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===4.2 Laboratory informatics and reporting requirements=== | ===4.2 Laboratory informatics and reporting requirements=== | ||
Before we can talk about the details of COVID-19 reporting, we first must briefly discuss the science of epidemiology. The CDC defines epidemiology as "the method used to find the causes of health outcomes and diseases in populations."<ref name="CDCWhatIs16">{{cite web |url=https://www.cdc.gov/careerpaths/k12teacherroadmap/epidemiology.html |title=What is Epidemiology? |work=Teacher Roadmap |publisher=Centers for Disease Control and Prevention |date=17 June 2016 |accessdate=14 September 2021}}</ref> As we'll soon learn, finding those causes depends on quality data and reporting. | |||
Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activities that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.<ref name="NaitoUtil14">{{cite journal |title=Utilization and application of public health data in descriptive epidemiology |journal=Journal of Epidemiology |author=Naito, M. |volume=24 |issue=6 |pages=435–6 |year=2014 |doi=10.2188/jea.je20140182 |pmid=25327184 |pmc=PMC4213216}}</ref> Analytical epidemiology allows for the testing of those hypotheses using both experimental and observational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for proving or disproving hypotheses.<ref name="CDCPrinc12">{{cite book |url=https://www.cdc.gov/csels/dsepd/ss1978/SS1978.pdf |format=PDF |title=Principles of Epidemiology in Public Health Practice |author=Centers for Disease Control and Prevention |edition=3rd |publisher=Centers for Disease Control and Prevention |year=2012 |accessdate=11 April 2020}}</ref> In both cases, proper reporting of public health data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.<ref name="HamiltonUsing19">{{cite book |chapter=Chapter 5: Using Technologies for Data Collection and Management |title=The CDC Field Epidemiology Manual |author=Hamilton, J.J.; Hopkins, R.S. |editor=Rasmussen, S.A.; Goodman, R.A. |publisher=Oxford University Press |edition=4th |pages=71–104 |year=2019 |isbn=9780190933692}}</ref><ref name="vonElmTheStren07">{{cite journal |title=The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies |journal=PLoS Medicine |author=von Elm, E.; Altman, D.G.; Egger, M. et al. |volume=4 |issue=10 |at=e296 |year=2007 |doi=10.1371/journal.pmed.0040296 |pmid=17941714 |pmc=PMC2020495}}</ref><ref name="Crear-PerryTheHid20">{{cite web |url=https://www.statnews.com/2020/11/05/rapid-covid-19-tests-hidden-public-health-hazard/ |title=The hidden public health hazard of rapid Covid-19 tests |author=Crear-Perry, J. |work=STAT |date=05 November 2020 |accessdate=21 November 2020}}</ref> This includes point-of-care and at-home testing results, which are at times more difficult to capture.<ref name="Crear-PerryTheHid20" /> | Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activities that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.<ref name="NaitoUtil14">{{cite journal |title=Utilization and application of public health data in descriptive epidemiology |journal=Journal of Epidemiology |author=Naito, M. |volume=24 |issue=6 |pages=435–6 |year=2014 |doi=10.2188/jea.je20140182 |pmid=25327184 |pmc=PMC4213216}}</ref> Analytical epidemiology allows for the testing of those hypotheses using both experimental and observational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for proving or disproving hypotheses.<ref name="CDCPrinc12">{{cite book |url=https://www.cdc.gov/csels/dsepd/ss1978/SS1978.pdf |format=PDF |title=Principles of Epidemiology in Public Health Practice |author=Centers for Disease Control and Prevention |edition=3rd |publisher=Centers for Disease Control and Prevention |year=2012 |accessdate=11 April 2020}}</ref> In both cases, proper reporting of public health data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.<ref name="HamiltonUsing19">{{cite book |chapter=Chapter 5: Using Technologies for Data Collection and Management |title=The CDC Field Epidemiology Manual |author=Hamilton, J.J.; Hopkins, R.S. |editor=Rasmussen, S.A.; Goodman, R.A. |publisher=Oxford University Press |edition=4th |pages=71–104 |year=2019 |isbn=9780190933692}}</ref><ref name="vonElmTheStren07">{{cite journal |title=The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies |journal=PLoS Medicine |author=von Elm, E.; Altman, D.G.; Egger, M. et al. |volume=4 |issue=10 |at=e296 |year=2007 |doi=10.1371/journal.pmed.0040296 |pmid=17941714 |pmc=PMC2020495}}</ref><ref name="Crear-PerryTheHid20">{{cite web |url=https://www.statnews.com/2020/11/05/rapid-covid-19-tests-hidden-public-health-hazard/ |title=The hidden public health hazard of rapid Covid-19 tests |author=Crear-Perry, J. |work=STAT |date=05 November 2020 |accessdate=21 November 2020}}</ref> This includes point-of-care and at-home testing results, which are at times more difficult to capture.<ref name="Crear-PerryTheHid20" /> | ||
