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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].
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><ref name="MITWhat21">{{cite web |url=https://news.mit.edu/2021/what-has-pandemic-revealed-about-us-health-care-what-needs-change-0405 |title=What has the pandemic revealed about the US health care system — and what needs to change? |work=MIT News |publisher=Massachusetts Institute of Technology |date=05 April 2021 |accessdate=13 September 2021}}</ref><ref name="ScottTheUS21">{{cite web |url=https://www.vox.com/policy-and-politics/22555949/us-health-care-system-ranking-covid-19-pandemic |title=The US health system was already falling short. Then Covid-19 happened. |author=Scott, D. |work=Vox |date=06 July 2021 |accessdate=13 September 2021}}</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):


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 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 planned, 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>:
* name, date of birth, and gender
* race and ethnicity
* demographic information such as full address and phone number
* ordering physician or attending health care provider for test (if applicable)
* facility's National Provider Identifier (NPI)
* 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 (federal reporting requirement)
* 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 (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/agencies/owcp/FECA/InfoFECACoverageCoronavirus |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=06 May 2021 |accessdate=13 September 2021}}</ref><ref name="MichiganWorkers20">{{cite web |url=https://www.michigan.gov/ag/0,4534,7-359-98784_98791-523085--,00.html |archiveurl=https://web.archive.org/web/20200821194015/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 |archivedate=21 August 2021 |accessdate=13 September 2021}}</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>)


<blockquote>We want to ensure that laboratories located in the United States applying for a CLIA certificate are able to begin testing for COVID-19 as quickly as possible. Once the laboratory has identified a qualified laboratory director and has provided all required information on the CMS-116 application, a CLIA number will be assigned. Once the CLIA number has been assigned, the laboratory can begin testing as long as applicable CLIA requirements have been met (e.g., establishing performance specifications).</blockquote>
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) have historically provided 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 were enforced still managed to cause 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 could turn to the NDMS (until funds ran out) to pay uninsured claims at 110% of Medicare rates—with states' opting to cover those costs through their Medicaid program—providers were not obligated by the law to seek reimbursement from those entities and could optionally bill the uninsured patient directly, which was 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> Given these past problems and any lingering questions about existing programs like the HHS and HRSA coverage assistance programs<ref name="HSRACOVID20" />, 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 Health Resources & Services Administration's [https://www.hrsa.gov/CovidUninsuredClaim information page] and [https://www.hrsa.gov/coviduninsuredclaim/frequently-asked-questions associated FAQ].


On the HIPAA side of things, you'll want to tap into resources such as the HHS' [https://www.hhs.gov/hipaa/for-professionals/training/index.html HIPAA training materials and resources], as well as their previously mentioned COVID-19 announcements and guidance.
For Medicare, Medicaid, and otherwise insured patients, the lab will likely have (or presumably acquire) someone on hand with billing experience. However, the preregistration information previously mentioned will still be important to implement. And staying up-to-date regarding billing issues is also important (e.g., CMS' October 2020 announcement about payment for high-throughput COVID-19 tests and turnaround times<ref name="CMSChanges20">{{cite web |url=https://www.cms.gov/newsroom/press-releases/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing |title=CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing |work=CMS Newsroom |publisher=Centers for Medicare & Medicaid Services |date=15 October 2020 |accessdate=20 November 2020}}</ref>


Other considerations include<ref name="PaulAGuide20">{{cite web |url=https://www.clinicallabmanager.com/insight/a-guide-to-setting-up-a-coronavirus-covid-19-clinical-diagnostic-testing-laboratory-22850 |title=A Guide to Setting up a Coronavirus (COVID-19) Clinical Diagnostic Testing Laboratory |author=Paul, S. |work=Clinical Lab Manager |date=29 May 2020 |accessdate=13 September 2021}}</ref><ref name="BuchanInterim19">{{cite web |url=https://asm.org/ASM/media/Policy-and-Advocacy/Biosafety-white-paper-2019.pdf |format=PDF |title=Interim Clinical Laboratory Guideline for Biological Safety |author=Buchan, B.W.; Mahlen, S.D.; Relich, R.F. |publisher=The American Society for Microbiology |date=January 2019 |accessdate=20 August 2020}}</ref><ref name="CDCFrequently20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html |title=Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=24 August 2021 |accessdate=13 September 2021}}</ref><ref name="OSHACOVID20">{{cite web |url=https://www.osha.gov/coronavirus/control-prevention/laboratory |title=COVID-19 - Control and Prevention - Laboratory Workers and Employers |publisher=Occupational Safety and Health Administration |accessdate=13 September 2021}}</ref>:
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.
 
