Today's News and Commentary

A neuro-metabolic account of why daylong cognitive work alters the control of economic decisions A fascinating (and bizarre) article about the brain chemistry guiding human behavior.
”Highlights

•Cognitive fatigue is explored with magnetic resonance spectroscopy during a workday

•Hard cognitive work leads to glutamate accumulation in the lateral prefrontal cortex

•The need for glutamate regulation reduces the control exerted over decision-making

•Reduced control favors the choice of low-effort actions with short-term rewards”

About Covid-19

 UK becomes first country to approve Omicron-specific Covid booster “The UK has become the first country to authorise a Covid-19 vaccine tailored to the Omicron variant, setting the stage for an autumn booster campaign using Moderna’s two-strain shot. The Medicines and Healthcare products Regulatory Authority — which was the first in the world to approve an original Covid-19 jab — has granted conditional authorisation to the vaccine, which targets both the original strain of the virus and Omicron BA.1. The vaccine is authorised for use in people aged 18 and over but, to prepare for an expected rise in cases over the winter, the UK plans to focus its booster programme on the over-fifties and those at higher clinical risk of developing severe Covid.”

To Avoid Paxlovid Rebound, Some Experts Call for Longer Courses of Treatment The extension would be three to five days.

  CDC Back Control of Pandemic Hospitalization Data Despite Criticism ”The US won’t renew its contract with TeleTracking Technologies Inc., a private company that took over Covid-19 hospitalization data collection from CDC in 2020, according to an email seen by Bloomberg News. Hospitals will resume reporting the data to the CDC in mid-December, with TeleTracking’s contract expiring on Dec. 31.” 

About the public’s health

 WHO renames two monkeypox variants to avoid geographic references “The World Health Organization (WHO) announced Saturday that it renamed variants of the virus monkeypox as it looks to counter concerns about the original naming conventions.
’Newly identified viruses, related diseases & virus variants are given names to avoid causing offence to any cultural, social, national, regional, professional, or ethnic groups, & minimize the negative impact on trade, travel, tourism, or animal welfare,’ the WHO said in its announcement. 
The Congo Basin and West African variants were reclassified as Clade I and Clade II, the latter of which has two subclades. The new names go into effect immediately.”

Person-years of life lost and lost earnings from cigarette smoking-attributable cancer deaths, United States, 2019 “Here, using state-specific population data and census data on annual median earnings, the authors estimated the number of smoking-attributable deaths and potentially avoidable losses in earnings for 2019. Analyses indicate that in 2019, for persons age 25 to 79, cigarette smoking-attributable cancer deaths accounted for 2.2 million person-years of life lost (PYLL) and approximately $21 billion in lost earnings. Analyses further suggest that greater than half of PYLL and lost earnings were avoidable.”

Risk of hip fracture in meat-eaters, pescatarians, and vegetarians: results from the UK Women’s Cohort Study “Amongst 26,318 women, 822 hip fracture cases were observed (556,331 person-years). After adjustment for confounders, vegetarians (HR (95% CI) 1.33 (1.03, 1.71)) but not occasional meat-eaters (1.00 (0.85, 1.18)) or pescatarians (0.97 (0.75, 1.26)) had a greater risk of hip fracture than regular meat-eaters. There was no clear evidence of effect modification by BMI in any diet group (p-interaction = 0.3).”

About healthcare quality

The Joint Commission to add health equity standards to accreditations “As of Jan. 1, accreditation programs for primary care clinics, behavioral health centers, critical access facilities and hospitals will include new mandates for their leaders.
 The updated standards include designating an officer to lead a strategy for reducing health disparities and screening patients for social determinants of health.
The Oakbrook Terrace-based commission is also requiring accredited organizations to add demographic breakdowns to quality and safety data. The stratifications will assist organizations in identifying disparities in health outcomes, which the accreditation group will require them to use to develop an action plan to eliminate [them].”

Today's News and Commentary

About Covid-19

 FDA recommends repeat at-home Covid tests to reduce risk of false negatives Further explanations of the new guidelines: The FDA issued guidance “recommending that people testing themselves for COVID-19 at home take a repeat test within 48 hours to rule out a potential false negative.
In its guidance, the FDA noted that at-home tests are less likely to detect the coronavirus than PCR lab tests. This inaccuracy is more likely to occur early on in the infection in people who display no symptoms…
The FDA recommended that people take one initial test if they suspect they may be infected or exposed to COVID-19. If they test negative and have some symptoms, then they should test again 48 hours after the first test. If the second test is still negative, a laboratory molecular-based test should be considered.
If a person has no COVID-19 symptoms but believes they have been exposed to the virus, the FDA said they should also test themselves a second time, also 48 hours after their first at-home test. If the second test is negative, they should take an additional third test another 48 hours afterward.”

About health insurance

Trends in the Source of New Enrollees to Medicare Advantage [MA] From 2012 to 2019 “This study found that from 2012 to 2019, growth in MA enrollment was primarily attributable to TM [traditional Medicare] beneficiaries who switched to MA rather than to newly eligible Medicare beneficiaries enrolling in MA. Also, beneficiaries who switched from TM were more likely to have a disability or to be dually eligible for Medicaid than were new enrollees.”
The authors speculated on reasons for these findings but neglected to mention lower overall beneficiary costs for MA plans, particularly for those need frequent services.

 Humana Completes Divestiture of Majority Interest in Kindred at Home Hospice and Personal Care Divisions to CD&R “Humana Inc. today announced that it has successfully completed its previously-announced transaction with private investment firm Clayton, Dubilier & Rice (‘CD&R’) to divest a majority interest [60%] in the Hospice and Personal Care divisions of Humana’s Kindred at Home subsidiary (‘KAH Hospice’). These divisions include patient-centered services for Hospice, Palliative, Community and Personal Care. Upon closing, the Hospice and Personal Care divisions have been restructured into a new standalone company.”
The $2.8 billion deal was first announced in April.

Health Care Service Corporation to Acquire Trustmark Health Benefits “ Health Care Service Corporation (HCSC) has signed a definitive agreement with Trustco Holdings, Inc. (Trustmark) to purchase its wholly owned subsidiary, Trustmark Health Benefits (Health Benefits), which is a leading third-party administrator of health benefits. The acquisition will provide HCSC with additional capabilities to serve a broader set of customers seeking customizable and flexible health benefit solutions.”

Oscar Health sees big enrollment growth in Q2, will pause +Oscar deals As usual, the “good news” is reported first- higher enrollment and higher revenue. It is only in point three that we get to the important information: “The company lost $112.1 million in the second quarter. In the first six months of the year, the company lost $189.4 million, rising 16.8 percent from a loss of $162.2 million year over year.”
The loss did not come from spending on patient care, since: “The company's medical loss ratio in the second quarter was 82.2 percent, which was only slightly different from 82.4 percent during the same period last year.”
Perhaps the company has a failed business model?

About the public’s health

 Polio virus is found in New York City wastewater “Health authorities announced Friday that polio virus has been found in New York City wastewater, a discovery that extends the known presence of the virus from the region’s northern suburbs to the nation’s largest city.
City and state health departments offered no details of where in New York City the virus was discovered but said there were six positive samples collected in June and July. They said the finding suggests ‘likely local circulation of the virus.’”
Officials suggest checking/updating immunization status. The next question is whether other cities should also test their waste waters?

J&J to remove talc products from shelves worldwide, replacing with cornstarch-based portfolio Finally: “After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.
J&J is beginning the transition to an all cornstarch-based baby powder portfolio...”

The Implications of the Supreme Court Decision to Overturn Roe v Wade for Women With Pregnancy-Associated Cancers The headline explains the article’s content. It is well-written and thoughtful.

About health technology

NEW STUDY SHOWS ABBOTT'S BLOOD TEST FOR CONCUSSION COULD PREDICT OUTCOMES FROM BRAIN INJURY AND INFORM TREATMENT INTERVENTIONS “A new study published in The Lancet Neurology demonstrates the ability of two blood-based biomarkers to predict how someone will recover from traumatic brain injury (TBI). Testing for these two biomarkers in the immediate aftermath of an injury can help health care providers determine the best way to treat and care for patients.
This research shows that when a clinician conducts a blood test for these brain proteins soon after a possible injury, they quickly get a more accurate picture of how severe the injury is, the expected course of recovery and the longer-term implications of the TBI. The markers were measured using Abbott's i-STAT™ TBI Plasma test, as well as on the company's ARCHITECT core laboratory instrument using research prototype assays, both of which helped predict recovery…
The day-of-injury blood tests had a high probability of predicting death at six months, 87% for GFAP and 89% for UCH-L1; and a high probability of predicting severe disability at the same timepoint, 86% for both GFAP and UCH-L1.”
The test is an important breakthrough in addressing TBI; however, it will need to be priced low enough to gain widespread use- think about high school football games.

Today's News and Commentary

About Covid-19

 The US is on a Covid plateau, and no one's sure what will happen next “The United States seems to have hit a Covid-19 plateau, with more than 40,000 people hospitalized and more than 400 deaths a day consistently over the past month or so…
 ‘We've never really cracked that: why these surges go up and down, how long it stays up and how fast it comes down,’ said Dr. Eric Topol, a cardiologist and professor of molecular medicine at Scripps Research. ‘All these things are still somewhat of a mystery.’
BA.5 remains the dominant subvariant in the US for now, causing most new cases as it has since the last week of June.”

CDC eases Covid-19 quarantine and testing guidelines as it marks a new phase in pandemic “People who are not up to date with their Covid-19 vaccines and who are exposed to someone infected with the coronavirus no longer need to quarantine, according to updated recommendations issued Thursday by the Centers for Disease Control and Prevention.
Instead, they should just wear a mask for 10 days in indoor settings and test on day 5,  according to the guidance. They were previously recommended to stay home.
The new guidelines could also ease the testing burden on schools. While people showing symptoms of Covid should be tested, the recommendations say broader screening “might not be cost-effective in general community settings, especially if Covid-19 prevalence is low.” Such widespread testing could still be done in certain settings like long-term care facilities, correctional facilities, and homeless shelters.”

About health insurance

 Eight Charged in Alleged $150M Crestar Labs Fraud Scheme “According to the U.S. Department of Justice (DOJ) announcement, the individuals charged, including the owner of a series of Tennessee-based labs known as Crestar Labs, LLC, were allegedly involved in a scheme in which marketers signed fake contracts and were paid kickbacks to target elderly beneficiaries of federal healthcare programs at senior health fairs, nursing homes, and other locations for their genetic material and urine analysis samples.
That material was then used in genetic testing approved by telehealth doctors who had no interaction with the patients. In many cases, the patients and the doctors actually treating them never received the test results, the DOJ alleges. Crestar Labs’ owner and the others involved in the scheme allegedly paid bribes and kickbacks for tests and doctor’s orders “without regard to medical necessity” and falsely billed Medicare and Medicaid more than $150 million, the DOJ statement adds.”

FTC Action Against Benefytt Results in $100 Million in Refunds for Consumers Tricked into Sham Health Plans and Charged Exorbitant Junk Fees “The Federal Trade Commission is taking action against healthcare company Benefytt Technologies, two subsidiaries, former CEO Gavin Southwell, and former vice president of sales Amy Brady, for lying to consumers about their sham health insurance plans and using deceptive lead generation websites to lure them in. According to the FTC complaint, Benefytt also illegally charged people exorbitant junk fees for unwanted add-on products without their permission. The proposed court orders require Benefytt to pay $100 million in refunds and prohibit the company from lying about their products or charging illegal junk fees. Southwell and Brady will be permanently banned from selling or marketing any healthcare-related product, and Brady will also be banned from telemarketing.”

Judge rejects New York doctor's challenge to surprise billing ban “A New York doctor has lost a challenge to the recently enacted federal law prohibiting surprise medical bills for out-of-network services.
U.S. District Judge Ann Donnelly in Brooklyn late Wednesday denied surgeon Daniel Haller's motion for an injunction blocking the law, which took effect in January, and dismissed his lawsuit claiming that it is unconstitutional.”

About hospitals and healthcare systems

 Colorado's new hospital price transparency law adds 'real teeth' to weak federal enforcement, experts say “The bipartisan “Prohibit Collection Hospital Not Disclosing Prices” was signed into law by Colorado Governor Jared Polis in June and went into effect Wednesday.
It prevents hospitals or their collectors from initiating or pursuing debt collection from a patient if the hospital’s website was not in compliance with the Centers for Medicare and Medicaid Services (CMS)’ price transparency requirements at the time services were delivered, according to the bill’s text.”
Perhaps state-level actions will correct federal inaction in addressing widespread non-compliance (see yesterday’s blog).

About pharma

 New drug candidate fights off more than 300 drug-resistant bacteria “Urinary tract infections are common, yet are increasingly tough to treat because the bacteria that cause them are becoming resistant to many antibiotics. Now, in ACS Central Science, researchers report a new molecule that inhibits drug-resistant bacteria in lab experiments, as well as in mice with pneumonia and urinary tract infections. The researchers say that this compound, fabimycin, could one day be used to treat challenging infections in humans…
 The team started with an antibiotic that was active against gram-positive bacteria and made a series of structural modifications that they believed would allow it to act against gram-negative strains. One of the modified compounds, dubbed fabimycin, proved potent against more than 300 drug-resistant clinical isolates, while remaining relatively inactive toward certain gram-positive pathogens and some typically harmless bacteria that live in or on the human body. In addition, the new molecule reduced the amount of drug-resistant bacteria in mice with pneumonia or urinary tract infections to pre-infection levels or below, performing as well as or better than existing antibiotics at similar doses. The researchers say the results show that fabimycin could one day be an effective treatment for stubborn infections.”

About the public’s health

Federal Health Agencies Unveil National Tool to Measure Health Impacts of Environmental Burdens The “Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR), in partnership with the Department of Health and Human Services’ Office of Environmental Justice, announce the release of the Environmental Justice Index (EJI). The EJI builds off existing environmental justice indexes to provide a single environmental justice score for local communities across the United States so that public health officials can identify and map areas most at risk for the health impacts of environmental burden.
It is the first national, geographic-driven tool designed to measure the cumulative impacts of environmental burden through the lenses of human health and health equity. Cumulative impacts are the total harm to human health that occurs from the combination of environmental burden such as pollution and poor environmental conditions, pre-existing health conditions, and social factors.”

 Monkeypox vaccine maker voices concerns on U.S. dose-splitting plan “The manufacturer of the only vaccine approved by the Food and Drug Administration to protect against monkeypox privately warned senior Biden health officials about their plan to split doses and change how the shots are delivered…
 ‘It would have been prudent’ to conduct further studies before overhauling the nation’s monkeypox vaccine strategy, [Bavarian Nordic CEO Paul] Chaplin said, adding that his company had been ‘inundated with calls from U.S. state government officials with questions and concerns’ about how to implement the new plan.
In interviews Wednesday, Biden administration officials acknowledged Bavarian Nordic’s concerns but said they would not affect their vaccine strategy.”

Longitudinal Assessments of Neurocognitive Performance and Brain Structure Associated With Initiation of Tobacco Use in Children, 2016 to 2021 “In this national cohort study of 17 073 children with neuroimaging outcomes, a significant association was found of early-age initiation of tobacco use with lower crystalized cognition composite score and impaired brain development in total cortical area and volume. Region of interest analysis also revealed smaller cortical area and volume across frontal, parietal, and temporal lobes.
Meaning  These findings suggest that initiation of tobacco use is associated with inferior neurocognitive functions; evidence-based intervention strategies and tobacco control policies should prevent tobacco initiation at a young age.”

About healthcare IT

Telehealth Utilization Grew 10.2 Percent Nationally in May 2022 “n May 2022, for the second straight month, telehealth utilization, as measured by telehealth's share of all medical claim lines, grew nationally and in every US census region (Midwest, Northeast, South, West), according to FAIR Health's Monthly Telehealth Regional Tracker.1 National telehealth utilization increased 10.2 percent, from 4.9 percent of medical claim lines in April to 5.4 percent in May. Regionally, the greatest increase was in the Midwest, where telehealth utilization grew 17.6 percent in May. The data represent the privately insured population, including Medicare Advantage and excluding Medicare Fee-for-Service and Medicaid.”

July-reported healthcare breaches exposed data on nearly 4M patients “About 3.9 million patients had data compromised in healthcare data breaches reported to the federal government last month, nearly half of which were attributed to a cyberattack at one payment vendor.” 

