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 HospitalsThis 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.”

Today's News and Commentary

About Covid-19

Covid-19 public health emergency extended in the US “The Biden administration on Friday extended the Covid-19 public health emergency for another three months.
US Department of Health and Human Services Secretary Xavier Becerra officially renewed the declaration, extending it through October 13, 2022.”

 White House COVID-19 coordinator says virus ‘still evolving rapidly’ “As variants continue to circulate and develop, White House COVID-19 response coordinator Ashish Jha says the U.S. has “got to stay on top of this virus” as it quickly evolves.
‘We’re still in the middle of this pandemic,’ Jha said Sunday on ABC’s ‘This Week.’
The latest COVID-19 subvariant, BA.5, is the most highly transmissible to date, Jha said. It’s also ‘immune-evasive,’ leading to high levels of reinfection and breakthrough infections. 
Vaccines are still effective at staving off severe illness, he added, but they’re not as protective against BA.5 compared to other iterations of the virus.”

WHO Advises Against Using Fluvoxamine and Colchicine for COVID-19 “The World Health Organization (WHO) has advised against the use of the antidepressant drug fluvoxamine and the gout drug colchicine for patients with mild-to-moderate COVID-19…
The panel based its advice on data from three clinical fluvoxamine trials and seven colchicine trials. Citing the lack of adequate data, the WHO did not make any recommendation on the use of the two drugs for patients with severe and critical cases of COVID-19.”

About health insurance

 CMS pitches outpatient payment rule: 5 things to know “Five takeaways from the 886-page proposed rule
1. Payment update. CMS proposed increasing OPPS rates for hospitals that meet quality reporting requirements by 2.7 percent in 2023 compared to this year. The department estimates that total payments to providers would be $86.2 billion in 2023, up $6.2 billion from 2022.
2. Inpatient only list. CMS proposed removing 10 services from the inpatient only list next year. The procedures were removed from the list in 2021 as part of the first phase of eliminating the IPO list, but they were added back to the list when the elimination process was halted last year. CMS said the codes for the maxillofacial procedures "meet the current criteria to remove services from the IPO list." 
3. 340B program. CMS said it anticipates applying a payment rate of average sales price plus 6 percent to certain drugs purchased through the 340B Drug Pricing Program. "We are still evaluating how to apply the Supreme Court's recent decision to prior calendar years," CMS said in a fact sheet.
4. Rural emergency hospitals. The proposed rule includes a payment model for rural emergency hospitals, including a monthly facility payment. "To improve access to all types of care in rural settings, CMS is broadly proposing to consider all covered outpatient department services … as REH services," CMS said. Rural emergency hospitals would be paid for providing services at a rate that is equal to the OPPS rate plus an additional 5 percent payment. 
5. Comment period. Public comments on the proposed rule are due by Sept. 13.”
See, also this CMS Fact Sheet.

Health insurance illiteracy costs employees, study finds “According to the latest Health Insurance Literacy Survey from HealthCare.com:

  • 1 in 4 Americans say lack of health insurance understanding caused them to receive a higher-than-expected medical bill.

  • Half believe that copays count toward deductibles, when they generally do not.

  • Half of respondents say they can’t afford health insurance without employer coverage.

  • 3 in 10 stay in jobs they don’t like or take jobs they don’t want so they can receive health insurance.”

About hospitals and healthcare systems

 Biden’s FTC Has Blocked 4 Hospital Mergers and Is Poised to Thwart More Consolidation Attempts “Under the FTC’s traditional economic theory, high prices in a region should attract new competitors and that competition will bring down prices. But regulatory hurdles and massive costs involved in setting up a health care network — which includes hospitals and doctors, as well other aspects like testing facilities — make such movement unlikely, if not impossible.
So Biden appointees at the FTC and Department of Justice have announced that they want to adopt some legal theories of antitrust enforcement that have been less frequently deployed…
Last December, FTC Chair Lina Khan said the agency would scrutinize how proposed mergers might affect not only prices but also workers in the labor market…
Excessive market power, she added, can allow companies to impose onerous, take-it-or-leave-it contract terms, including noncompete clauses…
The Democratic commissioners also want to take a tougher line in challenging so-called vertical mergers. In these deals, hospitals, insurers, or other types of health care companies seek to merge with or acquire companies that provide needed products, services, or staffing. One example is when hospitals or insurers acquire large physician practices, which studies have found leads to higher prices. Patients will visit a longtime physician only to find prices doubled or more, simply because the practice has been purchased by a hospital, which now sets the rates.”

About pharma

 The top 10 generic drug makers by 2021 revenue FYI

About healthcare IT

 iPad stolen from Kaiser Permanente hospital had info of 75,000 patients “The iPad included patient names, birth dates, medical record numbers and date of service information.There was no financial information or Social Security numbers in the iPad.”

About health technology

 GE Healthcare to retain its household corporate name in 2023 spinoff “General Electric took another step forward in its plan to split up its businesses among a trio of independent, publicly traded companies. It has set out a road map into early 2024 and announced the brand names of its new scions focused on medical products, aviation and energy.
In a decision that almost assuredly involved the transfer of large sums of money to market research professionals, GE Healthcare will be rechristened GE HealthCare…”

Today's News and Commentary

About Covid-19

 More than 1 in 2 Americans now live in an area where CDC urges indoor masking to curb COVID-19 surges “Fifty-five percent of the country's population now live in areas of "high" COVID-19 Community Levels, up from 32% last week, according to the CDC's weekly update. Another 30% are living in counties deemed to be ‘medium’risk.”

About health insurance

Some Medicare Part D Beneficiaries Pay Full Price for Generic Drugs “In this new assessment, Avalere finds that the share of patients paying the full cost of a generic medication placed on a preferred brand tier has increased over time. In 2020, 63% of beneficiaries across all Part D plans paid the full cost of a generic at least once, an increase of 18 percentage points from 2017 to 2020…”

 UnitedHealth Group's 13% revenue growth in Q2: 11 things to know “UnitedHealth Group saw double-digit revenue growth over the last three months driven by continued member growth under UnitedHealthcare and value-based arrangements at Optum Health, according to the company's second quarter 2022 earnings report released July 15.
UnitedHealthcare also said it would be getting rid out-of-pocket costs for some prescription drugs under fully insured group plans. Medications that will have a $0 cost-share include insulin, epinephrine, glucagon, naloxone and albuterol. Pending regulatory approvals, the policy could be in place by Jan. 1.”

Feds approve 'reinsurance' plan extension to control premiums on MNsure policies “The federal government has approved a five-year extension to Minnesota's "reinsurance" program to control premiums on health plans sold through the MNsure exchange.
In its approval application, the state Commerce Department said the program between 2018 and 2022 met its goal of a 15 to 20% average statewide reduction in premiums from what they would have been without reinsurance.
The Minnesota Premium Security Plan works by giving health insurers state-funded reimbursement for claims ranging from $50,000 to $250,000, which can stem from high-cost cases such as cancer treatments, intensive care, premature babies and severe cases of COVID-19.”

About hospitals and healthcare systems

 How Geisinger's refund program is faring amid patient experience crisis “In late 2015, the Danville, Pa.-based system rolled out the ProvenExperience program, which gives every patient the option to claim a full refund, no questions asked. The program works on a sliding scale, allowing patients to determine how much of their copay they'd like back if their service or experience expectations weren't met…
 ProvenExperience refunded $320,141 in financial year 2016. In 2020, Dr. Burke said Geisinger refunded about $84,000, and the program refunded $40,000 in 2021 — a surprising trend, given a national drop in patient experience satisfaction measures throughout the pandemic. Findings from a Press Ganey survey in November 2021 found patients' overall rating of hospital care fell 4 percentage points, and the likelihood of recommending their hospital fell 4.5 percentage points.”

HCA shares hit 1-year low “Shares of Nashville, Tenn.-based HCA Healthcare fell to a 52-week low of $164.47 in trading on July 14, according to a report from Seeking Alpha. Shares are down 24 percent over the last year and 34 percent year to date.”

