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Track overview

Short Description

NCPDP is working to define FHIR exchanges to help get specialty medications to the patient quicker--by providing pharmacies the information they need to dispense the drug, address insurance needs, and coordinate with the patient and other parties.

Long Description

For Oncology, Rheumatoid Arthritis, Infusion drugs, etc., the current process for exchanging data, including prescription data regarding specialty medications is complex and manual, taking days to weeks to begin a patient on therapy.

There is no industry standard for exchanging clinical data when necessary for dispensing specialty medications by pharmacies as well as facilitating enrollment of patient in programs offered by third parties such as Hub vendors or Pharmaceutical Manufacturers. NCPDP started a task group several years ago focused on the exchange of data needed to help shorten the time to therapy for a patient who has been prescribed a specialty medication and over the past two years have been focused on identifying demographic, clinical and financial information that needs to be exchanged in order to get the patient the therapy they need.

This information is outside of the current e-Prescription that is sent to the pharmacy today. After an extensive analysis of the types of additional information that is required along with the prescription it was determined that developing an implementation guide using HL7 FHIR would be the best approach to support the exchange of this information. 

We are in the process of creating a co-branded FHIR implementation Guide (Co-branded between HL7 and NCPDP) focused on the exchange of data (Demographic, prescription, clinical and financial) for dispensing specialty medications by pharmacies as well as facilitating enrollment of patients in programs offered by third parties such as but not limited to Hub vendors and Pharmaceutical manufacturers. 

Background information on the project is located here: Specialty Medication Prescribing and the draft implementation guide is located here: Specialty Medication DRAFT Imp Guide

Type

  • Test an Implementation Guide

Submitting Work Group/Project/Accelerator/Affiliate/Implementer Group

Pharmacy

Proposed Track Lead

Frank McKinney

frank.mckinney@pocp.com

Related tracks

none

FHIR Version

  • FHIR R4

Specification(s) this track uses

Specialty Medication DRAFT Implementation Guide

Track goals

  • Get feedback on the base set of information identified by the NCPDP task group to support the specialty Rx process (searches and resource definitions)
  • Get feedback on the IG’s exchange model
    • The goal is to enable all prescription fulfillment stakeholders to participate, including
      • Those that exchange prescriptions and related information through intermediaries and networks today – without direct connections or knowledge of data source locations
      • Those that can locate endpoints and exchange through direct connections
  • Get other feedback on the IG… things to clarify, correct or flesh out further

Artifacts of focus

Messaging and RESTful exchange model overview

http://build.fhir.org/ig/HL7/fhir-specialty-rx/branches/master/workflow.html

Required Searches

http://build.fhir.org/ig/HL7/fhir-specialty-rx/branches/master/request-queries.html

All profiles and examples

http://build.fhir.org/ig/HL7/fhir-specialty-rx/branches/master/artifacts.html

Clinical input requested (if any)

No clinical needs at this time

Patient input requested (if any)

No patient input needs at this time

Expected participants

EHRs, pharmacy organizations, intermediaries

Zulip stream

https://chat.fhir.org/#narrow/stream/235647-Specialty-Medications

Track Orientation

Recording

Sep 2020 Specialty Rx Track Orientation.mp4


Use Case Overview

Supported business functions

The implementation guide supports these business functions:

  • Specialty enrollment for programs or services.
  • Request of additional information to facilitate medication dispensing and billing.
  • Facilitation of clinical care management, education, and training

Process flows

Note: Both flows below take place after the specialty medication prescription has been received by the pharmacy (or received by a user of the system, e.g., by fax)

"Solicited" Workflow

    1. The Third Party System initiates a Specialty Rx Query when additional information relating to a specialty prescription is needed to facilitate dispensing or other activity.

  • This might be triggered automatically by the Third Party System upon receiving an electronic prescription (NewRx) or 
  • A person using the Third Party System might initiate the request manually, e.g., after receiving a faxed prescription

    2. The Prescriber System collects the requested information and responds with a Specialty Rx Query Response.

    Notes:

  • The response is typically synchronous.
  • The process may repeat one or more times, for example if the user of the Third Party System realizes they need additional information as a follow-up to information received in a previous Specialty Rx Query Response.

