Today's News and Commentary

About Covid-19

 Labcorp COVID-19 Test That Can Identify Viral Strains Gets EUA “The FDA has granted Emergency Use Authorization (EUA) to Laboratory Corporation of America’s Labcorp VirSeq SARS-CoV-2 next-generation sequencing test, which can differentiate between different strains of the virus that causes COVID-19.
The test analyzes positive samples identified using the company’s COVID-19 real-time polymerase chain reaction test, or its SARS-CoV-2 & Influenza A/B assay.”

About health insurance

 Anthem launches Carelon, Wellpoint ahead of Elevance Health rebrand “Anthem will officially become Elevance Health on June 28, and, as part of its corporate rebrand, it's also launching new brands for two of its subsidiaries.
The insurer will consolidate its healthcare services businesses under one umbrella, called Carelon. Carelon is a combination of the word "care" with the suffix "lon," which means full or complete, representing the company's ambition to offer an end-to-end care experience.
Carelon will include Anthem's in-house pharmacy benefit manager Ingenio Rx as well as recent acquisitions such as Beacon Health Options, a behavioral health provider, and myNEXUS, a home healthcare company. Carelon will serve 1 in 3 people in the U.S., according to the announcement.”

Inaccuracies in Medicare’s Race and Ethnicity Data Hinder the Ability To Assess Health Disparities Form the HHS OIG: “Medicare’s enrollment race and ethnicity data are less accurate for some groups, particularly for beneficiaries identified as American Indian/Alaska Native, Asian/Pacific Islander, or Hispanic. Data that are not accurate limit the ability to assess health disparities. Limited race and ethnicity categories and missing information contribute to inaccuracies in the enrollment data. Although the use of an algorithm improves the existing data to some extent, it falls short of self-reported data. Finally, Medicare’s enrollment data on race and ethnicity are inconsistent with Federal data collection standards; these inconsistencies inhibit the work of identifying and improving health disparities within the Medicare population…
Accordingly, we recommend that CMS:
(1) develop its own source of race and ethnicity data, (2) use self-reported race and ethnicity information to improve data for current beneficiaries, (3) develop a process to ensure that the data are as standardized as possible, and (4) educate beneficiaries about CMS’s efforts to improve the race and ethnicity information. CMS did not explicitly concur with the first recommendation and concurred with the other three recommendations.”

About pharma

 Pharmacy retail giant Walgreens looks to disrupt the clinical trials business Interesting read about how Walgreens will accomplish this goal.

About the public’s health

Biden launches plan to protect transgender youths’ health care “President Joe Biden on Wednesday will order his health agency to begin efforts to ban conversion therapy and expand access to gender-affirming treatment after a slew of state attempts to limit transgender health care, particularly for children.
The president’s executive order will call on the Department of Health and Human Services to clarify that federally funded programs cannot offer conversion therapy, a widely discredited practice that attempts to change a person’s sexual orientation or gender identity, and work on a public information campaign about the practice. Biden is also directing HHS to take “steps to address the barriers and exclusionary policies” to different types of health care and treatment.”

About healthcare IT

 Facebook Is Receiving Sensitive Medical Information from Hospital Websites “The Markup tested the websites of Newsweek’s top 100 hospitals in America. On 33 of them we found the tracker, called the Meta Pixel, sending Facebook a packet of data whenever a person clicked a button to schedule a doctor’s appointment. The data is connected to an IP address—an identifier that’s like a computer’s mailing address and can generally be linked to a specific individual or household—creating an intimate receipt of the appointment request for Facebook…
 The Markup also found the Meta Pixel installed inside the password-protected patient portals of seven health systems.”
Read the entire article. Researchers solicited comments from hospitals found to have this tracker. Many said they would remove it. The “lamest” response was from Northwestern Memorial: “The use of this type of code was vetted and is referenced in NM.org’s Terms and Conditions.” —Christopher King, chief media relations executive. I have a MyChart account at this hospital and was not given the opportunity to “opt out.”

Today's News and Commentary

Universal healthcare as pandemic preparedness: The lives and costs that could have been saved during the COVID-19 pandemic “Universal healthcare could have alleviated the mortality caused by a confluence of negative COVID-related factors. Incorporating the demography of the uninsured with age-specific COVID-19 and nonpandemic mortality, we estimated that a single-payer universal healthcare system would have saved 212,000 lives in 2020 alone. We also calculated that US$105.6 billion of medical expenses associated with COVID-19 hospitalization could have been averted by a Medicare for All system.”

About Covid-19

FDA advisers recommend greenlighting coronavirus vaccines for young kids “Independent advisers to the Food and Drug Administration on Wednesday recommended the use of the Moderna and Pfizer-BioNTech coronavirus vaccines for babies and young children, a milestone in the nation’s efforts to combat a wily pathogen that continues to infect tens of thousands of people a day and upend the lives of countless families across the country.”

 FDA advisers vote in favor of authorizing Moderna Covid-19 vaccine for ages 6-17 “Vaccine advisers to the US Food and Drug Administration decided unanimously Tuesday in favor of expanding the emergency use authorization of Moderna's Covid-19 vaccine to include older children and teens, ages 6 to 17, saying it would offer more benefits than risks.”

Pfizer halts Paxlovid trial for standard-risk patients “Pfizer-BioNTech will stop adding patients to its Paxlovid phase 2/3 trial after failing to prove the antiviral treatment reduced the relative risk of contracting COVID-19. 
The drugmaker could not produce statistically significant data on whether the nation's most prescribed COVID-19 treatment was effective in reducing the risk of hospitalizations and deaths, according to a June 14 news release…
The company said in the release that it plans to continue testing Paxlovid's efficacy in high-risk populations.”

About hospitals and healthcare systems

US Supreme Court overturns $1.6B 340B payment cut “The case centered [on] whether CMS has the authority to make cuts to the program under its  Medicare Outpatient Prospective Payment System. Under the payment rule, HHS cut the reimbursement rate for covered drugs by 28.5 percent in 2018, but it later lowered the reimbursement rate cut to 22.5 percent. 
Under the 340B program, eligible hospitals can buy outpatient drugs at a discount. A hospital typically pays 20 percent to 50 percent below the average sales price for the drugs through the program.”

 Financial updates from 20 health systems FYI

About pharma

 Mental-Health Startup Cerebral Investigated by FTC  The “FTC said it was investigating whether Cerebral engaged in deceptive or unfair practices related to advertising or marketing of mental-health services. The letter also directed the company to preserve documents.” See previous posts for the back story that led to this action.

Did J&J and BMS conspire on blood thinner price hikes? Congressional leaders want DOJ, FTC to look into it: report “When Johnson & Johnson’s Xarelto entered the market in 2011 and Bristol Myers Squibb’s Eliquis did the same in 2013, list prices for the popular blood thinners were $218 and $250, respectively, for a monthly supply.  
But by January of this year, those prices had mushroomed to $516 for Xarelto and $529 for Eliquis. As a result, Medicare Part D has spent more than $46 billion on the drugs since 2015, according to a report (PDF) from Patients for Affordable Drugs.”

About the public’s health

 Air pollution cuts life expectancy by more than two years, study says Highlights:
—97% of world lives in areas where pollution exceeds safe levels
—South Asians lose 5 years of life due to smog
—No country met WHO's air-quality standard in 2021 
For a more detailed analysis of the problem, see: AIR QUALITY LIFE INDEX® | JUNE 2022 [Annual Update]

EPA warns toxic ‘forever chemicals’ more dangerous than once thought “The Environmental Protection Agency warned Wednesday that a group of human-made chemicals found in the drinking water, cosmetics and food packaging used by millions of Americans pose a greater danger to human health than regulators previously thought.
The new health advisories for a ubiquitous class of compounds known as polyfluoroalkyl and perfluoroalkyl substances, or PFAS, underscore the risk facing dozens of communities across the country. Linked to infertility, thyroid problems and several types of cancer, these “forever chemicals” can persist in the environment for years without breaking down.”

Trends in Health Care Use Among Black and White Persons in the US, 1963-2019 “This study’s findings indicate that racial inequities in care have persisted for 6 decades and widened in recent years, suggesting the persistence and even fortification of structural racism in health care access. Reform efforts should include training more Black health care professionals, investments in Black-serving health facilities, and implementing universal health coverage that eliminates cost barriers.”

Today's News and Commentary

About Covid-19

 Covid is making flu and other common viruses act in unfamiliar ways Common viruses appear more virulent than before Covid-19 and are occurring at times of the year they were not usually seen.

About health insurance

 Orlando Health alleges healthcare sharing ministry told patients to hide membership for cheaper care “Florida-based nonprofit health system Orlando Health has sued faith-based healthcare-sharing ministry Liberty HealthShare, alleging that the organization instructed patients to hide their memberships in order to secure reduced rates for their care.”
This article is a great case study of a typical “ healthcare-sharing ministry.”

Spotlight on Medicare Advantage: An eHealth Survey June 2022 Some highlights:
—88% of enrollees express satisfaction with their Medicare Advantage plan, and 86% would recommend Medicare Advantage to family or friends; only 6% express dissatisfaction with their plan.
—Two thirds (67%) of those who chose Medicare Advantage over Medigap did so because Medigap was too expensive. If forced to look for similar coverage elsewhere, 73% of Medicare Advantage enrollees say they could afford monthly premiums of no more than $50.”
The latter finding might explain the first one.

Humana launches rebranded pharmacy businesses “Humana's pharmacy and specialty pharmacy businesses are now under its CenterWell brand. 
Humana Pharmacy and Humana Speciality Pharmacy will now be known as CenterWell Pharmacy and CenterWell Specialty Pharmacy, according to a June 13 Humana news release. 
The insurer's pharmacy benefit manager, Humana Pharmacy Solution, is keeping its name, according to the news release. Enclara Pharmacia, which provides pharmacy management services for the hospice industry, is also keeping its name.”

About hospitals and healthcare systems

 Best Children's Hospitals 2022-2023 Honor Roll and Overview FYI- from US News.

About pharma

 The top 10 most profitable pharma companies in 2021 Ranked by earnings not sales. “With $24 billion in net income, Novartis was unexpectedly the most profitable pharma company in 2021, beating Pfizer and J&J, which recorded $22 billion and $21 billion, respectively. While Novartis did improve its profit margins as a percentage of sales, it was one special item that helped nearly triple the Swiss pharma’s net profit.”

Basaglar 'Copycat' Insulin for Diabetes Has Advantages Over Lantus “The follow-on or copycat insulin glargine product Basaglar (Lilly) is similar to brand-name Lantus (Sanofi) in terms of efficacy and safety for the treatment of type 2 diabetes, but Basaglar cost less and had better adherence, new real-world data show.”
The article did not give the price of new medication.

Lilly, Incyte win FDA okay for first systemic alopecia areata treatment in US “The FDA announced Monday that it cleared Eli Lilly and Incyte's oral JAK1/JAK2 inhibitor Olumiant (baricitinib) for adults with severe alopecia areata, making it the first approval in the US of a systemic treatment for the condition. Kendall Marcus, director of the dermatology division at the FDA's Center for Drug Evaluation and Research, said the decision "will help fulfill a significant unmet need."
The priority review filing was backed by results from the placebo-controlled Phase III BRAVE-AA1 and BRAVE-AA2 trials of patients who had ≥50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than six months. Participants were randomised to receive Olumiant, at doses of 2mg or 4mg, or placebo every day.”

About the public’s health

Tobacco companies will be forced to reduce nicotine in U.S. cigarettes until they’re non-addictive, if the Biden administration has its way: report “Tobacco companies will be forced to reduce nicotine in cigarettes sold in the U.S. to nonaddictive, or minimally addictive, levels, if the Biden administration has its way.
The policy could be announced as early as this coming week, The Wall Street Journal reported Friday. But it likely won't take effect for several years. The U.S. Food and Drug administration would have to draft a proposed rule and open it for public comment. After it published the rule, tobacco companies could sue, delaying implementation.
Meanwhile, the U.K. government is considering raising the legal age for smoking each year until smoking is effectively outlawed, Bloomberg reported this week, adding that New Zealand plans a similar move that will eventually prohibit smoking.”

Brain lesions disrupting addiction map to a common human brain circuit  “We analyzed two cohorts of patients addicted to smoking at the time of focal brain damage (cohort 1 n = 67; cohort 2 n = 62)…
 Lesions disrupting smoking addiction occurred in many different brain locations but were characterized by a specific pattern of brain connectivity…
 We conclude that brain lesions disrupting addiction map to a specific human brain circuit and that hubs in this circuit provide testable targets for therapeutic neuromodulation.”

