Specialty Medication Enrollment

1a. Project Name	Specialty Medication Enrollment
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
2b. Co-Sponsor WG 3	Community Based Care and Privacy
2c. Co-Sponsor Level of Involvement	Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
2d. Project Facilitator	Melva Peters
2e. Other Interested Parties (and roles)
2f. Modeling Facilitator
2g. Publishing Facilitator	Frank McKinney
2h. Vocabulary Facilitator	Julie James
2i. Domain Expert Representative	Maggie Buchinger
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) AND PATIENT CONSENT NEEDED for dispensing OF specialty medications AND OTHER THERAPIES (EG SPECIALTY DEVICES USED FOR ONCOLOGY TREATMENT) by pharmacies AND OTHER DISPENSERS, as well as facilitating enrolment of patients in programs offered by third parties such as but not limited to Hub vendors and Pharmaceutical manufacturers. OUT OF SCOPE OF THIS GUIDE IS THE TRANSMISSION OF THE ORIGINAL PRESCRIPTION FROM THE PRESCRIBER TO DISPENSING PHARMACY, REQUESTS FOR CHANGES TO AN EXISTING PRESCRIPTION, AND TRANSMISSION OF DATA ABOUT DISPENSED MEDICATIONS. THESE FUNCTIONS ARE TYPICALLY ACCOMPLISHED IN THE US USING THE NCPDP SCRIPT E-PRESCRIBING STANDARD. 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. THIS SEPTEMBER 2021 UPDATE TO THE PSS EXPANDS THE IG'S SCOPE TO ADD THE EXCHANGE OF PATIENT CONSENT NEEDED FOR DISPENSING AND PARTICIPATION IN PATIENT SUPPORT PROGRAMS. EXPAND THE SPECIALITY MEDICATION ENROLMENT FHIR IG TO SUPPORT EXCHANGE OF RELATED PATIENT CONSENT.
Attachments	FHIR Profiles.pdf PSS Approval Background Info.pptx
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 enrolment 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. FURTHER, PATIENT CONSENT MAY BE NEEDED BY DISPENSERS OR PATIENT SUPPORT PROGRAMS SO THEY CAN RECEIVE PATIENT INFORMATION, PERFORM DISPENSING ACTIVITIES AND/OR INTERACT WIT THE PATIENT CARE TEAM. CURRENTLY, STAKEHOLDERS IN THE DISPENSING OF SPECIALTY PRODUCTS LACK DATA STANDARDS AND CONVENTIONS FOR REQUESTING AND SHARING PATIENT CONSENTS ASSOCIATED WITH THIS PROCESS. THE PRODPOSED ADDITION TO THIS IG WILL ESTABLISH THIS.
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. THIS EXPANSION OF THE IG IS DRIVEN BY THE WORK OF NCPDP WG18 PATIENT CONSENT TASK GROUP.
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 UPDATES: TARGET FOR STU2 - JUNE 2022 BALLOT CYCLE
3f. Common Names / Keywords / Aliases:	Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy, PATEINT CONSENT, DISPENSING
3g. Lineage	Specialty Medication Enrollment - STU1 - published June 2021
3h. Project Dependencies
3i. HL7-Managed Project Document Repository URL:	https://github.com/HL7/fhir-specialty-rx
3j. Backwards Compatibility	Yes
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, MEDICAL DEVICE AND OTHER SPECIALTY DISPENSERS, SPECIALTY HUBS
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	Nov 02, 2021
7a. Management Group(s) to Review PSS	FHIR
7b. Sponsoring WG Approval Date	Sep 21, 2021
7c. Co-Sponsor Approval Date	Jan 27, 2020
7c. Co-Sponsor 2 Approval Date	Jan 23, 2020
7c. Co-Sponsor 3 Approval Date	Oct 12, 2021
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	Oct 27, 2021
7g. V2 MG Approval Date
7h. Architecture Review Board Approval Date
7i. Steering Division Approval Date
7j. TSC Approval Date

Show Changes

Version	14
Modifier	Frank McKinney
Modify Date	Nov 22, 2021 21:16
1a. Project Name	Specialty Medication Enrollment
1b. Project ID	1573
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	Process Improvement Committee
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
2c. Co-Sponsor Level of Involvement	Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
2d. Project Facilitator	Melva Peters
2g. Publishing Facilitator	Frank McKinney
2h. Vocabulary Facilitator	Julie James
2i. Domain Expert Representative	Maggie Buchinger
