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This file is created on 2020-12-01 05:00:20am

About the ISA

Comment

HL7 Comments for ONC ISA 2021 Reference Edition

Attached are Health Level Seven (HL7) International 's comments on ONC’s Interoperability Standards Advisory (ISA) as ONC prepares to update the ISA for the 2021 “Reference Edition”.     

HL7 Response ISA Letter 11.08.20 FINAL .pdf

ISA Structure

Comment

Greater Emphasis on Testing Tools

HIMSS encourages ONC to determine how best to incorporate information on the testing of standards into ISA.  When the community looks at any standard, no matter how well the standard is written, it is the actual implementation of that standard where there is interpretation variability.  Overall, the community spends a significant amount of time talking about standards and implementation guides, but if those standards and guides are not tested once embedded into products and systems, there are questions about whether stakeholders are making the progress needed to propel broader interoperability efforts forward.       HIMSS would like ISA to include more quantitative data to support the assessment of standards adoption/maturity.  For example, one helpful approach would be to include more information about testing, test tools, testing events, as well as how and where particular standards can be tested and advanced.  We encourage ONC to work with Integrating the Healthcare Enterprise (IHE) and Health Level Seven International (HL7) to investigate whether the upcoming connectathon events that each organization sponsors would be the appropriate setting to provide additional quantitative data in support of this effort.  HIMSS would be interested in working with ONC to ascertain whether this idea is best suited for more references within ISA or to build out more robust testing standards as part of the Interoperability Proving Ground.    It is also important to note ONC’s reference to testing in the preamble to ISA, and how the agency encourages further pilot testing and industry experience to be sought with respect to standards and implementation specifications identified as “emerging” in ISA.  HIMSS would like to be helpful resource to ONC on this type of project.   

ISA Timeline and Comment Process

Comment

CMS Data Element Library HITWG Comments to ONC on ISA

Comments on the ONC Interoperability Standards Advisory submitted on behalf of the CMS Data Element Library Health IT Workgroup. 

CMS_DEL_HITWGComments ONC_ISA_2020NOV09.pdf

FEHRM Comments on ISA

On behalf of the Federal Electronic Health Record Modernization (FEHRM) Program Office, we appreciated the opportunity to comment on the Interoperability Standards Advisory (ISA).

FEHRM 2020 ISA Comments.pdf

Organization and Usability of ISA

ISA is a critical resource to the community as we move forward with broader data exchange across the healthcare ecosystem.  HIMSS thanks ONC for ISA’s new section organization and the clarity that it provides with the removal of section numbers and clearer naming and alphabetizing.  However, there are still some issues with not being able to access major sections of ISA, specifically around the new “Specialty Care and Settings” section.  HIMSS recommends that ONC take several steps to maximize the value of ISA to community stakeholder supporting these efforts.  Overall, ONC should work to promote and highlight ISA through additional means.  Creation of additional infographics that explain the purpose and benefits of utilizing ISA would be helpful.  Organizations like HIMSS could share those resources with our members and provide another opportunity to drive more utilization of ISA.  It may also be helpful to create brief video tutorials that provide examples of how different entities can access, use, and leverage ISA that furthers the goals of the program.  These resources could also point to previous ISA Reference Editions that are important for stakeholders to understand and see how standards have evolved over the course of several years to meet the requirements of the community.    Another opportunity to better promote ISA is to ensure robust alignment with USCDI as well as other interoperability efforts underway across ONC.   ONC has an opportunity to cross-reference both ISA and USCDI in each resource document to help ensure better alignment.  There is also an opening for improved mapping across the USCDI data classes and ISA interoperability needs.   We see a clear overlap that could be of value to the community for greater understanding of associated standards within the interoperability need.  For example, there is a USCDI data set for clinical notes as well as an ISA interoperability need for that topic. Cross-linking can raise awareness of both and help consider additional standards/needs associated with each data element or use case. In addition, we recommend ONC explore the concept of establishing a common evaluation process for ISA and USCDI on an annual basis, as a way of helping the community draw stronger connections between the resources.  Moreover, the idea of creating an ISA infographic resource could further tighten the linkages between ISA and USCDI by comparing and contrasting different sets of standards and describing what they have in common, where they diverge, and other distinguishing factors.   Finally, in terms of the organization of ISA and the “Appendix II – Models and Profiles” section, we ask ONC to update the link to our new Interoperability in Healthcare Guide on the HIMSS webpage for a discussion on different types of standards.   

