Submitted by nedragarrett_CDC on 2022-09-29
| Submitted By: Maria Michaels / CDC | |
|---|---|
| Data Element Information | |
| Rationale for Separate Consideration | USCDI data element is "Medication". In FHIR US Core, there is a distinction between "Medication" and "Medication Request"; base FHIR has "Medication Administration". Both concepts, prescribed and administered, should be explicitly included in USCDI. |
| Use Case Description(s) | |
| Use Case Description | Actively monitoring diseases, making decisions about public health threats, identifying trends in healthcare services utilization and other public health matters depend on accessible and accurate data. EHRs are a data source that can provide timely and relevant data beyond its use by health care providers. EHR data, if made more available for public health professionals and researchers, can lead to more rapid disease detection, tracking, and treatment and innovation in healthcare delivery. Medication information, including the date the medication is prescribed or administered, coded identification, and dosage of the medication prescribed or administered are important to multiple public health reporting and research use cases to track and analyze information about treatment for various health conditions. The reason code for the medication provides information to identify which particular condition the medication was used to treat. The Making EHR Data More Available for Research and Public Health (MedMorph) project's goal is to create a reliable, scalable, and interoperable method to get electronic health record data for multiple public health and research scenarios (use cases). MedMorph has identified Cancer Registry Reporting, Healthcare Surveys, Electronic Initial Case Reporting (eCR), Hepatitis C Reporting, and Research (PCORnet) use cases that support the adoption of some or all of these data elements. These specific use cases are described in more depth on their respective web pages. |
| Estimated number of stakeholders capturing, accessing using or exchanging | All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements. All hospitals and physicians who diagnose or treat cancer are required to provide cancer related medication (treatment) information to state cancer registries. Approximately 620,000 physicians in the US are active and have at least some component of ambulatory practice and thus are annually eligible to sampling and recruitment into the National Ambulatory Medical Care Survey (NAMCS), which samples from between 3,500 to 20,000 of these physicians annually. Presently each sampled physician submits one weeks' worth of patient encounters to NAMCS. Approximately 600 hospitals are in the National Hospital Care Survey (NHCS). 1/3 of that number are either in, or actively being recruited into, the EHR data submission mode for NHCS. NHCS is already receiving electronic CDA documents. When they reach their target of 200 hospitals submitting by this mode annually they will be receiving >1.2 million documents and sets including multiple sets of medication data annually. There were approximately 1,000,000 practicing physicians (as of 2020), approximately 120,000 certified physician assistants (as of 2019), and 290,000 licensed nurse practitioners (as of 2019). Most of these licensed clinicians interact with one of these public health use cases intermittently, annually. As of 2018, AHA reported 6,146 hospitals in the US experiencing 36,353,946 admissions. Almost all of those hospitals and at least half of the admissions interact with one or more of the public health use cases. The vast majority of these exchanges include full sets of medication data, including the data elements requested for USCDI consideration here. Supporting Links: MedMorph: https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html Cancer Reporting: https://www.cdc.gov/cancer/npcr/ Hepatitis C Reporting: https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf Health Care Survey: https://www.cdc.gov/nchs/dhcs/nhcs_registry_landing.htm eCR: https://www.cdc.gov/ecr/index.html PCORnet: https://pcornet.org/ |
| Link to use case project page | https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html Cancer Reporting: https://www.cdc.gov/cancer/npcr/ Hepatitis C Reporting: https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf |
| Supporting Attachments |
MedMorph-HealthCareSurveyReportingUseCase-DRAFT.pdf MedMorph-CancerReportingUseCase-DRAFT.pdf MedMorph-ChronicHepatitisCSurveillanceUseCase-DRAFT.pdf |
| Use Case Description | A foundational goal of MedMorph is generalizability beyond the 10 use cases that are actively informing the MedMorph project, in order to support many more public health and research use cases. Therefore, other public health and research use cases that use the MedMorph architecture will also benefit from adoption of these data elements. |
