Quick Summary

• Specialty drug spend increases each year
• Prescribing specialty drugs continue to be highly manual 
• Since many specialty drugs are covered by a patient's medical benefit rather than pharmacy benefit, coverage information can be lacking at the point-of-care
• Leveraging a combination of NCPDP SCRIPT and HL7 FHIR can help ameliorate some of these challenges now. There is no need to wait. 

Specialty drugs offer new hope for the rising number of patients with chronic illnesses, which are the leading cause of death and disability in the United States. An estimated 60% of Americans have at least one chronic disease. Specialty medications are being developed to treat these conditions and many of these expensive drugs will be approved each year.

According to one estimate, 225 specialty-type medications will be available by 2025. With that robust pipeline in place, the volume of prescriptions for these game-changing therapies will increase exponentially every year, however, that is only part of the story. Specialty medications account for roughly half of all prescription volume as measured by drug spend. This is because they are covered under patients’ medical benefit and require prior authorization (PA), resulting in more burden and costs to prescribers.

Furthermore, specialty prescribing is not yet automated. Today, specialty prescribing is largely a time-consuming, frustrating, paper-based process that is outside prescriber’s workflow—unlike the process for prescribing medications covered under the pharmacy benefit, which has long been automated. Worse yet, the cumbersome, inefficient specialty prescribing process can take days before notification of prior authorization is provided. This results in delays in patient treatment and missed opportunities to find, discuss and prescribe alternative therapies. Having providers receive prompt PA notifications for specialty medications can vastly improve continuity of care for chronically ill patients. Access to medical benefit coverage at the point of prescribing, including when PA is required, creates the opportunity for discussion about alternative therapies during the same office visit as opposed to delaying care due to multiple visits or phone calls and faxes. 

Reducing burden and administrative overhead and improving patient outcomes are among the reasons why the industry has been working to streamline specialty prescribing and bring it into the electronic age. The National Council for Prescription Drug Programs (NCPDP) is already working on ways to automate the specialty prescribing process using its SCRIPT standard. NCPDP SCRIPT is widely used for prior authorizations required under a patient’s pharmacy benefit and successfully improves pharmacy workflow. Now the industry is considering the opportunities posed by use of HL7’s Fast Healthcare Interoperability Resources (FHIR) standard for prescriptions for medications covered under the medical benefit.

Why FHIR? FHIR is viewed as the go-to standard for health care interoperability. It is a building block for clinical data exchange in new and existing clinical workflows in electronic health records and mobile applications. This is important because clinical data must be exchanged before a PA can be approved, which is necessary for almost all specialty medications.

Moreover, specialty medications are mainly prescribed for the chronically ill, who often see multiple providers and experience fragmented care coordination. This requires many, iterative handoffs and the sharing of detailed clinical information. FHIR facilitates the sharing of patient and administrative information among those disconnected providers and the patient’s insurance company, reducing burden and increasing speed to therapy.

Taking it to the next level. Use of FHIR is being explored by collaborative efforts to address many of the common pain points associated with specialty prescribing. Prior authorization is a case in point.

 The Da Vinci Project. HL7’s Da Vinci Project is a multi-stakeholder collaborative that aims to use FHIR to support and integrate value-based care data exchange across communities. Da Vinci has developed several use cases that are linked to high-volume manual activities which would benefit from automation of those portions of the workflow that collect critical data to improve outcomes. So far, several cases could address portions of the specialty medication prescribing process leading to prior authorizations:

Coverage Requirements Discovery. Providers need to easily discover which payer- covered services or devices are affected by specific documentation requirements; whether rules are in place for determining need for specific treatments/services, as well as requirements for PA or other approvals; and other specific guidance. With a FHIR-based application programming interface (API), providers can discover in real-time specific payer requirements that may affect the ability to have certain services or devices covered by the responsible payer. For specialty medications, this will reduce time and minimize delay to therapy with real-time knowledge of PA requirements.

Documentation Templates and Coverage Rules. The goal of this use case is to reduce provider burden and simplify the process by establishing electronic versions of administrative and clinical requirements that can become part of providers’ specialty prescribing workflow. Included are templates for question sets typically associated with specialty prescribing and a standardized way to ascertain payers’ rules for coverage.

Prior Authorization Support (PAS). Nearly all specialty medications require PA. The goal of this use case is to define FHIR-based services to enable the provider, at the point of service, to request authorization (including all necessary clinical information to support the request) and receive it at once.  

The HL7 and NCPDP collaboration on specialty enrollment. Before they can get their specialty prescriptions filled, patients must go through today’s complex manual processes for enrollment using a specialty pharmacy or “hub” associated with the drug’s manufacturer. This pain point has been ripe for automation. The NCPDP Specialty Requirements for ePrescribing task group worked with the  HL7 Pharmacy work group to create a FHIR implementation guide focused on the exchange of data (demographic, clinical and financial) that can be sent along with an electronic prescription for dispensing specialty medications by pharmacies. This information also will help ease enrollment of patients in programs offered by third parties, such as hub vendors and pharmaceutical manufacturers.

Now is the time. With available standards such as FHIR and NCPDP SCRIPT transactions and collaboration among stakeholders, the movement for electronic submission of prior authorization is continuing to accelerate. Recent federal requirements are new drivers for adoption. The Centers for Medicare and Medicaid Services (CMS) now requires that Medicare Part D plan sponsors support version NCPDP SCRIPT 2017071 for four electronic prior authorization  transactions, and prescribers must use that standard when handling prior authorizations for Part D-covered drugs for their Part D beneficiaries. CMS also proposed a burden reduction rule back in December 2020 that would require APIs to support data exchange and prior authorization using FHIR for most federal payers. However, the burden reduction rule, while announced as final in early 2021, has not yet been published in the Federal Register, so the details of what will be required and for which programs may be different than what was in the “announced final rule” earlier this year. Indications are that the FHIR API component will likely remain.

Conclusion. FHIR will be at the heart of the transformational path to automating specialty pharmacy prescribing. That said, it does not support everything needed by specialty pharmacy and specialty prescribing. Taking it to the next level will require that:

• HL7, NCPDP, other standards development organizations and other multistakeholder groups continue to collaborate. This will yield benefits for specialty prescribing and other facets of medication management.
• Payers should strategically align their platforms to enable FHIR, if they have not done so already.
• Electronic health record, health information technology and electronic prescribing vendors should look to adapt business models and create innovate new products incorporating FHIR for greater interoperability to support specialty pharmacy prescribing.

Need more information? I’d be happy to help. Please contact me at phung.matthews@pocp.com.