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This file is created on 2022-09-29 06:01:02am

About the ISA

Comment

ACLA ISA comment re: Annual Reference Edition

We appreciate the annual Reference Edition .pdf, but Is it also possible to get a revision marked version of the annual draft for comment and reference edition ISA in future? Narrowing the review to content that has changed will allow us greater focus on future comments.

ACLA Comments on ONC's ISA Annual Update

The American Clinical Laboratory Association (ACLA) is pleased to submit our comments in response to the ONC Interoperability Standards Advisory (ISA) for the 2022 ISA Reference Edition. Our comments are attached. Thank you for the opportunity to comment on the annual update. If there are any questions regarding these comments, please do not hesitate to contact us. 

ACLA comments - 2022 ONC ISA_09.30.2021 final submitted.pdf

HL7 Comments on ONC's ISA Annual Update

Health Level Seven (HL7) International welcomes the opportunity to submit comments on ONC’s Interoperability Standards Advisory (ISA) as ONC prepares to update the ISA for the 2022 “Reference Edition”.  Our comments are attached.  Please let us know if you have questions or need more information.    

HL7 Response ISA Letter FINAL.pdf

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

Patient Naming Policy

I support AHIMA's Patient Naming Policy to improve patient safety.

AIRA Comments

On behalf of the American Immunization Registry Association (AIRA) we are pleased to submit comments on the Office of the National Coordinator’s (ONC’s) updated Interoperability Standards Advisory. These comments are a compilation of the input of our members which include over 80 organizations representing Public Health Immunization Information Systems (IIS), IIS implementers and vendors, non-profit organizations and partners. Immunization Information Systems interface with a broad range of stakeholders, including providers, pharmacists, schools, child care facilities, health plans and payers, among others. Most of AIRA's comments were uploaded on specific pages, but the comment below likely needs a new page: AIRA proposes the addition of a new HL7-balloted Implementation guide for Immunization Decision Support Forecast (http://hl7.org/fhir/us/immds/). This emerging FHIR R4 standard has been balloted through HL7, published, and is in use in several pilots and/or proof of concepts. AIRA is happy to discuss in greater detail how to represent this new standard on the ISA. We believe this should fit nicely within Content/Structure or Services/Exchange Standards within their respective Clinical Decision Support sections. Thank you for the opportunity to provide comments, and please let us know if there are any follow up questions. 

DirectTrust's Comments on ISA

Thank you for the opportunity to comment on the Interoperability Standards Advisory.  See attached. 

ISA Updates 2021 0930 v2.xls

Academy of Nutrition and Dietetics Comments on 2021 ISA

On behalf of the Academy of Nutrition and Dietetics, thank you for the opportunity to provide our feedback on the Interoperability Standards Advisory.

Academy Comments on 2021 Interoperability Standards Advisory.pdf

terminologies referenced by ISA

It would be very useful to have an "index," so to speak, of all the terminologies/code sets/vocabularies referenced by ISA and where in ISA they're referenced. Does such a thing already exist?

Comments from the College of American Pathologists

Please see attached.

CAP Comments on ONC-ISA.pdf

American Association of Colleges of Nursing submits comments

Please see attached PDF

AACN ONC Comments 2021.pdf

Support of the Gravity Project’s Submission to Include SDOH

To: The Honorable Donald Rucker, M.D. National Coordinator for Health Information Technology U.S. Department of Health and Human Services 330 C Street SW, 7th Floor Washington, D.C.  20201   Re: In Support of the Gravity Project’s Submission to Include Social Determinants of Health in the U.S. Core Data for Interoperability   Dear National Coordinator Rucker: I write on behalf of the Gravity Project to ask for your quick help with a major opportunity—adding structured social determinants of health (SDOH) data to the U.S. Core Data for Interoperability (USCDI). The Gravity Project has done considerable groundwork and submitted the SDOH data elements to the Office of the National Coordinator (ONC), and ONC, in turn, has elevated the submission to the next step. The Gravity Project’s submissions would add critical domains such as food insecurity, housing instability, transportation insecurity, social isolation, and stress to the USCDI, integrated with core clinical activities such as assessments, diagnoses, interventions, and outcomes.  As a healthcare provider for many years, I have seen firsthand the impact SDOH has on managing care and improving outcomes for patients. The challenges with meeting the needs of all seeking care have been exacerbated by COVID and have highlighted the inequities in the healthcare system. Addressing SDOH will be essential to ensure adequate care is received by all by including data elements to accurately and timely identify social needs and match those needs with community resources. The inclusion of SDOH as a new data class in USCDI, as proposed by the Gravity Project, will provide a consistent method to document and communicate these factors during a health care encounter. The Gravity Project has over 1,200 collaborators nationwide, representing diverse stakeholders who are committed to the goals of this project, standardize data collection and coding, and seamlessly exchanging SDOH data among all caregivers.   Sincerely,  Dr. Lisa Lucas National Director Healthcare Informatics SAS Institute        

Data Element: Health Concerns

This data element may have merit, especially if there are differences in the data element for Patient Goals and Encounter Diagnosis; but may be redundant...Also, maybe difficult to capture if it is not entered in a discrete field as part of the Nursing Care Plan or Physician Treatment Plan

FAQs

Comment

Access USCPI Plus

How do I access USCDI plus


Vocabulary/Code Set/Terminology

Allergies and Intolerances

Representing Patient Allergic Reactions

Comment

Testing comment for basic registered user

Testing only, please discard.

NCPDP Comments

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?

NCPDP Commnet

NCPDP supports ONC’s recommendations.

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.

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.

NCPDP Comment

NCPDP supports ONC’s recommendations.

Either or both value sets are large

Either or both value sets are large, establish a core commonly charted values list for implementation. Support outliers.

ONC response to comments

"Problem" VS extremely broad, recommend removal and suggest using "Adverse Clinical Reaction" and "Allergic and Intolerance Type" VSs as starter set.  Links added to VSAC.  Validation of comprehensiveness is difficult, although second VS is stewarded by HL7 Terminology workgroup.

Links to value sets

Links to value sets in VSAC, PHINVADS or elsewhere would be very helpful.  A URN or OID means NOTHING to about 98% of the affected parties.

The value sets are a start, but the first represents about 1/3 of all SNOMED CT codes. This is not a useful reduction to something that represents value to the community.

The second appears to be useful, but without a way to understand the process by which the codes were selected, it is difficult to validate it. That would require a rather deep analysis.  It would be helpful if VSAC value sets included something more than a one line description of the value set.  Without further information about the value set, and considering its source from a federal group rather than a standards organization, it is hard to judge whether this valueset is viable.

 

Representing Patient Allergies and Intolerances; Environmental Substances

Comment

NCPDP Comments

NCPDP supports ONC’s recommendations.

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.

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.

SNOMED CT value needs…

SNOMED CT value needs further restriction for Environmental Substances

UNII is really not all that helpful for clinical use.

Representing Patient Allergies and Intolerances; Food Substances

Comment

NCPDP Comments

NCPDP supports ONC’s recommendations.

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.

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.

Should use the American Allergy and Immunology list

It is short (but longer than the one below), uncluttered by special forms of food and is authoritative. While any food can cause an adverse reaction, eight types of food account for about 90% of all reactions:

http://acaai.org/allergies/types/food-allergy

Eggs, Milk, Peanuts, Tree nuts, Fish, Shellfish, Wheat, Soy 

What is the state of UNII, its not listed

What is the state of UNII, its not listed? UNII has been problematic when implementing related to the volume of choices.  SNOMED has a similar issue.  Establish a top used list for Food Substances as core implementation list. Allow outliers where needed, this will improve implementation and interoperability.  

Food substances too broad

There are over 4000 of these codes in SNOMED CT. It is still way to broad to be useful. Would suggest that a value set that would be useful would cover top 100 food items.  Avoid repetition like

256349002 Peanut - dietary (substance)      
229889003 Peanut brittle (substance)      
102260001 Peanut butter (substance)      
412047006 Peanut containing products (substance)

 

How many different ways do we need to say an interpret Peanut containing products?  Would you feed peanuts to someone with a peanut butter allergy?  That kind of clinical decision making needs to go into the making of these value sets.

 

UNII code system and value set is specific to FDA Product labeling and is not all that helpful for clinical use.  SNOMED CT is much better suited for this purpose.

UNII has broad coverage and…

UNII has broad coverage and connections to many other code systems and to chemical structures. Also includes what food and/or allergens. Would not dismiss it out of hand.

Representing Patient Allergies and Intolerances; Medications

Comment

NCPDP Comments

NCPDP supports ONC’s recommendations.

Tighten up the applicable starter sets

The various identified "starter value sets" in this section presents a confusing overlapping collection. The three items listed as "representing drug classes" are not equivalent and only the SNOMED CT (SCT) Product hierarchy is actually aligned with actual drug class concepts. SNOMED CT Drug product class concepts are uniquely valuable because NLM links SCT product class concepts to the appropriate RXNorm drug ingredients to support Drug class to RxNorm or even NDC codes identification via available APIs at RxClass. The other two suggested sets (Common Drug Classes for Allergy and Intolerance documentation and Common Drug Substances for Allergy and Intolerance documentation) do not represent useful drug classes and should not be listed in the Drug Classes for Allergy and Intolerance documentation section. For the Representing Medication section, the listed set Clinical Drug Ingredient (2.16.840.1.113762.1.4.1010.7) (RxNorm ingredient codes) is a subset of all potential drug ingredient RxNorm codes that was based on a historical review of common drug ingredients listed as causes of allergy or intolerance in clinical records done a number of years ago. While this list has not been updated, it is useful. I suggest adding to the suggestions in this section the set you will remove from the "class" set as it is the list of every ingredient or related code type in RxNorm - over 25,000 codes. This is the Common Drug Substances for Allergy and Intolerance documentation (2.16.840.1.113762.1.4.1186.1) set.

NCPDP Commnet

NCPDP supports ONC’s recommendations.

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.

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.

NCPDP Comment

  1. 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 – N/A Federally Required – No Cost – $ Test Tool Availability – Yes Test Tool Link: https://tools.ncpdp.org/erx/#/home  
  1. NCPDP SCRIPT Standard Version 2017071 allows for transmission of all the data sets.

Pharmacy HIT Collaborative's Comments on ONC's Proposed 2018 ISA

The Pharmacy HIT Collaborative supports using RxNorm and SNOMED CT; however, we ask for clarification as to why MED-RT (formerly NDF-RT) has been removed as a standard/implementation specification, as it was included in the final 2017 ISA and is currently included under “Representing Patient Medications.” We recommend that it be returned.   

Class Medication Allergen - Suggest SNOMED CT Substance Hierarch

Strong support SNOMED CT as replacement to NDF-RT which is no longer supported.  In past modeling, have recommended the "substance" domain in lieu of the listed "product" domain as the "class" substance contains relationships to related medication ingredient substances.  For example, current NDF-RT N0000011281 "Penicillins" spans RXCUI 7986 within RxNorm.  RXCUI 7986 also spans SNOMED CT 373270004 "Penicillin -class of antibiotic- (substance)," and 6369005 "Penicillin -class of antibiotic- (product)" - the "substance" value has links to the ingredient "children" that would be expected to span the class, such as "amoxicillin". The "product" hierarchy does not have a direct path to member "ingredient" based concepts.. instead, it links to a product concept such as "product containing amoxicillin".

Consider including MED-RT to represent classes of medications

MED-RT is an emerging standard that allows for representing classes of medications.  This has already been added under "Representing Patient Medications".  Shouldn't this also be added here for representing allergies to a class of medication? 

Agree - MED-RT should be the…

Agree - MED-RT should be the preferred class specification. It is tied to RxNorm and reasonably sized.

Clinical Notes

Representing Clinical Notes

Comment

NCPDP Comments

NCPDP supports ONC’s recommendations.

