About the public’s health
COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card: The FDA issued “an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer…
A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result.
WHERE IT CAN BE USED:
This test could be used at point-of-care settings, like a doctor’s office, emergency room or some schools. This test has been authorized for use in patients suspected of COVID-19 by their healthcare provider within seven days of symptom onset. Given the simple nature of this test, it is likely that these tests could be made broadly available. According to the test manufacturer, Abbott, it plans to make up to 50 million tests available monthly in the U.S. at the beginning of October 2020.“
Pence offers revisionist history of the coronavirus pandemic in the U.S.: Here is a good summary of the VP’s accounting of the COVID-19 pandemic and an accompanying fact check.
Individuals with obesity and COVID‐19: A global perspective on the epidemiology and biological relationships: The article is a good review of why obese persons do poorly when infected. One reason is: “Being an individual with obesity has modulatory effects on key immune cell populations critical in the response to SARS‐CoV‐2. Specifically, increased BMI is associated with greater frequency of the anti‐inflammatory CD4 T cell subsets Th2 and T regulatory cells. Increased anti‐inflammatory cells may inhibit the ability to reduce the infection, as inflammatory responses are needed to control viral spread.”
Covid-19 vaccine makers lobby EU for legal protection: The headline speaks for itself. We already have a vaccine harm compensation system in this country. Whether manufacturers will consider it enough protection remains to be seen.
New federal virus testing advice sparks criticism, confusion:”U.S. health officials sparked criticism and confusion after posting guidelines on coronavirus testing from the White House task force that run counter to what scientists say is necessary to control the pandemic.
The new guidance says it’s not necessary for people who have been in close contact with infected people, but don’t feel sick, to get tested. It was posted earlier this week on the website of the Centers for Disease Control and Prevention.
The CDC previously had advised local health departments to test people who have been within 6 feet of an infected person for more than 15 minutes.
Across the country, public health experts called the change bizarre. They noted that testing contacts of infected people is a core element of public health efforts to keep outbreaks in check, and that a large percentage of infected people — the CDC has said as many as 40% — exhibit no symptoms.”
Covid-19 child cases in the US have increased by 21% since early August, new data shows: ”More than 70,000 new Covid-19 cases in children have been reported across the US since early August, new data shows.
Child cases increased by 21% between August 6 and August 20, according to an updated joint report from the American Academy of Pediatrics and the Children's Hospital Association. More than 440,000 children have been infected in the US since the start of the pandemic, the report said.”
Failure by WHO team to visit Wuhan sparks concerns over virus probe:”A recently concluded three-week trip to China by the two-person WHO team did not entail a visit to Wuhan, the central Chinese city where the first cases of novel coronavirus were detected in December 2019, the UN agency has confirmed. The WHO said the team was merely laying the groundwork in advance of a full international mission to investigate the virus but it was also vague on whether this larger task force would visit Wuhan.”
Sex differences in immune responses that underlie COVID-19 disease outcomes: “By focusing our analysis on patients with moderate disease who had not received immunomodulatory medications, our results revealed that male patients had higher plasma levels of innate immune cytokines such as IL-8 and IL-18 along with more robust induction of non-classical monocytes. In contrast, female patients mounted significantly more robust T cell activation than male patients during SARS-CoV-2 infection, which was sustained in old age. Importantly, we found that a poor T cell response negatively correlated with patients’ age and was associated with worse disease outcome in male patients, but not in female patients. Conversely, higher innate immune cytokines in female patients associated with worse disease progression, but not in male patients. These findings reveal a possible explanation underlying observed sex biases in COVID-19, and provide an important basis for the development of a sex-based approach to the treatment and care of men and women with COVID-19.”
Social Distancing Is a Lot More Complicated Than Staying 6 Feet Apart: The distancing and risk depend on indoors versus outdoors, length of exposure to others and their verbal activities (silent to singing). The article has an easy-to-read chart of risks under different circumstances.
About hospitals and health systems
These organizations are announcing second quarter (and first half) results for the year. Here are some examples that show the range of COVID-19’s impact.
Mayo generates $154M in operating income in Q2 despite sharp drops in volume due to COVID-19
Sutter Health posts $857M loss in first half of 2020 due to COVID-19
UPMC's revenue tops $11B in first half of year: “UPMC reported higher revenue in the first half of this year than in the same period of 2019, but the Pittsburgh-based health system's operating income declined year over year, according to unaudited financial documents.
UPMC reported revenue of $11.1 billion in the first six months of this year, up nearly $1 billion from the same period of 2019. A year-over-year decline in net patient service revenue attributed to volume declines linked to the COVID-19 pandemic was offset by gains in insurance enrollment revenue. Enrollment in UPMC's health plans grew to 3.9 million members as of June 30.”
About pharma
Anticoagulation [AC], Mortality, Bleeding and Pathology Among Patients Hospitalized with COVID-19: A Single Health System Study: “AC was associated with lower mortality and intubation among hospitalized COVID-19 patients. Compared to prophylactic AC, therapeutic AC was associated with lower mortality, though not statistically significant.”
