1. Continued discussion on Section I: Best Available Vocabulary/Code Set/Terminology Standards and Implementation Specifications 2015 Interoperability Standards Advisory July 30, 2015 Interoperability Standards Advisory Task Force Meeting Mark Roche, MD – comments in orange.

2. SECTION I DISCUSSION: Best Available Vocabulary/Code Set/Terminology Standards and Implementation Specifications 1

3. Allergic Reactions Allergens MRoche: – The title of the slide was inconsistent with the content of the slide. Allergic Reaction is clinical manifestation of an adverse event triggered by a drug/substance/ ingredient…etc. – The slides discusses AE/allergy-causing substances and not allergic reactions. Proposed: SNOMED-CTSNOMED-CT Public comments: – Recommend grouping all allergies together – General support for SNOMED-CT Workgroup Discussion (7/16) – The ISA needs to clearly differentiate between standards for allergic reactions versus the allergen (the substance creating the reaction). Mroche: Suggest deleting this. This has already been clarified and clarification is visible in C-CDA and many other standards. – The attributes for the type of allergen (medication vs food vs environmental) which caused the allergic reaction needs to be discretely captured and linked for improved clinical decisions and to see the different types of allergens creating the reactions. – The ISA should advise on the standards ability to qualify the allergic reactions in regards to severity and criticality. – Consistency and constraints in vocabulary implementations needs to be articulated clearly for allergen concept as there are currently complex cascades of vocabularies for medications and no current regulatory vocabularies for food or environmental allergens. – ISA should make available the big 8 contributors of the most critical food allergens to encourage developers to start semantically defining in structured fields. For example, FDA has stated, “1. (A) eight major foods or food groups--milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans-- account for 90 percent of food allergies.” See Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282, Title II): http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106187.htmhttp://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106187.htm – (Mroche: Suggest adding following) – Suggest refining Allergen codes that are being used in existing Implementation Guides such as C-CDA, and ensure that the use of Allergen codes is consistent across standards required for EHR certification. 2

4. Allergens MRoche: Most current value set for Allergens is “Substance-Reactant for Intolerance” 2.16.840.1.113762.1.4.1010.1 This value set is quite general and includes concepts that may never cause an adverse event, particularly the included SNOMED CT concepts. The code system- specific value sets in this grouping value set are intended to provide broad coverage of all kinds of agents, but the expectation for use is that the chosen concept identifier for a substance should be appropriately specific and drawn from the available code systems in the following priority order: NDFRT, then RXNORM, then UNII, then SNOMED CT. This overarching grouping value set is intended to support identification of drug classes, individual medication ingredients, foods, general substances and environmental entities. The value set constists of following code subsets: – Medication Drug Class (2.16.840.1.113883.3.88.12.80.18) (NDFRT drug class codes) – Clinical Drug Ingredient (2.16.840.1.113762.1.4.1010.7) (RxNORM ingredient codes) – Unique Ingredient Identifier - Complete Set (2.16.840.1.113883.3.88.12.80.20) (UNII ingredient codes) – Substance Other Than Clinical Drug (2.16.840.1.113762.1.4.1010.9) (SNOMED CT substance codes). 3

5. Care Team Member Proposed: National Provider Identifier (NPI)National Provider Identifier (NPI) Public comments: – NPI not inclusive of all care team members/other provider types – Identification of need for identifier that encompasses broader array of care team members. Workgroup Discussion (7/16) – The objective of the curating and maintaining a list of all the care team members needs to be defined. – The codification system would need to be able to delineate care team members by role and others such as groups, institutions, labs, suppliers etc.. – One potential option discussed for codifying the care team members is through the National Provider Identifier (NPI) which has been adopted by certain healthcare team members but not all and is required by Medicare as a HIPAA Administrative Simplification Standard. However, it is unclear if the NPI will be able to delineate care team members by role and meet the needed objectives. MRoche: – NPI number has no intrinsic meaning. It does not contain any embedded information on the type/role of healthcare provider. – Suggest clarifying which care team members are not included by NPI. – NUCC code system is already in use in C-CDA and it provides over 800 categories of health provider (e.g. Acupuncturist, Registered Nurse, etc.). 4