The proper reporting of COVID-19 case data is no exception. In the United States, the [[Centers for Disease Control and Prevention]] (CDC) has taken a standardized approach to collecting reports on individuals with "lab-confirmed and probable cases of COVID-19."<ref name="CDCInstruct20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/downloads/COVID-19-Persons-Under-Investigation-and-Case-Report-Form-Instructions.pdf |format=PDF |title=Instructions for Completing the Human Infection with 2019 Novel Coronavirus (COVID-19) Case Report Form |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=01 May 2020 |accessdate=21 November 2020}}</ref><ref name="CDCInformRepo20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html |title=Information for Health Departments on Reporting Cases of COVID-19 |author=Centers for Disease Control and Prevention |work=Coronavirus Disease 2019 (COVID-19) |publisher=Centers for Disease Control and Prevention |date=05 May 2020 |accessdate=21 November 2020}}</ref> Their COVID-19 Case Report Form is designed to collect a wide variety of information about a COVID-19 case, including patient demographics, epidemiological characteristics, exposure and contact history, | The proper reporting of COVID-19 case data is no exception. In the United States, the [[Centers for Disease Control and Prevention]] (CDC) has taken a standardized approach to collecting reports on individuals with "lab-confirmed and probable cases of COVID-19."<ref name="CDCInstruct20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/downloads/COVID-19-Persons-Under-Investigation-and-Case-Report-Form-Instructions.pdf |format=PDF |title=Instructions for Completing the Human Infection with 2019 Novel Coronavirus (COVID-19) Case Report Form |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=01 May 2020 |accessdate=21 November 2020}}</ref><ref name="CDCInformRepo20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html |title=Information for Health Departments on Reporting Cases of COVID-19 |author=Centers for Disease Control and Prevention |work=Coronavirus Disease 2019 (COVID-19) |publisher=Centers for Disease Control and Prevention |date=05 May 2020 |accessdate=21 November 2020}}</ref> Their COVID-19 Surveillance Worksheet (formerly Case Report Form) is designed to collect a wide variety of information about a COVID-19 case, including patient demographics, epidemiological characteristics, exposure and contact history, clinical diagnosis, treatment procedures, and vaccination history. Currently, the CDC is asking healthcare providers and [[Laboratory|laboratories]] that are operating as testing sites to "report data for all diagnostic and screening testing completed, which includes molecular, antigen, and antibody testing, for each individual tested" on a daily basis, "within 24 hours of test completion."<ref name="CDCHowToRep20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html |title=How to Report COVID-19 Laboratory Data |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=26 January 2021 |accessdate=14 September 2021}}</ref> Local, state, tribal, and territorial public health departments are then asked to submit case reports etc. to the CDC. Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Recognizing the disparate reporting mechanisms across various state health departments and the problems this causes, particularly during an epidemic, funding efforts are under way to assist the CDC—as well as state, local, and tribal governments—better report disease information through a modernized, centralized public health data management platform.<ref name="Crear-PerryTheHid20" /><ref name="CDCCentral20">{{cite web |url=https://sam.gov/opp/f0fc727c642640ed829d98fc880d4713/view |title=Centralized National Reporting Mechanism for COVID-19 Laboratory Tests Results and Other Reportable Conditions, United States |author=Centers for Disease Control and Prevention |work=SAM.gov |date=16 November 2020 |accessdate=14 September 2021}}</ref> | ||
