User:Shawndouglas/sandbox/sublevel36 - Revision history

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	<div class="nonumtoc">__TOC__</div>		<div class="nonumtoc">__TOC__</div>

	~~====2.4.5 Antigen tests====~~
	An antigen is a substance—often a protein but may also be an environmental like a virus—that provokes the immune system to produce an antibody against it.<ref name="MPAntigen">{{cite web \|url=https://medlineplus.gov/ency/article/002224.htm \|title=Antigen \|work=MedlinePlus \|publisher=U.S. National Library of Medicine \|accessdate=07 August 2020}}</ref> As such, another approach to testing for the presence of a virus in a specimen is to test for the antigen rather than the antibody. An antigen test is useful as a repeated surveillance test, but it has drawbacks as a one-time diagnostic test.<ref name="Anderson5Invest20">{{cite web \|url=https://www.wcvb.com/article/5-investigates-concerns-about-current-use-of-rapid-antigen-tests-for-covid-19/33538332 \|title=5 Investigates: Concerns about current use of rapid antigen tests for COVID-19 \|author=Anderson, K. \|work=WCVB 5 ABC \|date=06 August 2020 \|accessdate=07 August 2020}}</ref><ref name="ServiceRadical2020">{{cite journal \|title=Radical shift in COVID-19 testing needed to reopen schools and businesses, researchers say \|journal=Science \|author=Service, R.F. \|year=2020 \|doi=10.1126/science.abe1546}}</ref><ref name="KremerUWSys20">{{cite web \|url=https://urbanmilwaukee.com/2020/08/07/uw-system-orders-350000-covid-19-tests/ \|title=UW System Orders 350,000 COVID-19 Tests \|author=Kremer, R. \|work=Urban Milwaukee \|date=07 August 2020 \|accessdate=07 August 2020}}</ref> For COVID-19 and other viral infections, an antigen test has the advantage that specimen collection can typically be done with a simple nasal swab rather than a more invasive [[nasopharyngeal swab]]. Another advantage, on one hand, is that antigen testing is more rapid and convenient because the extraction and amplification steps of PCR are not used. On the other, antigen testing is less sensitive for the same reason: you test only what's there (rather than amplifying the amount for greater sensitivity).<ref name="ServiceRadical2020" /><ref name="GuglielmiTheExp20">{{cite journal \|title=The explosion of new coronavirus tests that could help to end the pandemic \|journal=Nature \|author=Guglielmi, G. \|volume=583 \|pages=506–09 \|year=2020 \|doi=10.1038/d41586-020-02140-8}}</ref>

	A theory increasingly gaining traction, however, is that "[a] higher frequency of testing makes up for poor sensitivity.”<ref name="ServiceRadical2020" /><ref name="KremerUWSys20" /><ref name="ClarkCOVID20">{{cite web \|url=https://www.medpagetoday.com/infectiousdisease/covid19/87930 \|title=COVID Antigen Tests: Coming to Case Counts Near You? \|author=Clark, C. \|work=MedPage Today \|date=06 August 2020 \|accessdate=07 August 2020}}</ref> Several researchers have shared pre-print and published research suggesting this outcome<ref name="ServiceRadical2020" />:

	<blockquote>Larremore and his colleagues have modeled the benefits of more frequent tests, even ones that are less accurate than today’s. Fast tests repeated every three days, with isolation of people who test positive, prevents 88% of viral transmission compared with no tests; a more sensitive test used every two weeks reduced viral transmission by about 40%, they report in a 27 June preprint on medRxiv. Paltiel and his colleagues reached much the same conclusion when they modeled a variety of testing regimes aimed at safely reopening a 5000-student university. In a 31 July paper in JAMA Network Open, they found that, with 10 students infected at the start of the semester, a test that identified only 70% of positive cases, given to every student every two days, could limit the number of infections to 28 by the end of the semester. Screening every seven days allowed greater viral spread, with the model predicting 108 infections.</blockquote>

	As such, the utility of antigen testing, despite its lower sensitivity, appears to be surveillance situations where a large group of individuals who are at risk can be screened at regularly scheduled intervals of two to four days. The end result, in theory, would be few people who are target-positive would be missed, positives could be isolated and verified with a more sensitive test, and more target-positive people would be identified and isolated before reaching peak infectivity.<ref name="ServiceRadical2020" /><ref name="CourageCovid20">{{cite web \|url=https://www.vox.com/2020/7/31/21336212/covid-19-test-results-delays \|title=Should we be testing fewer people to stop the spread of Covid-19? \|author=Courage, K.H. \|work=Vox \|date=31 July 2020 \|accessdate=05 August 2020}}</ref> To be clear, it's not a perfect solution, but as Harvard epidemiologist Michael Mina and Boston University economist Laurence Kotlikoff suggest, "[w]e need the best means of detecting and containing the virus, not a perfect test no one can use."<ref name="CourageCovid20" /> A coalition of six U.S. state governors has bought into that concept and agreed to work together with the Rockefeller Foundation, as well as the Quidel Corporation and Becton, Dickinson and Company, which have received FDA EUAs to market antigen tests for SARS-CoV-2.<ref name="ClarkCOVID20" /><ref name="MervoshItsLike20">{{cite web \|url=https://www.nytimes.com/2020/08/04/us/virus-testing-delays.html \|title=‘It’s Like Having No Testing’: Coronavirus Test Results Are Still Delayed \|author=Mervosh, S.; Fernandez, M. \|work=The New York Times \|date=04 August 2020 \|accessdate=05 August 2020}}</ref> However, it's not clear how those six states will best put the tests to use despite 1. their moderate sensitivity (and thus a greater chance of false negatives<ref name="ClarkCOVID20" />) and 2. the question of whether or not the two companies can produce enough test kits for repeat testing in those states.<ref name="ServiceRadical2020" /> As of August 2020, three total vendors have FDA EUAs for antigen tests: the two mentioned, plus LumiraDx UK Ltd.<ref name="FDAEmerg20" />



	==3. Adding COVID-19 and other virus testing to your laboratory==		==3. Adding COVID-19 and other virus testing to your laboratory==

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	===3.1 What methodologies will you use?===		===3.1 What methodologies will you use?===
	====3.1.1 PCR====		====3.1.1 PCR====
	In the previous chapter, the most common testing methodologies for [[COVID-19]] and other [[Coronavirus\|coronaviruses]] were discussed in detail. The prevailing method (often called the "gold standard") among them all is real-time reverse-transcription [[polymerase chain reaction]] (rRT-PCR) assays for testing. Broadly speaking, PCR is useful in pharmaceutical, biotechnology, and genetic engineering endeavors, as well as clinical diagnostics. As such, labs in those industries that already have PCR infrastructure in place have a theoretical step-up over a lab that doesn't.		[[File:Test PCR dépistage SARS-CoV-2 prélèvement nasal Strasbourg 21 août 2020.jpg\|right\|thumb\|400px\|SARS-CoV-2 PCR screening test by nasal swab in Strasbourg on August 21, 2020.]]In the previous chapter, the most common testing methodologies for [[COVID-19]] and other [[Coronavirus\|coronaviruses]] were discussed in detail. The prevailing method (often called the "gold standard") among them all is real-time reverse-transcription [[polymerase chain reaction]] (rRT-PCR) assays for testing. Broadly speaking, PCR is useful in pharmaceutical, biotechnology, and genetic engineering endeavors, as well as clinical diagnostics. As such, labs in those industries that already have PCR infrastructure in place have a theoretical step-up over a lab that doesn't.