"Unsolicited" Workflow

An alternative flow, in which the prescribing system proactively transmits patient information in conjunction with an electronic specialty prescription, will be included in the Specialty Rx IG, but will not be tested during this Connectathon

System Roles

Requesting system. In this workflow, the requesting system is used by a stakeholder that requires information to perform an activity related to a specialty medication prescription (generalized as a Third Party System).

The actors below may initiate a specialty Rx data request:

Pharmacy (user of Third Party System)

     The pharmacy typically will:

  • Receive the NewRx transaction requiring more information to be provided before it can be dispensed
  • Request additional information from prescriber or their EHR system
  • Determine when additional information necessary to dispense medication has been satisfied

Other Third Parties (examples include but are not limited to intermediary, hub, manufacturer) (user of Third Party System)

     These other parties typically will:

  • Request additional information from prescriber or their EHR system
  • Determine when additional information necessary to dispense medication has been satisfied


Responding system. The responding system is used by the prescriber of the specialty medication or associated staff (Prescriber System).

The actors below respond to a specialty Rx data request:

Prescriber (Prescriber System)

     The prescriber typically will:

  • Create a New Prescription using the NCPDP SCRIPT (NewRx) transaction requiring more information to be provided before it can be dispensed
  • Provide appropriate responses to requests for information from other parties

Prescriber Agent (Prescriber System)

     The prescriber agent can:

  • Provide appropriate responses to requests on behalf of the provider

EHR System (Prescriber System)

     The EHR system typically will:

  • Respond automatically when a request from a third party is received
  • Allow users to respond to requests for additional information when requested from other parties


See Specialty IG - Workflow for additional details about roles

Track details

Data Exchange Roles (to be tested during the Connectathon)

  • Messaging Requester (pharmacy*): Requests, receives patient info using FHIR messages
  • Messaging Data Source (EHR*): Accepts message requests and transmits patient info in a message response
  • RESTful Data Source (EHR): Responds to REST search request
  • Connectathon sandbox
    • Acts as a requester

    • Acts as a data source

    • Acts as an intermediary…

      • Between two messaging participants: Routes between parties
      • Between a messaging requester and RESTful data source: Performs REST searches on behalf of the requester

* The sandbox system can also serve as the requester or data source

Connectathon scenario 1: Request / Response using FHIR Messaging

Summary: A pharmacy or other Third Party System requests a set of information related to a specialty medication prescription it's received. 

Action: The Third Party system creates a Specialty Rx Query Request message bundle and submits it to the Prescriber System endpoint using the $process-message operation. (The sandbox system can play the role of either sender or receiver during the Connectathon)

The request bundle contains the following resources:

  • MessageHeader
  • Parameters resource containing search strings and references to:
    • Patient
    • MedicationRequest (optional)
    • Practitioner (optional)
    • Pharmacy Organization (optional)

Preconditions:

  • Clinical and administrative information about the patient resides in the Prescriber System (see test patient defined below)
  • The Third Party System knows the address and connection details of the Prescriber System endpoint or that of its intermediary.
  • The Prescriber System knows the address and connection details of the Third Party System endpoint or that of its intermediary.

Success Criteria: 

The Prescriber System executes the searches specified in the request and initiates a Specialty Rx Query Response to the requesting Third Party System.

  • The response bundle contains the resources necessary to supply the requested information.


