HHS has postponed the implementation of the HIPAA final rule modifying retail pharmacy standards, citing the need for further review and correction of compliance timeline errors.
What happened
The U.S. Department of Health and Human Services (HHS) has postponed the effective date for the final rule modifying the National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards and the Medicaid Pharmacy Subrogation Standard. Originally set for February 11, 2025, the implementation has now been delayed until April 14, 2025.
Going deeper
The final rule, published in December 2024, updates standards for electronic transactions related to healthcare claims, eligibility verification, referral certification, authorization, and coordination of benefits. It also introduces a modified standard for Medicaid pharmacy subrogation transactions.
The delay stems from President Trump’s January 20, 2025, memorandum, titled “Regulatory Freeze Pending Review.” Acting HHS Secretary Dorothy A. Fink announced that the 60-day postponement will allow for further examination of potential legal, factual, and policy considerations. HHS determined that a formal notice and comment period was unnecessary and expedited the delay by waiving procedural requirements.
Additionally, the postponement allows time to correct an error in the compliance timeline. The transition period leading up to full compliance was mistakenly set to begin on August 11, 2027, instead of the correct date of June 11, 2027. Publishing the correction in the Federal Register is required.
What was said
Fink stated that delaying the rule’s effective date aligns with HHS’s obligation to conduct a thorough review, ensuring that all regulatory modifications are accurate and legally sound. The agency has justified skipping public notice and comment by citing public interest concerns.
The big picture
While delays in regulatory implementation are not uncommon during administrative transitions, this decision signals a broader reassessment of healthcare regulations under the new administration. The modifications to pharmacy transaction standards are still expected to take effect, but organizations relying on these standards now have additional time to prepare.
FAQs
What does the HIPAA final rule change for retail pharmacies?
The rule updates standards for electronic transactions, including healthcare claims, eligibility verification, referral certification, and Medicaid pharmacy subrogation.
What are the National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards and the Medicaid Pharmacy Subrogation Standard?
The NCPDP Retail Pharmacy Standards govern electronic transactions for processing prescriptions, verifying insurance eligibility, and coordinating benefits among payers. The Medicaid Pharmacy Subrogation Standard facilitates the automated process of recovering costs when Medicaid initially pays for a prescription that should have been covered by another insurer.
How does the delay impact healthcare organizations?
Organizations have additional time to update systems and ensure compliance with the revised standards before full implementation.
Will there be another delay or change to the final rule?
While possible, no further delays have been announced. However, regulatory reviews under new administrations can lead to modifications.
Farah Amod
