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Nov 9 -- Office of the Secretary, Department of Health and Human Services (HHS). This proposed rule would adopt updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These updated versions would be modifications to the currently adopted standards for the following retail pharmacy transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits. The proposed rule would also broaden the applicability of the Medicaid pharmacy subrogation transaction to all health plans. To that end, the rule would rename and revise the definition of the transaction and adopt an updated standard, which would be a modification for state Medicaid agencies and an initial standard for all other health plans. To be assured consideration, comments must be received at one of the addresses provided below, January 9, 2023.

The rule proposes to modify the currently adopted retail pharmacy standards and adopt a new standard. These proposals would provide improvements such as more robust data exchange, improved coordination of benefits, and expanded financial fields that would avoid the need to manually enter free text, split claims, or prepare and submit a paper Universal Claim Form.

But for a small modification to the requirement for the use of a particular data field, adopted in 2020, the presently adopted pharmacy standards were finalized in 2009. Since then, the National Committee on Vital and Health Statistics (NCVHS) has recommended that HHS publish a proposed rule adopting more recent standards to address evolving industry changing business needs. Consistent with NCVHS recommendations and collaborative industry and stakeholder input, we believe the updated retail pharmacy standards we propose here are sufficiently mature for adoption and that covered entities are ready to implement them.

The provisions in this proposed ruled would adopt the NCPDP Telecommunication Standard Implementation Guide, Version F6 (Version F6) and equivalent NCPDP Batch Standard Implementation Guide, Version 15 (Version 15); and NCPDP Batch Standard Pharmacy Subrogation Implementation Guide, Version 10, for non-Medicaid health plans. These updated standards would replace the currently adopted NCPDP Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0) and the equivalent NCPDP Batch Standard Implementation Guide, Version 1, Release 2 (Version 1.2); and NCPDP Batch Standard Medicaid Subrogation Implementation Guide, Version 3.0, Release 0.

Industry stakeholders report that Version F6 would bring much needed upgrades over Version D.0, such as improvements to the information attached to controlled substance claims, including refinement to the quantity prescribed field. This change would enable refills to be distinguished from multiple dispensing events for a single fill, which would increase patient safety. Version F6 provides more specific fields to differentiate various types of fees, including taxes, regulatory fees, and medication administration fees. Finally, Version F6 increases the dollar amount field length and would simplify coverage under prescription benefits of new innovative drug therapies priced at, or in excess of, $1 million. The current adopted Version D.0 does not support this business need.

The current Medicaid Subrogation Implementation Guide Version 3.0 (Version 3.0) was adopted to support federal and state requirements for state Medicaid agencies to seek reimbursement from the correct responsible health plan. However, industry stakeholders reported that there is a need to expand the use of the subrogation transaction beyond Medicaid agencies, and noted that the use of a subrogation standard that would apply to other payers would be a positive step for the industry. Whereas HIPAA regulations currently require only Medicaid agencies to use Version 3.0 in conducting the Medicaid pharmacy subrogation transaction, all health plans would be required to use the Pharmacy Subrogation Implementation Guide for Batch Standard, Version 10, to transmit pharmacy subrogation transactions, which would allow better tracking of subrogation efforts and results across all health plans, and support cost containment efforts.

Should these proposals be adopted as proposed, it would require covered entities to comply 24 months after the effective date of the final rule. Small health plans would have 36 months after the effective date of the final rule to comply.

We estimate that the overall cost for pharmacies, pharmacy benefit plans, and chain drug stores to move to the updated versions of the pharmacy standards and the initial adoption of the pharmacy subrogation transaction standard would be approximately $386.3 million. The cost estimate is based on the need for technical development, implementation, testing, initial training, and a 24-month compliance timeframe. We believe that HIPAA covered entities or their contracted vendors have already largely invested in the hardware, software, and connectivity necessary to conduct the transactions with the updated versions of the pharmacy standards.

FRN: https://www.federalregister.gov/d/2022-24114

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