Digital Divide Consults and Devices for VA Video Connect [VVC] Appointments A report from the VA’s OIG.
The VA spent $11.3 million to purchase mobile devices for beneficiaries who could not afford to by them. The purpose was to facilitate appointment scheduling and telehealth appointments. The OIG found that, among other things, “About 49 Percent of the Patients Who Were Sent a Device Went on to Complete a VVC Appointment” and the money was not wisely spent.

About healthcare personnel

 Biden to name Monica Bertagnolli as National Cancer Institute director “Harvard Medical School surgeon Dr. Monica Bertagnolli is poised to become the first woman to lead the National Cancer Institute after President Joe Biden said on Wednesday he plans to appoint her to the position.
Bertagnolli currently serves as the Richard E. Wilson professor of surgery in the field of surgical oncology at Harvard as well as a surgeon at Brigham and Women's Hospital.”

Today's News and Commentary

About Covid-19

 Ancestral SARS-CoV-2, but not Omicron, replicates less efficiently in primary pediatric nasal epithelial cells  Many critics of Covid immunizations for the young base their arguments on low infection/severity rates in that population. This article explains why this finding was true for the delta variant, but emphasizes the protective mechanism does not hold for newer variants. Childhood Covid Immunization is, therefore, important.

About health insurance

 Judge Approves Blue Cross’s $2.67 Billion Antitrust Settlement “A federal judge approved Blue Cross Blue Shield companies’ settlement of a sweeping antitrust suit filed on behalf of their customers, with the insurers agreeing to pay $2.67 billion and change certain practices that allegedly limited competition…
There are currently 34 companies that own Blue Cross Blue Shield health plans, with many operating as nonprofits. Together, the Blue insurers cover more than 100 million Americans…
The suit alleged that the companies acted like a cartel, illegally conspiring to divvy up markets and avoid competing against one another, driving up customers’ prices.
Under the settlement, the Blue insurers would drop a Blue Cross Blue Shield Association rule that limits the share of each company’s total national revenue that can come from business that isn’t under Blue brands.
That change could increase competition among the companies if they choose to expand their non-Blue lines of business in one another’s geographies, insurance experts said.”

About hospitals and healthcare systems

Third Semi-Annual Hospital Price Transparency Report August 2022 “Under the authority of the Affordable Care Act (ACA), a federal hospital price transparency rule took effect January 1, 2021, requiring hospitals to post all prices online, easily accessible and searchable without having to submit personal identifying information. Prices are required to be in the form of:
• A single machine-readable standard charges file for all items and services for all payers and all plans as well as all discounted cash prices.
• A standard charges display with actual prices or a price estimator tool for the 300 most common shoppable services…
Of the 2,000 total hospitals reviewed, we found:
• Only 319 (16.0%) were complying with the rule.
• 101 hospitals (5.1%) did not post any standard charges file and were in total noncompliance.
• Although 793 (39.7%) of hospitals posted negotiated prices clearly associated with payers and plans, 407 of the 793 (51.3%) failed compliance because the majority of their pricing data was missing or incomplete.
• Of the three largest hospital systems in the country, HCA Healthcare and Ascension continued to flout the law with zero compliance, while 45 of 111 hospitals owned by CommonSpirit Health, the second largest hospital system, are now in compliance.”

 ByteDance Pays $1.5 Billion for China Hospital Chain in Health Foray “TikTok owner joins tech giants in seeking growth in the area.” More evidence that cross category diversification in healthcare is international.

 HCA Healthcare, J&J explore better outcomes, nurse training, early cancer detection in new partnership “HCA Healthcare and Johnson & Johnson outlined Tuesday morning three areas in which the former’s 35 million annual patient encounters and 93,000 nurses could benefit from the latter’s research and development knowhow.
First, the companies will be collaborating on a ‘scalable program’ to detect early-stage lung cancer among Black patients, kicking off with an early identification pilot program they will begin to build “in the coming months.”
Second, HCA will be incorporating Johnson & Johnson’s nursing resources within its facilities and affiliate Galen College of Nursing. The two will also jointly build nurse education programs intended to address health equity, build nurses’ skills and improve patient outcomes.
Finally, the hospital chain’s HCA Healthcare Research Institute will be working with Johnson & Johnson on various cardiovascular health research projects. Among those teased were a retrospective analysis of heart arrhythmia patients and an investigation on how digital health technology could impact coronary artery disease and peripheral artery disease outcomes.”

About pharma

In warranty program, Pfizer will refund up to $50K for patients who discontinue use of rare disease drug 
Last year the pharma giant introduced its first warranty program, using it to promote lung cancer drug Xalkori. Now Pfizer has opened a similar program for newly approved Panzyga, which treats the rare disorder chronic inflammatory demyelinating polyneuropathy (CIPD).”
This trend of refunding costs for expensive, ineffective drugs is continuing.

Walmart has a new policy denying some telehealth prescriptions for controlled drugs. It's implicating patients in recovery “Walmart did not respond to multiple requests for comment, but one Walmart pharmacy employee confirmed the existence of the policy applicable to all Walmart and Sam’s Club pharmacies that began in July.”

BREAKING: Walgreens Fueled SF Opioid Epidemic, Judge Rules “ Pharmacy giant Walgreens dispensed hundreds of thousands of suspicious prescriptions for narcotic painkillers in San Francisco without proper screening and is liable for ensuing opioid problems in the Bay Area, a California federal judge ruled Wednesday. The ruling from U. S. District Judge Charles R. Breyer followed a bench trial earlier this year that initially featured several drug companies but gradually generated several settlements, leaving Walgreens as the sole defendant.”

Faced with thousands of opioid lawsuits, Endo says it will likely file for bankruptcy 'imminently' “The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that ‘these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.’”

About the public’s health

China discovers potentially fatal new virus passed to humans from shrews “China has discovered a potentially fatal new virus that is believed to have been passed to humans by shrews, as reported Independent on Tuesday.
The Langya henipavirus has infected 35 people, although no one has died or suffered a serious illness, said Taiwan's Centers for Disease Control.
There is no vaccine and, in severe cases, it can have a fatality rate of up to 75%, according to the World Health Organization.”

Todays News and Commentary

About health insurance

3.7 Million People Would Gain Health Coverage in 2023 if the Remaining 12 States Were to Expand Medicaid Eligibility From the RWJF: “Key Findings:

• Black individuals, young adults, and women—particularly women of reproductive age—would realize the largest coverage gains. 

• Federal spending on Medicaid and marketplaces in the 12 non-expansion states would be partially offset by $2.6 billion in federal government savings on uncompensated care.

  • State spending on Medicaid in those states would be partially offset by $1.7 billion.

  • Comprehensive analyses of states that expanded Medicaid demonstrate that expansion generated savings and increased revenues to outweigh any new spending.”

Illinois customers sue health insurance giant Centene “The lawsuit, filed in the U.S. District Court for the Eastern Division of the Northern District of Illinois on Friday, alleges that Centene, through its subsidiaries, sold ‘fraudulent health insurance policies’ to millions of consumers across 26 states, including Illinois, since 2013…
The primary issue consumers raise in the complaint is that many members of Ambetter, Centene's consumer-facing insurance plans, have difficulty finding an in-network provider and, in some cases, have been unable to find any provider that takes Ambetter plans.
As a result, some Ambetter members have suffered delays in treatment, been unable to find treatment, been forced to travel hundreds of miles to in-network providers and pay out-of-pocket fees. The complaint also alleges that Ambetter plans refuse to pay for some services they advertised covering.”

About hospitals and healthcare systems

 Kaiser posts $1.3B loss in Q2 “Kaiser, which provides healthcare and health plans, reported operating revenue of $23.47 billion in the second quarter of 2022, down from $23.69 billion in the same quarter of 2021. The organization's expenses climbed from $23.34 billion in the second quarter of last year to $23.38 billion in the same period this year. 
‘Much like the entire health care industry, we continue to address deferred care while navigating COVID-19 surges and associated expenses,’ Kathy Lancaster, Kaiser executive vice president and CFO, said in an Aug. 5 earnings release.
Kaiser ended the second quarter of this year with operating income of $89 million, down from $349 million a year earlier.”

About pharma

 GSK bets $1.3B on Mersana’s preclinical ADC and chance to expand portfolio beyond Blenrep “GSK has paid out $100 million cash to Mersana Therapeutics for the potential to add a second antibody-drug conjugate (ADC) to its portfolio, which currently consists of approved multiple myeloma drug Blenrep. The new deal encompasses XMT-2056, Mersana’s preclinical ADC asset aimed at treating a range of HER-2 cancers.   
The global agreement gives GSK an exclusive option to co-develop and commercialize XMT-2056. If GSK exercises the option, Mersana could make up to $1.36 billion in biobucks, making the deal one of the largest to date for a preclinical ADC asset.”

Pfizer to buy Global Blood Therapeutics under $5.4-billion deal “Pfizer agreed to buy Global Blood Therapeutics (GBT) for $68.50 per share in cash, or a total enterprise value of approximately $5.4 billion, the companies said Monday… The boards of both drugmakers have unanimously approved the transaction, which represents a premium of nearly 43% to GBT's closing share price on August 4…
The purchase will give Pfizer rights to GBT's sickle cell disease therapy Oxbryta (voxelotor), which is approved in a number of markets, including the US and Europe, and generated sales of around $195 million last year. Pfizer said it ‘plans to accelerate’ distribution of Oxbryta to parts of the world most impacted by sickle cell disease.”

To avoid shortage of Merck's diabetes drug, FDA allows higher impurity levels temporarily “The FDA said Tuesday that it recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck’s type 2 diabetes drug Januvia.
To avoid a shortage of the drug that pulled in more than $10.5 billion for Merck in 2020 and 2021, and to help ensure patients have access to an adequate supply, the FDA said it will not object to the temporary distribution of sitagliptin containing the impurity above the acceptable intake limit.
Typically, if a drug contains levels of nitrosamines above the acceptable daily intake limit, the FDA recommends the manufacturer conduct a recall.”
I have never seen this permission before for any drug.

About the public’s health

Limited monkeypox vaccine supply would be stretched under FDA plan “The strategy, first described publicly by Food and Drug Administration Commissioner Robert Califf last week, would allow the Biden administration to stretch its limited supply of monkeypox vaccines by changing how those shots are administered. Rather than inject doses of Jynneos subcutaneously, a traditional way of delivering vaccines into the fatty tissue under the skin, the doses would instead be injected under the top layer of the skin. This approach, known as an intradermal injection, uses a thinner needle and less vaccine, but leads to a small bubble forming on the surface of the skin that can scar.”

 Group of 23 states tells U.S. court CDC lacks authority to set transit mask rules “A group of 23 state attorneys general led by Florida told a federal court on Monday that the U.S. Centers for Disease Control and Prevention (CDC) lacks the legal authority to impose a nationwide transportation mask mandate to address COVID-19…
 A group of 17 Republican U.S. lawmakers including Senator Rand Paul and Representative Thomas Massie also filed a brief Monday arguing the CDC lacked the authority to impose masking requirements.”

A Huge Amount of Data From Cancer Trials Remains Hidden, Researchers Warn “Data from more than half of cancer trials underpinning drug approvals remains inaccessible, according to a shocking new study that audited over 300 clinical trials backing anti-cancer medicines approved by the US drug regulator over the last 10 years.
Of the 304 industry-sponsored clinical trials that provided data for 115 anti-cancer drugs approved by the US Food and Drug Administration (FDA) between 2011 and 2021, only 45 percent had publicly shared patient-level data – or said they would do so when the researchers enquired about accessing data.
What's more, less than one-tenth of trials cited on product labels of three of the top-selling anti-cancer drugs made individual patient data available, the study found.”

About healthcare IT

 Predicting Race And Ethnicity To Ensure Equitable Algorithms For Health Care Decision Making [From Health Affairs, subscription required] “Algorithms are currently used to assist in a wide array of health care decisions. Despite the general utility of these health care algorithms, there is growing recognition that they may lead to unintended racially discriminatory practices, raising concerns about the potential for algorithmic bias. An intuitive precaution against such bias is to remove race and ethnicity information as an input to health care algorithms, mimicking the idea of ‘race-blind’ decisions. However, we argue that this approach is misguided. Knowledge, not ignorance, of race and ethnicity is necessary to combat algorithmic bias….
 We describe two applications in which imputation of race and ethnicity can help mitigate potential algorithmic biases: equitable disease screening algorithms using machine learning and equitable pay-for-performance incentives.”

The Impact of Telemedicine on Physicians’ After-hours Electronic Health Record “Work Outside Work” During the COVID-19 Pandemic: Retrospective Cohort Study “Taking physicians’ clinical load into account, physicians who devoted a higher proportion of their clinical time to telemedicine throughout various stages of the pandemic engaged in higher levels of EHR-based after-hours work compared to those who used telemedicine less intensively. This suggests that telemedicine, as currently delivered, may be less efficient than in-person–based care and may increase the after-hours work burden of physicians.” 

About health technology

Pathogenic variants damage cell composition and single cell transcription in cardiomyopathies “The cellular and molecular architectures that induce heart failure are both shared and distinct across genotypes. These data provide candidate therapeutic targets for future research and interventional opportunities to improve and personalize treatments for cardiomyopathies and heart failure.” 

Hydrogel keeps vaccines alive “Most vaccines require constant refrigeration during shipment to remain effective. An international research team led by ETH Zurich has now developed a special hydrogel that vastly improves the shelf life of vaccines, even without refrigeration. The development could save many lives and lower the cost of cold chains.” 

Today's News and Commentary

Senate approves Inflation Reduction Act, clinching long-delayed health and climate bill Some healthcare implications (in addition to climate control measures): “The prescription drug pricing reforms aim to help cut costs for seniors enrolled in Medicare. It caps their out-of-pocket costs at $2,000 annually, while allowing the U.S. government to negotiate the price of a small set of medicines beginning in 2026. The landmark proposal is expected to save elderly Americans money and achieve billions in savings for Washington over the next decade. Pharmaceutical giants, which forcefully opposed the bill, also would be required to pay “rebates” to the federal government if they raise Medicare drug prices beyond the rate of inflation.
But Democrats did not accomplish everything they sought. An attempt to lower and cap the price of insulin, for example, faltered after Republicans on Sunday stripped it from the bill. Their opposition appeared to doom the plan for the remainder of the year, because a bipartisan attempt to reduce the cost of the lifesaving diabetes drug previously failed to secure GOP support…
The bill also includes $64 billion to stave off health insurance premium increases for about 13 million Americans who buy coverage through state and federal exchanges under the Affordable Care Act. These beneficiaries currently receive discounted coverage under a coronavirus-era program set to expire this year, threatening them with premium increases into hundreds of dollars next month.”

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW  “As of August 3, 2022, the current 7-day moving average of daily new cases (117,351) decreased 7.3% compared with the previous 7-day moving average (126,537). A total of 91,676,264 COVID-19 cases have been reported in the United States as of August 3, 2022.”
And globally:  COVID cases drop 9% globally last week, deaths stable

BioNTech expects Omicron-adapted vaccine deliveries as soon as October”BioNTech expects to begin deliveries of two Omicron-adapted vaccines as soon as October, which will help spur demand in the fourth quarter, the German biotech firm said on Monday as it reaffirmed its vaccine-revenue forecast for the year.
Demand for the vaccine, 3.6 billion doses of which have been shipped globally, is waning as most people in the Western world have received three or four shots already.”
In a related story: With COVID vaccine demand in free fall, BioNTech's revenue plummets nearly 50% in second quarter “After four consecutive quarters in which revenue topped 5 billion euros ($5.1 billion)—nearly all of it attributed to sales of its Pfizer-partnered COVID-19 vaccine—BioNTech is coming to grips with a decline in demand for the shot, known commercially as Comirnaty.
And the fall is coming quicker than expected. On Monday, the German company reported revenue of 3.2 billion euros ($3.3 billion) for the second quarter. It was a 40% decline from the same period last year and nearly a 50% drop from the company's first quarter revenue figure of 6.4 billion euros.”

Post–COVID-19 Symptoms and Conditions Among Children and Adolescents — United States, March 1, 2020–January 31, 2022 “Compared with patients aged 0–17 years without previous COVID-19, those with previous COVID-19 had higher rates of acute pulmonary embolism (adjusted hazard ratio = 2.01), myocarditis and cardiomyopathy (1.99), venous thromboembolic event (1.87), acute and unspecified renal failure (1.32), and type 1 diabetes (1.23), all of which were rare or uncommon in this study population.”