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 and care planning for a patient with a known cognitive impairment.  The services performed include:
  • Cognition-focused evaluation with pertinent history and examination,
  • Functional assessment for ability to perform various activities and decision-making capacity,
  • Use of standardized tests for staging of dementia,
  • Medication review for high-risk medications,
  • Evaluation for neuropsychiatric and behavioral symptoms using standardized screening tests,
  • Evaluation of environmental safety,
  • Evaluation of caregivers and their knowledge, needs, and supports,
  • Development, revision, or review of a care plan,
  While the LOINC codes that assess cognitive status and the FHIR use case used to support the exchange of functional and cognitive status assessment information are still in development, the CPT code 99483 is an adopted standard. The CPT code conveys the same or similar information as the LOINC codes for cognitive function (11333-2, 75275-8, and 11332-4), which is currently listed as a standard for this interoperability need.     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 Comments

NCPDP supports ONC’s recommendations.

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.

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.

COVID-19 Novel Coronavirus Pandemic

COVID-19 Novel Coronavirus Pandemic

Comment

SANER FHIR IG is an interoperability specification

We're not sure why the SANER FHIR IG is listed under terminology.  It's not a terminology IG but makes use of other terminology sets.  I would likely be better to be placed under Services/Exchange under Public Health.

WA State Department of Health SANER Comments

Washington State Department of Health fully supports the listing of the emerging standard Situational Awareness for Novel Epidemic Response (SANER). It is vital to ensuring public health and others can effectively monitor supplies, patient capacity and counts of patient’s being cared for during an outbreak or pandemic.

ACLA request to update content

Please revise both hyperlinks for Logica (https://covid-19-ig.logicahealth.org/index.html) to reference the official HL7 Logica webpage: http://hl7.org/standards/hsp-marketplace/index.html. The current ISA LOGICA hyperlink is to a non-HL7 website; HL7 projects must be hosted on an HL7 website per HL7 policy.
  • Justification statement: We believe HL7 will maintain their website supporting HL7 standards perpetually so an HL7.org hyperlink is preferable.
  The SANER specification was published by HL7. Please update the hyperlink to the published version at: HL7 FHIR® Implementation Guide: Situational Awareness for Novel Epidemic Response (SANER) STU 1: http://hl7.org/fhir/uv/saner/STU1/ The current hyperlink is to HL7 FHIR’s ‘build’ environment which is preparatory to balloting and publication. (build.fhir.org/ig/HL7/fhir-saner/)
  • Justification statement: We believe HL7 will maintain their website supporting HL7 standards perpetually so an HL7.org hyperlink is preferable.
  Please remove the June 4, 2020 date from the following reference: it has been updated twice since original publication: CARES Act Section 18115 require laboratories to report results of SARS-CoV2 or COVID-19 testing to the Secretary of HHS in the form and manner outlined in this memo "COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115 June 4, 2020"    

WA State Department of Health SANER Comments

Washington State Department of Health fully supports the listing of the emerging standard Situational Awareness for Novel Epidemic Response (SANER). It is vital to ensuring public health and others can effectively monitor supplies, patient capacity and counts of patient’s being cared for during an outbreak or pandemic.

NCPDP Comments

  1. Request ONC to add NDC as a value where NDC is used.
  2. Add the following:
Type-Standard Standard Implementation/Specification- National Drug Code (NDC) Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 5 Federally Required – Yes Cost – $ Test Tool Availability – N/A
  1. NCPDP Emergency Preparedness Guidance document - Declared emergencies, such as weather-related events (e.g., hurricanes, fires, floods, etc.), natural disasters (e.g., earthquakes) or pandemics (e.g., H1N1, COVID-19), have led NCPDP to create this document. This document provides guidance to the pharmacy industry for resources available during a declared emergency. The intended audience is healthcare providers who would need resource information for assisting patients in accessing their products and services provided by pharmacies during declared emergencies. This document will be updated as new information is available.
  Additionally, this document addresses certain emergency preparedness processes and procedures that could be established as daily occurrences to be invoked at a moment’s notice, mitigating urgent training for emergency situations. For example:
        1. Payers/pharmacy benefit managers should have declared emergency criteria established within standard plan benefit templates.
        2. Pharmacy systems should support declared emergency plan billing rules and claim routing information as part of their normal procedures.
        3. Enrollment files and product history are routinely updated and should be accessible during a declared emergency.
  For details, refer to the NCPDP EMERGENCY PREPAREDNESS GUIDANCE document on the Resources page of the NCPDP website.

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

NCPDP Comments

NCPDP supports ONC’s recommendations.

Representing Nutrition Assessment, Diagnosis, Interventions and Monitoring/Evaluation

Comment

The AMA requests that the…

The AMA requests that the following bullet under “Applicable Value Set(s) and Starter Set(s)” be deleted:  
  • CPT Category II  3759F and 3760F: identify assessment and screening for nutrition within the treatment of another clinical condition
  Use of CPT Category II codes are limited to the quality measures for which they were developed.

NCPDP Comments

NCPDP supports ONC’s recommendations.

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.

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.

Emergency Medical Services

Representing Health Care Data for Emergency Medical Services

Comment

WA State Department of Health EMS Comments

Washington State Department of Health supports the listing of the National Emergency Medical Services Information System (NEMSIS) standards for EMS data and only has one recommended change at this time. Washington State Department of Health recommends adding NEMSIS 3.5 as an emerging standard for emergency medical services data exchange, with implementation having began in Summer 2022. NEMSIS standards are an important collector of data for EMS in various contexts including public health, quality assurance and traffic safety.

WA State Department of Health EMS Comments

Washington State Department of Health supports the listing of the National Emergency Medical Services Information System (NEMSIS) standards for EMS data and only has one recommended change at this time. Washington State Department of Health recommends adding NEMSIS 3.5 as an emerging standard for emergency medical services data exchange as it likely could start being used in Spring of 2022. NEMSIS standards are an important collector of data for EMS in various contexts including public health, quality assurance and traffic safety.

NCPDP Comments

  1. When Emergency Medication is being administered, NDC and RxNorm could be used. Request ONC to add NDC and RxNorm as a value.
  2. Add the following:
Type-Standard Standard Implementation/Specification- National Drug Code (NDC) Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 5 Federally Required – Yes Cost – $ Test Tool Availability – N/A
  1. Add the following:
Type-Standard Standard Implementation/Specification- RxNorm Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 4 Federally Required – Yes Cost – Free Test Tool Availability – N/A

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.

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.

Regenstrief - Comment

We concur that the NEMSIS data set is an important collector of variables in the EMS context. In addition, we note that LOINC contains terms for observations and observation values for the complete NEMSIS data set (see panel 84428-2). Additionally, HL7 has developed the HL7 Version 3 Implementation Guide for CDA Release 2 - Level 3: Emergency Medical Services; Patient Care Report, Release 2 - US Realm, which uses the LOINC observation and observation values codes. http://www.hl7.org/implement/standards/product_brief.cfm?product_id=438

Further, it may also be worth mentioning that there is correlation between the NEMSIS (pre-hospital) data elements and the National Trauma Data Bank (NTDB) data dictionary, with the idea that the trauma registry could be “auto-populated” with the subset of relevant prehospital data. The National Trauma Data Standard data dictionary (2018 version) is also represented in LOINC (see panel 87825-6). HL7 has developed the HL7 CDA® R2 Implementation Guide: Trauma Registry Data Submission, Release 1 - US Realm, which uses LOINC. http://www.hl7.org/implement/standards/product_brief.cfm?product_id=355.

Last, the German Interdisciplinary Association of Intensive Care and Emergency Care Medicine defined a data set to enable efficient exchange from EMS pre-hospital services to receiving institutions. This complete data set of variables in the rescue service protocols are represented in LOINC (see panel 88677-0). This further supports the use of LOINC as a code system for use in this context.

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. This request was made in 2020 during which time the CPT code set was added and then removed.   The CPT Evaluation and Management codes specifically address multiple categories and subcategories for the broad range and levels of assessing and treatment planning for the patient, including:
  • Office or other outpatient services
  • Hospital observation services
  • Hospital inpatient services
  • Consultations
  • Emergency department services
  • Critical care services
  • Nursing facility services
  • Domiciliary, rest home, or custodial care
  • Home services
  • Case management services
  • Non-face-to-face services
  The CPT codes convey the types of information that is required to alert providers and will empower them to proactively monitor their patients throughout the care continuum, improving patient outcomes and enhancing care continuity, while reducing preventable readmissions. In addition, the need for hospitals to share Admit, Discharge and Transfer data throughout the care community is critical, and now required, from improving interoperability and transitions of care for patients. These types of alerts to providers will empower them to proactively monitor their patients throughout the entire continuum of care, significantly improving patient outcomes and care continuity, while reducing preventable readmissions.   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 Comments

NCPDP supports ONC’s recommendations.

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.

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.

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.

SNODENT free cost?

per link to snodent - the entry 'free' in cost is incorrect.

 

See the text on the website.

SNODENT is owned, maintained and distributed by the American Dental Association (ADA). The SNODENT code set is available under license at no cost for non commercial use. The license agreement terms also permit licensees to use SNODENT in the development of non-commercial, academic, scholarly articles and presentations for publication. For inquires about SNODENT licenses, use the contact information below.

 

 

Consider describing the license details in the preconditions section.

Representing Patient Medical Encounter Diagnosis

Comment

NCPDP Comments

NCPDP supports ONC’s recommendations.

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 Comment

While use of ICD-10 is limited, when transmitting diagnosis information it is required. HIPAA mandates the use of ICD-10 for pharmacy claims using NCPDP standards. SNOMED is optional. Adoption level for ICD-10 for the pharmacy is 5.

Family Health History

Representing Patient Family Health History

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, 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.

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.

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.

feedback

Consider adding the following info to starter set

OMOP common data model is using SNOMED CT concepts (descendants of SNOMED CT term 125677006 (http://snomed.info/id/125677006))  to standardize family relationships (reference: https://github.com/OHDSI/CommonDataModel/wiki/FACT_RELATIONSHIP#conventions  ). 

Standard for observation…

Standard for observation values: should probably be Standard for observation values that are represented as codes (won't apply if they are free text or numbers).

Many of the details of Family Genomic History are not capturable by SNOMED CT. They will require the code systems provided by NCBI such as ClinVar, dbSNP, etc.

This is a greatly exaggerated assessment in the CMS Assessments. A large provider of IHE interfaces see SNOMED CT codes for 5% or fewer variables with multiple choice answers. Most are either text and/or local codes. 

Are the value sets in ISA accounting for the decisions and imple

  • Personal Relationship Role Type”  Personal Relationship Role Type urn:oid:2.16.840.1.113883.1.11.19563
  • There is a discrepancy between this value set and FHIR 4.0.  More generally are the value sets in ISA accounting for the decisions and implementations being made with FHIR?
    • Definition:          
      • A relationship between two people characterizing their "familial" relationship
      • OID:       2.16.840.1.113883.1.11.19579 (for OID based terminology systems)
    • Title:      V3 Value SetFamilyMember
    • Name:  v3.FamilyMember
    • Defining URL:     http://terminology.hl7.org/ValueSet/v3-FamilyMember

NCBI genomic data resources

NCBI resources for sequences, including RefSeq, dbVar, and dbSNP,  can be found here:

https://www.ncbi.nlm.nih.gov/guide/all/

Need code system for family…

Need code system for family relationships, SNOMED CT and HL7 V3 Personal Relationship have good value sets for this.

Functional Status/Disability

Representing Patient Functional Status and/or Disability

Comment

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

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.

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.

The use of OIDs alone is a…

The use of OIDs alone is a bad way to suggest a value set. Readers need some way to see the actual content of the value set, either via URL or, if it is short, as an actual enumeration.

The adoption level is…

The adoption level is greatly exaggerated. Only IRFPAI of the CMS assessments provides SNOMED CT options in addition to LOINC LA answer lists. All of the categorical answers have LA codes of which there are about 100 unique codes. Some of the answers also have SNOMED CT codes (about  50 unique such codes). The names of the SNOMED Codes are often approximates of the CMS string name for the codes.  All of the other CMS assessments include LOINC LA codes or all of their categorical answers and very few SNOMED CT codes except for yes/no. See https://del.cms.gov/DELWeb/pubDownloadHitCodesForm to verify.