FAQs

Comment


Vocabulary/Code Set/Terminology

Allergies and Intolerances

Representing Patient Allergic Reactions

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Allergic Reactions. The Allergy and Clinical Immunology CPT codes (95004 – 95199) identify patient assessment and intervention for allergy testing, ingestion challenge testing, and allergen immunotherapy. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

NCPDP Commnet

NCPDP supports ONC’s recommendations.

NCPDP Comment

This comment should be applied universally across the 2020 ISA Reference Edition. All hyperlinks for the NCPDP Standards should be updated to reflect: https://standards.ncpdp.org/Access-to-Standards.aspx?

Representing Patient Allergies and Intolerances; Environmental Substances

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Allergies and Intolerances; Environmental Substances. The Allergy and Clinical Immunology CPT codes (95004 – 95199) identify patient assessment and intervention for allergy testing and allergen immunotherapy, including environmental substances. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Representing Patient Allergies and Intolerances; Food Substances

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Allergies and Intolerances; Food Substances. The Allergy and Clinical Immunology CPT codes (95004 – 95199) identify patient assessment and intervention for allergy testing, ingestion challenge testing, and allergen immunotherapy, including food substances. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Representing Patient Allergies and Intolerances; Medications

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Allergies and Intolerances; Medications. The Allergy and Clinical Immunology CPT codes (95004 – 95199) identify patient assessment and intervention for allergy testing, ingestion challenge testing, and allergen immunotherapy, including medications. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

NCPDP Commnet

NCPDP supports ONC’s recommendations.

Clinical Notes

Representing Clinical Notes

Comment

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Cognitive Status

Representing Patient Cognitive Status

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Cognitive Status. The CPT code set contains Evaluation and Management code 99483, which identifies a comprehensive cognitive assessment of the patient, including, but not limited to:
  • Cognition-focused evaluation,
  • Functional assessment, including decision-making capacity,
  • Use of standardized instruments for staging of dementia,
  • Evaluation of safety,
  • Identification of caregivers, and
  • Creation of a written care plan.
CPT codes 96105-96146 identify neuro-cognitive assessments and tests, including cognitive performance testing, interactive feedback, neurobehavioral status examination, and neuropsychological testing evaluation services. Cognitive skills are also identified in the Occupational Therapy Evaluations codes, 97165 – 97167, and Therapeutic Procedures, 97129. In addition, CPT Category II codes 3720F and 3755F identify assessment and screening for cognitive impairment or dysfunction within the treatment of other clinical conditions. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

COVID-19 Novel Coronavirus Pandemic

COVID-19 Novel Coronavirus Pandemic

Comment

Opportunity to Better Highlight the Specialty Care and Settings

HIMSS appreciates the addition of the new “Specialty Care and Settings” section of ISA, which includes information about COVID-19 needs.  However, it may be beneficial to find other approaches to highlight this section as an opportunity to help address the pandemic.  For example, when you click on the ISA Content tab, it does not include this new section.  We ask ONC to create a new tab for the “Interoperability for COVID-19 Novel Coronavirus Pandemic” Section that makes it more visible to ISA users.  Given the importance of federal guidance to respond to the pandemic, it seems like a missed opportunity to not highlight critical public health interoperability needs on COVID-19 in an easily accessible way.  As an initial step, ONC should also include an overview of this section and link on the main ISA webpage to enhance its overall visibility.  We also ask that ONC consider “Telehealth/Remote Patient Monitoring” an additional specialty care/setting for inclusion in this section.  There is a growing need to consider data exchange for home settings and considerations around device interoperability.  There are a number of applications in use and this setting requires work across a number of systems (emergency medical services, hospital electronic health records, telemedicine system (synchronous and asynchronous) and, remote patient monitoring and device management).  ISA should provide guidance on specific standards to assist in exchange with this setting.  In addition, HIMSS asks ONC to describe what the process is to determine inclusion in the Specialty Care and Setting section, including certain criteria that must be met.  A better overview of this section and how additional inclusions are determined would be beneficial and further highlight the information included there. 

