Specialty medications are changing healthcare, offering life-saving treatments for serious conditions. While these therapies bring hope, they also introduce challenges—particularly around access and affordability. These challenges, along with evolving regulations, highlight the urgent need to fix workflow inefficiencies. Our recent webinar, led by Drew Hunsinger, VP, Corporate Business Development and Tyler Wince, VP, Product & Technology, Specialty Solutions, spoke to these hurdles and offered solutions for managing the increasing use of specialty medications.
If you’re grappling with rising costs, juggling specialty medication prior authorizations under medical or pharmacy benefits, or preparing for upcoming regulations, check out the key takeaways below.
Traditionally, most prescriptions were for standard medications, but this is rapidly changing. In 2023, specialty medications made up 80% of all newly approved drugs by the FDA. These treatments target complex, chronic, and life-threatening conditions such as cancer, multiple sclerosis, and autoimmune disorders. Because they are costly and typically administered by a clinician, specialty medications increasingly fall under medical benefits—or a combination of medical and pharmacy benefits—leading to more complicated approval processes. In many cases, patients also need additional support programs to overcome cost barriers so they can start or stay on therapy.
As more medications are categorized as “specialty,” it’s crucial to adopt technologies that simplify workflows, making it easier for patients to access their treatments quickly and for providers to manage these complex medications with fewer administrative hurdles.
One of the main difficulties in managing specialty medications is navigating the differences between medical and pharmacy benefits. Some drugs are covered by one, others by both, each with a unique approval process. For example, infusion therapies may fall under medical benefits, while oral therapies might be covered by pharmacy benefits. Navigating these two separate workflows often creates confusion and delays for providers and patients alike.
Pharmacy benefits: Typically easier to manage because of existing e-prescribing systems, but they still need eligibility checks, formulary reviews, and prior authorizations.
Medical benefits: Far more cumbersome, often requiring providers to manually submit paperwork, navigate multiple payer portals, or spend hours on the phone with insurers.
By adopting intelligent technology that consolidates both medical and pharmacy benefits workflows, providers can eliminate much of the manual work that delays patient access to medications. This type of technology allows providers to automate repetitive tasks and simplifies the approval process, ultimately saving time and reducing errors.
Upcoming regulatory shifts will significantly impact how prior authorizations are handled. The Centers for Medicare & Medicaid Services (CMS) and the newly renamed Office of the Assistant Secretary for Technology Policy (ASTP) are introducing new mandates that will standardize electronic prior authorization (ePA) using APIs based on the Fast Healthcare Interoperability Resources (FHIR) standard.
HTI-1 Rule Compliance by December 31, 2025
Providers must implement FHIR endpoints, enabling third-party applications and payers to access electronic health record (EHR) data, paving the way for faster, more automated prior authorizations.
CMS-0057-F (Interoperability and ePA Final Rule) Compliance by January 1, 2026
CMS will require payers to use FHIR APIs to automate critical steps in the prior authorization process, such as determining if prior authorization is needed, submitting required documentation, and tracking authorization status.
HTI-2 Rule Compliance by December 31, 2026
The HTI-2 rule requires healthcare organizations to adopt real-time, detailed data-sharing capabilities to enhance coordination between departments and external providers. The rules aims to reduce the time it takes to access critical patient information.
These changes are designed to make it easier for providers to manage prior authorizations, but they also mean healthcare organizations, EHRs, and other healthcare IT providers need to update systems to remain compliant. Manual processes, especially for medical benefits, will no longer be sustainable under these new requirements.
For many patients, specialty medications are vital to their quality of life. Physicians report that delays due to prior authorization challenges can lead to more ER visits and hospitalizations. On top of that, patients often face financial barriers that prevent them from filling prescriptions even after they’ve been approved. In fact, patients are five times more likely to abandon a prescription if it costs $50 or more.
As regulations become more stringent and specialty medication use grows, adopting automated and intelligent workflows will be key to minimizing these delays. By reducing the time spent on administrative tasks, clinicians can focus more on patient care, ensuring that patients receive their treatments when they need them.
With specialty medications becoming more prevalent, automating prior authorizations and building out intelligent workflows will be critical. An integrated solution can manage medical and pharmacy benefits, price transparency at the point of care, and prior authorizations more efficiently. This helps ensure a smoother process—from prescription to patient access.
Get ahead of the curve by reviewing your current workflows and adopting more efficient technologies. Doing so will not only prepare you for upcoming regulatory changes but will also help reduce the burden on your clinical staff while ensuring patients get timely access to their therapies.
The specialty medication landscape is evolving rapidly, but with the right tools, these challenges can be addressed. Are you ready to enable more efficient workflows, improve access to medication, and ensure compliance with new regulations? Take the next steps needed to enhance both clinical efficiency and patient care.
Want to learn more? Watch the full webinar for deeper insights and strategies on managing specialty medications effectively.