	PCR technology has advanced to the point where it is more efficient and user-friendly than prior, yet "the high cost of the instruments, servicing contracts, and reagents pose major challenges for the market, especially to the price-sensitive academics."<ref name="MWPoly20">{{cite web \|url=https://www.marketwatch.com/press-release/polymerase-chain-reaction-market-sector-analysis-report-regional-outlook-competitive-share-forecast---2023-2020-06-23 \|title=Polymerase Chain Reaction Market Sector Analysis Report, Regional Outlook & Competitive Share & Forecast - 2023 \|author=Kenneth Research \|work=MarketWatch \|date=23 June 2020 \|accessdate=06 August 2020}}</ref> Writing about the thirty-fifth anniversary of PCR in 2018, science writer Alan Dove not only highlighted these cost issues but also the size and energy requirements for running the equipment. "As a result, one of the defining techniques of modern molecular biology has remained stubbornly inaccessible to educators and unusable in many remote locations."<ref name="DovePCR18">{{cite journal \|title=PCR: Thirty-five years and counting \|journal=Science \|author=Dove, A. \|volume=360 \|issue=6389 \|pages=670–672 \|year=2018 \|doi=10.1126/science.360.6389.673-c}}</ref> Various efforts have been made over the years to bring costs down by modifying how heating and temperature control are performed<ref name="WongARapid15">{{cite journal \|title=A Rapid and Low-Cost PCR Thermal Cycler for Low Resource Settings \|journal=PLoS One \|author=Wong, G.; Wong, I. Chan, K. et al. \|volume=10 \|issue=7 \|at=e0131701 \|year=2015 \|doi=10.1371/journal.pone.0131701}}</ref><ref name="KuznetsovDIYbio15">{{cite journal \|title=DIYbio Things: Open Source Biology Tools as Platforms for Hybrid Knowledge Production and Scientific Participation \|journal=Proceedings of the 33rd Annual ACM Conference on Human Factors in Computing Systems \|author=Kuznetsov, S.; Doonan, C.; Wilson, N. et al. \|pages=4065–68 \|year=2015 \|doi=10.1145/2702123.2702235}}</ref><ref name="NortonPhila16">{{cite web \|url=https://www.bizjournals.com/philadelphia/news/2016/05/11/government-contract-biomeme-hiring-med-tech.html \|title=Phila. med tech startup working on multimillion dollar government contract \|author=Norton, D. \|work=Philadelphia Business Journal \|date=11 May 2016 \|accessdate=06 August 2020}}</ref><ref name="AnLow20">{{cite journal \|title=Low-Cost Battery-Powered and User-Friendly Real-Time Quantitative PCR System for the Detection of Multigene \|journal=Micromachines \|author=An, J.; Jiang, Y.; Shi, B. et al. \|volume=11 \|at=435 \|year=2020 \|doi=10.3390/mi11040435}}</ref>, but many of those system aren't typically optimal during a pandemic when turnaround time is critical.		PCR technology has advanced to the point where it is more efficient and user-friendly than prior, yet "the high cost of the instruments, servicing contracts, and reagents pose major challenges for the market, especially to the price-sensitive academics."<ref name="MWPoly20">{{cite web \|url=https://www.marketwatch.com/press-release/polymerase-chain-reaction-market-sector-analysis-report-regional-outlook-competitive-share-forecast---2023-2020-06-23 \|title=Polymerase Chain Reaction Market Sector Analysis Report, Regional Outlook & Competitive Share & Forecast - 2023 \|author=Kenneth Research \|work=MarketWatch \|date=23 June 2020 \|accessdate=06 August 2020}}</ref> Writing about the thirty-fifth anniversary of PCR in 2018, science writer Alan Dove not only highlighted these cost issues but also the size and energy requirements for running the equipment. "As a result, one of the defining techniques of modern molecular biology has remained stubbornly inaccessible to educators and unusable in many remote locations."<ref name="DovePCR18">{{cite journal \|title=PCR: Thirty-five years and counting \|journal=Science \|author=Dove, A. \|volume=360 \|issue=6389 \|pages=670–672 \|year=2018 \|doi=10.1126/science.360.6389.673-c}}</ref> Various efforts have been made over the years to bring costs down by modifying how heating and temperature control are performed<ref name="WongARapid15">{{cite journal \|title=A Rapid and Low-Cost PCR Thermal Cycler for Low Resource Settings \|journal=PLoS One \|author=Wong, G.; Wong, I. Chan, K. et al. \|volume=10 \|issue=7 \|at=e0131701 \|year=2015 \|doi=10.1371/journal.pone.0131701}}</ref><ref name="KuznetsovDIYbio15">{{cite journal \|title=DIYbio Things: Open Source Biology Tools as Platforms for Hybrid Knowledge Production and Scientific Participation \|journal=Proceedings of the 33rd Annual ACM Conference on Human Factors in Computing Systems \|author=Kuznetsov, S.; Doonan, C.; Wilson, N. et al. \|pages=4065–68 \|year=2015 \|doi=10.1145/2702123.2702235}}</ref><ref name="NortonPhila16">{{cite web \|url=https://www.bizjournals.com/philadelphia/news/2016/05/11/government-contract-biomeme-hiring-med-tech.html \|title=Phila. med tech startup working on multimillion dollar government contract \|author=Norton, D. \|work=Philadelphia Business Journal \|date=11 May 2016 \|accessdate=06 August 2020}}</ref><ref name="AnLow20">{{cite journal \|title=Low-Cost Battery-Powered and User-Friendly Real-Time Quantitative PCR System for the Detection of Multigene \|journal=Micromachines \|author=An, J.; Jiang, Y.; Shi, B. et al. \|volume=11 \|at=435 \|year=2020 \|doi=10.3390/mi11040435}}</ref>, but many of those system aren't typically optimal during a pandemic when turnaround time is critical.
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	====3.1.5 Point-of-care and other alternative testing====		====3.1.5 Point-of-care and other alternative testing====
	On August 5, 2020, the WHO published a draft blueprint for what they call Target Product Profiles (TPP), which "describe the desirable and minimally acceptable profiles" for four difference COVID-19 test categories.<ref name="WHOCOVIDTarget20">{{cite web \|url=https://www.who.int/publications/m/item/covid-19-target-product-profiles-for-priority-diagnostics-to-support-response-to-the-covid-19-pandemic-v.0.1 \|title=COVID-19 Target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.0.1 \|author=World Health Organization \|publisher=World Health Organization \|date=05 August 2020 \|accessdate=12 August 2020}}</ref> Addressing POC testing, the WHO recommends that such assays<ref name="WHOCOVIDTarget20" /><ref name="PeplowRapid20">{{cite web \|url=https://cen.acs.org/analytical-chemistry/diagnostics/Rapid-COVID-19-testing-breaks/98/web/2020/08 \|title=Rapid COVID-19 testing breaks free from the lab \|author=Peplow, M. \|work=Chemical & Engineering News \|date=10 August 2020 \|accessdate=12 August 2020}}</ref>:		[[File:Microfluidic chip for point-of-care medical devices.jpg\|right\|thumb\|400px\|Example of a microfluidic chip used in point-of-care medical devices]]On August 5, 2020, the WHO published a draft blueprint for what they call Target Product Profiles (TPP), which "describe the desirable and minimally acceptable profiles" for four difference COVID-19 test categories.<ref name="WHOCOVIDTarget20">{{cite web \|url=https://www.who.int/publications/m/item/covid-19-target-product-profiles-for-priority-diagnostics-to-support-response-to-the-covid-19-pandemic-v.0.1 \|title=COVID-19 Target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.0.1 \|author=World Health Organization \|publisher=World Health Organization \|date=05 August 2020 \|accessdate=12 August 2020}}</ref> Addressing POC testing, the WHO recommends that such assays<ref name="WHOCOVIDTarget20" /><ref name="PeplowRapid20">{{cite web \|url=https://cen.acs.org/analytical-chemistry/diagnostics/Rapid-COVID-19-testing-breaks/98/web/2020/08 \|title=Rapid COVID-19 testing breaks free from the lab \|author=Peplow, M. \|work=Chemical & Engineering News \|date=10 August 2020 \|accessdate=12 August 2020}}</ref>:

	* have a sensitivity (true positive rate) or at least 70 percent;		* have a sensitivity (true positive rate) or at least 70 percent;

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	====3.3.3 Billing, Medicare, and Medicaid====		====3.3.3 Billing, Medicare, and Medicaid====
	The COVID-19 pandemic has unquestionably put the U.S. health care system in a tough spot. That health care system, with all its warts<ref name="PreskittHealth08">{{cite journal \|title=Health care reimbursement: Clemens to Clinton \|journal=Baylor University Medical Center Proceedings \|author=Preskitt, J.T. \|volume=21 \|issue=1 \|pages=40–4 \|year=2008 \|doi=10.1080/08998280.2008.11928358 \|pmid=18209755 \|pmc=PMC2190551}}</ref><ref name="FiferHealth16">{{cite web \|url=https://www.asha.org/Articles/Health-Care-Economics-The-Real-Source-of-Reimbursement-Problems/ \|title=Health Care Economics: The Real Source of Reimbursement Problems \|author=Fifer, R. \|publisher=American Speech-Language-Hearing Association \|date=July 2016 \|accessdate=21 August 2020}}</ref><ref name="HuckmanWhat20">{{cite web \|url=https://hbr.org/2020/04/what-will-u-s-health-care-look-like-after-the-pandemic \|title=What Will U.S. Health Care Look Like After the Pandemic? \|author=Huckman, R.S. \|work=Harvard Business Review \|date=07 April 2020 \|accessdate=21 August 2020}}</ref>, has arguably not done well to handle so many unanticipated health issues from a broad portion of the population.<ref name="HuckmanWhat20" /><ref name="DorsettPoint20">{{cite journal \|title=Point of no return: COVID-19 and the U.S. healthcare system: An emergency physician’s perspective \|journal=Science Advances \|author=Dorsett, M. \|volume=6 \|issue=26 \|at=eabc5354 \|year=2020 \|doi=10.1126/sciadv.abc5354 \|pmid=32637627 \|pmc=PMC7319747}}</ref><ref name="SlotkinHow20">{{cite web \|url=https://hbr.org/2020/06/how-one-health-system-is-transforming-in-response-to-covid-19 \|title=How One Health System Is Transforming in Response to Covid-19 \|author=Slotkin, J.R.; Murphy, K.; Ryu, J. \|work=Harvard Business Review \|date=11 June 2020 \|accessdate=21 August 2020}}</ref><ref name="MendelsonProvid20">{{cite web \|url=https://www.forbes.com/sites/danielmendelson/2020/06/30/the-impact-of-covid-19-on-providers-risk-recession-and-reimbursement/ \|title=The Impact Of COVID-19 On Providers: Risk, Recession And Reimbursement \|author=Mendelson, D. \|work=Forbes \|date=30 June 2020 \|accessdate=21 August 2020}}</ref>		The COVID-19 pandemic has unquestionably put the U.S. health care system in a tough spot. That health care system, with all its warts<ref name="PreskittHealth08">{{cite journal \|title=Health care reimbursement: Clemens to Clinton \|journal=Baylor University Medical Center Proceedings \|author=Preskitt, J.T. \|volume=21 \|issue=1 \|pages=40–4 \|year=2008 \|doi=10.1080/08998280.2008.11928358 \|pmid=18209755 \|pmc=PMC2190551}}</ref><ref name="FiferHealth16">{{cite web \|url=https://www.asha.org/Articles/Health-Care-Economics-The-Real-Source-of-Reimbursement-Problems/ \|title=Health Care Economics: The Real Source of Reimbursement Problems \|author=Fifer, R. \|publisher=American Speech-Language-Hearing Association \|date=July 2016 \|accessdate=21 August 2020}}</ref><ref name="HuckmanWhat20">{{cite web \|url=https://hbr.org/2020/04/what-will-u-s-health-care-look-like-after-the-pandemic \|title=What Will U.S. Health Care Look Like After the Pandemic? \|author=Huckman, R.S. \|work=Harvard Business Review \|date=07 April 2020 \|accessdate=21 August 2020}}</ref>, has arguably not done well to handle so many unanticipated health issues from a broad portion of the population.<ref name="HuckmanWhat20" /><ref name="DorsettPoint20">{{cite journal \|title=Point of no return: COVID-19 and the U.S. healthcare system: An emergency physician’s perspective \|journal=Science Advances \|author=Dorsett, M. \|volume=6 \|issue=26 \|at=eabc5354 \|year=2020 \|doi=10.1126/sciadv.abc5354 \|pmid=32637627 \|pmc=PMC7319747}}</ref><ref name="SlotkinHow20">{{cite web \|url=https://hbr.org/2020/06/how-one-health-system-is-transforming-in-response-to-covid-19 \|title=How One Health System Is Transforming in Response to Covid-19 \|author=Slotkin, J.R.; Murphy, K.; Ryu, J. \|work=Harvard Business Review \|date=11 June 2020 \|accessdate=21 August 2020}}</ref><ref name="MendelsonProvid20">{{cite web \|url=https://www.forbes.com/sites/danielmendelson/2020/06/30/the-impact-of-covid-19-on-providers-risk-recession-and-reimbursement/ \|title=The Impact Of COVID-19 On Providers: Risk, Recession And Reimbursement \|author=Mendelson, D. \|work=Forbes \|date=30 June 2020 \|accessdate=21 August 2020}}</ref> From a provider side, proper reimbursement for COVID-19 testing is among the many issues that must be addressed. One key aspect of ensuring proper reimbursement in a reasonable time frame is first making sure a clear preregisteration process that captures critical patient and facility information is conducted. (This can be facilitated and made easier as a first-step process in a clinical informatics solution, for example.) Critical patient and facility information includes (but is not limited to):

	From a provider side, proper reimbursement for COVID-19 testing is among the many issues that must be addressed. One key aspect of ensuring proper reimbursement in a reasonable time frame is first making sure a clear preregisteration process that captures critical patient and facility information is conducted. (This can be facilitated and made easier as a first-step process in a clinical informatics solution, for example.) Critical patient and facility information includes (but is not limited to):