| Estimated number of stakeholders capturing, accessing using or exchanging | All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements. All hospitals and physicians who diagnose or treat cancer are required to provide cancer related medication (treatment) information to state cancer registries. Approximately 620,000 physicians in the US are active and have at least some component of ambulatory practice and thus are annually eligible to sampling and recruitment into the National Ambulatory Medical Care Survey (NAMCS), which samples from between 3,500 to 20,000 of these physicians annually. Presently each sampled physician submits one weeks' worth of patient encounters to NAMCS. Approximately 600 hospitals are in the National Hospital Care Survey (NHCS). 1/3 of that number are either in, or actively being recruited into, the EHR data submission mode for NHCS. NHCS is already receiving electronic CDA documents. When they reach their target of 200 hospitals submitting by this mode annually they will be receiving >1.2 million documents and sets including multiple sets of medication data annually. There were approximately 1,000,000 practicing physicians (as of 2020), approximately 120,000 certified physician assistants (as of 2019), and 290,000 licensed nurse practitioners (as of 2019). Most of these licensed clinicians interact with one of these public health use cases intermittently, annually. As of 2018, AHA reported 6,146 hospitals in the US experiencing 36,353,946 admissions. Almost all of those hospitals and at least half of the admissions interact with one or more of the public health use cases. The vast majority of these exchanges include full sets of medication data, including the data elements requested for USCDI consideration here. |
| Healthcare Aims |
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| Maturity of Use and Technical Specifications for Data Element | |
| Applicable Standard(s) | Date Medication Prescribed and Date Medication Administered: dateTime Data Type (FHIR): http://hl7.org/fhir/datatypes.html#dateTime Medication Prescribed Code and Medication Administered Code: RxNorm: https://www.nlm.nih.gov/research/umls/rxnorm/index.html Medication Prescribed Dose Units and Medication Administration Dose Units: UCUM: http://unitsofmeasure.org http://hl7.org/fhir/datatypes.html#dateTime https://www.nlm.nih.gov/research/umls/rxnorm/index.html http://unitsofmeasure.org |
| Additional Specifications | HL7 CDA ® Release 2 Implementation Guide: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1, DSTU Release 1.1 – US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=398. SHALL for the following elements: Date Medication Administered, Medication Administered Code, Medication Administered Reason Reference, Medication Administration Dose. SHOULD for the following elements: Medication Administration Dose Units HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=385 HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes - US Realm (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492). SHALL for the following elements: Date Medication Administered, Medication Administered Code, Medication Administered Reason Reference, Medication Administration Dose. SHOULD for the following elements: Medication Administration Dose Units HL7 FHIR® US Core Implementation Guide STU3 Release 3.1.1 (https://www.hl7.org/fhir/us/core/index.html) HL7 FHIR US Core Medication Request (http://hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html). MustSupport for the following elements: Medication Prescribed Code, Medication Prescribed Dose, Medication Prescribed Dose Units HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) - US Realm (http://hl7.org/fhir/us/ecr/STU1/Electronic_Initial_Case_Report_(eICR)_Transaction_and_Profiles.html) HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm - the Electronic Initial Case Report (eICR) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436) |
| Current Use | Extensively used in production environments |
| Supporting Artifacts |
Level 2 – at scale, or in more widespread production use (routinely collected already) on several different EHR/HIT systems. Widely available in EHR systems. These data elements exist in FHIR with a FHIR Maturity level of 2 for MedicationAdministration and 3 for MedicationRequest. FHIR MedicationAdministration: http://hl7.org/fhir/medicationadministration.html. FHIR MedicationRequest: http://hl7.org/fhir/medicationrequest.html. ONC Interoperability Standards Advisory - Sending Health Care Survey Information to Public Health Agencies: https://www.healthit.gov/isa/sending-health-care-survey-information-public-health-agencies. Part of Core EHR Certification since at least 2014. Specified in Meaningful Use/Promoting Interoperability since Stage 1. Part of EHR Certification for Transmission to Cancer Registries (2015 and 2014 Editions). Promoting Interoperability Programs Eligible Hospitals and Critical Access Hospitals are required to, and Merit-based Incentive Payment System (MIPS) participants may optionally, report on any two measures under the Public Health and Clinical Data Exchange objective of these programs. The § 170.315(f)(5) – Transmission to public health agencies – electronic case reporting certification criteria in the 2015 Edition Final Rule and the ONC Cures Act Final Rule, the § 170.315(f)(7) – Transmission to public health agencies – health care surveys, and the § 170.315 (f)(4) – Transmission to Cancer Registries are three such options to meet these measures. The current standard for § 170.315(f)(5), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7® CDA® R2 Implementation Guide: Public Health Case Report, Release 2: the Electronic Initial Case Report (eICR), Release 1, STU Release 1.1. ONC’s Certified Health IT Product List (CHPL) lists 73 EHR or HIT Module products certified to (f)(5) using this standard. eCR IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436. The current standard for § 170.315(f)(7), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 DSTU Release 1.2 - US Realm. ONC’s Certified Health IT Product List (CHPL) lists 116 EHR or HIT Module products certified to (f)(5) using this standard. NHCS IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=385. The current standard for § 170.315 (f)(4), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7 CDA® R2 IG: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, R1, DSTU