Elsewhere, Canada has similar reporting expectations to the U.S. CDC, with their own case report form and electronic data submission process through the Public Health Agency of Canada.<ref name="CanadaInterim20">{{cite web |url=https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals/interim-guidance-surveillance-human-infection.html |title= | Elsewhere, Canada has similar reporting expectations to the U.S. CDC, with their own case report form and electronic data submission process through the Public Health Agency of Canada.<ref name="CanadaInterim20">{{cite web |url=https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals/interim-guidance-surveillance-human-infection.html |title=National surveillance for Coronavirus disease (COVID-19) |author=Government of Canada |publisher=Government of Canada |date=19 March 2021 |accessdate=14 September 2021}}</ref> And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System, with "additional enhanced surveillance ... established through The European Surveillance System - TESSy."<ref name="ECDCCaseDef20">{{cite web |url=https://www.ecdc.europa.eu/en/covid-19/surveillance |title=EU level surveillance of COVID19 |author=European Centre for Disease Prevention and Control |publisher=European Centre for Disease Prevention and Control |work=COVID-19 Portal |date=29 May 2020 |accessdate=21 November 2020}}</ref> | ||
====4.2.1 ICD, CPT, and HCPCS coding==== | ====4.2.1 ICD, CPT, and HCPCS coding==== | ||
[[File:Icd10codeslogo.png|left|240px]]Related are any test reporting and billing requirements in labs and medical facilities. The [[International Statistical Classification of Diseases and Related Health Problems]] (ICD) is a commonly used system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. Their ICD-10-CM code set has been modified to include lab testing codes for COVID-19, as has the [[Current Procedural Terminology]] (CPT) code set. This guide provides basic information about these codes (which should not be considered legally binding advice); however, see the referenced material (and following citations) for more details concerning those codes<ref name=" | [[File:Icd10codeslogo.png|left|240px]]Related are any test reporting and billing requirements in labs and medical facilities. The [[International Statistical Classification of Diseases and Related Health Problems]] (ICD) is a commonly used system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. Their ICD-10-CM code set has been modified to include lab testing codes for COVID-19, as has the [[Current Procedural Terminology]] (CPT) code set. This guide provides basic information about these codes (which should not be considered legally binding advice); however, see the referenced material (and following citations) for more details concerning those codes<ref name="AMA-COVIDCPT">{{cite web |url=https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance |title=COVID-19 CPT coding and guidance |work=COVID-19 CPT codes |author=American Medical Association |accessdate=14 September 2021}}</ref><ref name="AHAFreq21">{{cite web |url=https://www.codingclinicadvisor.com/faqs-icd-10-cm-coding-covid-19 |title=Frequently Asked Questions Regarding ICD-10-CM Coding for COVID-19 |work=AHA Coding Clinic Advisor |publisher=American Hospital Association |date=27 August 2021 |accessdate=14 September 2021}}</ref><ref name="CMS-ICD10CM21">{{cite web |url=https://www.cms.gov/files/document/fy-2022-icd-10-cm-coding-guidelines.pdf |format=PDF |title=ICD-10-CM Official Guidelines for Coding and Reporting FY 2022 |author=Centers for Medicare and Medicaid Services |date=10 August 2021 |accessdate=14 September 2021}}</ref><ref name="CMS-COVIDFAQFFS21">{{cite web |url=https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf |format=PDF |title=COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing |publisher=Centers for Medicare and Medicaid Services |date=02 July 2021 |accessdate=14 September 2021}}</ref><ref name="ASCO-COVIDReport21">{{cite web |url=https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020-COVID19-Billing-and-Coding-Resource.pdf |format=PDF |title=COVID-19 Coding and Reporting Information New CPT, HCPCS, and ICD-10 CM Codes |publisher=American Society of Clinical Oncology |date=26 August 2021 |accessdate=14 September 2021}}</ref>: | ||
* The CPT code 87635 has the long descriptor of "Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique." The American Medical Association's ''CPT Assistant'' [https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance fact sheet] for SARS-CoV-2 reporting proves useful in supplying assistance on how and when to apply this CPT code in reporting. | * The CPT code 87635 has the long descriptor of "Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique." The American Medical Association's ''CPT Assistant'' [https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance fact sheet] for SARS-CoV-2 reporting proves useful in supplying assistance on how and when to apply this CPT code in reporting. | ||
* Since the pandemic has progressed, | * Since the pandemic has progressed, numerous other CPT codes have become available. This includes a series of parent and child codes for antibody testing, neutralizing antibody screens, antigen testing, and vaccination. Resources for guidance concerning these codes include the [https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance American Medical Association] and the [https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020-COVID19-Billing-and-Coding-Resource.pdf American Society of Clinical Oncology] (PDF). | ||
