16 Jun HIT End-Users Alliance Responds to CMS Prior Authorization for Drugs Proposed Rule
Dr. Mehmet Oz
Administrator
Centers for Medicare and Medicaid Services
US Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850
Dear Administrator Oz:
The Health IT End-Users Alliance (the Alliance) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) Interoperability Standards and Prior Authorization for Drugs Proposed Rule published in the April 14, 2026, Federal Register (CMS-0062-P).
The Alliance brings together health information professionals, physicians, hospitals, and other front-line healthcare providers and organizations that use health information technology (IT) to ensure that policy and standards development activities reflect the complex web of clinical and operational challenges facing those who use such technologies today. By working collaboratively, the Alliance is focused on priorities for how technology can best support clinical care and operations.
The Alliance supports CMS’ goal to improve the prior authorization process and reduce burden on end- users. We supported and provided feedback on the policies within the 2024 CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F), and applaud CMS applying these policies to include drugs, which have long been a major point of frustration and burden in prior authorization for healthcare organizations and end-users. We support the proposals related to process improvements, including metrics reporting, quicker decision timeframes, and transparency on prior authorization information and application programming interface (API) usage, and encourage CMS to align these across all CMS-regulated and impacted payers.
However, we caution that achieving this goal depends on successful implementation of standards, which will require federal support for more robust real-world testing of the interoperability standards and implementation guides (IGs) intended to facilitate automation. IGs guide the execution and use of a particular standard in care settings by defining data elements, workflows, business rules, and system behaviors. It is important for standards and IGs to be thoroughly tested and vetted prior to implementation in clinical and operational settings to avoid risk and additional burden.
Executing real-world testing and achieving the goal of improved and streamlined prior authorization will require greater engagement with the health IT end-user and provider community to understand the effort required to operationalize the technology solutions and business processes needed to interact with payer systems. In addition to testing, the Alliance urges CMS to support end-user implementation by providing resources, technical assistance, and flexibilities, especially for under-resourced organizations, as they work to implement policies in CMS-0057-F and any forthcoming finalized policies that result from this proposed rule. This will ensure that the standards and IGs function as intended to support end-users truly conducting streamlined, electronic prior authorization.
The Alliance supports the healthcare industry’s move from X12 standards to HL7® Fast Healthcare Interoperability Resources (FHIR) standards, including the proposed adoption of FHIR standards as the HIPAA standard for electronic prior authorization, either replacing existing X12 standards or providing a FHIR standard where there currently is no standard. The healthcare industry has long awaited a solution or the lack of an attachment standard to accompany the X12 278 transaction standard, and we appreciate CMS clarifying and proposing to adopt the suite of FHIR standards to support electronic prior authorization transactions.
However, the Alliance has concerns about requiring adoption of FHIR standards and IGs that are not yet sufficiently mature, particularly in the absence of a clear roadmap for real-world testing and reporting that would demonstrate when these standards and IGs will be mature and how they can and will be incorporated into end-user workflows with minimal burden. This should happen before compliance is enforced. We encourage CMS to extend the compliance deadlines for use of the FHIR standards and implement flexibilities to ensure the X12 278 standard continues to be available as a method for data exchange as we transition to FHIR standards and IGs maturation and use in real-world settings. This would ensure that method of data exchange is still available until the FHIR-supported ecosystem has proven to work as intended.
Real-world testing is a critical component of ensuring standards and IGs function as intended in real-world settings, support the needs of end-users, and can support the successful implementation of policies that rely on the use of those standards. The lack of robust real-world testing may cause increased burden on the end-user due to technology that is poorly designed or does not meet real-world workflows. Other consequences due to lack of adequate real-world testing include:
• adoption and implementation of standards that require significant workarounds by healthcare
organizations;
• adoption and implementation of incomplete or immature standards;
• standards and policies that do not achieve the desired goal when deployed;
• excessive burden added to end-users;
• wasted money on failed implementations; and
• confusion from patients with respect to technological capabilities.
By working together with end-users earlier through real-world testing, developers, impacted payers, healthcare organizations, and policymakers can ensure the successful streamlining and efficiency of electronic prior authorization with fewer burdens. As part of the Appendix to this letter, we have included our Real-world Testing Consensus Statement that includes further policy recommendations.
Work with end-users should also extend to CMS’ continued exploratory activities related to the proposed rule’s request for information (RFI) on event notifications and proposals related to API endpoints. While two different technologies, both will require extensive input from the technology development community and the end-user community to ensure CMS’ policy goals are ultimately accomplished. CMS should engage in extensive public convenings and stakeholder requests for input processes. This will help CMS ensure any new policy proposals create guardrails to maintain accuracy in API endpoints, without disrupting existing end-user processes related to event notifications in value-based care, with the ultimate goal of improving the interoperable flow of data while minimizing disruption to the healthcare community.
The proposed 24-month implementation timeline will be challenging for end-users to adhere to. With final rule publication, electronic health record (EHR) vendors must interpret the IG specification, build or update software, and release it to customers, which can take at least 12 months. Following, healthcare organizations need to configure, test, and validate the new functionality in their environments, as well as train staff, redesign workflows, and coordinate with payer partners. Ideally, after the standards and IGs are live, organizations will be required to monitor performance, troubleshoot issues, and retrain and redesign workflows where needed. Thus, we encourage CMS to consider a phased compliance timeline or finalize a longer implementation timeline, as well as provide support for real-world testing, technical assistance, and implementation of standards and IGs before enforcement.
The Health IT End-Users Alliance thanks CMS for its commitment to improving electronic prior authorization processes, and we are committed to being a partner in this effort by providing the end-user perspective to strengthen these policies.