* taking the time to get accredited to ISO 15189:2012 Medical laboratories — Requirements for quality and competence, "used by medical laboratories in developing their quality management systems and assessing their own competence"<ref name="ISO15189">{{cite web |url=https://www.iso.org/standard/56115.html |title=ISO 15189:2012 Medical laboratories — Requirements for quality and competence |publisher=International Organization for Standardization |date=August 2014 |accessdate=20 August 2020}}</ref>;
* understanding and training on packaging (e.g., UN3373 Biological Substance, Category B) and shipping COVID-19 specimens (e.g., International Air Transport Association (IATA) Dangerous Goods Regulations), if you will be conducting such activities;
* understanding the significance of and validating workflow procedures to at least Biosafety Level 2 (note there is no single U.S. government entity which has total responsibility for enforcing biosafety levels<ref name="NASNRCBiosec12">{{cite book |url=https://www.ncbi.nlm.nih.gov/books/NBK196149/ |chapter=Appendix E - Country and Region Overviews |title=Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories: Summary of a Workshop |author=National Academy of Sciences and National Research Council |publisher=National Academies Press |pages=193–204 |year=2012 |isbn=9780309225786 |doi=10.17226/13315}}</ref>); and
* understanding and training on Occupational Safety and Health Administration (OSHA) requirements for laboratory workers and employers for COVID-19.


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

Revision as of 19:57, 3 February 2022

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[1][2][3], has arguably not done well to handle so many unanticipated health issues from a broad portion of the population.[3][4][5][6][7][8] 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
  • race and ethnicity
  • demographic information such as full address and phone number
  • ordering physician or attending health care provider for test (if applicable)
  • facility's National Provider Identifier (NPI)
  • 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 (federal reporting requirement)
  • 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[9])
  • whether or not the patient is a healthcare worker (federal reporting requirement; also, e.g., may affect the patient's worker's compensation claim[10][11])
  • 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[12][13])

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) have historically provided 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 were enforced still managed to cause problems.[14] For example, while providers could turn to the NDMS (until funds ran out) to pay uninsured claims at 110% of Medicare rates—with states' opting to cover those costs through their Medicaid program—providers were not obligated by the law to seek reimbursement from those entities and could optionally bill the uninsured patient directly, which was against the spirit of the FFCRA.[14][15][16] Given these past problems and any lingering questions about existing programs like the HHS and HRSA coverage assistance programs[12], 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 Health Resources & Services Administration's information page and associated FAQ.

For Medicare, Medicaid, and otherwise insured patients, the lab will likely have (or presumably acquire) someone on hand with billing experience. However, the preregistration information previously mentioned will still be important to implement. And staying up-to-date regarding billing issues is also important (e.g., CMS' October 2020 announcement about payment for high-throughput COVID-19 tests and turnaround times[17]

For further guidance on billing issues, you may wish to consult with CMS' 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