About health insurance

 CVS Plans to Bid for Signify Health “CVS Health Corp. is seeking to buy Signify Health Inc., according to people familiar with the matter, as the drugstore and insurance giant looks to expand in home-health services.
Signify Health is exploring strategic alternatives including a sale, The Wall Street Journal reported this past week. Initial bids are due this coming week and CVS is planning to enter one, some of the people said. Others also are in the mix, they said, and CVS could face competition from other managed-care providers and private-equity firms.
There is no guarantee any of them will reach a deal for Signify, which has a market value of around $4.7 billion after its shares rose on the news of a potential sale.”

Analysis of Recent National Trends in Medicaid and CHIP Enrollment “After declines in enrollment from 2017 through 2019, preliminary data for April 2022 show that total Medicaid/CHIP enrollment grew to 88.3 million, an increase of 17.0 million from enrollment in February 2020 (23.9%), right before the pandemic and when enrollment began to steadily increase (Figure 1).1Increases in enrollment may reflect changes in the economy, changes in policy (like recent adoption of the Medicaid expansion in the Affordable Care Act), and the temporary continuous enrollment requirement created by the Families First Coronavirus Response Act (FFCRA).”
The article has great graphics displaying trends.

About pharma

The most significant FDA citations of 2021-2022 FYI

How 6 drugmakers fared in Q2 FYI

Jury finds MN pharmacist did not discriminate in denying emergency contraception “An Aitkin County jury on Friday found that a central Minnesota pharmacist did not discriminate when he refused to provide emergency contraceptives to a woman in 2019.
Andrea Anderson of McGregor Minn., sought to fill her prescription for Ella, which is used to stop a pregnancy before it starts, after a condom broke during intercourse. 
She had the prescription sent to a nearby Thrifty White pharmacy, but when she called to confirm, pharmacist George Badeaux told her he would not fill it due to ‘personal reasons.’
According to the lawsuit, he said a colleague might be willing to fill it, but with a snowstorm imminent that person may not make it into work. Anderson got the prescription filled in Brainerd, but it required a 100-mile drive round trip in a snowstorm that allegedly took Anderson more than three hours.”

About the public’s health

 Over half of known human pathogenic diseases can be aggravated by climate change “It is relatively well accepted that climate change can affect human pathogenic diseases; however, the full extent of this risk remains poorly quantified. Here we carried out a systematic search for empirical examples about the impacts of ten climatic hazards sensitive to greenhouse gas (GHG) emissions on each known human pathogenic disease. We found that 58% (that is, 218 out of 375) of infectious diseases confronted by humanity worldwide have been at some point aggravated by climatic hazards; 16% were at times diminished. Empirical cases revealed 1,006 unique pathways in which climatic hazards, via different transmission types, led to pathogenic diseases. The human pathogenic diseases and transmission pathways aggravated by climatic hazards are too numerous for comprehensive societal adaptations, highlighting the urgent need to work at the source of the problem: reducing GHG emissions.” 

Abortion law in Indiana leads to fallout for state, politics “Indiana’s new sweeping ban on abortion produced immediate political and economic fallout Saturday, as some of the state’s biggest employers objected to the restrictions, Democratic leaders strategized ways to amend or repeal the law, and abortion rights activists made plans to arrange alternative locations for women seeking procedures.”

Today's News and Commentary

About health insurance

 Big payers ranked by Q2 revenue FYI

About hospitals and healthcare systems

 RURAL HOSPITALS AT RISK OF CLOSING “More than 600 rural hospitals – nearly 30% of all rural hospitals in the country – are at risk of closing in the near future.”  The article gives insightful details.

How US News' 20 Honor Roll hospitals fared with CMS star ratings this year The answer is that except Barnes-Jewish hospital in St. Louis (#11 and 3 stars), all have 4 or 5 stars.

About pharma

 A New Therapeutic Drug for Alzheimer’s Disease without Inflammatory Side Effects​ “Although Aduhelm, a monoclonal antibody targeting amyloid beta (Aβ), recently became the first US FDA approved drug for Alzheimer’s disease (AD) based on its ability to decrease Aβ plaque burden in AD patients, its effect on cognitive improvement is still controversial. Moreover, about 40% of the patients treated with this antibody experienced serious side effects including cerebral edemas (ARIA-E) and hemorrhages (ARIA-H) that are likely related to inflammatory responses in the brain when the Aβ antibody binds Fc receptors (FCR) of immune cells such as microglia and macrophages…
To overcome these problems, a team of researchers at KAIST in South Korea has developed a novel fusion protein drug, αAβ-Gas6, which efficiently eliminates Aβ via an entirely different mechanism than Aβ antibody-based immunotherapy. In a mouse model of AD, αAβ-Gas6 not only removed Aβ with higher potency, but also circumvented the neurotoxic inflammatory side effects associated with conventional antibody treatments.  Their findings were published on August 4 in Nature Medicine.”

About the public’s health

 Has the treatment gap for opioid use disorder [OUD] narrowed in the U.S.?: A yearly assessment from 2010 to 2019   “Adjusted estimates suggest past-year OUD affected 7,631,804 individuals in the U.S. in (2,773 per 100,000 adults 12+), relative to only 1,023,959 individuals who received MOUD [medication for OUD] (365 per 100,000 adults 12+). This implies approximately 86.6% of individuals with OUD nationwide who may benefit from MOUD treatment do not receive it. MOUD receipt increased across states over the past decade, but most regions still experience wide gaps between OUD prevalence and MOUD receipt.”

About healthcare personnel

 63 healthcare orgs call on Congress to extend, expand visa waiver for international medical graduates “The two letters, sent to the House and Senate’s Judiciary Committee leaders late last week, address the Conrad 30 Waiver Program.
The program allows foreign students who come to the U.S. for medical training to forego visa requirements that would force them to return to their home country for at least two years…
The healthcare industry has already been straining for years under the weight of a widespread workforce shortage, but the issue is only expected to worsen due to heightened post-pandemic demand, the organizations told committee leaders.”

Today's News and Commentary

About Covid-19

 Eli Lilly to make COVID-19 antibody drug commercially available from August “Eli Lilly and Co said on Wednesday it plans to make its COVID-19 antibody drug commercially available to U.S. states as well as hospitals and other healthcare providers from August….
The U.S. government will exhaust their supply of bebtelovimab as early as the week of August 22 and, without congressional appropriations, does not have the funds to purchase more, Lilly told Reuters.
Lilly would make bebtelovimab commercially available through a sole distributor beginning the week of Aug. 15, the company said.”

About health insurance

 CVS plans to make a major primary care play by the end of 2022 “CVS, which operates 9,900 locations across the country, is looking to enhance its health services in primary care, provider enablement and home health, CVS CEO Karen Lynch said during the company's second-quarter earnings call Wednesday morning.
M&A will be a key part of that strategy, she said.”

Cigna boosts guidance as it posts $1.6B in profit for Q2 “Cigna posted $1.6 billion in profit and $45.5 billion in revenue for the second quarter, according to its earnings report released Thursday.
Both results beat Wall Street analysts' forecasts… They also represent growth year over year, as in the second quarter of 2021 Cigna brought in $43.1 billion in revenue and $1.5 billion in profit.
Through the first half of this year, Cigna has earned $2.7 billion in profit and $89.5 billion in revenue. By comparison, the insurer earned $2.6 billion in profit and $84.1 billion in revenue in the first six months of 2021.”

About hospitals and healthcare systems

 Studies show that hospitals that serve black patients receive less financial assistance “According to a recent study by medical researchers at UCLA and Princeton, Johns Hopkins and Harvard Universities, hospitals that serve a large proportion of black patients receive less financial support for care compared to hospitals that serve a smaller proportion.
The peer-reviewed study collected data from Medicare and the American Hospital Association on 5,740 hospitals from 2016 to 2018. Of these hospitals, 574 were identified as “serving blacks” or in the top 10% for the largest proportion of black patients. among Medicare inpatients. Most of the hospitals serving blacks were concentrated in the southern and/or urban areas.
The researchers found that total reimbursement, which includes payments from patients and insurers for patient care per day, was on average 21.6% lower at hospitals serving blacks. Hospitals serving more black patients lost $17 per patient per day on average, compared with an average profit of $126 per patient per day among other study hospitals.
Median profits at black hospitals were $111 lower per patient per day, adjusted for a variety of cases and conditions.”

About pharma

 Amgen chief Bradway nabs a rare disease player in $4B buyout as the M&A tempo accelerates “Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.
Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.”

FDA approves Cimerli as interchangeable biosimilar to Lucentis “The FDA approved Cimerli as a biosimilar to and interchangeable with Lucentis, according to a press release from Coherus BioSciences.
The approval confirms that Cimerli (ranibizumab-eqrn), an anti-VEGF therapy that helps patients with retinal diseases maintain or gain vision, meets all FDA safety, efficacy and quality standards. It is indicated for neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization.”
Lucentis is very expensive and some ophthalmologists use generic Avastin (off label) instead.
Cimeril will have a list price of $1,130 per single-use vial, a 40% discount to Lucentis.
Compare the price to generic Avastin, which costs $50 per dose.

Court Says AstraZeneca, Merck and Takeda Should Face Litigation Over Nexium and Prevacid “A federal judge in New Jersey has recommended that AstraZeneca, Merck and Takeda Pharmaceuticals should face litigation for failure to add warnings on two proton pump inhibitors about the risk of kidney injury.
The case concerns two antacids, AstraZeneca and Merck’s Nexium (esomeprazole magnesium) and Takeda’s Prevacid (lansoprazole).”

Gilead to acquire biotech company for $405M “Biopharmaceutical company Gilead Sciences has agreed to acquire MiroBio, a biotechnology company focused on the research of cellular immunity. 
Once the transaction is complete, Gilead will have the rights to MiroBio's entire catalog of immune inhibitory receptors and MiroBio's platform used to develop antibodies targeting immune inhibitory receptors. Gilead will acquire MiroBio for $405 million, according to the Aug. 4 press release.”

About the public’s health

U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year “The shortage of vaccines to combat a fast-growing monkeypox outbreak was caused in part because the Department of Health and Human Services failed early on to ask that bulk stocks of the vaccine it already owned be bottled for distribution, according to multiple administration officials familiar with the matter.
By the time the federal government placed its orders, the vaccine’s Denmark-based manufacturer, Bavarian Nordic, had booked other clients and was unable to do the work for months, officials said — even though the federal government had invested well over $1 billion in the vaccine’s development.
The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak. It does not expect the next delivery, of half a million doses, until October.”
And in a related story: U.S. declares monkeypox outbreak a public health emergency

Biden issues second executive order to protect abortion access “The executive order directs the Department of Health and Human Services to ‘consider action to advance access’ to reproductive health services, including through Medicaid for patients who travel out of state.”

Association Between Prostate-Specific Antigen Screening and Prostate Cancer Mortality Among Non-Hispanic Black and Non-Hispanic White US Veterans ”In this cohort study of 45 834 US veterans, PSA screening was associated with decreased risk of prostate cancer–specific mortality (PCSM) among Black men and White men. Compared with less frequent screening, annual screening was associated with decreased risk of PCSM among Black men but not among White men.”

About healthcare IT

 Digital therapeutics for mental health: Is attrition the Achilles heel? “To date, only a few clinically tested software devices have been authorized by the U.S. Food and Drug Administration for treating specific mental health disorders (excluding devices marketed under pandemic-related emergency use authorization). These include reSET for substance abuse disorder, reSET-O for opioid use disorder, Somryst for chronic insomnia and EndeavorRx for pediatric attention deficit hyperactivity disorder. SaMDs and MMAs for treating mild cognitive impairment, Alzheimer's disease, schizophrenia, autism, depression, social anxiety disorder, phobias and PTSD are in clinical trials and may also come to market soon.”
However: “Our scrutiny of published data also reveals several scientific gaps. First is the lack of standardized definitions of attrition and engagement in the field of digital therapeutics. Second is the lack of standardized reporting requirements by journals. A single digital therapeutic session can generate a dozen or more different metrics of how a user may interact with the app. Even widely used clinical trials reporting checklists, such as CONSORT, have not yet required the reporting of all such engagement metrics in digital trials. This makes it hard to extract such data from published reports and compare metrics across trials and products. Third, is the lack of a standardized definition of compliance. Fourth is the lack of standardized statistical methods, such as mixed models or last observation carried forward, to account for attrition and engagement biases in digital trials.”
The article offers some potential ways to address these obstacles.

About health technology

 A physical wiring diagram for the human immune system “A first of its kind comprehensive map of the network of connections that make up the human immune system has been created, which could lead to new immunotherapies to treat cancer, infectious diseases, and other conditions where immune responses play a role.”

New patent-pending method mass-produces antitumor cells to treat blood diseases and cancer “Xiaoping Bao, a Purdue University assistant professor from the Davidson School of Chemical Engineering, said CAR-neutrophils, or chimeric antigen receptor neutrophils, and engraftable HSCs, or hematopoietic stem cells, are effective types of therapies for blood diseases and cancer. Neutrophils are the most abundant white cell blood type and effectively cross physiological barriers to infiltrate solid tumors. HSCs are specific progenitor cells that will replenish all blood lineages, including neutrophils, throughout life…
Bao has developed a patent-pending method to mass-produce CAR-neutrophils from human pluripotent stem cells (hPSCs), that is, cells that self-renew and are able to become any type of human cell. The chimeric antigen receptor constructs were engineered to express on the surface of the hPSCs, which were directed into functional CAR-neutrophils through a novel, chemically defined protocol.”

Today's News and Commentary

About Covid-19

 Association of Receiving a Fourth Dose of the BNT162b Vaccine With SARS-CoV-2 Infection Among Health Care Workers in Israel “In this multicenter cohort study of 29 611 health care workers in Israel, the breakthrough infection rate among those who received 4 doses was 6.9% compared with 19.8% in those who received 3 doses.”

About health insurance

National Uninsured Rate Reaches All-Time Low in Early 2022 From HHS: “The nation’s uninsured rate declined significantly in 2021 and early 2022, reaching an all-time low of 8.0 percent for U.S. residents of all ages in the first quarter (January-March) of 2022, based on new data from the National Health Interview Survey.
Approximately 5.2 million people – including 4.1 million adults ages 18-64 and 1 million children ages 0-17 – have gained health coverage since 2020.”
Read the announcement for more details.

 The Senate passes help for veterans exposed to toxins, after a reversal drew fury “The U.S. Senate, in a bipartisan 86-11 vote, approved a measure to provide health care and benefits for millions of veterans injured by exposure to toxins, from Agent Orange in Vietnam to burn pits in Iraq and Afghanistan.
Known as the PACT Act, the bill no longer would force generations of veterans to prove that their illness was caused by toxic exposures suffered in the military in order to get VA coverage. It had been hailed as the largest expansion of care in VA history, and was expected to cost $280 billion over a decade.
The House passed the measure in July. President Biden, who supports the PACT Act, is expected to sign it into law.”

Part D premiums to decline by 2% in 2023: CMS “The Centers for Medicare & Medicaid Services (CMS) said Friday that it expects the average premium to decrease to $31.50 in 2023, or about 1.8% from the 2022 rate of $32.08.
The projected monthly premiums are based on bids to CMS from Part D plan sponsors, the agency said.”
Understand that these figures are averages. According to the Kaiser Family Foundation: “The average Medicare beneficiary has a choice of 54 Medicare plans with Part D drug coverage in 2022, including 23 Medicare stand-alone drug plans and 31 Medicare advantage drug plans.”

About pharma

The web is home to an illegal bazaar for abortion pills. The FDA is ill-equipped to stop it. An important investigative piece in Politico. At the center of the problem is the fact that: “Of the roughly 35,000 online pharmacies worldwide, 95 percent operate illegally, according to the National Association of Boards of Pharmacy.”

Civica launches 1st drug At a cost 95 percent less than Medicare's prices, nonprofit generic drug company Civica premiered its first drug Aug. 3 with a treatment used for prostate cancer that has spread.
The abiraterone acetate 250 milligram tablets are $160 for a month's supply, and Civica recommends pharmacies selling the product cap prices at $171 per bottle, according to a press release.”
For comparison, GoodRx sells the same medication for as low as $185.40.