Regenstrief - Comment

It would be worthwhile to clarify what the ISA means by functional status and/or disability. These words mean different things to different audiences. We recommend anchoring the ISA notion to the WHO-developed ICF conceptual framework for describing functioning and disability. The ICF has a biopsychosocial model of disability, based on an integration of the social and medical models of disability.

In this model, functioning is an umbrella term for body function, body structures, activities and participation. It denotes the positive or neutral aspects of the interaction between a person’s health condition(s) and that individual’s contextual factors (environmental and personal factors).

Disability is an umbrella term for impairments, activity limitations and participation restrictions. It denotes the negative aspects of the interaction between a person’s health condition(s) and that individual’s contextual factors (environmental and personal factors).

So, what we believe the ISA to be referring to in this interoperability need is the “middle” part of the ICF: the activities of people (functioning at the level of the individual) and the activity limitations they experience; plus the participation or involvement of people in all areas of life, and the participation restrictions they experience (functioning of a person as a member of society). Such clarifications are important for knowing whether something like “cognitive function” is in or out of this domain.

We propose that it would exclude the notion of functioning at the level of the body, that is, impairments of body functions and structures (e.g. measurement of deep tendon reflex of biceps). It would also exclude the notion of environmental factors (e.g. physical geography), whether facilitators or barriers, that affect a person’s experiences.

With that as the framing, we concur with the identification of the terminologies listed in this domain (LOINC and SNOMED CT) as the most appropriate for the observations and observation values related to functioning. In post-acute care settings, functional status is a required component (e.g. Section GG) of the CMS assessment instruments (e.g. MDS, LCDS, IRF-PAI, and OASIS). Through close collaboration between CMS and Regenstrief, all of the variables in these instruments are represented in LOINC. There are other sets of relevant patient reported variables (such as the PROMIS physical function short form, Hip Dysfunction and Osteoarthritis Outcome Score, etc) and clinical assessments of function represented in LOINC. The American Physical Therapy Association identified all of the variables for its national outcomes registry (including items related to functioning) with LOINC.

It is worth noting that LOINC represents the strings of the observation values for standardized assessments as LOINC Answer codes, but these answers for many standardized assessments of functioning are not well represented in SNOMED CT due to their specialized nature. So, just like standardized nursing assessments, LOINC Answer codes should be used to reflect the precise responses on these functional status assessments. The “Adoption Level” for SNOMED CT in this context should be one star at best. There are very few functional status observation values that are even represented in SNOMED CT, and their deployment in this context is very limited.

Last, the NMMDS reference in “Applicable Value Set(s) and Starter Set(s)” should be removed because the NMMDS is about administrative and management information for the provision of nursing care. It doesn’t have variables related to an individual’s functioning/disability.

 

AMA's comments to ONC on proposed 2018 ISA

On behalf of American Medical Association (AMA) I appreciate the ability to comment on the 2018 Interoperability Standards Advisory (ISA).

Comment:

The AMA recommends adding the “Guides to the Evaluation of Permanent Impairment, Sixth Edition” (“Guides”) as an additional resource for this interoperability need in the Limitations, Dependencies, and Preconditions for Consideration.  The Guides are a standardized, objective approach to conducting impairment ratings that result in detailed documentation of functional outcomes, physical findings, and clinical test results and have been shown to improve the overall consistency, transparency, and precision of impairment ratings.  Users include physicians, other health care providers, attorneys, employers, and claims professionals.  The Guides are adopted by U.S. Department of Labor’s Division of Federal Employees’ Compensation for schedule award entitlement determinations.  They are also adopted in 19 states and used internationally in Canada, Australia, New Zealand, Hong Kong, Korea, South Africa, and The Netherlands.

The standards named in this…

The standards named in this domain (LOINC and SNOMED CT) are appropriate and we concur with their inclusion here. However, a couple of clarifications are needed. The first bullet should be removed as it suggests that the CMS-required MDS should be used more widely and in different settings than for which it is designed. The IMPACT Act requires that CMS make certain assessment data elements standardized and interoperable so that this data may be exchanged and used by post-acute care and other providers to support care coordination and improved outcomes. CMS is working directly with the Regenstrief Institute to represent all data elements in the assessment instruments they require in different care settings (e.g. MDS, LCDS, IRF-PAI, and OASIS) in LOINC. This work includes current versions of these instruments, as well as their intended harmonization over time. 

In addition, many clinical assessments of functional status are well represented in LOINC and SNOMED CT.

None of the three existing…

None of the three existing CMS assessment tools for functional status assessment (MDS, OASIS, IRF-PAI) adequately covers all patients.  We need a uniform assessment instrument.

Goals

Representing Patient Goals

Comment

NCPDP Comments

Modify LOINC and SNOMED CT adoption levels to 1.

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.

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.

Health Care Providers, Family Members, and Other Caregivers

Representing Health Care Providers

Comment

NCPDP Comments

Modify Adoption level of NPI to 5.

NCPDP Comment

Modify Adoption level of NPI for pharmacy to 5

NCPDP Comment

  1. NPI is mandated in HIPAA transactions however not all prescribers (for example veterinarians) are able to obtain an NPI.)
  2. Adoption level of NPI for pharmacy is 5

NCPDP Comment

NPI is mandated in HIPAA process however not all prescribers (for example veterinarians) are able to obtain an NPI.

Good choice of coding system…

Good choice of coding system but doubt it is used much. Some empirical data from an IHE or even a illustrative EHR could help settle. 

Regenstrief - Comment

We should clarify that there are two purposes subsumed by this current interoperability need. The first is to uniquely identify the person (provider). That need is addressed by the NPI. It is an “instance” identifier. The second need is to categorize or identify the type of provider they are. That is addressed by the NUCC Health Care Provider Taxonomy. But, there is already a “Representing Provider Role in Team Care Settings” section, so it seems more appropriate for the NUCCPT to be listed as a standard there rather than here.

NCPDP - Comment

The NPI is mandated in HIPAA named standard transactions; however other identifiers are used as needed (e.g.: State PDMP, state government programs)

Should NUCC Provider Taxonomy be used here?

Given that there is also a Representing Provider Role in Care Setting section that presumably is used to represent a care setting specific role, then some clarification is needed for how the NUCC PT code system would be used here, particularly when the NPI is not a role, it is an identifier. These are two very different kinds of concepts and I suspect they should not both be used here. Perhaps NUCC PT should only be used in the Representing Provider Role in Care Setting section.

Value set link and OID for NUCC Provider Taxonomy

  1. Please change the NUCC standard to "National Uniform Claim Committee (NUCC) Health Care Provider Taxonomy" Or you can just use NUCC Health Care Provider Taxonomy if you want it shorter. The provider taxonomy is the main thing people get from the NUCC, but NUCC provides other code sets so just saying NUCC is not specific. 
  2. The link you should use for the taxonomy is http://www.nucc.org/index.php/code-sets-mainmenu-41/provider-taxonomy-mainmenu-40
  3. VSAC provides a value set for the provider taxonomy. The OID is 2.16.840.1.114222.4.11.1066.
  4. VSAC has a direct link to the latest expansion for this value set here: https://vsac.nlm.nih.gov/valueset/2.16.840.1.114222.4.11.1066/expansion.
    1. This syntax will work for every value set VSAC has. I would suggest you use it for all VSAC value sets so users can click and directly go to the value set expansion view
  5. It would be good to standardize on how to represent OIDs. In some places you just list the OID, in others you list it as a URI (urn:oid:2.16.840.1.114222.4.11.1066)

Representing Provider Role in Team Care Settings

Comment

NCPDP Comments

NCPDP supports ONC’s recommendations.

NCPDP Comment

  1. NUCC does not represent all providers, such as Assistant Physician. NCPDP worked with the appropriate provider organizations to request a new taxonomy code for Assistant Physicians. However, the request was not supported by NUCC because it is a license type versus a provider type. While CMS does not allow Assistant Physicians to enroll, CMS agreed to research internal processes to determine if a distinct taxonomy identifier could improve the process.

NUCC is too precise

NUCC is too precise, combining specialty and setting. Providers or care team members may have more than one role or more than one care setting. The precision of NUCC essentially decreases accuracy.  

NUCC Taxonomy is challenging…

NUCC Taxonomy is challenging.  SNOMED CT is better for this purpose, as it references ONLY the singular aspect of provider role and does not merge three separate aspects (role, setting and specialty).

NCPDP - Comment

Taxonomy codes should be added as a standard. The pharmacy industry uses this value set to determine covered practice settings.

Use of the NUCC Provider Taxomony

I commented on how to properly reference the NUCC Provider Taxonomy code system and a value set that represents it in the Representing Health Care Providers section. The value set has an old name that perhaps should be changed to remove the "(HIPAA)". Noting that this element exists and is the proper use of the NUCC Provider Taxonomy, there can be confusion about how those concepts should also be used in the Representing Health Care Providers section. 

Representing Relationship Between Patient and Another Person

Comment

NCPDP Comments

NCPDP supports ONC’s recommendations.

Health Concerns

Representing Patient Health Concerns

Comment

NCPDP Comments

Modify LOINC and SNOMED CT adoption levels to 1.

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.

The American Medical…

The American Medical Association requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Imaging Diagnostics, Interventions and Procedures. The CPT code set contains a comprehensive and regularly curated list of diagnostic and interventional radiology procedures. Because of the federal and private initiatives to provide patients access to their health care data using claims data, including CPT as a standard would support the exchange of this information. CPT was created over 50 years ago and is a 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.

Recommendations for Section II: Content/Structure & Imp Specs

Recommendations for Section II:  Content/Structure Standards and Implementation Specifications
  1. Break this into two blocks – the new block would be titled: Interoperability Need: Format of Medical Images for Exchange and Distribution
In that block insert the: (See image 1 from uploaded file) followed by a row: Implementation Specification,  PS3.3 Digital Imaging and Communications in Medicine (DICOM) Standard – Part 3: Image Object Definitions,  Final,  Production,  5 black circles, No, Free, Yes
  1. For now, keep the 2nd block as is (same as the original block)

Recommendations for Section II_DICOM.docx

Regenstrief - Comment

Please correct the typo of Regenstreif to Regenstrief. Also, there are two relevant value sets that should be listed here. The first is the “LOINC/RSNA Radiology Playbook”. This set is identified by the OID 1.3.6.1.4.1.12009.10.2.5.1 and the URI is http://loinc.org/vs/loinc-rsna-radiology-playbook. The current FHIR R4 Mixed Normative/Trial Use Ballot #2 binds to this collection as code set for the ImagingStudy.procedureCode.

The second is the collection of terms in LOINC representing imaging procedures/reports. This set is called “LOINC Imaging Document Codes” and includes all radiology procedures as well as terms from some other imaging specialties. It is identified by the OID 1.3.6.1.4.1.12009.10.2.5 and the URI http://loinc.org/vs/loinc-imaging-document-codes. This is the value set named in C-CDA’s Diagnostic Imaging Report template and DICOM’s standard for Imaging Reports using HL7 CDA.

We concur with the…

We concur with the recommendation of LOINC as the vocabulary standard for this domain. The Regenstrief Institute and the RSNA have created a unified terminology standard for radiology procedures that builds on the strengths of LOINC and the RadLex Playbook. The LOINC/RSNA Radiology Playbook File now contains a unified representation of all existing LOINC and RadLex Playbook content, connecting LOINC radiology terms to a rich set of attributes represented with Radlex terms. The LOINC/RSNA Radiology Playbook File is now jointly published as part of the main LOINC release and it's Maturity should be listed as Production (it is actively being used by radiology centers, in health information exchanges, etc).