About healthcare IT

The harm of class imbalance corrections for risk prediction models: illustration and simulation using logistic regression “Methods to correct class imbalance (imbalance between the frequency of outcome events and nonevents) are receiving increasing interest for developing prediction models. We examined the effect of imbalance correction on the performance of logistic regression models…
Imbalance correction led to models with strong miscalibration without better ability to distinguish between patients with and without the outcome event. The inaccurate probability estimates reduce the clinical utility of the model, because decisions about treatment are ill-informed… imbalance correction may even worsen model performance.”

Guidance on How the HIPAA Rules Permit Covered Health Care Providers and Health Plans to Use Remote Communication Technologies for Audio-Only Telehealth “The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) developed this guidance to help covered entities understand how they can use remote communication technologies for audio-only telehealth in compliance with the HIPAA Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth Remote Communications (Telehealth Notification) is no longer in effect.”
I find it amusing that landline calls are exempt because they do not involve electronic communication as defined by HIPAA.

Arizona hospital says SSNs of 700,000 people leaked during April ransomware attack “In letters to victims recently made public, Yuma Regional Medical Center (YRMC) said it discovered a ransomware attack on April 25 and immediately took systems offline before contacting cybersecurity experts and law enforcement.”

Kaiser Permanente notifies nearly 70,000 patients of email data breach “Kaiser Permanente is notifying 69,589 patients of a data breach that occurred when someone accessed an employee's emails.
The emails contained protected health information, including first and last names and lab test results, but the health plan said it had no indication that the data was accessed or misused.”

Top 10 medical marketing agencies by revenue FYI
Comment from my co-author (Strategic Marketing for Health Care Organizations), Robert Stevens: “Many of these companies are in actuality pharma and medtech ad agencies.  Marketing is a stretch. 
An exception is nearby [he lives in N.C.] Syneos Health.  It’s been a CRO [contract research organization] since 1999.  Today Syneos does not want to be positioned as a CRO.  It’s current positioning is as a ‘Biopharmaceutical Acceleration Model’ or BAM organization.  That may be a good differentiator.  The value prop, however, seems muddy.”

About healthcare finance

 Where investment dollars are flowing in biotech startups “Biotech startups that utilize platform-based therapeutics received a large proportion of investment dollars from 2019 to 2021, according to a June 10 McKinsey article
Here are five platform-based startup types to watch, as they received the most VC investment:

  1. Cell therapy represented $7.7 billion of total funding.

  2. Next-generation gene therapies brought in $7.6 billion in funding.

  3. Precision medicine companies got $4.5 billion in funding.

  4. Machine-learning-enabled drug discovery brought in $4.4 billion.

  5. Startups focusing on hard-to-hit targets, or "undruggable" targets, got $4 billion in funding.”

Today's News and Commentary

The Role Of Clinical Waste In Excess US Health Spending “Top Findings From The Literature

  • Clinical waste is caused by failures of care delivery, failures of care coordination, and overtreatment, accounting for 5.4–15.7 percent of all health spending in the US.

  • Failures of care delivery account for 2.7–5.7 percent of total US health spending.

  • Failures of care coordination account for 0.7–2.1 percent of total US health spending.

  • Overtreatment accounts for 2.0–8.4 percent of total US health spending.”

About Covid-19

Pfizer-BioNTech shot for children under 5 safe and effective, FDA staff says “The analysis by FDA scientists was released ahead of a meeting Wednesday of the agency’s independent experts, who will consider a request for emergency use authorization for the Pfizer-BioNTech vaccine in the youngest children. It will also review a request from Moderna to use its vaccine in children younger than 6. FDA staff Friday said Moderna’s shot for infants and young children was safe and effective.”

 COVID DATA TRACKER WEEKLY REVIEW “As of June 8, 2022, the current 7-day moving average of daily new cases (109,032) increased 8.0% compared with the previous 7-day moving average (100,916). A total of 85,084,715 COVID-19 cases have been reported in the United States as of June 8, 2022.” 

About hospitals and healthcare systems

 How did 7 gallons of fentanyl go missing from a hospital? Regulators launch investigation “State regulators have suspended the licenses of several leaders at Cheshire Medical Center in Keene, N.H., as they investigate how more than seven gallons of fentanyl went missing from the hospital across a four-month period. On June 29, the hospital will find out whether the state's pharmacy board is suspending or revoking its pharmacy permit.” 

About pharma

 U.S. Supreme Court Rebuffs Opioid Maker Insys Founder's Conviction Appeal “The U.S. Supreme Court on Monday rejected bids by Insys Therapeutics Inc founder John Kapoor and another former executive of the drugmaker to overturn their convictions for conspiring to bribe doctors to prescribe addictive opioids and defraud insurers into paying for them” 

CBER Aims to Resume Normal Operations in 2023 “The FDA’s Center for Biologics Evaluation and Research (CBER) said it plans to resume normal operations starting calendar year 2023…”

About the public’s health

 Inhaled vaccines offer better protection than nasal sprays, study shows “For the study, published online in the journal Frontiers in Immunology, the researchers used a tuberculosis vaccine to compare delivery methods by measuring the distribution of droplets, immune responses and potency in animals.When the vaccine was delivered directly into the lungs it stimulated stronger immune responses, providing much better protection from TB.” 

Three articles illustrate the complexity of addressing dietary issues for the public’s health

Calorie counts on menus: Have they helped?“‘Labeling did not have any impact that we could observe on people’s food purchasing behaviors,’ said study author Brian Elbel, a professor of population health and health policy at New York University.”

 Diet quality, energy intake do not mediate link between food insecurity and obesity “In findings from the 2015-2016 National Health and Nutrition Examination Survey, adults experiencing food insecurity had a higher BMI and waist circumference than food-secure individuals. However, energy intake did not explain the associations with BMI or waist circumference, and diet quality only partially mediated the association between food insecurity and waist circumference.”

Association of Socioeconomic and Geographic Factors With Diet Quality in US Adults “In this cross-sectional analysis of 155 331 adults participating in a nationwide US cohort study, Black individuals, White individuals with limited income, participants with low educational attainment, and people living in rural areas or food deserts were more likely to have overall poor diet quality. All dietary components, but especially sugar-sweetened beverages and processed meats, contributed to the disparities observed.”

About healthcare IT

 Startup gets green light to use Apple Watch to track Parkinson’s symptoms “The StrivePD system uses Apple’s Movement Disorder API to track tremors and dyskinetic symptoms of Parkinson’s from the Apple Watch. The data is all collected in an iPhone application, which allows patients to record their symptoms and keep tabs on medication.” 

About healthcare personnel

 ‘The New Nurse’ Is the New Normal “Key Findings

  • Between March 2021 and March 2022, median nursing tenure fell by 19.5%.

  • Shifts covered by nurses new to the organization in the last 30 days increased in all regions.

  • The number of 12-hour shifts filled by nurses new to the organization within the last year also rose by 55.5%.” 

Today's News and Commentary

About Covid-19

 U.S. to lift coronavirus testing requirement for flyers returning to the country “International travelers flying to the United States will no longer need to show proof of a negative coronavirus test before boarding their flights to the U.S., a senior Biden administration official said Friday, ending one of the nation’s last pandemic-related travel requirements.
The requirement will end at 12:01 a.m. Sunday.”

About health insurance

 Disparities in Health Care Spending and Utilization Among Black and White Medicaid Enrollees “In this cross-sectional study of 1 966 689 Black and White Medicaid enrollees in 3 states, Black enrollees used fewer services, including primary care, and generated lower spending than White enrollees, but were more likely to utilize the emergency department for avoidable reasons. Differences persisted among enrollees residing in the same zip codes who were treated by the same health care professionals.”

About pharma

 New Drug Prices Soar to $180,000 a Year on 20% Annual Inflation “The median launch price of a new drug in the US soared from $2,115 in 2008 to $180,007 in 2021, a 20% annual inflation rate over the period, researchers at Harvard-affiliated Brigham and Women’s Hospital in Boston found. Even after adjusting for factors such as drugmakers’ focus on expensive disease categories like cancer and estimated discounts that manufacturers give some purchasers, the annual inflation rate in launch prices over the period was still almost 11%…
 Over 47% of new drugs introduced in 2020 and 2021 cost more than $150,000 per year, compared to just 9% of new drugs from 2008 to 2013, the researchers found.”

 CVS study: Using evidence-based guidelines may decrease total cost of cancer care “Researchers at CVS studied the relationship between total cost of care and the use of National Comprehensive Cancer Network (NCCN) guidelines to direct care and found savings among both breast cancer and colon cancer patients…
The first study included 937 patients with colon cancer. Among Medicare beneficiaries, concordance with NCCN guidelines was linked to a 33% reduction in total cost per care per member per month. The results were less significant among commercially insured patients.
In the second study, the researchers retrospectively looked at 315 patients with breast cancer. They found total cost of care reductions for patients treated in ways consistent with NCCN across multiple insurance types, including 25% among fully insured commercial patients, 28% among self-insured commercial patients and 43% in Medicare.”

The Facts About Medicare Spending A great overview of current Medicare stats from the KFF.

Bluebird bio's gene therapy for blood disorder gets FDA panel backing ”The panel of 13 outside experts on Friday voted unanimously for beti-cel as a one-time gene therapy to treat Beta-thalassemia patients dependent on blood transfusions.
The FDA is expected to decide on beti-cel's fate by Aug. 19 and eli-cel's by Sept. 16.”

Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 “This cross-sectional study found that of 89 new oncology therapies approved by both the FDA and EMA from 2010 to 2019, the FDA approved 95% of therapies first, with a median delay to market authorization in Europe of 241 days…
The FDA received licensing applications sooner and had shorter review times. However, more therapies were approved prior to licensing study publication, leaving uncertainty for practitioners regarding clinical utility and safety of newly approved therapies.”
An accompanying editorial (The Timing of Cancer Drug Approvals in the United States and Europe) notes, among other things: “Although the speed of FDA review times and subsequent number of approvals have increased over time, the proportion of cancer drugs that improve survival has declined. Furthermore, although other countries approve fewer medicines than the US, available therapies tend to offer more benefit to patients.” In other words, quality not quantity or speed.

How to Retain Employees by Offering the Right Health Benefits “To prevent employees from becoming another statistic in the Great Resignation, companies may want to revisit the health benefits they offer. Some small business owners are embracing a perk once rarely found outside of the U.S. military--no-cost health insurance…
Nearly half of the 475 companies on Inc.'s 2022 Best Workplaces list now offer entirely employer-paid health insurance. And 90 percent of employers rank health as the benefit their workforce values the most, according to the Society for Human Resource Management Benefits Survey.”
Read the article for examples.

About the public’s health

GSK announces positive pivotal phase III data for its respiratory syncytial virus (RSV) vaccine candidate for older adults Key findings:

  • “First RSV vaccine candidate to show statistically significant and clinically meaningful efficacy in adults aged 60 years and above

  • The magnitude of effect observed was consistent across RSV A and B strains, key secondary endpoints and in those aged 70 years and above”

European Commission and United States sign cooperation arrangement on preparedness and response to public health threats “Following the statement by President Ursula von der Leyen and U.S. President Joe Biden marking the second Global COVID-19 Summit, the European Commission and the U.S. Department of Health and Human Services have signed an arrangement to strengthen cooperation on preparedness and response to public health threats. This will enable the Commission and the U.S. to work together on a broad range of topics to jointly tackle health emergencies, contributing to establishing a strong global health architecture.”

 Takeda's dengue vaccine shows continued efficacy through 4.5 years “Takeda on Thursday reported results from a long-term exploratory analysis indicating that its dengue vaccine TAK-003 continued to protect against illness and hospitalisations from the mosquito-borne infection 4.5 years after immunisation in the Phase III TIDES study, with no important safety risks emerging. The tetravalent vaccine candidate, which is based on a live-attenuated dengue serotype 2 virus, is currently undergoing regulatory review for the prevention of dengue disease in children and adults in the EU and select dengue-endemic countries.”