Demographics

Representing Patient Contact Information for Telecommunications

Comment

Representing Nutrition Assessment, Diagnosis, Interventions and Monitoring/Evaluation

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Nutrition Assessment, Diagnosis, Interventions and Monitoring/Evaluation. CPT codes 97802 – 97804 identify patient assessment and intervention of medical nutrition therapy. In addition, CPT Category II codes 3759F and 3760F identify assessment and screening for nutrition within the treatment of another clinical condition. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Emergency Medical Services

Representing Health Care Data for Emergency Medical Services

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Health Care Data for Emergency Medical Services. CPT codes 99281 – 99285 identify patient evaluation, examination, and medical decision making for emergency department services. CPT code 99288 identifies the direction of emergency care to emergency medical services personnel by a physician or other qualified health care professional. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Encounter Diagnosis, Assessment and Plan

Representing Assessment and Plan of Treatment

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Assessment and Plan of Treatment. The CPT Evaluation and Management codes specifically address multiple categories and subcategories for the broad range and levels of assessing and planning treatment for the patient. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Representing Patient Dental Encounter Diagnosis

Comment

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Representing Patient Medical Encounter Diagnosis

Comment

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Family Health History

Representing Patient Family Health History

Comment

Wrong code system referenced for Problem Type

2.16.840.1.113883.3.88.12.3221.7.2 - this code system is not LOINC as referenced above...it is SNOMED.

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Family Health History. The CPT Evaluation and Management codes specifically address capturing the patient’s family health history. The E/M codes specifically provide information about:
  • The health status or cause of death of parents, siblings, and children;
  • Specific diseases related to problems identified in the chief complaint or history of the present illness, and/or system review
  • Diseases of family members that may be hereditary or place the patient at risk
Also, CPT code 96040 identifies medical genetics and genetic counseling services. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Functional Status/Disability

Representing Patient Functional Status and/or Disability

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Functional Status and/or Disability. CPT codes 99455 and 99456 identify the completion of medical history, examination, diagnosis, development of a treatment plan, and completion of necessary documents for a patient with a work related or medical disability.  Functional status and disability are also identified in the Physical Therapy Evaluations codes, 97161 – 97164, and Occupational Therapy Evaluations codes, 97165 – 97167, which include patient history, examination, clinical decision making, and development of a treatment plan. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Comments from the Alliance for Nursing Informatics

Thank you for the opportunity to provide comments on the Interoperability Standards Advisory (ISA) and the Standards Version Advancement Process (SVAP). The ANI strongly supports further development to include Functional Status standards in regulations and as federal program requirements. Please see attachment for our full comments

ANI COMMENTS on ISA-SVAP _FINAL.pdf

Goals

Representing Patient Goals

Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Goals. CPT Category II codes for Health and Well-Being Coaching (0591T – 0593T) identify services for goal setting, education, and monitoring related to those goals.   CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Health Care Providers, Family Members, and Other Caregivers

Representing Health Care Providers

Comment

NCPDP Comment

Modify Adoption level of NPI for pharmacy to 5

Representing Provider Role in Team Care Settings

Comment

Representing Relationship Between Patient and Another Person

Comment

Imaging (Diagnostics, Interventions and Procedures)

Representing Imaging Diagnostics, Interventions and Procedures

Comment

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Immunizations

Representing Immunizations – Administered

Comment

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider and determine/resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

NCPDP Comment

  1. The lot number should be added as a requirement when NDC is used. The lot number is used in conjunction with the NDC when reporting immunizations to state registries.
  2. RxNorm – is not utilized by Pharmacy for dispensing purposes.