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 the exchange of data (Demographic, prescription, clinical and financial) AND PATIENT CONSENT NEEDED for dispensing OF specialty medications AND OTHER THERAPIES (EG SPECIALTY DEVICES USED FOR ONCOLOGY TREATMENT) by pharmacies AND OTHER DISPENSERS, as well as facilitating enrolment of patients in programs offered by third parties such as but not limited to Hub vendors and Pharmaceutical manufacturers. OUT OF SCOPE OF THIS GUIDE IS THE TRANSMISSION OF THE ORIGINAL PRESCRIPTION FROM THE PRESCRIBER TO DISPENSING PHARMACY, REQUESTS FOR CHANGES TO AN EXISTING PRESCRIPTION, AND TRANSMISSION OF DATA ABOUT DISPENSED MEDICATIONS. THESE FUNCTIONS ARE TYPICALLY ACCOMPLISHED IN THE US USING THE NCPDP SCRIPT E-PRESCRIBING STANDARD. 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. THIS SEPTEMBER 2021 UPDATE TO THE PSS EXPANDS THE IG'S SCOPE TO ADD THE EXCHANGE OF PATIENT CONSENT NEEDED FOR DISPENSING AND PARTICIPATION IN PATIENT SUPPORT PROGRAMS. EXPAND THE SPECIALITY MEDICATION ENROLMENT FHIR IG TO SUPPORT EXCHANGE OF RELATED PATIENT CONSENT.
Attachments	FHIR Profiles.pdf PSS Approval Background Info.pptx
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 enrolment 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. FURTHER, PATIENT CONSENT MAY BE NEEDED BY DISPENSERS OR PATIENT SUPPORT PROGRAMS SO THEY CAN RECEIVE PATIENT INFORMATION, PERFORM DISPENSING ACTIVITIES AND/OR INTERACT WIT THE PATIENT CARE TEAM. CURRENTLY, STAKEHOLDERS IN THE DISPENSING OF SPECIALTY PRODUCTS LACK DATA STANDARDS AND CONVENTIONS FOR REQUESTING AND SHARING PATIENT CONSENTS ASSOCIATED WITH THIS PROCESS. THE PRODPOSED ADDITION TO THIS IG WILL ESTABLISH THIS.
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. THIS EXPANSION OF THE IG IS DRIVEN BY THE WORK OF NCPDP WG18 PATIENT CONSENT TASK GROUP.
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 UPDATES: TARGET FOR STU2 - JUNE 2022 BALLOT CYCLE
3f. Common Names / Keywords / Aliases:	Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy, PATEINT CONSENT, DISPENSING
3g. Lineage	Specialty Medication Enrollment - STU1 - published June 2021
3i. HL7-Managed Project Document Repository URL:	https://github.com/HL7/fhir-specialty-rx
3j. Backwards Compatibility	Yes
3l. Using Current V3 Data Types?	N/A
3m. External Vocabularies	Yes
3n. List of Vocabularies	NCPDP Code Lists
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
5a. Project Intent	Implementation Guide (IG) will be created/modified
5a. Is the project adopting/endorsing an externally developed IG?	No
5b. Project Ballot Type	STU to Normative, 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), Other
6f. Other Stakeholders	Pharmacies, Providers, MEDICAL DEVICE AND OTHER SPECIALTY DISPENSERS, SPECIALTY HUBS
6g. Vendors	EHR, PHR, Health Care IT
6h. Providers	Healthcare Institutions (hospitals, long term care, home care, mental health), Other
6h. Other Providers	Pharmacies
6i. Realm	U.S. Realm Specific
7a. Management Group(s) to Review PSS	FHIR
7b. Sponsoring WG Approval Date	Sep 21, 2021
7c. Co-Sponsor Approval Date	Jan 27, 2020
7c. Co-Sponsor 2 Approval Date	Jan 23, 2020
7c. Co-Sponsor 3 Approval Date	Oct 12, 2021
7d. US Realm Approval Date	Nov 02, 2021
7f. FMG Approval Date	Oct 27, 2021

Version	13
Modifier	Anne Wizauer
Modify Date	Nov 09, 2021 22:18
1a. Project Name	Specialty Medication Enrollment
1b. Project ID	1573
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	Process Improvement Committee
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
2c. Co-Sponsor Level of Involvement	Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
2d. Project Facilitator	Melva Peters
2g. Publishing Facilitator	Frank McKinney
2h. Vocabulary Facilitator	Julie James
2i. Domain Expert Representative	Maggie Buchinger