* The U.S. government-adopted ICD-10-CM—an authorized version of WHO's ICD-10<ref name="CDCIntern20">{{cite web |url=https://www.cdc.gov/nchs/icd/icd10cm.htm |title=International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) |author=National Center for Health Statistics |publisher=Centers for Disease Control and Prevention |date= | * The U.S. government-adopted ICD-10-CM—an authorized version of WHO's ICD-10<ref name="CDCIntern20">{{cite web |url=https://www.cdc.gov/nchs/icd/icd10cm.htm |title=International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) |author=National Center for Health Statistics |publisher=Centers for Disease Control and Prevention |date=30 July 2021 |accessdate=14 September 2021}}</ref>—has been updated by the CDC and the National Center for Healthcare Statistics. It includes not only codes for conditions associated with COVID-19, but also codes for exposure, screening, and vaccination. The principal diagnosis code "U07.1, COVID-19" is sequenced first for a confirmed COVID-19 diagnosis, followed by any appropriate codes for associated manifestations (though there is an obstetrics exception). CMS's [https://www.cms.gov/files/document/fy-2022-icd-10-cm-coding-guidelines.pdf coding guidelines], as well as [https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance American Medical Association] guidance, may prove useful in choosing the correct codes. The [https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020-COVID19-Billing-and-Coding-Resource.pdf American Society of Clinical Oncology] (PDF) is also maintaining a document with ICD-10-CM information. | ||
* Since the pandemic started, new HCPCS codes have been released by the Centers for Medicare & Medicaid Services (CMS). These are to be used solely for Medicare claims. The [https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020-COVID19-Billing-and-Coding-Resource.pdf American Society of Clinical Oncology] (PDF) is maintaining a helpful document with that information. | * Since the pandemic started, new HCPCS codes have been released by the Centers for Medicare & Medicaid Services (CMS). These are to be used solely for Medicare claims. The [https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020-COVID19-Billing-and-Coding-Resource.pdf American Society of Clinical Oncology] (PDF) is maintaining a helpful document with that information. | ||
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====4.2.2 Reporting to local and regional health departments==== | ====4.2.2 Reporting to local and regional health departments==== | ||
Given the valuable nature of case reports during an epidemic<ref name="HamiltonUsing19" /><ref name="vonElmTheStren07" />, health care providers, facilities, and laboratories are being held responsible for sending case data to their local and regional health departments. That information then feeds up to the state-level health department, which then makes its way to the national-level entity responsible for handling epidemiology (in the case of the U.S., the CDC). Significant decisions are typically based on that data. For example, the U.S. CDC has been conducting seroprevalance (determination of the "percentages of people who were previously infected with SARS-CoV-2") surveys of various regions of the United States.<ref name="CDCCommercial20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/commercial-lab-surveys.html |title=Commercial Laboratory Seroprevalence Surveys |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date= | Given the valuable nature of case reports during an epidemic<ref name="HamiltonUsing19" /><ref name="vonElmTheStren07" />, health care providers, facilities, and laboratories are being held responsible for sending case data to their local and regional health departments. That information then feeds up to the state-level health department, which then makes its way to the national-level entity responsible for handling epidemiology (in the case of the U.S., the CDC). Significant decisions are typically based on that data. For example, the U.S. CDC has been conducting seroprevalance (determination of the "percentages of people who were previously infected with SARS-CoV-2") surveys of various regions of the United States.<ref name="CDCCommercial20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/commercial-lab-surveys.html |title=Commercial Laboratory Seroprevalence Surveys |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=01 December 2020 |accessdate=14 September 2021}}</ref> The insights and decisions the CDC makes depends on cooperation and proper reporting by state and local health departments. | ||