Representing Immunizations – Historical

Comment

Preserving Clinical Context

  General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost. 

    NCPDP Comment

    NCPDP supports ONC’s recommendations.

    Industry and Occupation

    Representing Patient Industry and Occupation

    Comment

    Proposed Addition of Work Information to the ISA

    Subject: Proposed Addition of Work Information to the Interoperability Standards Advisory (ISA) Submitted by: The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Work Information has been proposed as a new Data Class to be included in the U.S. Core Data for Interoperability (USCDI). Work Information is defined as a framework for a person’s self-reported, structured and standardized work history that has broad applicability to healthcare as part of the medical record; it is suitable for many use cases supporting patient care, population health, and public health. NIOSH proposes adding a Work Information Vocabulary/Code Set/Terminology section to the ISA. Currently, the only related section is for “Industry and Occupation.” Since Work Information includes additional Data Elements, NIOSH proposes replacing that section as described in the attached document. The proposal includes all of the Work Information vocabulary that was included in the USCDI application and clarifies the use of certain Occupation and Industry value sets. NIOSH also proposes adding a Work Information (Social History) Content/Structure section to the ISA as described in the attached document. Currently there is no similar section. The proposal would move the structure specifications from the current Industry and Occupation Vocabulary section to this new section.

    ISA_WorkInformation_1120_final_1.docx

    Laboratory

    Representing Laboratory Tests

    Comment

    Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
    • Resolving to myriad de-coupled fragments
    • With vanishingly little focus on:
      • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
      • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
    It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      NCPDP Comment

      For SNOMED CT® pharmacy adoption level should be 3.

      Representing Laboratory Values/Results

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      Medications

      Representing Patient Medications

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      Nursing

      Representing Clinical/Nursing Assessments

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, outcomes, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      Representing Nursing Interventions

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, outcomes, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      Representing Outcomes for Nursing

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, outcomes, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      Representing Patient Problems for Nursing

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, outcomes, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      Patient Clinical “Problems” (i.e., conditions)

      Representing Patient Clinical “Problems” (i.e., Conditions)

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, outcomes, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      NCPDP Comment

      1. Request ONC add ICD-10 as a value. In NCPDP SCRIPT Standard Version 2017071 when clinical problems are reported, ICD-10 is required and SNOMED CT® is optional.
      2. Add the following:
      Type-Implementation Specification Standard Implementation/Specification- ICD-10 Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 4 Federally Required – Yes Cost – $ Test Tool Availability – Yes
      1. Include Test Tool Link: https://tools.ncpdp.org/erx/#/home

      Preferred Language

      Representing Patient Preferred Language (Presently)

      Comment

      Adding Cantonese to preferred language set

      I serve a large population of Cantonese speaking Chinese patients in Northern California. The prior EHR version of Centricity allowed me to pick Cantonese as a preferred language so as to facilitate identification of those patients in verbal communications from the office. Now they have adopted the list from ONC, Cantonese is no longer an option. Please add Cantonese to the list. Thank you.

      Procedures

      Representing Dental Procedures Performed

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, outcomes, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      Representing Medical Procedures Performed

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, outcomes, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

      Provenance

      Representing Data Provenance

      Comment

      Race and Ethnicity

      Representing Patient Race and Ethnicity

      Comment

      Research

      Representing Data for Biomedical and Health Services Research Purposes

      Comment

      Sex at Birth, Sexual Orientation and Gender Identity

      Representing Patient Gender Identity

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Gender Identity. CPT code 55970 identifies an intersex surgery of male to female. CPT code 55980 identifies an intersex surgery of female to male. Evaluation and Management codes for a new patient (99381) and established patient (99391) include completing a gender appropriate history, exam, counseling and interventions. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Patient Sex (At Birth)

