Specialty Medication Enrollment
2.1.0 - CI Build

Specialty Medication Enrollment, published by HL7 International - Pharmacy. This is not an authorized publication; it is the continuous build for version 2.1.0). This version is based on the current content of https://github.com/HL7/fhir-specialty-rx/ and changes regularly. See the Directory of published versions

## IG Home Page

### Overview

This FHIR implementation Guide describes the exchange of patient demographic, clinical, consent and coverage data to support fulfillment of specialty medication prescriptions by pharmacies, and enrollment of patients into related support programs offered by parties such as Hub vendors and pharmaceutical manufacturers.

This guide is the result of collaboration between HL7 and the National Council for Prescription Drug Programs (NCPDP).

### Background

Specialty medications are generally defined as those of high cost or requiring special handling. The use of these medications may be constrained based on indication for use, risks to patient health vs. potential benefits, cost, etc.

There can be different settings for administration as well as limitations on where they can be dispensed. Additional steps in the prescribing and dispensing process may exist, including the need to share consent information. Consent may be needed to authorize contact by patient support programs, sharing of patient clinical and other information to support steps to obtain insurance coverage or other financial support, etc.

The current process for exchanging information to support specialty medication fulfillment is complex and manual, often resulting in delays of days to weeks before patients can begin their therapy. This is caused largely by the absence of an industry standard for exchanging clinical data needed to dispense specialty medications and enroll the patient into associated support and savings programs.

NCPDP created a task group to focus on the exchange of this data, with the goal of reducing the time to therapy for a patient who has been prescribed a specialty medication. The group identified demographic, clinical and coverage information needed to support the process, and defined data exchange workflows between the clinic, pharmacy and other fulfilling parties to efficiently deliver the data to the parties that need it.

This information is outside of the scope of the NCPDP e-prescription standard that conveys specialty orders to pharmacies in the US today. After an extensive analysis of the types of information required beyond what is carried in the prescription, the task group determined that developing an implementation guide using HL7 FHIR would be the best approach for meeting this need. Exchange of that information is the focus of this guide.

### Scope of This Guide

This guide addresses the exchange of information to support specialty medication fulfillment functions, including:

- medication dispensing and billing
- specialty enrollment for programs or services, including the gathering of consent
- facilitation of clinical care management, education, and training.

The guide does not address transmission of the original prescription from the prescriber to dispensing pharmacy, which is typically accomplished in the US using the NewRx message defined in the NCPDP SCRIPT standard.

Further, the exchanges described in the guide are not intended to be used to request a change to a received prescription or to propose a particular clarification; these functions are supported by the NCPDP SCRIPT RxChangeRequest and RxChangeResponse messages.

This implementation guide is intended be used in the United States. It reflects US pharmacy processes and conventions.

### Content and Organization

The guide is organized into the following sections:

- Use Cases and Roles gives an overview of the guide’s goals and participants.
- Systematic Query Workflows describes the exchanges that retrieve information systematically from the patient’s records.
- Information Flows Requiring Human Interaction describes a process enabling the prescriber or staff to provide information through a SMART application launched from the EHR.
- Consent Workflows gives an overview of consent scenarios supported by the guide.
- Search Conventions defines required and recommended searches and conventions for specifying searches in Specialty Rx messages.
- Patient Matching describes methods for identifying the patient for whom information is being exchanged.
- Message Structures and Message Submission give details related to the Specialty Rx messaging options.
- Error Handling defines expectations for handling exception situations.
- Conformance Expectations defines use of Must Support elements and also describes conventions for situations where information is not available.
- Intermediary Facilitation describes how an intermediary can enable exchange between implementers of the guide’s RESTful and messaging options.
- Security provides information for implementers related to security and privacy.
- Specialty Rx Profiles, Terminology and Examples lists all profiles and terminology defined in this guide. It also provides examples instances that conform to the guide’s profiles.
- Applicable US Core Profiles defines expectations for the use of US Core profiles in the guide’s searches.
- Capability Statements defines sets of guide functionality that can be implemented individually or in combination.

### FHIR Basics

For those new to FHIR, the material below describes basic FHIR principles and gives guidance for reading FHIR specifications.

- FHIR overview
- Developer’s introduction (or Clinical introduction)
- FHIR data types
- Using codes
- References between resources
- How to read resource & profile definitions
- Base resource

### Authors

HL7 Pharmacy Workgroup
NCPDP Workgroup 18 - Specialty Requirements for ePrescribing Taskgroup
NCPDP Workgroup 10 / 11 - Patient Consent Taskgroup
Frank McKinney | frank.mckinney@pocp.com

### Dependencies

IG | Package | FHIR | Comment
--- | --- | --- | ---
Specialty Medication Enrollment | hl7.fhir.us.specialty-rx#2.1.0 | R4 |
HL7 Terminology (THO) | hl7.terminology.r4#5.0.0 | R4 | Automatically added as a dependency - all IGs depend on HL7 Terminology
US Core | hl7.fhir.us.core#3.1.1 | R4 |

Package hl7.fhir.us.core#3.1.1

### Cross Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.fhir.us.specialty-rx.r4) and R4B (hl7.fhir.us.specialty-rx.r4b) are available.