CVS beats the Street with $2.95B in profit for Q2 “CVS Health beat the Street in the second quarter with $2.95 billion in profit, according to its earnings report released Wednesday morning.
That's a notable increase from the $2.8 billion in the company posted in the prior-year quarter. The healthcare giant also surpassed analysts' expectations with $80.6 billion in revenue for the quarter…
At the company's Aetna subsidiary, revenues were $22.8 billion, up nearly 11% year over year thanks to growth across all of its product lines…
Revenues at Caremark were up 11.7% compared to the second quarter of 2021, reaching $42.8 billion…
CVS Pharmacy also saw its revenues increase year over year, according to the report, reaching $26.3 billion. Growth in the retail segment was driven primarily by increased prescription and front store volume…”

Eli Lilly Must Pay $61M For False Medicaid Rebate Calculation “Illinois federal jury hit Eli Lilly and Co. with a $61 million verdict Wednesday after finding that the drug manufacturer deliberately shorted the Medicaid program by leaving retroactive drug price increases out of the metrics it was required to include for drug rebate calculations.”

About the public’s health

Isolation and Prevention Practices for People with Monkeypox The latest advice from the CDC.

 Justice Department sues Idaho to reverse 'near-total' abortion ban “HHS issued guidance last month saying physicians in hospitals that participate in Medicare have an obligation under the federal Emergency Medical Treatment and Labor Act (EMTALA) to provide abortions as part of emergency care such as for ectopic pregnancies.
But the DOJ is arguing that the Idaho law, which goes into effect Aug. 25, prohibits all abortions and conflicts with EMTALA.”

Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups “At the request of Congress, Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups identifies policies, procedures, programs, or projects aimed at increasing the inclusion of these groups in clinical research and the specific strategies used by those conducting clinical trials and clinical and translational research to improve diversity and inclusion. This report models the potential economic benefits of full inclusion of men, women, and racial and ethnic groups in clinical research and highlights new programs and interventions in medical centers and other clinical settings designed to increase participation.”
This site will help you connect to the (free) report. If you want to get directly to recommendations, scroll down to page 130.
See Lack of diversity in clinical trials costs billions of dollars. Incentives can spur innovation from STAT for an excellent summary.

About healthcare IT

 Another class action over Meta's alleged patient data mining lists UCSF, Dignity Health as defendants “A second class action lawsuit has been filed against Facebook parent company Meta related to allegations of hospital website data collection, this time also listing UCSF Medical Center and Dignity Health as co-defendants.
 Similar to the prior class action and research investigation from June…, the plaintiff outlined ‘illegal information gathering’ via a tracker called the Facebook/Meta Pixel embedded on hospitals' websites.”

About healthcare personnel

Physician Flash Report “Physician practices across the country remained busy throughout the second quarter of 2022. Patient volumes rose from first-quarter levels as physician productivity and revenues also increased.
However, higher volumes contributed to bigger investments/ subsidies to support physician practices. They also led to continued expense increases as practices contend with inflation and a tight labor market. Total Direct Expense per Physician Full-Time Equivalent (FTE) continued its upward trajectory, reaching a new two-year high.”

 Inaccurate Cost Estimates Could Push 60% of Patients to Switch Providers “For “The Healthcare Conundrum: The Impact of Unexpected Patient Costs on Care,” a PYMNTS and Experian Health collaboration, we surveyed 2,483 consumers to learn about the effects of rising healthcare costs on patient care, including how accurate and timely cost estimates drive patient satisfaction and improve care.”
Highlights of the study:
—Three-quarters of millennials canceled a healthcare appointment after receiving a high cost estimate, as have 60% of consumers living paycheck to paycheck with issues paying their bills.
—More than two in five patients who received inaccurate cost estimates said they spent more on healthcare than they could afford.
—The average amount consumers paid for surprise medical bills is $675.

About health technology

 Blood Test Could Provide Insight Into Patients' Metastatic Cancer  So-called liquid biopsies are not new, but this research provided fascinating findings. Previously, all metastases were thought to be the same and, thus treated with a single approach. However the “researchers assessed all classes of genomic alterations and found that ctDNA [circulating tumor DNA] contains multiple dominant populations, indicating that most people with metastatic cancer have different metastases spread around the body. They found that the whole-genome sequencing process provides a host of information about these different metastases.
The research team used newly developed computer programs to provide information about the genetic makeup of each cancer population, which can tell researchers about a person's overall disease rather than about one metastatic tumor. In the future, this information could allow clinicians to make better decisions about managing a patient's cancer.”

New smartphone clip-on can detect Zika virus in blood samples “In a new study, researchers at the University of Illinois Urbana-Champaign have combined their efforts to develop an instrument that can be clipped on to a smartphone to rapidly test for Zika virus in a single droplet of blood.”

Apple Watch Parkinson Disease Symptom Monitor Is Cleared “A program that uses motion sensors built into the Apple Watch to monitor symptoms of Parkinson disease gained FDA clearance.
In addition to recording tremors and uncontrolled body movements, or dyskinesia, the StrivePD software from Rune Labs tracks medication use, adverse events, and patient-reported outcomes such as mood and overall health. When integrated with the Medtronic Percept PC Deep Brain Stimulator, it may also gather detailed brain activity information, a company statement noted.”

PerkinElmer to rebrand as life-science-focused supplier, sell off other businesses in $2.45B deal “PerkinElmer is slimming down to focus solely on diagnostics and life sciences research, selling off its other businesses in a deal that will hand it $2.3 billion in cash. The funding is expected to allow the company to redouble its efforts in healthcare and attain a new name.
Through a sale to private equity firm New Mountain Capital, PerkinElmer is divesting its food safety, environmental testing and industrial quality assurance divisions, including its chromatography and mass spectrometry hardware made for use in forensics, semiconductor manufacturing, chemical production and more.
The transaction is slated to close in the first quarter of 2023, according to a press release.”

About healthcare quality

Quality Measures for Patients at Risk of Adverse Outcomes in the Veterans Health Administration: Expert Panel Recommendations “The systematic review identified 519 measure concepts, from which 15 domains and 49 measure concepts were proposed for expert panel consideration. After panel discussions and changes to measure concepts, the expert panel rated 63 measure concepts in 13 domains. The measure concepts with the highest median ratings focused on caregiver availability and support, COVID-19 vaccination, and pneumonia vaccination (all rated 9.0); housing instability (rated 8.5); and physical function, depression symptoms, cognitive impairment, prescription regimen, primary care follow-up after an emergency department visit or hospitalization, and timely transmission of discharge information to primary care (all rated 8.0). Recommendations to improve care included timely assessment of housing instability, caregiver support, physical function, depression symptoms, and cognitive impairment; annual prescription regimen review; coordinated transitions in care; and preventive care including vaccinations.”

Today's News and Commentary

About hospitals and healthcare systems

 CMS finalizes 4.3% bump for hospital inpatient payments in 2023 “The Biden administration finalized a 4.3% bump for inpatient payments for the federal fiscal year 2023, an increase compared to the 3.2% that was originally proposed back in April….
Acute care hospitals paid under the IPPS and also meaningfully use electronic health records can expect to see a 4.3% increase in their rates based on a market basket update of 4.1%…
Long-term care hospitals can expect to see hikes of 2.4% in payments or $71 million…
The rule adds three measures to the inpatient quality reporting program focused on equity. The first aims to assess a hospital’s equity culture by examining strategic planning and leadership engagement. The other two measures focus on screening and identification of social needs such as food insecurity and transportation….
Other updates in the final rule include:

• Creation of a “birthing-friendly” hospital designation that provides important information to consumers on how the hospital has reduced maternal morbidity and mortality.

• Continuing current COVID-19 reporting requirements for hospitals and critical access hospitals but it will not finalize proposed requirements for any future public health emergencies.

• A distribution of roughly $6.8 billion in uncompensated care payments for fiscal year 2023, a decline of approximately $318 million from the previous fiscal year. The change reflects projections on the impact of the pandemic, CMS said.”

About pharma

 Optum, Sanofi team to make low-cost insulin available to uninsured “The UnitedHealth Group subsidiary announced Monday that it would make a 30-day supply of insulin available for $35 on Optum Store for those who do not have insurance. The insulin is available now for patients who have a valid prescription for the drug.
The news comes on the heels of an announcement from UnitedHealthcare that the insurer will eliminate cost-sharing on five preferred drugs, including insulin and several emergency medications, for people who are enrolled in its fully insured group plans.”

About the public’s health

 PCORI approves $258 million to fund research studies addressing mental health, heart-related care, and a range of chronic and acute conditions “The Patient-Centered Outcomes Research Institute (PCORI) has approved funding awards totaling $258 million to support 26 new research studies. These studies aim to fill evidence gaps and improve health care decision making for a range of high-burden conditions among adults and children, including asthma, bone fractures, migraines, intellectual and developmental disabilities, and sinus infections.
Five comparative clinical effectiveness research (CER) studies focus on improving mental health and another four CER studies focus on heart conditions, which have both continued to worsen in the U.S. amid the COVID-19 pandemic.
Additionally, PCORI… announced about $3.9 million for two projects that aim to promote wider, faster adoption of useful findings from completed PCORI-funded CER studies into typical care practices.”

Cardiovascular Disease Projections in the United States Based on the 2020 Census Estimates “By the year 2060, compared with the year 2025, the number of people with diabetes mellitus will increase by 39.3% (39.2 million [M] to 54.6M), hypertension by 27.2% (127.8M to 162.5M), dyslipidemia by 27.5% (98.6M to 125.7M), and obesity by 18.3% (106.3M to 125.7M). Concurrently, projected prevalence will similarly increase compared with 2025 for ischemic heart disease by 31.1% (21.9M to 28.7M), heart failure by 33.0% (9.7M to 12.9M), myocardial infarction by 30.1% (12.3M to 16.0M), and stroke by 34.3% (10.8M to 14.5M). Among White individuals, the prevalence of CV risk factors and disease is projected to decrease, whereas significant increases are projected in racial and ethnic minorities.”

Biden names FEMA, CDC officials to head monkeypox response “The White House said Biden will announce Tuesday that he has tapped Robert Fenton, who helped lead FEMA’s mass vaccination effort for COVID-19 as the agency’s acting administrator when Biden first took office, as the White House coordinator. Dr. Demetre Daskalakis of the CDC will be named his deputy. Daskalakis, the director of the agency’s HIV prevention division and a national expert on issues affecting the LGBTQ community, previously helped lead New York City’s COVID-19 response.”
About healthcare quality

NCQA Updates & Releases New Quality Measures for HEDIS® 2023 with a Focus on Health Equity “The National Committee for Quality Assurance (NCQA)… announced new and revised quality measures for health plans in the Healthcare Effectiveness Data and Information Set (HEDIS) for measurement year 2023. Notable updates include the introduction of race/ethnicity stratifications and revisions to acknowledge and affirm member gender identity—changes that build on NCQA’s dedication to advancing health equity….”
To support this effort, one of the added HEDIS measures is:
”Social Need Screening and Intervention (SNS-E). To encourage health plans to assess and address the food, housing and transportation needs of their patient populations, this measure helps health plans identify specific needs and connect members with resources necessary to address unmet social needs. This measure assesses members who were screened, using prespecified instruments, at least once during the measurement period for unmet food, housing, and transportation needs, and who received a corresponding intervention if they screened positive.”

About healthcare IT

 Healthcare ransomware attacks up 328% “Healthcare ransomware attacks jumped 328 percent in the second quarter of this year, despite a drop in the attacks globally, according to the 2022 midyear update of the ‘SonicWall Cyber Threat Report.’ 

Today's News and Commentary

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW “As of July 27, 2022, the current 7-day moving average of daily new cases (126,272) decreased 0.9% compared with the previous 7-day moving average (127,478). A total of 90,749,469 COVID-19 cases have been reported in the United States as of July 27, 2022.”

COVID vaccine patch fights variants better than needles “A needle-free vaccine patch could better fight COVID-19 variants, such as Omicron and Delta, than a traditional needle vaccine according to a University of Queensland study in mice.
The research, conducted in partnership with Brisbane biotechnology company Vaxxas, tested the Hexapro SARS-CoV-2 spike vaccine using the Vaxxas high-density microarray patch (HD-MAP) technology, and the results found the patch was far more effective at neutralising COVID-19 variants.”

NorthShore reaches $10.3M settlement in vaccine mandate case “The settlement signifies the nation's first classwide lawsuit for healthcare workers over a COVID shot mandate, according to Liberty Counsel, a Christian organization that filed the lawsuit on behalf of employees who were denied a religious exemption for the health system's COVID-19 vaccine mandate. The settlement agreement was filed on Friday, July 29 in the federal Northern District Court of Illinois.”

About hospitals and healthcare systems

 National Hospital Flash Report July report just issued: “U.S. hospitals and health systems are now halfway through an extremely challenging year. While margins were up in June compared to May,expenses remain at historic highs, leaving hospitals with cumulatively negative margins. In June, operating margins rose from the previous month, but remained significantly lower than pre-pandemic levels and May 2021. Outpatient volumes were up from the previous month, and expenses were generally down from May, but remain extremely elevated from pre-pandemic levels.”
The full report has much more detail.

About pharma

 90% of Americans live close to a pharmacy, analysis finds “According to the findings, 48.1 percent of Americans live within 1 mile of a pharmacy, 73.1 percent within 2 miles, 88.9 percent within 5 miles and 96.5 percent within 10 miles.”

Characteristics Of Key Patents Covering Recent FDA-Approved Drugs “Among seventy-eight qualifying drug approvals in 2019 and 2020, ten had zero patents, and the remaining sixty-eight drugs listed 322 different patents (the median number was 4). The most common category of patents, based on the nature of the invention being protected, was chemical compound (201; 62 percent), followed by method of use (195; 61 percent). The median time from originator drug approval to the expiration date of the final patent listed on our date of data collection was 10.3 years. About one in five patents had no counterparts in other major jurisdictions around the world, suggesting either a different manufacturer strategy or a differing application of patent standards in the US than in other comparable settings. Patents covering newly approved drugs largely protect the product and its uses; this shows that patent reform, rather than changes to nonpatent exclusivities, is the key to ensuring timely generic entry.”

About the public’s health

 NCCN Publishes New Patient Guidelines for Breast Cancer Screening and Diagnosis Emphasizing Annual Mammograms for All Average-Risk Women Over 40 “ ‘Most women with average risk should get screened every year, beginning at age 40, but if there are additional risk factors present, a provider might recommend an earlier start.’ According to the guidelines, women should undergo a risk assessment for developing breast cancer starting at age 25.”

Thousands of lives depend on a transplant network in need of ‘vast restructuring’ “The system for getting donated kidneys, livers and hearts to desperately ill patients relies on out-of-date technology that has crashed for hours at a time and has never been audited by federal officials for security weaknesses or other serious flaws, according to a confidential government review obtained by The Washington Post.”
A great piece of investigative journalism.

About health technology

 ‘New era in digital biology’: AI reveals structures of nearly all known proteins  “DeepMind and its partners unveiled the likely structures of nearly all known proteins, more than 200 million from bacteria to humans, a striking achievement for AI and a potential treasure trove for drug development and evolutionary studies.” Fascinating article! The implications are enormous.

New Photoacoustic Endoscope Fits Inside a Needle “Researchers have created a photoacoustic imaging endoscope probe that can fit inside a medical needle with an inner diameter of just 0.6 millimeters. Photoacoustic imaging, which combines light and sound to create 3D images, can provide important clinical information…”

Bioadhesive ultrasound for long-term continuous imaging of diverse organs Research from MIT: “We report a bioadhesive ultrasound (BAUS) device that consists of a thin and rigid ultrasound probe robustly adhered to the skin via a couplant made of a soft, tough, antidehydrating, and bioadhesive hydrogel-elastomer hybrid. The BAUS device provides 48 hours of continuous imaging of diverse internal organs, including blood vessels, muscle, heart, gastrointestinal tract, diaphragm, and lung. The BAUS device could enable diagnostic and monitoring tools for various diseases.”

Today's News and Commentary

About Covid-19

 Biden Administration Plans to Offer Updated Booster Shots in September “The Biden administration now expects to begin a Covid-19 booster campaign with retooled vaccines in September because Pfizer and Moderna have promised that they can deliver doses by then, according to people familiar with the deliberations.
With updated formulations apparently close at hand, federal officials have decided against expanding eligibility for second boosters of the existing vaccines this summer. The new versions are expected to perform better against the now-dominant Omicron subvariant BA.5, although the data available so far is still preliminary.” 