However, acquiring standardized data at the national level can be challenging. In the case of the U.S., general disease reporting requirements vary from state to state, with | However, acquiring standardized data at the national level can be challenging. In the case of the U.S., general disease reporting requirements vary from state to state, with many states encouraging full electronic laboratory reporting (ELR), while some still encourage faxed or mailed reports. Add in the urgency and confusion associated with a pandemic, and COVID-19 reporting requirements prove to vary just as much. Some states' health departments have taken a proactive approach to reporting. For example, Iowa's Department of Public Health has issued several mandatory COVID-19 reporting orders meant to supplement existing reporting rules, including an order requiring all Iowa health care providers and public, private, and hospital laboratories "to immediately report all positive and negative Coronavirus Disease 2019 (COVID-19) testing results to the department."<ref name="ClabaughRescind20">{{cite web |url=https://idph.iowa.gov/Portals/1/userfiles/61/covid19/Mandatory%20Reporting%20Order.pdf |format=PDF |title=Temporary Novel Coronavirus Disease 2019 (COVID-19) Mandatory Reporting Order |author=Garcia, K.; Pedati, C. |publisher=Iowa Department of Public Health |date=31 December 2020 |accessdate=14 September 2021}}</ref> Other states have not been as clear on their reporting requirements, in some cases not having any guidance documents or clear information on their health department website for how providers, facilities, and labs should report COVID-19. In those cases, the presumption is that most labs have contacted the health department for advice or are reporting COVID-19 cases as immediately reportable, based upon the state's existing reporting requirements for immediately reportable diseases. | ||
The CDC, however, [https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html maintains a page] concerning how to report COVID-19 laboratory data. It's important to note their take on using standard terminology, which is based on [https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html their mapping tool] ''LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests''<ref name="CDCHowToRep20" />: | The CDC, however, [https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html maintains a page] concerning how to report COVID-19 laboratory data. It's important to note their take on using standard terminology, which is based on [https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html their mapping tool] ''LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests''<ref name="CDCHowToRep20" />: | ||
<blockquote>This specification supports the use of standardized LOINC and SNOMED Clinical Terms (CT) codes to improve the accuracy of reporting tests for the SARS-CoV-2 virus. Using these harmonized LOINC and SNOMED-CT codes helps ensure that the same type of test is represented uniformly across the United States ... LOINC codes must be used to represent the “question” a | <blockquote>This specification supports the use of standardized LOINC and SNOMED Clinical Terms (CT) codes to improve the accuracy of reporting tests for the SARS-CoV-2 virus. Using these harmonized LOINC and SNOMED-CT codes helps ensure that the same type of test is represented uniformly across the United States ... LOINC codes must be used to represent the “question” a test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes must be used to represent the diagnostic “answer” (e.g., what was detected?).</blockquote> | ||
The CDC's Excel-based mapping tool lists the current (and previous) FDA EUAed diagnostic tests with codes for LOINC test order, LOINC test result, SNOMED-CT test description, SNOMED-CT specimen source, and Device Identifier. Ensure that your laboratory is using these LOINC and SNOMED-CT codes for reporting to your local and state health departments. | The CDC's Excel-based mapping tool lists the current (and previous) FDA EUAed diagnostic tests with codes for LOINC test order, LOINC test result, SNOMED-CT test description, SNOMED-CT specimen source, and Device Identifier. Ensure that your laboratory is using these LOINC and SNOMED-CT codes for reporting to your local and state health departments. |
Revision as of 19:36, 14 September 2021
4.2 Laboratory informatics and reporting requirements
Before we can talk about the details of COVID-19 reporting, we first must briefly discuss the science of epidemiology. The CDC defines epidemiology as "the method used to find the causes of health outcomes and diseases in populations."[1] As we'll soon learn, finding those causes depends on quality data and reporting.
Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activities that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.[2] Analytical epidemiology allows for the testing of those hypotheses using both experimental and observational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for proving or disproving hypotheses.[3] In both cases, proper reporting of public health data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.[4][5][6] This includes point-of-care and at-home testing results, which are at times more difficult to capture.[6]
The proper reporting of COVID-19 case data is no exception. In the United States, the Centers for Disease Control and Prevention (CDC) has taken a standardized approach to collecting reports on individuals with "lab-confirmed and probable cases of COVID-19."[7][8] Their COVID-19 Surveillance Worksheet (formerly Case Report Form) is designed to collect a wide variety of information about a COVID-19 case, including patient demographics, epidemiological characteristics, exposure and contact history, clinical diagnosis, treatment procedures, and vaccination history. Currently, the CDC is asking healthcare providers and laboratories that are operating as testing sites to "report data for all diagnostic and screening testing completed, which includes molecular, antigen, and antibody testing, for each individual tested" on a daily basis, "within 24 hours of test completion."[9] Local, state, tribal, and territorial public health departments are then asked to submit case reports etc. to the CDC. Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Recognizing the disparate reporting mechanisms across various state health departments and the problems this causes, particularly during an epidemic, funding efforts are under way to assist the CDC—as well as state, local, and tribal governments—better report disease information through a modernized, centralized public health data management platform.[6][10]
Elsewhere, Canada has similar reporting expectations to the U.S. CDC, with their own case report form and electronic data submission process through the Public Health Agency of Canada.[11] And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System, with "additional enhanced surveillance ... established through The European Surveillance System - TESSy."[12]
4.2.1 ICD, CPT, and HCPCS coding
Related are any test reporting and billing requirements in labs and medical facilities. The International Statistical Classification of Diseases and Related Health Problems (ICD) is a commonly used system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. Their ICD-10-CM code set has been modified to include lab testing codes for COVID-19, as has the Current Procedural Terminology (CPT) code set. This guide provides basic information about these codes (which should not be considered legally binding advice); however, see the referenced material (and following citations) for more details concerning those codes[13][14][15][16][17]:
- The CPT code 87635 has the long descriptor of "Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique." The American Medical Association's CPT Assistant fact sheet for SARS-CoV-2 reporting proves useful in supplying assistance on how and when to apply this CPT code in reporting.
- Since the pandemic has progressed, numerous other CPT codes have become available. This includes a series of parent and child codes for antibody testing, neutralizing antibody screens, antigen testing, and vaccination. Resources for guidance concerning these codes include the American Medical Association and the American Society of Clinical Oncology (PDF).
- The U.S. government-adopted ICD-10-CM—an authorized version of WHO's ICD-10[18]—has been updated by the CDC and the National Center for Healthcare Statistics. It includes not only codes for conditions associated with COVID-19, but also codes for exposure, screening, and vaccination. The principal diagnosis code "U07.1, COVID-19" is sequenced first for a confirmed COVID-19 diagnosis, followed by any appropriate codes for associated manifestations (though there is an obstetrics exception). CMS's coding guidelines, as well as American Medical Association guidance, may prove useful in choosing the correct codes. The American Society of Clinical Oncology (PDF) is also maintaining a document with ICD-10-CM information.
- Since the pandemic started, new HCPCS codes have been released by the Centers for Medicare & Medicaid Services (CMS). These are to be used solely for Medicare claims. The American Society of Clinical Oncology (PDF) is maintaining a helpful document with that information.
Laboratories analyzing specimens for SARS-CoV-2 must be equipped to implement and handle analytical testing and test orders using the new test codes. However, they also must be able to quickly and accurately transfer vital case information to the appropriate health authority. This may include using other types of codes such as Logical Observation Identifiers Names and Codes (LOINC) and SNOMED-CT codes, which are briefly discussed in the next subsection.