Connectathon scenario 2: Request / Response with RESTful Data Source

Summary: An EHR responds to RESTful search requests made by a pharmacy or intermediary (roles that can be played by the sandbox system during the Connectathon)

Action: The EHR responds to the set of required searches defined in the Specialty Rx Implementation guide (http://build.fhir.org/ig/HL7/fhir-specialty-rx/branches/master/request-queries.html)

Preconditions:

  • Clinical and administrative information about the patient resides in the EHR (see test patient defined below)

Success Criteria: 

  • The EHR executes the submitted searches, conforming to the US Core profiles for clinical information and the Specialty Rx Coverage profile


Connectathon Sandbox System

There will be a test sandbox running during the Connectathon that can interact with participants as…

Messaging-based Requester

  • Submit a Specialty Rx Query request to a messaging-based EHR or RESTful EHR
  • Receive the synchronous Specialty Rx Query Response message

Messaging-based EHR

  • Accept a Specialty Rx Query request from a Messaging Requester
  • Respond with a synchronous Specialty Rx Query Response


Sandbox URL

https://specialty-fhir.azurewebsites.net/


Sanbox usage:

To use the sandbox as a mock message-based requester...

  • An EHR processes a request message sent by the Sandbox


To use the sandbox as a mock EHR...

  • A Messaging Requester (Pharmacy) submits a request message and receives a response


To use the sandbox as a messaging-to-REST intermediary...

  • A RESTful Data Source (EHR) processes searches submitted by the Sandbox

Security and Privacy Considerations

Security

  • The sandbox can be accessed without authentication credentials
  • The sandbox works with an open EHR FHIR server and has an option to manually send an authorization token

Privacy

  • All information accessible through the sandbox is fictional
  • Participants must be sure not expose any real person information in requests or responses exchanged during the connectathon

Test Patient

The mock EHRs provided by the test harness require that the patient's first and last name match exactly

Family name: Doe
Given name: Tim

Phone: 555-555-5555
use: home
email: tim.doe@example.com
gender: male
birthDate 1987-02-20
address
line: 2224 Century Avenue
city: Minnetonka
state: MN
postalCode: 55345
country: US

Test data load scripts (transactions)

tim-doe-data-load.zip

Track Report Out

Track summary

The Specialty Medication Prescribing IG aims to help get specialty medications to the patient quicker--by providing pharmacies, specialty Hubs and others the information they need to dispense the drug, address insurance needs, and coordinate with the patient and other parties.

Track goals:

  • Build awareness of the Specialty Rx Implementation Guide
  • Vet the IG’s exchange flows and content against the participants real-world scenarios
  • Identify any opportunities to adjust the scope of the IG—e.g., to support additional workflows
  • Introduce the IG’s testing sandbox server
  • Identify topics and questions to bring back to the sponsoring NCPDP and HL7 working groups

Paticipants

ParticipantOrganization
Todd AndersonSurescripts
Stefan AndrasiKroger Specialty Pharmacy
Pooja BabbrahPoint of Care Partners
Maggie BuchingerSurescripts
Glenn ConneryOccam Health Services
Jeffrey DanfordAllscripts
Sathya KrishnasamyAnthem
Frank McKinneyPoint of Care Partners
Tim McNeilSurescripts
John MoehrkeBy Light Professional IT Services
Ryan OwensKroger Pharmacy
Shelly SpiroPharmacy HIT Collaborative
Margaret WeikerNCPDP
Krzysztof WilczekGenentech


         


              






Systems that have implemented the IG

  • Surescripts: Sandbox server supporting ~75% of the IG

Notable achievements

  • In-depth discussion of how the IG’s exchange flows and content match up to challenges the specialty pharmacies and specialty Hubs
  • Dug into specifics of the interactions and data to support
    • Asking a provider to provide a needed lab

Links, screenshots

Specialty Rx IG:  http://build.fhir.org/ig/HL7/fhir-specialty-rx/branches/master/index.html

Sandbox server: https://specialty-fhir.azurewebsites.net/

Zulip stream: https://chat.fhir.org/#narrow/stream/235647-Specialty-Medications


Discovered issues / questions

Identified potential additional workflows that the IG might address:

  • Communicating dispensed medication data from the pharmacy to a Hub
  • Communicating the results of benefits investigation
  • Sharing information with a patient

Now what?

  • Determine if the additional workflows should be included
  • Further off-line discussion w/participants
  • Bring some of the points discussed into the sponsoring NCPDP task group and HL7 workgroups








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