Non-imaging and non-laboratory tests performed that result in structured or unstructured findings specific to the patient to facilitate the diagnosis and management of conditions.
The name of the non-imaging or non-laboratory test performed on a patient.
Submitted By: Joel Andress
/ Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ)
Data Element Information
Use Case Description(s)
Use Case Description
Diagnostic studies and exams performed with results are key data elements currently used in CMS eCQMs across hospital and clinician reporting programs. These data are necessary to confirm appropriate care is received for patients across different populations. Similar to labs and vital signs, it is clinically relevant from a care perspective and a quality measurement perspective to have access to and use diagnostic study/exam results for care decision making. This information can support surveillance of appropriate use and adherence to care guidelines for value-based care of patients.
Diagnostic study/exam concepts represented in measures include and eye/disc/macular exams and ejection fraction studies. Results for these types of studies and exams are available in structured fields and exchanged for quality measurement purposes.
Estimate the breadth of applicability of the use case(s) for this data element
1 million providers currently capture, access and exchange this diagnostic study/exam information. This information is currently electronically submitted by providers and hospitals to CMS for quality measurement purposes, including QPP.
eCQI resource center, includes measure specifications for CMS program eCQMs (i.e. CMS 143, 135): https://ecqi.healthit.gov/ecqms
Data exchange of diagnostic study/exam information is critical for clinical care. Clinician’s need to be aware of recent tests completed to both ensure the patient is receiving appropriate care and reduce duplicity which drives up healthcare costs.
Diagnostic study and exam information including studies/exams performed, result, and the type of test completed via standard terminology can be exchanged via C-CDA for patient care coordination.
Estimate the breadth of applicability of the use case(s) for this data element
Majority or hospital and clinical providers are capturing, accessing and exchanging this information.
5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Restrictions on Standardization (e.g. proprietary code)
No challenges anticipated. This data is available in standard terminology that can be publicly accessed via the VSAC and HL7.
Restrictions on Use (e.g. licensing, user fees)
We are not aware of any restrictions.
Privacy and Security Concerns
This data, like any patient data should be exchanged securely. Current processes exist, governed by CMS and ONC, to securely transfer this data.
Estimate of Overall Burden
Diagnostic study and exam performance is regularly captured as part of EHR systems. Most hospitals, including critical access hospitals, and providers are already capturing and exchanging these data for quality measurement to CMS.
Some additional efforts may be necessary to build out Observation profile or additional resources in FHIR US Core Implementation Guide, though base resources exist in FHIR and profiles exist in QI Core Implementation Guide.
The Connected Health Initiative supports adding the Current Procedural Terminology (CPT) code set to the applicable vocabulary standards for Clinical Tests – Clinical Tests, as the CPT code set contains numerous codes for non-imaging and non-laboratory clinical tests.
The Connected Health Initiative supports adding the Current Procedural Terminology (CPT) code set to the Applicable Vocabulary Standards listed in Clinical Tests – Clinical Tests. The CPT code set contains numerous codes for non-imaging and non-laboratory clinical tests, including, but not limited to electroencephalography (EEG), echocardiography (EKG), cardiovascular and exercise stress tests, pulmonary function tests, electromyography (EMG), electroretinography (ERG), audiologic function tests, evoked potential tests, intraocular pressure measurement, visual acuity and function tests, allergy challenge tests, fetal monitoring, and sleep studies.
The AMA requests that the Current Procedural Terminology (CPT) code set be added to the applicable vocabulary standards for Clinical Tests – Clinical Tests. The CPT code set contains numerous codes for non-imaging and non-laboratory clinical tests. (See our previous comment on 4/17/2023 for a list of clinical tests and additional information.) The following are research examples where EHR data, including CPT clinical test codes, were used for the data analysis.