About health insurance

 More in U.S. Retiring, or Planning to Retire, Later According to a recent Gallup poll:
”Average expected retirement age among nonretirees now 66, vs. 60 in 1995
Average retirement age among retirees up to 61, from 57 in the 1990s
Percentage of adults aged 55 to 74 who are retired is declining”
These findings are great news for funding the Medicare Part A fund and also delays Medicare expenses (since Medicare is secondary to employer-sponsored insurance.)

The Uninsured Rate Is Down, Just In Time For Congress To Debate Health Care Again “The percentage of Americans without health insurance has fallen again, according to a government study released early Thursday…
The study was a long-planned, regular update to the National Health Insurance Survey, one of several tools that government and independent researchers use to assess health coverage in America. The study found that the percentage of Americans without health insurance has declined by 1.5 percentage points in the past year, from 9.5% in the first quarter of 2021 to 8% in the first quarter of 2022.”

U.S. says insurers must still cover birth control after Supreme Court abortion ruling “The Biden administration on Thursday warned U.S. businesses and health insurance providers that limiting coverage of contraceptives, after a U.S. Supreme Court ruling that overturned the constitutional right to abortion, would violate federal law.
The U.S. Department of Health and Human Services (HHS) issued guidance clarifying that the Affordable Care Act (ACA), commonly known as Obamacare, requires insurance plans to provide free birth control and family-planning counseling to insured individuals and their dependents.”

About hospitals and healthcare systems

 HCA hit with SEC complaint, antitrust suit “On July 27, the city of Asheville, N.C., and Buncombe County filed a lawsuit against HCA and Mission Health, which is owned by HCA. The lawsuit alleges the health systems have engaged in anti-competitive practices. It is the third lawsuit of its kind filed against HCA and Mission in less than a year by entities in Western North Carolina, according to the Citizen Times.”

CMS Reported Collecting Just Over Half of the $498 Million in Medicare Overpayments Identified by OIG Audits “Of the $498 million in Medicare overpayments identified in HHS-OIG audit reports issued during our audit period that CMS sustained, CMS reported that it had collected only $272 million (55 percent) and that it had not collected $226 million (45 percent). Further, CMS provided documentation sufficient to support that it had collected only $120 million of the $272 million. CMS did not provide adequate documentation to support that it had collected the remaining $152 million….
In addition, CMS did not take corrective action in response to all of the recommendations made in our prior audit report, Obstacles to Collection of Millions in Medicare Overpayments. In that audit report, issued on May 18, 2012, we made six recommendations (listed in Appendix D) and CMS agreed to implement four of them. Of those four recommendations, CMS implemented two, partially implemented one, and did not implement one.”
CMS did not agree with the report, resulting in more back and forth between it and the OIG.

About pharma

Vizient Projects 3.26% Drug Price Inflation Rate for 2023 in Latest Pharmacy Market Outlook Read the entire report for details; one bright spot for cost savings is the coming generics and biosimilar/biobetters. Still, biologicals are driving increased costs overall.

 Pfizer posts record quarterly sales, driven by Comirnaty, Paxlovid  The article has a breakdown of sales by products.

Innovations at Retail Pharmacies Accelerate as Digital Competition, Health and Wellness Offerings Grow, J.D. Power Finds Highlights:

• Customers are interested in routine healthcare services at their pharmacies: Among pharmacy customers who are interested in receiving routine healthcare services, 33% are interested in vision and hearing services and 27% are interested in physical exams and routine lab tests at their local retail pharmacies. However, most customers recognize their pharmacies are not currently offering these services.

• Health and wellness service utilization associated with higher loyalty and brand advocacy: On average, 52% of customers who rely on their pharmacies for health and wellness services say they will not switch pharmacies. This compares with just 45% among those who have not used their pharmacy’s health and wellness services. Likewise, Net Promoter Scores®[3] are 14 points higher when customers use health and wellness services.

• Watch out for Amazon: Nearly two-thirds (66%) of brick-and-mortar pharmacy customers currently have an Amazon Prime account and nearly half (48%) of pharmacy customers are aware of pharmacy services offered by Amazon.  To date, 14% of those who are aware of Amazon’s Pharmacy Services have used Pill Pack filled through Amazon Pharmacy. Of that group, 38% say they “definitely will” switch pharmacies in the next 12 months.

• Mobile apps could become prescription management battleground: Among brick-and-mortar customers who use their pharmacy’s mobile app, 59% use the app to manage prescription refills and 57% use the app to view prescriptions. Overall satisfaction among those who have used their pharmacy’s mobile app six or more times in the past 12 months is 715 (on a 1,000-point scale), which is 32 points higher than among those who used the app up to five times. Frequent app users are also less likely to say they will switch pharmacy providers.”

See the report for preferred pharmacy rankings.

About the public’s health

 Association of Ultraprocessed Food Consumption With Risk of Dementia Another cohort study by this group, using the UK biobank. (See yesterday’s post about activity and dementia).
”There has been a growing body of evidence associating consumption of ultra-processed foods (UPF) with adverse health outcomes including depression, cardiovascular disease, all-cause mortality. However, whether UPF are associated with dementia is unknown….
In this prospective cohort study, higher consumption of UPF was associated with higher risk of dementia, while substituting unprocessed or minimally processed foods for UPF was associated lower risk of dementia.”

Chronic Conditions Among Adults Aged 18─34 Years — United States, 2019 Despite the date, the CDC published this report today.
”In 2019, 53.8% of adults aged 18─34 years had at least one chronic condition, and 22.3% had more than one condition. Prevalence of any as well as specific chronic conditions varied by population subgroup.”
Specifics about the conditions are in the article.

Assessment of Lung Cancer Risk Among Smokers for Whom Annual Screening Is Not Recommended “What is the risk of lung cancer among smokers for whom annual low-dose computed tomography screening is not recommended?
In this cohort study of 4279 individuals 65 years and older who were followed up for a median (IQR) of 13.3 (7.9-18.8) years, former smokers with a 20 pack-year or greater smoking history who quit 15 or more years before baseline and current smokers with less than 20 pack-years of smoking (2 groups not recommended for lung cancer screening) had a 10-fold greater risk of lung cancer than never smokers.
These findings suggest that there is a need to develop and test prediction models to identify high-risk subsets of these smokers for lung cancer screening and highlight the importance of abstinence and early cessation.”

About healthcare IT

 Amazon.com Announces Second Quarter Results Highlights:
Operating cash flow decreased 40% to $35.6 billion for the trailing twelve months, compared with $59.3 billion for the trailing twelve months ended June 30, 2021.
Net sales increased 7% to $121.2 billion in the second quarter, compared with $113.1 billion in second quarter 2021. Excluding the $3.6 billion unfavorable impact from year-over-year changes in foreign exchange rates throughout the quarter, net sales increased 10% compared with second quarter 2021.
Operating income decreased to $3.3 billion in the second quarter, compared with $7.7 billion in second quarter 2021.
Net loss was $2.0 billion in the second quarter, or $0.20 per diluted share, compared with net income of $7.8 billion, or $0.76 per diluted share, in second quarter 2021. Second quarter 2022 net loss includes a pre-tax valuation loss of $3.9 billion included in non-operating expense from our common stock investment in Rivian Automotive, Inc.”

Today's News and Commentary

Inflation-Adjusted Health Care Spending is Falling for the First Time in Half a Century “…for the first time in 2021, real health care spending growth was flat, and in the first quarter of 2022, real health care spending actually declined by 1.7% year over year (Figure 1). This is seven full percentage points lower than the long-term average (+5.3%). As a result, we have also seen health spending decline as a percentage of US GDP (falling from a peak of over 20% in mid-2020 to 18.0% in May 2022) as overall US economic growth has rebounded much faster than health spending in the post-2020 period…
This decline in real health care spending is driven largely by a decline in health care price growth relative to economywide inflation (though slower utilization growth has also had an impact)….
However, despite indications of a slowing health care cost trend over the past 18 months, many of these impacts are expected to be short-lived.”

Schumer, Manchin announce deal on reconciliation bill with tax, climate, energy provisions The healthcare highlights include savings of “$288 billion through prescription drug pricing reforms, including measures to allow Medicare to negotiate drug prices and cap out-of-pocket costs to $2,000” and spending of “$64 billion from extending an expanded Affordable Care Act program for three years, through 2025.
The full Senate will consider the bill next week, Schumer and Manchin said. They hope that the legislation will meet the Senate Parliamentarian’s budget reconciliation rules, allowing Democrats to pass it without needing GOP votes.”

About Covid-19

 Fall COVID-19 booster drive could save up to 160,000 U.S. lives: report The headline is the story.

Promising developments in pursuit to design pan-coronavirus vaccine “Researchers at the Francis Crick Institute have shown that a specific area of the SARS-CoV-2 spike protein is a promising target for a pan-coronavirus vaccine that could offer some protection against new virus variants, common colds, and help prepare for future pandemics.”

Texas Panel Upholds School District's Vax Mandate “Texas Gov. Greg Abbott cannot prevent the San Antonio Independent School District from requiring its employees to be vaccinated against COVID-19, a state appellate court panel ruled on Wednesday, finding the governor doesn't have authority over policies implemented by school districts. A three-judge panel of the Fourth Court of Appeals in San Antonio affirmed a Bexar County District Court judge's order denying Texas' bid to prevent school district officials from implementing a vaccine mandate that requires its staff to get inoculated or face termination. “

About health insurance

 Attorney General James Sues CVS for Harming New York Safety Net Hospitals and Clinics by Diverting Millions from Underserved Communities “New York Attorney General Letitia James today sued CVS Health Corporation (CVS) for violating antitrust laws and hurting New York safety net hospitals and clinics that provide care for underserved communities across the state. CVS required New York safety net hospitals and clinics to exclusively use a CVS-owned company, Wellpartner, to process and obtain federal subsidies on prescriptions filled at CVS pharmacies. CVS’s scheme forced safety net health care providers to incur millions in additional costs, while CVS continued to benefit through its subsidiary. The lawsuit alleges that CVS’s unfair business practice deprived safety net hospitals and clinics of critical federal funding that could have been used to improve and expand patient care. Through her lawsuit, Attorney General James is seeking to end CVS’s unfair and illegal practices and to recoup lost revenue for impacted safety net hospitals and clinics that would improve health care services.”

CMS drops 3 final payment rules: 8 things to know “CMS has released its annual payment updates for hospices, inpatient psychiatric facilities and inpatient rehabilitation facilities for fiscal year 2023.”
The article is a nice, short summary of these rules.

About hospitals and healthcare systems

Preventing Patient Harm and Death from Diagnostic Errors: New Leapfrog Report Identifies 29 Recommended Practices that Hospitals Should Implement Now “The Leapfrog Group… today released the report Recognizing Excellence in Diagnosis: Recommended Practices for Hospitals. This landmark report is the result of an intensive year-long effort bringing together the nation’s leading experts on diagnostic excellence, including physicians, nurses, patients, health plans, and employers. Together, the multi-stakeholder group reviewed the evidence and identified 29 evidence-based actions hospitals can implement now to protect patients from harm or death due to diagnostic errors…
Leapfrog will use practices from the report issued today and survey hospitals on their current implementation status via a national pilot in fall 2022. The feedback collected from hospitals during the pilot will be used to develop a new section on the Leapfrog Hospital Survey slated for launch in 2024. The Society to Improve Diagnosis in Medicine (SIDM), a key partner in this initiative, was a leading stakeholder in identifying the practice recommendations and will develop tools and training materials to support hospitals in implementing the practices outlined in the report.”
[Disclosure: I am on SIDM’s finance committee.]

 CHS posts $326M loss in Q2 “Franklin, Tenn.-based Community Health Systems, which operates 83 hospitals, saw revenues decrease in the second quarter of this year and ended the period with a net loss. 
In financial documents released July 27, CHS said revenues and admissions were down in the three months ended June 30. Admissions declined 3.4 percent year over year and revenues were down 2.4 percent compared to the second quarter of 2021.  

About pharma

Top 15 specialty pharmacies by revenue The top 4 are:

CVS Specialty — $52.9 billion

2. Accredo / Freedom Fertility — $43.5 billion

3. Optum Specialty Pharmacy — $25.8 billion

4. AllianceRx / Walgreens stores — $19.2 billion 

TO highlight the market dominance of these firms, each of the other 11 have revenues <$5 billion.

AbbVie's Allergan reaches $2 bln opioid lawsuit settlement “AbbVie Inc's unit Allergan has reached an agreement to pay over $2 billion to resolve thousands of lawsuits related to the marketing of its opioid painkiller…
The deal would settle more than 3,000 lawsuits filed by state and local governments, but complete terms of the settlement are still being chalked out, according to the report. Thousands of lawsuits have been filed against drugmakers, distributors and pharmacies over the U.S. opioid crisis.”

GSK, still early in US launch, licenses long-acting HIV PrEP drug Apretude to patent pool for poorer nations “GSK has signed a licensing deal with the United Nations-backed Medicines Patent Pool (MPP) for its long-acting HIV PrEP drug Apretude, or cabotegravir, the two parties unveiled during the 24th International AIDS Conference. The arrangement gives selected generics manufacturers rights to make and supply copycats of Apretude for 90 poorer countries.”

About the public’s health

 Modification of the Association Between Frequent Aspirin Use and Ovarian Cancer Risk: A Meta-Analysis Using Individual-Level Data From Two Ovarian Cancer Consortia “This study, the largest to-date on aspirin use and ovarian cancer, provides evidence that frequent aspirin use is associated with lower ovarian cancer risk regardless of the presence of most other ovarian cancer risk factors. Risk reductions were also observed among women with multiple risk factors, providing proof of principle that chemoprevention programs with frequent aspirin use could target higher-risk subgroups.” 

An additional 786,000 monkeypox vaccine doses will soon be available in the United States “The US Food and Drug Administration said Jynneos monkeypox vaccine doses filled and finished at a Denmark manufacturing facility meet the agency’s quality standards and it has approved a supplement to the vaccine’s biologics license. Doses that were previously manufactured at the facility had already been shipped to the United States, so the FDA action clears the way for doses to be distributed and administered.”

Physical and Mental Activity, Disease Susceptibility, and Risk of Dementia “In a prospective cohort study based on UK Biobank, 501,376 dementia-free participants were recruited in 2006-2010 and followed from one year after the recruitment date until the end of 2019 for ascertainment of dementia…
Activity patterns more adherent to frequent vigorous and other exercises, housework-related activity, and friend/family visit were associated with a reduced risk of multiple types of dementia. Such associations are independent of disease susceptibility, highlighting the potential of these physical and mental activity patterns, as effective interventions, in the primary prevention of dementia.”

The Best & Worst States for Health Care The best is Hawaii; the worst (by far) is West Virginia.

About healthcare IT

 Major privacy issues in IQVIA’s data sharing deal with Experian An investigative story from STAT (subscription required):
“Health analytics company IQVIA has carefully crafted a reputation for its deep commitment to data privacy. But internal documents paint a different picture — including what experts say are major privacy lapses in a marketing data partnership with credit reporting company Experian…
IQVIA purchased detailed consumer data from Experian and links it to Americans’ health records to deliver marketing insights to its customers, drug companies and device makers. While IQVIA compiled anonymized personal and financial information from the credit reporting company on 120 million people, its employees worried that the data, including information about income, jobs, and ethnicity, could put consumer privacy at risk. 
’There are a number of changes and indications in emails that have us concerned about the exposure of these data,’ said one email from an IQVIA employee in 2016. The company also went several years without commissioning an expert privacy review of its use of Experian’s data, internal company emails show.”

Medicare Telehealth Services Extension Approved by House 
Bill would extend Medicare telehealth waivers through Dec. 31, 2024
Over 28 million beneficiaries used telehealth services in 2020

Teladoc takes hefty impairment charge in Q2 with losses mounting to nearly $10B “The company took a $3 billion hit from an impairment charge that pushed the company to a loss of $19.22 per share in the second quarter compared to a loss of $133.8 million, or a loss of 86 cents per share, for the same period a year ago…
Companies opt for impairment when the value of assets or goodwill on their books is no longer fully recoverable.”

About healthcare personnel

 Medical Education Goes Woke:Future doctors will be obliged to learn how health relates to ‘systems of oppression.’  “The Association of American Medical Colleges (AAMC)… recently released a report describing the new “diversity, equity and inclusion competencies” that medical students and residents will be expected to master.” That sentence is the premise of this Wall Street Journal editorial. It is well-worth trying to get a copying think about all the issues it raises.