6. Ethnicity Proposed: [R] OMB standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, Oct 30, 1997[R] OMB standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, Oct 30, 1997 Related question: Should more detailed value sets for race and ethnicity be identified as a standard or implementation specification? Public Comments: – OMB standards do not align with IOM report. – More detailed granularity is needed. – Possible alternatives include: CDC Race & Ethnicity Code SetCDC Race & Ethnicity Code Set Workgroup Discussion (7/16): – The use case for the need for Race and Ethnicity needs to be defined as the OMB Standard may be suitable for statistical or epidemiologic purposes but may not be adequate in the pursuit of precision medicine and directing therapy or clinical decisions – The standard should allow for multiple races and ethnicity's to be chosen. MRoche: – CDC Race & Ethnicity Code Set is already used in C-CDA as core code system both for Race and Ethnicity. – CCDA R2 already allows multiple races to be documented for the same patient. – Suggest reviewing all existing code subsets for Race and Ethnicity in use across all MU standards and aligning these. Suggest that duplicative or incomplete value sets be discontinued from use. 5

7. Food Allergies Question: Should “Food allergies” be included as a purpose in this document or is there another approach for allergies that should be represented instead? Are there standards that can be called “best available” for this purpose? Public Comments: – Group all allergies together – Some support for exploring SNOMED-CT for this purpose. – Comments related to C-CDA use of UNII for non-medication allergies Mroche: See slide for “Allergens”. – Code systems for capturing allergens are overlapping For example, RxNorm, UNII, and SNOMED CT contain codes for peanut allergen. – Current recommendation for Allergen codes is to use value set developed for CCDA R2, which favors following code systems in the order of their appearance: RxNorm, NDF-RT, UNII, SNOMED CT. Suggest that organizations who maintain those systems discuss together how best to clarify the boundaries and use of codes for food and other ingredients. 6

8. Immunizations Administered Proposed: National Drug Codes (NDC)National Drug Codes (NDC) Related Question: Public health stakeholders have noted the utility of NDC codes for inventory management as well as public health reporting when such information is known/recorded during the administration of a vaccine. Should vaccines administered be listed as a separate purpose with NDC as the code set? Public Comments: – Recommend alternative of RxNorm codes or CVX/MVX – Notes that NDC codes should not be used as they can change meaning over time or be re-used by manufacturers, although some supportive comments for NDC use. – Some recommendations to group administered and historical vaccinations together, including CVX/MVX and NDC codes for each entry. Mroche: – CVX code system is currently required in CCDA to capture info about vaccines administered, with suggested support for RxNorm codes. Suggest keeping this requirement unless there is demonstrated need to use other code systems. 7

9. Industry and Occupation Question: Is there a best available standard to represent industry and occupation that should be considered for inclusion in the 2016 Advisory? Public comments: – Numerous comments recommend U.S. Department of Labor Standard Occupational Classification (SOC) codes – Several also reference National Uniform Claim Committee Health Care Taxonomy (NUCC) codes, but not limited use outside of healthcare. – Others mentioned include: National Institute for Occupational Safety and Health (NIOSH) list (which includes an Industry and Occupation Computerized Coding System (NIOCCS), International Standard Classification of Occupations (ISCO), exploring possible use of SNOMED-CT for this purpose. MRoche: – IG for cancer reporting to CDC did create two code sets that explicitly capture occupation and industry info as part of person’s employment history. Industry CDC Census 2010 Occupation CDC Census 2010 8

10. Lab Tests Proposed: [R] LOINC [R] LOINC Public comments: – Recommend breaking out two purposes for lab orders and lab results – Mixed opinions on standards to be used, with some recommending use of LOINC for orders/results, some recommending use of LOINC for order and SNOMED-CT for results. – Other comments related to LOINC / local code usage. Mroche: – Lab Tests are already split in CCDA. If Lab test is ordered, this is considered a Procedure, which can be captured using LOINC or SNOMED CT. Lab Test results are required to use LOINC to identify lab test. SNOMED CT is used for microorganism result reporting. 9

11. Medications Proposed: [R] RxNormR] RxNorm Public comments: – Medication History is missing – could reference NCPDP SCRIPT v 10.6 – Consider adding medical cannabis as medication to RxNorm so all medications can be included in medication list. – 2015 Edition Certification Criteria proposes to adopt NLM Feb 2, 2015 Release. Mroche: – Medication History is already part of CCDA (Medication Section), every medication info can capture medication start and medication end date. – Users should update RxNorm on a monthly basis and use the most recent version of the code system. – Re medical cannabis, RxNorm already contains 3 codes for cannabis as Ingredients: “CANNABIS SATIVA SEED OIL”, “Cannabis sativa seed extract” and “Cannabis sativa subsp. flowering top extract”. Suggest reaching out to NLM to add specific formulations of cannabis to RxNorm. 10