About healthcare personnel

 Trends and Disparities in the Distribution of Outpatient Physicians’ Annual Face Time with Patients, 1979–2018 “Our sample included n = 1,108,835 patient visits. From 1979 to 2018, annual outpatient physician face time per capita rose from 40.0 to 60.4 min, an increase driven by a rise in mean visit length and not in the number of visits. However, since 2005, mean annual face time with a primary care physician has fallen, a decline offset by rising time with specialists. Face time provided per physician changed little given growth in the physician workforce. A racial/ethnic gap in physician visit time present at the beginning of the study period widened over time. In 2014–2018, White individuals received 70.0 min of physician face time per year, vs. 52.4 among Black and 53.0 among Hispanic individuals. This disparity was driven by differences in visit rates, not mean visit length, and in the provision of specialist but not primary care.”

Today's News and Commentary

About Covid-19

 Biden Administration Announces Operational Plan for COVID-⁠19 Vaccinations for Children Under 5 “The Biden Administration’s plan includes: 
Securing vaccine supply for our nation’s children. The Administration has procured a significant supply of vaccines for this age group, with 10 million doses available initially and millions more available in the coming weeks…
Making vaccinations available in convenient places parents and families know and trust. Working with states, localities, Tribes and territories, the Administration will make vaccinations for our nation’s youngest children widely available at thousands of trusted, accessible sites across the country—with 85 percent of children under the age of five living within five miles of a potential vaccination site…
Leveraging federal programs to reach parents and families with information and advance equity. As with prior vaccination efforts, the Administration will leverage existing federal programs and capabilities to ensure that we are reaching parents and families with the information they need…
Supporting education and engagement efforts to build trust among parents and families…To ensure that parents and families have answers to their questions and information from sources that they trust, HHS will work with a broad range of national organizations to launch a national public education campaign that reaches parents, guardians, and families with facts and information that they need to make informed choices for both their youngest and their older children…”

Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 “Molnupiravir-treated participants had a decreased need for respiratory interventions versus placebo-treated participants (relative risk reduction [RRR], 34.3%…), with similar findings in participants who were hospitalized after randomization (RRR, 21.3%…). Hospitalized participants who received molnupiravir were discharged a median of 3 days before those who received placebo. Acute care visits (7.2% vs. 10.6%; RRR, 32.1%…) and COVID-19–related acute care visits (6.6% vs. 10.0%; RRR, 33.8%…) were less frequent in molnupiravir- versus placebo-treated participants.”

About health insurance

 CMS: Payers that cut or reduce agent commissions are violating the ACA “Payers that reduce or eliminate compensation for insurance agents and brokers who help enroll people in ACA plans during a special enrollment period are in violation of the ACA, according to a FAQ published by CMS on June 7.
The move comes after reports of Bright Healthcare, Oscar Health, Molina Healthcare and some Blue Cross companies cutting or limiting agents' commissions after record ACA enrollment earlier this year.”

Medicare FFS Claims: 2% Payment Adjustment (Sequestration) Changes A reminder that at the end of the month, the sequester goes back up to 2%. Here is a recent history:
The Protecting Medicare and American Farmers from Sequester Cuts Act impacts payments for all Medicare Fee-for-Service (FFS) claims:

  • No payment adjustment through March 31, 2022

  • 1% payment adjustment April 1 – June 30, 2022

  • 2% payment adjustment beginning July 1, 2022

Pharmaceutical company to pay $12.9M to settle Texas Medicaid fraud claim Dr. Reddy's Laboratories, an “India-based multinational pharmaceutical manufacturer has agreed to pay $12.9 million to settle claims it reported inflated prices to the Texas Medicaid program, the Texas attorney general said June 8.”
The “alleged inflated price-reporting began in October 2003, according to the settlement agreement.”

About hospitals and healthcare systems

 Two hospitals are being fined for disobeying price transparency rules  After a grace period, CMS is finally enforcing this requirement. “The agency sent letters, dated Tuesday, to both hospitals detailing the alleged violations and the fines. (Hospital officials didn’t respond to a request for comment as of publication time.) Here's what CMS wrote in letters quietly posted online Wednesday: 

Reimagining Primary Health Care after COVID-19 (A monograph from the World Bank Group)
Most countries (with the notable exception of the U.S.) build their healthcare systems around the provision of primary care. But even those countries have not lived up to the promises of such a design. Here is a summary of this extensive document:
”In this report, we argue that a robust and reimagined primary health care (PHC) agenda, as part of a broader reinvigoration of UHC [universal health coverage], must be part of the post-COVID-19 story—both to dig the world out of the COVID-19 ditch and to prevent similar catastrophes in the future. To be clear, we do not claim that the COVID-19 crisis was entirely or mostly the result of weak or nonfunctional PHC services. Yet PHC was often the weakest link in the national and community responses, despite its critical importance as a backstop to ‘flatten the curve’ and prevent hospital saturation. Core PHC functions such as surveillance, testing, and contact tracing first fell through the cracks and then were ultimately assumed by newly created teams or by hospitals. Now we will again need PHC to close the COVID-19 chapter and make up for lost time—by administering vaccines against COVID-19; recouping losses to reproductive health, preventive care, and mental health; and building back better to meet the evolving needs of the global population.
[The report] builds on the vast literature on PHC, revisiting the concept, its underpinnings, country experiences, and lessons learned. The report also is fully aligned with the 2018 Declaration of Astana on PHC as the main pillar of universal health coverage and the health-related Sustainable Development Goals… its emphasis is on the ‘how’—what it takes to build a fit-for-purpose primary health care service delivery platform—and it spells out how countries could reimagine it…”

About pharma

 Generic drugmakers win one, lose one in sweeping price-fixing case involving 49 states, 20 companies “On Tuesday, a federal district court judge in Pennsylvania ruled (PDF) that states were not entitled to a cut of the profits generics manufacturers allegedly made from their scheme.
Judge Cynthia Rufe said that disgorgement was not an available avenue for the states to pursue under federal antitrust laws.
But it wasn’t a complete victory for the drugmakers. Rufe also rejected the companies’ attempt to dismiss the states’ effort to score injunctive relief, which would allow the court to intervene in their operations…
Most of the world’s prolific makers of generics are named in the case including Teva, Sandoz, Par Pharmaceuticals and Mylan (now Viatris).”

About the public’s health

STATNEWS reviewed highlights from the just-concluded American Society of Clinical Oncology (ASCO) annual meeting.

 More than 1,000 monkeypox cases reported to WHO - briefing “WHO Director-General Tedros Adhanom Ghebreyesus said the risk of monkeypox becoming established in these non-endemic countries was real but preventable at this point.
Twenty-nine countries have reported cases in the current outbreak, which began in May. None have reported deaths. 
At a media briefing in Geneva, Tedros also said there had been more than 1,400 suspected cases of monkeypox this year in Africa and 66 deaths…
Rosamund Lewis, WHO technical lead on monkeypox, said that "interpersonal close contact" was the main way monkeypox spreads, although she added that the risk of aerosol transmission was not yet fully known. Health workers caring for monkeypox patients should wear a mask, she said.”

About healthcare personnel

 Use of a Real-Time Locating System [RTLS] to Assess Internal Medicine Resident Location and Movement in the Hospital “In this cross-sectional study, 43 internal medicine interns wore an RTLS badge during the 2018-2019 academic year with usable data. Interns spent only 13.4% of their time in patient rooms; there was significant interindividual variation in bedside time and significant interservice differences in time spent in patient rooms during rounds, with most time spent in the hallway or the workroom…
By some estimates, time at the bedside has decreased by almost half since the 1990s. A number of factors contribute to less time at the bedside, including operational constraints, duty hour requirements, a focus on patient throughput, and electronic health record workflows. This shift away from time with patients coincides with a decline in clinical skills and an increase in burnout, particularly among trainees.”
The next step is to minimize non-productive work.

UnitedHealth to invest $100M in diversifying healthcare workforce “The United Health Foundation, the philanthropic arm of UnitedHealth Group, will invest $100 million over the next decade to drive a more diverse healthcare workforce…
The investment is the single largest contribution ever made by United Health Foundation and will provide scholarships and support to 10,000 clinicians from underrepresented communities. The program will back 5,000 new students, with a focus on primary care, as well as support 5,000 clinics that want to progress careers in medicine, nursing, midwifery, mental health and other specialties.”

About health technology

 Wearables Market Sees First Decline at Beginning of 2022 as Demand Normalizes, According to IDC A good summary of the latest updates on the industry’s leading companies.

Today's News and Commentary

About Covid-19

MODERNA ANNOUNCES OMICRON-CONTAINING BIVALENT BOOSTER CANDIDATE MRNA-1273.214 DEMONSTRATES SUPERIOR ANTIBODY RESPONSE AGAINST OMICRON The headline is the story. Read the article for specifics of the vaccine’s performance. “Moderna is planning to submit the interim analysis and data to regulators for review in the coming weeks.”

 The Association Between COVID-19 Mortality And The County-Level Partisan Divide In The United States “Majority Republican counties experienced 72.9 additional deaths per 100,000 people relative to majority Democratic counties during the study period, and COVID-19 vaccine uptake explains approximately 10 percent of the difference. Our findings suggest that county-level voting behavior may act as a proxy for compliance with and support of public health measures that would protect residents from COVID-19.” 

White House shifts pandemic money to vaccines, cutting other programs “The Biden administration is shifting dwindling federal coronavirus funds toward securing another round of vaccines and treatments — rationing money and cutting back on other critical public health programs as Congress remains at odds over whether to spend more to battle the pandemic.
The U.S. government plans to redirect about $5 billion in existing funds so it can purchase any new, updated versions of the vaccines if they become available, according to an administration official, who spoke on the condition of anonymity to describe the deliberations. The government also intends to repurpose another $5 billion in previously authorized aid so it can secure access to therapeutics, including the pill Paxlovid, the aide said.”

About health insurance

 An Out-Of-Pocket Spending Cap Would Make Medicare More Affordable For Millions “More than 4.5 million Medicare enrollees (12 percent) will incur over $5,000 in cost-sharing expenditures next year. A $5,000 out-of-pocket spending cap for traditional Medicare would:

  • Save beneficiaries an average of $5,500 a year, for those individuals whose annual out-of-pockets exceed $5,000.

  • Decrease out-of-pocket costs for high spending enrollees by 51 percent; reduce supplementary plan spending by about 51 percent; and lower Medicaid spending by about 58 percent.

  • Increase Medicare spending by $38.8 billion in 2023 relative to current law.”

About hospitals and healthcare systems

 

 

 

About pharma

 FTC Launches Inquiry Into Prescription Drug Middlemen Industry “The Federal Trade Commission announced today that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc.” 

Trends in Prescription Drug Launch Prices, 2008-2021 “From 2008 to 2021, launch prices for new drugs increased exponentially by 20% per year. In 2020-2021, 47% of new drugs were initially priced above $150 000 per year. Prices increased by 11% per year even after adjusting for estimated manufacturer discounts and changes in certain drug characteristics, such as more oncology and specialty drugs (eg, injectables, biologics) introduced in recent years. The study was limited to drugs sold by public companies…
The trend in prices for new drugs outpaces growth in prices for other health care services. Even after drugs are marketed, manufacturers routinely increase prices over time; in another analysis, net prices increased by 4.5% per year from 2007 to 2018. In response to the current trends, the US could stop allowing drug manufacturers to freely set prices and follow the example of other industrialized countries that negotiate drug prices at launch.”

About the public’s health

 Coffee Consumption May Mitigate the Risk for Acute Kidney Injury [AKI]: Results From the Atherosclerosis Risk in Communities Study “Higher coffee intake was associated with a lower risk of incident AKI and could present an opportunity for cardiorenal protection through diet. Further evaluation of the physiological mechanisms underlying the cardiorenal protective effects of coffee consumption is necessary.” 

About healthcare IT

 Oracle closes $28B deal to buy EHR giant Cerner “Software maker Oracle has closed its deal to acquire health IT company Cerner, effective Wednesday.
Austin-based Oracle finalized a stock tender offer on Monday with 69.2% of all Cerner shares being tendered to the acquiring company.
The all-cash deal values Cerner at $95 a share.”

Apple Watch's 'AFib History' feature ripens with new FDA clearance “The AFib History feature will be able to estimate how frequently an Apple Watch wearer shows signs of the irregular and often extremely rapid heartbeat. The software received 510(k) clearance from the FDA at the beginning of this month, allowing it to be used by people aged 22 and older who have already been diagnosed with afib…
Previous versions of the Apple Watch’s operating system have been able to track how many hours of sleep a wearer gets each night and their respiratory rate throughout. The OS 9 update builds on that, using the device’s accelerometer, heart rate sensor and built-in machine learning algorithms to detect when a user is in REM, core or deep sleep…
Another new addition to the software offers a module to Apple Watch and iPhone users to help track their medications.”