### Global Profiles

There are no Global profiles defined

### IP Statements

This publication includes IP covered under the following statements.

- Copyright HL7. Licensed under creative commons public domain
  Show Usage
  - identifierType: Bundle/specialty-rx-query-1, Bundle/specialty-rx-query-response-1... Show 10 more, Bundle/specialty-rx-query-response-2, Bundle/specialty-rx-query-response-3-w-op-outcome, Bundle/specialty-rx-query-response-unsolicited-1, SpecialtyRxCoverage, SpecialtyRxTaskConsentRequest, SpecialtyRxTaskSmartLaunch, Task/specialty-rx-task-consent-request-1, Task/specialty-rx-task-consent-request-2-completed, Task/specialty-rx-task-consent-request-contained and Task/specialty-rx-task-smart-launch-2-ids
- HL7 Inc.
  Show Usage
  - Coverage Class Codes: Bundle/specialty-rx-query-response-1, Coverage/specialty-rx-coverage-1 and SpecialtyRxCoverage
- ISO Maintains the copyright on the country codes, and controls it's use carefully. For futher details see the ISO 3166 web page: https://www.iso.org/iso-3166-country-codes.html
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  - ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code: SpecialtyRx, SpecialtyRxBundleError... Show 35 more, SpecialtyRxBundleQuery, SpecialtyRxBundleQueryResponse, SpecialtyRxBundleQueryResponseUnsolicited, SpecialtyRxBundleSearchResult, SpecialtyRxCodeSystemEventType, SpecialtyRxCodeSystemTaskCharacteristic, SpecialtyRxConsent, SpecialtyRxConsentRequested, SpecialtyRxCoverage, SpecialtyRxDataConsumerMessaging, SpecialtyRxDataConsumerRestful, SpecialtyRxDataSourceMessaging, SpecialtyRxDataSourceRESTful, SpecialtyRxMessageDefinitionError, SpecialtyRxMessageDefinitionQuery, SpecialtyRxMessageDefinitionQueryResponse, SpecialtyRxMessageDefinitionQueryResponseUnsolicited, SpecialtyRxMessageHeaderError, SpecialtyRxMessageHeaderQuery, SpecialtyRxMessageHeaderQueryResponse, SpecialtyRxMessageHeaderQueryResponseUnsolicited, SpecialtyRxOrganizationPharmacy, SpecialtyRxParametersQuery, SpecialtyRxParametersQueryResponse, SpecialtyRxParametersQueryResponseUnsolicited, SpecialtyRxPatient, SpecialtyRxPractitioner, SpecialtyRxPrescription, SpecialtyRxTaskConsentRequest, SpecialtyRxTaskSmartLaunch, SpecialtyRxValueSetConsentStatus, SpecialtyRxValueSetEventType, SpecialtyRxValueSetTaskInputType, SpecialtyRxValueSetTaskOutputType and SpecialtyRxValueSetTaskType
- The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
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  - Unified Code for Units of Measure (UCUM): Bundle/specialty-rx-query-response-1
- This material contains content from LOINC. LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.
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  - LOINC: Bundle/specialty-rx-query-response-1, Consent/specialty-rx-consent-1, Consent/specialty-rx-consent-requested-1 and Task/specialty-rx-task-consent-request-contained
- This material contains content that is copyright of SNOMED International. Implementers of these specifications must have the appropriate SNOMED CT Affiliate license - for more information contact http://www.snomed.org/snomed-ct/get-snomed-ct or info@snomed.org.
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  - SNOMED Clinical Terms® (SNOMED CT®): Bundle/specialty-rx-query-response-1, Bundle/specialty-rx-query-response-2, Bundle/specialty-rx-query-response-3-w-op-outcome, Bundle/specialty-rx-query-response-unsolicited-1 and Bundle/specialty-rx-search-response-2-w-revinclude
- Using RxNorm codes of type SAB=RXNORM as this specification describes does not require a UMLS license. Access to the full set of RxNorm definitions, and/or additional use of other RxNorm structures and information requires a UMLS license. The use of RxNorm in this specification is pursuant to HL7's status as a licensee of the NLM UMLS. HL7's license does not convey the right to use RxNorm to any users of this specification; implementers must acquire a license to use RxNorm in their own right.
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  - RxNorm: Bundle/specialty-rx-query-response-1, Bundle/specialty-rx-query-response-unsolicited-1, Bundle/specialty-rx-search-response-1-w-include and MedicationRequest/specialty-rx-medicationrequest-1