	* name, date of birth, and gender		* name, date of birth, and gender
	* race and ethnicity		* race and ethnicity
	* demographic information such as full address and phone number		* demographic information such as full address and phone number
	* ordering physician or attending health care provider for test (if applicable)		* ordering physician or attending health care provider for test (if applicable; see )
	* facility's National Provider Identifier (NPI)		* facility's National Provider Identifier (NPI)
	* patient insurance company name, policy ID, group ID, insured's name, and insured relationship to patient (if insured)		* patient insurance company name, policy ID, group ID, insured's name, and insured relationship to patient (if insured)
	* whether or not it's the patient's first test		* whether or not it's the patient's first test (federal reporting requirement)
	* whether or not the patient is a resident of a congregate care setting (e.g., additional Medicaid reimbursement may be available in some states<ref name="FlinnStates20">{{cite web \|url=https://www.leadingage.org/regulation/states-leverage-medicaid-provide-nursing-homes-lifeline-through-covid-19 \|title=States Leverage Medicaid to Provide Nursing Homes a Lifeline through COVID-19 \|author=Flinn, B. \|work=LeadingAge \|date=12 June 2020 \|accessdate=21 August 2020}}</ref>)		* whether or not the patient is a resident of a congregate care setting (federal reporting requirement; also, e.g., additional Medicaid reimbursement may be available in some states<ref name="FlinnStates20">{{cite web \|url=https://www.leadingage.org/regulation/states-leverage-medicaid-provide-nursing-homes-lifeline-through-covid-19 \|title=States Leverage Medicaid to Provide Nursing Homes a Lifeline through COVID-19 \|author=Flinn, B. \|work=LeadingAge \|date=12 June 2020 \|accessdate=21 August 2020}}</ref>)
	* whether or not the patient is a healthcare worker (e.g., may affect the patient's worker's compensation claim<ref name="DOLClaimsUnder20">{{cite web \|url=https://www.dol.gov/owcp/dfec/InfoFECACoverageCoronavirus.htm \|title=Claims under the Federal Employees' Compensation Act due to the 2019 Novel Coronavirus (COVID-19) \|author=Division of Federal Employees' Compensation \|publisher=U.S. Department of Labor \|date=2020 \|accessdate=21 August 2020}}</ref><ref name="MichiganWorkers20">{{cite web \|url=https://www.michigan.gov/ag/0,4534,7-359-98784_98791-523085--,00.html \|title=Worker's Compensation for First Responders \|author=Department of Attorney General \|publisher=State of Michigan \|date=2020 \|accessdate=21 August 2020}}</ref>)		* whether or not the patient is a healthcare worker (federal reporting requirement; also, e.g., may affect the patient's worker's compensation claim<ref name="DOLClaimsUnder20">{{cite web \|url=https://www.dol.gov/owcp/dfec/InfoFECACoverageCoronavirus.htm \|title=Claims under the Federal Employees' Compensation Act due to the 2019 Novel Coronavirus (COVID-19) \|author=Division of Federal Employees' Compensation \|publisher=U.S. Department of Labor \|date=2020 \|accessdate=21 August 2020}}</ref><ref name="MichiganWorkers20">{{cite web \|url=https://www.michigan.gov/ag/0,4534,7-359-98784_98791-523085--,00.html \|title=Worker's Compensation for First Responders \|author=Department of Attorney General \|publisher=State of Michigan \|date=2020 \|accessdate=21 August 2020}}</ref>)
	* whether or not the patient is pregnant (e.g., Medicare will ''only'' accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium<ref name="HSRACOVID20">{{cite web \|url=https://www.hrsa.gov/CovidUninsuredClaim \|title=COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured \|publisher=Health Resources & Services Administration \|date=May 2020 \|accessdate=21 August 2020}}</ref><ref name="ACEPCoding20">{{cite web \|url=https://www.acep.org/administration/reimbursement/covid-19/ \|title=Coding Guidance for COVID-19 \|publisher=American College of Emergency Physicians \|date=2020 \|accessdate=21 August 2020}}</ref>)		* whether or not the patient is pregnant (federal reporting requirement; also, e.g., Medicare will ''only'' accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium<ref name="HSRACOVID20">{{cite web \|url=https://www.hrsa.gov/CovidUninsuredClaim \|title=COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured \|publisher=Health Resources & Services Administration \|date=May 2020 \|accessdate=21 August 2020}}</ref><ref name="ACEPCoding20">{{cite web \|url=https://www.acep.org/administration/reimbursement/covid-19/ \|title=Coding Guidance for COVID-19 \|publisher=American College of Emergency Physicians \|date=2020 \|accessdate=21 August 2020}}</ref>)

			Secondarily, it's also important to have a plan in place for testing the uninsured. While the Families First and Coronavirus Relief Act (FFCRA) and the National Disaster Management System (NDMS) provide legal mechanisms for reimbursement for what should otherwise be free patient testing for SARS-CoV-2 and the associated visit, ambiguities of these mechanisms and how they are enforced are still creating problems.<ref name="AdlerTheLaws20">{{cite web \|url=https://www.brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2020/07/13/the-laws-governing-covid-19-test-payment-and-how-to-improve-them/ \|title=The laws governing COVID-19 test payment and how to improve them \|author=Adler, L.; Young, C.L. \|work=USC-Brookings Schaeffer Initiative for Health Policy \|publisher=Brookings Institution \|date=13 July 2020 \|accessdate=21 August 2020}}</ref> For example, while providers can turn to the NDMS (until funds run out) to pay uninsured claims at 110% of Medicare rates—with states' opting to cover those costs through their Medicaid program—providers are not obligated by the law to seek reimbursement from those entities and can optionally bill the uninsured patient directly, which is against the spirit of the FFCRA.<ref name="AdlerTheLaws20" /><ref name="DawsonTheNat20">{{cite web \|url=https://www.kff.org/coronavirus-covid-19/issue-brief/the-national-disaster-medical-system-ndms-and-the-covid-19-pandemic/ \|title=The National Disaster Medical System (NDMS) and the COVID-19 Pandemic \|author=Dawson, L. \|work=KFF \|date=22 April 2020 \|accessdate=21 August 2020}}</ref><ref name="CRSHealth20">{{cite web \|url=https://crsreports.congress.gov/product/pdf/R/R46316 \|title=Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127 \|author=Congressional Research Service \|date=17 April 2020 \|accessdate=21 August 2020}}</ref> As such, it's important to know what your lab's policy will be on managing uninsured patient claims. How will you get reimbursed if you're accepting uninsured patients? Resources that may help with these decisions include the [https://www.phe.gov/Preparedness/responders/ndms/definitive-care/Pages/default.aspx NDMS Definitive Care Reimbursement Program portal] and the Health Resources & Services Administration's [https://www.hrsa.gov/CovidUninsuredClaim information page] and [https://www.hrsa.gov/coviduninsuredclaim/frequently-asked-questions associated FAQ].

	~~Secondarily~~, ~~it's also important to have a plan in place for testing the uninsured. While the Families First and Coronavirus Relief Act (FFCRA)~~ and the ~~National Disaster Management System~~ (~~NDMS~~) provide legal mechanisms for reimbursement for what should otherwise be free patient testing for SARS-CoV-2 and the associated visit, ambiguities of these mechanisms and how they are enforced are still creating problems.<ref name="AdlerTheLaws20">{{cite web \|url=https://www.~~brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2020/07/13/the-laws-governing-covid-19-test-payment-and-how-to-improve-them/ \|title=~~The ~~laws governing COVID-19 test payment and how~~ to ~~improve them \|author=Adler, L.; Young, C~~.~~L. \|work=USC-Brookings Schaeffer Initiative for Health Policy \|publisher=Brookings Institution \|date=13 July 2020 \|accessdate=21 August 2020}}</ref>~~ For ~~example~~, ~~while providers can turn to the NDMS (until funds run out)~~ to ~~pay uninsured claims at 110% of Medicare rates—with states~~' opting to cover those costs through their Medicaid program—providers are not obligated by the law to seek reimbursement from those entities and can optionally bill the uninsured patient directly, which is against the spirit of the FFCRA.<ref name="AdlerTheLaws20" /><ref name="DawsonTheNat20">{{cite web \|url=https://www.~~kff~~.~~org~~/~~coronavirus~~-covid-19~~/issue~~-~~brief/the~~-~~national-disaster-medical-system-ndms-and-the-covid~~-19~~-pandemic/ \|title=The National Disaster Medical System~~ (~~NDMS~~) ~~and the COVID~~-19 Pandemic \|author=Dawson, L. \|work=KFF \|date=22 April 2020 \|accessdate=21 August 2020}}</ref><ref name="CRSHealth20">{{cite web \|url=https://crsreports.congress.gov/product/pdf/R/R46316 \|title=Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-~~127 \|author=Congressional Research~~ Service ~~\|date=17 April 2020 \|accessdate=21 August 2020}}</ref> As such, it~~'~~s important to understand what your reimbursement options are if you~~'~~re accepting uninsured patients~~. ~~Resources that may help include~~ the ~~[https://www.phe.gov/Preparedness/responders/ndms/definitive-care/Pages/default.aspx NDMS Definitive Care Reimbursement Program portal]~~ and ~~the Health Resources & Services Administration's [https://www.hrsa.gov/CovidUninsuredClaim information page] and [https://www.hrsa.gov/coviduninsuredclaim/frequently-asked-questions associated FAQ]~~.		For Medicare, Medicaid, and otherwise insured patients, the lab will likely have (or presumably acquire) someone on hand with billing experience. The preregistration information previously mentioned will still be important to implement. For further guidance on billing issues, you may wish to consult with CMS' [https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf extensive document] titled ''COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing''. Also, the next chapter addresses code sets for reporting and billing, which may prove useful.