About pharma

 Novo Nordisk, Eli Lilly poised to divvy up obesity market that could be worth $50B in 2030: analysts “While reimbursement and education challenges persist, drugmakers like Eli Lilly and Novo Nordisk are poised to unlock a global obesity market that could be worth more than $50 billion by the end of the decade, analysts at Morgan Stanley Research wrote in a note to clients Friday.
Novo’s latest semaglutide med, Wegovy, scored its landmark obesity nod last summer. And Eli Lilly’s tirzepatide, recently approved as Mounjaro, has big weight loss ambitions beyond its initial diabetes green light.”

About the public’s health

 The national suicide hotline is changing to 988 starting Saturday “The nationwide hotline for mental health emergencies switches to a simple 988 number on Saturday, a transition that is expected to bring millions more calls, chats and texts into a system where readiness to handle the surge varies from place to place.” 

Associations Between Prenatal Urinary Biomarkers of Phthalate Exposure and Preterm Birth “In this pooled analysis of 16 studies in the US including 6045 pregnant individuals, phthalate metabolites were quantified in urine samples collected during pregnancy. Higher urinary metabolite concentrations for several prevalent phthalates were associated with greater odds of delivering preterm, and hypothetical interventions to reduce phthalate exposure levels were associated with fewer preterm births…
Phthalates are synthetic chemicals used in everyday consumer products such as personal care items and food processing or packaging. Exposure can occur through many sources, including household dust, diet, and personal care products like cosmetics.”

Texas sues Biden over new abortion guidance as conservative groups mull more challenges “The Texas attorney general filed a lawsuit Thursday challenging new abortion guidance the Biden administration released this week — arguing that it violates the rights of doctors not to participate in terminating a pregnancy and steps on the state’s right to regulate the procedure within its borders.
The suit against the Biden administration’s top health officials only targets one of the two main actions the federal government has taken in response to the fall of Roe v. Wadea memo to hospitals and doctors across the country on Monday arguing that federal law requires them to provide abortions in emergency circumstances regardless of whatever bans their state imposes…
The Texas case will go before Judge James Hendrix, an appointee of President Donald Trump, and if appealed would go to the right-leaning 5th Circuit Court of Appeals and then up to the Supreme Court.”

Monkeypox patients should not be left to suffer when an FDA-approved drug could help More than one million doses of tecovirimat are currently sitting in the National Strategic Stockpile, with only a few doses having been released to health departments for use, even as monkeypox cases continue to rise.”
Read the article for a fascinating story about this medication.
Meanwhile: US government orders 2.5M more monkeypox vaccine doses from Bavarian Nordic via CMO

About health technology

 DOJ files False Claims Act case against dialysis giant Fresenius alleging unnecessary vascular procedures “The whistleblower complaint alleges that from about January 1, 2012 through June 30, 2018, Fresenius routinely performed certain procedures on patients with end stage renal disease (ESRD) who were receiving dialysis, without sufficient clinical indication that the patients needed the procedures. Fresenius knowingly subjected ESRD patients—who included elderly, disadvantaged minority, and low-income individuals—to these procedures to increase its revenues, the DOJ complaint states.”

Today's News and Commentary

About Covid-19

Newly Published Phase 3 Study in People with COVID-19 Shows SaNOtize Nitric Oxide Nasal Spray Reduced Viral Load by 99% within Two Days “Phase 3 trial demonstrated a reduction in SARS-CoV-2 viral load in high-risk COVID-19 patients by 94% and 99% within 24 and 48 hours of treatment, respectively
Median time to a negative PCR test was three days after beginning treatment in the nitric oxide group vs. seven days in the placebo group (P < 0.05)
Participants recruited during delta and omicron surges, suggesting antiviral properties of nitric oxide effective against evolving variants of concern”
Here is the research article.

Long-term Immune Response to SARS-CoV-2 Infection Among Children and Adults After Mild Infection “ In this cohort study of 252 family clusters with COVID-19, anti–SARS-CoV-2 spike receptor-binding domain IgG persisted until 12 months after infection in all age groups, showing significant higher antibody peaks for younger individuals at every follow-up time point. Children younger than 3 years were found to develop higher levels of binding antibodies compared with adults older than 18 years.”

About health insurance

 Are Financial Barriers Affecting the Health Care Habits of American Men? From the Commonwealth Fund: “Highlights:

  • Looking across the 11 high-income countries in our study, rates of avoidable deaths, chronic conditions, and mental health needs for U.S. men are among the highest in our analysis.

  • Men in the U.S. have the lowest rate of prostate cancer–related deaths.

  • Men in Canada, the United States, and Sweden are the least likely to have a regular doctor and have among the highest rates of emergency department use for conditions that could have been treated in a doctor’s office.

  • Men in the U.S. and Switzerland skip needed care because of costs and incur medical bills at the highest rates.

  • In the U.S., men with lower income or frequent financial stress are less likely to get preventive care, more likely to have problems affording their care, and more likely to have physical and mental health conditions.”

Profits, medical loss ratios, and the ownership structure of Medicare Advantage [MA] plans “In 2021, about 67% of enrollment in MA was accounted for by 5 large insurers: United, Humana, CVS/Aetna, Kaiser, and Anthem. These firms typically have a few related businesses that provide at least some services to their MA plans. For example, Humana owns part of “Kindred at Home,” a home health and hospice provider. Likewise, Kaiser owns Kaiser Foundation Hospitals and the Permanente Medical Groups that all contract with Kaiser MA plans. CVS/Aetna, United, and Cigna all own PBMs that contract with their MA plans. Other businesses include physician practices, pharmacies, ambulances, and dental, vision, and hearing services providers.”
The average gross margin for the top 10 companies in 2019 was 4.35%. But the article has many caveats about how difficult it is to calculate this figure, especially because of the interrelated businesses of the parent company.

Jury Convicts Man of $600 Million Health Care Fraud, Wire Fraud, and ID Theft Scheme “According to court documents and evidence presented at trial, Mathew James, 54, of East Northport, operated a medical billing company that billed for procedures that were either more serious or entirely different than those James’ doctor-clients performed. James directed his doctor-clients to schedule elective surgeries through the emergency room so that insurance companies would reimburse at substantially higher rates. When insurance companies denied the inflated claims, James impersonated patients to demand that the insurance companies pay the outstanding balances of tens or hundreds of thousands of dollars.”

Payers' underwriting earnings dropped 65% in 2021 “Six things to know:

  1. Among all payers, underwriting profits declined 65 percent to $23.9 billion.

  2. Commercial payers saw underwriting profits decrease 90 percent to $1.2 billion. This was driven by COVID-19 variant waves in the summer of 2021.

  3. Medicare Advantage plans reported a profit increase of $7.4 billion.

  4. Premiums grew in 2021 industrywide, but there was a slight decrease among group plans. That dip was offset by a major increase in individual ACA enrollment, which grew from 2.5 million to 14.5 million.

  5. Payers with diversified product portfolios weathered the decline better than those whose portfolios lacked diversity.

  6. Despite the pandemic impact, U.S. payers recorded record capital and a surplus of $273 billion for 2021, a 13.5 percent increase year over year.”

Health insurance status and cancer stage at diagnosis and survival in the United States “Compared with privately insured patients, Medicaid-insured and uninsured patients were significantly more likely to be diagnosed with late-stage (III/IV) cancer for all stageable cancers combined and separately. For all stageable cancers combined and for six cancer sites—prostate, colorectal, non-Hodgkin lymphoma, oral cavity, liver, and esophagus—uninsured patients with Stage I disease had worse survival than privately insured patients with Stage II disease. Patients without private insurance coverage had worse short-term and long-term survival at each stage for all cancers combined; patients who were uninsured had worse stage-specific survival for 12 of 17 stageable cancers and had worse survival for leukemia and brain tumors. Expanding access to comprehensive health insurance coverage is crucial for improving access to cancer care and outcomes, including stage at diagnosis and survival.”

About pharma

 Theravance cashes in Trelegy Ellipta royalty rights for $1.1 billion upfront “Theravance Biopharma announced that it entered into a definitive agreement to sell its royalty rights on global net sales of GSK's asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to Royalty Pharma for over $1.5 billion, including an upfront cash payment of around $1.1 billion. The transaction is expected to close in the next 10 business days.”