Cassiopea scores FDA approval for Winlevi, the first novel acne med in decades:The medication works by targeting the androgen receptors directly in the skin.
FDA balks at recalls for 2 tuberculosis meds despite possible carcinogen contamination: “Despite finding elevated levels of possible carcinogens in tuberculosis meds rifampin and rifapentine, the FDA will not request a withdrawal from U.S. shelves over fears a recall would cause a supply shortage, the agency said Wednesday.”
6 recent drug, device recalls: Read the article for details.
FDA delays collecting drugmaker data required by CARES Act:”The FDA said this week that it won't begin collecting new data required from drugmakers under the Coronavirus Aid, Relief, and Economic Security Act…
Though the rule is set to take effect next month, the FDA says the electronic data submission portal it's developing for drugmakers to submit the information won't be ready by then…
The CARES Act sets new reporting requirements for drugmakers that are intended to improve the FDA's response to drug shortages. The rules require drugmakers to report shortages of drugs that are critical to public health during a public health emergency as well as the active pharmaceutical ingredients of those drugs. Drugmakers are also now required to report manufacturing volume data annually, including the amount of each drug that was manufactured, prepared, propagated, compounded or processed for commercial distribution…”
About health insurance
CMS needs another year to work on anticipated changes to the physician self-referral rule: “The Centers for Medicare and Medicaid Services is pushing back the timeline on anticipated modifications to the physician self-referral rule until August 2021, the agency revealed Wednesday.
CMS first issued its proposed changes to the Stark Law—established to prevent docs from referring patients to entities in which they have a financial interest—back in October. Those revisions were meant to ‘modernize’ the law for the first time since its creation in 1989, carving out exceptions for providers in some value-based payment models.”
OIG warns Medicare Advantage encounter data have gaps in information critical to oversight: “A new watchdog report finds that Medicare Advantage encounter data often lack key information necessary to oversight.
The Department of Health and Human Services' Office of Inspector General found that MA encounter data are largely missing national provider identifiers (NPIs) for the providers ordering or referring services in the claims.
Those data, according to the report, are crucial to tracking prescribing habits to catch any red flags as part of fraud and abuse oversight.”
Proposed 2021 Medicare Physician Payment and Quality Reporting Changes MGMA Member-Exclusive Analysis: A really good summary of proposed changes.
Trump admin alters key disaster policy for MA, Part D star ratings due to COVID-19: “CMS posts online star ratings on each MA and Part D plan based on a series of quality and performance measures. The rating is also used to determine the amount of quality bonus payments for plans…
The new emergency regulation changes a disaster policy that CMS implemented a few years ago to help plans that have a lot of beneficiaries in a natural disaster area.
The policy said that if 60% or more of a MA or Part D plan’s beneficiaries are in a federally designated disaster area then that plan’s star rating gets an adjustment to compensate. Over the past several years when the policy has been enacted, it has applied to a limited number of plans.
‘The disaster policy was not designed to address global pandemics,’ the rule said.
But the pandemic now counts as a disaster and most plans will be eligible for the disaster policy adjustments, CMS said in the rule. The agency said that if all U.S. plans are affected by the policy, then it will throw off the entire methodology for calculating and assigning star ratings.
So in the new rule CMS is removing the 60% policy for COVID-19 areas to ‘avoid having to exclude the vast majority of contracts from the methodology used to assign star ratings.’”
About healthcare professionals
Women in healthcare: Moving from the front lines to the top rung: 2nd annual McKinsey report found that: “Women account for 66 percent of all entry-level healthcare employees—an increase of three percentage points since last year—compared with 49 percent across all US industries. While the share of women declines in more senior roles, moving to 30 percent of C-suite positions, healthcare still outperforms all industries.”
About healthcare IT
Introducing Amazon Halo and Amazon Halo Band: “Amazon today introduced Amazon Halo, a new service dedicated to helping customers improve their individual health and wellness. Amazon Halo combines a suite of AI-powered health features that provide actionable insights into overall wellness via the new Amazon Halo app with the Amazon Halo Band, which uses multiple advanced sensors to provide the highly accurate information necessary to power Halo insights. Customers in the U.S. can request early access to Amazon Halo starting today, with the Amazon Halo Band and 6 months of Halo membership available for a special price of $64.99…
Amazon Halo Band is purpose-built to focus on your health and wellness—unlike smartwatches and fitness trackers, it doesn’t have a screen or constant notifications. The small sensor capsule delivers highly accurate data, and includes an accelerometer, a temperature sensor, a heart rate monitor, two microphones, an LED indicator light, and a button to turn the microphones on or off, among other functions. Amazon Halo Band is water resistant for all-day wear and the comfortable fit means it won’t snag or irritate at night. Plus, the battery lasts up to seven days and fully charges in under 90 minutes. Customers can choose from three fabric band colors at purchase, with fabric and silicone sport accessory bands available in 15 additional colors.”