October 4, 2024

Micky Tripathi, PhD, MPP National Coordinator

Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology

U.S. Department of Health and Human Services 330 C Street, SW, 7th Floor

Washington, DC 20024

Submitted electronically via Regulations.gov

RE: HTI-2 Proposed Rule

Dear Assistant Secretary Tripathi,

The Alliance of Specialty Medicine (Alliance) represents more than 100,000 specialty physicians across 16 specialty and subspecialty societies. The Alliance is deeply committed to improving access to specialty medical care by advancing sound health policy. On behalf of the undersigned members, we are writing to voice our overall support for the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, which seeks to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.

Updated Certification Criteria

Through earlier rulemaking, the Alliance expressed its support for Centers for Medicare and Medicaid Services (CMS) policies that require certain payers to improve their prior authorization processes, including implementation of electronic prior authorization processes, shortened time frames for responding to prior authorization requests, and other policies that would make the prior authorization process more efficient and transparent. We also noted that integration of prior authorization requirements within EHR systems is critical to ensuring that providers can track and manage active prior authorizations with minimal burden and submit requests at the point of care. We encouraged what is now referred to as the Office of the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC, formerly ONC) to consider adding certification criteria to the ONC Health Information Technology Certification Program to support payer requirements regarding the adoption of electronic prior authorization processes.

The Alliance continues to believe that improving the exchange of health information and streamlining prior authorization should be a top priority of both the ASTP/ONC and CMS. As such, we appreciate that ASTP/ONC is proposing to adopt a set of certification criteria to support data exchange between payers, physicians, other providers, and patients. These criteria will help to improve provider and patient access to patient data, promote care continuity when patients switch payers, reduce the complexity and burden associated with prior authorization processes, and ensure that patients receive the care they need in a timely manner.

As ASTP/ONC considers future certification criteria to support electronic prior authorization processes, we urge it to do so in the context of the following recommendations, which the Alliance previously shared with CMS:

• CMS should apply electronic prior authorization policies and associated payer requirements to outpatient drugs, including drugs administered by a physician, rather than limit them to items and services only.
• With the adoption of automated processes and standards, impacted payers should be required (and able to) respond within 48 hours for standard requests and within 24 hours for expedited/urgent requests.
• CMS should require real-time prior authorization decisions for routinely approved For many specialty-focused conditions, time can make a significant and sometimes life-altering difference in the patient’s outcome.
• Payers should be required to publicly report electronic prior authorization metrics, with data being reported on an individual service basis rather than in the aggregate.

We also reiterate our earlier concerns that certified Health IT vendors will pass the costs of complying with these new criteria onto physicians or implement other potentially coercive contractual clauses related to these new functionalities. Physicians already must invest significant resources to adopt and maintain certified EHR technology (CEHRT) since they are essentially mandated to use CEHRT that includes API technology and to provide patients with access to data via those APIs. We request clearer guidance from ASTP/ONC to ensure that Health IT developer charges are truly reasonable and that providers, who are already required to buy and upkeep this technology, are not responsible for unreasonable costs outside of their control.

Information Blocking

In general, the Alliance appreciates ASTP/ONC’s ongoing efforts to clarify and update information blocking definitions and exceptions. Many physicians are still unsure of their obligations under these relatively new regulations and the proposed enhancements will help to provide assurances regarding the appropriate exchange, access, and use of electronic health information. We urge ASTP/ONC to continue to issue guidance materials and educational webinars to help physicians navigate this evolving and often confusing landscape.

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The Alliance appreciates the opportunity to share its feedback with ASTP/ONC. We look forward to working with your office to further develop policies that allow our members to focus on providing high quality patient care rather than administrative compliance.

Should you have any questions or would like to meet with the Alliance to discuss our comments further, please contact us at info@specialtydocs.org.