12. Medication Allergies Proposed: [R] RxNorm [R] RxNorm Public comments: – Some support for RxNorm as best standard for medication allergies, with SNOMED-CT as terminology also referenced. – Recommend grouping of all allergies together by several. – One commenter recommends using Allergies for only medication, and moving others to problem/diagnosis. See “Allergen” slides – RxNorm is principal terminology for documenting drug allergies in CCDA. However, users can use NDF-RT, UNII and SNOMED CT as well. – Recommend further clarifying value set for Allergen in CCDA and providing clear guidance and rules on which code systems to use for which allergen type. 11

13. Numerical References and Values Proposed: The Unified Code of Units of MeasureThe Unified Code of Units of Measure Public comments: – Broad support for UCUM for this purpose. – Name for this purpose should be changed to “Units of Measure” (for use w/ numerical references and values). – Notes that issues with UCUM in laboratory domain remain unresolved with recommendation for ONC to convene a summit to resolve. – Note regarding use of case sensitivity in UCUM to avoid ambiguity. Mroche: – UCUM codes are case sensitive to ensure clarity in interpretation. – Which issues are being raised about UCUM? 12

14. Patient “Problems” (i.e., conditions) Proposed: [R] SNOMED-CT [R] SNOMED-CT Public comments: – Note that large terminologies are often difficult to implement/maintain and recommendation for ONC to provide clear guidance on what subsets of terminology are appropriate for each purpose. Mroche: – Implementation guides currently in MU provide SNOMED CT code subset for encoding “Problem”. 13

15. Procedures (medical) Proposed: [R] SNOMED-CT, the combination of CPT- 4/HCPCS, and [R] ICD-10-PCS [R] SNOMED-CTCPT- 4HCPCS [R] ICD-10-PCS Public comments: – General support for this purpose and standards identified. – Note that CPT-4 codes are used for administrative (billing) purposes, so are out of scope/should be removed. – Encouragement for consideration for cost, openness and administration burden of licensing with use of proprietary terminologies are specified as standards. Mroche – Suggest creating subset of SNOMED CT codes for Procedures, since SNOMED CT code system contains many other codes beside procedure codes. 14

16. Race Proposed: [R] OMB standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, Oct 30, 1997. [R] OMB standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, Oct 30, 1997. Public Comments: – Greater level of detail/specificity is needed for race/ethnicity than OMB code set provides. – Numerous recommendations to use CDC Race & Ethnicity Code SetCDC Race & Ethnicity Code Set – Several recommendations to explore us of SNOMED-CT Mroche: – CDC REC is already being used throughout MU. – Some CDC REC code subsets were created to satisfy OMB reporting requirements, while others contain a list of ~900 race codes that can also be used. – Suggest identifying list of all CDC REC value sets, and pruning out duplicates and overlaps. 15

17. Smoking Status Proposed: [R] SNOMED-CT [R] SNOMED-CT Public Comments: – Concerns that smoking stats values do not appear to be harmonized with quality measures or Joint Commission reporting requirements. – Recommend adding a purpose of substance use that can be exchanged via standards such as NCPDP SCRIPT including substance type (i.e. tobacco, alcohol, cannabis), level of use, and route of administration. Mroche: – Eight SNOMED CT codes are used for reporting smoking history. These codes do not have level of precision to describe number of units smoked per day, unit name, tobacco type, frequency and duration (e.g. smokes 1 pack of cigarettes per day for the last 5 years). 16

18. Unique Device Identification Proposed: [R] Unique device identifier as defined by the Food and Drug Administration at 21 CFR 830.3 [R] Unique device identifier as defined by the Food and Drug Administration at 21 CFR 830.3 Public Comments: – Support for this purpose and standard. – One recommendation to also use the HL7 developed Harmonization Pattern for Unique Device Identifiers, November 13, 2014 as the implementation guide.Harmonization Pattern for Unique Device Identifiers, November 13, 2014 Mroche: – Suggest capturing UDI information in distinct fields across standards used for MU (and HIE). Currently, UDI is communicated as a string in one field, meaning that every sender and receiver need to have and maintain algorithm to “de-crypt” string meaning into distinct informational components. 17