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 the exchange of data (Demographic, prescription, clinical and financial) AND PATIENT CONSENT NEEDED for dispensing OF specialty medications AND OTHER THERAPIES (EG SPECIALTY DEVICES USED FOR ONCOLOGY TREATMENT) by pharmacies AND OTHER DISPENSERS, as well as facilitating enrolment of patients in programs offered by third parties such as but not limited to Hub vendors and Pharmaceutical manufacturers. OUT OF SCOPE OF THIS GUIDE IS THE TRANSMISSION OF THE ORIGINAL PRESCRIPTION FROM THE PRESCRIBER TO DISPENSING PHARMACY, REQUESTS FOR CHANGES TO AN EXISTING PRESCRIPTION, AND TRANSMISSION OF DATA ABOUT DISPENSED MEDICATIONS. THESE FUNCTIONS ARE TYPICALLY ACCOMPLISHED IN THE US USING THE NCPDP SCRIPT E-PRESCRIBING STANDARD. 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. THIS SEPTEMBER 2021 UPDATE TO THE PSS EXPANDS THE IG'S SCOPE TO ADD THE EXCHANGE OF PATIENT CONSENT NEEDED FOR DISPENSING AND PARTICIPATION IN PATIENT SUPPORT PROGRAMS. EXPAND THE SPECIALITY MEDICATION ENROLMENT FHIR IG TO SUPPORT EXCHANGE OF RELATED PATIENT CONSENT.
Attachments	FHIR Profiles.pdf PSS Approval Background Info.pptx
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 enrolment 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. FURTHER, PATIENT CONSENT MAY BE NEEDED BY DISPENSERS OR PATIENT SUPPORT PROGRAMS SO THEY CAN RECEIVE PATIENT INFORMATION, PERFORM DISPENSING ACTIVITIES AND/OR INTERACT WIT THE PATIENT CARE TEAM. CURRENTLY, STAKEHOLDERS IN THE DISPENSING OF SPECIALTY PRODUCTS LACK DATA STANDARDS AND CONVENTIONS FOR REQUESTING AND SHARING PATIENT CONSENTS ASSOCIATED WITH THIS PROCESS. THE PRODPOSED ADDITION TO THIS IG WILL ESTABLISH THIS.
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. THIS EXPANSION OF THE IG IS DRIVEN BY THE WORK OF NCPDP WG18 PATIENT CONSENT TASK GROUP.
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 UPDATES: TARGET FOR STU2 - JUNE 2022 BALLOT CYCLE
3f. Common Names / Keywords / Aliases:	Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy, PATEINT CONSENT, DISPENSING
3g. Lineage	Specialty Medication Enrollment - STU1 - published June 2021
3i. HL7-Managed Project Document Repository URL:	https://github.com/HL7/fhir-specialty-rx
3j. Backwards Compatibility	Yes
3l. Using Current V3 Data Types?	N/A
3m. External Vocabularies	Yes
3n. List of Vocabularies	NCPDP Code Lists
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
5a. Project Intent	Implementation Guide (IG) will be created/modified
5a. Is the project adopting/endorsing an externally developed IG?	No
5b. Project Ballot Type	STU to Normative, 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), Other
6f. Other Stakeholders	Pharmacies, Providers, MEDICAL DEVICE AND OTHER SPECIALTY DISPENSERS, SPECIALTY HUBS
6g. Vendors	EHR, PHR, Health Care IT
6h. Providers	Healthcare Institutions (hospitals, long term care, home care, mental health), Other
6h. Other Providers	Pharmacies
6i. Realm	U.S. Realm Specific
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	Oct 12, 2021
7d. US Realm Approval Date	Nov 02, 2021
7f. FMG Approval Date	Oct 27, 2021

Version	12
Modifier	Frank McKinney
Modify Date	Nov 08, 2021 20:02
1a. Project Name	Specialty Medication Enrollment
1b. Project ID	1573
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	Process Improvement Committee
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
2c. Co-Sponsor Level of Involvement	Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
2d. Project Facilitator	Melva Peters
2g. Publishing Facilitator	Frank McKinney
2h. Vocabulary Facilitator	Julie James
2i. Domain Expert Representative	Maggie Buchinger
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 the exchange of data (Demographic, prescription, clinical and financial) AND PATIENT CONSENT NEEDED for dispensing OF specialty medications AND OTHER THERAPIES (EG SPECIALTY DEVICES USED FOR ONCOLOGY TREATMENT) by pharmacies AND OTHER DISPENSERS, as well as facilitating enrolment of patients in programs offered by third parties such as but not limited to Hub vendors and Pharmaceutical manufacturers. OUT OF SCOPE OF THIS GUIDE IS THE TRANSMISSION OF THE ORIGINAL PRESCRIPTION FROM THE PRESCRIBER TO DISPENSING PHARMACY, REQUESTS FOR CHANGES TO AN EXISTING PRESCRIPTION, AND TRANSMISSION OF DATA ABOUT DISPENSED MEDICATIONS. THESE FUNCTIONS ARE TYPICALLY ACCOMPLISHED IN THE US USING THE NCPDP SCRIPT E-PRESCRIBING STANDARD. 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. THIS SEPTEMBER 2021 UPDATE TO THE PSS EXPANDS THE IG'S SCOPE TO ADD THE EXCHANGE OF PATIENT CONSENT NEEDED FOR DISPENSING AND PARTICIPATION IN PATIENT SUPPORT PROGRAMS. EXPAND THE SPECIALITY MEDICATION ENROLMENT FHIR IG TO SUPPORT EXCHANGE OF RELATED PATIENT CONSENT.