      Comment

      Representing Patient-Identified Sexual Orientation

      Comment

      Social, Psychological, and Behavioral Data

      Representing Alcohol Use

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Alcohol Use. CPT codes 99408 and 99409 identify patient screening and intervention for alcohol abuse. CPT codes 8032-80322 identify testing for alcohol. CPT code 82075 identifies an alcohol breath test. In addition, CPT Category II codes identify a patient screened for unhealthy alcohol use (3016F), patient counseled about risks of alcohol use (4158F), and patient counseled for pharmacologic treatment for alcohol dependence (4320F). CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      NCPDP Comment

      1. Substance use fields are available in NCPDP SCRIPT Standard Version 2017071 to allow alcohol use information to be transmitted via SNOMED codes
      2. Add the following:
      Type-Implementation Specification Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 1 Federally Required – Yes Cost – $ Test Tool Availability – Yes
      1. Include Test Tool Link: https://tools.ncpdp.org/erx/#/home

      Representing Depression

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Depression. CPT code 96127 identifies patient screening through a behavioral assessment for depression.  CPT code 99483 includes an assessment for depression within the cognitive care plan.  CPT code 96127 includes an assessment for depression with this developmental/behavioral screening and testing. In addition, CPT Category II code 1040F, 2060F, and 3088F – 3093F identify evaluations of major depressive disorder. CPT Category II codes 1220F, 3351F – 3354F, 3725F identify a patient screened for depression within the treatment of other clinical conditions. CPT Category II codes 4060F – 4067F identify various services provided depression. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Drug Use

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Drug Use. CPT codes 99408 and 99409 identify patient screening and intervention for substance abuse. CPT codes 80320 – 80377 identify definitive drug testing. In addition, CPT Category II codes identify a patient screened for injection drug use (4290F) and counseled for pharmacologic treatment for opioid addiction (4306F). CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Exposure to Violence (Intimate Partner Violence)

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Exposure to Violence (Intimate Partner Violence). The CPT Evaluation and Maintenance services include assessing a patient’s risk and exposure to violence. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Financial Resource Strain

      Comment

      Representing Food Insecurity

      Comment

      Representing Housing Insecurity

      Comment

      Representing Level of Education

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Level of Education. The CPT Evaluation and Maintenance services include assessing a patient’s level of education. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Physical Activity

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Physical Activity. Physical activity is identified in the Physical Therapy Evaluations codes, 97161 – 97164, and Occupational Therapy Evaluations codes, 97165 – 97167. CPT codes 97169 – 97172 identify athletic training evaluations, which includes a physical activity profile. The CPT Evaluation and Maintenance services include assessing a patient’s level of physical activity. CPT codes 97750 and 97755 identify tests and measurements of physical performance. In addition, CPT Category II code 1003F identifies an assessment of patient level of activity. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Social Connection and Isolation

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Social Connection and Isolation. The CPT Evaluation and Maintenance services include assessing a patient’s social history. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Stress

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Stress. The CPT codes 90839 and 90840 are used to identify psychotherapy for a crisis. Also, the CPT Evaluation and Maintenance services include assessing a patient’s level of stress. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Transportation Insecurity

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Transportation Insecurity. The CPT Evaluation and Maintenance services include assessing a patient’s level of transportation insecurity. Care plan services also address transportation needs. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Comments from the Alliance for Nursing Informatics

      Thank you for the opportunity to provide comments on the Interoperability Standards Advisory (ISA) and the Standards Version Advancement Process (SVAP). ANI strongly endorses social determinants of health (SDOH) as a key interoperability need for better care and health nationwide, amplified as a need during the COVID-19 public health emergency. While SDOH data elements are present within the ISA, but adoption is low, and standards are not federally required. Therefore, ANI strongly supports further development to include SDOH standards in regulations and as federal program requirements. Please see attachment for our full comments.