	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}

Shawndouglas at 20:49, 21 August 2020

2020-08-21T20:49:32Z

← Older revision		Revision as of 20:49, 21 August 2020
Line 520:		Line 520:
	* whether or not the patient is pregnant (e.g., Medicare will ''only'' accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium<ref name="HSRACOVID20">{{cite web \|url=https://www.hrsa.gov/CovidUninsuredClaim \|title=COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured \|publisher=Health Resources & Services Administration \|date=May 2020 \|accessdate=21 August 2020}}</ref><ref name="ACEPCoding20">{{cite web \|url=https://www.acep.org/administration/reimbursement/covid-19/ \|title=Coding Guidance for COVID-19 \|publisher=American College of Emergency Physicians \|date=2020 \|accessdate=21 August 2020}}</ref>)		* whether or not the patient is pregnant (e.g., Medicare will ''only'' accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium<ref name="HSRACOVID20">{{cite web \|url=https://www.hrsa.gov/CovidUninsuredClaim \|title=COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured \|publisher=Health Resources & Services Administration \|date=May 2020 \|accessdate=21 August 2020}}</ref><ref name="ACEPCoding20">{{cite web \|url=https://www.acep.org/administration/reimbursement/covid-19/ \|title=Coding Guidance for COVID-19 \|publisher=American College of Emergency Physicians \|date=2020 \|accessdate=21 August 2020}}</ref>)

	Secondarily, it's also important to have a plan in place for testing the uninsured. While the Families First and Coronavirus Relief Act (FFCRA) and the National Disaster Management System (NDMS) provide legal mechanisms for reimbursement for what should otherwise be free patient testing for SARS-CoV-2 and the associated visit, ambiguities of these mechanisms and how they are enforced are still creating problems.<ref name="AdlerTheLaws20">{{cite web \|url=https://www.brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2020/07/13/the-laws-governing-covid-19-test-payment-and-how-to-improve-them/ \|title=The laws governing COVID-19 test payment and how to improve them \|author=Adler, L.; Young, C.L. \|work=USC-Brookings Schaeffer Initiative for Health Policy \|publisher=Brookings Institution \|date=13 July 2020 \|accessdate=21 August 2020}}</ref> For example, while providers can turn to the NDMS (until funds run out) to pay uninsured claims at 110% of Medicare rates—with states' opting to cover those costs through their Medicaid program—providers are not obligated by the law to seek reimbursement from those entities and can optionally bill the uninsured patient directly, which is against the spirit of the FFCRA.<ref name="AdlerTheLaws20" /><ref name="DawsonTheNat20">{{cite web \|url=https://www.kff.org/coronavirus-covid-19/issue-brief/the-national-disaster-medical-system-ndms-and-the-covid-19-pandemic/ \|title=The National Disaster Medical System (NDMS) and the COVID-19 Pandemic \|author=Dawson, L. \|work=KFF \|date=22 April 2020 \|accessdate=21 August 2020}}</ref>		Secondarily, it's also important to have a plan in place for testing the uninsured. While the Families First and Coronavirus Relief Act (FFCRA) and the National Disaster Management System (NDMS) provide legal mechanisms for reimbursement for what should otherwise be free patient testing for SARS-CoV-2 and the associated visit, ambiguities of these mechanisms and how they are enforced are still creating problems.<ref name="AdlerTheLaws20">{{cite web \|url=https://www.brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2020/07/13/the-laws-governing-covid-19-test-payment-and-how-to-improve-them/ \|title=The laws governing COVID-19 test payment and how to improve them \|author=Adler, L.; Young, C.L. \|work=USC-Brookings Schaeffer Initiative for Health Policy \|publisher=Brookings Institution \|date=13 July 2020 \|accessdate=21 August 2020}}</ref> For example, while providers can turn to the NDMS (until funds run out) to pay uninsured claims at 110% of Medicare rates—with states' opting to cover those costs through their Medicaid program—providers are not obligated by the law to seek reimbursement from those entities and can optionally bill the uninsured patient directly, which is against the spirit of the FFCRA.<ref name="AdlerTheLaws20" /><ref name="DawsonTheNat20">{{cite web \|url=https://www.kff.org/coronavirus-covid-19/issue-brief/the-national-disaster-medical-system-ndms-and-the-covid-19-pandemic/ \|title=The National Disaster Medical System (NDMS) and the COVID-19 Pandemic \|author=Dawson, L. \|work=KFF \|date=22 April 2020 \|accessdate=21 August 2020}}</ref><ref name="CRSHealth20">{{cite web \|url=https://crsreports.congress.gov/product/pdf/R/R46316 \|title=Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127 \|author=Congressional Research Service \|date=17 April 2020 \|accessdate=21 August 2020}}</ref> As such, it's important to understand what your reimbursement options are if you're accepting uninsured patients. Resources that may help include the [https://www.phe.gov/Preparedness/responders/ndms/definitive-care/Pages/default.aspx NDMS Definitive Care Reimbursement Program portal] and the Health Resources & Services Administration's [https://www.hrsa.gov/CovidUninsuredClaim information page] and [https://www.hrsa.gov/coviduninsuredclaim/frequently-asked-questions associated FAQ].


	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}

Shawndouglas at 20:37, 21 August 2020

2020-08-21T20:37:51Z

← Older revision		Revision as of 20:37, 21 August 2020
Line 520:		Line 520:
	* whether or not the patient is pregnant (e.g., Medicare will ''only'' accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium<ref name="HSRACOVID20">{{cite web \|url=https://www.hrsa.gov/CovidUninsuredClaim \|title=COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured \|publisher=Health Resources & Services Administration \|date=May 2020 \|accessdate=21 August 2020}}</ref><ref name="ACEPCoding20">{{cite web \|url=https://www.acep.org/administration/reimbursement/covid-19/ \|title=Coding Guidance for COVID-19 \|publisher=American College of Emergency Physicians \|date=2020 \|accessdate=21 August 2020}}</ref>)		* whether or not the patient is pregnant (e.g., Medicare will ''only'' accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium<ref name="HSRACOVID20">{{cite web \|url=https://www.hrsa.gov/CovidUninsuredClaim \|title=COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured \|publisher=Health Resources & Services Administration \|date=May 2020 \|accessdate=21 August 2020}}</ref><ref name="ACEPCoding20">{{cite web \|url=https://www.acep.org/administration/reimbursement/covid-19/ \|title=Coding Guidance for COVID-19 \|publisher=American College of Emergency Physicians \|date=2020 \|accessdate=21 August 2020}}</ref>)