Attachments	FHIR Profiles.pdf PSS Approval Background Info.pptx
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 enrolment 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. FURTHER, PATIENT CONSENT MAY BE NEEDED BY DISPENSERS OR PATIENT SUPPORT PROGRAMS SO THEY CAN RECEIVE PATIENT INFORMATION, PERFORM DISPENSING ACTIVITIES AND/OR INTERACT WIT THE PATIENT CARE TEAM. CURRENTLY, STAKEHOLDERS IN THE DISPENSING OF SPECIALTY PRODUCTS LACK DATA STANDARDS AND CONVENTIONS FOR REQUESTING AND SHARING PATIENT CONSENTS ASSOCIATED WITH THIS PROCESS. THE PRODPOSED ADDITION TO THIS IG WILL ESTABLISH THIS.
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. THIS EXPANSION OF THE IG IS DRIVEN BY THE WORK OF NCPDP WG18 PATIENT CONSENT TASK GROUP.
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 UPDATES: TARGET FOR STU2 - JUNE 2022 BALLOT CYCLE
3f. Common Names / Keywords / Aliases:	Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy, PATEINT CONSENT, DISPENSING
3g. Lineage	Specialty Medication Enrollment - STU1 - published June 2021
3i. HL7-Managed Project Document Repository URL:	https://github.com/HL7/fhir-specialty-rx
3j. Backwards Compatibility	Yes
3l. Using Current V3 Data Types?	N/A
3m. External Vocabularies	Yes
3n. List of Vocabularies	NCPDP Code Lists
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
5a. Project Intent	Implementation Guide (IG) will be created/modified
5a. Is the project adopting/endorsing an externally developed IG?	No
5b. Project Ballot Type	STU to Normative, 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), Other
6f. Other Stakeholders	Pharmacies, Providers, MEDICAL DEVICE AND OTHER SPECIALTY DISPENSERS, SPECIALTY HUBS
6g. Vendors	EHR, PHR, Health Care IT
6h. Providers	Healthcare Institutions (hospitals, long term care, home care, mental health), Other
6h. Other Providers	Pharmacies
6i. Realm	U.S. Realm Specific
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	Oct 12, 2021
7d. US Realm Approval Date	Feb 25, 2020
7f. FMG Approval Date	Feb 26, 2020
7i. Steering Division Approval Date	Mar 08, 2020
7j. TSC Approval Date	Mar 16, 2020

Version	11
Modifier	Frank McKinney
Modify Date	Nov 08, 2021 19:58
1a. Project Name	Specialty Medication Enrollment
1b. Project ID	1573
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	Process Improvement Committee
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
2c. Co-Sponsor Level of Involvement	Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
2d. Project Facilitator	Melva Peters
2g. Publishing Facilitator	Frank McKinney
2h. Vocabulary Facilitator	Julie James
2i. Domain Expert Representative	Maggie Buchinger
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 the exchange of data (Demographic, prescription, clinical and financial) AND PATIENT CONSENT NEEDED for dispensing OF specialty medications AND OTHER THERAPIES (EG SPECIALTY DEVICES USED FOR ONCOLOGY TREATMENT) by pharmacies AND OTHER DISPENSERS, as well as facilitating enrolment of patients in programs offered by third parties such as but not limited to Hub vendors and Pharmaceutical manufacturers. OUT OF SCOPE OF THIS GUIDE IS THE TRANSMISSION OF THE ORIGINAL PRESCRIPTION FROM THE PRESCRIBER TO DISPENSING PHARMACY, AS WELL AS REQUESTS FOR CHANGES TO AN EXISTING PRESCRIPTION. THESE FUNCTIONS ARE TYPICALLY ACCOMPLISHED IN THE US USING THE NCPDP SCRIPT E-PRESCRIBING STANDARD. 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. THIS SEPTEMBER 2021 UPDATE TO THE PSS EXPANDS THE IG'S SCOPE TO ADD THE EXCHANGE OF PATIENT CONSENT NEEDED FOR DISPENSING AND PARTICIPATION IN PATIENT SUPPORT PROGRAMS. EXPAND THE SPECIALITY MEDICATION ENROLMENT FHIR IG TO SUPPORT EXCHANGE OF RELATED PATIENT CONSENT.