Bayer offloads Nebido as part of pharma unit transformation “Bayer agreed to sell its male hypogonadism treatment Nebido (testosterone undecanoate) to Grünenthal for up to €500 million as the German drugmaker continues to focus on its key areas of innovation. Last year, the long-acting injectable generated sales of €117 million.”

Judge Approves $264 million Mylan/Viatris Settlement Over High EpiPen Prices “Viatris, formerly Mylan, now must pay out a settlement of $264 million to consumers, insurers and pension funds who sued the company over steep price spikes for EpiPen, which is used to quickly administer epinephrine to treat potentially fatal allergic reactions.”

Alnylam Sues Pfizer, BioNTech and Moderna Again Over Alleged Patent Infringement “Alnylam Pharmaceuticals has filed new complaints against Pfizer-BioNTech and Moderna over alleged patent infringement of its biodegradable lipids, which the company claims are essential to the safety and efficacy of the companies’ messenger RNA-based COVID-19 vaccines.
Alnylam previously filed suit against the companies in March for alleged infringement of its patented lipid nanoparticle technology. In the new complaint, which cites a different patent, Alnylam said the lipid technology is used to help prevent the rapid degradation of the vaccines upon administration.”

Few biopharma risers stand out at the half year “Only a fifth of the 660 global drug developers tracked by Evaluate Vantage ended June in positive territory. Among the winners Lantheus stands out as the only stock to produce a triple-digit gain, excluding takeover targets, while Covid fatigue caused valuations at the big pandemic plays to continue ebbing away.
Pfizer, Moderna, Biontech, Novavax and Curevac registered some of the biggest declines in their respective market cap brackets. Covid is far from over, but questions about the durability of revenues from vaccines and other treatments is causing investors to look for new growth stories.”
Read the article for details by company.

About the public’s health

 Studies Probe Adenovirus Link to Childhood Hepatitis Cases “Two new studies, published in the New England Journal of Medicine on Wednesday, report that two medical centers — one in Birmingham, Ala., and another in Birmingham, England — have seen increases in the number of children with acute, unexplained hepatitis in recent months.
The research also presents more circumstantial evidence that adenovirus 41, which often causes gastrointestinal symptoms, may be a contributing factor. In both studies, adenovirus infections were detected in about 90 percent of children tested, and children who developed acute liver failure or required transplants had higher average levels of the virus in their blood than those with milder cases.”

About health technology

 Illumina loses challenge to block EU antitrust probe into $8B Grail buyout “Fighting to push its $8 billion acquisition of Grail past European regulators, Illumina suffered a key setback Wednesday when an EU court ruled an antitrust probe into the buyout can proceed.Illumina was challenging the inquiry after the EU objected to the acquisition over concerns it would concentrate most available genetic sequencing tests under one roof. The company has said it would appeal the ruling to Europe’s highest court…, but the bloc’s antitrust group may not wait for that process — which could take years — to wrap up before deciding whether to block the deal.” 

Today's News and Commentary

About Covid-19

 Biden Administration to Again Extend the Covid Public-Health Emergency “The Department of Health and Human Services has repeatedly renewed the emergency since it was originally declared in January 2020, with the most recent extension set to expire July 15. The next extension is expected to take effect Friday, according to a person familiar with the matter who asked not to be identified because the details aren’t public.” 

Moderna to advance two Omicron vaccine candidates against newer variants “Moderna Inc said on Monday it was advancing two Omicron vaccine candidates for the fall, one designed against the BA.1 variant and another against the BA.4 and BA.5.”

About health insurance

Optum, Red Ventures partner on consumer healthcare platform “UnitedHealth Group's provider arm, Optum Health, has teamed up with Red Ventures on a new consumer health-focused joint venture, RVO Health, which among other things includes doctor ratings through Healthgrades.
Red Ventures is a portfolio of bands that includes Healthgrades, Healthline Media, Optum Perks and Optum Store, as well as virtual coaching programs. Those will all be folded into the RVO Health venture.
According to a report from Moody's Investors Service, RVO Health will combine 120 million UHG customers and 50 million-plus members with Red Ventures' 95 million unique monthly visitors.”

About hospitals and healthcare systems

 HHS clarifies: All US hospitals must provide abortions in emergency cases “HHS issued guidance to hospitals July 11 to clarify that abortion is covered under the federal law requiring Medicare hospitals to provide all patients appropriate emergency care — including abortion care — regardless of state law…
The Emergency Medical Treatment and Labor Act was enacted in 1986 by Congress to require that Medicare hospitals provide all patients an appropriate emergency care — including medical screening, examination, stabilizing treatment and transfer, if necessary — irrespective of any state laws or mandates that apply to specific procedures. If a hospital is in a state that prohibits abortion by law and does not make exceptions for the health or life of a pregnant person, EMTALA preempts that state law.
HHS enforces EMTALA through CMS and a complaint-driven process.”

About pharma

 FDA to review first ever over-the-counter birth control pill “Perrigo Company said on Monday its unit HRA Pharma has asked the U.S. Food and Drug Administration (FDA) to approve a daily birth control pill for over-the-counter (OTC) sale, the first such request for this type of contraception…
The contraceptive is currently a prescription drug sold under brand Opill.
HRA Pharma expects the regulator to hold an advisory committee meeting and approve the application in the first half of 2023…”
And in a related article: Oral Contraceptives, Hormone Replacement Therapy, and Stroke Risk “Millions of women worldwide use exogenous hormones as oral contraceptives or hormone replacement therapy. Still, time-dependent and long-term consequences of exogenous hormones on stroke risk remains unclear…
Oral contraceptive use and hormone replacement therapy were associated with an increased risk of stroke, especially during the first year of use, possibly due to immediate changes in hemostatic balance. This study provides new insights on the effects of hormone exposure on stroke risk and provide evidence of not only an overall risk but also a pronounced effects seen in the beginning of treatment.”

Robert Califf Sounds Alarm if User Fees Aren’t Reauthorized Quickly ”Five months into his tenure as FDA commissioner, Robert Califf warned that the agency’s ability to review medical products would be drastically curtailed if Congress doesn’t pass a user fee reauthorization package by August.”

Merck sues HHS to avoid fine over 340B contract pharmacy restrictions “The pharmaceutical giant argues in a federal lawsuit filed Friday in the U.S. District Court for the District of Columbia that favorable rulings in similar cases make a warning letter from the federal government moot. The lawsuit is the latest in a feud between the federal government and drugmakers over the 340B program.”

Economic Evaluation of Cost and Time Required for a Platform Trial vs Conventional Trials “Conventionally, clinical trials have a defined end and only compare pre-specified intervention(s), meaning that therapeutic discoveries made during the trial are evaluated in a new trial. This results in multiple independent trials, requiring new infrastructure for each shorter-term evaluation and more patients randomized to placebo or standard-of-care compared with platform trials.
Platform trials are randomized clinical trials that allow for multiple interventions to be simultaneously compared and new interventions to be added after the trial is initiated. They typically aim to continue for an extended period or in perpetuity with interventions entering and leaving the platform at different times. Many published reviews on platform trials describe the statistical efficiencies of platform trials over conventional trial approaches. There is little guidance, however, on substantive resources to establish and maintain platform trials…
The findings of this study suggest that despite having larger initial setup requirements, consolidating clinical evaluation of multiple interventions into a single platform trial can drastically reduce cost and efforts.”
Also, see: An Economic Perspective on Platform Trials—The Gift and the Curse

About the public’s health

 Superbug infections spiked in pandemic's first wave “The first wave of the Covid pandemic created the perfect storm for superbugs in the U.S., with cases and deaths from dangerous drug-resistant bacterial and fungal infections spiking in hospitals in 2020, a report published Tuesday finds. 
The spike, the Centers for Disease Control and Prevention report said, wiped out the progress made against the deadly pathogens before the pandemic.”

About healthcare IT

 Machine Learning Analysis of Handgun Transactions to Predict Firearm Suicide Risk “In this prognostic study of nearly 2 million individuals with handgun transaction records, among transactions classified in the riskiest 5%, close to 40% were associated with a purchaser who died by firearm suicide within 1 year. Among the small number of transactions with a random forest score of 0.95 and above, more than two-thirds were affiliated with a purchaser who died by firearm suicide within 1 year (24 of 35).”
Fascinating, but the gun lobby will never let this technology achieve widespread acceptance. 

