About the public’s health
As Wuhan’s lockdown ends, residents leave messages for the dead doctor who sounded the alarm on coronavirus: Many experts are concerned this relaxation might make a second wave much worse.
Neutralizing antibody [NAb]responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications [This article is a preprint and has not been peer-reviewed]:” Methods Plasma collected from 175 COVID-19 recovered patients with mild symptoms…SARS-CoV-2-specific NAbs were detected in patients from day 10-15 after the onset of the disease…The titers of NAbs were variable in different patients. Elderly and middle-age patients had significantly higher plasma NAb titers (P<0.0001) and spike-binding antibodies (P=0.0003) than young patients. Notably, among these patients, there were ten patients whose NAb titers were under the detectable level of our assay.” If this study is confirmed, it means we need far more information on the variability of antibody responses to make intelligent clinical decisions about who is infected and who has recovered.
Mysterious Heart Damage, Not Just Lung Troubles, Befalling COVID-19 Patients: The article is a discussion of how the COVID-19 illness may directly affect the heart.
COVIDView: A Weekly Surveillance Summary of U.S. COVID-19 Activity: The CDC has a weekly update on COVID-19 activity. Here is the first installment.
CDC removes unusual guidance to doctors about drug favored by Trump: “The U.S. Centers for Disease Control and Prevention has removed from its website highly unusual guidance informing doctors on how to prescribe hydroxychloroquine and chloroquine, drugs recommended by President Donald Trump to treat the coronavirus... Reuters …reported that the original guidance was crafted by the CDC after President Trump personally pressed federal regulatory and health officials to make the malaria drugs more widely available to treat the novel coronavirus, though the drugs in question had been untested for COVID-19.”
Hospitals say feds are seizing masks and other coronavirus supplies without a word: “Although President Trump has directed states and hospitals to secure what supplies they can, the federal government is quietly seizing orders, leaving medical providers across the country in the dark about where the material is going and how they can get what they need to deal with the coronavirus pandemic.
Hospital and clinic officials in seven states described the seizures in interviews over the past week. The Federal Emergency Management Agency is not publicly reporting the acquisitions, despite the outlay of millions of dollars of taxpayer money, nor has the administration detailed how it decides which supplies to seize and where to reroute them.”
Trouble in testing land: University of Oxford Professor Sir John Bell wrote in his blog that: “Multiple tests have been provided for evaluation, and a range of convalescent sera has been used to determine whether the tests can identify both low and high levels of antibodies. We have been very careful to test using gold standards checked against a sensitive enzyme-linked immunosorbent assay (Elisa) of the spike protein and other viral proteins. Sadly, the tests we have looked at to date have not performed well. [Emphasis added.] We see many false negatives (tests where no antibody is detected despite the fact we know it is there) and we also see false positives. None of the tests we have validated would meet the criteria for a good test as agreed with the MHRA. This is not a good result for test suppliers or for us.” As previously reported, the rapid proliferation of barely-tested diagnostics may not be helping public health efforts.
Walgreens Expanding Drive-Thru Testing To 15 New Locations in Seven States:”Walgreens is working to expand drive-thru testing to 15 new sites in seven states, the company announced today. The states included are Arizona, Florida, Illinois, Kentucky, Louisiana, Tennessee and Texas…Testing will be available at no cost to eligible individuals who meet criteria established by the Centers for Disease Control and Prevention (CDC). Patients will need to pre-register in advance in order to schedule an appointment for testing.”
About health insurance
UnitedHealth fast-tracks $2B in payments to providers: “UnitedHealth's initiative, announced April 7, will fast-track claim payments to medical and behavioral care providers in UnitedHealthcare's fully insured commercial, Medicare Advantage and Medicaid networks. The healthcare company will also provide up to $125 million in small business loans to OptumHealth's clinical operator partners.” I wonder if this insurer (and CMS) will slow down payments again when the crisis is over.
Estimated Cost of Treating the Uninsured Hospitalized with COVID-19: This Kaiser Family Fund analysis estimates “total payments to hospitals for treating uninsured patients under the Trump administration policy would range from $13.9 billion to $41.8 billion. At the top end of the range, payments on behalf of the uninsured would consume more than 40% of the $100 billion fund Congress created to help hospitals and others respond to the COVID-19 epidemic. Given the uncertainty of our estimates of the total funding that will be needed to reimburse hospitals, and the fact that infections may come in several waves over the next year, it is unclear whether the new fund will be able to cover the costs of the uninsured in addition to other needs, such as the purchase of medical supplies and the construction of temporary facilities.”
Relationship of a Claims-Based Frailty Index to Annualized Medicare Costs: A Cohort Study: “Medicare uses the Centers for Medicare & Medicaid Services Hierarchical Condition Category (CMS-HCC) model to predict patients' annualized Medicare costs in value-based payment programs. The CMS-HCC model does not include measures of frailty, and prior research shows that it systematically underpredicts costs for frail Medicare beneficiaries…The frailty index addition to the CMS-HCC model predicted on average an additional $2712, $7915, and $16 449 in costs for prefrail, mildly frail, and moderately to severely frail patients, respectively, beyond the CMS-HCC model alone. On average, the model with the frailty index addition resulted in more accurate predictions of costs for patients at all 4 levels of frailty. However, observed costs remained more widely distributed than predictions from the enhanced model at all levels of frailty.”
About pharma
Eli Lilly makes new $35 insulin copay available in US during coronavirus pandemic: “Eli Lilly said Tuesday that in light of the crisis caused by the coronavirus pandemic, it is introducing a programme that caps the out-of-pocket cost for most of the company's insulin products, including all Humalog (insulin lispro) formulations, to $35 per month for anyone with commercial insurance, as well as those without insurance. However, patients with government insurance such as Medicaid, Medicare, Medicare Part D or any state patient or pharmaceutical assistance programme are not eligible for the scheme.” Like many other special plans, is it cheaper to pay out of pocket and not use insurance?
FDA Drug Approval: Application Review Times Largely Reflect FDA Goals: The “GAO was asked to examine NDA [New Drug Approval] review times across FDA's divisions. In this report, GAO examines (among other things) differences between FDA divisions in the key features of the NDAs they review and initial review times, as well as the extent to which key NDA features contribute to these differences…
GAO's analysis of 637 NDAs submitted from fiscal years 2014 through 2018 indicated that the proportion of NDAs …key features differed among FDA review divisions. For example, 6 percent of the NDAs reviewed by the dermatology and dental division had a priority designation, compared to 56 percent for the anti-infective division. FDA has reported that some divisions, such as the oncology divisions, generally regulate products for conditions that are more likely to be serious or life-threatening, and, therefore, those products may be more likely to qualify for priority designation and other expedited programs... Controlling for the effects of these target time frames and the number of expedited programs for which the NDA qualified, GAO found that most of the divisions' average review times were similar to (within 2 weeks of) each other.”
About healthcare IT
Diagnostic Category Prevalence in 3 Classification Systems Across the Transition to the International Classification of Diseases, Tenth Revision, Clinical Modification: Many were worried that the change from ICD 9 to ICD 10 would distort historical trend analysis by changing diagnostic classifications. This research is the first I have seen on the topic and shows that the concerns were warranted. “These findings suggest that the ICD-10-CM transition was associated with large prevalence changes for many diagnostic categories. Diagnostic classification systems developed using ICD-9-CM may need to be refined using ICD-10-CM data to avoid unintended consequences for disease surveillance, performance assessment, and risk-adjusted payments.”