Release 1.1 - US Realm. ONC’s Certified Health IT Product List (CHPL) lists 288 EHR or HIT Module products certified to (f)(4) using this standard. Cancer Reporting IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=398. These three widely adopted CDA standards have many of the Medication data elements contained on this form as Shall (required) or Should (best practice to include if available) conformance criteria, which demonstrates the maturity of these commonly exchanged data elements. Supporting Links: EPIC Medication Request API: https://fhir.epic.com/Specifications?api=996 Cerner Medication Request API: https://fhir.cerner.com/millennium/r4/medications/medication-request/ Allscripts API: https://developer.allscripts.com/FHIR?PageTitle=Resources Evident API: https://api.evident.com/dstu2/medication-order Cancer Test Procedures: https://www.healthit.gov/test-method/transmission-cancer-registries#test_procedure 2014 Edition Test Methods: https://www.healthit.gov/sites/default/files/2014_test_methods/2014_edition_test_methods_archived.zip http://hl7.org/fhir/medicationadministration.html FHIR MedicationRequest: http://hl7.org/fhir/medicationrequest.html EPIC Medication Request API: https://fhir.epic.com/Specifications?api=996 |
| Number of organizations/individuals with which this data element has been electronically exchanged | 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders. |
| Supporting Artifacts |
Level 2 – exchanged between 4 or more different EHR/HIT systems. More routinely exchanged between multiple different systems can justify adding to the next draft version. At least 38 state cancer registries have received cancer reports from at least one provider (per internal technical and programmatic documentation) that include these data elements: Date Medication Prescribed, Medication Prescribed Code, Medication Prescribed Dose, Medication Prescribed Dose Units, Date Medication Administered, Medication Administered Code, Medication Administration Dose, and Medication Administration Dose Units. HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436) - the Electronic Initial Case Report (eICR) is currently implemented in 5,400+ reporting sites nationally and exchanges all the Medication described in this submission. As part of Cancer Reporting CDA IGs: IHE Connectathons 2010-2020 HIMSS Interoperability Showcase 2010-19 Public Health Informatics Conference Interoperability Showcase 2014, 2016, 2018 NACCHO 360X Interoperability Demonstrations, 2020 As part of National Health Care Surveys CDA IGs: IHE Connectathons 2019-2020 ONC Interoperability Standards Advisory - Sending Health Care Survey Information to Public Health Agencies: https://www.healthit.gov/isa/sending-health-care-survey-information-public-health-agencies. Supporting Links: https://chpl.healthit.gov/#/search: 170.315 (f)(4): Transmission to Cancer Registries Retired | 170.314 (f)(5): Optional - ambulatory setting only - cancer case information Retired | 170.314 (f)(6): Optional - ambulatory setting only - transmission to cancer registries) IHE Connectathon: https://connectathon-results.ihe.net/ https://chpl.healthit.gov/#/search |
| Potential Challenges | |
| Restrictions on Standardization (e.g. proprietary code) | None |
| Restrictions on Use (e.g. licensing, user fees) | None |
| Privacy and Security Concerns | None |
| Estimate of Overall Burden | Low. All providers need to capture medication prescription and administration information as a basic component of patient care. Several existing IGs, as listed, require the exchange of this data element. The Promoting Interoperability Programs Objective 8 - Public Health and Clinical Data Registry Reporting, Measures 1: Immunization Registry Reporting, 2: Syndromic Surveillance Reporting, 3: Electronic Case Reporting and 4: Public Health Registry Reporting all require these data elements. This information is routinely communicated in HL7 CDA Documents and some FHIR API transactions. |
| Other Implementation Challenges | None |
Submitted by Svellanky on 2022-09-29
CMS/CDC Joint USCDIv4 Priority: Medication Prescribed Code
CMS urges adding more specificity to the USCDI Medications Data Class as interoperability of medication information and management of medications is critical to patient care and coordination between providers, as well as related quality and public health enterprises—we continue to support the concept of a USCDI Task Force to appropriately specify and advance this important data class. The highlighted additional data elements serve the ONC USCDI v4 stated priorities related to mitigating health inequities and disparities, addressing needs of underserved populations, and addressing public health reporting needs. Specifically, these medication data elements are necessary for understanding adverse drug events, opioid use and misuse, and medication access. The current concept of medications in USCDI does not differentiate among medications that are active, ordered, and actually administered/dispensed to the patient. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care. These detailed medication data were also previously identified as a joint CMS-CDC priority area as they are used extensively in quality measurement and public health —for example, to monitor and respond to antibiotic prescribing patterns that facilitate the emergence of drug-resistant pathogens, but also exposes patients to needless risk for adverse effects. They are also routinely exchanged when prior authorization is required. Maturity: These elements are classified as Level 2 by ONC and continues to have strong standardization and be in wide use.