Attachments	FHIR Profiles.pdf PSS Approval Background Info.pptx
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 enrolment 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. FURTHER, PATIENT CONSENT MAY BE NEEDED BY DISPENSERS OR PATIENT SUPPORT PROGRAMS SO THEY CAN RECEIVE PATIENT INFORMATION, PERFORM DISPENSING ACTIVITIES AND/OR INTERACT WIT THE PATIENT CARE TEAM. CURRENTLY, STAKEHOLDERS IN THE DISPENSING OF SPECIALTY PRODUCTS LACK DATA STANDARDS AND CONVENTIONS FOR REQUESTING AND SHARING PATIENT CONSENTS ASSOCIATED WITH THIS PROCESS. THE PRODPOSED ADDITION TO THIS IG WILL ESTABLISH THIS.
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. THIS EXPANSION OF THE IG IS DRIVEN BY THE WORK OF NCPDP WG18 PATIENT CONSENT TASK GROUP.
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 UPDATES: TARGET FOR STU2 - JUNE 2022 BALLOT CYCLE
3f. Common Names / Keywords / Aliases:	Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy, PATEINT CONSENT, DISPENSING
3g. Lineage	Specialty Medication Enrollment - STU1 - published June 2021
3i. HL7-Managed Project Document Repository URL:	https://github.com/HL7/fhir-specialty-rx
3j. Backwards Compatibility	Yes
3l. Using Current V3 Data Types?	N/A
3m. External Vocabularies	Yes
3n. List of Vocabularies	NCPDP Code Lists
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
5a. Project Intent	Implementation Guide (IG) will be created/modified
5a. Is the project adopting/endorsing an externally developed IG?	No
5b. Project Ballot Type	STU to Normative, 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), Other
6f. Other Stakeholders	Pharmacies, Providers, MEDICAL DEVICE AND OTHER SPECIALTY DISPENSERS, SPECIALTY HUBS
6g. Vendors	EHR, PHR, Health Care IT
6h. Providers	Healthcare Institutions (hospitals, long term care, home care, mental health), Other
6h. Other Providers	Pharmacies
6i. Realm	U.S. Realm Specific
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	Oct 12, 2021
7d. US Realm Approval Date	Feb 25, 2020
7f. FMG Approval Date	Feb 26, 2020
7i. Steering Division Approval Date	Mar 08, 2020
7j. TSC Approval Date	Mar 16, 2020

Version	10
Modifier	Melva Peters
Modify Date	Oct 26, 2021 19:51
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 now proceeding to Normative directly or after being either Informative or STU?	No
2a. Primary/Sponsor WG	Process Improvement Committee
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
2c. Co-Sponsor Level of Involvement	Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
2d. Project Facilitator	Melva Peters
2g. Publishing Facilitator	Frank McKinney
2h. Vocabulary Facilitator	Julie James
2i. Domain Expert Representative	Maggie Buchinger
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 the exchange of data (Demographic, prescription, clinical and financial) AND PATIENT CONSENT NEEDED for dispensing OF specialty medications AND OTHER THERAPIES (EG SPECIALTY DEVICES USED FOR ONCOLOGY TREATMENT) by pharmacies AND OTHER DISPENSERS, as well as facilitating enrolment 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. THIS SEPTEMBER 2021 UPDATE TO THE PSS EXPANDS THE IG'S SCOPE TO ADD THE EXCHANGE OF PATIENT CONSENT NEEDED FOR DISPENSING AND PARTICIPATION IN PATIENT SUPPORT PROGRAMS. EXPAND THE SPECIALITY MEDICATION ENROLMENT FHIR IG TO SUPPORT EXCHANGE OF RELATED PATIENT CONSENT.
