Why the Life Science Industry Should Care About the Proposed HTI-2 Rule

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Posted By: Industry Expert August 28, 2024

By Kim Boyd, Regulatory Resource Center Lead & Senior Consultant, Point-of-Care Partners
LinkedIn: Kim Boyd
LinkedIn: Point-of-Care Partners
Read Kim’s HTI-2 Series

In an era where data fluidity is transforming healthcare, life sciences manufacturers must stay attuned to evolving Health IT policies given that many of these policies have downstream effects on life sciences and access to expanded deidentified and aggregated datasets. The proposed HTI-2 rule is a critical piece of this transformation, offering profound implications for the industry. Here’s why life sciences companies should monitor this rule and consider engaging by submitting comments (Due October 4, 2024).

Real-Time Prescription Benefit (RTPB) Certification: A Market Access Opportunity

The HTI-2 rule proposes the certification of Real-Time Prescription Benefit (RTPB) standards, which is a game-changer for patients’ access to their needed therapies. By standardizing and certifying RTPB solutions, the rule aims to make coverage and cost-related information more readily accessible and standardize the way the information is accessed and delivered, reducing data fragmentation. Should this rule be finalized the way it is proposed, certification requirements would be effective January 1, 2028. This increased transparency will:

  • Improve Access: Patients and providers will have real-time information on drug coverage, costs, and alternatives, facilitating more informed and timely treatment decisions.
  • Enhance Market Reach: Pharmaceutical companies can benefit from improved communications and clear approval requirements between payers and providers.

Richer Data Sharing for Prior Authorization (PA) Insights

The proposed rule emphasizes enhanced prior authorization (PA) processes through better data sharing. This can provide life sciences manufacturers with valuable insights into patient and drug mix, as well as denial statistics:

  • Understanding Barriers: Detailed data on PA denials can help manufacturers identify patterns and barriers, such as the lack of real-world efficacy data, leading to targeted improvements.
  • Creating New Clinical Guidelines: Armed with comprehensive data, manufacturers can work with healthcare providers to develop new clinical guidelines that improve patient outcomes and reduce denials.

Rethinking Digital Health Offerings

The HTI-2 rule emphasizes the importance of capturing and utilizing health data effectively which may encourage a reevaluation of digital health offerings:

  • Patient Education: Enhanced data sharing enables better patient education programs, ensuring patients understand their treatments and adhere to prescribed regimens.
  • Early Testing and Identification: Identifying patients early for testing and treatments becomes more streamlined, improving overall health outcomes and pharmaceutical companies will benefit from faster diagnoses and treatment of patients.
  • Data from Digital Health Programs: Integrating data from digital health initiatives provides a richer dataset for manufacturers to analyze and improve their products. Collaborating with platforms like CoverMyMeds can yield deeper insights into reasons for PA denials and improve product efficacy.

Bulk Data Access: A Treasure Trove for Analytics

The rule’s provision for bulk data access using HL7 FHIR Bulk Data Access v2.0.0 may improve life sciences manufacturers access to:

  • Enhanced Analytics: Given various deidentified data access relationships, access to bulk data could provide greater opportunities for the performance of comprehensive data analyses, leading to better population health management and targeted interventions.
  • Larger datasets: Access to large datasets can drive more robust clinical research and innovation, accelerating the development of new treatments.

Immunization Registry Reporting

New standards for immunization registry reporting under HTI-2 will ensure better tracking and management of vaccine data:

  • Enhanced Data Insights: Improved standards for immunization registry reporting by healthcare providers could lead to more comprehensive and accurate vaccine uptake data. This could provide valuable insights for manufacturers in areas such as:
    • Market penetration analysis
    • Identifying areas of low vaccination rates for targeted education campaigns
    • Post-market surveillance and real-world evidence studies
  • Public Health Collaboration: While not directly reporting to registries, manufacturers could potentially leverage the improved data standards to enhance collaboration with public health authorities on vaccine effectiveness studies or outbreak response planning.
  • Supply Chain Optimization: Better immunization tracking could lead to more accurate demand forecasting, helping manufacturers optimize their production and distribution strategies. The Broader Implications for Health IT Policy

Beyond the specifics of HTI-2, life sciences manufacturers should recognize the broader implications of evolving Health IT policies:

  • Foundational Business Impacts: Data fluidity facilitated by policies like HTI-2 may improve foundational business processes, from R&D to market access and patient engagement.
  • Enhanced Collaboration: Improved data exchange standards promote collaboration across the healthcare ecosystem, leading to more cohesive and effective patient care strategies that will benefit life sciences brands.

The proposed HTI-2 rule represents a significant step forward in health IT policy, with down-stream implications for life sciences manufacturers. By engaging with these developments, companies can ensure they are at the forefront of a more transparent, efficient, and patient-centric healthcare landscape. Monitoring and adapting to these changes will not only enhance market access but also drive innovation and improve patient outcomes. Life sciences companies must stay informed and proactive in responding to these critical regulatory shifts.

For more details, refer to the ONC HTI-2 Proposed Rule and the HHS Press Release.

This article was originally published on the POCP blog and is republished here with permission.

The proposed rule published in the Federal Register on August 5, 2024 and is available for public comment until October 4, 2024.