On Feb. 11, 2025, HHS published notice of delayed effectiveness of updated pharmacy standards in federal register, in accordance with regulatory freeze order, see #240867.
Rule effectiveness delayed to Apr. 14, 2025, compliance extended to Apr. 14, 2028.
On Nov. 9, HHS retail pharmacy standards for electronic transactions.
HHS proposed updated versions of pharmacy standards for electronic transactions.
Adopted under the health ins portability and accountability act (HIPAA) (45 CFR 160).
Revised standards for health care claims/equivalent encounter information, eligibility for a health plan, referral certification and authorization, and coordination of benefits.
Rule Provisions
Broaden applicability of Medicaid pharmacy subrogation transaction to all health plans.
Implemented updated National council for prescription drug programs (NCPDP) guides.
Proposal adopted the NCPDP telecommunication standard implementation guide, version F6, and equivalent NCPDP batch standard implementation guide, version 15.
As well as the NCPDP batch standard pharmacy subrogation implementation guide, version 10 for non-Medicaid health plans; provided upgrades over previous system.
Enabled refills to be distinguished from multiple dispensing events for a single fill.
Provided more specific fields to differentiate various types of fees, including regulatory fees, taxes, and medication administration fees; increases dollar amount field length.
Simplified coverage under prescription benefits of new innovative drug therapies priced at, or in excess of, $1mn; covered entities must comply within 24 months of approval.
Small health plans have 36 months after the effective date of the final rule to comply.
Consultation
Comments on the proposal to amend pharmacy standards are due by Jan. 9, 2023.
Dec. 2024 HHS Final Rule
On Dec. 13, 2024, HHS published final rule on pharmacy standards in federal register.
In response to public comments, modifies rule to adopt NCPDP batch standard subrogation implementation guide version 10 solely for State Medicaid agencies.
Final rule is effective on Feb. 11, 2025, compliance required beginning Feb. 11, 2028.
Feb. 2025 HHS Delayed Effectiveness
On Feb. 11, 2025, HHS published notice of delayed effectiveness of updated pharmacy standards in federal register, in accordance with regulatory freeze order, see #240867.
Rule effectiveness delayed to Apr. 14, 2025, compliance extended to Apr. 14, 2028.