Use of the Postacute Sequelae of COVID-19 Diagnosis Code in Routine Clinical Practice in the US

McGrath, Leah J.; Scott, Amie; Surinach, Andy; Chambers, Richard; Benigno, Michael; Malhotra, Deepa

doi:10.1001/jamanetworkopen.2022.35089

Cited by 22 publications

(17 citation statements)

References 11 publications

(24 reference statements)

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“…6,7 A code in the International Classification of Diseases, 10 th Edition, was not added until October 2021, and there are concerns about its sensitivity and specificity. 1,8,9 COVID-OUT was a phase 3 randomized, quadruple-blinded placebo-controlled trial of early outpatient treatment of SARS-CoV-2 that included monthly follow-up for 300 days to test the hypothesis that early treatment of Covid-19 with the study drugs would prevent Long Covid. 10 The trial used a 2 by 3 factorial design of parallel treatments to assess: metformin, ivermectin, and/or fluvoxamine.…”

Section: Introductionmentioning

confidence: 99%

Outpatient treatment of Covid-19 with metformin, ivermectin, and fluvoxamine and the development of Long Covid over 10-month follow-up

Bramante

Buse

Liebovitz

et al. 2022

Preprint

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Background Long Covid is an emerging chronic illness potentially affecting millions, sometimes preventing the ability to work or participate in normal daily activities. COVID-OUT was an investigator-initiated, multi-site, phase 3, randomized, quadruple-blinded placebo-controlled clinical trial (NCT04510194). The design simultaneously assessed three oral medications (metformin, ivermectin, fluvoxamine) using two by three parallel treatment factorial assignment to efficiently share placebo controls and assessed Long Covid outcomes for 10 months to understand whether early outpatient treatment of SARS-CoV-2 with metformin, ivermectin, or fluvoxamine prevents Long Covid. Methods: This was a decentralized, remotely delivered trial in the US of 1,125 adults age 30 to 85 with overweight or obesity, fewer than 7 days of symptoms, and enrolled within three days of a documented SARS-CoV-2 infection. Immediate release metformin titrated over 6 days to 1,500mg per day 14 days total; ivermectin 430mcg/kg/day for 3 days; fluvoxamine, 50mg on day one then 50mg twice daily through 14 days. Medical-provider diagnosis of Long Covid, reported by participant by day 300 after randomization was a pre-specified secondary outcome; the primary outcome of the trial was severe Covid by day 14. Result: The median age was 45 years (IQR 37 to 54), 56% female of whom 7% were pregnant. Two percent identified as Native American; 3.7% as Asian; 7.4% as Black/African American; 82.8% as white; and 12.7% as Hispanic/Latino. The median BMI was 29.8 kg/m2 (IQR 27 to 34); 51% had a BMI >30kg/m2. Overall, 8.4% reported having received a diagnosis of Long Covid from a medical provider: 6.3% in the metformin group and 10.6% in the metformin control; 8.0% in the ivermectin group and 8.1% in the ivermectin control; and 10.1% in the fluvoxamine group and 7.5% in the fluvoxamine control. The Hazard Ratio (HR) for Long Covid in the metformin group versus control was 0.58 (95% CI 0.38 to 0.88); 0.99 (95% CI 0.592 to 1.643) in the ivermectin group; and 1.36 in the fluvoxamine group (95% CI 0.785 to 2.385). Conclusions: There was a 42% relative decrease in the incidence of Long Covid in the metformin group compared to its blinded control in a secondary outcome of this randomized phase 3 trial. Trial registration:NCT04510194; IND 152439

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Section: Introductionmentioning

confidence: 99%

Outpatient treatment of Covid-19 with metformin, ivermectin, and fluvoxamine and the development of Long Covid over 10-month follow-up

Bramante

Buse

Liebovitz

et al. 2022

Preprint

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“…Representative surveys may provide evidence that is unavailable from administrative sources, such as insurance claims or electronic health records, which have also been found to have limitations because of clinical uncertainty, limited diagnostic testing and coding of PCC, and exclusion of people not receiving care. 50 , 51 , 52 , 53 …”

Section: Discussionmentioning

confidence: 99%

Health Care Access and Affordability Among US Adults Aged 18 to 64 Years With Self-reported Post–COVID-19 Condition