Epic's revenue up 13% in 2021, hit $3.8B “Epic reported a 15 percent annual growth rate for the decade leading up to last year and then saw 13 percent revenue growth to $3.8 billion.”

About health technology

 Medtronic begins Class I recall of 1 million dialysis catheters at risk of leaking “Medtronic has asked healthcare providers to immediately stop using more than 1 million catheters distributed across the U.S. and around the world after discovering a potential safety risk within the devices.
The alert marks the latest Class I recall for a company that has racked up half a dozen such safety events since the start of the year. The FDA dished out its most serious classification to the catheter recall last week, about a month after Medtronic initiated it in early June.”

Philips scores FDA clearance for faster MRI scanning powered by AI “Philips has secured an FDA clearance for artificial-intelligence-powered software designed to speed up the MRI scanning process while still delivering high-resolution images. 
Dubbed SmartScan, Philips said the program can help complete scans up to three times faster with ‘virtually no loss in image quality,’ allowing radiology departments to see more patients with the same hardware in about 97% of cases.
That covers a wide range of clinical protocols including the use of injected contrast agents as well as diffusion weighted imaging and quantitative scans of the brain, liver, heart and musculoskeletal system. It is also compatible with implants and can capture organs in motion or even a restless patient.”

Abbott's personalized brain stimulator earns FDA breakthrough tag for treating depression “Abbott said Tuesday that it has earned the agency’s acknowledgement for an ongoing project to apply its deep brain stimulation system to treatment-resistant depression. The label gives the technology a more expedited pathway toward potential FDA clearance.”

CEO of Dozens of Companies and Entities Charged in Scheme to Traffic an Estimated $1 Billion in Fraudulent and Counterfeit Cisco Networking Equipment “According to the indictment, Onur Aksoy, aka Ron Aksoy, aka Dave Durden, 38, of Miami, allegedly ran at least 19 companies formed in New Jersey and Florida as well as at least 15 Amazon storefronts, at least 10 eBay storefronts, and multiple other entities (collectively, the ‘Pro Network Entities’) that imported tens of thousands of fraudulent and counterfeit Cisco networking devices from China and Hong Kong and resold them to customers in the United States and overseas, falsely representing the products as new and genuine. The operation allegedly generated over $100 million in revenue, and Aksoy received millions of dollars for his personal gain.”

Today's News and Commentary

About Covid-19

 Biden-Harris Administration secures 3.2 million doses of Novavax COVID-19 Vaccine “The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD)…announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC)…
The Novavax COVID-19 Vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. The Novavax vaccine contains a very small amount of the SARS-CoV-2 spike protein, which elicits an immune response, in combination with an adjuvant, which boosts the immune system response to vaccine.”

Boston researchers may have found biomarker for long COVID

  1. “Researchers have found the SARS-CoV-2 spike protein circulating in the blood of long COVID-19 patients up to 12 months after they were diagnosed, The Boston Globe reported.

  2. The scientists said the findings suggested the spike protein was a potential biomarker that could be helpful in diagnosing and treating long COVID patients.

  3. ‘Strikingly, we detect SARS-CoV-2 spike antigen in a majority of [long COVID] patients up to 12 months post-diagnosis, suggesting the presence of an active persistent SARSCoV-2 viral reservoir,’ the study said.

  4. Meanwhile, the spike antigen was not detected in patients who recovered from COVID-19 but did not get long COVID.

  5. Senior author David Walt said the results suggest that ‘if someone could somehow get to that viral load and eliminate it, it might lead to resolution of symptoms.’”

About hospitals and healthcare systems

 Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019 “In this serial cross-sectional study of 244 542 adult patients hospitalized in 3156 US hospitals from 2010 to 2019, there were statistically significant decreases in the annual rates of in-hospital adverse events for admissions for acute myocardial infarction (annual adjusted relative risk [RR], 0.94), heart failure (RR, 0.95), pneumonia (RR, 0.94), major surgical procedures (RR, 0.93), and all other conditions (RR, 0.97).” 
Despite these improvements, as the accompanying editorial (Improvements in Hospital Adverse Event Rates) notes: “the report by Eldridge and colleagues on a decade of hospital trends is an unfortunate reminder that adverse events remain unacceptably frequent.”

About pharma

FDA rule would facilitate prescription-to-OTC switches but nix a third class of drugs “After a decade-long wait, the Food and Drug Administration finally issued a proposed rule in late June that would make it easier for pharmaceutical companies to switch products from prescription-only to over-the-counter status while still retaining a prescription version.
Under the rule, patients would enjoy access to medications that previously required an office visit and a prescription, while payers would reap the financial benefits of fewer medical and prescription claims. Whether the change would be a challenge or an opportunity for pharmacies depends entirely on how the rule is implemented. [Comment: And relative charges.]
Under the proposed rule, an OTC drug could have the same active ingredient, dosage form, strength, route of administration, and indication as its prescription-only counterpart.
What the rule does not do is create a third class of drugs that would not require a prescription yet, instead of being available over the counter, would be ‘behind-the-counter’ and could be purchased only after consulting with a pharmacist. The possibility of this third class has been in play since 2012.”

 Effect of Pharmacogenomic Testing for Drug-Gene Interactions on Medication Selection and Remission of Symptoms in Major Depressive Disorder [MMD] “In this randomized clinical trial that included 1944 patients with MDD, provision of pharmacogenomic tests for drug interactions compared with usual care resulted in prescriptions with no predicted drug-gene interactions in 45% vs 18%, respectively, a difference that was statistically significant. Remission of symptoms reached a maximum difference of 16.5% vs 11.2% at 12 weeks but was not significantly different at 24 weeks.”
Is genome sequencing valuable for preventing drug-drug interactions or improving targeted treatments? The answer varies with different drugs and illnesses. 
See the accompanying editorial: Pharmacogenomic Testing for Next-Step Antidepressant Selection

About the public’s health

 Spirituality in Serious Illness and Health Question  How can considerations of spirituality guide health care and health outcomes?…
The serious illness Delphi expert panel review identified 8 findings, as enumerated: (1) spirituality is important to most patients with serious illness (eg, literature estimates ranged from 71%-99%); (2) spiritual needs are common in that setting (eg, estimates ranged from 23%-98%); (3) spiritual care is frequently desired by patients with serious illness (eg, estimates ranged from 50%-96%); and (4) spirituality can influence medical decision-making in serious illness. Despite these findings, (5) spiritual needs of patients with serious illness are frequently unaddressed within medical care, especially since (6) spiritual care is infrequent in the care of such patients (eg, estimates of patients not receiving spiritual care ranged from 49%-91%). Findings noted that (7) the provision of spiritual care in the medical care of patients with serious illness was associated with better end-of-life outcomes, while (8) unaddressed spiritual needs can be associated with poorer patient quality of life.”
Look at the definitions and Tables 4 and 5.

Apgar scores are less predictive of infant mortality for Black babies than white ones, study finds ”The study, published Tuesday in PLOS Medicine, found that more Black infants were assigned low Apgar scores than white infants and that the scores were better at predicting death in the first year of life in white infants compared with Black babies.”

Today's News and Commentary

About Covid-19

 About 300,000 children under 5 have received at least one Covid-19 shot, White House says The headline should probably start with the word “Only.”

COVID-19 hospitalizations hit highest national average since March “COVID-19 hospitalizations have steadily increased to reach the highest national average since early March, with more than 33,000 people in U.S. hospitals with coronavirus on a given day.
Hospitalizations are up 18 percent nationwide over the past 14 days, with a daily average of 37,472 people hospitalized with COVID-19 as of July 11, according to HHS data…”

Covid-19 reinfections may increase the likelihood of new health problems “Repeatedly catching Covid-19 appears to increase the chances that a person will face new and sometimes lasting health problems after their infection, according to the first study on the health risks of reinfection.
The study, which is based on the health records of more than 5.6 million people treated in the VA Health System, found that, compared with those with just one Covid-19 infection, those with two or more documented infections had more than twice the risk of dying and three times the risk of being hospitalized within six months of their last infection. They also had higher risks for lung and heart problems, fatigue, digestive and kidney disorders, diabetes and neurologic problems.”