The Rise and Potential of Physician Unions FYI

About health technology

 Oldest patient yet cured of HIV after stem cell transplant – researchers “The oldest patient yet has been cured of HIV after receiving a stem cell transplant for leukaemia, researchers reported on Wednesday.
While the transplant was planned to treat the now-66-year-old's leukaemia, the doctors also sought a donor who was naturally resistant to the virus that causes AIDS…”

Labcorp is spinning out its clinical development unit in major shakeup “Labcorp announced this morning that it is spinning out most of its CRO business, eight years after its $6 billion Covance acquisition.
Labcorp will keep its core business directed at diagnostic testing, the company said Thursday morning after the Wall Street Journal reported the split earlier in the morning, citing sources familiar with the matter. A tax-free spinout is expected in the second half of next year, the company said.
The new spinout accounted for roughly 20% of Labcorp’s $13.5 billion 2021 revenue, WSJ reported, excluding Covid-19 testing.”

Today's News and Commentary

About Covid-19

 Brii Biosciences Announces Positive Data Demonstrating its Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, Retains Neutralizing Activity Against Live Omicron Virus BA.4/5 and BA.2.12.1 Subvariants  The headline is the story.

Moderna vaccines better protect long-term care home residents “The research team found 17 percent of almost 1,000 LTC residents had a confirmed post-vaccine Omicron infection between Dec. 15, 2021 and May 3, 2022. The majority of infections (68 percent) occurred in people who had three Pfizer shots, while people who had had at least three Moderna jabs or a combination of any three mRNA shots were less likely to have infections. Importantly, having had any fourth dose reduced the risk of infection.
The study has been published by the preprint server medRxiv…”

Texas School Mask Mandate Ban Upheld by Federal Appeals Court “A three-judge panel of the 5th US Circuit Court of Appeals on Monday said that a group of disabled students failed to show that their allegedly increased risk of contracting Covid-19 due [to] the mask mandate ban was an injury the courts could address.”
Another crazy Texas outcome.

About health insurance

 The Latest Legal Challenge to the Affordable Care Act’s Preventive Services Guarantee “Despite the importance of prevention to good health, a new lawsuit, Kelley v. Becerra, threatens to upend these gains. Filed by a group of employers and individuals who object to providing certain kinds of preventive care or simply don’t want to pay for preventive care they feel they don’t need, the suit argues that the ACA’s requirement for insurers and health plans is unconstitutional. If it succeeds, millions of Americans could lose access to all preventive care guaranteed by the ACA or be forced to pay out of pocket for these vital services.”
READ THE ENTIRE ARTICLE. The specious political/”Constitutional” arguments are a travesty.

Humana's Q2 profits grow nearly 20% year over year to $696M “In the second quarter of 2021, the insurer reported $588 million in profit for an increase of 18.4%, according to its earnings report released Wednesday. Humana also brought in $23.7 billion in revenue for the quarter, an increase of 14.6% from the $20.6 billion reported in the second quarter of 2021.”

About hospitals and healthcare systems

 429 hospitals with 5 stars from CMS: 2022 CMS updated its Overall Hospital Quality Star Ratings for 2022, giving 429 hospitals a rating of five stars.
CMS assigned star ratings to hospitals nationwide based on their performance across five quality categories. This year:

• 192 hospitals received a one-star rating

• 692 hospitals received a two-star rating

• 890 hospitals received a three-star rating

• 890 received a four-star rating

• 429 received a five-star rating

Here are the hospitals that received a five-star rating from CMS, broken down by state, as listed on the Hospital Compare website.”

About pharma

 GSK boosts annual guidance, led by demand for Shingrix See the article for a breakdown by product.

About the public’s health

 Long-Term Leisure-Time Physical Activity Intensity and All-Cause and Cause-Specific Mortality: A Prospective Cohort of US Adults “The 2018 physical activity guidelines for Americans recommend a minimum of 150 to 300 min/wk of moderate physical activity (MPA), 75 to 150 min/wk of vigorous physical activity (VPA), or an equivalent combination of both. However, it remains unclear whether higher levels of long-term VPA and MPA are, independently and jointly, associated with lower mortality…
[This study found that the]  nearly maximum association with lower mortality was achieved by performing ≈150 to 300 min/wk of long-term leisure-time VPA, 300 to 600 min/wk of long-term leisure-time MPA, or an equivalent combination of both.”

Turning users into ‘unofficial brand ambassadors’: marketing of unhealthy food and non-alcoholic beverages on TikTok “This is the first study, to the best of our knowledge, to examine marketing of unhealthy food and non-alcoholic beverages on TikTok. Videos posted by top food brands frequently feature branding, product images, engagement and celebrities/influencers. Engagement includes instigation of branded hashtag challenges that encourage users to create content featuring brands’ products, brands’ videos and/or branded effects. User-generated content from these challenges collectively receives millions—and sometimes billions—of views, frequently features branding and product images and mostly portrays a positive sentiment.
Given evidence of the impact of food marketing on food preferences, purchasing, requests and consumption, our findings reinforce the urgent need for policies to protect children from the harmful impact of food marketing on social networking platforms.”

Patient-level factors influencing adherence to follow-up imaging recommendations “Patients with Medicaid had over four times lower odds of completing follow-up imaging compared to patients with commercial insurance (OR 0.24, 95% CI 0.06–0.88, p = 0.032). Age, gender, race/ethnicity, smoking history, primary language, BMI, and neighborhood socioeconomic status were not independently associated with differences in follow-up imaging completion.”
Sometimes insurance does not account for payments. Recall that Medicaid patients have no premiums or out-of-pocket expenses. In other words, unlike privately insured patients who have copays or deductibles, the follow-up is free to Medicaid patients. The reason for this finding requires further investigation.

About healthcare IT

 Baxter Healthcare Corporation Recalls Abacus Order Entry and Calculation Software for Risk of Medication Label Errors “Abacus is a software application that performs calculations for compounding liquid doses of medications. When connected to a compounder that mixes these doses according to the calculation, the Abacus software can translate a physician’s order into a compounded solution ready to be given to a patient…
Baxter Healthcare Corporation is recalling the Abacus software application due to a risk that final printed bag labels for compounded mixtures may contain incorrect information. The issue may occur if a user unintentionally or incorrectly modifies a label template that is used to provide clinical care.”

AmerisourceBergen launches tech to help docs dispense digital therapeutics to patients “AmerisourceBergen plans to launch DTx Connect, a fully integrated ordering, dispensing and fulfillment platform that aims to facilitate patient access to physician-ordered digital therapeutics and diagnostics…
The platform, which seamlessly integrates with electronic medical record (EMR) systems, enables physicians to easily access and order prescription and non-prescription DTx through their e-prescribing workflow and subsequently monitor patient fulfillment, according to the company.”

Johns Hopkins sepsis alert tool reduced patient deaths, studies find “Three studies published in Nature by researchers at Johns Hopkins University and machine learning startup Bayesian Health found that a sepsis early detection tool reduced relative deaths from sepsis by 18.2%…
The prospective studies, which took place across five hospitals, found that Bayesian’s machine learning platform identified 82% of sepsis cases, and 38% of alerts were confirmed by a doctor. When an alert was confirmed by a doctor within three hours, patients received antibiotics nearly two hours faster than patients whose alert was addressed later, dismissed or never confirmed.”

Digital Biomarkers Market Revenue to be Worth $21,986.2 Million by 2030, says P&S Intelligence “According to the latest market research report published by P&S Intelligence, the digital biomarkers market accounted for around $1,850.8 million revenue in 2021, which is on the way to hitting $21,986.2 million by 2030, at a massive compound annual growth rate of 31.6% from 2021 to 2030. During the pandemic, the emergence of mHealth applications, integration of AI into the wearable technology, and rise of telemedicine and remote patient monitoring devices drove the market.”

How much does a data breach cost in 2022? IBM’s annual report.
”Data breach average cost increased 2.6% from USD 4.24 million in 2021 to USD 4.35 million in 2022. The average cost has climbed 12.7% from USD 3.86 million in the 2020 report.
The share of organizations deploying zero trust grew from 35% in 2021 to 41% in 2022. Organizations that don't deploy zero trust incurred an average USD 1 million greater breach costs compared to those with zero trust deployed.
Stolen or compromised credentials were responsible for 19% of breaches. Phishing was responsible for breaches 16% of the time. Cloud misconfiguration caused 15% of breaches.”
The average costs of healthcare breaches increased by nearly $1 million since the 2021 report, to $10.1 million, making this sector the costliest among industries for the 12th consecutive year.

Patient survey shows unresolved tension over health data privacy “More than 92% of patients believe privacy is a right and their health data should not be available for purchase, according to a survey released today by the American Medical Association (AMA)…
The survey found an overwhelming percentage of patients demand accountability, transparency, and control as it relates to health data privacy. More than nine out of ten (94%) patients want companies to be held legally accountable for uses of their health data. A similar majority of patients (93%) want health application (app) developers to be transparent about how their products use and share personal health data. To prevent unwanted access and use of personal health data, patients want control over what companies collected about them and how it is used:

• Almost 80% of patients want to be able to opt-out of sharing some or all their health data with companies.

• More than 75% of patients want to opt-in before a company uses any of their health data.

• More than 75% of patients want to receive requests prior to a company using their health data for a new purpose”

About health technology

 The Next Blood Pressure Breakthrough: Temporary Tattoos  “The thin, sticker-like wearable electronic tattoos can provide continuous, accurate blood pressure monitoring, the researchers report in their new study.”
The next step in continuous ambulatory blood pressure monitoring.

About healthcare finance

 Illumina's quest for Grail potentially blocked for good, as EU jacks up legal pressure: report “After extending yet another olive branch to the European antitrust regulators adjudicating its premature acquisition, Reuters reports that the $8 billion deal is likely to be vetoed. 
Earlier this month, the DNA sequencing giant had offered to give its rivals royalty-free access to certain global patent licenses and pledged a three-year truce on patent litigation against its Chinese competitor BGI. However, the European Commission's concerns remain, and the watchdogs aren't convinced that the latest proposal would boost competition…”

Today's News and Commentary

About Covid-19

 Symptoms and risk factors for long COVID in non-hospitalized adults “A total of 62 symptoms were significantly associated with SARS-CoV-2 infection after 12 weeks. The largest aHRs [adjusted hazard rates] were for anosmia (aHR 6.49, 95% CI 5.02–8.39), hair loss (3.99, 3.63–4.39), sneezing (2.77, 1.40–5.50), ejaculation difficulty (2.63, 1.61–4.28) and reduced libido (2.36, 1.61–3.47). Among the cohort of patients infected with SARS-CoV-2, risk factors for long COVID included female sex, belonging to an ethnic minority, socioeconomic deprivation, smoking, obesity and a wide range of comorbidities. The risk of developing long COVID was also found to be increased along a gradient of decreasing age. SARS-CoV-2 infection is associated with a plethora of symptoms that are associated with a range of sociodemographic and clinical risk factors.”

Interferon resistance of emerging SARS-CoV-2 variants “Here, we compared the potency of 17 different human interferons against multiple viral lineages sampled during the course of the global outbreak, including ancestral and five major variants of concern that include the B.1.1.7 (alpha), B.1.351 (beta), P.1 (gamma), B.1.617.2 (delta), and B.1.1.529 (omicron) lineages. Our data reveal that relative to ancestral isolates, SARS-CoV-2 variants of concern exhibited increased interferon resistance, suggesting that evasion of innate immunity may be a significant, ongoing driving force for SARS-CoV-2 evolution. These findings have implications for the increased transmissibility and/or lethality of emerging variants and highlight the interferon subtypes that may be most successful in the treatment of early infections.”

KFF COVID-19 Vaccine Monitor: July 2022 Lots of good information in this report, but see Figure 1.”More Than Four In Ten Parents Of Children Under 5 Eligible For The Vaccine Say They Will "Definitely Not" Vaccinate Their Child For COVID-19.” Disturbing!

About health insurance

 Medical Device Manufacturer Biotronik Inc. Agrees To Pay $12.95 Million To Settle Allegations of Improper Payments to Physicians “Biotronik Inc. (Biotronik), a medical device manufacturer based in Oregon, has agreed to pay $12.95 million to resolve allegations that it violated the False Claims Act by causing the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce their use of Biotronik’s implantable cardiac devices, such as pacemakers and defibrillators.”

Former Texas health system CEO charged in $1.2B fraud crackdown “The former CEO of Little River Healthcare was among 36 defendants across the U.S. charged in criminal cases for their alleged involvement in fraudulent telemedicine, durable medical equipment and cardiovascular and cancer genetic testing fraud.”

Health Disparities in Employer-Sponsored Insurance July 2022 From MorganHealth and NORC. Although the data source spans several years there are no trends presented. The updated figures are interesting but no new findings.

Most workers say they are satisfied with their employer’ health benefits “The survey showed that although 54% of the 1,000 adults surveyed said they are satisfied with the current health system overall, 67% said they were satisfied with the coverage they receive through their employer.
What makes someone satisfied with their coverage? The top three reasons given were:
Affordability – 45%
Comprehensive coverage – 45%
Choice of providers – 44%

Other factors that rounded out the list of reasons for being satisfied included: free preventive services, consistency, customer service, the ability to receive care locally, wellness incentives and innovation…
It is more important for employer-provided coverage to be comprehensive than it is for it to be affordable, survey respondents said. This was especially true of those 55 years old and older, with 77% of that age group saying it is more important that their health insurance covers every service they need.”

About hospitals and healthcare systems

 America's Best Hospitals: the 2022-2023 Honor Roll and Overview From US News.

Big Hospitals Provide Skimpy Charity Care—Despite Billions in Tax Breaks This article is an investigative piece that appears today on the front page of The Wall Street Journal. The article is well-worth reading if you can access it. One major finding: “These charitable organizations, which comprise the majority of hospitals in the U.S., wrote off in aggregate 2.3% of their patient revenue on financial aid for patients’ medical bills. Their for-profit competitors, a category including publicly traded giants such as HCA Healthcare Inc., wrote off 3.4%, the Journal found in an analysis of the most-recent annual reports hospitals file with the federal government…
The value of nonprofit hospitals’ subsidy from avoiding taxes is more than $60 billion a year, according to estimates by Johns Hopkins University professor Gerard Anderson.”
In calculating the charitable expenses, “The Journal analyzed annual cost reports filed by thousands of hospitals with Medicare for the most recent year available—typically fiscal 2020 or 2021—comparing hospitals’ charity-care costs and net revenue from patient care to gauge how much help they give to patients struggling with medical bills.” Recall that the Medicare cost report is based on a cost accounting system that maximizes charges attributable to Medicare patients.
Now that hospitals must publish their rates for all payers, perhaps a more accurate figure for charity care can be calculated.

Centene boosts guidance despite $172M loss in Q2 “Centene posted a $172 million loss in the second quarter, still beating the Street and slimming its losses compared to the prior-year quarter.
In the second quarter of 2021, Centene reported a loss of $535 million, according to its earnings report released Tuesday morning. Through the first six months of this year, the government insurance giant has brought in $677 million in profit, compared to $164 million through the first half of 2021.
The company brought in $35.9 billion in revenue for the quarter, up from $31 billion in the second quarter of 2021. In the first half of this year, revenues were $73.1 billion, according to the report, compared to $61 billion in the first half of 2021.”

About pharma

Pfizer loses U.S. appeal over co-pays for heart failure patientsA federal appeals court on Monday rejected Pfizer Inc's challenge to a U.S. anti-kickback law the drugmaker said prevented it from helping heart failure patients, many with low incomes, afford medicine that cost $225,000 per year.
A unanimous three-judge panel of the New York-based 2nd U.S. Circuit Court of Appeals rejected Pfizer's effort to directly cover co-pays for patients taking its Vyndaqel and Vyndamax drugs. 