Interstate telehealth visits in jeopardy as pandemic licensure waivers expire “In March 2020, the Centers for Medicare and Medicaid Services (CMS) allowed individual states to waive within-state licensure requirements for Medicare beneficiaries obtaining telehealth services. Around this time, all 50 U.S. states and Washington, D.C., passed licensure waivers, which permitted patients to access telehealth visits with out-of-state providers. Now, the authors noted, this provision remains active in only 15 states.”

About healthcare personnel

 Why PAs aren't using the term 'physician associate' yet “The American Academy of Physician Assistants has officially changed its name to the American Academy of Physician Associates as part of a larger rebranding effort for the profession, but the association is not advising PAs to use the new term in a professional capacity yet…
News of the rebranding was met with opposition from several medical groups, including the American Medical Association and American Osteopathic Association. The groups argued that the new term would confuse patients, undermine the physician-led care team model and violate state laws regarding truth in advertising. 
While AAPA has officially rebranded, the organization is not recommending PAs use the term in clinical practice yet, per guidance from its legal counsel.”

About health technology

 

 

About healthcare finance

 

 

Today's News and Commentary

About Covid-19

 Advisers to the FDA back Novavax COVID vaccine “An FDA summary found the Novavax COVID vaccine had 90% efficacy in protecting people against mild, moderate and severe disease. The main study that the agency used to evaluate the Novavax vaccine's efficacy included about 30,000 patients in the U.S and Mexico. But data collection ended in late September 2021, months before omicron was detected in the U.S.
The Novavax vaccine uses copies of the SARS-CoV-2 spike protein produced in a factory rather than snippets of genetic code to instruct the body's cells to make the protein that prompts an immune response. Both approaches have proved succesful against COVID-19.”

China offers Covid vaccine insurance to win over jab sceptics Fascinating idea: “Dozens of cities across the country have begun offering people aged 60 and older free insurance that pays out up to Rmb500,000 ($75,000) if they fall ill — or worse — because of Covid-19 vaccines. The packages also promise payouts to families if it can be proven that a loved one’s death was related to receiving a jab. In Beijing alone, about 60,000 seniors have signed up for the coverage since April.”

AB-2098 Physicians and surgeons: unprofessional conduct.(2021-2022) A Bill passed by the California legislature: “This bill would designate the dissemination or promotion of misinformation or disinformation related to the SARS-CoV-2 coronavirus, or “COVID-19,” as unprofessional conduct. The bill would require the board to consider specified factors prior to bringing a disciplinary action against a physician and surgeon.”

About health insurance

 Study: 87% of Medicare Advantage plans could lose one or more stars in 2023 ratings “More than 80% of Medicare Advantage plans are in danger of losing at least one star in one or more of their ratings for 2023, potentially imperiling millions in quality bonuses for plans, a new analysis finds…
The analysis from Press Ganey, which can conduct experience surveys from plan members, is based on preliminary 2022 data from 446 MA plans. It showed that 48% of MA plans are at risk of losing a star on the measure of getting needed prescription drugs, while 44% are at risk of losing one due to customer service and for care coordination…
Due to a final rule released in 2020, there are several CAHPS measures that have a greater emphasis on star ratings for 2023. 
Some of the measures that were weighted a two in 2022 will be a four next year, including:

  • Customer service

  • Getting needed prescription drugs

  • Rating of drug plan

  • Care coordination

  • Rating of healthcare quality”

About hospitals and healthcare systems

 The top 10 nonprofit health systems by 2021 operating revenue  FYI

 HCA Healthcare Hit With More Price Inflation Allegations “The city of Brevard, North Carolina sued HCA Healthcare for allegedly inflating healthcare costs after it acquired Mission Health.
Nashville, Tennessee-based hospital giant HCA controls more than an 85% of the acute care market in the Asheville, North Carolina area and at least 70% of that market in the surrounding region, city officials claim in a complaint filed Friday in a North Carolina federal court. That leverage allegedly allowed HCA to force insurers and employers into anticompetitive contracts that included all-or-nothing provisions that required them to include all of their facilities in the health plan networks and steered patients away from competitors.”

About pharma

 California aims to slash insulin prices and challenge Big Pharma. Can it succeed? “[Governor] Newsom is asking state lawmakers to pump $100 million into an ambitious initiative to launch California’s generic drug label, CalRx, and begin producing insulin in the next few years, said Alex Stack, a Newsom spokesperson. The state is also working to identify other generic drugs it could bring to market, targeting those that are expensive or in short supply.” 

About the public’s health

 Menthol-flavored cigarettes may lead to increased smoking among teens, study finds “Researchers found that teen consumption of menthol cigarettes was associated with nearly three additional days of smoking over a 30-day period, a 38 percent higher risk of becoming a frequent smoker and an 8 percent higher nicotine dependency.
The Food and Drug Administration (FDA) in April proposed a ban on menthol cigarettes and flavored cigars and the agency is taking public comments on the matter through July 5 before making a final decision.” 

About healthcare IT

 Teladoc lawsuit claims company 'misled' investors “Teladoc is facing a lawsuit alleging the company misled investors regarding its business, operations and future prospects that will result in "significant losses and damages" for stakeholders.  
The lawsuit, filed June 6 on the behalf of parties that purchased Teladoc shares between October and April, accuses the company, along with CEO Jason Gorevic and CFO Mala Murthy, of downplaying competition in the mental health and chronic care business sectors, along with issuing "unrealistic" financial expectations for 2022.” 

About healthcare personnel

 Healthcare access looms as doctors' top concern, followed by substance abuse, racial disparities and gun control  “A strong majority, 85%, cited healthcare access as their most important concern, followed by substance/opioid abuse (66%), racial disparities (54%), gun control (53%) and climate change (51%), according to a new Medscape survey.
Nearly all the doctors surveyed say they support gun background checks, and a majority are in favor of abortion access with some restrictions by trimester.”

About health technology

 GE's contrast dye plant nears 100% capacity “Production of an X-ray imaging dye at a Shanghai plant will resume at normal speed this week after COVID-19-related shutdowns halted supply in May.
As hospitals postpone operations and ration the dye used for about 50 million annual CT scans and other imaging procedures, GE Healthcare expects the global supply of iodinated contrast media to progressively recover in the coming weeks, according to a June 2 press release from the company.”

Today's News and Commentary

About Covid-19

COVID DATA TRACKER WEEKLY REVIEW “As of June 1, 2022, the current 7-day moving average of daily new cases (100,684) decreased 8.5% compared with the previous 7-day moving average (110,081). A total of 84,315,762 COVID-19 cases have been reported in the United States as of June 1, 2022.”
To put the numbers in perspective, new COVID-19 cases have decreased for the first time since late March.

About health insurance

 DOJ joins whistleblower suit accusing Fresenius Medical Care of performing thousands of unnecessary vascular procedures “Two doctors allege in a lawsuit that the country's largest dialysis provider performed potentially thousands of unnecessary, invasive vascular procedures on late-stage kidney disease patients and fraudulently charged Medicare and Medicaid for these procedures.  
The Department of Justice has now joined the False Claims Act whistleblower lawsuit filed against dialysis giant Fresenius Medical Care, according to court documents filed in U.S. District Court in Brooklyn…
Nineteen states also are included in the lawsuit and potentially could join the case.”

HHS, CMS Extend American Rescue Plan Funding For HCBS Another Year “The US Department of Health and Human Services (HHS) and CMS announced that states will have another year to invest American Rescue Plan funds in home- and community-based services (HCBS).”

Justices side with Florida’s Medicaid program in payment dispute with accident victim “The Supreme Court on Monday ruled that state Medicaid programs can seek reimbursement from tort-settlement payments that are allocated for accident victims’ future medical care.
Justice Clarence Thomas wrote the opinion in Gallardo v. Marstiller. Justice Sonia Sotomayor (joined by Justice Stephen Breyer) dissented.
The issue in Gallardo was what to do when a state Medicaid program pays for injuries if the injured person later recovers a tort settlement from a third party. The case involved a Florida girl who suffered catastrophic injuries when she was hit by a pickup truck in 2008. By a 7-2 vote, the court upheld Florida’s effort to recover the portion of her tort settlement that reflects future medical expenses.”
This repayment is standard in commercial insurance.

Did the Comprehensive Care for Joint Replacement Program Make a Difference? “There is a paucity of literature on racial differences across a full total joint arthroplasty (TJA) “episode of care” and beyond. Given various incentives, the Comprehensive Care for Joint Replacement (CJR) program in the U.S. may have impacted preexisting racial differences across this care continuum. The purposes of the present study were (1) to assess trends in racial differences in care/outcome characteristics before, during, and after TJA surgery and (2) to assess if the CJR program coincided with reductions in these racial differences…
Racial differences persist among patients managed with TJA. The CJR program coincided with reductions in some racial differences, thus identifying bundle design as a potential novel strategy to target racial disparities.”
Read the detailed results for the affected metrics. It is clear that the findings are associations rather than proved causalities. 

About pharma

 Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer Numerous news outlets have cited this study as a major breakthrough in breast cancer treatment. “Among breast cancers without human epidermal growth factor receptor 2 (HER2) amplification, overexpression, or both, a large proportion express low levels of HER2 that may be targetable. Currently available HER2-directed therapies have been ineffective in patients with these ‘HER2-low’ cancers…”
While success markers such as disease progression, death and overall survival are impressive in terms of percentages, the actual improvements are in months not years. The medication comes from  AstraZeneca and Daiichi Sankyo.

Washington State Supreme Court Sides With Lilly Regarding Drug Warnings This ruling, if applied nationally, is a landmark in defining drug liability. “The ruling concluded a case against Lilly by an individual who alleged that he suffered a hemorrhage leading to a stroke less than two hours after taking the company’s erectile dysfunction drug Cialis (tadalafil), arguing that the company was negligent in not warning about the risk.
Lilly successfully argued that it had provided adequate warnings to the prescribing physician under the ‘learned intermediary doctrine,’ whereby the manufacturer of a prescription medical product must warn doctors, not patients, of a product’s risks and doctors must then convey the warnings to patients. The doctrine has been adopted in most states.”

BD to enter pharmacy automation market with $1.5B Parata purchase “BD is looking to dive into the growing market of automated hardware for dispensing medications in hospitals and retail pharmacies, and it’s paying $1.525 billion for the privilege.
The medtech company has signed up to buy Parata Systems from its corporate owner, the private equity firm Frazier Healthcare Partners, through an all-cash deal expected to close before next March…”

Tirzepatide Once Weekly for the Treatment of Obesity The percentage of participants who had weight reduction of 5% or more was 85% (95% CI, 82 to 89), 89% (95% CI, 86 to 92), and 91% (95% CI, 88 to 94) with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and 35% (95% CI, 30 to 39) with placebo; 50% (95% CI, 46 to 54) and 57% (95% CI, 53 to 61) of participants in the 10-mg and 15-mg groups had a reduction in body weight of 20% or more, as compared with 3% (95% CI, 1 to 5) in the placebo group (P<0.001 for all comparisons with placebo). Improvements in all prespecified cardiometabolic measures were observed with tirzepatide. The most common adverse events with tirzepatide were gastrointestinal, and most were mild to moderate in severity, occurring primarily during dose escalation.”

About the public’s health

 What Overturning Roe v Wade May Mean for Assisted Reproductive Technologies in the US An excellent review of this topic.

About healthcare IT

 The State of Ransomware in Healthcare 2022 Some highlights regarding healthcare organizations:
66% hit by ransomware in the last year

61% attacks resulted in data encryption [industry-wide figure was 65%]

69%  increase in volume of cyber attacks, highest across all sectors

67% increase in complexity of cyber attacks, highest across all sectors

59% increase in impact of cyber attacks, second-highest across all sectors”
These figures highlight the profitability of these attack compared to “hacks” in other sectors.

 About health technology

 Caris Life Sciences to launch cancer blood test that spans a whopping 22,000 genes “The company has only presented early validation data on the Assure liquid biopsy assay, which made its debut at the annual meeting of the American Society of Clinical Oncology. But Caris says it scans for as many as 22,000 genes—using a combination of whole-exome and whole-transcriptome sequencing that sifts through the pieces of DNA and RNA found floating in the bloodstream.”