In addition, Regenstrief curates a value set of LOINC Imaging Document Codes (OID: 1.3.6.1.4.1.12009.10.2.5) that contains terms for imaging procedures/reports from Radiology, Endoscopy, Cardiology, and other imaging specialties. This is the value set named in C-CDA’s Diagnostic Imaging Report template and DICOM’s standard for Imaging Reports using HL7 CDA.

RadLex seems to be the way…

RadLex seems to be the way to go, LOINC is nonspecific wrt to Radiology.  Need value set identified from whichever standard is selected.

Some misunderstanding: there…

Some misunderstanding: there is a LOINC code for every RSNA/Radlex study and vice versa (RSNA used LOINC codes).

Immunizations

Representing Immunizations – Administered

Comment

Applicable Value Set(s) and Starter Set(s

The three links in the blue “Applicable Value Set(s) and Starter Set(s)” are incorrect and should reference the source of truth CDC sites for these vocabularies.

NCPDP Comments

  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. There is no standard codification for lot numbers.
  2. RxNorm – is not utilized by Pharmacy for dispensing purposes.

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.

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.

NCPDP Comment

NDC is used by pharmacy to identify and report immunizations.  Adoption rate = 5.

RxNorm Complicates Implementation

RxNorm unless it fills a specific gap not covered with the other code sets it will only complicate implementation

AMA comments on the 2018 ISA

On behalf of American Medical Association (AMA) I appreciate the ability to comment on the 2018 Interoperability Standards Advisory (ISA).

Comment:

The AMA recommends that the adoption level for CPT be changed from “Feedback Requested” to “high or widespread adoption.” The CPT procedure codes for vaccines and immune globulins products have been in place for decades and are updated as appropriate for new products. The product codes are reported in addition to the relevant administration procedure code to accurately capture the route of immunization and counseling related to the administered vaccine product. The combination of these codes is widely used for tracking immunizations in the pediatric population. CPT has a high level of maturity for its development process and implementation, and is the most widely adopted outpatient procedure code set. It is also federally required.

AMA comments on the 2018 ISA

On behalf of American Medical Association (AMA) I appreciate the ability to comment on the 2018 Interoperability Standards Advisory (ISA).

Comment:

The AMA recommends that the adoption level for CPT be changed from “Feedback Requested” to “high or widespread adoption.” The CPT procedure codes for vaccines and immune globulins products have been in place for decades and are updated as appropriate for new products. The product codes are reported in addition to the relevant administration procedure code to accurately capture the route of immunization and counseling related to the administered vaccine product. The combination of these codes is widely used for tracking immunizations in the pediatric population. CPT has a high level of maturity for its development process and implementation, and is the most widely adopted outpatient procedure code set. It is also federally required.

CVS seems more appropriate…

CVS seems more appropriate than NDC, as it is specific to immunization, and can be reconciled well with historical data that largely uses it.  A CPT to CVX valueset recommendation might be published (and has been in the past), but it should not be considered to be the primary vocabulary.

Representing Immunizations – Historical

Comment

AIRA Comments - Administered and Historical Immunizations

The "Representing Immunizations - Historical" page is very similar to the administered page. It includes the same 5 code sets and mostly the same considerations (in blue). AIRA proposes these be consolidated into a single page and deal with the nuanced differences in the blue Considerations section rather than retain and maintain two nearly identical pages.

NCPDP Comments

RxNorm – is not utilized for reporting of previous dispensing.

NCPDP Comment

NCPDP supports ONC’s recommendations.

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. 

    The American Medical…

    The American Medical Association requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Immunizations - Historical. The CPT code set is identified as a terminology standard for Representing Immunizations – Administered, so therefore, it should be included as a standard for historical immunizations. CPT was created over 50 years ago and is a 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. Request ONC to add NDC as a value. NDC has historically been used by pharmacy to report immunizations.
    2. Add the following:
    Type-Implementation Specification Standard Implementation/Specification- National Drug Code Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 5 Federally Required – Yes Cost – Free Test Tool Availability – N/A

    Agree, it should not be…

    Agree, it should not be required because it can't be obtained from a patient's history.

    RxNorm and Immunizations?

    These are the correct value sets to represent Historical immunizations. 

    RxNorm is included in list of value and starter sets. (RxNorm Vaccine Clinical Drug 2.16.840.1.113762.1.4.1010.8)

    If CVX and MVX have it covered what is the use case for RxNorm?  

    This is clearly the right…

    This is clearly the right value set for historical data, as that is the value set used.

    Laboratory

    Representing Laboratory Test Ordered

    Comment

    ACLA ISA comment re: ISA clarifications and AMA CPT code proposa

    Please clarify the term “harmonization status”.  We suggest this term be removed until it can be further clarified for expected implementation, clearly measured, etc.  It is too nebulous as currently stated.  For example, can it be measured and if so, how is it validated and how does it relate to the laboratory order or provider’s EHR system laboratory order? Does “numerically or categorically” mean/refer to “quantitative or qualitative”?  If so, we suggest using the terms “quantitative or qualitative” to avoid confusion. (These terms were used in the 2022 ONC’s LOINC survey so also for consistency.) Currently SNOMED CT codes are not used for ordering laboratory tests.  We suggest removing the 1st bullet entirely or move it the “Representing Test Performed” category which does address the laboratory results where SNOMED CT codes may be used.  Also remove the 3rd bullet since SNOMED CT is not pertinent to laboratory orders. We suggest you move the last bullet to the “Representing Test Performed” since it pertains to laboratory results.  It is confusing to have references to laboratory results (test performed) in the same category as the test ordered. Re: AMA’s suggestion to use CPT codes for laboratory orders, we suggest that AMA first work with HL7 to determine if CPT codes are approved by HL7 for laboratory test orders and if yes, how messaged. This must be done in conjunction with the HL7 Orders & Observations Work Group for maintenance of the LOI guide.  There are several issues:
    • ORC-16 suggested by AMA is the Order Control Code Reason, defined as: “This field contains the explanation (either in coded or text form) of the reason for the order event described by the order control code (HL7 Table 0119). Whereas an NTE after the order-specific segment (e.g., RXO, ORO, OBR) would provide a comment for that specific segment, the purpose of the order control code reason is only to expand on the reason for the order event.” 
    OBX-16 field uses HL7 controlled vocabulary (HL7 Table 0119) and is NOT the code for the test ordered. Per HL7 rules, you cannot use CPT codes in this field.
    • The LOI IG requires use of LOINC for order codes:
    “LOINC shall be used as the standard vocabulary to identify the ordered test in OBR-4(Universal Service Identifier) when an applicable LOINC code is available and provided by the laboratory. When no valid orderable LOINC code exists, the local code may be the only code sent.” “shall” is a modal verb equivalent to “required” or “must” per HL7 conformance “local code” is used by laboratories, for example, pending assignment of a LOINC code by Regenstrief or identified by the IVD equipment manufacturer
    • Currently the only mention of AMA in the HL7 LOI is “Following is a non-exhaustive list of third-party terminologies that may require a separate license:”
      • What is justification to introduce a new vocabulary, which would be additional expense for EHR systems/providers/and laboratories when there is already significant effort supporting LOINC for order codes, and LOINC codes are better suited for laboratory test order codes.
      • Typically, CPT codes are used by laboratories for billing/claims, not clinical laboratory test orders.  CPT typically indicates the procedure performed.  Multiple different tests are performed the same way, and therefore would have the same CPT code for multiple clinical laboratory tests.
      • CPT codes are too general for many laboratory clinical tests and might perpetuate many to one mapping issues as shown in CPT Code examples below:
        • CPT 80305 is drug screening by dipsticks, cups, cards or cartridges read visually
        • CPT 80306 is drug screening by dipsticks, cups, cards or cartridges read on an instrument reader
        • CPT 80307 is drug screening on a chemistry analyzer
        • Each code is only reported once per date of service regardless of the number of drugs tested
        • The codes include sample validation testing such as pH, specific gravity, nitrites, etc.
         

    AMA ISA comment re: ISA clarifications and AMA CPT code set

    The AMA’s understanding of the Interoperability Standards Advisory is that it provides a catalogue of available standards that inform developers’ choices for meeting interoperability needs, and not just for EHR systems. We do not believe current implementations for representing laboratory orders should limit developers’ coding system options for new solutions. The ONC ISA Content/Structure section for Laboratory identifies HL7 Version 2.5.1 Implementation Guide: Laboratory Orders from EHR (LOI) Release 1, STU Release 3 - US Realm as the implementation specification for “Ordering Laboratory Tests for a Patient.” Within this implementation guide, OBR-4 (Universal Service Identifier) does include a note stating that LOINC is to be used to identify the ordered test. There are other areas in the implementation guide that open the potential for other coding systems, including:
    • Section 1.4.4 references LOINC and SNOMED CT as examples of vocabulary standards but does not limit the guide to their usage only.
    • Section 5.1 includes the data for common order (ORC). ORC.16 Order Control Reason Code includes ORC.16.3 Name of Coding System and it points to Table 0396 – Coding System. CPT is included in this table of coding systems.
    • Observation/Result (OBX) also includes Name of Coding System (OBX.3.3) with the same Table 0396.
    Because CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, laboratory services, and diagnostic services, it should be included as a coding and terminology option for Representing Laboratory Tests Ordered. CPT has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. Again, the AMA’s understanding of the Interoperability Standards Advisory is that it provides a catalogue of available standards that inform developers’ choices for meeting interoperability needs, and not just for EHR systems. The inclusion of CPT is justified by the fact that implementations for representing laboratory orders should not limit developers’ coding system options for new solutions, but instead provide them a choice. CPT codes are used to represent lab test orders in the health care community. As such, developers should benefit from ONC's curation of available coding terminologies that reflects codes as they are used. Creating successful digital health products requires that developers are aware of the coding systems their customers use, have insight into available options and choices, and can leverage the ISA to help meet their customers' needs. CPT, as a comprehensive and regularly curated uniform language, is a viable terminology and coding option for developers to consider when developing solutions for representing laboratory orders interoperability needs.

    The AMA is requesting the…

    The AMA is requesting the Current Procedural Terminology (CPT) code set be added to the standards listed in the Vocabulary/Code Set/Terminology Section: Representing Laboratory Tests. The implementation specification named in the Content/Structure Section of the ISA is the HL7 Version 2.5.1 Implementation Guide: Laboratory Orders from EHR (LOI) Release 1, STU Release 3 - US Realm, which defines the specifications and standards and provides implementation guidance for the electronic ordering of lab tests. Included in the LOI guide is the trigger event OML_O21 for sending the lab order and the ORC segment for Common Order. The CPT code set is a valid terminology for ORC.16 where the lab order code set is identified.   Based on the content standard of LOI supporting the use of the CPT code set for sending a lab order, we believe CPT should be included as an additional terminology for “Representing Laboratory Tests” in the Vocabulary/Code Set/Terminology Section. Since “the ISA should serve as the first resource consulted to inform the selection of standards and implementation specifications,” it would be reasonable for terminologies supported by a named content implementation specification be named in the ISA’s corresponding terminology interoperability need.

    Representing Laboratory Test Performed

    Comment

    ACLA ISA comment re: clarifications to laboratory test performed

    Please clarify that “laboratory test performed” refers to the result(s) reported by the laboratory. Please clarify the 1st bullet; are you trying to state that additional information, such as the IVD equipment (Abbott, etc.), the way the test is resulted, etc. is the level of granularity necessary? We suggest this bullet should be removed. Please clarify the term “harmonization status”?  We suggest this term be removed until it can be further clarified for expected implementation, clearly measured, etc.  It is too nebulous as currently stated.  For example, can it be measured and if so, how is it validated and how does it relate to the laboratory test performed or provider’s EHR system laboratory test performed.    