2023

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ImportanceMany US adults report having post–COVID-19 condition (PCC), but little is known about their access to health care.ObjectiveTo estimate the association of PCC with access and affordability challenges among US adults aged 18 to 64 years.Design, Setting, and ParticipantsThis survey study used data from the Health Reform Monitoring Survey, a probability-based internet survey conducted June 17 to July 5, 2022. Participants included a nationally representative sample of 9484 US adults ages 18 to 64 years drawn from the Ipsos KnowledgePanel.Main Outcomes and MeasuresSelf-reported PCC was defined as experiencing symptoms more than 4 weeks after first having COVID-19 that were not explained by another condition or factor. Access and affordability outcomes included having a usual place of care; forgoing care in the past 12 months because of costs, difficulty finding clinicians, or difficulty using health insurance; having problems paying family medical bills in the past 12 months; and having past-due medical debt.ResultsOf 19 162 panel members recruited for the survey, 9599 individuals completed the survey (completion rate, 50.1%) and 9484 respondents were included in the final analytic sample (4720 females [50.6%, weighted]; mean [SD] age, 41.0 [13.5] years). A total of 3382 respondents (36.4%; 95% CI, 34.7%-38.2%) reported ever being diagnosed with COVID-19, among whom, 833 respondents (22.5%; 95% CI, 20.9%-24.2%) reported currently having PCC. After adjustment for differences in demographic, health, and geographic characteristics, adults with PCC were more likely than 2549 adults with a COVID-19 diagnosis but no report of PCC and 6102 adults never diagnosed with COVID-19 to report unmet health care needs in the past 12 months because of the following challenges: costs (27.0%; 95% CI, 23.2%-30.7% vs 18.3%; 95% CI, 15.9%-20.7% and 17.5%; 95% CI, 15.4%-19.6%) and difficulties finding clinicians accepting new patients (16.4%; 95% CI, 14.3%-18.4% vs 10.1%; 95% CI, 8.8%-11.5% and 10.7%; 95% CI, 9.6%-11.8%), getting a timely appointment (22.0%; 95% CI, 19.3%-24.8% vs 14.4%; 95% CI, 13.2%-15.7% and 13.9%; 95% CI, 12.9%-14.8%), and getting health plan care authorization (16.6%; 95% CI, 14.6%-18.6% vs 10.8%; 95% CI, 9.6%-12.1% and 10.3%; 95% CI, 9.4%-11.2%) (P &lt; .001 for all comparisons).Conclusions and RelevanceThis study found that adults aged 18 to 64 years with PCC were more likely than other adults to have difficulty getting and paying for health care. These findings suggest that policies aimed at improving access and affordability may focus on accelerating development of treatments and clinical guidelines, training clinicians, and addressing insurance-related administrative and cost barriers.

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“…6 The World Health Organization (WHO) introduced an ICD-10 code specifically for long COVID (U09.9) in October of 2021. 7 This code can enable retrospective studies of long COVID using EHR data by helping researchers define clinical cohorts and ascertain outcomes. Given the very recent rollout of the code and the inherent ambiguity in PASC clinical case definitions, it is therefore of great importance to better understand how the new ICD-10 code for long COVID is being used in real-world settings.…”

Section: Introductionmentioning

confidence: 99%

Characterizing the use of the ICD-10 Code for Long COVID in 3 US Healthcare Systems

Zhang

Maripuri²,

Samayamuthu

et al. 2023

Preprint

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The International Classification of Diseases (ICD)-10 code (U09.9) for post-acute sequelae of COVID-19 (PASC) was introduced in October of 2021. As researchers seek to leverage this billing code for research purposes in large scale real-world studies of PASC, it is of utmost importance to understand the functional use of the code by healthcare providers and the clinical characteristics of patients who have been assigned this code. To this end, we operationalized clinical case definitions of PASC using World Health Organization and Centers for Disease Control guidelines. We then chart reviewed 300 patients with COVID-19 from three participating healthcare systems of the 4CE Consortium who were assigned the U09.9 code. Chart review results showed the average positive predictive value (PPV) of the U09.9 code ranged from 40.2% to 65.4% depending on which definition of PASC was used in the evaluation. The PPV of the U09.9 code also fluctuated significantly between calendar time periods. We demonstrated the potential utility of textual data extracted from natural language processing techniques to more comprehensively capture symptoms associated with PASC from electronic health records data. Finally, we investigated the utilization of long COVID clinics in the cohort of patients. We observed that only an average of 24.0% of patients with the U09.9 code visited a long COVID clinic. Among patients who met the WHO PASC definition, only an average of 35.6% visited a long COVID clinic.

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Use of the Postacute Sequelae of COVID-19 Diagnosis Code in Routine Clinical Practice in the US

Cited by 22 publications

References 11 publications

Outpatient treatment of Covid-19 with metformin, ivermectin, and fluvoxamine and the development of Long Covid over 10-month follow-up

Outpatient treatment of Covid-19 with metformin, ivermectin, and fluvoxamine and the development of Long Covid over 10-month follow-up

Health Care Access and Affordability Among US Adults Aged 18 to 64 Years With Self-reported Post–COVID-19 Condition

Characterizing the use of the ICD-10 Code for Long COVID in 3 US Healthcare Systems

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