Reporting Requirement: Group health plans and insurers must submit detailed reports on prescription drug and healthcare spending. ClearScript manages this process for our clients, ensuring all required pharmacy data is submitted by the June 1st deadline each year, in accordance with CMS RxDC Reporting Instructions.
  • Limitations: While we provide comprehensive pharmacy data, some files or narratives – such as premium information or medical benefit spending – may be excluded due to reporting constraints. Additional coordination with medical benefit providers is required to meet this regulation.
  • Next Deadline: The 2025 reference year report is due June 1, 2026. We will continue to guide you through compliance requirements as deadlines approach.

Gag Clause Compliance

  • Requirement: Pharmacy network contracts must not contain “gag clauses” that restrict sharing cost or quality information. Self-funded group health plan sponsors must file an annual attestation of compliance by December 31. 
  • ClearScript’s Assurance: Our pharmacy network contracts are free of gag clauses and fully compliant, supporting clients in meeting this obligation. 

PBM State Regulations

  • Nationwide Licensing: All 50 states now regulate PBMs, with varying licensing and business practice requirements. These may include contracting requirements, network requirements, transparency and reporting requirements – such as submission of financials and organizational information – and regulation of other business practices.
  • ClearScript’s Approach: We continuously review and update our licenses as applicable to our business, as well as other operations to ensure full compliance with both state and federal regulations.

INDUSTRY NEWS AND UPDATES

Pharmaceutical Tariffs

  • Current Developments: The U.S. government is engaged in ongoing global discussions about tariffs on imported drugs. The U.S. Supreme Court is reviewing the legality of presidential authority to impose tariffs under emergency powers. If struck down, many tariffs, including those on drug imports, could be invalidated. The ruling is expected by mid-2026.
  • Client Impact: ClearScript is closely monitoring these developments and will provide updates on any changes affecting pharmacy spend and supply chain stability.

Direct-to-Consumer (DTC) Drug Purchasing Programs

  • TrumpRx Launch: Scheduled for early 2026, TrumpRx is a federal initiative seeking to lower drug costs by enabling consumers to purchase select brand-name medications directly from manufacturers. 
  • How will it work? 
    • Consumers will use the TrumpRx platform to search eligible drugs and connect to manufacturer direct-to-consumers (DTC) platforms for purchase.
    • Pricing will follow a Most-Favored-Nation (MFN) model, requiring participating manufacturers to offer U.S. consumers prices equal to or better than the lowest price available globally, including foreign governments. 
    • The manufacturer ships the medication directly to the patient. 
  • Important note: 
    • This option is similar to other existing cash-pay programs and does not include additional manufacturer discounts beyond negotiated pricing.
    • Purchases made through TrumpRx will not apply toward deductible or out-of-pocket accumulators under pharmacy benefits.
    • TrumpRx bypasses insurance networks and offers an alternative for consumers seeking direct savings, but does not integrate with benefit plans.

The Impact: While advertised discounts may appear attractive, members may find their plan’s negotiated rates or copays are more cost effective than the DTC cash prices. Some analysts predict that the uninsured or members with high-deductible plans may benefit most from the new platform. As such, there may be little impact to plan sponsor’s utilization and/or pharmacy plan spend.

ClearScript’s position: Although many details of this program have yet to be resolved, ClearScript supports initiatives that help to lower drug costs and promote PBM transparency. As always, our goal is to optimize benefit designs for cost savings, clinical appropriateness, and member access.

Sources: 
Healthline – TrumpRx: New Prescription Drug Program to Lower Costs of GLP-1s
GovFacts Explainer – TrumpRx: How the Drug Pricing Program Works

FDA Biosimilar Policy Changes 

  • What Changed: The FDA recently announced major reforms to accelerate biosimilar approvals, including eliminating requirements for comparative clinical efficacy studies and switching studies for interchangeability. 
  • Why It Matters: These changes are expected to increase biosimilar launches for high-cost biologics, driving down pricing and creating opportunities for plan sponsors to reduce specialty spend. Interchangeability also simplifies substitution, enabling a more streamlined process for programs that favor lower-cost biosimilars. 

These FDA changes are currently in draft guidance. They will be effective upon finalization of the guidance, which is expected after the public comment period and publication in the Federal Register. 

However, state substitution laws that prohibit substitution or require prescriber/patient notification before substitution could create hurdles in some situations.

As always, ClearScript is actively monitoring FDA approvals and managing our formulary to prioritize clinically appropriate, cost-effective biosimilars. 

FDA Press Release (Oct 2025): FDA News

OUR COMMITMENT

ClearScript is dedicated to supporting our clients with timely updates, expert guidance, and responsive service. We continue to monitor developments in the industry and proactively incorporate them in our formulary management strategies We will keep our clients informed of market influences and any potential impact to drug pricing, their pharmacy benefit utilization, and/or plan spend.

For questions or further information, please contact your ClearScript Account Team.