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=== | ===4.2 Laboratory informatics and reporting requirements=== | ||
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> | 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> | ||
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 at least one respiratory specimen that tested positive for the virus that causes COVID-19."<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=21 March 2020 |accessdate=21 March 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, and clinical diagnosis and treatment procedures. Currently, the CDC is asking | 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 at least one respiratory specimen that tested positive for the virus that causes COVID-19."<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=21 March 2020 |accessdate=21 March 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, and clinical diagnosis and treatment procedures. Currently, the CDC is asking asking healthcare providers and [[Laboratory|laboratories]] that 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."<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=17 August 2020 |accessdate=23 August 2020}}</ref> Local and state health departments are then asked to submit case reports etc. to the CDC. The CDC has also slimmed its reporting requirements, limiting reporting of "persons under investigation" to areas where testing must be forwarded to the CDC due to insufficient capacity to test locally.<ref name="CDCInformRepo20" /> Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Canada has similar reporting expectations, 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=Interim national surveillance guidelines for human infection with Coronavirus disease (COVID-19) |author=Government of Canada |publisher=Government of Canada |date=10 February 2020 |accessdate=11 April 2020}}</ref> And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System.<ref name="ECDCCaseDef20">{{cite web |url=https://www.ecdc.europa.eu/en/case-definition-and-european-surveillance-human-infection-novel-coronavirus-2019-ncov |title=Case definition and European surveillance for COVID-19, as of 2 March 2020 |author=European Centre for Disease Prevention and Control |publisher=European Centre for Disease Prevention and Control |work=COVID-19 Portal |date=02 March 2020 |accessdate=11 April 2020}}</ref> | ||
==== | ====4.2.1 ICD, CPT, and HCPCS coding==== | ||
[[File:Icd10codeslogo.png|left|240px]]Related are any | [[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="GreenCoding20">{{cite web |url=https://www.mgma.com/data/data-stories/coding-guidance-for-new-icd-10-cm-and-lab-testing |title=Coding guidance for new ICD-10-CM and lab testing codes for COVID-19 |work=MGMA Stat |author=Green, C.; Bradley, V. |date=01 April 2020 |accessdate=11 April 2020}}</ref><ref name="AAPHowTo20">{{cite web |url=https://www.aappublications.org/news/2020/03/12/coding031220 |title=How to use ICD-10-CM, new lab testing codes for COVID-19 |author=AAP Division of Health Care Finance |publisher=American Academy of Pediatrics |date=12 March 2020 |accessdate=11 April 2020}}</ref><ref name="RCA_CDCPub20">{{cite web |url=https://revenuecycleadvisor.com/news-analysis/cdc-publishes-icd-10-cm-official-guidelines-covid-19 |title=CDC publishes ICD-10-CM Official Guidelines for COVID-19 |work=Revenue Cycle Advisor |date=06 April 2020 |accessdate=25 April 2020}}</ref><ref name="RemerWeNow20">{{cite web |url=https://www.icd10monitor.com/we-now-have-a-code-for-covid-19-here-s-how-to-use-it-correctly |title=We now Have a Code for COVID-19; Here’s How to use it Correctly |author=Remer, E.E. |work=ICD-10 Monitor |date=15 April 2020 |accessdate=25 April 2020}}</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/system/files/2020-03/cpt-assistant-guide-coronavirus.pdf 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/system/files/2020-03/cpt-assistant-guide-coronavirus.pdf 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, additional CPT codes have become available. This includes a series of parent and child codes for antibody testing, neutralizing antibody screens, and antigen testing. Resources for guidance concerning these codes include the [https://www.ama-assn.org/practice-management/cpt/covid-19-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=31 March 2020 |accessdate=25 April 2020}}</ref>—has been updated by the CDC and the National Center for Healthcare Statistics. It includes not only new codes for conditions associated with COVID-19 but also codes for exposure and screening. The principal diagnosis code "U07.1, COVID-19" is sequenced first, followed by any appropriate codes for associated manifestations (though there is an obstetrics exception). The CDC's [https://www.cdc.gov/nchs/data/icd/COVID-19-guidelines-final.pdf official coding guidelines], as well as [https://www.icd10monitor.com/we-now-have-a-code-for-covid-19-here-s-how-to-use-it-correctly guidance] from Dr. Erica Remer 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. | ||
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<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 Survey Data |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=26 June 2020 |accessdate=08 July 2020}}</ref> The insights and decisions the CDC makes depends on cooperation and proper reporting by state and local 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 Survey Data |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=26 June 2020 |accessdate=08 July 2020}}</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 some states encouraging full electronic laboratory reporting (ELR), while others still encouraging 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/7/Mandatory%20Reporting%20Order.pdf |format=PDF |title=Rescind the March 5, 2020 Temporary Novel Coronavirus Disease 2019 (COVID-19) Mandatory Reporting Requirement and Replace With the Following Order |author=Clabaugh, G. |publisher=Iowa Department of Public Health |date=19 March 2020 |accessdate=25 April 2020}}</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. | 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 some states encouraging full electronic laboratory reporting (ELR), while others still encouraging 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/7/Mandatory%20Reporting%20Order.pdf |format=PDF |title=Rescind the March 5, 2020 Temporary Novel Coronavirus Disease 2019 (COVID-19) Mandatory Reporting Requirement and Replace With the Following Order |author=Clabaugh, G. |publisher=Iowa Department of Public Health |date=19 March 2020 |accessdate=25 April 2020}}</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" />: | |||
