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1a. Project Name

Specialty Medication Prescribing

1b. Project ID

1573

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

No

1e. Today's Date

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Pharmacy

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

Monthly

2b. Co-Sponsor WG 2

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

Monthly

2d. Project Facilitator

Melva Peters

2e. Other Interested Parties (and roles)

2f. Modeling Facilitator

2g. Publishing Facilitator

2h. Vocabulary Facilitator

Julie James

2i. Domain Expert Representative

2j. Business Requirements Analyst

2k. Conformance Facilitator

TBD

2l. Other Facilitators

2m. Implementers

EHRs, Pharmacies, Intermediaries.

3a. Project Scope

The goal of this project is to create 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.

If NCPDP code sets are present in the implementation guide, examples will be provided in guide content. To access the full code set, user must purchase a NCPDP membership. Use this link https://www.ncpdp.org/Membership/Apply-Online to obtain a NCPDP membership and access to the full code set.

Attached are some examples of elements from different resources we intend to use as well as the background information used to review this project with the Patient Care and Orders & Observations work groups. This FHIR implementation guide uses the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.

Attachments

3b. Project Need

By 2020, a projected 9 out of 10 top selling-drugs by revenue will be Specialty. Examples of specialty medication categories include 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.

3c. Security Risk

No

3d. External Drivers

Complex medical conditions including cancer, hepatitis, multiple sclerosis and other chronic diseases often require a specialty medication. There are several paths for processing a specialty medication and the current lack of standardization around the process means it can take days, weeks or even months to get a patient on their treatment regimen. In the specialty pharmacy realm, there is often additional information needed before a prescription can be dispensed. This information is provided by the prescriber (or someone in the prescriber’s office). This information includes additional patient demographic and clinical information, order-specific clinical information and instructions related to delivery of the medication (i.e. to the patient or the clinic, nursing services required). This information would be added to the appropriate SCRIPT Standard and/or Specialized Standard transactions, depending on analysis.

3e. Objectives/Deliverables and Target Dates

PSS Approved - 21 February 2020
NIB - 5 July 2020
Content Complete - 19 July 2020
Submit for Ballot - 9 August 2020

3f. Common Names / Keywords / Aliases:

Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

HL7 GitHub - specific URL to be determined

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCPDP Code Lists

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative, Joint Ballot (with other SDOs)

5c. Additional Ballot Info

5d. Joint Copyright

Yes

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

Yes

6a. External Project Collaboration

NCPDP

6b. Content Already Developed

20%

6c. Content externally developed?

6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?

6f. Stakeholders

Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmacies, Providers,

6g. Vendors

EHR, PHR, Health Care IT

6g. Other Vendors

6h. Providers

Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Pharmacies

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

Feb 25, 2020

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Feb 17, 2020

7c. Co-Sponsor Approval Date

Jan 27, 2020

7c. Co-Sponsor 2 Approval Date

Jan 23, 2020

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

Feb 26, 2020

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

Mar 08, 2020

7j. TSC Approval Date

Mar 16, 2020


 Show Changes

Version

6

Modifier

Pooja Babbrah

Modify Date

Oct 08, 2019 18:57

1a. Project Name

Specialty Medication Prescribing

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Pharmacy

2d. Project Facilitator

Melva Peters

2k. Conformance Facilitator

TBD

2m. Implementers

EHRs, Pharmacies, Intermediaries.

3a. Project Scope

The goal of this project is to create a co-branded FHIR implementation Guide (Co-branded between HL7 and NCPDP) focused on a set of standard messages to exchange clinical data necessary for dispensing specialty medications by pharmacies as well as facilitating enrollment of patients in programs offered by third parties.

3b. Project Need

By 2020, a projected 9 out of 10 top selling-drugs by revenue will be Specialty. 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.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

A FHIR R4 Implementation Guide
The desired ballot is June 2020.
Rough timeline TBD

3f. Common Names / Keywords / Aliases:

Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy

3j. Backwards Compatibility

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCPDP?

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

Joint Ballot (with other SDOs)

5d. Joint Copyright

Yes

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

Yes

6a. External Project Collaboration

NCPDP

6b. Content Already Developed

20%

6f. Stakeholders

Standards Development Organizations (SDOs)

6g. Vendors

EHR, PHR, Health Care IT

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

5

Modifier

Pooja Babbrah

Modify Date

Oct 08, 2019 18:51

1a. Project Name

Specialty Medication Prescribing

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Pharmacy

2d. Project Facilitator

Melva Peters

2k. Conformance Facilitator

TBD

2m. Implementers

EHRs, Pharmacies, Intermediaries.

3a. Project Scope

The goal of this project is to create a co-branded implementation Guide (Co-branded between HL7 and NCPDP) focused on a set of standard messages to exchange clinical data necessary for dispensing specialty medications by pharmacies as well as facilitating enrollment of patients in programs offered by third parties.

3b. Project Need

By 2020, a projected 9 out of 10 top selling-drugs by revenue will be Specialty. 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.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

A FHIR R4 Implementation Guide
The desired ballot is June 2020.
Rough timeline TBD

3f. Common Names / Keywords / Aliases:

Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy

3j. Backwards Compatibility

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCPDP?