      ANI COMMENTS on ISA-SVAP _FINAL_1.pdf

      Tobacco Use

      Representing Patient Electronic Cigarette Use (Vaping)

      Comment

      NCPDP Comment

      1. Substance use fields are available in NCPDP SCRIPT Standard Version 2017071 to allow tobacco use information to be transmitted via SNOMED codes
      2. Add the following:
      Type-Implementation Specification Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 1 Federally Required – Yes Cost – $ Test Tool Availability – Yes
      1. Include Test Tool Link: https://tools.ncpdp.org/erx/#/home

      Representing Patient Second Hand Tobacco Smoke Exposure

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Second Hand Tobacco Smoke Exposure. CPT Category II code 1032F identifies a patient who is a current smoker or currently exposed to secondhand smoke.   CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Patient Tobacco Use (Smoking Status)

      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Tobacco Use (Smoking Status). CPT codes 99406 and 99407 identify the patient as a tobacco user and that cessation counseling was provided. In addition, CPT Category II codes identify assessment of tobacco use (1000F), current tobacco user with asthma (1032F), current tobacco user with heart disease (1034F), tobacco use cessation counseling (4000F), tobacco use cessation pharmacologic therapy (4001F), and patient screened as a tobacco user and received cessation intervention (4004F). CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      NCPDP Comment

      1. Substance use fields are available in NCPDP SCRIPT Standard Version 2017071 to allow tobacco use information to be transmitted via SNOMED codes
      2. Add the following:
      Type-Implementation Specification Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 1 Federally Required – Yes Cost – $ Test Tool Availability – Yes
      1. Include Test Tool Link: https://tools.ncpdp.org/erx/#/home

      Units of Measure

      Representing Units of Measure (For Use with Numerical References and Values)

      Comment

      Vital Signs

      Representing Patient Vital Signs

      Comment

      Preserving Clinical Context

      General Comments: USCDI specifies lots of clinical data classes and data elements
      • Resolving to myriad de-coupled fragments
      • With vanishingly little focus on:
        • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, outcomes, protocols, care plans and status...
        • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
      It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.


      Content/Structure

      Admission, Discharge, and Transfer

      Sending a Notification of a Long Term Care Patient’s Admission, Discharge and/or Transfer Status to the Servicing Pharmacy

      Comment

      NCPDP Comment

      1. Need to change NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 to NCPDP Specialized Standard, Implementation Guide, Version 2017071 with the following updates:
      Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 3 Federally Required – No Cost – $ Test Tool Availability – Yes
      1. Test Tool Link: https://tools.ncpdp.org/erx/#/home
      2. For NCPDP SCRIPT Standard, Implementation Guide, Version 10.6, need to update the Test Tool Availability to Yes. Test Tool Link: https://tools.ncpdp.org/erx/#/home

      Sending a Notification of a Patient’s Admission, Discharge and/or Transfer Status to Other Providers

      Comment

      Care Coordination for Referrals

      Referral from Acute Care to a Skilled Nursing Facility

      Comment

      Referral to a Specialist - Request, Status Updates, Outcome

      Comment

      Referral to Extra-Clinical Services - Request, Updates, Outcome

      Comment

      Care Plan

      Documenting and Sharing Care Plans for a Single Clinical Context

      Comment

      NCPDP Comment

      1. Modify the following:
      Type- Standard Standard Implementation/Specification- HL7® FHIR® US Core R.3.0 - Care Plan Profile Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 3
      1. Modify the following:
      Type-Emerging Implementation Specification Standard Implementation/Specification- HL7® C-CDA on FHIR® Care Plan Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 1
      1. Add the following:
      Type- Emerging Implementation Specification Standard Implementation/Specification- HL7® FHIR® US Core R.4.0 - Care Plan Profile Standards Process Maturity – In development Implementation Maturity- Need Feedback Adoption Level – Need Feedback Federally Required - No Cost - free Test Tool Availability - No

