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HHS Proposes Modifying HIPAA Standards for Certain Electronic Pharmacy-Related Transactions


· 5 minute read


· 5 minute read

Proposed Rule, Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Adoption of Pharmacy Subrogation Standard, 45 CFR Part 162, 87 Fed. Reg. 67634 (Nov. 9, 2022); HIPAA Administrative Simplification Information Bulletin: Notice Regarding Publication of Proposed Rule (Nov. 7, 2022)

Proposed Regulations


HHS has proposed regulations that would update HIPAA’s electronic transaction standards for certain retail pharmacy transactions related to health care claims, eligibility for a health plan, referral certification and authorization, and coordination of benefits. The proposals would also broaden the applicability of the Medicaid pharmacy subrogation transaction standard to all health plans. As background, HIPAA requires that covered entities (and their business associates) comply with rules that are designed to standardize the format and content of specified electronic transactions. HHS has adopted regulations establishing and updating these standards, including regulations adopted in 2009 with standards for certain electronic pharmacy-related transactions (see our Checkpoint article).

The modifications in the proposed regulations are intended to provide more robust data exchange, improved coordination of benefits, and expanded financial fields that would avoid the need to manually enter certain data. To this end, the proposals would modify the current retail pharmacy standards by altering the use or structure of data fields, inserting new data segments, and adding new functionality. For instance, the modified standards would include certain information needed for prior authorizations and enhancements to the drug utilization review fields in certain claim response transactions. The proposed regulation would also broaden the application of the Medicaid pharmacy subrogation transaction by updating the standard for state Medicaid agencies seeking reimbursement from a responsible health plan and adopting an initial standard applicable to health plans.

EBIA Comment: Although HHS has proposed that covered entities would generally need to comply with the new standards within 24 months after the effective date of the final rule, covered entities and business associates that engage in covered transactions electronically should begin to digest these detailed rules and develop an implementation plan. Comments on the proposals must be received by January 9, 2023. For more information, see EBIA’s HIPAA Portability and Privacy manual at Section XXXII (“Electronic Transactions and Code Sets”).

Contributing Editors: EBIA Staff.

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