Today's News and Commentary

The 2022 Axios Harris Poll 100 reputation rankings The only pure-play healthcare organization in the top 25 is The Blue Cross Blue Shield Association (#13).

About Covid-19

Worldwide coronavirus cases cross 527.28 million, death toll at 6,703,868 “Infections have been reported in more than 210 countries and territories since the first cases were identified in China in December 2019.”
For Reuter’s interactive global tracker, click: tmsnrt.rs/2FThSv7.

 Risk factors for SARS-CoV-2 infection and transmission in households with asthmatic and allergic children. A prospective surveillance study [Preprint] “In a multi-center SARS-CoV-2 surveillance study, conducted among asthmatic/allergic disease cohorts, participants with self-reported asthma were not at increased
risk for infection. However, self-reported food allergy and increasing BMI were associated with  decreased and increased risk for infection, respectively.”

Cross-reactive immunity against the SARS-CoV-2 Omicron variant is low in pediatric patients with prior COVID-19 or MIS-C “Overall, children and adolescents show some loss of cross-neutralization against all variants, with the most pronounced loss against Omicron. In contrast to SARS-CoV-2 infection, children vaccinated twice demonstrated higher titers against Alpha, Beta, Gamma, Delta and Omicron. These findings can influence transmission, re-infection and the clinical disease outcome from emerging SARS-CoV-2 variants and supports the need for vaccination in children.”

Pfizer says COVID-19 vaccine lawsuit is based on bogus patent “Pfizer and BioNTech told a Delaware federal court that Alnylam filed the lawsuit despite knowing that their vaccine did not infringe its patent on lipid nanoparticle (LNP) technology for transporting genetic material.
They argued the patent was invalid and unenforceable…
Cambridge, Massachusetts-based Alnylam separately sued Moderna Inc and Pfizer Inc in Delaware over their vaccines in March, seeking royalties for the LNP technology the shots use to deliver genetic material known as mRNA.”

J&J, BMS arthritis drugs lowered death risk among hospitalized COVID patients in federal study “The National Institutes of Health (NIH) led a large clinical trial on rheumatoid arthritis drugs in hospitalized COVID-19 patients. While researchers found that the treatments did not significantly shorten recovery time, they did improve clinical status and reduce deaths.”
Read the article for examples. The absolute percentage advantages were small.

Pfizer's Paxlovid reduces COVID risk in seniors regardless of vaccine status -study “Pfizer Inc's antiviral treatment Paxlovid reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, according to a new study in Israel conducted during the rise of the Omicron variant of the coronavirus.
The treatment, however, was not found to prevent severe illness among younger adults, according to research from Clalit Health Services, Israel's largest healthcare provider.”

About health insurance

 Traditional Medicare Spending Fell Almost 6% in 2020 as Service Use Declined Early in the COVID-19 Pandemic From the KFF:
Highlights:

  1. Total spending on Part A and Part B services for traditional Medicare beneficiaries was $348.0 billion in 2020, a decrease of 5.8% ($21.4 billion) from 2019.

  2. Spending per traditional Medicare beneficiary for Part A and Part B services fell 3.6%, or $402, to $10,739 per person in 2020, compared to $11,142 per person in 2019.

  3. The decline in traditional Medicare spending reflects decreases in spending for most types of services, ranging from 0.1% less for durable medical equipment to 13.1% less for procedures, compared to 2019. Only spending on skilled nursing facilities, Part B drugs, and hospice increased in 2020

  4. Use of nearly all types of services by traditional Medicare beneficiaries was lower in 2020 compared to 2019. Only three types of services had increases across all measures of utilization: hospice, dialysis, and Part B drugs. Skilled nursing facilities had lower use but higher spending”

A SUMMARY OF THE 2022 ANNUAL REPORTS from the Social Security and Medicare Boards of Trustees
Based on our best estimates, the 2022 reports determine:

• The Old-Age and Survivors Insurance (OASI) Trust Fund, which pays retirement and survivors benefits, will be able to pay scheduled benefits on a timely basis until 2034, one year later than reported last year. At that time, the fund's reserves will become depleted and continuing tax income will be sufficient to pay 77 percent of scheduled benefits. 

• The Disability Insurance (DI) Trust Fund, which pays disability benefits, is no longer projected to be depleted within the 75-year projection period. By comparison, last year's report projected that it would be able to pay scheduled benefits only until 2057. 

• The OASI and DI funds are separate entities under law. The report also presents information that combines the reserves of these two funds in order to illustrate the actuarial status of the Social Security program as a whole. The hypothetical combined OASI and DI funds would be able to pay scheduled benefits on a timely basis until 2035, one year later than reported last year. At that time, the combined funds' reserves will become depleted and continuing tax income will be sufficient to pay 80 percent of scheduled benefits.

• The Hospital Insurance (HI) Trust Fund, or Medicare Part A, which helps pay for services such as inpatient hospital care, will be able to pay scheduled benefits until 2028, two years later than reported last year. At that time, the fund's reserves will become depleted and continuing total program income will be sufficient to pay 90 percent of total scheduled benefits.

• The Supplemental Medical Insurance (SMI) Trust Fund is adequately financed into the indefinite future because current law provides financing from general revenues and beneficiary premiums each year to meet the next year's expected costs. Due to these funding provisions and the rapid growth of its costs, SMI will place steadily increasing demands on both taxpayers and beneficiaries. 

• For the sixth consecutive year, the Trustees are issuing a determination of projected excess general revenue Medicare funding, as is required by law whenever annual tax and premium revenues of the combined Medicare funds will be below 55 percent of projected combined annual outlays within the next 7 fiscal years. Under the law, two such consecutive determinations of projected excess general revenue consitute a ‘Medicare funding warning.’ Under current law and the Trustees' projections, such determinations and warnings will recur every year through the 75-year projection period.”
Look at Table 6 for some interesting financial dates.

About pharma

 Bristol Myers strikes up Roche rivalry with $4.1B Turning Point buy “Eyeing a rivalry with Roche and a new cancer asset slated to hit the markets next year, Bristol Myers Squibb is picking up Turning Point Therapeutics in a $4.1 billion acquisition.
BMS will gain access to repotrectinib, a midstage candidate in testing for first-line lung cancer as a potential competitor to Roche’s Rozlytrek. The Big Pharma landed Turning Point for $76 per share, with both companies’ boards approving the transaction that is slated to close in the third quarter. 

About the public’s health

 Trends in Annual Sales and Pack Price of Cigarettes in the US, 2015-2021 “From February 1, 2015, to December 26, 2021, the annual number of cigarette packs sold decreased by 27.2%, from 12.5 billion packs to 9.1 billion packs... During this period, dollar sales decreased overall by 6.0%, from $69.8 billion to $65.6 billion…, while prices increased by 29.5%, from $5.57 to $7.22 per pack (AAPC, 4.3%; 95% CI, 4.1% to 4.6%). Menthol cigarettes accounted for 33.0% of total sales in 2021; there was no significant change in this percentage from 2015 to 2021.
From January 26, 2020, to December 26, 2021, annual cigarette pack sales decreased by 7.6% (9.8 billion to 9.1 billion packs); dollar sales decreased by 1.4% ($66.5 billion to $65.6 billion), while prices increased by 6.8% ($6.76 to $7.22 per pack). Menthol share remained stable at 33.0%.”

Bariatric Surgery and Cancer Risk [Editorial] “In summary, bariatric surgery appears to be associated with a decreased risk of incident cancer and cancer mortality. More work needs to be done through large, well-designed studies that would include data on cancer screening, data from tumor registries, more detailed individual patient data, and investigations of the basic mechanisms of effect. If this association is further validated, it would extend the benefits of bariatric surgery to another important area of long-term health and prevention. This additional information could then further guide for whom bariatric surgery is most beneficial.” 

Gen Z wants health providers to ask about food, housing, safety and more “More than 1,000 youth aged 14 to 24 answered five open-ended questions via text message in March 2021. Nearly 39% of respondents came from families whose income levels qualified them for free or reduced-price school lunch under national criteria.
The poll asked about housing, food, education, safety and discrimination – all factors that can affect a person’s health in the short and long term, and their ability to seek care and keep up with treatments. 
In all, 81% of youth said providers should ask about such factors. Nearly a third said that embarrassment might keep them from seeking help for such issues if they were experiencing them. 
In addition, a quarter said they would want providers to offer resources for people with social needs, and a nearly equal percentage said providers should offer information about resources that could assist people with such needs.”

Genetic data indicate at least two separate monkeypox outbreaks underway, suggesting wider spread “The Centers for Disease Control and Prevention said Friday that new genetic sequencing data indicate there are at least two distinct monkeypox outbreaks underway outside Africa — a surprise finding that one official said suggests international spread is wider, and has been occurring for longer than has been previously realized.
Three of 10 viruses the CDC has sequenced from recent U.S. monkeypox cases — two from 2021 and eight from 2022 — are different from the viruses that have been sequenced by several countries involved in the large outbreak that is spreading in and from Europe. That outbreak is currently being driven by infections in gay, bisexual, and other men who have sex with men.” 

About health technology

 Abbott plans new wearable sensor for catching diabetic ketoacidosis “Abbott’s proposed new biowearable would continuously track both glucose and ketone levels in a single sensor, helping users catch rising ketones as early as possible, well before it develops into diabetic ketoacidosis.
The sensor—still in development—will be the same size as the FreeStyle Libre 3 device, which boasts a small and thin form factor measuring in with a width of just two stacked pennies.”

Today's News and Commentary

About Covid-19

Pfizer seeks authorization of coronavirus shot for children under 5  “Pfizer and its German partner, BioNTech, on Wednesday finished submitting an application for regulatory authorization of a coronavirus vaccine for children younger than 5.”

DOJ asks federal appeals court to reverse order lifting travel mask mandate “The Justice Department asked a federal appeals court on Tuesday to overturn last month's court decision by a federal judge that declared the mandate requiring masks on airplanes and other public transportation unlawful.
In a 48-page document filed in the 11th U.S. Circuit Court of Appeals, the Justice Department argues that the order issued by the Centers for Disease Control and Prevention in early 2021 "falls easily within the CDC's statutory authority."

About health insurance

 Data Note: 2022 Medical Loss Ratio Rebates “Expected rebate amounts vary by market segment, with the majority going to individual market enrollees, including ACA Marketplace enrollees. Insurers in the individual market estimate they will issue $603 million in rebates, small group market insurers will issue $275 million in rebates, and large group market insurers will issue $168 million in rebates later this year.”

Optum's buying streak continues with acquisition of Healthcare Associates of Texas: report “Optum is still on an acquisition hot streak, scooping up Healthcare Associates of Texas, Axios reported Wednesday.
Sources told the news outlet that the purchase from Webster Equity Partners would earn HCAT a $300 million enterprise value and earnings before interest, taxes, depreciation and amortization in the high teens. UnitedHealth Group, Optum's parent company, has made overtures to purchase HCAT in the past, according to the report.”

Humana rebrands Kindred at Home as CenterWell in 14 more states “Humana is transitioning Kindred at Home to its CenterWell brand in 14 additional states, the insurer announced Wednesday.
The second phase of the transition brings the number of states where Kindred has made or begun the switch to 21, Humana said. Updating the branding is a key step in integrating Kindred at Home into Humana's broader healthcare services enterprise.”

About hospitals and healthcare systems

8 health systems opening hospitals FYI. Despite financial stresses, building continues.

Texas hospital will pay employees $10K to get healthcare degree “University Medical Center of El Paso (Texas) has launched two programs focused on retaining current employees.
Under the CARES Pursuing Upward Learning and Legacy program, the hospital will pay up to $5,000 per year for two years for an employee to get their degree in a hard-to-fill career field, such as nursing, respiratory or imaging…
Employees do not have to currently work in clinical areas to be considered for the program. However, they must be a full-time employee with at least one year of employment, according to a flier from the hospital. They also must apply for admission via an approved educational program and agree to stay at UMC four years after graduating from the program.”

 Butler Health, Excela Health will merge to scale operations in western PA “Butler Health System and Excela Health, two health systems based in western Pennsylvania, are planning to merge into a new health system serving the region, the organizations announced Wednesday. 
The systems hope to leverage the merger to scale and be more relevant in the region’s competitive marketplace. The new health system will support five hospitals including Butler, Clarion, Frick, Latrobe and Westmoreland. It is expected to generate more than $1 billion in revenue and employ about 7,300 people, including more than 1,000 clinicians. The total population served will be 750,000.”