Kadambi P, Hart KW, Adeoye OM, Lindsell CJ, Knight WA 4th. Electroencephalography findings in patients presenting to the ED for evaluation of seizures. Am J Emerg Med. 2015 Jan;33(1):100-3. doi: 10.1016/j.ajem.2014.10.041. Epub 2014 Oct 30. PMID: 25468214; PMCID: PMC4847441.
Floris-Moore M, Edmonds A, Napravnik S, Adimora AA. Computerized Adjudication of Coronary Heart Disease Events Using the Electronic Medical Record in HIV Clinical Research: Possibilities and Challenges Ahead. AIDS Res Hum Retroviruses. 2020 Apr;36(4):306-313. doi: 10.1089/AID.2019.0036. Epub 2019 Sep 10. PMID: 31407587; PMCID: PMC7185364.
Shin CH, Grabitz SD, Timm FP, Mueller N, Chhangani K, Ladha K, Devine S, Kurth T, Eikermann M. Development and validation of a Score for Preoperative Prediction of Obstructive Sleep Apnea (SPOSA) and its perioperative outcomes. BMC Anesthesiol. 2017 May 30;17(1):71. doi: 10.1186/s12871-017-0361-z. PMID: 28558716; PMCID: PMC5450400.
The American Medical Association requests that the Current Procedural Terminology (CPT) code set be added to the Applicable Vocabulary Standards listed in Clinical Tests – Clinical Tests. The CPT code set contains numerous codes for non-imaging and non-laboratory clinical tests, including, but not limited to electroencephalography (EEG), echocardiography (EKG), cardiovascular and exercise stress tests, pulmonary function tests, electromyography (EMG), electroretinography (ERG), audiologic function tests, evoked potential tests, intraocular pressure measurement, visual acuity and function tests, allergy challenge tests, fetal monitoring, and sleep studies. The CPT code set was added in 2022 to the Interoperability Standards Advisory (ISA) vocabulary list for Representing Non-Imaging and Non-Laboratory Clinical Tests. In a 2022 study, CPT was identified as an important component needed to study the value of certain clinical tests performed preoperatively before cataract surgery. (Harris AHS, Bowe T, Kamal RN, Sears ED, Hawn M, Eisenberg D, Finlay AK, Hagedorn HJ, Mudumbai S. Frequency and costs of low-value preoperative tests for patients undergoing low-risk procedures in the veterans health administration. Perioper Med (Lond). 2022 Sep 13;11(1):33. doi: 10.1186/s13741-022-00265-0. PMID: 36096937; PMCID: PMC9469517.) The CPT code set is a comprehensive and regularly curated uniform language that provides reliable communication among users. It has an extremely mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders.
There was much interest from the Task Force in adding clinical variables beyond laboratory to USCDI. This is a suggested starting set. We would suggest that users would not be required to use these specific codes listed under a given panel verbatim. They could drop codes that did not fit and add other LOINC codes as appropriate. This starter set should get the ball rolling to deliver richer clinical data that has been available for years and is in high demand by clinicians and patients.
2021 03 29 Some clinical measure tests panels available from LOINC just some to explore.docx
CMS agrees with the need to make this additional clinical data available via inclusion in the USCDI. We agree LOINC terminology is an appropriate applicable standard to accompany the data element. CMS identified some critical diagnostic studies/exams including cardiac exams (ejection fraction from echocardiography tests), and colonoscopy; many of these align with the exams provided in this document.
There was much interest from the Task Force in adding clinical variables beyond laboratory to USCDI. This is a suggested starting set. We would suggest that users would not be required to use these specific codes listed under a given panel verbatim. They could drop codes that did not fit and add other LOINC codes as appropriate. This starter set should get the ball rolling to deliver richer clinical data that has been available for years and is in high demand by clinicians and patients.
Submitted by brianscarpelli on
Comments of the Connected Health Initiative
The Connected Health Initiative supports adding the Current Procedural Terminology (CPT) code set to the applicable vocabulary standards for Clinical Tests – Clinical Tests, as the CPT code set contains numerous codes for non-imaging and non-laboratory clinical tests.