On December 21, 2022, HHS issued a new proposed rule to implement the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Patient Protection and Affordable Care Act (ACA). Specifically, the proposed rule would adopt standards for what HHS calls “health care attachments” transactions to enable patient health information to be exchanged more efficiently between provider and health plan in the claims adjudication and prior authorization processes. The stated goal of the proposed rule is to reduce the burden on providers who may otherwise be required to submit health care attachments like prior authorization requests manually via mail or fax, and to standardize these processes across the health care industry.

Based on industry research by the Council for Affordable Quality Healthcare (CAQH), CMS estimates that implementing a fully electronic system for transmitting prior authorization information could save as much as $454 million annually, and that similar savings can be expected by switching to health care attachments for claims adjudication.

HHS had originally issued a proposed rule implementing HIPAA’s administrative simplification requirements to require standardized electronic transactions for certain health care transactions in 2005, but that proposed rule was not adopted due to stakeholder feedback. In 2010, the ACA reinforced HIPAA’s administrative simplification requirement by requiring the HHS Secretary to adopt and regularly update electronic transaction standards, code set standards, unique identifiers as well as operating rules for the electronic exchange and use of health information for health insurance administration.

The new proposed health care attachments standards cover three general use cases wherein a provider submits documentation to a health plan:

• Prior Authorization: When a health plan requires prior approval for a service before it is rendered, the proposed rule implements a standardized electronic format for a provider to submit the necessary documentation supporting a prior authorization electronically using HIPAA standards, and for the health plan to provide a response. Specifically, the proposed rule adopts X12N 278—Health Care Services Request for Review and Response (006020X315)—as the standard a health plan must use to electronically request attachment information from a health care provider to support a prior authorization transaction—and X12N 275—Additional Information to Support a Health Care Services Review (006020X316)—as the standard a provider must use to electronically transmit attachment information to a health plan to support a health care provider’s prior authorization request.
• Solicited Documents: When a health plan requests additional information in order to adjudicate a submitted claim, the proposed rule adopts a standardized electronic format for a provider to submit the requested documentation. Specifically, the proposed rule adopts X12N 277—Health Care Claim Request for Additional Information (006020X313)—as the standard a health plan must use to electronically request attachment information from a health care provider to support a health care claim.
• Unsolicited Documents: When a provider submits a claims attachment along with their initial submission of a health care claim (for instance, if required by the health plan’s payment policies), the proposed rule adopts a standardized electronic format to submit such attachments. Specifically, the proposed rule adopts X12N 275—Additional Information to Support a Health Care Claim or Encounter (006020X314)—as the standard a provider must use to electronically transmit attachment information to a health plan to support a health care claims or equivalent encounter information transaction.

The proposed rule also adopts the HL7 CDA standard for transmitting clinical information as part of these health care attachments. Specifically, HHS is proposing adopting the following three HL7 CDA standards:

• HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 1—Introductory Material, June 2019 with Errata
• HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 2—Templates and Supporting Material, June 2019 with Errata
• HL7 CDA R2 Attachment Implementation Guide: Exchange of C-CDA Based Documents, Release 1, March 2017

The proposed rule would also permit providers to sign health care attachments electronically. The proposed rule defines the term “electronic signature” broadly so that it encompasses current and future electronic signature technologies, and adopts an implementation guide called the HL7 Implementation Guide for CDA Release 2: Digital Signatures and Delegation of Rights, Release 1 (Digital Signatures Guide).

Finally, the proposed rule adopts a modification to the standard for the referral certification and authorization transaction (X12 278) to move from Version 5010 to Version 6020.

The text of the proposed rule is available here. A CMS fact sheet on the proposed rule is available here, and a CMS press release announcing the proposed rule is here.