About pharma

 Biogen, Samsung Bioepis launch first US biosimilar, a copycat of Roche's Lucentis, at 40% discount “Byooviz’s FDA approval covers Lucentis’ indications of wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. The biosimilar currently isn’t allowed for diabetic macular edema or diabetic retinopathy because the dosing formulation is different…
Byooviz [has] list price of $1,130 per single-use vial, a 40% discount from Roche’s originator, according to the companies.”
However, even at that price, it is still more expensive than Avastin, which many ophthalmologists have been successfully using.

Regeneron pays Sanofi $900M for full rights to cancer drug Libtayo as it looks to become a force in oncology “In addition to that up-front payment, Sanofi will receive an 11% royalty on worldwide sales of Libtayo as well as $100 million in regulatory milestone payments and up to $100 million of sales-related milestone payments over the next two years. Regeneron expects the deal to be complete in the third quarter of this year.”

Astellas Subsidiary Xyphos and GO Therapeutics Ink Deal Worth More Than $763 Million “Under the agreement, the companies will select two novel antibodies using GO Therapeutics’ platform-based approach for targeting cancer-specific glycoproteins.
Xyphos will bring its CAR T-cell know-how to the collaboration. The company’s proprietary convertibleCAR technology creates cell therapies that can mobilize immune cells to find and destroy target tumor cells.”

Bristol Myers triples-down on Immatics, bringing deal to $4.2B total biobucks. Why not just buy it? “Bristol Myers Squibb is once again revising a massive research collaboration with immunotherapy drug discovery biotech Immatics. BMS is adding new deal with $60 million upfront and $700 million down the line for at least two new programs, plus expanding its prior arrangement.
That brings the total value of the collaborations to $4.2 billion in biobucks. The deal was originally signed in 2019 by Celgene before it was absorbed into BMS, and BMS again inked an agreement with Immatics in 2021…
The new agreement will involve Immatics’ gamma delta T cell-derived, allogeneic adoptive cell therapy platform, called ACTallo. The companies will develop multiple allogeneic, or so-called off-the-shelf, TCR-T and CAR-T programs.
Besides the initial two programs, BMS also has an option for up to four additional programs each. BMS will pay the upfront fee plus milestones and royalties.” 

About healthcare IT

 Oracle secures regulatory approvals for $28B Cerner takeover. Deal set to close next week “Software maker Oracle cleared the final regulatory hurdle for its pending $28.3 billion acquisition of Cerner, the companies announced Wednesday. The deal is set to close next week.
Oracle said it obtained the required antitrust approvals for the deal, including European Commission clearance. The company expects to complete the tender offer following the expiration of that offer at midnight Eastern time on June 6, the company said in a press release.” 

About healthcare quality

Aetna and HCSC join NCQA’s Digital Solutions Program for Quality Assurance “The National Committee for Quality Assurance has launched a Digital Quality Assurance Solutions Pilot Program in which health care plans, delivery systems, and health information technology companies can test and analyze to align quality measurements across the health care industry.
Aetna, Health Care Service Corporation, 1UpHealth, ApolloMed, Change Healthcare, and Centauri Health Solutions will participate in a six-month pilot project that will include workshops, product feature testing, and feedback sessions…
Participants will evaluate quality improvement and care management efforts and comment on the NCQA health performance dataset and information reports, in which health care systems align themselves to a standardized set of quality and safety metrics.”

Today's News and Commentary

Twelve propositions on the state of the world This article, by Martin Wolf of the Financial Times (FT), is an excellent overview on the “state of the world.” This link is only good for the first three readers who access it. It is well worth reading if you can get access to the FT.

20 best-managed healthcare companies “One healthcare company is among the top 10 best-managed businesses in the U.S., according to the annual ranking by the Drucker Institute.” That company is J&J. See the article for 19 others in the top 150.

About Covid-19

 Trends in Medical Debt During the COVID-19 Pandemic Perhaps contrary to common opinion: “We found no evidence of a net association between the COVID-19 pandemic and medical debt, overall or across areas with different incomes and pandemic severity. These results are consistent with any increase in medical debt being offset by decreases in elective medical procedures and new health care–related governmental policies.” 

About health insurance

 Moody's: Outlook stable for insurers even as Medicaid, ACA enrollment declines loom “Insurers can expect a stable credit outlook and low double-digit earnings growth this year after a strong first quarter, according to a forecast from Moody's Investors Service.
The analysts' report finds that the average growth in earnings before interest, taxes, depreciation and amortization (EBITDA) was 3.7% in the first quarter among seven major national payers. When excluding investment income and realized gains and losses, however, EBITDA was up 10.3% on average.
What was driving this performance? Strong enrollment growth in Medicare Advantage and Medicaid as well as improvements in the commercial book, analysts said.”

About hospitals and healthcare systems

 Highmark reports operating gain of $100M, net loss of $150M “Pittsburgh-based Highmark Health posted an operating gain of $100 million for the three months ended March 31, according to its financial results released May 31.
Highmark Health — which includes the eight-hospital Allegheny Health Network — reported $6.4 billion in revenue for the first quarter of 2022, according to a May 31 news release.The organization had a net loss of $150 million, which was driven by lower equity performance, Highmark said.
Allegheny Health Network reported a $67 million loss before interest, taxes, depreciation and amortization for the first quarter, largely due to high labor and supply chain costs. It had an operating loss of $100 million.”

About pharma

U.S. Consumers Overpay for Generic Drugs “Generics account for only a slice—about 18%—of overall U.S. retail prescription drug expenditures, which reached nearly $350 billion in 2020.5,6 Nonetheless, by one estimate, U.S. use of generic and biosimilar drugs in place of branded drugs in 2020 saved $338 billion, with 10-year estimated savings from generics of nearly $2.4 trillion.”
However: “An analysis by Schaeffer Center researchers, for example, found that Medicare Part D standalone drug plans paid $2.6 billion more in 2018 for 184 common generic medications compared with prices for the same drugs available to cash-paying Costco members…
A 2018 Schaeffer Center study found that commercially insured patients’ copayments for a generic prescription exceeded the total cost of the medicine more than a quarter of the time (28%), with an average overpayment of $7.32.24 Total overpayments in the commercial claims studied amounted to $10.51 per member per year. Known as a copayment “clawback,” the practice was abetted by “gag clauses” in PBM/ insurer contracts that prevented pharmacists from telling consumers they could save money by paying the cash price; Congress outlawed such gag clauses in 2018.25 However, PBM contracts commonly require pharmacies to give the PBM their lowest price when accepting reimbursement for a prescription. As a result, pharmacies are careful to set cash prices higher than their negotiated PBM rates. Without prohibition of such anticompetitive contract clauses, pharmacies will not offer competitive cash prices for fear of triggering these best-price clauses.”
The problems with patients filling their prescriptions at “cash” pharmacies is that coordination of care may suffer (no feedback about their filling/refilling prescriptions) and the amount of spending is not counted toward their deductibles and annual out of pocket maximums.
Read the article for thoughtful solutions to these problems.

Who needs Humira? AbbVie projected to be the top pharma company by sales in 2028: analysts “Reports of the demise of AbbVie—concurrent with the loss of exclusivity for its mega-blockbuster drug Humira—have been greatly exaggerated.  
At least that’s the consensus view of sell-side analysts polled by Evaluate Pharma, who predict that the Illinois-based pharma giant will generate more prescription sales than any company in the industry in 2028.
They see AbbVie's $65.7 billion in expected 2028 sales closely followed by Roche at $65 billion. Johnson & Johnson ($62.3 billion), Merck ($59.7 billion) and Pfizer ($57.1 billion) round out the top 5 in their projections.”

Pfizer to sell stake in GSK's consumer healthcare firm after spin-off “Pfizer plans to sell its stake in Haleon, the consumer healthcare company to be spun-out of GSK later this year, as it continues to increase its focus on medicines and vaccines. GSK said Wednesday that Pfizer ‘intends to exit its 32% ownership interest in Haleon in a disciplined manner, with the objective of maximising value for Pfizer shareholders.’”

World Health Organization Resolves to Improve Clinical Trials Globally “In an effort to prepare for future health emergencies, the World Health Organization (WHO) has adopted a resolution geared toward delivering higher quality data and improving the conduct and coordination of clinical trials around the world.”
Here is the full text of the resolution from the Seventy-fifth World Health Assembly last week.

About the public’s health

 Biden-Harris Administration Establishes HHS Office of Environmental Justice The “U.S. Department of Health and Human Services (HHS) is establishing an Office of Environmental Justice (OEJ) to better protect the health of disadvantaged communities and vulnerable populations on the frontlines of pollution and other environmental health issues. The new office will sit within the Office of Climate Change and Health Equity at HHS…
As the HHS-wide hub for environmental justice policy, programming, and analysis, the Office of Environmental Justice is tasked with:

  • Leading initiatives that integrate environmental justice into the HHS mission to improve health in disadvantaged communities and vulnerable populations across the nation.

  • Developing and implementing an HHS-wide strategy on environmental justice and health.

  • Coordinating annual HHS environmental justice reports.

  • Providing HHS’ Office of Civil Rights with environmental justice expertise to support compliance under Title VI of the Civil Rights Act of 1964.

  • Promoting training opportunities to build an environmental justice workforce.” 

WHO: Monkeypox won’t turn into pandemic, but many unknowns “The World Health Organization’s top monkeypox expert said she doesn’t expect the hundreds of cases reported to date to turn into another pandemic, but acknowledged there are still many unknowns about the disease, including how exactly it’s spreading and whether the suspension of mass smallpox immunization decades ago may somehow be speeding its transmission.”

Outcomes Following Taxation of Sugar-Sweetened Beverages: A Systematic Review and Meta-analysis Use of higher taxes on harmful items (like cigarettes) have consistently been the best way to reduce usage. This meta-analysis of sugar-sweetened beverages reconfirms this fact.
”In this systematic review of 86 studies and a meta-analysis of 62 studies, implemented SSB taxes were associated with higher prices of targeted beverages (tax pass-through of 82%) and 15% lower SSB sales, with a price elasticity of demand of −1.59. No negative changes in employment were identified.”

About healthcare IT

 VA now required to report performance, costs of troubled EHR system to Congress This article is a update on the long saga of the VA’s (less than successful and over-budget) implementation of its IT system. “The Department of Veterans Affairs (VA) will now have to submit regular reports to Congress about the performance of its new $16 billion medical records system, including incidents that risk patient safety, under new legislation headed to President Joe Biden's desk.
The Senate approved a bill (PDF) last week that aims to increase transparency surrounding the VA's electronic health record modernization (EHRM) program, a project that has been plagued with problems as it has been rolled out to three VA locations.
This legislation already passed the House of Representatives and will now go to the president to be signed into law.”

BD to patch cybersecurity risks found in drug dispensing, lab management tech “BD said it would issue software updates for two of its products after discovering separate privacy concerns and potential hacking risks in each.
The affected technologies are BD’s Pyxis systems for medication management and dispensing and its Synapsys workflow management software for clinical diagnostic labs. BD voluntarily reported each of the cybersecurity issues to the FDA and other relevant authorities, including the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency, or CISA.”

About health technology

 Racial and Ethnic Discrepancy in Pulse Oximetry and Delayed Identification of Treatment Eligibility Among Patients With COVID-19 “Are there systematic racial and ethnic biases in pulse oximetry among patients with COVID-19, and is there an association between such biases and unrecognized or delayed recognition of eligibility for oxygen threshold–specific therapy?…
The study results suggest that overestimation of arterial oxygen saturation levels by pulse oximetry occurs in patients of racial and ethnic minority groups with COVID-19 and contributes to unrecognized or delayed recognition of eligibility to receive COVID-19 therapies.”