<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 viral 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 tst 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. | 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. |
Revision as of 18:42, 23 August 2020
4.2 Laboratory informatics and reporting requirements
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.[1] 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.[2] 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.[3][4]
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 at least one respiratory specimen that tested positive for the virus that causes COVID-19."[5] 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, and clinical diagnosis and treatment procedures. Currently, the CDC is asking asking healthcare providers and laboratories that 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."[6] Local and state health departments are then asked to submit case reports etc. to the CDC. The CDC has also slimmed its reporting requirements, limiting reporting of "persons under investigation" to areas where testing must be forwarded to the CDC due to insufficient capacity to test locally.[5] Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Canada has similar reporting expectations, with their own case report form and electronic data submission process through the Public Health Agency of Canada.[7] And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System.[8]
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[9][10][11][12]:
- 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, additional CPT codes have become available. This includes a series of parent and child codes for antibody testing, neutralizing antibody screens, and antigen testing. 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[13]—has been updated by the CDC and the National Center for Healthcare Statistics. It includes not only new codes for conditions associated with COVID-19 but also codes for exposure and screening. The principal diagnosis code "U07.1, COVID-19" is sequenced first, followed by any appropriate codes for associated manifestations (though there is an obstetrics exception). The CDC's official coding guidelines, as well as guidance from Dr. Erica Remer 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[3][4], 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.[14] 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 some states encouraging full electronic laboratory reporting (ELR), while others still encouraging 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."[15] 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[6]:
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 viral 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 tst 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.
|
|
- ↑ 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.
- ↑ 3.0 3.1 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.
- ↑ 4.0 4.1 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.
- ↑ 5.0 5.1 Centers for Disease Control and Prevention (21 March 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 March 2020.
- ↑ 6.0 6.1 Centers for Disease Control and Prevention (17 August 2020). "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 23 August 2020.
- ↑ Government of Canada (10 February 2020). "Interim national surveillance guidelines for human infection with 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 11 April 2020.
- ↑ European Centre for Disease Prevention and Control (2 March 2020). "Case definition and European surveillance for COVID-19, as of 2 March 2020". COVID-19 Portal. European Centre for Disease Prevention and Control. https://www.ecdc.europa.eu/en/case-definition-and-european-surveillance-human-infection-novel-coronavirus-2019-ncov. Retrieved 11 April 2020.
- ↑ Green, C.; Bradley, V. (1 April 2020). "Coding guidance for new ICD-10-CM and lab testing codes for COVID-19". MGMA Stat. https://www.mgma.com/data/data-stories/coding-guidance-for-new-icd-10-cm-and-lab-testing. Retrieved 11 April 2020.
- ↑ AAP Division of Health Care Finance (12 March 2020). "How to use ICD-10-CM, new lab testing codes for COVID-19". American Academy of Pediatrics. https://www.aappublications.org/news/2020/03/12/coding031220. Retrieved 11 April 2020.
- ↑ "CDC publishes ICD-10-CM Official Guidelines for COVID-19". Revenue Cycle Advisor. 6 April 2020. https://revenuecycleadvisor.com/news-analysis/cdc-publishes-icd-10-cm-official-guidelines-covid-19. Retrieved 25 April 2020.
- ↑ Remer, E.E. (15 April 2020). "We now Have a Code for COVID-19; Here’s How to use it Correctly". ICD-10 Monitor. https://www.icd10monitor.com/we-now-have-a-code-for-covid-19-here-s-how-to-use-it-correctly. Retrieved 25 April 2020.
- ↑ National Center for Health Statistics (31 March 2020). "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 25 April 2020.
- ↑ Centers for Disease Control and Prevention (26 June 2020). "Commercial Laboratory Seroprevalence Survey Data". Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/commercial-lab-surveys.html. Retrieved 08 July 2020.
- ↑ Clabaugh, G. (19 March 2020). "Rescind the March 5, 2020 Temporary Novel Coronavirus Disease 2019 (COVID-19) Mandatory Reporting Requirement and Replace With the Following Order" (PDF). Iowa Department of Public Health. https://idph.iowa.gov/Portals/1/userfiles/7/Mandatory%20Reporting%20Order.pdf. Retrieved 25 April 2020.