Medication-access transparency standards
- New HTI-4 standards are being developed to make medication-access status and barriers more visible across payers and vendors. - The goal is to eliminate the current ‘transparency black hole’ that leaves clinicians and patients uncertain about coverage and access. - If adopted, these standards will change how denials, documentation requirements, and medication status appear inside clinical workflows and external exchanges (pharmaceuticalcommerce.com).
Federal health officials have set new HTI-4 standards to make a patient’s drug coverage status visible inside prescribing systems before a prescription stalls. (healthit.gov) The Assistant Secretary for Technology Policy and the Office of the National Coordinator finalized HTI-4 on July 31, 2025, as part of the fiscal 2026 inpatient payment rule, with an effective date of Oct. 1, 2025. The rule adds certification criteria for electronic prescribing, real-time prescription benefit checks, and electronic prior authorization. (healthit.gov) For software already certified for electronic prescribing, developers must update to the National Council for Prescription Drug Programs SCRIPT Version 2023011 by Dec. 31, 2027. Those same products must also add the new real-time prescription benefit function, and the Base Electronic Health Record definition adds that function on Jan. 1, 2028. (healthit.gov) A real-time prescription benefit check works like an instant insurance quote inside the exam room. It lets a prescriber compare formulary status, patient-specific coverage options, and medication costs at the point of care instead of finding out at the pharmacy counter. (healthit.gov) Electronic prior authorization is the other half of the change: software can package the clinical details a payer needs and send them electronically rather than by fax or phone. HTI-4 also finalized standards for application programming interfaces, or software connectors, to exchange clinical and administrative information with payers. (healthit.gov) The technical backbone comes from Health Level Seven Fast Healthcare Interoperability Resources, usually called FHIR, and implementation guides from the HL7 Da Vinci Project. CMS says its testing tools already check payer APIs against Da Vinci guides that support coverage discovery, documentation rules, and prior authorization workflows. (cms.gov) (build.fhir.org) This rule lands as CMS is pushing the same problem from the payer side. On April 14, 2026, CMS proposed a separate rule to extend prior-authorization API and transparency requirements to drugs for Medicare Advantage, Medicaid, Children’s Health Insurance Program, and federally facilitated exchange plans, with comments due June 15, 2026. (federalregister.gov) CMS said that 2026 proposal would extend the agency’s 2024 prior-authorization framework, which focused on non-drug items and services, to prescription drugs. The proposal also says the department would adopt certain FHIR standards under the Health Insurance Portability and Accountability Act for prior-authorization transactions. (cms.gov) Vendors say parts of the workflow already exist in leading electronic health record and e-prescribing products, but the deadlines force broader adoption and common formatting. Colin Banas, chief medical officer at DrFirst, said the aim is to make the status of a prescription “as clear and actionable as tracking a takeout order.” (pharmaceuticalcommerce.com) The next dates are now fixed: HTI-4 has been in effect since Oct. 1, 2025, key certification updates arrive by the end of 2027, and CMS is still taking public input on the drug prior-authorization proposal through June 15, 2026. (healthit.gov) (federalregister.gov)