NZ-based AI firm launches tool to assess heart risk through retinal scans in U.S.Toku Eyes, a New Zealand-based healthcare AI company, is launching its tool that assesses heart risk through a retinal scan in the U.S.
The tool, called ORAiCLE, uses an AI platform to identify cardiovascular threats more accurately than existing risk calculators, the company claims. The platform recognizes subtle changes in aspects like blood vessels and pigmentation to identify a person’s risk of a stroke or heart attack in the next five years…
Since using a retinal camera and the AI software requires minimal training, it is more cost-effective and accessible, the company argues. The AI platform uses an image of the back of the eye to do its assessment. It then provides personalized health guidance or recommends a specialist referral. The company says the technology also works accurately with low-resolution images.
 ORAiCLE is being released as a wellness device and therefore does not require FDA clearance…”

Today's News and Commentary

HHS Secretary Becerra Establishes ARPA-H within NIH, Names Adam H. Russell, D.Phil. Acting Deputy Director “Health and Human Services Secretary Xavier Becerra… announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health and the appointment of Adam H. Russell, D.Phil., as acting deputy director…
With broad technical and management experience across several disciplines, ranging from cognitive neuroscience and physiology to cultural psychology and social anthropology, Dr. Russell will guide the early stages of building the administrative structure of the agency and oversee the hiring of initial operational staff to ensure the agency is stood up as effectively and efficiently as possible. President Biden will appoint an ARPA-H Director who will be responsible for administration and operation of ARPA-H and will report to the HHS Secretary.”

About Covid-19

 As summer begins, US COVID-19 cases six times higher than last year “As the US marks Memorial Day weekend and the unofficial start of summer, the seven-day average for COVID-19 cases in the U.S. are more than six times what they were a year ago. 
The Johns Hopkins Coronavirus Resource Center showed a seven-day average of 119,725 cases as of Saturday. That figure held at 17,887 cases on May 28 of last year…
The seven-day average of 470 deaths reported on Friday marked a decrease from 637 on the same day last year.”

About health insurance

 Medicare recipients to see premium cut — but not until 2023 “Medicare recipients will get a premium reduction — but not until next year — reflecting what Health and Human Services Secretary Xavier Becerra said Friday was an overestimate in costs of covering an expensive and controversial new Alzheimer’s drug.
Becerra’s statement said the 2022 premium should be adjusted downward but legal and operational hurdles prevented officials from doing that in the middle of the year. He did not say how much the premium would be adjusted.”

About hospitals and healthcare systems

 National Hospital Flash Report: May 2022  Among the highlights:
—”The median Kaufman Hall Year-To-Date (YTD) Operating Margin Index reflecting actual margins was -3.09% through April.
The median change in Operating Margin was down 38.1% from last month and 76% from April 2021…
—Patient Days were down 5.7% month-over-month and 1.8% compared to April 2021. Adjusted Patient Days dropped 6.5% from March to April but were up 1.8% compared to April 2021…
—Volume lags resulted in poor revenue performance in April. Gross Operating Revenue was down 7% from March and Outpatient (OP) Revenue dropped 7% from March levels. However, Gross Operating Revenue is up 6.6% YTD, while OP Revenue is up 8.5% YTD. Similarly, Inpatient Revenue dropped 7.1% from the previous month and is up 5.3% this year…
—Total Expenses remained high in April, dropping only 4.3% from March. Expenses have continued to rise compared to 2020 and are well above pre-pandemic levels. As labor shortages and supply chain challenges continued, Total Expenses grew by 8.3% YOY and 9.6% YTD…
—The emergency department is no longer the hospital’s front door.
More patients are seeking care outside of the hospital, choosing urgent care centers, telemedicine, and even primary care providers instead of the emergency department…
—Patients are sicker and more expensive to treat.”

About pharma

 The FDA is busy busting up drug counterfeiting rings—but is it doing enough to protect patients? “The FDA’s Office of Criminal Investigations staged 130 counterfeit drug busting operations between 2016 and 2021, according to a new report published in the journal Annals of Pharmacotherapy. But one expert says all of those operations ‘barely scratch the surface’ of the problem and that serious safety risks remain…
All told, about 65% of the FDA’s enforcement actions centered on phony products sold over the internet. In about 85% of the FDA’s operations, patients could obtain the counterfeit drugs—often controlled substances like opioids, stimulants and benzodiazepines—without a prescription…”

The top 20 drugs by worldwide sales in 2021 FYI. No surprise, #1 is Comirnaty (Pfizer/BioNTech’s Covid 19 vaccine). #2 is Humira.

Amgen's Neulasta faces more competition as FDA okays another biosimilar “Amneal Pharmaceuticals announced Friday that the FDA approved Fylnetra (pegfilgrastim-pbbk), its biosilimar version of Amgen's Neulasta. In recent years, the US regulator has cleared several biosimilar competitors to Neulasta, which is used to reduce the incidence of infection associated with febrile neutropenia in patients undergoing chemotherapy.”
Each new biosimilar lowers the market charges for that drug, so any new approvals are very welcome.

GSK expands vaccine portfolio with $3.3-billion deal for Affinivax “GSK announced Tuesday a definitive agreement to acquire Affinivax for up to $3.3 billion, including an upfront payment of $2.1 billion, boosting its vaccine portfolio against pneumococcal disease. Hal Barron, GSK's chief scientific officer, said the deal ‘further strengthens our vaccines R&D pipeline, provides access to a new, potentially disruptive technology, and broadens [our] existing scientific footprint in the Boston area.’
According to GSK, Affinivax's Multiple Antigen-Presenting System (MAPS) technology ‘supports higher valency than conventional conjugation technologies, enabling broader coverage…and potentially creating higher immunogenicity than current vaccines.’ The company's lead vaccine candidate AFX3772 includes 24 pneumococcal polysaccharides plus two conserved pneumococcal proteins, while a 30-plus valent pneumococcal candidate vaccine is also in preclinical development.”

FDA Grants Fast-Track Label to Pfizer’s Combination Therapy for NASH “The FDA has handed Fast-Track designation to Pfizer’s investigational combination therapy ervogastat and clesacostat for the treatment of nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease.
The agency’s decision is based on study results showing that the ervogastat and clesacostat treatment combination led to a reduction of liver fat along with a favorable tolerability and safety profile.”

About the public’s health

 Daily E-cigarette Use and the Surge in JUUL Sales: 2017–2019 “Among baseline nondaily tobacco users, only those aged 14 to 17 years had an increase in the 2-year incidence of new daily tobacco use (2014 cohort = 4.8%, 95% confidence interval 4.3, 5.5 vs 2017 cohort = 6.3%, 95% confidence interval 5.8–7.0) to rates approaching those in the 1990s. In 2019, three-quarters of new daily tobacco users aged 14 to 17 vaped daily and had e-cigarette dependence scores similar to daily cigarette smokers and older adult e-cigarette vapers. We estimate that about 600 000 Americans aged <21 years used JUUL products daily in 2019, a rate 2.5 times those aged 25 to 34 years.”

FDA investigating hepatitis A outbreak possibly linked to fresh strawberries “The FDA with the US Centers for Disease Control and Prevention, the Public Health Agency of Canada, the Canadian Food Inspection Agency and state and local partners, said the strawberries were branded as FreshKampo and HEB and purchased between March 5 and April 25.
They were distributed nationwide and sold at a number of retailers including Aldi, HEB, Kroger, Safeway, Sprouts Farmers Market, Trader Joe's, Walmart, Weis Markets and WinCo Foods.”

Association of Sugar-Sweetened, Artificially Sweetened, and Unsweetened Coffee Consumption With All-Cause and Cause-Specific Mortality “Moderate consumption of unsweetened and sugar-sweetened coffee was associated with lower risk for death.”
An accompanying editorial comments: “Unfortunately, Liu and colleagues' study does not quite get at what we really want to know. Is drinking coffee laden with sugar and calories still potentially beneficial, or at least not harmful? The coffee consumption data used in their study reflected consumption from approximately 10 years ago in a country [UK] where tea is a competing beverage. The average dose of added sugar per cup of sweetened coffee was only a little over a teaspoon, or about 4 grams. This is a far cry from the 15 grams of sugar in an 8-ounce cup of caramel macchiato at a popular U.S. coffee chain. Nonetheless, Liu and colleagues' data are reassuring in demonstrating that most study participants who drank coffee added no or only small amounts of sugar and this pattern of intake was not harmful from a mortality risk perspective and was potentially beneficial.”

Top-RatedHealthcare: The US States with the Best HealthcareWe ranked all 50 states based on five factors: % of “A” Grade Hospitals (patient safety), number of honor roll hospitals, number of hospitals in America’s top 50, hospitals per million people and staffed hospital beds per million people. These factors combined give each state a healthcare rank you can use as a guide to where you can find the best level of healthcare in the US.”
See if you agree with the rankings. For example, this methodology ranks Hawaii #47- very much lower than many other “lists.”

Austin pushing to effectively decriminalize abortion ahead of ruling on Roe “The city of Austin is attempting to shield its residents from prosecution under a Texas law that would criminalize almost all abortions if Roe v. Wade is overturned — the first push by a major city in a red state to try to circumvent state abortion policy.
Councilmember Chito Vela is proposing a resolution that would direct the city’s police department to make criminal enforcement, arrest and investigation of abortions its lowest priority and restrict city funds and city staff from being used to investigate, catalogue or report suspected abortions.”

About health technology

 Medtronic, DaVita to form new kidney care company “According to a news release, the new company will bring together Medtronic’s capabilities as a healthcare technology leader and DaVita’s expertise as a comprehensive kidney care provider. The new company will focus on developing a wide range of novel kidney care products and solutions, including future home-based products to make different dialysis treatments more accessible.”

Today's News and Commentary

This week is the American Society of Clinical Oncology (ASCO) 2022 Meeting. Here is a link to the abstracts.

HHS withdraws controversial Trump-era sunset rule that required review of all regulations “The Department of Health and Human Services (HHS) has withdrawn a controversial Trump-era rule that would have required the agency to do a massive review of its existing regulations. 
HHS issued a final rule Thursday that would get rid of the sunset rule passed at the tail end of the Trump administration. The agency said the rule’s requirements for reviewing existing agency regulations to keep them up to date created major burdens on staff and the industry.”

About Covid-19

 CDC Plans to Stop Reporting Suspected Covid Cases to Ease Burden “The Centers for Disease Control and Prevention plans to simplify the Covid-19 hospital data it collects as the demands of the pandemic evolve and some assembled information has become outdated or redundant. 
The agency is likely to stop collecting data from hospitals on suspected Covid cases that haven’t been confirmed by tests, for example, and may also wind down federal reporting from rehabilitation and mental health facilities that aren’t major intake points for virus cases, according to a draft of the plan that was viewed by Bloomberg News.”
On the other hand: CMS turning attention to hospitals with Covid outbreaks “The Centers for Medicare and Medicaid Services is probing hospitals where a high rate of patients have gotten Covid-19 infections after cases spiked to record highs this year.
Jon Blum, the agency’s principal deputy administrator and chief operating officer, told POLITICO on Wednesday that the regulator is focusing on facilities with Covid outbreaks, taking into account patient and health workers’ safety complaints, a change from the agency’s “less rigorous” process early in the pandemic.”

COVID-19 vaccine effectiveness in patients with cancer: remaining vulnerabilities and uncertainties “Vaccine effectiveness was compared between a cohort of patients with cancer and a control cohort of participants without cancer. Although initially similar between the cohorts, vaccine effectiveness waned more rapidly in the cancer cohort, falling to 47·0% (95% CI 46·3–47·6) at 3–6 months, than in the control cohort, in which it decreased to 61·4% (61·4–61·5). Waning of vaccine effectiveness was greatest in patients with leukaemia or lymphoma or a recent cancer diagnosis and in those who had received systemic anticancer therapy or radiotherapy within the preceding 12 months. A post-hoc analysis estimated that vaccine effectiveness was 74·6% (72·8–76·3) against COVID-19-related hospitalisation and 90·3% (89·3–91·2) against COVID-19-related death at 3–6 months after the second dose in the cancer cohort; other studies have reported a more severe disease course and higher mortality associated with SARS-CoV-2 breakthrough infections in patients with cancer versus those without.”

About health insurance

 More in the news about the effects of termination of ACA plan subsidies. Today’s The Washington Post has a great summary of the issues and impact. The other side of the coin is this study: What Will Happen to Healthcare Spending if the American Rescue Plan Act Premium Tax Credits Expire?  “Key Findings:

  • Hospital spending would decline by $3.8 billion.

  • Prescription drug spending would decline by $3.4 billion.

  • Spending on services provided outside of hospitals and physician offices would decline by $2.8 billion.

  • Spending on physician practice services would decline by $1.3 billion.

  • Florida, Georgia, North Carolina, South Carolina, and Texas would experience the largest decline in total healthcare spending, ranging from 1.3% to 1.9%.”

