The following is a guest article by Nick Barger, PharmD, Vice President, Product at DrFirst. This article is the sixth in the Healthcare Regulatory Talk series.
Prior authorization (PA) is the poster child for administrative tasks that spawn inefficiencies in our healthcare system, impacting providers and patients alike. Clinicians and other staff lose hours every day to the mind-numbing task of deciphering submission requirements, filling out forms correctly, and tracking status. Patients know that whenever PA is required, delays will probably follow.
A recent study shows the impact, with 95% of physicians reporting that PA increases feelings of burnout and that 78% of patients are likely to give up on prescribed treatment because of approval delays. As the use of specialty medications grows, so will burnout and prescription abandonment.
For health information technology (HIT) and electronic health record (EHR) vendors, new regulations that promote interoperability and transparency for PA workflows are an opportunity to significantly improve the experience for providers and the patients they serve. However, there is also an opportunity cost inherent in the “the build-or-buy question,” so companies must carefully consider whether to tackle the necessary updates in-house or outsource them to a trusted partner.
HTI-1, HTI-2, and CMS-0057-F Rules
First, let’s look at the rules proposed over the past year and where we stand as we prepare for 2025. The Health Data, Technology, and Interoperability (HTI-2) proposed rule was released in July 2024, and the newly renamed Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) is expected to issue the final rule late in 2024. The proposed rule pushes for significant upgrades in e-prescribing processes, building on the HTI-1 rule, which laid the framework for interoperability.
HTI-2 includes an update to the United States Core Data for Interoperability (USCDI) v4, as well as standards and criteria related to public health information exchange and e-prescribing—specifically electronic prior authorization (ePA). The new mandates will standardize ePA using APIs based on the Fast Healthcare Interoperability Resources (FHIR) standard and require EHRs to support prescription ePA and use the new National Council for Prescription Drug Programs (NCPDP) SCRIPT standard as part of their certification criteria.
For medical ePA, the rule also includes a new set of certification criteria for FHIR-based prior authorization APIs to enable identification of coverage requirements and PA request submissions.
Earlier in 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Interoperability and Patient Access Final Rule (CMS-0057-F)—requiring impacted payers to implement and maintain an ePA-specific API to automate the process for providers. Payers must determine whether prior authorization is required, identify documentation requirements, and facilitate the exchange of requests and decisions with providers’ EHRs or practice management systems.
HTI-2 proposes criteria that take further steps to improve access, including requiring APIs that enable:
- Patient access: Allowing patients to access their insurance coverage and claims information, including drug formulary.
- Provider access: Allowing providers to access information on patient claims.
- Visibility: Identifying coverage and prior authorization submission requirements for providers.
While providers and patients welcome these changes, the onus for development is on EHR and HIT vendors—triggering some fear, uncertainty, and doubt about how to comply with all these new rules. Many are looking at their planning calendar with trepidation based on the following deadlines:
- ASTP/ONC HTI-1: December 31, 2025
- CMS-0057-F: January 1, 2027
- ASTP/ONC HTI-2: January 1, 2028
The dates may seem far away, but they are intended to give HIT and EHR vendors the necessary runway for development and certification—and to give hospitals and health systems enough time for implementation. In other words, you are going to need that much time.
There is an opportunity for those who are ahead of the game, as early adopters can gain a competitive advantage with HTI-2-compliant systems that attract more partnerships and provider contracts. On the other hand, organizations that fail to meet these regulatory milestones risk more than fines for non-compliance; they risk losing market share to those who are compliant.
The Future of Prior Authorization
Until these new regulations are implemented, PA remains a significant pain point—especially for providers in specialty disciplines. Inconsistency between different payers and whether the order is covered by medical or pharmacy benefits means that tracking down the correct form disrupts workflows and takes time away from direct patient care.
Electronic prior authorization for services, procedures, and certain specialty medications covered by medical benefits is still in its infancy stage. Prescription ePA was introduced more than 10 years ago, with DrFirst as one of its early adopters.
Yet even though prescription ePA is more mature, it is still not where it needs to be. For example, digitized versions of paper-based prior authorization questionnaires don’t always work intuitively with automation. As a result, clinicians spend considerable time re-entering data from the patient’s chart, opening the door to preventable errors or omissions.
However, matching data into form fields can be done more efficiently. Machine learning and intelligent automation can continuously compile updated lists of payer rules, interpret these rules, automate submissions, and track ePA on a dashboard. DrFirst can offer these technologies thanks to 25 years as a leader in the e-prescribing space and the acquisition of Myndshft, the only unified platform that streamlines prior authorization and related services for both medical and pharmacy benefits.
Prior authorization’s well-earned reputation as a major pain for providers and patients will not be eradicated overnight. There is hard work to be done. A clear path to compliance for HIT and EHR vendors means juggling multiple compliance deadlines and reconstructing your roadmap to handle all e-prescribing changes—not just those related to PA.
Interested in partnering with a trusted platform vendor to meet new e-prescribing standards and comply with regulatory updates to prior authorization processes? Check out DrFirst’s recent on-demand webinar about HTI-2 or reach out to speak with one of our experts here.
About Nick Barger, PharmD
Nick is Vice President of Product at DrFirst, where he leads design and development of intelligent medication management solutions for the e-prescribing pioneer and the 300 EHRs and health information systems they partner with, providing clinical, regulatory, and digital workflow solutions that make healthcare more efficient and effective. Check out all the articles in the Healthcare Regulatory Talk series.
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