Attachments	FHIR Profiles.pdf PSS Approval Background Info.pptx
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 enrolment 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. FURTHER, PATIENT CONSENT MAY BE NEEDED BY DISPENSERS OR PATIENT SUPPORT PROGRAMS SO THEY CAN RECEIVE PATIENT INFORMATION, PERFORM DISPENSING ACTIVITIES AND/OR INTERACT WIT THE PATIENT CARE TEAM. CURRENTLY, STAKEHOLDERS IN THE DISPENSING OF SPECIALTY PRODUCTS LACK DATA STANDARDS AND CONVENTIONS FOR REQUESTING AND SHARING PATIENT CONSENTS ASSOCIATED WITH THIS PROCESS. THE PRODPOSED ADDITION TO THIS IG WILL ESTABLISH THIS.
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. THIS EXPANSION OF THE IG IS DRIVEN BY THE WORK OF NCPDP WG18 PATIENT CONSENT TASK GROUP.
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 UPDATES: TARGET FOR STU2 - JUNE 2022 BALLOT CYCLE
3f. Common Names / Keywords / Aliases:	Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy, PATEINT CONSENT, DISPENSING
3g. Lineage	Specialty Medication Enrollment - STU1 - published June 2021
3i. HL7-Managed Project Document Repository URL:	https://github.com/HL7/fhir-specialty-rx
3j. Backwards Compatibility	Yes
3l. Using Current V3 Data Types?	N/A
3m. External Vocabularies	Yes
3n. List of Vocabularies	NCPDP Code Lists
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
5a. Project Intent	Implementation Guide (IG) will be created/modified
5a. Is the project adopting/endorsing an externally developed IG?	No
5b. Project Ballot Type	STU to Normative, 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), Other
6f. Other Stakeholders	Pharmacies, Providers, MEDICAL DEVICE AND OTHER SPECIALTY DISPENSERS, SPECIALTY HUBS
6g. Vendors	EHR, PHR, Health Care IT
6h. Providers	Healthcare Institutions (hospitals, long term care, home care, mental health), Other
6h. Other Providers	Pharmacies
6i. Realm	U.S. Realm Specific
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	Oct 12, 2021
7d. US Realm Approval Date	Feb 25, 2020
7f. FMG Approval Date	Feb 26, 2020
7i. Steering Division Approval Date	Mar 08, 2020
7j. TSC Approval Date	Mar 16, 2020

Version	9
Modifier	Melva Peters
Modify Date	Oct 25, 2021 21:44
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 now proceeding to Normative directly or after being either Informative or STU?	No
2a. Primary/Sponsor WG	Process Improvement Committee
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
2c. Co-Sponsor Level of Involvement	Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
2d. Project Facilitator	Melva Peters
2g. Publishing Facilitator	Frank McKinney
2h. Vocabulary Facilitator	Julie James
2i. Domain Expert Representative	Maggie Buchinger
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 the exchange of data (Demographic, prescription, clinical and financial) AND PATIENT CONSENT NEEDED for dispensing OF specialty medications AND OTHER THERAPIES (EG SPECIALTY DEVICES USED FOR ONCOLOGY TREATMENT) by pharmacies AND OTHER DISPENSERS, as well as facilitating enrolment 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. THIS SEPTEMBER 2021 UPDATE TO THE PSS EXPANDS THE IG'S SCOPE TO ADD THE EXCHANGE OF PATIENT CONSENT NEEDED FOR DISPENSING AND PARTICIPATION IN PATIENT SUPPORT PROGRAMS. EXPAND THE SPECIALITY MEDICATION ENROLMENT FHIR IG TO SUPPORT EXCHANGE OF RELATED PATIENT CONSENT.