Repeat Dosing of Evusheld Recommended for Ongoing COVID-19 Protection “The Food and Drug Administration (FDA) has revised the fact sheet for Evusheld™(tixagevimab co-packaged with cilgavimab) to include a recommendation for repeat dosing every 6 months for the preexposure prophylaxis of COVID-19.
Evusheld is a combination of 2 long-acting monoclonal antibodies designed to bind to distinct sites on the SARS-CoV-2 spike protein. The product is authorized for emergency use for individuals who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2, and:

  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination; or

  • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID19 vaccine component(s).”

About health insurance

 2023 employer health and benefit strategies focused on affordability and access, Mercer survey “The survey found that 70% of all large employers are planning benefit enhancements for 2023.
While small employers are somewhat less likely to be planning enhancements, still, more than half (53%) say that they are…
When asked whether benefits enhancements would be targeted to specific employee groups, about a fifth of large employers say they are focusing on their hourly and low- wage workers…
While hourly workers are the group most likely to be singled out for special attention across all industries, highly skilled workers are the priority for large health care employers (24%).”
This short report is well worth at least a quick look.

Association Between Self-reported Health-Related Social Needs and Acute Care Utilization Among Older Adults Enrolled in Medicare Advantage “To what extent are self-reported health-related social needs (HRSNs) associated with acute care utilization among older adults enrolled in Medicare Advantage, and are there specific HRSNs that seem to matter more?
Findings  In this cross-sectional study of 56 155 older adults enrolled in Medicare Advantage, HRSNs were associated with statistically significantly higher rates of acute care utilization, with the largest association observed for avoidable hospital stays (53.3% increase). Unreliable transportation had the largest association with hospital stays and emergency department visits (marginal effects of 51.2 and 95.5 events per 1000 beneficiaries, respectively).”

UnitedHealth accused of underpaying for telehealth “The lawsuit, filed in federal court in Connecticut on Thursday by a Chicago woman using the pseudonym CP, seeks to represent a class of "at least hundreds and likely thousands" of beneficiaries of UnitedHealth insurance plans covered by the federal Employee Retirement Income Security Act (ERISA).”
The claim is that United paid at a rate based on an old Medicare rate instead of the updated telehealth rate based on parity with in-person visits.

Surprise Medical Bills Have Been Banned Since January. 1 in 5 Americans Say They or Their Family Have Gotten an Unexpected Charge Anyway

  • “20% of adults said they or their family have received an unexpected medical bill this year, and 22% of them were charged over $1,000.

  • 45% of adults said they are confident they would know their emergency room bill up front.

  • 63% of adults said they’re confident they would be able to address a surprise bill that they believed to be illegal with a provider or insurer.”

CMS proposes slight doc pay cut in 2023 and several reforms to ACOs, dental service coverage “CMS proposed a 2023 fee schedule conversion factor of $33.08 for each relative unit, which determines how Medicare payments to doctors are calculated. That factor is a slight decline of the 2022 factor of $34.61. 
The factor considers a statutory requirement that the conversion factor for 2023 remains flat and the expiration of a 3% bump in fee schedule payments that went away in 2022. The slight bump was installed to help physicians weather the revenue impact from the COVID-19 pandemic. 
The fee schedule must also be budget neutral under federal law.
In addition to the payment changes, CMS is proposing to expand the dental services that would get coverage from Medicare. Currently, Medicare only pays for certain treatments such as reconstruction of a jaw after an injury or tooth extraction following cancer care. 
Now, CMS proposed to also pay for a dental exam and treatment preceding an organ transplant as well as several other services. The agency also wants comments on what else Medicare should reimburse for dental services…
CMS also proposed several major changes to the Medicare Shared Savings Program (MSSP) that oversees ACOs. Chief among them is a proposal to install a health equity adjustment of up to 10 bonus points to the ACO’s Merit-based Incentive Payment System (MIPS) quality performance score. The equity adjustment would only positively impact an ACO but not penalize them, CMS said in a release…
CMS is proposing that an organization new to MSSP which is not renewing or reentering as an ACO and qualifies as low revenue can get a one-time payment of $250,000 and quarterly payments for the first two years of a five-year period.”

About pharma

Amid drug pricing debate, feds reveal plan to crack down on 'incremental' patents “Watch out, pharma—the federal government has its eye on add-on drug patents that can lead to higher prices. In a new effort, the FDA and the U.S. Patent and Trademark Office (PTO) are teaming up to take a close look at patenting procedures… [T]he PTO said it plans to crack down on patenting of “incremental, obvious changes to existing drugs that do not qualify" for new protections.”

Certain discarded drugs will soon cost pharma companies “According to an infrastructure bill passed last year, drug manufacturers must refund Medicare for unused drugs in single-dose vials beginning in 2023. Medicare also included the update in its latest proposed rule…
Back in 2020, Medicare paid nearly $720 million for discarded drugs paid under Part B, the agency said in its proposal. That’s on par with prior years dating back to 2017, when Medicare shelled out between $700 million and $750 million per year for discarded drugs.
A large portion of those unused drugs were ones dosed based on a patient’s body weight or surface area. When a patient’s dose is drawn from more than one vial, any remaining drug must be discarded.
The mandate applies only to single-dose vials or single-use packaged drugs — not to radiopharmaceutical or imaging agents, certain drugs that require filtration, or ‘certain new drugs,’ according to Medicare. And the amount of discarded drugs must be higher than 10% to get a refund.”

 Newsom announces California will produce its own ‘low cost’ insulin “Newsom said that the state budget he recently signed includes $100 million for California to ‘contract and make [its] own insulin at a cheaper price, close to at cost, and to make it available to all.’
He said $50 million of that budget will go to the development of the low cost insulin, while the additional $50 million will go toward a California-based manufacturing facility for the drug, which Newsom claims ‘will provide new, high-paying jobs and a stronger supply chain.’
Newsom also noted in his announcement that he had signed an executive order his first day in office to put California on the path to creating its own prescription drugs, touting that ‘now it’s happening.’” 

About the public’s health

Childhood Obesity Rate in the U.S. Higher Now Than 12 Years Prior “The researchers noted a 4.5 percent relative increase in the cumulative incidence of new obesity cases by the end of fifth grade across cohorts among children who did not have obesity at kindergarten entry (15.5 versus 16.2 percent), although no substantial change was seen in annual incidence. For children who had a normal body mass index at kindergarten entry, the risk for incident obesity stayed the same, while the risk for incident obesity increased slightly among overweight kindergarteners. There was an expansion of social disparities in obesity incidence: A 29 percent increase was seen in the incidence of new cases during primary school among non-Hispanic Black children, while the risk stayed stable or decreased for other race-ethnic groups. A 15 percent higher cumulative incidence was seen across primary schools in 2010 versus 1998 for children from the most socioeconomically disadvantaged households.”

Monkeypox cases rise 77% in UN agency's latest weekly count

  • The World Health Organization (WHO) on Thursday reported a 77% weekly increase in the number of lab-confirmed monkeypox cases, to more than 6000 worldwide, as well as two more deaths in parts of Africa…

  • Most of the cases were reported in Europe and Africa. The agency said the outbreak continues to mainly affect men who have had sex with men, and that other population groups showed no signs of sustained transmission.

  • The WHO said it counted 6027 laboratory-confirmed cases of monkeypox from 59 countries as of Monday, an increase of 2614 cases since its last count for the week that ended June 27. It added that three people have now died in connection with the outbreak, all in Africa.

  • It noted that nine additional nations had reported cases, while 10 countries had not reported any new cases for more than three weeks, which is the maximum incubation period.

  • WHO Director-General Tedros Adhanom Ghebreyesus said he remained ‘concerned by the scale and spread of the virus,’ noting that more than 80% of the cases turned up in Europe. He said he plans to convene the next meeting of a WHO expert panel that is monitoring the outbreak for no later than the week of July 18.”

Biden signs order on abortion access after Supreme Court ruling “Biden formalized instructions to the Departments of Justice and Health and Human Services to push back on efforts to limit the ability of women to access federally approved abortion medication or to travel across state lines to access clinical abortion services.”

