HR-7312 : Still Just a Bill

The Electronic Prescribing for Controlled Substances Act (EPCS 2.0 Act) or H.R. 7312, aims to mandate electronic prescribing of controlled substances under group health plans and individual and group health insurance coverage. Key provisions include:

• General Requirement: Starting January 1, 2026, group health plans and health insurance issuers must have policies requiring electronic transmission of prescriptions for Schedule II, III, IV, and V controlled substances.
• Exceptions: The bill outlines several exceptions where electronic prescribing may be waived, such as:
  • When the prescriber and pharmacy are the same entity.
  • When electronic transmission is technically infeasible.
  • Cases of economic hardship or technological limitations for the provider.
  • Situations where timely access to medication would be impractical for the patient.
  • Prescriptions under research protocols.
  • Drugs requiring elements not compatible with electronic prescribing.
  • Hospice patients or nursing facility residents.
  • Temporary technological or electrical failures.
  • Non-patient specific prescriptions during public health emergencies.
• Rules of Construction:
  • Pharmacies are not required to verify a provider's waiver status.
  • The bill does not affect the authority to cover or dispense prescriptions that are otherwise valid.
  • Patient choice in selecting a pharmacy is protected.
• Policy Requirements: The Secretaries of Health and Human Services, Labor, and the Treasury will issue regulations for the policies, including uniform processes for setting e-prescribing requirements, granting waivers, and recognizing waivers issued under Medicare Part D.
• Prohibitions: Health plans and insurers cannot:
  • Require pharmacies to confirm electronic issuance.
  • Require additional data beyond standard claim processing.
  • Reject claims based on prescription format.
  • Mandate specific e-prescribing vendors or systems.
• Attestation of Compliance: Plans and issuers must annually attest to compliance.
• Consultation Requirement: The Secretaries must consult with stakeholders, including pharmacies, state regulators, insurers, and healthcare practitioners, during rulemaking.
• Biometric Component Update: The Attorney General will update regulations for the biometric component of multifactor authentication for electronic prescriptions of controlled substances.