    Representing Laboratory Values/Results

    Comment

    ACLA ISA comment re: clarification to section title, ‘actors’, a

    The title of this section is more limited than what is covered in this section; please clarify the actors this section applies to, e.g., Electronic Health Record (EHR) systems, Laboratory Information Systems (LIS), laboratories, exchanges, etc.  Refer to the IHE LAW and LTW profiles “Intended Audience”; is the target audience the same for this section? Some of these statements should be in the “Content/Structure” section of the ISA, not the “Vocabulary/Code Set/Terminology” section; there is overlap with the “Exchanging InVitro Diagnostics (IVD) Test Orders & Results” Content /Structure section of the ISA. Please clarify the term “harmonization status”.  We suggest this term be removed until it can be further clarified for expected implementation, clearly measured, etc.  It is too nebulous as currently stated.  For example, can it be measured and if so, how is it validated and how does it relate to the laboratory values/results or provider’s EHR system laboratory values/results? Do these terms, such as “standard scales” or “grading schemes” represent the end result of using of standard terminology such as LOINC or SNOMED CT? Please clarify.    

    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

    NCPDP Comments

    While RxNorm is useful for communication of clinical data for clinical care, the NDC is critical for specific product identification in research, dispensing and administrative workflows. The NDC is the key, unique, product identifier and is the standard of practice used throughout the pharmacy industry to identify the specific product. The industry heavily relies on the NDC in all aspects of its business, including, but not limited to, drug ordering, medication dispensing, reporting, billing, rebates, adverse event reporting and patient safety. RxNorm lacks the specificity required to uniquely identify a product.

    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

    1. Please remove previous NCPDP comments from 2017, as they no longer apply.
    2. NDC Adoption level is 5 since it is mandated by HIPAA.

    Compounded products will not…

    Compounded products will not have an NDC code. Herbal products do... good point.

    RxNorm is a good choice…

    RxNorm is a good choice. Hadn't realized that NDC was federally required. Ideally there would not be a choice of sending either RxNorm OR NDC because that would break interoperability. If both are sent that would be OK.

    UOM and VSAC

    Medications category should include code system for unit of measure to be complete (UCUM).  A defined and limited value set of medication units of measure should be identified and available in VSAC

    NCPDP - Comments - Not applicable to 2018 edition

    The National Drug Code (NDC) should have an Adoption Level of 5 and Federally Required should be a Yes. It is mandated under HIPAA.

    SNOMED is not currently used. NCPDP Standards would need to be modified to support SNOMED.

    Medication Reference Terminology (MED-RT) is not currently used.  NCPDP Standards would need to be modified to support MED-RT.

    NDC Federally Required and Adoption level

    Thank you for your comments.  We acknowledge the federal requirement to include NDC on CMS 1500 claim form.  With respect to adoption level, we would appreciate  your comments on level of adoption and use of NDC within existing health IT systems.

    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.

    May be underestimating the…

    May be underestimating the adoption level. Vital signs are nursing variables and they are required by Meaningful Use. Other nursing variables like Braden scores are also common - so maybe two bubbles.

    Regenstrief - Comment

    We concur with the recommended standards here (LOINC and SNOMED CT). The second sentence in Limitations, Dependencies, and Preconditions for Consideration should be amended because it only applies to SNOMED: Concepts for observation values from SNOMED CT should generally be chosen from two axes: Clinical finding and Situation with explicit context.

    Question / Answer Pairs

    Question / Answer pairs are valuable, supporting context of the assessment.  The assessment should not be limited to Q/A pairs. Full question with answer must be included in communication.

    We strongly approve of Nursing practice being included in ISA.  

    Agree with use of name/value pairs

    The Joint Commission agrees with the use of name/value pairs to represent clinical assessments.  This is the current structure used in electronic clinical quality measures (eCQMs).

    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.

    Should clarify what is meant…

    Should clarify what is meant by a nursing intervention and provide a definition and examples. If a request for vital signs is a nursing intervention then it will be hard to know when the request is fulfilled. if the code doesn't match it will be hard to manage the process from request to fulfillment

    We are delighted to see the…

    We are delighted to see the addition of Nursing content in the 2017 ISA and concur with all of the recommendations for use of LOINC and SNOMED CT.

    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.

    Regenstrief - Comment

    We concur with the recommendations for use of LOINC and SNOMED CT.

    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

    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

    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.

    Post-coordination

    • The 2nd and 3rd bullets both describe post-coordination and could be combined into one.
    • 'left leg fracture' now has a single SNOMED CT code; ‘left kidney stone’ could be used instead as an example of post-coordination.

    Agree with Rob McClure,…

    Agree with Rob McClure, LOINC does NOT seem appropriate in this context.

    Use of LOINC needs more explanation

    Not sure how LOINC would be used. You should explain how that code system is appropriate here.

    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.

    NCPDP Comment

    1. NCPDP supports ONC’s recommendation.

    I believe this is a very…

    I believe this is a very large set of languages that includes dead language and many variants. There are smaller and more reasonable subsets. If users take this as being the required menu to present for all questions about language use, it adds a burden and time cost to filling out the required language field.

    Believe there should be a required subset (and an optional extended set as is the case for racial categories) to reduce the time and burden of patient registration.

    Yeah, you finally got this…

    Yeah, you finally got this one right ;-) !!!