About healthcare IT

 Teladoc adds medication delivery, in-home phlebotomy to primary care service Primary360 “Primary360 will now provide care coordination support and health plan in-network referrals alongside free same-day medication delivery from Capsule and in-home, on-demand phlebotomy services backed by Scarlet Health, according to an announcement Wednesday from Teladoc.”

Today's News and Commentary

About Covid-19

FDA allows licensed pharmacists to prescribe Pfizer's Paxlovid under certain conditions “The US Food and Drug Administration revised the emergency use authorization for Pfizer's Covid-19 antiviral treatment, Paxlovid, on Wednesday to allow state-licensed pharmacists to prescribe the treatment to people who are eligible.” So far, so good. However: “Those who want to get Paxlovid from a pharmacist need to have with them electronic or printed health records that are less than 12 months old and that include blood work to review for kidney or liver problems, as well as a list of all medications being taken, both over-the-counter and prescription, to screen for drug interactions. The health records could also be obtained through a consult between the pharmacist and a person's health care provider.”

About health insurance

 Health Care Fraud and Abuse Control [HCFAC] Program Annual Report for Fiscal Year 2021 “During the fiscal year, the Federal Government won or negotiated more than $5.0 billion in judgments and settlements and attained additional administrative impositions in health care fraud casesandproceedings.9 Becauseoftheseefforts,aswellasthoseofprecedingyears,almost $1.9 billion was returned to the Federal Government or private persons. Of this $1.9 billion, the Medicare Trust Funds received transfers of approximately $1.2 billion during this period; approximately $98.7 million in federal Medicaid money was transferred to the Centers for Medicare & Medicaid Services separately due to these efforts.
In addition to these enforcement actions, numerous audits, evaluations, and other coordinated efforts yielded recoveries of overpaid funds and prompted changes in federal health care programs that reduce vulnerability to fraud.
The return on investment (ROI) for the HCFAC program over the last three years (2019–2021) is $4.00 returned for every $1.00 expended. Because the annual ROI can vary from year to year depending on the number and type of cases that are settled or adjudicated during that year, DOJ and HHS use a three-year rolling average ROI for results contained in the report.”

Effect of Social Needs Case Management on Hospital Use Among Adult Medicaid Beneficiaries “Enrollees were offered 12 months of social needs case management, which provided more intensive services to patients with higher demonstrated needs…
Participants in the intervention group visited the ED at ratios of 0.96 (95% CI, 0.91 to 1.00) for all visits and 0.97 (CI, 0.92 to 1.03) for avoidable visits relative to the control group. The intervention group was hospitalized at ratios of 0.89 (CI, 0.81 to 0.98) for all admissions and 0.72 (CI, 0.55 to 0.88) for avoidable admissions…
Although social needs case management programs may reduce health care use, these savings may not cover full program costs. More work is needed to identify ways to increase patient uptake and define characteristics of successful programs.”

About hospitals and healthcare systems

 Risk of Closure Among Independent and Multihospital-Affiliated Rural Hospitals “In this 13-year cohort study from 2007 to 2019 among rural US hospitals that faced financial distress in 2007, affiliation was associated with a lower risk of closure compared with being independent. Conversely, among hospitals with financial stability in 2007, affiliation was associated with a higher risk of closure compared with being independent.” 

About pharma

 Hospitals and for-profit PBMs are diverting billions in 340B savings from patients in need An excellent review of this program.

About the public’s health

 Disposable Hospital Gowns Could Expose Health Workers to Infection “Disposable gowns designed to deflect the splatter of bodily fluids, used in thousands of U.S. hospitals, have underperformed in recent and ongoing laboratory tests and may fall short of safety standards, leaving health care workers with a greater risk of infection than advertised.
A peer-reviewed academic study, published to little notice amid the coronavirus pandemic, found that isolation gowns commonly worn in medical units or intensive care units ripped too easily and allowed about four to 14 times the expected amount of liquid to seep through when sprayed or splashed.”

CMS Innovation Center Tackles Implicit Bias “The assessment focused on three established models: the Kidney Care Choices Model, Comprehensive Care for Joint Replacement Model, and Million Hearts® Cardiovascular Risk Reduction Model
The assessment examined three models to identify potential sources of bias and found that use of certain risk-assessment and screening tools, provider tools, and payment design and risk-adjustment algorithms has led to the exclusion of some beneficiaries from these models. These findings are troubling not only because of the limited access to the benefits of Innovation Center models but also because diverse model participation is critical for robust evaluation and confidence in generalizing results to all of the populations served through CMS programs.
As described above, the Innovation Center has taken initial actions to address these sources of bias for ongoing models; however, the findings underscore the need for a more systematic evaluation of implicit bias in current and new models.

About healthcare IT

 Major payment vendor data breach, North Korean threat raise ransomware concerns for hospitals “A recently disclosed ransomware attack at a payment vendor [Northern Colorado-based debt collections firm Professional Finance Company] could have exposed patient data from more than 650 healthcare providers, including those at Arizona-based nonprofit Banner Health and Nevada physician network Renown Health.
While the exact number of patients affected is unclear, it could be one of the biggest healthcare data breaches this year given the extensive network of providers involved.
In addition, the federal government issued an advisory Wednesday warning healthcare and public health organizations that North Korea government-sponsored hackers have been targeting the industry using a particular form of ransomware for the past year.”

Association of Remote Technology Use and Other Decentralization Tools With Patient Likelihood to Enroll in Cancer Clinical Trials “In this cross-sectional survey study of 1183 patients with cancer and survivors of cancer, self-reported patient disposition toward enrollment in cancer clinical trials increased for modifications using remote technology and other decentralization tools. The majority of respondents (60%-85%) reported being more likely to enroll if the participation-related time and travel burden decreased as a result of these practices.”

About healthcare personnel

 Job Cuts Surge in June 2022, Up 57% From May, 59% From June 2021; Highest Quarterly Total Since Q1 2021  “Health Care/Products manufacturers and providers announced the most job cuts this year with 19,390, up 54% from the 12,620 announced through June 2021.” 

About health technology

Former Theranos executive Sunny Balwani convicted on 12 fraud counts “Former Theranos executive Ramesh “Sunny” Balwani, who long served as the second-in-command to founder Elizabeth Holmes, was convicted of all 12 counts in federal court in San Jose for defrauding investors and patients connected to the biotech company, according to the Associated Press.”

Groundbreaking Alzheimer's Treatment Study Fascinating science! Read the entire article.

How A Shortage of Plastic Is Impacting Health Care “It’s been a years-long challenge. Prior to the pandemic, prices for raw material plastics were relatively stable... Then Covid led to an increase in demand for manufactured goods. And intense storms in 2021 damaged some of the American oil refineries that are at the beginning of the plastic supply chain, decreasing production and increasing prices…
 Baxter International Inc. makes machines that hospitals and pharmacies use to mix different sterile liquids together. But one plastic component of the machines was in short supply, the company said in an April letter to health care providers…
[Also] the resin shortage was affecting multiple product lines at the end of June, including blood collection, laboratory and respiratory products.”

Today's News and Commentary

About Covid-19

 Nanoparticle Vaccine Protects Against a Spectrum of COVID-19-causing variants and Related Viruses “Betacoronaviruses, including those that caused the SARS, MERS, and COVID-19 pandemics, are a subset of coronaviruses that infect humans and animals. The vaccine works by presenting the immune system with pieces of the spike proteins from SARS-CoV-2 and seven other SARS-like betacoronaviruses, attached to a protein nanoparticle structure, to induce the production of a broad spectrum of cross-reactive antibodies. Notably, when vaccinated with this so-called mosaic nanoparticle, animal models were protected from an additional coronavirus, SARS-CoV, that was not one of the eight represented on the nanoparticle vaccine.”

COVID-19 Vaccination Activates Antibodies Targeting Parts of Virus Spike Protein Shared Between Coronaviruses “Could the SARS-CoV-2 vaccine reawaken previous antibody responses and point the way to a universal coronavirus vaccine? A new analysis of the antibody response to a COVID-19 vaccine suggests the immune system’s history with other coronaviruses, including those behind the common cold, shapes the patient’s response, according to a study published today in Cell Reports
Led by scientists at the Translational Genomics Research Institute (TGen), part of City of Hope, and Northern Arizona University (NAU), a research team found that the vaccine generates antibodies that target regions of the SARS-CoV-2 spike protein that are unique to the new virus, while also targeting regions of the protein that are shared or conserved among many coronaviruses. 
What’s more, the antibody response to these different coronaviruses appears to follow different paths. Over the course of 140 days following vaccination, the response to common cold coronaviruses started early but diminished over time. The response to SARS-CoV-2 continued to get stronger and stronger over time.”