	Secondarily, it's also important to have a plan in place for testing the uninsured. While the Families First and Coronavirus Relief Act (FFCRA) and the National Disaster Management System (NDMS) provide legal mechanisms for reimbursement for what should otherwise be free patient testing for SARS-CoV-2 and the associated visit, ambiguities of these mechanisms and how they are enforced are still creating problems.<ref name="AdlerTheLaws20">{{cite web \|url=https://www.brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2020/07/13/the-laws-governing-covid-19-test-payment-and-how-to-improve-them/ \|title=The laws governing COVID-19 test payment and how to improve them \|author=Adler, L.; Young, C.L. \|work=USC-Brookings Schaeffer Initiative for Health Policy \|publisher=Brookings Institution \|date=13 July 2020 \|accessdate=21 August 2020}}</ref>		Secondarily, it's also important to have a plan in place for testing the uninsured. While the Families First and Coronavirus Relief Act (FFCRA) and the National Disaster Management System (NDMS) provide legal mechanisms for reimbursement for what should otherwise be free patient testing for SARS-CoV-2 and the associated visit, ambiguities of these mechanisms and how they are enforced are still creating problems.<ref name="AdlerTheLaws20">{{cite web \|url=https://www.brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2020/07/13/the-laws-governing-covid-19-test-payment-and-how-to-improve-them/ \|title=The laws governing COVID-19 test payment and how to improve them \|author=Adler, L.; Young, C.L. \|work=USC-Brookings Schaeffer Initiative for Health Policy \|publisher=Brookings Institution \|date=13 July 2020 \|accessdate=21 August 2020}}</ref> For example, while providers can turn to the NDMS (until funds run out) to pay uninsured claims at 110% of Medicare rates—with states' opting to cover those costs through their Medicaid program—providers are not obligated by the law to seek reimbursement from those entities and can optionally bill the uninsured patient directly, which is against the spirit of the FFCRA.<ref name="AdlerTheLaws20" /><ref name="DawsonTheNat20">{{cite web \|url=https://www.kff.org/coronavirus-covid-19/issue-brief/the-national-disaster-medical-system-ndms-and-the-covid-19-pandemic/ \|title=The National Disaster Medical System (NDMS) and the COVID-19 Pandemic \|author=Dawson, L. \|work=KFF \|date=22 April 2020 \|accessdate=21 August 2020}}</ref>


	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}

Shawndouglas at 20:18, 21 August 2020

2020-08-21T20:18:14Z

← Older revision		Revision as of 15:06, 23 August 2020
Line 492:		Line 492:
	===3.3 What other considerations should be made?===		===3.3 What other considerations should be made?===
	====3.3.1 U.S. regulatory compliance====		====3.3.1 U.S. regulatory compliance====
	In the previous chapter, the regulatory hurdles of the [[Health Insurance Portability and Accountability Act]] (HIPAA) and the [[Clinical Laboratory Improvement Amendments]] (CLIA) were addressed. For those laboratories ~~who~~ are already operating in the clinical laboratory sphere, it should be relatively simple to address the additional considerations and pandemic-specific changes to those two regulations as described previously. In addition to that information, you can always periodically check the U.S. Department of Health & Human Services' (HHS') [https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-covid19/index.html Office for Civil Rights] and their COVID-19 announcements and guidance, as well as the Centers for Medicare & Medicaid Services (CMS) [https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page emergencies page].		In the previous chapter, the regulatory hurdles of the [[Health Insurance Portability and Accountability Act]] (HIPAA) and the [[Clinical Laboratory Improvement Amendments]] (CLIA) were addressed. For those laboratories that are already operating in the clinical laboratory sphere, it should be relatively simple to address the additional considerations and pandemic-specific changes to those two regulations as described previously. In addition to that information, you can always periodically check the U.S. Department of Health & Human Services' (HHS') [https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-covid19/index.html Office for Civil Rights] and their COVID-19 announcements and guidance, as well as the Centers for Medicare & Medicaid Services (CMS) [https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page emergencies page].

	If for some reason you're not a clinical lab—or want to start a new lab—and want to take on COVID-19 and other clinical testing, you're going to need to get fast tracked into the CLIA program, for starters. Fortunately, CMS has already displayed a willingness to help labs wanting to perform COVID-19 testing receive their CLIA certificate rapidly. [https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf Form CMS-116] will need to be completed and submitted to your [https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf state survey agency contact]. Of course, while you're waiting, you'll also want to become familiar with the trappings of CLIA by tapping into resources like the [https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index?redirect=/CLIA/05_CLIA_Brochures.asp CMS page for CLIA], [https://www.cdc.gov/clia/quick-tips.html CDC page for CLIA], and resources available from professional organizations like the [https://www.aafp.org/family-physician/practice-and-career/managing-your-practice/clia.html American Academy of Family Physicians]. If all goes as plan, and directions are followed, you should have your CLIA certificate in no time. CMS adds<ref name="CMSFAQ">{{cite web \|url=https://www.cms.gov/files/document/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf \|format=PDF \|title=Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency \|author=Centers for Medicare and Medicaid Services \|accessdate=20 August 2020}}</ref>:		If for some reason you're not a clinical lab—or want to start a new lab—and want to take on COVID-19 and other clinical testing, you're going to need to get fast tracked into the CLIA program, for starters. Fortunately, CMS has already displayed a willingness to help labs wanting to perform COVID-19 testing receive their CLIA certificate rapidly. [https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf Form CMS-116] will need to be completed and submitted to your [https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf state survey agency contact]. Of course, while you're waiting, you'll also want to become familiar with the trappings of CLIA by tapping into resources like the [https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index?redirect=/CLIA/05_CLIA_Brochures.asp CMS page for CLIA], [https://www.cdc.gov/clia/quick-tips.html CDC page for CLIA], and resources available from professional organizations like the [https://www.aafp.org/family-physician/practice-and-career/managing-your-practice/clia.html American Academy of Family Physicians]. If all goes as plan, and directions are followed, you should have your CLIA certificate in no time. CMS adds<ref name="CMSFAQ">{{cite web \|url=https://www.cms.gov/files/document/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf \|format=PDF \|title=Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency \|author=Centers for Medicare and Medicaid Services \|accessdate=20 August 2020}}</ref>:
Line 511:		Line 511:

	====3.3.3 Billing, Medicare, and Medicaid====		====3.3.3 Billing, Medicare, and Medicaid====
	The COVID-19 pandemic has unquestionably put the U.S. health care system in a tough spot. That health care system, with all its warts<ref name="PreskittHealth08">{{cite journal \|title=Health care reimbursement: Clemens to Clinton \|journal=Baylor University Medical Center Proceedings \|author=Preskitt, J.T. \|volume=21 \|issue=1 \|pages=40–4 \|year=2008 \|doi=10.1080/08998280.2008.11928358 \|pmid=18209755 \|pmc=PMC2190551}}</ref><ref name="FiferHealth16">{{cite web \|url=https://www.asha.org/Articles/Health-Care-Economics-The-Real-Source-of-Reimbursement-Problems/ \|title=Health Care Economics: The Real Source of Reimbursement Problems \|author=Fifer, R. \|publisher=American Speech-Language-Hearing Association \|date=July 2016 \|accessdate=21 August 2020}}</ref><ref name="HuckmanWhat20">{{cite web \|url=https://hbr.org/2020/04/what-will-u-s-health-care-look-like-after-the-pandemic \|title=What Will U.S. Health Care Look Like After the Pandemic? \|author=Huckman, R.S. \|work=Harvard Business Review \|date=07 April 2020 \|accessdate=21 August 2020}}</ref>, has arguably not done well to handle so many unanticipated health issues from a broad portion of the population.<ref name="HuckmanWhat20" /><ref name="DorsettPoint20">{{cite journal \|title=Point of no return: COVID-19 and the U.S. healthcare system: An emergency physician’s perspective \|journal=Science Advances \|author=Dorsett, M. \|volume=6 \|issue=26 \|at=eabc5354 \|year=2020 \|doi=10.1126/sciadv.abc5354 \|pmid=32637627 \|pmc=PMC7319747}}</ref><ref name="SlotkinHow20">{{cite web \|url=https://hbr.org/2020/06/how-one-health-system-is-transforming-in-response-to-covid-19 \|title=How One Health System Is Transforming in Response to Covid-19 \|author=Slotkin, J.R.; Murphy, K.; Ryu, J. \|work=Harvard Business Review \|date=11 June 2020 \|accessdate=21 August 2020}}</ref><ref name="MendelsonProvid20">{{cite web \|url=https://www.forbes.com/sites/danielmendelson/2020/06/30/the-impact-of-covid-19-on-providers-risk-recession-and-reimbursement/ \|title=The Impact Of COVID-19 On Providers: Risk, Recession And Reimbursement \|author=Mendelson, D. \|work=Forbes \|date=30 June 2020 \|accessdate=21 August 2020}}</ref> From a provider side, proper reimbursement for COVID-19 testing is among the many issues that must be addressed. One key aspect of ensuring proper reimbursement in a reasonable time frame is first making sure a clear ~~preregisteration~~ process that captures critical patient and facility information is conducted. (This can be facilitated and made easier as a first-step process in a clinical informatics solution, for example.) Critical patient and facility information includes (but is not limited to):		The COVID-19 pandemic has unquestionably put the U.S. health care system in a tough spot. That health care system, with all its warts<ref name="PreskittHealth08">{{cite journal \|title=Health care reimbursement: Clemens to Clinton \|journal=Baylor University Medical Center Proceedings \|author=Preskitt, J.T. \|volume=21 \|issue=1 \|pages=40–4 \|year=2008 \|doi=10.1080/08998280.2008.11928358 \|pmid=18209755 \|pmc=PMC2190551}}</ref><ref name="FiferHealth16">{{cite web \|url=https://www.asha.org/Articles/Health-Care-Economics-The-Real-Source-of-Reimbursement-Problems/ \|title=Health Care Economics: The Real Source of Reimbursement Problems \|author=Fifer, R. \|publisher=American Speech-Language-Hearing Association \|date=July 2016 \|accessdate=21 August 2020}}</ref><ref name="HuckmanWhat20">{{cite web \|url=https://hbr.org/2020/04/what-will-u-s-health-care-look-like-after-the-pandemic \|title=What Will U.S. Health Care Look Like After the Pandemic? \|author=Huckman, R.S. \|work=Harvard Business Review \|date=07 April 2020 \|accessdate=21 August 2020}}</ref>, has arguably not done well to handle so many unanticipated health issues from a broad portion of the population.<ref name="HuckmanWhat20" /><ref name="DorsettPoint20">{{cite journal \|title=Point of no return: COVID-19 and the U.S. healthcare system: An emergency physician’s perspective \|journal=Science Advances \|author=Dorsett, M. \|volume=6 \|issue=26 \|at=eabc5354 \|year=2020 \|doi=10.1126/sciadv.abc5354 \|pmid=32637627 \|pmc=PMC7319747}}</ref><ref name="SlotkinHow20">{{cite web \|url=https://hbr.org/2020/06/how-one-health-system-is-transforming-in-response-to-covid-19 \|title=How One Health System Is Transforming in Response to Covid-19 \|author=Slotkin, J.R.; Murphy, K.; Ryu, J. \|work=Harvard Business Review \|date=11 June 2020 \|accessdate=21 August 2020}}</ref><ref name="MendelsonProvid20">{{cite web \|url=https://www.forbes.com/sites/danielmendelson/2020/06/30/the-impact-of-covid-19-on-providers-risk-recession-and-reimbursement/ \|title=The Impact Of COVID-19 On Providers: Risk, Recession And Reimbursement \|author=Mendelson, D. \|work=Forbes \|date=30 June 2020 \|accessdate=21 August 2020}}</ref> From a provider side, proper reimbursement for COVID-19 testing is among the many issues that must be addressed. One key aspect of ensuring proper reimbursement in a reasonable time frame is first making sure a clear preregistration process that captures critical patient and facility information is conducted. (This can be facilitated and made easier as a first-step process in a clinical informatics solution, for example.) Critical patient and facility information includes (but is not limited to):

	* name, date of birth, and gender		* name, date of birth, and gender
	* race and ethnicity		* race and ethnicity
	* demographic information such as full address and phone number		* demographic information such as full address and phone number
	* ordering physician or attending health care provider for test (if applicable~~; see~~ )		* ordering physician or attending health care provider for test (if applicable)
	* facility's National Provider Identifier (NPI)		* facility's National Provider Identifier (NPI)
	* patient insurance company name, policy ID, group ID, insured's name, and insured relationship to patient (if insured)		* patient insurance company name, policy ID, group ID, insured's name, and insured relationship to patient (if insured)
Line 527:		Line 527:

	For Medicare, Medicaid, and otherwise insured patients, the lab will likely have (or presumably acquire) someone on hand with billing experience. The preregistration information previously mentioned will still be important to implement. For further guidance on billing issues, you may wish to consult with CMS' [https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf extensive document] titled ''COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing''. Also, the next chapter addresses code sets for reporting and billing, which may prove useful.		For Medicare, Medicaid, and otherwise insured patients, the lab will likely have (or presumably acquire) someone on hand with billing experience. The preregistration information previously mentioned will still be important to implement. For further guidance on billing issues, you may wish to consult with CMS' [https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf extensive document] titled ''COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing''. Also, the next chapter addresses code sets for reporting and billing, which may prove useful.


