Today's News and Commentary

About health insurance

Deep red Missouri becomes 38th state to approve Medicaid expansion under Obamacare:”Voters on Tuesday made Missouri the 38th state to approve expanding Medicaid health care coverage to thousands more low-income adults.
Support for the constitutional amendment means that as many as 250,000 more adults could choose to be covered by government health insurance beginning in July 2021, according to estimates from the state auditor.”

CMS Announces a Temporary Policy for Premium Reductions: “…the Centers for Medicare & Medicaid Services (CMS) announced a policy that will allow issuers to offer temporary premium reductions for individuals with 2020 coverage in the individual and small group markets. CMS is providing this additional flexibility to help ensure that consumers struggling to pay their premiums can continue to be covered and receive the care they may need during this time.” Normally premiums are fixed after the start of the year.

About pharma

Blood-thinner with no bleeding side-effects is here: If this medicine pans out it will be a huge blockbuster:
”In a study led by EPFL (Ecole Polytechnique Fédérale de Lausanne) scientists have developed a synthetic blood-thinner that, unlike all others, doesn’t cause bleeding side-effects. The highly potent, highly selective, and highly stable molecule can suppress thrombosis while letting blood clot normally following injury.” The substance is an inhibitor of an enzyme called “coagulation factor XII” (FXII). “The only problem is that the inhibitor has a relatively short retention time in the body: it’s too small and the kidneys would filter it out. In the context of artificial lungs, this would mean constant infusion, since suppressing blood clotting for several days, weeks or months requires a long circulation time.” But researchers are working on a longer-lived version.

Gilead's COVID med remdesivir is scarce and costly, AGs say, urging feds to sidestep its patents: “Unhappy with the price and availability of Gilead’s remdesivir—the only drug with FDA clearance to treat COVID-19—dozens of state attorney generals have called for the federal government to exercise march-in rights to allow for broader production of the medicine.
In a letter to the heads of the FDA, HHS and NIH, 34 attorneys general wrote that Gilead has been unable to ensure “sufficient” supply and has priced the medicine out of reach for many patients who need it. Gilead is charging $3,120 per treatment course for patients with commercial insurance, Medicare or Medicaid, and $2,340 for patients on certain smaller federal programs. 
Federal laws allow the government to sidestep patents if the patent holder received taxpayer support and isn't meeting public health needs, the AGs wrote.”

FDA Updates Purple Book to Include All CBER-, CDER-licensed Biologics:”The FDA has updated its Purple Book to include information on all biologics approved by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).”

MedWatch to Manufacturer Program:”The U.S. Food and Drug Administration has discontinued the MedWatch to Manufacturers Program (MMP) as of July 31, 2020. This program allowed participating drug and biologic manufacturers to receive information from the FDA on serious adverse event reports that are submitted directly to FDA by voluntary reporters for new molecular entities and original biologics for the first three years after approval. 
Since the introduction of the FDA Adverse Event Reporting System (FAERS) Public Dashboard in 2017, manufacturers can now directly search and download publicly available information from adverse event reports in FAERS, including adverse event reports submitted voluntarily  to FDA.“

About the public’s health

6 states band together to secure rapid COVID testing: “Bipartisan governors of six states have entered into a first-of-its-kind agreement to jointly purchase rapid coronavirus testing kits.
The governors — from Virginia, Louisiana, Massachusetts, Michigan, Ohio and Maryland — said the goal of the compact is to show private companies that there is significant demand to scale up the production of these tests, which deliver results in 15 to 20 minutes.
The states will also coordinate on policies and protocols regarding the testing technology.”

A 50-State COVID-19 Survey from the The COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States (July): Summary:

  • “Most (63%) people are not getting results within the 1-2 days that would be optimal to aid contact tracing.

  • A substantial minority (21%) of individuals are receiving test results too late (5+ days) to be of any significant assistance in helping to control the spread of COVID-19.

  • The testing challenges are national in scope, with most states reporting a median waiting time of 3 days or more.

  • Waiting times are longer for African Americans (5 days) and Hispanic Americans (4.6 days) compared to white respondents.”

For those affected by dementia, the pandemic has been especially grim: “…there is evidence in some rich countries that the age-specific incidence of dementia is declining, even as the overall prevalence increases as societies get older.”
“… as many as 40% of dementia cases might in theory be delayed or prevented by tackling 12 ‘modifiable’ risk factors.” Among the most important are: smoking, high blood pressure, obesity, hearing loss, a low level of education, diabetes, excessive drinking in middle age, head injuries (also in middle age), and exposure to air pollution in later life.

Johnson & Johnson pledges 100M coronavirus vaccine doses to U.S. for $10 each: The headline speaks for itself.

Ancestry rolls out more advanced DNA testing to flag risk of heart disease, breast cancer: “Ancestry is stepping up its consumer DNA testing using next-generation sequencing developed by Quest Diagnostics.
The family history and consumer genomics company is relaunching its AncestryHealth service with more advanced genetic testing technology to flag cutsomers' risk for developing certain inheritable diseases.
The sequencing-based tests replace Ancestry's previous microarray-based tests, the company said in a release. The tests are physician-ordered, are not diagnostic and have not been reviewed or approved by the Food and Drug Administration (FDA).”

About healthcare IT

Teladoc to take over Livongo in $18.5B digital health deal:”Telehealth giant Teladoc has moved to absorb the digital disease management company Livongo through a deal worth as much as $18.5 billion, reflecting the growing importance of virtual healthcare platforms as the world is caught in the wake of the COVID-19 pandemic.
The massive medtech acquisition takes the crown not two days after Siemens Healthineers announced a $16.4 billion offer for the cancer radiotherapy player Varian Medical Systems.”