Teva Reaches $5B National Opioid Deal “Lead attorneys for local governments, Native American tribes and states on Tuesday said they had reached a nearly $5 billion settlement in principle with drugmaker Teva, including about $3. 7 billion in cash, to end litigation over the nation's opioid crisis. The plaintiffs' executive committee said the $3. 7 billion includes about $650,000 earmarked for previously settled cases. The abatement funds will be spread out over  13 years, according to the committee, with legal fees and costs to be paid out over six years. Teva will also provide the option of donating $1. 2 billion of a generic version of its overdose drug Narcan…”

About the public’s health

 Biden administration weighs declaring monkeypox a health emergency “The Biden administration is weighing whether to declare the nation’s monkeypox outbreak a public health emergency and also plans to name a White House coordinator to oversee the response as officials attempt to keep the virus from becoming entrenched in the United States.” 
And in a related article: U.S. may need $7 billion for monkeypox, Biden administration estimates

HHS proposes restoring transgender health protections stripped by Trump-era rule “The Biden administration aims to restore nondiscrimination protections to transgender individuals that were stripped in a Trump-era rule.
The Department of Health and Human Services (HHS) issued a proposed rule Monday expanding Section 1557 of the Affordable Care Act, which prohibits discrimination based on sex, race, color, national origin, age and disability for certain health activities. The agency also wants to expand the purview of the rule to anyone that gets Medicare Part B.”

Behavioral Counseling Interventions to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Cardiovascular Disease Risk Factors- US Preventive Services Task Force Recommendation Statement “The USPSTF recommends that clinicians individualize the decision to offer or refer adults without CVD risk factors to behavioral counseling interventions to promote a healthy diet and physical activity. (C recommendation)…
The US Preventive Services Task Force (USPSTF) concludes with moderate certainty that behavioral counseling interventions have a small net benefit [emphasis in the original] on CVD risk in adults without CVD risk factors.”

About healthcare finance

 3M to spin off $8.6B healthcare business to publicly traded company “Material science company 3M said it plans to spin off its healthcare ventures into two publicly traded companies, New 3M and Health Care, by the end of 2023. 
‘The New 3M will remain a leading global material science innovator serving customers across a range of industrial and consumer end markets, and Health Care will be a leading global diversified healthcare technology company focused on wound care, healthcare IT, oral care and biopharma filtration,’ the conglomerate said in a July 26 news release…
The transaction is pending approval from the company's board of directors, the IRS and the Securities and Exchange Commission.”

Today's News and Commentary

About Covid-19

 Second coronavirus booster shots for people under 50 on hold amid drive to speed up new vaccine “Second booster shots of the coronavirus vaccine for people younger than 50 are on hold as the Biden administration tries to accelerate a fall vaccination campaign using reformulated shots that target the now-dominant omicron subvariants, according to federal health officials.
Officials are hoping vaccine makers — Moderna and Pfizer and its German partner, BioNTech — are able to make the updated shots available as soon as early to mid-September instead of later in the fall, said three officials who spoke on the condition of anonymity because they were not authorized to talk about the issue.”

CDC stops reporting coronavirus cases on cruise ships “A notice posted on the CDC website for cruise travel said the program ended Monday. A sortable color-coded chart and spreadsheet that detailed the level of spread on ships is no longer viewable on the webpage, the agency confirmed.
‘CDC has determined that the cruise industry has access to the necessary tools (e.g., cruise-specific recommendations and guidance, vaccinations, testing instruments, treatment modalities, and non-pharmaceutical interventions) to prevent and mitigate COVID-19 on board,’ CDC spokeswoman Kristen Nordlund said in an email.”

Judge tosses lawsuit challenging FBI’s coronavirus testing policy “A federal judge in Virginia on Thursday dismissed a lawsuit from a group of employees at the FBI and other national security and defense agencies who argued it was “unlawful and unconstitutional” to require unvaccinated staff get tested weekly for the coronavirus.
U.S. District Judge Leonie M. Brinkema agreed with Justice Department lawyers that the federal employees who sued must instead pursue administrative grievances, through a process established by the Civil Service Reform Act…
Brinkema tossed the lawsuit on procedural grounds but also made comments from the bench addressing the merits of the case.
‘This is an effort by the agencies involved to keep the workforce safe,’ Brinkema said.”

About health insurance

 CBO letter to Mike Crapo, Ranking Member Committee on Finance U.S. Senate regarding making permanent the enhanced premium tax credit structure provided in section 9661 of the American Rescue Plan Act of 2021 (ARPA) “Under the May 2022 baseline, CBO and JCT estimate that if the enhancements became permanent, federal deficits would increase by $247.9 billion over the 2023-2032 period…
CBO and JCT expect that, on average, the enhanced subsidies would attract 4.8 million new enrollees to the marketplaces in each year over the 2023-2032 period relative to current law…
CBO and JCT expect that if the enhancement became permanent,
2.2 million fewer people would be without health insurance, on average, in each year over the 2023-2032 period, relative to current law.”

CMS releases home- and community-based quality [HCB Service] measure set “CMS said the release of this voluntary measure set is also a critical step to promoting health equity among the millions of older adults and people with disabilities who need long-term care because of disabling conditions and chronic illnesses…
Nationally, more than 7 million people receive HCBS under Medicaid, and Medicaid-funded HCBS accounts for $125 billion annually in state and federal spending.”

About pharma

 CVS prods prescriptions that can induce abortion “In states where medication abortion, an FDA-approved regimen that can induce an abortion within the first 10 weeks of pregnancy, is illegal, CVS is instructing its pharmacists to first confirm prescriptions for some drugs aren't intended for an abortion.” 

USD 11 million in illicit medicines seized in global INTERPOL operation “The global trade in illicit pharmaceuticals is a vast and lucrative crime area – valued at USD 4.4 billion – which attracts the involvement of organized crime groups around the world.
Over just one week (23-30 June), 94 INTERPOL member countries representing every continent launched a coordinated crackdown on illicit online pharmacies in Operation Pangea XV.
Globally, law enforcement made more than 7,800 seizures of illicit and misbranded medicines and healthcare products, totaling more than 3 million individual units.
During the week, law enforcement:

• Investigated more than 4,000 web links, mainly from social media platforms and messaging apps

• Shut down or removed more than 4,000 web links containing adverts for illicit products

• Inspected nearly 3,000 packages and 280 postal hubs at airports, borders and mail distribution or cargo mail centres

• Opened more than 600 new investigations and issued more than 200 search warrants

While results are still coming in from countries, enforcement actions have already disrupted the activities of at least 36 organized crime groups.”

Drugmakers are slow to prove medicines that got a fast track to market really work “NPR analyzed 30 years of FDA and National Institutes of Health data and found that 42% of currently outstanding confirmatory studies, or 50 of them, either took more than a year to begin following accelerated approval or hadn't started at all. Nineteen of those required studies still haven't started three years or more after accelerated approval. Four of them haven't started more than ten years later.”
Read the entire article. Clearly, a change in process is needed.

About the public’s health

 WHO declares monkeypox a global health emergency as infections soar “The decision to label the outbreak a Public Health Emergency of International Concern, the highest level of alert the WHO can issue, is expected to marshal new funding and to pressure governments into action. More than 16,500 cases have been reported in 75 countries.”

New studies offer theory on cause of unusual hepatitis cases in kids “Two new and as-yet-unpublished studies from scientists in the United Kingdom theorize that children who have developed the hepatitis cases may have been co-infected with two different viruses and had a genetic predisposition to have an over-exuberant immune response when that happened.
Previously the leading hypothesis was that adenovirus 41, which had been found in a number of the infected children, was causing the liver damage…
But the new studies report finding the presence of something called adeno-associated virus 2 — AAV2 for short — in the blood and in liver tissues from a number of affected children. They also found the children were infected with adenoviruses or herpes viruses.”

About health technology

 Unique Device Identification System (UDI System) “On July 22, 2022, the FDA posted the final guidance: Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices. This final guidance describes the FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products.”

Comparing Racial Differences in Emphysema Prevalence Among Adults With Normal Spirometry: A Secondary Data Analysis of the CARDIA Lung Study “Emphysema is often present before spirometry findings become abnormal, particularly among Black men. Reliance on spirometry alone to differentiate lung health from lung disease may result in the underrecognition of impaired respiratory health and exacerbate racial disparities.”

Today's News and Commentary

About Covid-19

 BA.5 is causing more Covid-19 reinfections, data suggests, but they don't appear to be more frequent “It's not your imagination: As the rapidly spreading BA.5 coronavirus subvariant causes a surge in infections across the United States, more people are catching Covid-19 for the second or third time.
But on average, these reinfections do not seem to be happening more rapidly, according to a new analysis from the gene sequencing company Helix.
BA.5, another offshoot of the Omicron variant, is now causing about 80% of new Covid-19 infections in the United States, according to the latest data from the US Centers for Disease Control and Prevention.”

A Novel COVID-19 Vaccine Using Modified Bacterial DNA “The research involved building plasmids genetically altered to contain bits of genetic material specifically intended to target a vulnerability in the SARS-CoV-2 virus’s spike protein, a portion of the virus critical to binding and infecting cells. Plasmids are small, circular DNA molecules from bacteria that are physically separate from chromosomal DNA and can replicate independently. They can be used by scientists to transfer genetic material from one cell to another, after which the introduced genetic material can replicate in the receiving cell.”
The findings are publish in the July 21, 2022 online issue of PLOS Pathogens.

About health insurance

 Survey Finds 36% of Americans Have Researched Healthcare Service Prices, 60% of Those Who Do Would Look to Health Insurance Companies for Pricing “In the national survey of more than 2,000 adults, 36% indicated they have researched prices for healthcare services. Of these individuals, 60% would look to their insurance provider for pricing information, with nearly half (44%) reporting they would look on the websites of health insurers, and more than a quarter (29%) would call their health insurance company. (Respondents could select more than one option):

• 44% would try looking for pricing information on the health insurance company website

• 39% would visit a physician or hospital website

• 34% would opt to call their physician or hospital for pricing information

• 32% would access a patient portal for the information

• 29% would call their insurance company

Additionally, 44% of survey respondents say their health insurance company does not provide pricing information for local healthcare providers, and 34% don't know if this information is available.”

High-Performing and Low-Performing Hospitals Across Medicare Value-Based Payment Programs “Over the past decade, the Centers for Medicare & Medicaid Services (CMS) has introduced 3 major hospital value-based payment programs that aim to improve quality: the Hospital Value-Based Purchasing Program (HVBP), the Hospital Readmissions Reduction Program (HRRP), and the Hospital-Acquired Condition Reduction Program (HACRP)…
Less than 5% of US hospitals demonstrate high performance across all 3 of Medicare’s hospital value-based payment programs. This could reflect efforts by CMS to capture separate domains of quality and would imply that very few US hospitals provide high-quality care globally. Alternatively, it may result from idiosyncrasies of program design and measures that hamper reliable assessment of hospital quality and that may warrant attention and reform.
Hospitals that performed poorly across programs were more likely to be located in areas with a higher proportion of socially vulnerable populations, including immigrants and racial and ethnic minority groups. Nearly half of low-performing hospitals were located in the Southeastern US, where many communities experience disproportionately poor health outcomes. Financial penalties levied by hospital value-based programs, particularly when compounded, may exacerbate disparities in care for these populations.”

State of Medicare Advantage REPORT July 2022 From Better Medicare Alliance: “Today, more than 28 million Americans, 45% of the total Medicare population, have made an active choice for the quality, affordable, coordinated coverage and care uniquely found in Medicare Advantage.
It’s not hard to see why: seniors are saving nearly $2,000 per year, taxpayers are seeing lower per-beneficiary government spending, beneficiaries report a 94% satisfaction rate, and 99.9% of Medicare Advantage plans are offering supplemental benefits unavailable in fee-for-service Medicare.”
A good resource about current MA statistics. One surprise (for me was the state with the highest percentage enrollment- Alabama at 53.35%.

About hospitals and healthcare systems

 HCA, Tenet profits sink: 10 things to know  FYI

 340B DSH Hospitals Increased Uncompensated Care in 2020 Despite Significant Financial Stress “To understand how the events of 2020 impacted the health care safety net in which 340B DSH hospitals play a vital role, this study compares 340B DSH hospitals to non-340B hospitals on two financial metrics: operating margins and the provision of uncompensated and unreimbursed care. We found:

• 340B DSH hospitals experienced a sharp decline in their average operating margin, which already was negative, of 2.6 percentage points or 74%. In fiscal year (FY) 2019, 340B hospitals’ average operating margin was -3.5%, and in FY 2020 the average was -6.1%.

• At the same time, 340B DSH hospitals increased their average provision of uncompensated and unreimbursed care by nearly 10%. In FY 2020, 340B DSH hospitals provided 67% of all such care while representing only 44% of hospitals.

• The experience of non-340B hospitals was substantially different. For these hospitals, the average operating margin increased by 21% while the average level of uncompensated and unreimbursed care remained flat.

  This pattern provides important evidence that 340B DSH hospitals are continuing to fulfill the program’s purpose as set out by Congress in 1992.”

About pharma

 FDA Explains Therapeutic Equivalence Evaluations in Draft Guidance “To qualify for therapeutic equivalence, a drug product must show pharmaceutical equivalence, bioequivalence and the same clinical effect and safety profile for the conditions of use specified in the labeling as the reference product, the agency said.
To determine pharmaceutical equivalence, the product needs to be identical in dosage form and route or routes of administration, contain identical amounts of the identical active drug ingredient and meet the identical compendial or other applicable standard of identity, strength, quality and purity, including potency and, where applicable, content uniformity, disintegration times and/or dissolution rates…
The deadline for comment on the draft is Sept. 19.
Read the draft guidance here: bit.ly/3OpEctK.”

About the public’s health

 Assessment of Patterns in e-Cigarette Use Among Adults in the US, 2017-2020 “In this cross-sectional study involving 994 307 adults from US states and territories that reported data on e-cigarette use in the 2017, 2018, and 2020 Behavioral Risk Factor Surveillance System, the prevalence of current e-cigarette use increased from 4.4% to 5.5% between 2017 and 2018 but decreased slightly to 5.1% in 2020; this decrease, though modest, was observed mainly among those aged 18 to 20 years. The prevalence of daily e-cigarette use increased consistently, from 1.5% in 2017 to 2.1% in 2018 and 2.3% in 2020, with the most significant increase among adults aged 21 to 24 years.” 

La. schools prepare to add eating disorder education to curriculum “With a new school year coming up, Louisiana schools are adding a new element to their curriculum- talking about eating disorders. In Calcasieu Parish, teachers are turning to LSU Ag Center program “Health Rocks” to educate students in grades six through 12 on healthy eating habits and to warn them of the dangers of eating disorders.”

About healthcare IT

 54% of healthcare organizations hit with cyberattacks in the last year, survey says “More than half of healthcare organizations have been targeted by hackers in the past year, with most organizations feeling ill-prepared for such attacks, according to a survey from digital security company SecureLink…
It found that 54 percent of healthcare organizations said that they'd experienced a third party data breach in the past 12 months, and 65 percent said that they felt their IT systems don't make security and access a top priority. More than half of the companies surveyed also said that managing third-party security was a burden.”

About healthcare personnel

 Average salary for 55 hospital jobs  Look at the bottom for who makes the most and by how much.

 When peer comparison information harms physician well-being “Motivating physicians to adhere to medical best practices is a constant concern for health system leaders and policymakers. Meanwhile, burnout rates among physicians are rising—often resulting in mental health problems, job turnover, and higher healthcare costs. In our study, a commonly used behavioral intervention—informing physicians about how their performance compares to that of their peers—has no statistically significant impact on performance. However, it does decrease physicians’ job satisfaction and increase burnout. We uncover one mechanism behind this backfiring effect, namely, that the intervention may signal a lack of leadership support. Consistent with this account, we find that training leaders to offer support offsets the negative impact. We discuss lessons for the design, implementation, and evaluation of behavioral interventions and policies.”

Today's News and Commentary

Amazon scoops up primary care company One Medical in deal valued at $3.9B “The online retail giant plans to buy One Medical for $18 per share in an all-cash transaction valued at approximately $3.9 billion including the company's net debt, according to a press release.
The deal expands Amazon's reach into primary care as it also operates Amazon Care, which offers both virtual care services as well as in-home care to employees and other companies.
One Medical went public in January 2020 at a price of $14 a share. But shares in One Medical’s parent company, 1life Healthcare, have lost 75% of their value in the past year.”