    Pregnancy Status

    Representing Patient Pregnancy Status

    Comment

    ACOG Comments RE: Proposed Representing Pregnancy Status

    For full formatted version, please see the attached word document.   Pregnancy Status Class Comment on the class: ACOG supports the comment already made supporting HL7s CCDA “Pregnancy Status” as it is comprehensive in this area and would better support both clinical research and public health use cases. https://www.hl7.org/implement/standards/product_brief.cfm?product_id=494   1. PREGNANCY STATUS 1A. Requirement Level: Must Have 1A. Value set: Yes, No, Unknown, currently pregnant or confirmed pregnant, not currently pregnant or pregnancy refuted, recently pregnant, possibly pregnant. 1A. Comments
    • Values have unnecessary overlap.  Clinically the importance is around confirmation of pregnancy.  ACOG recommends five values in this value set:  
    • Yes, confirmed pregnant;
    • No, confirmed not pregnant;
    • Unknown, possibly pregnant;
    • Recently pregnant within the last 12 months
    ACOG recommends that “recently pregnant” be defined as within the last 12 months to capture pregnancy related complications. Importantly, pregnancy-related deaths may occur well beyond the early postpartum period.  Per the CDC:  “A pregnancy-related death is defined as the death of a woman while pregnant or within 1 year of the end of a pregnancy –regardless of the outcome, duration or site of the pregnancy–from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes.”
    • ACOG supports a new data class called “Pregnancy Episode” of which pregnancy status would be a data element.  Pregnancy Episode would have data elements that include a start and end date, pregnancy status, postpartum period, and a lactation period if relevant. End date of pregnancy would be defined both by an actual known date and be defined by a calculation off EDD such that the Pregnancy Episode would automatically close at a specified period of time post the EDD.
    1A. Use Case: The Use Case for Pregnancy Episode is to ensure that a status of pregnancy is accurate and not reflective of a pregnancy that took place in the past.  It is also important to ensure that multiple pregnancies within a given time period are accurately reflected. This is important for clinical care as well as for both research and public health use cases. 1A. ACOG Related MaterialsCO736 | Optimizing Postpartum Care (05/2018)   1B. Requirement Level: Nice to Have 1B. Value set: Patient reported, pregnancy test, urine-based pregnancy test, serum-based pregnancy test, ultrasound, clinical impression, history of hysterectomy other. 1B. Comments: ACOG questions the need for these ‘nice to have’ values under pregnancy status as they are duplicative of values that exist elsewhere. Pregnancy tests and ultrasound are already covered in the Laboratory and Procedures Class and thus do not have a need to be restated here. History of hysterectomy more appropriately belongs with a designation of medically unable to conceive. Patient reported is a general health concern.  Clinical impression is covered by yes, confirmed pregnant.       2. DATE PREGNANCY STATUS Requirement Level: Must Have Value Set: Date No ACOG comments.       3. ESTIMATED DELIVERY DATE (EDD) Requirement Level: Must Have if pregnant, preferred Value Set: Date Comments
    • The correct clinical terminology is Estimated Due Date, not Estimated Delivery Date
    • EDD and GA are calculations of one another and thus appropriately belong together as in that if you have one, you have the other.  As such they need to be treated the same by USCDI in terms of “must have”/”nice to have”, the difference being that they have two different value sets.  EDD is a “Must Have” as an alternative to GA; GA is a “Must Have” as an alternative to EDD. 
    ACOG Related Materials (ReVITALize): Obstetrics Data Definitions: Estimated Due Date (EDD): The best EDD is determined by last menstrual period if confirmed by early ultrasound or no ultrasound performed, early ultrasound if no known last menstrual period or the ultrasound is not consistent with last menstrual period, or known date of fertilization (e.g., assisted reproductive technology).       4. EDD DETERMINATION METHOD Requirement Level: Nice to have if EDD used Value Set: LMP, ultrasound first trimester, ultrasound second trimester, ultrasound third trimester, ultrasound, Ovulation date, Embryo transfer, Other. Comments
    • The determination method is a “Must Have” for both EDD and GA.  The method reflects on the accuracy of the resulting date and is critical information to capture.  Being able to assess the reliability of the EDD/GA directly impacts clinical management of a pregnant individual; being unable to assess reliability represents a patient safety issue for both the mother and fetus.
    Value set comments:
    • ACOG recommends the following value set for EDD determination method:
      • LMP
      • Earliest ultrasound date and gestation age in weeks/days
      • First trimester ultrasound
      • Second trimester ultrasound
      • Third trimester ultrasound
      • Ultrasound, unknown trimester
      • Ovulation date
      • Embryo transfer date
      • Intrauterine insemination date
      • Other
    ACOG Related Materials
    • ACOG Committee Opinion #700 Methods for Estimating the Due Date (05/2017)
    • ACOG Committee Opinion #688 Management of Sub-optimally Dated Pregnancies (03/2017)
    • ACOG Committee Opinion #671 Perinatal Risks Associated with Assisted Reproductive Technology (09/2016)
          5. GESTATIONAL AGE Requirement Level: Must Have if Pregnant alternative to EDD Value Set: Number with units = weeks or days Comments: Should be weeks AND days, not weeks OR days ACOG Related Materials (ReVITALize): Obstetrics Data Definitions:  Gestational age  (written with both weeks and days; e.g., 39 weeks and 0 days) is calculated using the best obstetrical EDD based on the following formula: gestational age = (280 - (EDD - Reference Date))/ 7         6. DATE GESTATIONAL AGE DETERMINED Requirement Level: Must have if GA is used Value Set: Date No ACOG comments.       7. GESTATIONAL AGE DETERMINATION METHOD Requirement Level: Must have if GA is used Value Set: Ultrasound, EDD, ovulation date, OTHERS? Comments: Dates should be supplied with the determination method as done with EDD determination method.  The same value set may be used as EDD determination method:  Embryo transfer, Ovulation date, ultrasound, ultrasound third trimester, ultrasound second trimester, ultrasound first trimester, LMP, Other, with the same comment above with dates added (embryo transfer date, ultrasound dates).  Intrauterine Insemination needs to be added to the value set.       8. PREGNANCY OUTCOME Requirement Level: Nice to have if postpartum status is yes Value Set: Molar pregnancy, elective termination, spontaneous termination <20 weeks gestation, still birth, ectopic/tubal, live birth, unknown, other, not a live birth Comments
    • This should be a “Must Have” as pregnancy outcome impacts care both in the short term and management of future pregnancies
    • ACOG proposes the current proposed value set be replaced with: Live birth, Gestational Trophoblastic Disease, elective termination, early pregnancy loss (<13 weeks), early second trimester loss[1] (loss <20 weeks), stillbirth/fetal death (20 weeks or greater), ectopic/tubal, term birth, preterm birth, unknown, other. Justification:
      • Molar pregnancy should be replaced with Gestational Trophoblastic Disease as the more correct clinical terminology.
      • “Not a live birth” should be removed as other values cover this value.
      • In the first trimester, the terms miscarriage, spontaneous abortion, and early pregnancy loss are used interchangeably; ACOG prefers the term ‘early pregnancy loss’ to reflect these events, and recommends it be added to the value set.  “Spontaneous termination < 20 weeks gestation” should be removed.
      • Fetal death is widely used and thus ACOG recommends that the value be stillbirth/fetal death to reflect this.
      • The value set should add premature delivery and term birth as both are important to clinical care, research and public health use cases.
    • The Pregnancy Outcome must have the outcome date associated with it as metadata.  A stand-alone Outcome Date risks not associating the correct pregnancy episode with that outcome.  As such they must be linked together.
    ACOG Related Materials
    • ACOG Practice Bulletin #200 | Early Pregnancy Loss (08/2018): Early pregnancy loss is defined as a nonviable, intrauterine pregnancy with either an empty gestational sac or a gestational sac containing an embryo or fetus without fetal heart activity within the first 12 6/7 weeks of gestation.
    • ACOG Obstetric Care Consensus #10 | Management of Stillbirth (03/2020): The U.S. National Center for Health Statistics defines fetal death as the delivery of a fetus showing no signs of life as indicated by the absence of breathing, heartbeats, pulsation of the umbilical cord, or definite movements of voluntary muscles. There is not complete uniformity among states with regard to birth weight and gestational age criteria for reporting fetal deaths. However, the suggested requirement is to report fetal deaths at 20 weeks or greater of gestation (if the gestational age is known), or a weight greater than or equal to 350 grams if the gestational age is not known. The cutoff of 350 grams is the 50th percentile for weight at 20 weeks of gestation. To promote the comparability of national data by year and state, U.S. vital statistics data are collected for fetal deaths with a stated or presumed period of gestation of 20 weeks or more. Terminations of pregnancy for life-limiting fetal anomalies and inductions of labor for previable premature rupture of membranes are specifically excluded from the stillbirth statistics and are classified as terminations of pregnancy
    • ACOG Practice Bulletin #143 | Medical Management of First-Trimester Abortion (03/2014)
    • ReVITALize: Gynecology Data Definitions  
    [1] The term ‘early’ second trimester loss is being used to reflect the time period of 13 weeks to 19 6/7 weeks during the second trimester.  Prior to 13 weeks ‘early loss’ should be used and after 20 weeks ‘stillbirth/fetal death’ applies.       9. PREGNANCY OUTCOME DATE Requirement Level: Must have if postpartum status is yes Value Set: Date Comments
    • The Pregnancy Outcome Date must have the Pregnancy Outcome linked to it. A standalone Outcome Date risks not associating the correct pregnancy episode with that outcome.  As such they must be linked together.
    • Pregnancy Outcome Date must also include the level of certainty in the date {certain, estimated, unknown} as some outcomes, particularly with ectopic and early pregnancy loss, may not have a known outcome date.  
    •  The requirement level is a “Must Have” when there is any “Pregnancy Outcome”, not just postpartum status of yes.  Not all pregnancies result in a postpartum state, such as an ectopic pregnancy.
          10. ANT PREGNANCY OUTCOME WITHIN THE LAST 42 DAYS? Requirement Level: Must have if not pregnant Value Set: Yes, no, unknown Comments
    • ACOG proposes that the data element of “Any pregnancy outcome within the last 42 days?” be replaced with the data element of “Not Pregnant”, with an expanded value set .  The data element of “Any pregnancy outcome within the last 42 days?” is covered  by data element number 8: “Pregnancy Outcome”.  What is missing from the Pregnancy Status Class is a specific data element of “Not Pregnant”
    • Value set for “Not Pregnant”: LMP, method of contraception, pregnancy intention, pregnancy prevention intention-reported, medically unable to conceive {hysterectomy, inability to conceive with current partner, bilateral oophorectomy, bilateral salpingectomy, genetically unable to conceive, menopause}.
    • ACOG recommends the Pregnancy Intention value set include the values specified by LOINC 86645-9:  Yes, I want to become pregnant; I'm OK either way; No, I don't want to become pregnant; Unsure                  
    • ACOG recommends the Pregnancy Prevention Intention -Reported value set include the values specified by LOINC 91144-6: I am already doing something to prevent pregnancy; I want to start preventing pregnancy; I don't want to prevent pregnancy;  I am unsure whether I want to prevent pregnancy;  I prefer not to answer; This question does not apply to me.
    Use Case: Support of clinical decision support (CDS) for medication prescribing; necessary data elements to support research which may require confirmation of protection against pregnancy. LOINC Details: Pregnancy prevention intention – Reported has existing LOINC codes.  LOINC Term Description: A patient’s current intentions to prevent pregnancy. This includes a male patient’s intentions to prevent pregnancy with a female partner. This term was created for, but not limited in use to, the Office of Population Affair’s (OPA’s) clinical performance measures for contraceptive provision endorsed by the National Quality Forum (NQF).     https://loinc.org/91144-6/ Pregnancy Intention is a component of the LOINC Pregnancy and Contraception Panel 86642-6 (FPAR) Family Planning Annual Report.  LOINC Term Description: A patient's intention or desire in the next year to either become pregnant or prevent a future pregnancy. This includes male patients seeking pregnancy with a female partner. Pregnancy intention may be used to help improve preconception health screenings and decisions, such as determining an appropriate contraceptive method, taking folic acid, or avoiding toxic exposures such as alcohol, tobacco and certain medications. This term was based on, but is not limited in use to, Power to Decide's One Key Question®, used by the Office of Population Affair's (OPA's) Family Planning Annual Report (FPAR).  https://loinc.org/86645-9/       11. LMP (Last Menstrual Period) Requirement Level: Nice to have alternate to EDD/GA not dependent on pregnant Value Set: Date Comments
    • Last menstrual period (LMP) should be a “Must Have” and not a “Nice to Have” as a data element.  LMP remains important in determining EDD/GA along with the first accurate ultrasound or both.
    • Value set, in addition to date, should include certain, estimated, unknown, N/A.  N/A should have the ability to include the reason for no menses {pre-menarcheal, hormonal suppression, breastfeeding, hysterectomy, endometrial ablation}.
    ACOG Related Materials
    • ReVITALize: Obstetrics Data Definitions: Estimated Due Date (EDD): The best EDD is determined by last menstrual period if confirmed by early ultrasound or no ultrasound performed, early ultrasound if no known last menstrual period or the ultrasound is not consistent with last menstrual period, or known date of fertilization (e.g., assisted reproductive technology).
    • ACOG Committee Opinion #700 Methods for Estimating the Due Date (05/2017)
          12. MULTIPLICITY OF BIRTH/PREGNANCY Requirement Level: Nice to have Value Set: Numeric Comments
    • Multiplicity of birth/pregnancy should be a “Must Have” and not a “Nice to Have” data element.  Twins and higher order pregnancies have an increase in fetal morbidity and mortality, primarily due to prematurity.  Because of the increase in adverse outcomes with non-singleton pregnancies, it is important to capture this data for both clinical research and public health use cases.  
    ACOG Related Materials
    • Practice Bulletin #169 Multifetal Gestations: Twin, Triplet, and Higher-Order Multifetal Pregnancies (10/2016)

    20200921_USCDI ACOG.docx

    Regenstrief - Comment

    We concur with the recommendations on the use of LOINC and SNOMED CT here, and the pattern holds for additional relevant information collected.

    Error in table of contents

    When using the left-hand side-bar, and select Pregnancy Status, the link displayed is incorrect. It is to Representing Health Care Data for Emergency Medical Services, but should be Representing Patient Pregnancy Status. Please see attached documentation for more details.

    ISA_link issue.docx

    Thanks - we will look into…

    Thanks - we will look into this and correct this issue ASAP.

    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.

    Have to be very careful with…

    Have to be very careful with the scope of what is intended by procedures. Historically, HL7 distinguished surgical procedures from diagnostic procedures. Currently, all of the LRI and LOR require LOINC for the order and for the result. ISA specifies LOINC for the name of radiology tests.  If a diagnostic test is defined as a procedure as below then there will be no way to verify that by comparing codes if the test ordered got results.  

    In the 4th bullet point under limitations, SNOMED CT is described as for coding treatments. That distinction regarding procedures should be made more broadly, so avoid the use of one code system to order a diagnostic study and another to report it.     

    New IHE Profile IHE  [PCS] Paramedicine Care Summary 

    Be aware of and promote new profile. IHE  [PCS] Paramedicine Care Summary maps the flow of the patient information from the ambulance patient record, commonly known as the electronic Patient Care Record (ePCR), to the hospital Electronic Medical Record (EMR).

    From Profile - Currently, interventions and assessments are written into an ambulance electronic Patient Care Record (ePCR), and are either manually updated by the Emergency Medical Services (EMS) crew, or collected from electronic devices (e.g., hemodynamic monitor). The ePCR is updated with treatments and interventions that are administered during the transport. The hospital will not typically have access to paper or electronic versions of this patient information until the report is finished and signed in the ePCR and it is requested by the hospital. In this profile, the prehospital and paramedicine interventions and patient assessments are made available to the hospital/emergency room IT system electronically when the patient arrives, or in advance of patient arrival to the hospital. This informs medical decision making during the hospital treatment to improve patient care and to save lives

    AMA comments on the 2018 ISA

    On behalf of American Medical Association (AMA) I appreciate the ability to comment on the 2018 Interoperability Standards Advisory (ISA).

    Comment:

    Under “Limitations, Dependencies, and Preconditions for Consideration,” the AMA recommends that “CPT” be removed from the statement – “CPT/HCPCS are billing codes used for Outpatient Procedures.”  The CPT code set is mandated and widely used for claims processing, but it also serves in various functions outside of billing, including medical care review guidelines, medical education, patient outcomes, health services, and quality research. 

    Provenance

    Representing Data Provenance

    Comment

    IHE - Document Sharing

    The IHE Document Sharing includes Provenance of documents that are shared.  See the IHE whitepaper describing the Foundations of Document Sharing exchanges https://profiles.ihe.net/ITI/HIE-Whitepaper/index.html# see the normative specification on Document Sharing metadata     https://profiles.ihe.net/ITI/TF/Volume3/ch-4.1.html#4.1.3

    Document Digital Signature

    The IHE-Document Digital Signature (DSG) profile Implementation Guide provides a method for digitally signing documents. Where documents are any form of stream of bytes including CDA and FHIR-Documents. The DSG profile is normative and can provide integrity protection with attribution to the signer.  The Normative publication at IHE is --  https://profiles.ihe.net/ITI/TF/Volume1/ch-37.html The Document Digital Signature (DSG) Profile defines general purpose methods of digitally signing of documents for communication and persistence. Among other uses, these methods can be used within an IHE Document Sharing infrastructure (e.g., XDS, XCA, XDM, XDR, and MHD). There are three methods of digital signature defined here: Enveloping, Detached (manifest), and SubmissionSet.
    • An Enveloping Signature is a Digital Signature Document that contains both the signature block and the content that is signed. Access to the contained content is through removing the Enveloping - Digital Signature. Among other uses, this method should not be used with Document Sharing infrastructure.
    • A Detached Signature is a Digital Signature Document that contains a manifest that points at independently managed content. Detached signatures leave the signed document or documents in the original form. Among other uses, this method is recommended for use with a Document Sharing infrastructure to support Digital Signatures, as this method does not modify the original Document Content. This method uses the Document Sharing “SIGNS” relationship provides linkage.
    • A SubmissionSet Signature is a Detached Signature Document that attests to the content in a SubmissionSet by: containing a manifest of all the other Documents included in the SubmissionSet, and a reference to the SubmissionSet. The Document Sharing “SIGNS” relationship may be used but is not required.
    Ink-on-paper signatures have been a part of the documentation process in health care and have traditionally been indicators of accountability. Reliable exchange and storage of electronic data between disparate systems requires a standard that implements equivalent non-repudiation to prevent document creators from denying authorship and rejecting responsibility.