4.2.2 Reporting to local and regional health departments
Given the valuable nature of case reports during an epidemic[4][5], health care providers, facilities, and laboratories are being held responsible for sending case data to their local and regional health departments. That information then feeds up to the state-level health department, which then makes its way to the national-level entity responsible for handling epidemiology (in the case of the U.S., the CDC). Significant decisions are typically based on that data. For example, the U.S. CDC has been conducting seroprevalance (determination of the "percentages of people who were previously infected with SARS-CoV-2") surveys of various regions of the United States.[19] The insights and decisions the CDC makes depends on cooperation and proper reporting by state and local health departments.
However, acquiring standardized data at the national level can be challenging. In the case of the U.S., general disease reporting requirements vary from state to state, with many states encouraging full electronic laboratory reporting (ELR), while some still encourage faxed or mailed reports. Add in the urgency and confusion associated with a pandemic, and COVID-19 reporting requirements prove to vary just as much. Some states' health departments have taken a proactive approach to reporting. For example, Iowa's Department of Public Health has issued several mandatory COVID-19 reporting orders meant to supplement existing reporting rules, including an order requiring all Iowa health care providers and public, private, and hospital laboratories "to immediately report all positive and negative Coronavirus Disease 2019 (COVID-19) testing results to the department."[20] Other states have not been as clear on their reporting requirements, in some cases not having any guidance documents or clear information on their health department website for how providers, facilities, and labs should report COVID-19. In those cases, the presumption is that most labs have contacted the health department for advice or are reporting COVID-19 cases as immediately reportable, based upon the state's existing reporting requirements for immediately reportable diseases.
The CDC, however, maintains a page concerning how to report COVID-19 laboratory data. It's important to note their take on using standard terminology, which is based on their mapping tool LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests[9]:
This specification supports the use of standardized LOINC and SNOMED Clinical Terms (CT) codes to improve the accuracy of reporting tests for the SARS-CoV-2 virus. Using these harmonized LOINC and SNOMED-CT codes helps ensure that the same type of test is represented uniformly across the United States ... LOINC codes must be used to represent the “question” a test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes must be used to represent the diagnostic “answer” (e.g., what was detected?).
The CDC's Excel-based mapping tool lists the current (and previous) FDA EUAed diagnostic tests with codes for LOINC test order, LOINC test result, SNOMED-CT test description, SNOMED-CT specimen source, and Device Identifier. Ensure that your laboratory is using these LOINC and SNOMED-CT codes for reporting to your local and state health departments.
Table 1 addresses the reporting requirements for the United States' 50 states, while Table 2 covers U.S. territories. If clear reporting guidance specific to COVID-19 could be found, it was described. If no such guidance could be found, then the state's existing guidance and rules regarding disease reporting were referenced. In some cases, the state health departments don't clearly spell out whether a faxed or mailed report is required after immediately phoning in a report. In other cases, it's not clear if ELR—though it exists—is an acceptable form of reporting COVID-19 cases. This ambiguity is stated in the form of a "(?)" found next to the "Y" and "N" for electronic filing and faxing. In all cases, if there is any doubt about reporting requirements, call your local health department to confirm.
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- ↑ "What is Epidemiology?". Teacher Roadmap. Centers for Disease Control and Prevention. 17 June 2016. https://www.cdc.gov/careerpaths/k12teacherroadmap/epidemiology.html. Retrieved 14 September 2021.
- ↑ Naito, M. (2014). "Utilization and application of public health data in descriptive epidemiology". Journal of Epidemiology 24 (6): 435–6. doi:10.2188/jea.je20140182. PMC PMC4213216. PMID 25327184. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4213216.
- ↑ Centers for Disease Control and Prevention (2012) (PDF). Principles of Epidemiology in Public Health Practice (3rd ed.). Centers for Disease Control and Prevention. https://www.cdc.gov/csels/dsepd/ss1978/SS1978.pdf. Retrieved 11 April 2020.
- ↑ 4.0 4.1 Hamilton, J.J.; Hopkins, R.S. (2019). "Chapter 5: Using Technologies for Data Collection and Management". In Rasmussen, S.A.; Goodman, R.A.. The CDC Field Epidemiology Manual (4th ed.). Oxford University Press. pp. 71–104. ISBN 9780190933692.