About health insurance

Claims Denials and Appeals in ACA Marketplace Plans in 2020 “We find that, across HealthCare.gov insurers with complete data, about 18% of in-network claims were denied in 2020. Insurer denial rates varied widely around this average, ranging from less than 1% to more than 80%.
CMS requires insurers to report the reasons for claims denials at the plan level. Of denials with a reason other than being out-of-network, about 16% were denied because the claim was for an excluded service, 10% due to lack of preauthorization or referral, and only about 2% based on medical necessity. Among 2% of claims identified as medical necessity denials, 1 in 5 were for behavioral health services. Most plan-reported denials (72%) were classified as ‘all other reasons’, without a specific reason.
As in our previous analysis of claims denials, we find that consumers rarely appeal denied claims and when they do, insurers usually uphold their original decision. In 2020, HealthCare.gov consumers appealed just over one-tenth of 1% of denied in-network claims, and insurers upheld most (63%) of denials on appeal.”


Children's Uninsurance Fell between 2019 and 2021, but Progress Could Stall When Pandemic Protections Expire From The Urban Institute: “We find the following:

  • Children’s uninsurance rates were relatively stable between early 2019 and early 2021, according to both the NHIS and the CPS [National Health Interview Survey and the Current Population Survey]. Recent NHIS data suggest a decline in uninsurance among children between early and late 2021; no data are yet available for this period from the CPS.

  • Overall, the NHIS indicates a decline in the annual uninsurance rate among children from 5.1 percent in 2019 to 4.1 percent in 2021, which translates to about 700,000 fewer uninsured children.

  • Both survey and administrative data sources suggest public coverage increased among children between early 2019 and early 2021.

    • The NHIS indicates a significant 4.9 percentage-point increase in public coverage and a roughly corresponding decline in private coverage over the period.

    • Changes in coverage on the CPS are much smaller in magnitude and not statistically significant but suggest offsetting public coverage gains and private coverage losses between March 2019 and March 2021.

    • Administrative data show that approximately 4 million more children were enrolled in Medicaid/CHIP in March 2021 than in March 2019.

  • Administrative data indicate further gains in Medicaid/CHIP and Marketplace enrollment among children between early 2021 and early 2022.”

Drivers of 2023 Health Insurance Premium Changes From the American Academy of Actuaries: “Key Points

  • Although COVID-19-related costs may be more predictable and
    the worst days of the pandemic appear to be over, there is still uncertainty regarding whether new variants will evade immunity and cause a resumption in more serious health problems.

  • The expiration of the ARPA enhanced premium subsidies will likely cause a decline in enrollment and a worsening of the risk pool, leading to higher premiums.

  • Medicaid redeterminations could cause an influx of people into the individual market, potentially improving the risk pool and lowering the premiums somewhat. Any effects would

    be less than those caused by the expiration of ARPA subsidies.

  • Inflation may have some effect on provider costs, but because provider payments lag inflation, real effects might not occur until later plan years. Nevertheless, workforce shortages could put upward pressure on provider payment rates.”

About hospitals and healthcare systems

 The Best Hospitals in America Yet another ranking. This one from Money magazine and the Leapfrog Group.

About pharma

 AstraZeneca to shell out $1.27B for biotech company TeneoTwo “Pharmaceutical company AstraZeneca has offered up to $1.265 billion to acquire TeneoTwo and the biotech company's lymphoma research currently in a phase 1 trial. 
In a July 5 press release, AstraZeneca said TeneoTwo's ‘promising" T-cell engager is designed to redirect the immune system to "recognize and kill cancer cells.’”

After its own vaccine flop, CureVac sues Pfizer partner BioNTech for patent infringement “A year after a high-profile flop with its COVID-19 vaccine candidate, CureVac is still trying to get a piece of the action.
On Monday, the company revealed that it is suing fellow German mRNA pioneer BioNTech for infringement of its intellectual property by developing the Pfizer-partnered COVID shot Comirnaty.
CureVac said it has no intention of disrupting the production, sale or distribution of BioNTech's megablockbuster vaccine with an injunction. Instead, the Tubingen-based company wants recognition and compensation for the technology it developed—beginning with work more than two decades ago—which it says was essential in BioNTech’s creation of its successful shot.”

About the public’s health

Labcorp launches monkeypox PCR tests through CDC initiative “…Labcorp announced Wednesday that it will begin testing for the viral disease using the CDC’s orthopoxvirus test, which Labcorp helped validate for the agency. The PCR test is designed to detect all non-smallpox-related orthopoxviruses, a group that includes cowpox, horsepox and camelpox, along with monkeypox.”

FDA temporarily suspends order banning Juul cigarettes “The Food and Drug Administration issued an administrative stay Tuesday on the order it issued last month for vaping company Juul to pull its electronic cigarettes from the market.
The agency said on Twitter that the stay temporarily suspends the marketing denial order while it conducts further review, but does not rescind it.”

Trends and Disparities in Cardiometabolic Health Among U.S. Adults, 1999-2018 Between 1999 and 2000 and 2017 and 2018, U.S. cardiometabolic health has been poor and worsening, with only 6.8% of adults having optimal cardiometabolic health, and disparities by age, sex, education, and race/ethnicity. These novel findings inform the need for nationwide clinical and public health interventions to improve cardiometabolic health and health equity.”

About healthcare IT

  Watson Health, under new investment firm ownership, is reborn as Merative “Investment firm Francisco Partners celebrated the close of its IBM Watson Health assets acquisition by announcing the launch of a new standalone data analytics company.
Called Merative, the Ann Arbor, Michigan-based business aims to offer its health data services to clients ranging from providers, health plans and employers to life sciences firms, imaging companies and government entities, according to the announcement.” 

 Machine Learning–Based Models Incorporating Social Determinants of Health vs Traditional Models for Predicting In-Hospital Mortality in Patients With Heart Failure “In this cohort study, ML models developed in the Get With The Guidelines–Heart Failure (GWTG-HF) registry using race-specific and race-agnostic approaches were associated with an improvement in the prediction of in-hospital mortality after hospitalization for HF compared with the existing and rederived logistic regression models. The addition of SDOH was associated with an improvement in the performance and prognostic utility of the ML models in Black patients but not in non-Black patients.”

About healthcare personnel

 HHS awards more than $155M for primary care training expansion “The HHS announced more than $155 million in awards for primary care and dental residency programs through the Health Resources and Services Administration, or HRSA.”

Today's News and Commentary

About Covid-19

 NYC to skirt pharmacies, hand out Paxlovid prescriptions at mobile test-to-treat sites The headline is the story.

About health insurance

Use and Cost of Low-Value Health Services Delivered or Paid for by the Veterans Health Administration “In this cross-sectional study of 5.2 million enrolled veterans, 19.6 low-value services per 100 veterans were delivered by VA facilities or VACC programs in fiscal year 2018, involving 13.6% of veterans at a cost of $205.8 million.” 

Return on Investment for Offering Employer- Sponsored Insurance[ESI] “According to Avalere’s analysis, ESI will provide an estimated 47% ROI to employers with 100 or more employees in 2022 and a 52% return in 2026. Key drivers of ROI include $275.6B from improved productivity in 2022 and $346.6B in 2026, $101B from a reduction in direct medical costs in 2022 and $108B in 2026, and $119.2B from tax benefits in 2022 and $139.7B in 2026.”

About hospitals and healthcare systems

 CMS proposal details how to become new rural hospital designation “The Biden administration released a proposed rule that grants more regulatory flexibility for small, rural hospitals in a bid to curb a worrying trend of facility closures. 
The Centers for Medicare and Medicaid Services’ proposed rule released Thursday outlines the conditions of participation for a facility to become a Rural Emergency Hospital, which enables a facility to offer emergency care, observation and other outpatient services.”