  1. ↑ Preskitt, J.T. (2008). "Health care reimbursement: Clemens to Clinton". Baylor University Medical Center Proceedings 21 (1): 40–4. doi:10.1080/08998280.2008.11928358. PMC PMC2190551. PMID 18209755. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2190551. 
  2. ↑ Fifer, R. (July 2016). "Health Care Economics: The Real Source of Reimbursement Problems". American Speech-Language-Hearing Association. https://www.asha.org/Articles/Health-Care-Economics-The-Real-Source-of-Reimbursement-Problems/. Retrieved 21 August 2020. 
  3. ↑ 3.0 3.1 Huckman, R.S. (7 April 2020). "What Will U.S. Health Care Look Like After the Pandemic?". Harvard Business Review. https://hbr.org/2020/04/what-will-u-s-health-care-look-like-after-the-pandemic. Retrieved 21 August 2020. 
  4. ↑ Dorsett, M. (2020). "Point of no return: COVID-19 and the U.S. healthcare system: An emergency physician’s perspective". Science Advances 6 (26): eabc5354. doi:10.1126/sciadv.abc5354. PMC PMC7319747. PMID 32637627. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7319747. 
  5. ↑ Slotkin, J.R.; Murphy, K.; Ryu, J. (11 June 2020). "How One Health System Is Transforming in Response to Covid-19". Harvard Business Review. https://hbr.org/2020/06/how-one-health-system-is-transforming-in-response-to-covid-19. Retrieved 21 August 2020. 
  6. ↑ Mendelson, D. (30 June 2020). "The Impact Of COVID-19 On Providers: Risk, Recession And Reimbursement". Forbes. https://www.forbes.com/sites/danielmendelson/2020/06/30/the-impact-of-covid-19-on-providers-risk-recession-and-reimbursement/. Retrieved 21 August 2020. 
  7. ↑ "What has the pandemic revealed about the US health care system — and what needs to change?". MIT News. Massachusetts Institute of Technology. 5 April 2021. https://news.mit.edu/2021/what-has-pandemic-revealed-about-us-health-care-what-needs-change-0405. Retrieved 13 September 2021. 
  8. ↑ Scott, D. (6 July 2021). "The US health system was already falling short. Then Covid-19 happened.". Vox. https://www.vox.com/policy-and-politics/22555949/us-health-care-system-ranking-covid-19-pandemic. Retrieved 13 September 2021. 
  9. ↑ Flinn, B. (12 June 2020). "States Leverage Medicaid to Provide Nursing Homes a Lifeline through COVID-19". LeadingAge. https://www.leadingage.org/regulation/states-leverage-medicaid-provide-nursing-homes-lifeline-through-covid-19. Retrieved 21 August 2020. 
  10. ↑ Division of Federal Employees' Compensation (6 May 2021). "Claims under the Federal Employees' Compensation Act due to the 2019 Novel Coronavirus (COVID-19)". U.S. Department of Labor. https://www.dol.gov/agencies/owcp/FECA/InfoFECACoverageCoronavirus. Retrieved 13 September 2021. 
  11. ↑ Department of Attorney General (2020). "Worker's Compensation for First Responders". State of Michigan. Archived from the original on 21 August 2021. https://web.archive.org/web/20200821194015/https://www.michigan.gov/ag/0,4534,7-359-98784_98791-523085--,00.html. Retrieved 13 September 2021. 
  12. ↑ 12.0 12.1 "COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured". Health Resources & Services Administration. May 2020. https://www.hrsa.gov/CovidUninsuredClaim. Retrieved 21 August 2020. 
  13. ↑ "Coding Guidance for COVID-19". American College of Emergency Physicians. 2020. https://www.acep.org/administration/reimbursement/covid-19/. Retrieved 21 August 2020. 
  14. ↑ 14.0 14.1 Adler, L.; Young, C.L. (13 July 2020). "The laws governing COVID-19 test payment and how to improve them". USC-Brookings Schaeffer Initiative for Health Policy. Brookings Institution. 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/. Retrieved 21 August 2020. 
  15. ↑ Dawson, L. (22 April 2020). "The National Disaster Medical System (NDMS) and the COVID-19 Pandemic". KFF. https://www.kff.org/coronavirus-covid-19/issue-brief/the-national-disaster-medical-system-ndms-and-the-covid-19-pandemic/. Retrieved 21 August 2020. 
  16. ↑ Congressional Research Service (17 April 2020). "Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127". https://crsreports.congress.gov/product/pdf/R/R46316. Retrieved 21 August 2020. 
  17. ↑ "CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing". CMS Newsroom. Centers for Medicare & Medicaid Services. 15 October 2020. https://www.cms.gov/newsroom/press-releases/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing. Retrieved 20 November 2020. 
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