Proposed Rule: Administrative Simplification: Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard, 45 CFR Parts 160 and 162, 87 Fed. Reg. 78438 (Dec. 21, 2022)
Available at https://www.govinfo.gov/content/pkg/FR-2022-12-21/pdf/2022-27437.pdf
HHS has proposed regulations that would adopt a set of standards for the electronic exchange of clinical and administrative data to support prior authorizations and health care claims adjudication. As background, HIPAA requires that covered entities (and their business associates) comply with rules designed to standardize the format and content of specified electronic transactions. Specifically, the proposed regulations would adopt standards for “health care attachments” transactions that would support both health care claims and prior authorization transactions, along with a standard for electronic signatures. Regulations proposed in September 2005 would have adopted certain standards for health care attachments, but were never finalized (see our Checkpoint article).
Explaining that the prior regulations were not finalized due to comments about the standards’ “lack of technical maturity and stakeholders’ lack of readiness to implement electronic capture of clinical data,” the preamble to the new proposed regulations notes that despite the subsequent widespread deployment of electronic health records and greater industry experience with the HIPAA standards, transmitting health care attachments is still primarily a manual process. The preamble provides detailed information about the organizations responsible for developing and maintaining the transactions standards and advises that the timing for implementation is right because the industry consensus-based standards are now mature, and covered entities are ready to implement them. The regulations do not propose to adopt attachments standards for all health care transaction business needs. Instead, the approach is for covered entities to gain experience with several standard electronic attachment types so that technical and business issues can be identified to inform potential future rulemaking for other electronic attachments standards.
EBIA Comment: HHS indicates that federal attachments standards would provide direction to support the broad use of automation in the health industry and ease the manual administrative burden for the exchange of medical documentation. The compliance date for these proposed standards is set for 24 months after the effective date of the final rule. Covered entities and business associates should digest the details of these rules and develop a plan for implementation. For more information, see EBIA’s HIPAA Portability, Privacy & Security manual at Section XXXII.D (“Electronic Transactions and Code Sets: What Transactions and Transmissions are Covered?”).
Contributing Editors: EBIA Staff.