- ↑ 5.0 5.1 von Elm, E.; Altman, D.G.; Egger, M. et al. (2007). "The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies". PLoS Medicine 4 (10): e296. doi:10.1371/journal.pmed.0040296. PMC PMC2020495. PMID 17941714. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2020495.
- ↑ 6.0 6.1 6.2 Crear-Perry, J. (5 November 2020). "The hidden public health hazard of rapid Covid-19 tests". STAT. https://www.statnews.com/2020/11/05/rapid-covid-19-tests-hidden-public-health-hazard/. Retrieved 21 November 2020.
- ↑ Centers for Disease Control and Prevention (1 May 2020). "Instructions for Completing the Human Infection with 2019 Novel Coronavirus (COVID-19) Case Report Form" (PDF). Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/downloads/COVID-19-Persons-Under-Investigation-and-Case-Report-Form-Instructions.pdf. Retrieved 21 November 2020.
- ↑ Centers for Disease Control and Prevention (5 May 2020). "Information for Health Departments on Reporting Cases of COVID-19". Coronavirus Disease 2019 (COVID-19). Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html. Retrieved 21 November 2020.
- ↑ 9.0 9.1 Centers for Disease Control and Prevention (26 January 2021). "How to Report COVID-19 Laboratory Data". Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html. Retrieved 14 September 2021.
- ↑ Centers for Disease Control and Prevention (16 November 2020). "Centralized National Reporting Mechanism for COVID-19 Laboratory Tests Results and Other Reportable Conditions, United States". SAM.gov. https://sam.gov/opp/f0fc727c642640ed829d98fc880d4713/view. Retrieved 14 September 2021.
- ↑ Government of Canada (19 March 2021). "National surveillance for Coronavirus disease (COVID-19)". Government of Canada. https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals/interim-guidance-surveillance-human-infection.html. Retrieved 14 September 2021.
- ↑ European Centre for Disease Prevention and Control (29 May 2020). "EU level surveillance of COVID19". COVID-19 Portal. European Centre for Disease Prevention and Control. https://www.ecdc.europa.eu/en/covid-19/surveillance. Retrieved 21 November 2020.
- ↑ American Medical Association. "COVID-19 CPT coding and guidance". COVID-19 CPT codes. https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance. Retrieved 14 September 2021.
- ↑ "Frequently Asked Questions Regarding ICD-10-CM Coding for COVID-19". AHA Coding Clinic Advisor. American Hospital Association. 27 August 2021. https://www.codingclinicadvisor.com/faqs-icd-10-cm-coding-covid-19. Retrieved 14 September 2021.
- ↑ Centers for Medicare and Medicaid Services (10 August 2021). "ICD-10-CM Official Guidelines for Coding and Reporting FY 2022" (PDF). https://www.cms.gov/files/document/fy-2022-icd-10-cm-coding-guidelines.pdf. Retrieved 14 September 2021.
- ↑ "COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing" (PDF). Centers for Medicare and Medicaid Services. 2 July 2021. https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf. Retrieved 14 September 2021.
- ↑ "COVID-19 Coding and Reporting Information New CPT, HCPCS, and ICD-10 CM Codes" (PDF). American Society of Clinical Oncology. 26 August 2021. https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020-COVID19-Billing-and-Coding-Resource.pdf. Retrieved 14 September 2021.
- ↑ National Center for Health Statistics (30 July 2021). "International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)". Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/icd/icd10cm.htm. Retrieved 14 September 2021.
- ↑ Centers for Disease Control and Prevention (1 December 2020). "Commercial Laboratory Seroprevalence Surveys". Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/commercial-lab-surveys.html. Retrieved 14 September 2021.
- ↑ Garcia, K.; Pedati, C. (31 December 2020). "Temporary Novel Coronavirus Disease 2019 (COVID-19) Mandatory Reporting Order" (PDF). Iowa Department of Public Health. https://idph.iowa.gov/Portals/1/userfiles/61/covid19/Mandatory%20Reporting%20Order.pdf. Retrieved 14 September 2021.