      Documenting and Sharing Medication-Related Care Plans by Pharmacists

      Comment

      NCPDP Comment

      1. Modify the following:
      Type- Standard Standard Implementation/Specification- HL7® FHIR® US Core R.3.0 - Care Plan Profile Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 3
      1. Modify the following:
      Type-Emerging Implementation Specification Standard Implementation/Specification- HL7® C-CDA on FHIR® Care Plan Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 1
      1. Add the following:
      Type- Emerging Implementation Specification Standard Implementation/Specification- HL7® FHIR® US Core R.4.0 - Care Plan Profile Standards Process Maturity – In development Implementation Maturity- Need Feedback Adoption Level – Need Feedback Federally Required - No Cost - Free Test Tool Availability - No

      Documenting Care Plans for Person Centered Services

      Comment

      Domain or Disease-Specific Care Plan Standards

      Comment

      NCPDP Comment

      1. Modify the following:
      Type- Standard Standard Implementation/Specification- HL7® FHIR® US Core R.3.0 - Care Plan Profile Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 3
      1. Modify the following:
      Type-Emerging Implementation Specification Standard Implementation/Specification- HL7® C-CDA on FHIR® Care Plan Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 1
      1. Add the following:
      Type- Emerging Implementation Specification Standard Implementation/Specification- HL7® FHIR® US Core R.4.0 - Care Plan Profile Standards Process Maturity – In development Implementation Maturity- Need Feedback Adoption Level – Need Feedback Federally Required - No Cost - Free Test Tool Availability - No

      Sharing Patient Care Plans for Multiple Clinical Contexts

      Comment

      Clinical Decision Support

      Communicate Appropriate Use Criteria with the Order and Charge to the Filling Provider and Billing System for Inclusion on Claims

      Comment

      Provide Access to Appropriate Use Criteria

      Comment

      Sharable Clinical Decision Support

      Comment

      Clinical Quality Measurement and Reporting

      Reporting Aggregate Quality Data for Quality Reporting Initiatives

      Comment

      Reporting Patient-level Quality Data for Quality Reporting Initiatives

      Comment

      Sharing Quality Measure Artifacts for Quality Reporting Initiatives

      Comment

      Data Provenance

      Establishing the Authenticity, Reliability, and Trustworthiness of Content Between Trading Partners

      Comment

      Diet and Nutrition

      Exchanging Diet and Nutrition Orders Across the Continuum of Care

      Comment

      Drug Formulary & Benefits

      Allows Pharmacy Benefit Payers to Communicate Formulary and Benefit Information to Prescriber Systems

      Comment

      NCPDP Comment

      1. Remove existing NCPDP verbiage under “Limitations”.
      2. Add the following:
      Type-Implementation Specification Standard Implementation/Specification- NCPDP Formulary and Benefit Standard, Implementation Guide, Version 53 Standards Process Maturity – Final Implementation Maturity – Feedback requested Adoption Level – Feedback requested Federally required – No Cost - $ Test Tool Availability – No
      1. Modify the following:
      Type-Implementation Specification Standard Implementation/Specification- NCPDP Real Time Prescription Benefit Standard Standards Process Maturity – Final Implementation Maturity – Production Adoption Level – 1

      Electronic Prescribing

      Allows a Long Term or Post-Acute Care to Request to Send an Additional Supply of Medication

      Comment

      NCPDP Comment

      1. Update the following:
      Type-Implementation Specification Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 Adoption Level - 3

      Allows a Pharmacy to Notify a Prescriber of Prescription Fill Status

      Comment

      NCPDP Comment

      1. Update the following:
      Type-Implementation Specification Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 Adoption Level - 3

      Allows a Pharmacy to Request a Change to a Prescription

      Comment

      NCPDP Comment

      1. Update the following:
      Type-Implementation Specification Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 Adoption Level - 3

      Allows a Pharmacy to Request a New Prescription For a New Course of Therapy or to Continue Therapy