Attachments	FHIR Profiles.pdf PSS Approval Background Info.pptx
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 enrolment 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. FURTHER, PATIENT CONSENT MAY BE NEEDED BY DISPENSERS OR PATIENT SUPPORT PROGRAMS SO THEY CAN RECEIVE PATIENT INFORMATION, PERFORM DISPENSING ACTIVITIES AND/OR INTERACT WIT THE PATIENT CARE TEAM. CURRENTLY, STAKEHOLDERS IN THE DISPENSING OF SPECIALTY PRODUCTS LACK DATA STANDARDS AND CONVENTIONS FOR REQUESTING AND SHARING PATIENT CONSENTS ASSOCIATED WITH THIS PROCESS. THE PRODPOSED ADDITION TO THIS IG WILL ESTABLISH THIS.
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. THIS EXPANSION OF THE IG IS DRIVEN BY THE WORK OF NCPDP WG18 PATIENT CONSENT TASK GROUP.
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 UPDATES: TARGET FOR STU2 - JUNE 2022 BALLOT CYCLE
3f. Common Names / Keywords / Aliases:	Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy, PATEINT CONSENT, DISPENSING
3g. Lineage	Specialty Medication Enrollment - STU1 - published June 2021
3i. HL7-Managed Project Document Repository URL:	https://github.com/HL7/fhir-specialty-rx
3j. Backwards Compatibility	Yes
3l. Using Current V3 Data Types?	N/A
3m. External Vocabularies	Yes
3n. List of Vocabularies	NCPDP Code Lists
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
5a. Project Intent	Implementation Guide (IG) will be created/modified
5a. Is the project adopting/endorsing an externally developed IG?	No
5b. Project Ballot Type	STU to Normative, 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), Other
6f. Other Stakeholders	Pharmacies, Providers, MEDICAL DEVICE AND OTHER SPECIALTY DISPENSERS, SPECIALTY HUBS
6g. Vendors	EHR, PHR, Health Care IT
6h. Providers	Healthcare Institutions (hospitals, long term care, home care, mental health), Other
6h. Other Providers	Pharmacies
6i. Realm	U.S. Realm Specific
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
7d. US Realm Approval Date	Feb 25, 2020
7f. FMG Approval Date	Feb 26, 2020
7i. Steering Division Approval Date	Mar 08, 2020
7j. TSC Approval Date	Mar 16, 2020

Version	8
Modifier	Melva Peters
Modify Date	Sep 21, 2021 21:15
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 now proceeding to Normative directly or after being either Informative or STU?	No
2a. Primary/Sponsor WG	Process Improvement Committee
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
2g. Publishing Facilitator	Frank McKinney
2h. Vocabulary Facilitator	Julie James
2i. Domain Expert Representative	Maggie Buchinger
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 the exchange of data (Demographic, prescription, clinical and financial) AND PATIENT CONSENT NEEDED for dispensing OF specialty medications AND OTHER THERAPIES (EG SPECIALTY DEVICES USED FOR ONCOLOGY TREATMENT) by pharmacies AND OTHER DISPENSERS, as well as facilitating enrolment 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. THIS SEPTEMBER 2021 UPDATE TO THE PSS EXPANDS THE IG'S SCOPE TO ADD THE EXCHANGE OF PATIENT CONSENT NEEDED FOR DISPENSING AND PARTICIPATION IN PATIENT SUPPORT PROGRAMS. EXPAND THE SPECIALITY MEDICATION ENROLMENT FHIR IG TO SUPPORT EXCHANGE OF RELATED PATIENT CONSENT.
Attachments	FHIR Profiles.pdf PSS Approval Background Info.pptx
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 enrolment 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. FURTHER, PATIENT CONSENT MAY BE NEEDED BY DISPENSERS OR PATIENT SUPPORT PROGRAMS SO THEY CAN RECEIVE PATIENT INFORMATION, PERFORM DISPENSING ACTIVITIES AND/OR INTERACT WIT THE PATIENT CARE TEAM. CURRENTLY, STAKEHOLDERS IN THE DISPENSING OF SPECIALTY PRODUCTS LACK DATA STANDARDS AND CONVENTIONS FOR REQUESTING AND SHARING PATIENT CONSENTS ASSOCIATED WITH THIS PROCESS. THE PRODPOSED ADDITION TO THIS IG WILL ESTABLISH THIS.
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. THIS EXPANSION OF THE IG IS DRIVEN BY THE WORK OF NCPDP WG18 PATIENT CONSENT TASK GROUP.