About Covid-19

Study shows AstraZeneca's Covid-19 mAb Evusheld may not work against dominant Omicron strain “AstraZeneca’s prophylactic treatment for Covid-19, known as Evusheld, has survived where other mAbs failed, showing efficacy for the immunocompromised and others who cannot be vaccinated across multiple variants, including Delta and several Omicron subvariants.
But new correspondence published in the New England Journal of Medicine yesterday says that the dominant Omicron subvariants right now are much less susceptible to Evusheld, which is a combination of tixagevimab and cilgavimab. That data may end up resulting in a pause in the use of Evusheld, although an AstraZeneca spokesperson insists that it won’t, and HHS has not indicated in recent days that it’ll make that pause anytime soon.”
The key words are “much less susceptible,” not zero. From the last paragraph of the study: “The main limitation of our study is the lack of clinical data on the efficacy of these monoclonal antibodies and antiviral drugs for the treatment of patients infected with BA.2.12.1, BA.4, or BA.5 subvariants. Overall, our data suggest that the three small-molecule antiviral drugs remdesivir, molnupiravir, and nirmatrelvir may have therapeutic value against the sublineages BA.2.12.1, BA.4, and BA.5 of SARS-CoV-2 omicron variants.” 

Waning effectiveness of BNT162b2 and ChAdOx1 [Pfizer-BioNTech and AstraZeneca] covid-19 vaccines over six months since second dose: OpenSAFELY cohort study using linked electronic health records “Despite waning vaccine effectiveness, rates of covid-19 related hospital admission and death were substantially lower among vaccinated than unvaccinated adults up to 26 weeks after the second dose, with estimated vaccine effectiveness ≥80% for BNT162b2, and ≥75% for ChAdOx1. By weeks 23-26, rates of positive SARS-CoV-2 test in vaccinated people were similar to or higher than in unvaccinated people (adjusted hazard ratios up to 1.72 (1.11 to 2.68) for BNT162b2 and 1.86 (1.79 to 1.93) for ChAdOx1).”

About health insurance

 Justice Department Charges Dozens for $1.2 Billion in Health Care Fraud “The Department of Justice today announced criminal charges against 36 defendants in 13 federal districts across the United States for more than $1.2 billion in alleged fraudulent telemedicine, cardiovascular and cancer genetic testing, and durable medical equipment (DME) schemes.
The nationwide coordinated law enforcement action includes criminal charges against a telemedicine company executive, owners and executives of clinical laboratories, durable medical equipment companies, marketing organizations, and medical professionals.
Additionally, the Centers for Medicare & Medicaid Services (CMS), Center for Program Integrity (CPI) announced today that it took adverse administrative actions against 52 providers involved in similar schemes. In connection with the enforcement action, the department seized over $8 million in cash, luxury vehicles, and other fraud proceeds…
The coordinated federal investigations announced today primarily targeted alleged schemes involving the payment of illegal kickbacks and bribes by laboratory owners and operators in exchange for the referral of patients by medical professionals working with fraudulent telemedicine and digital medical technology companies.”

About hospitals and healthcare systems

 M&A Quarterly Activity Report:Q2 2022 “M&A activity between hospitals and health systems in the second quarter of 2022 returned to both trendlines we have been tracking since the pandemic began. First, the number of announced transactions, 13, remained below what we saw in the years leading up to 2020 but was consistent with numbers for Q2 2021, when 14 transactions were announced. Second, we again saw the small number of transactions offset by a high percentage of ‘mega’ transactions, in which the smaller party or seller has annual revenues in excess of $1 billion (an exception to this trend was Q1 of this year, when no mega transactions were announced and 10 of the 12 announced transactions had smaller parties with less than $500 million in annual revenue). Indeed, the average size of the smaller party reached a record-setting $1.5 billion this quarter…
Total transacted revenue also reached an historic high of $19.2 billion this quarter. This more than doubles the total transacted revenue of $8.5 billion in Q2 2021, which had a similar number of announced transactions.”

About pharma

 PhRMA funnels $10M into new grassroots clinical trial diversity initiative—and hopes Big Pharma will take note “The industry group Pharmaceutical Research and Manufacturers of America (PhRMA) is hoping to break the mold, investing $10 million to launch 10 community-based trial sites in a new diversity initiative led by three medical schools.  
Dubbed Equitable Breakthroughs in Medicine Development, the initiative aims to tackle systemic barriers that communities of color and historically underserved patients face when trying to access clinical trials. The goal is to build sustainable, local clinical trial infrastructure with efforts that address lack of outreach, patient mistrust and lack of available sites.
Participating schools are the Yale School of Medicine, the Morehouse School of Medicine and its Research Centers in the Minority Institutions Coordinating Center and Vanderbilt University Medical Center.”

About the public’s health

 Systemic or Vaginal Hormone Therapy After Early Breast Cancer: A Danish Observational Cohort Study “Women treated for breast cancer (BC) often suffer genitourinary syndrome of menopause. These symptoms may be alleviated by vaginal estrogen therapy (VET) or menopausal hormone therapy (MHT). However, there are concerns of risks of recurrence of BC and death following treatment…
In postmenopausal women treated for early-stage estrogen receptor–positive BC, neither VET nor MHT was associated with increased risk of recurrence or mortality. A subgroup analysis revealed an increased risk of recurrence, but not mortality, in patients receiving VET with adjuvant aromatase inhibitors.”

Polygenic Risk, Midlife Life's Simple 7, and Lifetime Risk of Stroke “Recent genetic discoveries in stroke have unleashed the potential of using genetic information for risk prediction and health interventions aimed at disease prevention. We sought to estimate the lifetime risk of stroke (LTRS) by levels of genetic risk and to investigate whether optimal cardiovascular health can offset the negative impact of high genetic risk on lifetime risk of stroke…
 Maintaining an optimal midlife cardiovascular health offsets the lifetime risk of stroke by 30% to 43% and lengthens the years lived free of stroke by 5 to 6 years.”

Georgia’s Six-Week Abortion Ban Can Take Effect, Court Rules The last line of the 11th Circuit Court of Appeals decision states: “Because a constitutional right to abortion does not exist, we decline to engage in abortion exceptionalism.”

Unvaccinated Rockland County, N.Y. man diagnosed with polio “The first U.S. case of polio in nearly a decade has been confirmed in an unvaccinated individual in Rockland County, N.Y., local and state health officials announced Thursday.
While the origins of the case are still being investigated, the 20-year-old man had traveled to Poland and Hungary earlier this year and was hospitalized in June, according to a public health official close to the investigation who was not authorized to speak on the record. He was initially diagnosed with a possible case of acute flaccid myelitis, caused by inflammation of the spinal cord that results in severe muscle weakness and paralysis. But subsequent testing detected a type of polio that indicates transmission from outside the United States, according to a joint alert Thursday from the New York State Health Department and Rockland County.”

About healthcare IT

 VA’s $16 billion medical records overhaul could triple in cost “Veterans Affairs officials announced Wednesday they will delay the planned deployment of the department’s new electronic medical records to sites in Idaho amid concerns the $16-billion project could be endangering veterans and may triple in cost…
The 10-year, $16 billion project was approved in 2017 by President Donald Trump and touted by his administration as a transformational event for the department by putting VA records on the same system as the Department of Defense for the first time. Military officials began using a new records system based on the same software in 2015.”

Today's News and Commentary

About Covid-19

 Novavax’s Covid-19 vaccine wins backing of CDC advisory panel “The Advisory Committee on Immunization Practices voted 12-to-0 to recommend the vaccine, with several members expressing hope that the vaccine’s makeup may persuade some people who have been reluctant to get vaccinated against Covid to finally roll up a sleeve. The vaccine is a recombinant protein product, developed with the same kind of approach that has been used for a number of vaccines over the years. Some people who have refused Covid vaccines have expressed hesitancy over the messenger RNA vaccines produced by Moderna and the Pfizer and BioNTech partnership.” 

About health insurance

 Americans Confused By Basic Health Insurance Terms But Happy With Their Plans “A recent Forbes Advisor survey of 2,000 Americans who have health insurance found that over three-quarters can’t identify the term “coinsurance” and nearly half incorrectly defined copayment and deductible. That’s just the beginning of their confusion about the U.S. health insurance system.
The survey also found fairly significant knowledge gaps about open enrollment, Health Savings Accounts and medical billing…
Although survey respondents are confused by medical bills and many don’t have a full grasp on health insurance terminology, the vast majority of those surveyed said they’re happy with their health plans.
That includes 91% of men who said they’re either very or somewhat happy with their health plan compared to 82% of women. Only 2% of men said they’re very or somewhat unhappy with their plan.”

US health insurers raise rates to match increase in usage”After putting off routine health care for much of the pandemic, Americans are now returning to doctors’ offices in big numbers — a trend that’s starting to show up in higher insurance rates across the country.
Health insurers in individual marketplaces across 13 states and Washington D.C. will raise rates an average of 10% next year, according to a review of rate filings by the Kaiser Family Foundation.”

Aiming to help small businesses, Maine will merge public health insurance markets “ The federal government has approved Maine’s plan to improve health insurance for small businesses through a change in the way the state offers coverage through the federal Affordable Care Act, also known as Obamacare.
Maine plans to merge individual and small group coverage markets into a single, pooled market beginning in 2023. State officials believe the change will stabilize the health insurance market, and will extend federal funding through the Maine Guaranteed Access Reinsurance Association — which has stabilized Maine’s individual market since 2019 — to the small group market for the first time.”
This program is an example of an innovative state-based initiative.

About hospitals and healthcare systems

 Minimum Staffing Requirements Could Cost Nursing Homes $10B Annually “Nursing homes would have to spend up to $10 billion per year and hire almost 188,000 nurses to comply with increased minimum staffing requirements, according to a report from the American Health Care Association (AHCA) and accounting and consulting firm CLA (CliftonLarsonAllen LLP).” 

About pharma

Biogen agrees to pay $900 million to settle whistleblower case alleging kickbacks and sham speaking events “After a decade of legal squabbling, Biogen has agreed in principle to pay $900 million to settle a lawsuit filed by a former employee who alleged the company paid kickbacks to hundreds of physicians to boost sales of its multiple sclerosis drugs.”
However:  Biogen Inc. (BIIB) Q2 Earnings and Revenues Surpass Estimates 

About the public’s health

Officials reorganize HHS to boost pandemic response “The Biden administration is reorganizing the federal health department to create an independent division that would lead the nation’s pandemic response, amid frustrations with the Centers for Disease Control and Prevention.
The move elevates a roughly 1,000-person office within the department — known as the Office of the Assistant Secretary for Preparedness and Response, or ASPR — into a separate division, charged with coordinating the nation’s response to health emergencies, according to seven people briefed on the plan who spoke on the condition of anonymity because they were not authorized to comment, and a memo obtained by The Washington Post.”

FDA finds toxic arsenic, cadmium, lead in many baby foods “The Food and Drug Administration found significant levels of toxic heavy metals in the U.S. food supply during its ongoing monitoring efforts, the agency said in a new report. And baby foods were among the most contaminated for arsenic and lead.
The FDA's report analyzes the most recent data on nutrients and contaminants from its ongoing survey aimed at promoting food safety.”

 Overdose death rate increased by 30% in 2020, a 'staggering' rise “The death rate increased most dramatically — 44% — among Black Americans, from 27 deaths per 100,000 in 2019 to 38.9 deaths per 100,000 in 2020.
Among American Indian and Alaska Native populations, the rate increased by 39%, from 26.2 deaths to 36.4 per 100,000.
Fatal drug overdoses increased among whites, too, though at a slower rate, at 22%. In 2019, 25.2 overdose deaths per 100,000 people occurred among white Americans, compared with 30.7 per 100,000 in 2020.”

About healthcare IT

 Health Sector Suffered 337 Healthcare Data Breaches in First Half of Year “Fortified Health Security’s mid-year report on the state of healthcare cybersecurity observed slight shifts in healthcare data breach trends in the first half of 2022. The HHS Office for Civil Rights data breach portal showed that there have been 337 healthcare data breaches impacting more than 500 individuals each in the first half of this year, signifying a slight decrease from 368 at this time last year.” 

US to return $500K healthcare providers paid in ransom to North Korea hackers “The federal government recovered $500,000 that two hospitals paid as ransom to North Korean hackers and plans to return the funds, according to a July 19 U.S. Justice Department statement.
Court documents show the hackers installed Maui ransomware on an unnamed Kansas-based medical center to encrypt files and servers. The hospital notified the FBI and paid $100,000 in bitcoin to regain computer access. Federal investigators traced the payment to China-based money launderers, according to the Justice Department.”

Empowering people to live a healthier day: Innovation using Apple technology to support personal health, research, and care Apple’s latest gameplay for healthcare initiatives.

About healthcare personnel

 2022 Health Information Trends Usage, trust and impact among US adults “While health care providers are trusted a great deal or a lot by large majorities of the public and more so than non-provider information sources, the data show a decline in trust in PCPs and specialists and increases in trust in non-provider sources.

• PCPs and specialists are still trusted by majorities of adults a great deal or a lot, however, this is significantly lower than in 2019 (PCPs: 78% vs. 83%; specialist: 76% vs. 80%).

• During the same time period there has been an increase in the proportion who trust non-provider sources a great deal or a lot including internet searches (41% in 2022 vs. 33% in 2019), pharmaceutical companies (36% vs. 26%), patient advocacy groups or associations (35% vs. 28%), support groups (35% vs. 29%), and various types of media (broadcast: 26% vs. 19%; print: 26% vs. 20%; and social: 25% vs. 13%).”

About health technology

Roche's Alzheimer's blood test earns breakthrough label from FDA “The blood-based biomarker test has already garnered the FDA’s breakthrough device designation, Roche announced Tuesday. That label will speed up the test’s route through the review process on its way to a full-blown clearance. 
The Elecsys Amyloid Plasma Panel measures the amount of phosphorylated tau 181 and apolipoprotein e4 in an individual’s blood sample, also known as pTau-181 and ApoE4, respectively. Elevated levels of pTau have been shown to correlate with the onset of Alzheimer’s, while the presence of the ApoE4 gene is believed to be among the strongest risk factors for the disease—though not all carriers of the gene go on to develop Alzheimer’s.
The test isn’t meant to be used as a standalone diagnostic for the disease, but rather as part of an overall assessment that also takes into account a patient’s clinical information and the results of additional testing.”

Today's News and Commentary

About Covid-19

 Sore throat and cough top symptoms that could be Covid Top 5 symptoms are now:

• “Sore throat - reported by 58%

• Headache - 49%

• Blocked nose - 40%

• Cough no phlegm - 40%

• Runny nose - 40% “

Note that loss of taste and smell (10%) are not the most frequent symptoms.

About the public’s health

 Raising the Bar This monograph from the RWJ Foundation “provides an actionable framework for the entire healthcare sector to embed equity and excellence throughout its work. In this first part of the project the National Alliance to impact the Social Determinants of Health (NASDOH) convened extensive discussions with providers, hospitals, payers, and community leaders to develop foundational principles, essential roles, and concrete actions for the sector to help achieve optimal health for all.”
Usually reports on SDOH provide research showing what is common knowledge. This report actually provides “concrete actions” to address problems.

About healthcare IT

 CMS PROPOSES TO CUT AUDIO-ONLY TELEHEALTH COVERAGE “In a move expected to anger virtual care advocates, the Centers for Medicare & Medicaid Services has proposed dropping Medicare coverage for audio-only telehealth services, including telephone calls, in its 2023 Physician Fee Schedule. The proposed action would take place 151 days after the end of the public health emergency.” 

The New Electronic Health Record’s Unknown Queue Caused Multiple Events of Patient Harm From the VA OIG in response to ongoing implementation problems with the Oracle Cerner system. “The patient safety team identified 60 safety concerns across nine core domains and ranked these issues based on severity…
The clinical reviewers conducted 1,286 facility event assessments and identified and classified 149 adverse events for patients…

• ·  Major harm: 2

• ·  Moderate harm: 52

• ·  Minor harm: 95”

About healthcare personnel

 Top Lies Patients Tell Their Doctors  No surprises, but worth a quick read aa a reminder.

About health technology

 Synchron Announces Enrollment of First Patient in U.S. Endovascular Brain Computer Interface Study COMMAND in Patients With Severe Paralysis “Synchron, an endovascular brain-computer (BCI) interface company, today announced the enrollment of the first patient in the US clinical trial, COMMAND, for patients with severe paralysis, at Mount Sinai Hospital in New York. The clinical trial is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI. Previous BCI human clinical studies approved by FDA have been conducted in short term experimental settings.
The early feasibility study (EFS), funded by the National Institutes of Health (NIH), will primarily assess safety and begin to explore quantified efficacy measures of Synchron’s Stentrode™ in patients with severe paralysis with the goal of enabling the patient to control digital devices hands-free.”