    Document Metadata

    The Document Metadata defined in IHE XDS/XCA/XDR/XDM and in IHE MHD (using FHIR DocumentReference); provides full Provenance for the document the metadata describes. The metadata also describes things beyond just Provenance. See https://profiles.ihe.net/ITI/HIE-Whitepaper/index.html#2-principles-of-ihe-for-health-document-sharing

    Public Health Emergency Preparedness and Response

    Representing Healthcare Personnel Status

    Comment

    Representing Hospital/Facility Beds Utilization

    Comment

    Representing Laboratory Operations (Population Laboratory Surveillance)

    Comment

    Representing Mass Vaccination Status

    Comment

    NCPDP Comments

    1. Request ONC add ICD-10 as a value since pharmacies report maximum vaccinations using ICD-10.
    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 – N/A

    Representing Population-Level Morbidity and Mortality

    Comment

    Race and Ethnicity

    Representing Patient Race and Ethnicity

    Comment

    Oregon Health Authority ISA Comments

    Oregon has implemented standards for the collection of Race, Ethnicity, Disability, and Language (REALD). State legislation in 2013 (HB 2134) required OHA and the Oregon Department of Human Services (ODHS) to develop standards in all programs that collect, record, or report demographic data. It is critical to collect these data in a consistent and standardized manner to assess how racism impacts community and individual health. While we aim to align state standards to national standards where possible, specific to race and ethnicity, the CDC v1.0 standard is not inclusive enough and is missing two races that are collected, recorded, and reported in Oregon – Somali and Slavic. We are unclear on the pathway to recommend changes to the CDC standard and if approved the time for the standard to be updated. We encourage ONC to deploy a clear path and forum for states to use when updates to national standards for demographics data are needed.

    OHA ISA Comments on letterhead_.pdf

    Changes to the CDC Standard on Race and Ethnicity

    ONC continues to work with our federal partners on refining standards related to demographic data. This is an area that will continue to evolve over time.

    Difficult to know what the…

    Difficult to know what the CDC specification is: I could find no enumeration of the possible codes in the proposal. This makes it hard to know what is intended and why. Something clearer should be produced before asking respondent to comment. The current OMB is clear regarding the top 5 and the extension The proposal has a lot of content regarding options for entering more than one race (but thought that capability was available in current race specification).

    What Use Case Does LOINC Support?

    What use case does LOINC support that is not currently supportable with existing implementations?  We are concerned about adding additional complexity for implementing an additional value set that does not align.

    This is good.

    This is good.

    Research

    Representing Data for Biomedical and Health Services Research Purposes

    Comment

    On behalf of Wayne Kubick,…

    On behalf of Wayne Kubick, CTO of HL7: "Row 2 includes Pharmacogenomics and medical devices, which, to the best of my knowledge are rarely used or not used at all.  So lumping those with drug trials is inaccurate.  They should separate those out with adoption level 1.

    Row 3 - same comment as above:  Therapeutic Area Standards lists Process Maturity as Final, Implementation maturity as Production.  But, in fact, this refers to a whole series of IGs, some of which are in development as draft, some provisional (not quite final).  It’s not appropriate to lump them together and adopt the most mature value, but you don’t want to separate them out either.  I would change these values to Need Feedback or to some indication the they vary.  The phrase “apply across all therapeutic areas” is not correct.  They haven’t addressed, all, only some."

    On behalf of Wayne Kubick,…

    On behalf of Wayne Kubick, CTO of HL7: "The adoption levels in this section are mostly reasonable.  The exception is row 2 for SDTM. While EVS terminologies for drug trials are generally mature and widely adopted for regulatory submissions, row 2 includes Pharmacogenomics and medical device terminology, which, to the best of my knowledge are rarely used or not used at all.  So lumping those with drug trials is inaccurate.  They should separate those out.  Also, as a comment shows, they don’t really link to the appropriate terminology set — they just link to EVS.  The link should be to the appropriate code set not just the tool." 

    feedback

    Adoption of Sentinel and PCORNet is at least 2 dots. OMOP CDM adoption has increased in 2018 and should be changed to 4 dots. ADaM is an analytical standard but SDTM is not. SDTM is also listed in other parts of ISA. I think SDTM should be removed from the list here completely. Also, I fully agree with other commenter that the task "Representing Analytic Data for Research Purposes" should be defined in preconditions for considerations.  

    If they are talking about…

    If they are talking about research use, then LOINC, RxNorm, SNOMED CT, ICD and CPT should also be listed they are all incuded in OMOP. Believe that LOINC and some of the others are listed are in PCORI and I2B2.

    All claims data bases in the US carry CPT and ICD9/10.

    While mentioning databases I2B2 sHould also be listed 

    Believe OMOP (ODHSI) has the…

    Believe OMOP (ODHSI) has the best of the cross institutional data models. It is in the 3rd or 4th generation. More than 100 institutions have contributed to it. It is international including data sets from the US, Korea and many others. It carries an estimated 400 million distinct patients. Google Scholar asserts 2980 papers mention OMOP.  Think it qualifies as final production and adoption of 3-4 bullets. 

    The adoption level may…

    The adoption level may exaggerate the reality. First, it only applies to a limited context, not analytic data nor all research purposes and FDA submission constraint is not stated. Further, in some contexts the codes are post coordinated using 3-4 fields and are not consistently included.

    Regenstrief - Comment

    This major section is about Vocabularies/Code Systems/Terminology standards. There’s another section for data models or transport/exchange/API standards. As such, this list should be pruned to vocabularies only and the standards for data models, data tabulation models, and other storage/transport specifications should be moved elsewhere.

    The question posed last year remains. What is “analytic data” (besides the obvious “data that can be analyzed”)? How is it different from the other domains of content listed elsewhere? Surely lab data is is analyzed for researched purposes. The mention of the research network (OHDSI, PCORnet, etc) data models not intended to spur their listing here, but rather to illustrate that they have adopted the main vocabularies listed elsewhere in the ISA (e.g. LOINC, SNOMED, RxNorm) for “research purposes”. So it just isn’t clear at all what this interoperability need is really meant for and why it is here. Please clarify with a a better definition and purpose statement.

    This is an example of a…

    This is an example of a poorly crafted interoperability need. What is “analytic data” and which kinds of “research purposes” is this meant to cover? More importantly though is why/how is this need is different from all of the other kinds of content listed elsewhere in the ISA (e.g. Lab tests, medications, diagnoses, etc). Certainly all of the large scale observational research networks (OMOP, Mini Sentinel, OHDSI, PCORnet) have developed common data models that employ many of the same vocabularies (LOINC, SNOMED, ICD) listed elsewhere in the ISA.

    CDISC may be appropriate for…

    CDISC may be appropriate for clinical trials, but is inadequate for a wide variety of other Analytic research.  This area needs more work.

    list non-CDISC standards

    In addition to CDISC standards, AllOfUs project (and many others) are using OMOP Common Data Model to standardize data.

     

    This standard should be added to the list

    Specs are here

    https://github.com/ohdsi/commondatamodel/wiki

     

    OMOP CDM Conformance testing tool is here

    https://github.com/OHDSI/Achilles

     

    cost is free

    adoption: 2 dots

    both maturities are: production/final

     

     

     

    Sex at Birth, Sexual Orientation and Gender Identity

    Representing Patient Gender Identity

    Comment

    ACLA ISA comment re: Representing Gender Identity

    We suggest that if AMA codes are added to the ISA, they should be added in the appropriate category of their use.  For example, 55970 and 55980 as a new Gender Identity section under the existing Procedures category, perhaps with a new “sub-category” added to existing “Dental” and “Medical Procedures” sub-categories. Codes associated with billing functions are more appropriate under the Administrative section.   Current ISA Procedures

    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.

    Pharmacy HIT Collaborative's Comments on ONC's Proposed 2018 ISA

    The Pharmacy HIT Collaborative supports using LOINC and SNOMED CT; however, we ask for clarification as to why HL7 Version 3 Null Flavor was removed for 2018 review; it was added to the final 2017 ISA.  

    Regenstrief - Comment

    We concur with the recommendations on the use of LOINC and SNOMED CT (and null flavor) here. A new concept (and corresponding answer list) request for “Personal pronoun” will be submitted to LOINC and made available in a subsequent release.

    Personal Pronoun Value Set needed

    It is important and respectful to the patient to record their personal pronoun. Establish a value set for personal pronoun and include in transition of care documents.

    standard for preferred pronoun

    Please consider also a standard for preferred pronoun. Assuming gender based on the first name or registered sex and/or gender preference can present challenges to health care providers and their teams. In 2013, the World Professional Association for Trangender Health Electronic Medical Record Workging Group published recommendations for how gender should be recorded in EHRs. These recommendations specify that “Preferred Name, gender identity and pronoun preference, as defined by the patient, be included as demographic variables collected in the EHR.

    https://academic.oup.com/jamia/article/20/4/700/2909343

      AllianceChicago

     

    JAMIA - Transgender Health and EMRs.pdf

    Prounouns and name used are necessary too

    We think that the Applicable Value Set(s) and Starter Set(s) provide appropriate answer options to measure current gender identity. We also encourage the Office of the National Coordinator of Health Information Technology to encourage providers to ask the patient what pronoun and name the patient uses, use that pronoun and name when interacting with the patient, and enter this information into the Electronic Health Record. Knowledge of this information is essential to providing affirming health care to transgender patients.

    Chris Grasso, MPH

    Associate Vice President for Informatics and Data Services

    Fenway Health

     

    Please consider appropriate…

    Please consider appropriate vocabulary for preferred pronoun.  It would be extremely helpful to improve the patient-provider experience.

     

    NCPDP - Comment

    NCPDP currently uses sex/gender values of (M)ale, (F)emale and (U)nknown.  NCPDP is evaluating future modifications to include additional gender identity concepts.

    Representing Patient Sex (At Birth)

    Comment

    NCPDP Comment

    1. NCPDP recommends the addition of Non-Binary as a valid value.

    LOINC has a number of…

    LOINC has a number of observation codes that could appy including sex assigned at birth as suggested by at least 2 commentators.

    46098-0 Sex  74698-2 Sex [AHRQ]  72143-1 Sex [HL7.v3]  21840-4 Sex NAACCR v.11  54131-8 Sex [USSG-FHT]  76689-9 Sex assigned at birth 

    Best Practice Recommendation from American Clinical Lab Assoc.

    The American Clinical Laboratory Association (ACLA) has developed a Best Practice Recommendation for administrative sex and clinical patient gender used for laboratory testing and reporting. Please add the hyperlink below to the "Limitations, Dependencies, and Preconditions for Consideration" section, referencing ACLA's guidance document.

    http://www.acla.com/acla-best-practice-recommendation-for-administrative-and-clinical-patient-gender-used-for-laboratory-testing-and-reporting/

     

    Need Sex Assigned at Birth

    Administrative sex is used to indicate the sex a person has listed with their insurance company. Administrative sex and sex assigned at birth are not always the same. If someone legally changes their sex or the sex listed with their insurance company is different, then their administrative sex and sex assigned at birth no longer align. Therefore, it is necessary to ask both administrative sex and sex assigned at birth to accurately identify all transgender/GenderQueer patients. When insurance companies accept both sex assigned at birth and gender identity, then administrative sex will no longer be necessary.

     

    Chris Grasso, MPH

    Associate Vice President for Informatics and Data Services

    Fenway Health

    Is "Sex at birth" different…

    Is "Sex at birth" different from Administrative Gender collected during registration?  This needs clarification in the industry, as different approaches have been used in multiple places.  It appears that "Sex at birth" has a) been considered a clarification of the meaning of "Administrative Gender", and b) been considered to be a separate demographic.

