What you need to know
On April 10, 2026, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule - (91 Fed. Reg. 19890) to modernize prior authorization (PA) processes for prescription drugs for several federally regulated lines of business. If finalized, the rule would require faster decision timeframes, expanded electronic prior authorization (ePA) and increased transparency through public reporting, with compliance generally beginning in late 2027.
The proposal builds on existing standards already in use today, reinforcing National Council for Prescription Drug Programs (NCPDP) standards for pharmacy benefit drugs and Fast Healthcare Interoperability Resources (FHIR®) based standards for medical benefit drugs, rather than introducing new requirements.
A full summary of proposed provisions can be viewed here.
Prime backs efforts to modernize PA for better access, transparency, and less administrative work, and has invested in timely reviews, electronic workflows and client reporting that align with CMS’s proposals. We remain committed to efficiency and patient-first pharmacy care as requirements develop.
Prime will keep clients updated as details evolve.
Overview
On April 10, 2026, CMS issued the Interoperability Standards and Prior Authorization for Drugs proposed rule, building on CMS’ 2024 final rule, which focused on prior authorization modernization for non drug items and services. This proposal extends similar expectations to prescription drugs to reduce delays in access, streamline administrative processes, and increase transparency across federally regulated health care programs.
While specific details may change through the public comment and rulemaking process, the overall requirements are expected to remain largely consistent. This proposal reflects a continued push toward greater health care interoperability that began with the Affordable Care Act (ACA) and has advanced through subsequent CMS initiatives.
The proposed rule sets new prior authorization requirements for drugs, applicable to both medical and pharmacy benefits depending on coverage, including:
- Expanded ePA requirements, including standardized Application Programming Interface (API) — based workflows.
- Use of modern data standards with a two-track structure, FHIR® Da Vinci implementation guides apply to medical benefit drugs, and NCPDP standards apply to pharmacy benefit drugs. Which track applies is determined by the benefit under which the drug is managed.
- New turnaround times for PA decisions in Medicaid and Health Insurance Marketplace (HIM): 72 hours for standard drug PAs and as short as 24 hours for urgent drug PAs.
- New public and regulatory reporting requirements, including approval and denial rates, appeal outcomes, decision timeliness, and APIs utilization metrics.
Scope of impact and timing: The proposal applies to several federally regulated lines of business, including Medicaid FFS, Medicaid managed care, CHIP, and ACA exchange‑based Qualified Health Plans, with some requirements applying to existing requirements already applicable to Medicare Advantage. Fully insured large‑group commercial plans offered outside the ACA exchanges are not directly included.
CMS has indicated a public comment period through mid‑June 2026, with a final rule expected later in 2026 and phased implementation beginning in October 2027 and extending into 2028. CMS is requesting public input in five areas related to the proposal, including:
- Improving electronic notifications for care coordination.
- Strengthening health care cybersecurity and system resilience.
- Enhancing oversight of payer APIs.
- Streamlining step therapy processes.
- Improving PA for laboratory tests and durable medical equipment, prosthetics, orthotics and supplies.
Prime's position
Prime supports efforts to modernize prior authorization processes in a way that improves patient access to medications, promotes transparency, and reduces administrative burden for plans, providers and patients.
Prime has invested in prior authorization and utilization management capabilities that align with the direction CMS is proposing, including:
- Timely clinical review processes
- Continued advancement of electronic workflows
- Support for client reporting and transparency needs
While this is a proposed rule and requirements may evolve, the proposal reflects broader industry trends that Prime has been actively preparing for as part of our ongoing focus on access, efficiency and patient first pharmacy care.
Next steps
As a proposed rule, CMS’ requirements are subject to change following the public comment period. CMS will review stakeholder feedback and issue a final rule before implementation begins.
Prime is actively assessing the proposal and monitoring the CMS rulemaking process, including evaluating potential operational, technology and reporting considerations. We will share additional updates as the rule progresses and as more information becomes available. At this stage, no immediate action is required for clients.
Prime is also engaged in this issue through our trade association, the Pharmaceutical Care Management Association (PCMA), including evaluation of the proposed rule’s drug classification framework and participation in the formal comment process. We will keep clients informed as the rule develops and as industry feedback is incorporated into CMS’s final approach.
Questions
If you have questions or would like to discuss this proposed rule in more detail, please reach out to your Prime account team representative or client communications. |
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