CMS recently issued a final rule that introduces national standards for a secure electronic exchange of attaching clinical documentation (e.g., medical records) to health care claims. In addition, the final rule establishes requirements for electronic signatures to help ensure that claims attachment transactions are authenticated. The rule is intended to replace manual documentation processes — such as faxing, mailing, and payer‑specific portals — with standardized electronic transactions.
Health care professionals (including allergists), health plans, and health care clearinghouses that transmit health information electronically must comply with the requirements by May 26, 2028.
This article addresses the key provisions of the final rule, considerations for allergists, and ways to prepare for implementation.
Key provisions of the final rule
Health care claims attachments standards. The rule establishes a standardized way to electronically exchange medical documentation, submitted as attachments, to support health care claims during the claims review and payment process. In the final rule, a “health care claims attachments transaction” refers to the electronic exchange of this documentation between a health care professional and a health plan to support a claim or equivalent encounter information (used for reporting purposes). In practical terms, this is the process of sending or receiving medical records, such as clinical or progress notes, laboratory or other test results, or imaging reports, to support a claim. This includes documentation submitted by a health care professional and requests from a health plan for additional information. This standardized process does not apply to prior authorization requests, appeals, or dispute resolution processes.
Standardized electronic transactions and content formats. To support electronic claims attachments, the rule adopts specific transaction standards and content formats, including X12 standards for requesting and transmitting attachment information and Health Level Seven (HL7®) Consolidated Clinical Document Architecture (C-CDA) standards for the clinical content itself. These standards are intended to create uniformity across payers and reduce reliance on payer-specific proprietary submission methods.
Electronic signatures for claims attachments. The final rule also adopts standards for electronic signatures used in connection with claims attachments. When a health plan requires a signature on an electronically transmitted attachment, the signature must meet the adopted technical standards to ensure authentication and document integrity. The rule does not dictate when a signature is required, leaving that determination to health plan policies.
Considerations for allergy practices
For many allergy practices, particularly those already using electronic health record (EHR) systems or working closely with billing vendors or clearinghouses, the impact of the rule may be limited.
However, the implications may be more significant for small or independent practices that do not use EHR systems. While the rule does not require practices to implement new clinical documentation platforms or support every available electronic template, practices must ensure that any claims attachments sent electronically comply with the adopted standards. In many cases, this may be accomplished by working with vendors, clearinghouses, or other health IT partners rather than modifying internal workflows.
Preparing for implementation
Allergy practices should examine how claims attachments are currently sent and received. If necessary, allergy practices should consider connecting with vendors, clearinghouses, and health IT partners about compliance. Allergists should prepare early. Starting now will allow adequate time for testing and onboarding well ahead of the May 26, 2028, compliance deadline.
ACAAI will continue to monitor implementation of this rule and provide updates and guidance to support allergists as the health care system transitions to these new standards.
The Advocacy Council – ADVOCATING FOR ALLERGISTS AND THEIR PATIENTS.