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

Joint Ballot (with other SDOs)

5d. Joint Copyright

Yes

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

Yes

6a. External Project Collaboration

NCPDP

6b. Content Already Developed

20%

6f. Stakeholders

Standards Development Organizations (SDOs)

6g. Vendors

EHR, PHR, Health Care IT

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

4

Modifier

Pooja Babbrah

Modify Date

Oct 08, 2019 18:50

1a. Project Name

Specialty Medication Prescribing

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Pharmacy

2d. Project Facilitator

Melva Peters

2k. Conformance Facilitator

TBD

2m. Implementers

EHRs, Pharmacies,

3a. Project Scope

The goal of this project is to create a co-branded implementation Guide (Co-branded between HL7 and NCPDP) focused on a set of standard messages to exchange clinical data necessary for dispensing specialty medications by pharmacies as well as facilitating enrollment of patients in programs offered by third parties.

3b. Project Need

By 2020, a projected 9 out of 10 top selling-drugs by revenue will be Specialty. 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.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

A FHIR R4 Implementation Guide
The desired ballot is June 2020.
Rough timeline TBD

3f. Common Names / Keywords / Aliases:

Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy

3j. Backwards Compatibility

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCPDP?

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

Joint Ballot (with other SDOs)

5d. Joint Copyright

Yes

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

Yes

6a. External Project Collaboration

NCPDP

6b. Content Already Developed

20%

6f. Stakeholders

Standards Development Organizations (SDOs)

6g. Vendors

EHR, PHR, Health Care IT

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

3

Modifier

Melva Peters

Modify Date

Oct 08, 2019 18:21

1a. Project Name

Specialty Medication Prescribing

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Pharmacy

2d. Project Facilitator

Melva Peters

2k. Conformance Facilitator

TBD

3a. Project Scope

This project will create a NCPDP patient profile and set of standard messages to exchange clinical data necessary for dispensing specialty medications by pharmacies as well as facilitating enrollment of patients in programs offered by third parties. This transaction will be in addition to the electronic prescription sent from the prescriber to the pharmacy

3b. Project Need

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.

3c. Security Risk

Unknown

3d. External Drivers

NCPDP Workgroup meetings for voting or balloting additions to NCPDP standards

3e. Objectives/Deliverables and Target Dates

-New NCPDP patient profile
-New specialty prescribing message specification
Dates TBD after discussion

3f. Common Names / Keywords / Aliases:

Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment

3j. Backwards Compatibility

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCPDP?

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5b. Project Ballot Type

Joint Ballot (with other SDOs)

6a. External Project Collaboration

NCPDP

6b. Content Already Developed

20%

6f. Stakeholders

Standards Development Organizations (SDOs)

6g. Vendors

EHR, PHR, Health Care IT

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

2

Modifier

Maggie Buchinger

Modify Date

Sep 27, 2019 15:01

1a. Project Name

Specialty Medication Prescribing

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Pharmacy

2d. Project Facilitator

Pharmacy Workgroup

2k. Conformance Facilitator

TBD

3a. Project Scope

This project will create a NCPDP patient profile and set of standard messages to exchange clinical data necessary for dispensing specialty medications by pharmacies as well as facilitating enrollment of patients in programs offered by third parties. This transaction will be in addition to the electronic prescription sent from the prescriber to the pharmacy

3b. Project Need

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.

3c. Security Risk

Unknown

3d. External Drivers

NCPDP Workgroup meetings for voting or balloting additions to NCPDP standards

3e. Objectives/Deliverables and Target Dates

-New NCPDP patient profile
-New specialty prescribing message specification
Dates TBD after discussion

3f. Common Names / Keywords / Aliases:

Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment

3j. Backwards Compatibility

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCPDP?

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5b. Project Ballot Type

Joint Ballot (with other SDOs)

6a. External Project Collaboration

NCPDP

6b. Content Already Developed

20%

6f. Stakeholders

Standards Development Organizations (SDOs)

6g. Vendors

EHR, PHR, Health Care IT

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

1

Modify Date

Sep 26, 2019 21:02

1a. Project Name

Specialty Medication Prescribing

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Pharmacy

2d. Project Facilitator

Pharmacy Workgroup

3a. Project Scope

This project will create a NCPDP patient profile and set of standard messages to exchange clinical data necessary for dispensing specialty medications by pharmacies as well as facilitating enrollment of patients in programs offered by third parties. This transaction will be in addition to the electronic prescription sent from the prescriber to the pharmacy

3b. Project Need

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.

3c. Security Risk

Unknown

3d. External Drivers

NCPDP Workgroup meetings for voting or balloting additions to NCPDP standards

3j. Backwards Compatibility

No

7 Comments

  1. Melva Peters - we have updated this PSS with the additional information requested.  Are you and the other WG leaders able to review while you are at the WG meetings in Australia?  We are happy to answer any questions you may have so we can be prepared for a vote on this at the next meeting.  Thanks! John Hatem , Scott M. Robertson Jean Duteau

    1. We'll add this to the agenda for this week.

  2. Need to include more information in Project Need as background.  For example, define specialty medications.  Also, give some examples of what kind of data needs to be exchanged.

    1. Got it.  I will add additional info.

  3. Pooja, Pharmacy reviewed the PSS today and there are still lots of issue in the understanding of the PSS and the additional information.  The diagrams use terms like "Third Party" and no one understands what it means.  We suggest that you avoid use of terms like "message", "transaction" that are NCPDP and move to generic terms that would be used in FHIR.  

    I would suggest that you get someone who understands FHIR to help with the PSS so that it aligns with what will actually be in the PSS.

    Also, include definition and examples of specialty medications.

    Better describe the interaction/exchange model that would be expected after the implementation of the FHIR Implementation Guide.

  4. hi Melva Peters - I sent the link to all the co-leads earlier today, but not sure if it worked.  Maggie and I have updated the PSS per our discussion yesterday and we updated the background information to provide additional information on specialty prescribing workflow and the need that this transaction fills in the market.

    1. Thanks Pooja.  I have forwarded to the PMO.