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 UPDATES: TARGET FOR STU2 - JUNE 2022 BALLOT CYCLE
3f. Common Names / Keywords / Aliases:	Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy, PATEINT CONSENT, DISPENSING
3g. Lineage	Specialty Medication Enrollment - STU1 - published June 2021
3i. HL7-Managed Project Document Repository URL:	https://github.com/HL7/fhir-specialty-rx
3j. Backwards Compatibility	Yes
3l. Using Current V3 Data Types?	N/A
3m. External Vocabularies	Yes
3n. List of Vocabularies	NCPDP Code Lists
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
5a. Project Intent	Implementation Guide (IG) will be created/modified
5a. Is the project adopting/endorsing an externally developed IG?	No
5b. Project Ballot Type	STU to Normative, 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), Other
6f. Other Stakeholders	Pharmacies, Providers, MEDICAL DEVICE AND OTHER SPECIALTY DISPENSERS, SPECIALTY HUBS
6g. Vendors	EHR, PHR, Health Care IT
6h. Providers	Healthcare Institutions (hospitals, long term care, home care, mental health), Other
6h. Other Providers	Pharmacies
6i. Realm	U.S. Realm Specific
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
7d. US Realm Approval Date	Feb 25, 2020
7f. FMG Approval Date	Feb 26, 2020
7i. Steering Division Approval Date	Mar 08, 2020
7j. TSC Approval Date	Mar 16, 2020

Version	7
Modifier	Melva Peters
Modify Date	Sep 21, 2021 20:01
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 now proceeding to Normative directly or after being either Informative or STU?	No
2a. Primary/Sponsor WG	Process Improvement Committee
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
2g. Publishing Facilitator	Frank McKinney
2h. Vocabulary Facilitator	Julie James
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 the exchange of data (Demographic, prescription, clinical and financial) AND PATIENT CONSENT NEEDED for dispensing OF specialty medications AND OTHER THERAPIES (EG SPECIALTY DEVICES USED FOR ONCOLOGY TREATMENT) by pharmacies AND OTHER DISPENSERS, as well as facilitating enrolment 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. THIS SEPTEMBER 2021 UPDATE TO THE PSS EXPANDS THE IG'S SCOPE TO ADD THE EXCHANGE OF PATIENT CONSENT NEEDED FOR DISPENSING AND PARTICIPATION IN PATIENT SUPPORT PROGRAMS. EXPAND THE SPECIALITY MEDICATION ENROLMENT FHIR IG TO SUPPORT EXCHANGE OF RELATED PATIENT CONSENT.
Attachments	FHIR Profiles.pdf PSS Approval Background Info.pptx
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 enrolment 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. FURTHER, PATIENT CONSENT MAY BE NEEDED BY DISPENSERS OR PATIENT SUPPORT PROGRAMS SO THEY CAN RECEIVE PATIENT INFORMATION, PERFORM DISPENSING ACTIVITIES AND/OR INTERACT WIT THE PATIENT CARE TEAM. CURRENTLY, STAKEHOLDERS IN THE DISPENSING OF ...specialty products lack data standards and conventions for requesting and sharing patient consents associated with this process. The proposed addition to this IG will establish these.
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 UPDATES: TARGET FOR STU2 - JUNE 2022 BALLOT CYCLE
3f. Common Names / Keywords / Aliases:	Specialty enrollment, specialty referrals, hub enrollment, manufacturer enrollment, pharmacy
3i. HL7-Managed Project Document Repository URL:	https://github.com/HL7/fhir-specialty-rx
3j. Backwards Compatibility	Yes
3l. Using Current V3 Data Types?	N/A
3m. External Vocabularies	Yes
3n. List of Vocabularies	NCPDP Code Lists
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
5a. Project Intent	Implementation Guide (IG) will be created/modified
5a. Is the project adopting/endorsing an externally developed IG?	No
5b. Project Ballot Type	STU to Normative, 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), Other
6f. Other Stakeholders	Pharmacies, Providers, MEDICAL DEVICE AND OTHER SPECIALTY DISPENSERS, SPECIALTY HUBS
6g. Vendors	EHR, PHR, Health Care IT
6h. Providers	Healthcare Institutions (hospitals, long term care, home care, mental health), Other
6h. Other Providers	Pharmacies
6i. Realm	U.S. Realm Specific
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
7d. US Realm Approval Date	Feb 25, 2020
7f. FMG Approval Date	Feb 26, 2020
7i. Steering Division Approval Date	Mar 08, 2020
7j. TSC Approval Date	Mar 16, 2020

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

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