Local Supply Of Postdischarge Care Options Tied To Hospital Readmission Rates “The extent to which patients’ risk for readmission after a hospitalization is influenced by local availability of postdischarge care options is not currently known…Overall, readmission rates were negatively associated with per capita supply of primary care physicians (−0.16 percentage points per standard deviation) and licensed nursing home beds (−0.09 percentage points per standard deviation). In contrast, readmission rates were positively associated with per capita supply of nurse practitioners (0.09 percentage points per standard deviation). Our results suggest potential modifications to the Hospital Readmissions Reduction Program to account for local health system characteristics when assigning penalties to hospitals.”

About pharma

US Judge Finds for 3 Drug Distributors in WVa Opioid Lawsuit "‘The opioid crisis has taken a considerable toll on the citizens of Cabell County and the City of Huntington. And while there is a natural tendency to assign blame in such cases, they must be decided not based on sympathy, but on the facts and the law,’ U.S. District Judge David Faber wrote in the 184-page ruling. ‘In view of the court’s findings and conclusions, the court finds that judgment should be entered in defendants’ [AmerisourceBergen Drug Co., Cardinal Health Inc. and McKesson Corp.] favor.’”

Pharma industry spent a record $389M on US lobbying in 2021, but more is likely coming this year — report “The health sector was the biggest industry spender amongst all lobbyists, according to OpenSecrets, spending a combined $830 million between both the federal level and the states. And the pharma industry takes the trophy within the health sector over hospitals, nursing homes and health professionals after spending more than $350 million on just the federal level.”

About the public’s health

 Texas Supreme Court blocks order that allowed abortions to resume “The Texas Supreme Court in Austin granted an ‘emergency motion for temporary relief’ requested by the state’s attorney general, Republican Ken Paxton, on Wednesday that prevents a lower court order from taking effect.”

Will There Be Enough Monkeypox Vaccine? “A factory making Jynneos, the safest vaccine, has been closed since August, threatening global supplies as the virus spreads…
Jynneos, the only vaccine developed for monkeypox, is made by a small Danish company, Bavarian Nordic. The company is expected to send about two million doses to the United States by the end of the year, but can produce less than five million more for the rest of the world.”

About healthcare IT

 Google says it will delete location history for visits to abortion clinics, medical sites “Google said late Friday that it would work to quickly delete location history for people going to abortion sites and other medical sites following the Supreme Court’s overturning of Roe v. Wade last week.” 
Lest you think this risk of disclosure is hypothetical, read: Texts, web searches about abortion have been used to prosecute women

Today's News and Commentary

About Covid-19

 U.S. Supreme Court nixes religious challenge to New York vaccine mandate “The U.S. Supreme Court on Thursday declined to hear a challenge to New York's mandate that healthcare sector workers be vaccinated against COVID-19 brought by a group of doctors, nurses and others who objected on religious grounds.” 

About health insurance

 Aetna to roll back controversial prior authorization policy for cataract surgery “Under the program, Aetna required prior authorization for all cataract surgeries beginning on July 1, 2021. The policy was later modified amid outcry from ophthalmologists and other eye care experts, who urged the insurer to fully remove the requirements.
In a statement to Fierce, Aetna said that the program will be discontinued as of July 1, and that it chose to do so after gathering real-time data on cataract surgeries.”
Another instance of spending more than the resultant savings would realize.

Some medical debt is being removed from US credit reports “Starting Friday, the three major U.S. credit reporting companies will stop counting paid medical debt on the reports that banks, potential landlords and others use to judge creditworthiness. The companies also will start giving people a year to resolve delinquent medical debt that has been sent to collections before reporting it — up from six months previously.
Next year, the companies also will stop counting unpaid medical debt under at least $500.
The companies say these moves will wipe out nearly 70% of the medical debt listed on consumer credit reports.”

California first to cover health care for all immigrants “California on Thursday became the first state to guarantee free health care for all low-income immigrants living in the country illegally, a move that will provide coverage for an additional 764,000 people at an eventual cost of about $2.7 billion a year.”

Payers must post negotiated prices starting today: 8 things to know “CMS' Transparency in Coverage final rule took effect July 1, requiring payers nationwide to publish the cost of nearly every healthcare service they've negotiated with providers.”
Worth a read,

About hospitals and healthcare systems

 Fortune/Merative [Formerly IBMWatson Health]100 Top Hospitals 2022: Health Systems The top 15 health systems had better survival rates, fewer patient complications, fewer healthcare-associated infections, better long-term outcomes, better 30-day mortality/revisitation rates and more. 

About pharma

 Novartis to eliminate up to 8000 jobs under cost-cutting plan “Novartis disclosed Tuesday that it expects to cut as many as 8000 jobs, or roughly 7% of its global workforce, including some 1400 positions in its home base of Switzerland, as it looks to knock off at least $1 billion in expenses by 2024. The company had confirmed in April that there would be layoffs as part of a broader effort to merge its pharmaceuticals and oncology businesses into a single innovative medicines unit with separate US and international commercial organisations, and to boost sales by at least 4% through 2026.”

Novartis buys FDA priority review voucher from bankrupt Mallinckrodt for $100M FYI: The latest market value for such vouchers.

About the public’s health

Kentucky Court Blocks Abortion Bans “A Kentucky state court today granted a request from the American Civil Liberties Union (ACLU), ACLU of Kentucky, and Planned Parenthood Great Northwest, Hawai‘i, Alaska, Indiana, Kentucky for a restraining order (RO). The RO blocks two laws passed in 2019 that stopped abortion services in the state last Friday: a complete abortion ban that the Kentucky Attorney General threatened to enforce following the U.S. Supreme Court’s overruling of Roe v. Wade, and a six-week ban that has been blocked by a federal court.”

This Planned Parenthood Is Now Demanding Proof of Residency for Some Abortions Planned Parenthood of Montana will no longer provide medication abortions for patients from South Dakota, Arkansas, Missouri, and Oklahoma, and will now require proof of residency for the treatment, according to an internal email obtained by The Daily Beast.
In a Thursday morning email to the state’s staff, Montana Planned Parenthood President and CEO Martha Fuller attributed the new rules for non-surgical abortions to the ‘rapidly changing’ legal landscape around the right to choose.”

HHS, AMA dismayed by Supreme Court's controversial EPA power plant ruling “The Department of Health and Human Services (HHS) and the American Medical Association (AMA) chided the 6-3 ruling on Wednesday that restricts the Environmental Protection Agency’s (EPA's) ability to regulate carbon emissions via the Clean Air Act…
Many justices agreed with coal companies and several red states that Congress didn’t give EPA the authority to devise the emission caps outlined in the Obama-era rule, which has never gone into effect.”
Another assault on the public’s health.

74 nonprofit payers launch SDOH center aimed at reducing health disparities “The Association for Community Affiliated Plans has launched a new center aimed at offering resources to payers and policymakers that will support initiatives around social determinants of health and reductions in health disparities.
The ACAP Center for Social Determinants of Health Innovation will provide policy reports, market research and roundtable educational events that will help key stakeholders address social determinants that impact an individual's health…
The new center will draw on the knowledge and resources of the association's 74 nonprofit members that collectively serve 22 million beneficiaries nationwide. Lexington, Mass.-based consulting firm Spring Street Exchange will administer the center.”

White patients’ physical responses to healthcare treatments are influenced by provider race and gender “…we found that White patients were less physiologically responsive to the expectations set by Black as compared to Asian providers. For a variety of reasons, a Black provider may be less consistent with the image of a doctor than an Asian provider. What we did not anticipate, however, is that White patients would respond to the expectations set by the Asian providers in the same manner as the expectations set by the White providers. White patients responded to White and Asian providers similarly…”

About healthcare finance

 Blueprint rounds up $1.25B to grow cancer portfolio through internal R&D and dealmaking “The Massachusetts biotech is selling certain royalties to its targeted cancer drugs Ayvakit and Roche-partnered Gavreto and securing additional money for future business development in separate deals with Sixth Street and Royalty Pharma. The two agreements give Blueprint $575 million immediately in cash, and the total financing could reach $1.25 billion.
The transactions allow Blueprint to benefit now from its marketed meds and pipeline prospects, particularly when it comes to Ayvakit’s potential expansion into non-advanced systemic mastocytosis…”