	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}

← Older revision		Revision as of 20:18, 21 August 2020
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	====3.3.3 Billing, Medicare, and Medicaid====		====3.3.3 Billing, Medicare, and Medicaid====
	The COVID-19 pandemic has unquestionably put the U.S. health care system in a tough spot. That health care system, with all its warts<ref name="PreskittHealth08">{{cite journal \|title=Health care reimbursement: Clemens to Clinton \|journal=Baylor University Medical Center Proceedings \|author=Preskitt, J.T. \|volume=21 \|issue=1 \|pages=40–4 \|year=2008 \|doi=10.1080/08998280.2008.11928358 \|pmid=18209755 \|pmc=PMC2190551}}</ref><ref name="FiferHealth16">{{cite web \|url=https://www.asha.org/Articles/Health-Care-Economics-The-Real-Source-of-Reimbursement-Problems/ \|title=Health Care Economics: The Real Source of Reimbursement Problems \|author=Fifer, R. \|publisher=American Speech-Language-Hearing Association \|date=July 2016 \|accessdate=21 August 2020}}</ref><ref name="HuckmanWhat20">{{cite web \|url=https://hbr.org/2020/04/what-will-u-s-health-care-look-like-after-the-pandemic \|title=What Will U.S. Health Care Look Like After the Pandemic? \|author=Huckman, R.S. \|work=Harvard Business Review \|date=07 April 2020 \|accessdate=21 August 2020}}</ref>, has arguably not done well to handle so many unanticipated health issues from a broad portion of the population.<ref name="HuckmanWhat20" /><ref name="DorsettPoint20">{{cite journal \|title=Point of no return: COVID-19 and the U.S. healthcare system: An emergency physician’s perspective \|journal=Science Advances \|author=Dorsett, M. \|volume=6 \|issue=26 \|at=eabc5354 \|year=2020 \|doi=10.1126/sciadv.abc5354 \|pmid=32637627 \|pmc=PMC7319747}}</ref><ref name="SlotkinHow20">{{cite web \|url=https://hbr.org/2020/06/how-one-health-system-is-transforming-in-response-to-covid-19 \|title=How One Health System Is Transforming in Response to Covid-19 \|author=Slotkin, J.R.; Murphy, K.; Ryu, J. \|work=Harvard Business Review \|date=11 June 2020 \|accessdate=21 August 2020}}</ref>		The COVID-19 pandemic has unquestionably put the U.S. health care system in a tough spot. That health care system, with all its warts<ref name="PreskittHealth08">{{cite journal \|title=Health care reimbursement: Clemens to Clinton \|journal=Baylor University Medical Center Proceedings \|author=Preskitt, J.T. \|volume=21 \|issue=1 \|pages=40–4 \|year=2008 \|doi=10.1080/08998280.2008.11928358 \|pmid=18209755 \|pmc=PMC2190551}}</ref><ref name="FiferHealth16">{{cite web \|url=https://www.asha.org/Articles/Health-Care-Economics-The-Real-Source-of-Reimbursement-Problems/ \|title=Health Care Economics: The Real Source of Reimbursement Problems \|author=Fifer, R. \|publisher=American Speech-Language-Hearing Association \|date=July 2016 \|accessdate=21 August 2020}}</ref><ref name="HuckmanWhat20">{{cite web \|url=https://hbr.org/2020/04/what-will-u-s-health-care-look-like-after-the-pandemic \|title=What Will U.S. Health Care Look Like After the Pandemic? \|author=Huckman, R.S. \|work=Harvard Business Review \|date=07 April 2020 \|accessdate=21 August 2020}}</ref>, has arguably not done well to handle so many unanticipated health issues from a broad portion of the population.<ref name="HuckmanWhat20" /><ref name="DorsettPoint20">{{cite journal \|title=Point of no return: COVID-19 and the U.S. healthcare system: An emergency physician’s perspective \|journal=Science Advances \|author=Dorsett, M. \|volume=6 \|issue=26 \|at=eabc5354 \|year=2020 \|doi=10.1126/sciadv.abc5354 \|pmid=32637627 \|pmc=PMC7319747}}</ref><ref name="SlotkinHow20">{{cite web \|url=https://hbr.org/2020/06/how-one-health-system-is-transforming-in-response-to-covid-19 \|title=How One Health System Is Transforming in Response to Covid-19 \|author=Slotkin, J.R.; Murphy, K.; Ryu, J. \|work=Harvard Business Review \|date=11 June 2020 \|accessdate=21 August 2020}}</ref><ref name="MendelsonProvid20">{{cite web \|url=https://www.forbes.com/sites/danielmendelson/2020/06/30/the-impact-of-covid-19-on-providers-risk-recession-and-reimbursement/ \|title=The Impact Of COVID-19 On Providers: Risk, Recession And Reimbursement \|author=Mendelson, D. \|work=Forbes \|date=30 June 2020 \|accessdate=21 August 2020}}</ref>

	From a provider side, proper reimbursement for COVID-19 testing is among the many issues that must be addressed. One key aspect of ensuring proper reimbursement in a reasonable time frame is making sure a clear preregisteration process that captures critical patient and facility information is conducted. Critical patient and facility information includes (but is not limited to):		From a provider side, proper reimbursement for COVID-19 testing is among the many issues that must be addressed. One key aspect of ensuring proper reimbursement in a reasonable time frame is first making sure a clear preregisteration process that captures critical patient and facility information is conducted. (This can be facilitated and made easier as a first-step process in a clinical informatics solution, for example.) Critical patient and facility information includes (but is not limited to):

	* name, date of birth, and gender		* name, date of birth, and gender
	* race and ethnicity		* race and ethnicity
	* demographic information such as full address and phone number		* demographic information such as full address and phone number
	* ordering physician for test (if applicable)		* ordering physician or attending health care provider for test (if applicable)
	* facility's National Provider Identifier (NPI)		* facility's National Provider Identifier (NPI)
	* patient insurance company name, policy ID, group ID, insured's name, and insured relationship to patient (if insured)		* patient insurance company name, policy ID, group ID, insured's name, and insured relationship to patient (if insured)
	* whether or not it's the patient's first test		* whether or not it's the patient's first test
	* whether or not the patient is a resident of a congregate care setting		* whether or not the patient is a resident of a congregate care setting (e.g., additional Medicaid reimbursement may be available in some states<ref name="FlinnStates20">{{cite web \|url=https://www.leadingage.org/regulation/states-leverage-medicaid-provide-nursing-homes-lifeline-through-covid-19 \|title=States Leverage Medicaid to Provide Nursing Homes a Lifeline through COVID-19 \|author=Flinn, B. \|work=LeadingAge \|date=12 June 2020 \|accessdate=21 August 2020}}</ref>)
	* whether or not the patient is a healthcare worker		* whether or not the patient is a healthcare worker (e.g., may affect the patient's worker's compensation claim<ref name="DOLClaimsUnder20">{{cite web \|url=https://www.dol.gov/owcp/dfec/InfoFECACoverageCoronavirus.htm \|title=Claims under the Federal Employees' Compensation Act due to the 2019 Novel Coronavirus (COVID-19) \|author=Division of Federal Employees' Compensation \|publisher=U.S. Department of Labor \|date=2020 \|accessdate=21 August 2020}}</ref><ref name="MichiganWorkers20">{{cite web \|url=https://www.michigan.gov/ag/0,4534,7-359-98784_98791-523085--,00.html \|title=Worker's Compensation for First Responders \|author=Department of Attorney General \|publisher=State of Michigan \|date=2020 \|accessdate=21 August 2020}}</ref>)
	* whether or not the patient is pregnant (e.g., Medicare will ''only'' accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium<ref name="HSRACOVID20">{{cite web \|url=https://www.hrsa.gov/CovidUninsuredClaim \|title=COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured \|publisher=Health Resources & Services Administration \|date=May 2020 \|accessdate=21 August 2020}}</ref><ref name="ACEPCoding20">{{cite web \|url=https://www.acep.org/administration/reimbursement/covid-19/ \|title=Coding Guidance for COVID-19 \|publisher=American College of Emergency Physicians \|date=2020 \|accessdate=21 August 2020}}</ref>)		* whether or not the patient is pregnant (e.g., Medicare will ''only'' accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium<ref name="HSRACOVID20">{{cite web \|url=https://www.hrsa.gov/CovidUninsuredClaim \|title=COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured \|publisher=Health Resources & Services Administration \|date=May 2020 \|accessdate=21 August 2020}}</ref><ref name="ACEPCoding20">{{cite web \|url=https://www.acep.org/administration/reimbursement/covid-19/ \|title=Coding Guidance for COVID-19 \|publisher=American College of Emergency Physicians \|date=2020 \|accessdate=21 August 2020}}</ref>)

			Secondarily, it's also important to have a plan in place for testing the uninsured. While the Families First and Coronavirus Relief Act (FFCRA) and the National Disaster Management System (NDMS) provide legal mechanisms for reimbursement for what should otherwise be free patient testing for SARS-CoV-2 and the associated visit, ambiguities of these mechanisms and how they are enforced are still creating problems.<ref name="AdlerTheLaws20">{{cite web \|url=https://www.brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2020/07/13/the-laws-governing-covid-19-test-payment-and-how-to-improve-them/ \|title=The laws governing COVID-19 test payment and how to improve them \|author=Adler, L.; Young, C.L. \|work=USC-Brookings Schaeffer Initiative for Health Policy \|publisher=Brookings Institution \|date=13 July 2020 \|accessdate=21 August 2020}}</ref>


	==References==		==References==
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