    Administrative sex is not…

    Administrative sex is not perfectly aligned with "Sex at birth" because at birth an infant can be undifferentiated. In addition, if we want sex recorded on the birth certificate, then many sates allow this to be changed: https://www.lambdalegal.org/know-your-rights/article/trans-changing-birth-certificate-sex-designations And as of January 2017, NY has allowed a person to have "Non-binary" as her birth certificate gender identity, see http://www.pbs.org/newshour/rundown/new-york-city-issues-nations-first-birth-certificate-marked-intersex/

    Representing Patient-Identified Sexual Orientation

    Comment

    The answer list for the…

    The answer list for the LOINC term listed below  System Answer ID 1 Bisexual /snomed.info/sct ©: 42035005 Bisexual (finding)  LA22877-7 2 Heterosexual snomed.info/sct ©: 20430005 Heterosexual (finding)                        LA22876-9  Homosexual //snomed.info/sct ©: 38628009 Homosexual (finding)                    LA22875-1  Other LA46-8 5 Asked but unknown                                                                    LA20384-6  Unknown ://snomed.info/sct ©: 261665006 Unknown (qualifier value) HL7     LA4489-6 

    Not aware that there is as of yet a federal requirement to use any particular list, SNOMED CT or otherwise.  

    Sexual Orienation

    We think that the Applicable Value Set(s) and Starter Set(s) provide appropriate answer options to measure sexual orientation. Knowledge of this information is essential to providing affirming culturally competent health care to lesbian, gay and bisexual patients.

    Chris Grasso, MPH

    Associate Vice President for Informatics and Data Services

    Fenway Health

    Please consider a separate…

    Please consider a separate vocabulary term for asexual, a fairly common category.

    Social, Psychological, and Behavioral Data

    Representing Alcohol Use

    Comment

    NCPDP Comments

    NCPDP supports the use of SNOMED CT.

    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

    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. The SubstanceUse fields will be available in NCPDP SCRIPT Standard Version 2017071 to allow alcohol use information to be transmitted via SNOMED codes.

    NCPDP Comment

    1. Alcohol Use reporting via SNOMED codes is available in the NCPDP SCRIPT Standard Version 2017071.

    Type-Implementation Specification

    Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071

    Standards Process Maturity – Final

    Implementation Maturity- Pilot

    Adoption Level – 1

    Federally Required – No

    Cost – $

    Test Tool Availability – Yes.

    Since this LOINC code and…

    Since this LOINC code and answer set has been developed (30 behavior and functional status variables suggested by the IOM report and adopted for requirement in the last MU NPRM), the adoption level could now be very high.

    NCPDP - Comments

    SNOMED – Not currently used in NCPDP MMA mandated standards. Future versions of the NCPDP SCRIPT standard support SNOMED.

    Consider adding additional screening tools

    The Joint Commission currently has 3 chart-abstracted quality measures screening for alcohol use and treatment (SUB-1, SUB-2/2a, and SUB-3/3a) that are used by The Joint Commission and CMS in quality reporting programs.  We agree with inclusion of the Audit-C, as that is a validated screening tool for unhealthy alcohol use.  However, we also think that the AUDIT tool should be included as well.  This tool is also a validated survey instrument, and seems to be the most commonly used one for our chart-abstracted measures.  LOINC currently has 72110-0 Alcohol Use Disorder Identification Test [AUDIT] and 75624-7 Total Score [AUDIT].  In order for use, the rest of the questions from the survey instrument would need to be added in LOINC as well as the LOINC answer lists.

    AUDIT 10-question panel

    Thank you for your comment.  We have added the full AUDIT panel code and the total score code.  This does not imply any requirement for an EHR or other health IT system to capture the AUDIT test questions or total score, but we recognize that this test may currently be in use.

    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 specifically identifies the screening of a patient within a behavioral assessment for depression.  CPT code 99483 includes an assessment for depression within the cognitive care plan.  These identified CPT codes were designed based on objective criteria for evaluating and assessing the severity and co-morbidities associated with the assessment and treatment of depression that should be listed as a standard for this interoperability need. 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.

    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.

    General comment on social, psychological, and behavioral data

    The American Medical Association appreciates the opportunity to comment. Coding systems like SNOMED CT are designed to capture granular clinical data accurately. While it is possible to convert granular clinical data to ICD-10-CM (e.g., SNOMED CT -> ICD-10-CM), the reverse (e.g., ICD-10-CM -> SNOMED CT) is not reliable. Where ICD-10-CM may be the best choice to meet specific needs (e.g., public health reporting or administrative forms for payors), there are means whereby ICD-10-CM codes can be computed from the more specific clinical data provided by code systems like SNOMED CT. For these reasons, where there are established (legacy) code systems, we should continue to support them. However, where possible, we should also consider the graceful evolution to codings systems (e.g., SNOMED CT) that more accurately support granular clinical data.

    Since this LOINC code and…

    Since this LOINC code and answer set has been developed (30 behavior and functional status variables suggested by the IOM report and adopted for requirement in the last MU NPRM), the adoption level could now be very high.

    Representing Drug Use

    Comment

    NCPDP Comments

    NCPDP supports the use of SNOMED CT.

    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.

    Since this LOINC code and…

    Since this LOINC code and answer set has been developed (30 behavior and functional status variables suggested by the IOM report and adopted for requirement in the last MU NPRM), the adoption level could now be very high.

    Additional questions needed

    Additional questions needed 

    Exposure to firearms, I do not see a viable code set for this. It should be a single question and answer

    Has the patient or significant other been incarcerated?

    We applaud adding Social Determinates being added to ISA.

    Re: patient/significant…

    Re: patient/significant other been incarcerated: may be a privacy concern about this one, though, would likely have predictive value.

    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.

    Since this LOINC code and…

    Since this LOINC code and answer set has been developed (30 behavior and functional status variables suggested by the IOM report and adopted for requirement in the last MU NPRM), the adoption level could now be very high.

    Regenstrief - Comment

    Although there are many ways to record or observe physical activity, we agree that LOINC is the appropriate terminology for these observations and that the “exercise vital sign” screen is a good starting place.

    In version 2.64, LOINC published a slightly updated panel (89574-8) for the EVS that reflects Kaiser Permanente’s conceptualization of these screening observations. The two child elements in this panel are 89555-7 and 68516-4.

    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.

    Since this LOINC code and…

    Since this LOINC code and answer set has been developed (30 behavior and functional status variables suggested by the IOM report and adopted for requirement in the last MU NPRM), the adoption level could now be very high.

    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.

    Since this LOINC code and…

    Since this LOINC code and answer set has been developed (30 behavior and functional status variables suggested by the IOM report and adopted for requirement in the last MU NPRM), the adoption level could now be very high.

    LOINC cited is insufficient

    76542-0 is stated to be Occupational Stress Questionnaire.  Stress has multiple causes, Occupational, Personal, etc.  This needs exploration and better difinition   

    76542-0

    Do you feel stress - tense, restless, nervous, or anxious, or unable to sleep at night because your mind is troubled all the time - these days [OSQ]

    supplemental LONIC suggestion 

    66578-6

    Now thinking about your mental health, which includes stress, depression, and problems with emotions, for how many days during the past 30 days was your mental health not good [HRQOL]

     

    This is the specific one…

    This is the specific one chosen (from a Finnish survey instrument by the IOM report and required by ONC), it is what is in there.

    Representing Transportation Insecurity

    Comment

    Oregon Health Authority ISA Comments

    Oregon is pursuing multiple approaches to address unmet needs related to SDOH. We support the inclusion of standards for representing housing insecurity, representing food insecurity, and representing transportation insecurity. Although PRAPARE is one commonly used screening tool, other validated tools also are in widespread use. We encourage the inclusion of coding for additional screening tools as available, building on the work of the Gravity Project.

    OHA ISA Comments on letterhead__0.pdf

    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

    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.

    Tobacco Use

    Representing Patient Electronic Cigarette Use (Vaping)

    Comment

    WA State Department of Health Tobacco/Smoking/Vaping Comments

    In 2018, e-cigarette products with nicotine concentrations of five percent or greater comprised approximately two-thirds of the e-cigarette market, while zero-nicotine products accounted for less than one percent.[1] To more accurately assess nicotine intake and potential nicotine dependence among patients, Washington State Department of Health recommends distinguishing e-cigarette use by nicotine concentration, rather than e-cigarette liquid with nicotine versus e-cigarette liquid without nicotine. Additionally, Washington State Department of Health concurs with the recommendation submitted on September 19, 2018 by Dr. Michael Fiore and Robert Adsit to implement non-overlapping values for smoking status. [1] Romberg AR, Miller Lo EJ, Cuccia AF, Willet JG, Xiao H, Hair EC . . . King BA (2019). Patterns of nicotine concentrations in electronic cigarettes sold in the United States, 2013-2018, Drug and Alcohol Dependence, 203, 1-7. doi:10.1016/j.drugalcdep.2019.05.029.

    WA State Department of Health Tobacco/Smoking/Vaping Comments

    In 2018, e-cigarette products with nicotine concentrations of five percent or greater comprised approximately two-thirds of the e-cigarette market, while zero-nicotine products accounted for less than one percent.[1] To more accurately assess nicotine intake and potential nicotine dependence among patients, Washington State Department of Health recommends distinguishing e-cigarette use by nicotine concentration, rather than e-cigarette liquid with nicotine versus e-cigarette liquid without nicotine. Additionally, Washington State Department of Health concurs with the recommendation submitted on September 19, 2018 by Dr. Michael Fiore and Robert Adsit to implement non-overlapping values for smoking status. [1] Romberg AR, Miller Lo EJ, Cuccia AF, Willet JG, Xiao H, Hair EC . . . King BA (2019). Patterns of nicotine concentrations in electronic cigarettes sold in the United States, 2013-2018, Drug and Alcohol Dependence, 203, 1-7. doi:10.1016/j.drugalcdep.2019.05.029.

    NCPDP Comments

    Modify NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 Adoption Level to 5.

    Removed Reference

    Removed “See LOINC projects in the Interoperability Proving Ground” since LOINC has been removed from the Standards in this section.

    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

    WA State Department of Health Tobacco/Smoking/Vaping Comments

    In 2018, e-cigarette products with nicotine concentrations of five percent or greater comprised approximately two-thirds of the e-cigarette market, while zero-nicotine products accounted for less than one percent.[1] To more accurately assess nicotine intake and potential nicotine dependence among patients, Washington State Department of Health recommends distinguishing e-cigarette use by nicotine concentration, rather than e-cigarette liquid with nicotine versus e-cigarette liquid without nicotine. Additionally, Washington State Department of Health concurs with the recommendation submitted on September 19, 2018 by Dr. Michael Fiore and Robert Adsit to implement non-overlapping values for smoking status.   [1] Romberg AR, Miller Lo EJ, Cuccia AF, Willet JG, Xiao H, Hair EC . . . King BA (2019). Patterns of nicotine concentrations in electronic cigarettes sold in the United States, 2013-2018, Drug and Alcohol Dependence, 203, 1-7. doi:10.1016/j.drugalcdep.2019.05.029.

    WA State Department of Health Tobacco/Smoking/Vaping Comments

    In 2018, e-cigarette products with nicotine concentrations of five percent or greater comprised approximately two-thirds of the e-cigarette market, while zero-nicotine products accounted for less than one percent.[1] To more accurately assess nicotine intake and potential nicotine dependence among patients, Washington State Department of Health recommends distinguishing e-cigarette use by nicotine concentration, rather than e-cigarette liquid with nicotine versus e-cigarette liquid without nicotine. Additionally, Washington State Department of Health concurs with the recommendation submitted on September 19, 2018 by Dr. Michael Fiore and Robert Adsit to implement non-overlapping values for smoking status.   [1] Romberg AR, Miller Lo EJ, Cuccia AF, Willet JG, Xiao H, Hair EC . . . King BA (2019). Patterns of nicotine concentrations in electronic cigarettes sold in the United States, 2013-2018, Drug and Alcohol Dependence, 203, 1-7. doi:10.1016/j.drugalcdep.2019.05.029.

    NCPDP Comments

    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 – 5 Federally Required – Yes Cost – $ Test Tool Availability – Yes
    1. Include Test Tool Link: https://tools.ncpdp.org/erx/#/home

    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)