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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):
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* name, date of birth, and gender
==''Introduction to Quality and Quality Management Systems''==
* race and ethnicity
{{ombox
* demographic information such as full address and phone number
| type      = content
* ordering physician or attending health care provider for test (if applicable)
| style    = width: 500px;
* facility's National Provider Identifier (NPI)
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
* 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)
The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.
* 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>)


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].
;1. What is quality?
:''Key terms''
:[[Quality (business)|Quality]]
:[[Quality assurance]]
:[[Quality control]]
:''The rest''
:[[Data quality]]
:[[Information quality]]
:[[Nonconformity (quality)|Nonconformity]]
:[[Service quality]]
;2. Processes and improvement
:[[Business process]]
:[[Process capability]]
:[[Risk management]]
:[[Workflow]]
;3. Mechanisms for quality
:[[Acceptance testing]]
:[[Conformance testing]]
:[[Clinical quality management system]]
:[[Continual improvement process]]
:[[Corrective and preventive action]]
:[[Good manufacturing practice]]
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
:[[Quality management]]
:[[Quality management system]]
:[[Total quality management]]
;4. Quality standards
:[[ISO 9000]]
:[[ISO 13485]]
:[[ISO 14000|ISO 14001]]
:[[ISO 15189]]
:[[ISO/IEC 17025]]
:[[ISO/TS 16949]]
;5. Quality in software
:[[Software quality]]
:[[Software quality assurance]]
:[[Software quality management]]


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>  
<!--Place all category tags here-->
 
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==
{{Reflist|colwidth=30em}}

Latest revision as of 19:46, 9 February 2022

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Introduction to Quality and Quality Management Systems

The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information quality
Nonconformity
Service quality
2. Processes and improvement
Business process
Process capability
Risk management
Workflow
3. Mechanisms for quality
Acceptance testing
Conformance testing
Clinical quality management system
Continual improvement process
Corrective and preventive action
Good manufacturing practice
Malcolm Baldrige National Quality Improvement Act of 1987
Quality management
Quality management system
Total quality management
4. Quality standards
ISO 9000
ISO 13485
ISO 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management