About hospitals and healthcare systems

 UPMC's big losses in Q1: 6 things to know These issues are common to many hospitals. “The provider-payer cited the effect of COVID-19 and the most recent surge, along with labor conditions and supply markets as the reason for increased employment, staffing and operating expenses that have exceeded growth in revenue.” Also, the financial market dip had an effect: “The system lost $242 million in the first quarter from investing and financing activities. In the first quarter of 2021, the company made $326 million from investing and financing activities.”

Cleveland Clinic reports $282M quarterly loss “‘Operating revenues in the first quarter of 2022 were impacted by lower patients served, partially due to the postponement of nonessential surgeries and procedures during the month of January,’ the system said in an earnings release…
Cleveland Clinic reported expenses of $2.96 billion in the first quarter of this year, up from $2.56 billion in the same quarter of 2021. The system saw expenses rise across all categories, including supplies and salaries, wages and benefits.”

About the public’s health

Association of Inappropriate Outpatient Pediatric Antibiotic Prescriptions With Adverse Drug Events and Health Care Expenditures “The cohort included 2 804 245 eligible children… Overall, 31% to 36% received inappropriate antibiotics for bacterial infections and 4% to 70% for viral infections. Inappropriate antibiotics were associated with increased risk of several adverse drug events, including Clostridioides difficile infection and severe allergic reaction among children treated with a nonrecommended antibiotic agent for a bacterial infection… Thirty-day attributable health care expenditures were generally higher among children who received inappropriate antibiotics, ranging from $21 to $56 for bacterial infections and from −$96 to $97 for viral infections. National annual attributable expenditure estimates were highest for suppurative OM ($25.3 million), pharyngitis ($21.3 million), and viral URI ($19.1 million).”

Massachusetts General vaccinating employees against monkeypox “Boston-based Massachusetts General Hospital this week began vaccinating some employees against monkeypox who were in close contact with a patient diagnosed with the virus…
Previously, the Jynneos monkeypox vaccine had been used in the U.S. only in clinical trials, Brett Petersen, MD, deputy chief of the CDC's Poxvirus branch, confirmed to the newspaper. 
The workers were in close contact with the male patient, who was hospitalized at Massachusetts General Hospital from May 12-20.”
And in a related article: FDA Approves IV Form of TPOXX for Smallpox “The FDA has approved SIGA Technologies’ intravenous formulation of TPOXX (tecovirimat) for the treatment of smallpox.
The agency previously approved TPOXX in oral form in July 2018 as the first drug indicated for treatment of smallpox. But the new approval gives an option for those who are unable to swallow oral capsules of the drug, the company said…
SIGA said the drug could also be used in the treatment of monkeypox…”

Associations of Clinical and Social Risk Factors With Racial Differences in Premature Cardiovascular DiseaseAmong 2785 Black and 2327 White participants followed for a median 33.9 years (25th–75th percentile, 33.7–34.0), Black (versus White) adults had a higher risk of incident premature CVD (Black women: HR, 2.44 [95% CI, 1.71–3.49], Black men: HR, 1.59 [1.20–2.10] adjusted for age and center). Racial differences were not statistically significant after full adjustment (Black women: HR, 0.91 [0.55–1.52], Black men: HR 1.02 [0.70–1.49]). In women, the largest magnitude percent reduction in the β estimate for race occurred with adjustment for clinical (87%), neighborhood (32%), and socioeconomic (23%) factors. In men, the largest magnitude percent reduction in the β estimate for race occurred with an adjustment for clinical (64%), socioeconomic (50%), and lifestyle (34%) factors.”

Black Patients Often Never Given a Chance to Join Breast Cancer Trials “Among more than 400 respondents surveyed, 40% of Black patients said they were not told about the possibility of enrolling in a clinical trial versus 33% of patients who identified as being of another race or ethnicity, reported Stephanie Walker, RN, of the Metastatic Breast Cancer Alliance in New York City.
But 92% of Black respondents said they were interested in learning about trials, and 83% said they were either "somewhat or very likely" to consider enrolling, she said during a press briefing ahead of the American Society of Clinical Oncology (ASCO) annual meeting.
Walker noted that roughly 15% of breast cancer patients in the U.S. are Black, and these patients carry the highest mortality rates, yet Black patients make up only 4-6% of trial participants.
The survey identified several barriers to trial participation that if addressed could bolster enrollment, said Walker, including concerns over treatments, trust issues, and worry over potential costs.”

Comparison of Cancer-Related Spending and Mortality Rates in the US vs 21 High-Income Countries “In this cross-sectional study of 22 countries, the median cancer mortality rate was 91.4 per 100 000 population… The US cancer mortality rate was higher than that of 6 other countries (86.3 per 100 000). Median per capita spending in USD for cancer care was $296 (IQR, $222-$348), with the US spending more than any other country ($584). After adjusting for smoking, 9 countries had lower cancer care expenditures and lower mortality rates than the US. Of the remaining 12 countries, the US additionally spent more than $5 million per averted death relative to 4 countries, and between $1 and $5 million per averted death relative to 8 countries. Cancer care expenditures were not associated with cancer mortality rates, with or without adjustment for smoking…”

About healthcare IT

 CVS Health to launch new virtual primary care solution on single digital platform “The new offering, which is being sold to Aetna fully-insured, self-insured plan sponsors, and CVS Caremark clients now, will become effective for eligible Aetna members starting January 1, 2023, and for eligible CVS Caremark members during the second quarter of 2023. It complements Aetna’s virtual care strategy currently in market…
 CVS Health Virtual Primary Care will give members access to primary care, on-demand care, chronic condition management, and mental health services virtually, with the option of being seen in-person when needed at an in-network provider, including MinuteClinic. The virtual primary care provider can also help members identify appropriate in-network specialists and other in-network health service providers, if necessary.”

 About healthcare quality and safety

CMS Proposes to Suppress The Data on 25,000 Preventable Hospital Deaths Last Year. We Say No.  From The Leapfrog Group: “The data targeted for suppression includes rates of serious complications from surgery like sepsis and kidney harm, along with preventable complications from medical care such as deep bed sores, lung collapse, and blood clots…
Just two months ago, leaders at CMS and the Centers for Disease Control and Prevention (CDC) reported that since 2020, federal data shows a significant increase in the number of common hospital infections and patient safety mistakes occurring during the pandemic. These federal officials have the data, but now want to suppress much of it from the American public.”

Today's News and Commentary

About Covid-19

Biden Administration Announces Launch of First Federally-Supported Test to Treat Site “Today, Rhode Island will officially launch the nation’s first federally-supported Test-to-Treat site at a clinic in Providence. Federal reimbursement will now allow individuals who test positive for COVID-19 at the clinic to immediately receive an assessment from a medical provider and get oral antiviral treatments—if prescribed—all in one convenient location that serves some of the state’s highest-risk and hardest-hit populations. The clinic also currently offers vaccination, meaning that federal support will help enhance this site into being a true one-stop shop for individuals to protect themselves and their communities from COVID-19…
The Administration will open federally-supported Test-to-Treat sites in New York and Illinois in the coming weeks, and is working with other regions like Massachusetts and New York City to enhance existing state-led efforts to increase access to oral antivirals like Paxlovid.”

 Vaccines offer little protection against long Covid, study finds “The Covid vaccines, while holding up strong against hospitalization and death, offer little protection against long Covid, according to research published Wednesday in the journal Nature Medicine
Compared to an unvaccinated individual, the risk of long Covid in a fully vaccinated individual was cut by only about 15 percent, the study found.”
To put the findings into perspective: Vaccination significantly reduces the chance of getting Covid-19 infection. If you are infected, vaccination also significantly reduces the chance you will get a serious illness or die. But if you do get a Covid-19 infection, previous vaccination reduces your chances of getting “long Covid” by 15%.

About health insurance

 CMS extends annual postpartum Medicaid, CHIP coverage to 4 states “The Biden administration has approved four states—Florida, California, Oregon and Kentucky—to expand Medicaid and Children’s Health Insurance Program (CHIP) coverage to up to a year postpartum. 
The announcement on Wednesday brings the final number of states choosing to expand postpartum Medicaid coverage to seven overall.”

Normalizing Utilization and Pivot to Value-Based Care Delivery Models Present Opportunities for Employer-Sponsored Health Plans, J.D. Power Finds “Following are key findings of the 2022 study:

  • Overall satisfaction flat year over year: Overall satisfaction has increased 17 points (on a 1,000-point scale) during the past five years, but there is no change in 2022 from 2021, due in part to declines in satisfaction in customer service and dissatisfaction with coverage options and desired network providers.

  • Responsiveness and innovation drive higher satisfaction: The average overall satisfaction score among members who describe their health plan as being “responsive” is 847, which is 346 points higher than among those who describe their health plan as being “slow.” Similarly, the satisfaction performance gap between plans that are perceived as “innovative” (873) and those perceived as “conventional” (604) is 269 points.

  • Call center talent in crosshairs: Customer service call center performance among health plans declines overall in several metrics; including an index score decline of 5 points year over year (791 from 796). Members indicate putting more effort into calls handled by a customer service representative, citing examples of having to repeat information and not having their questions, requests or problems resolved in a timely manner. Phone hold times have increased an average of 52 seconds, or 15% year over year, while knowledge and clarity of information provided has declined.

  • Opportunities continue to leverage digital solutions and tools to improve care delivery: Although engagement activity has remained relatively consistent, members have declining satisfaction with text messaging support (-14 points), website (-6) and mobile app (-6). Consistent with this finding, just 22% of members describe their health plan as being “innovative,” a number that has not changed in the past three years.”

About pharma

 Importation of Prescription Drugs Final Rule  This FDA document provides guidance only for importation of drugs from Canada.
”Essentially, eligible prescription drugs are those that could be sold legally on either the Canadian market or the American market with appropriate labeling.
The final rule excludes certain types of drug products from eligibility: controlled substances, biological products, infused drugs (including peritoneal dialysis solutions), drugs that are inhaled during surgery, drugs that are injected intravenously (into a vein), intrathecally (into the spinal fluid), or intraocularly (into the eye), drugs that are subject to a risk evaluation and mitigation strategy (REMS), and drugs that are not subject to certain provisions of the Drug Supply Chain Security Act. For a drug product not excluded by the final rule, FDA will determine whether the product can be imported safely in the context of a specific SIP [Section 804 Importation Program] on a product-by-product basis.”  

About the public’s health

 Oklahoma governor signs the nation's strictest abortion ban “Oklahoma Gov. Kevin Stitt on Wednesday signed into law the nation's strictest abortion ban, making the state the first in the nation to effectively end availability of the procedure.
State lawmakers approved the ban enforced by civil lawsuits rather than criminal prosecution, similar to a Texas law that was passed last year. The law takes effect immediately upon Stitt's signature and prohibits all abortions with few exceptions. Abortion providers have said they will stop performing the procedure as soon as the bill is signed.”

About healthcare IT

 Anthem Looks to Fuel AI Efforts With Petabytes of Synthetic Data “Anthem Inc.’s chief information officer says he is working with Alphabet Inc.’s Google Cloud to create a synthetic data platform that will let the health insurance company better detect fraud and offer personalized care to its members.
Anil Bhatt said the plan is to use algorithms and statistical models to generate approximately 1.5 to 2 petabytes of synthetic data, including artificially generated data sets of medical histories, healthcare claims and other key medical data, created in partnership with Google Cloud.”

About healthcare personnel

 PROVIDER PAY AND THE DEMIC: REALIZING RECOVERY From the MGMA: “Primary care, surgical specialist, and nonsurgical specialist physician compensation, as well as advanced practice provider (APP) compensation, increased from 2020 to 2021. In particular:

—The area with the biggest percentage decline in median total compensation in the first year of the pandemic — nonsurgical specialist physicians — saw a 3.12% increase from 2020 and a 1.79% increase over 2019’s level.
—Surgical specialist physicians, who had the second-largest drop in compensation from 2019 to 2020, rebounded with a nearly 4% increase from 2020 to 2021, as median total compensation reached $517,501 last year.
—Primary care physicians saw compensation gains slightly behind those seen in 2020, with median total compensation reaching $286,525 in 2021…

With the first quarter of 2022 in the books, medical groups are signaling some optimism, with 85% reporting their year-to-date visit volumes are at or above 2021 levels.”

Today's News and Commentary

Doctors have joined the chorus for more gun restrictions Condolences to the families and friends of the Robb Elementary School victims. Today’s “The Health 202” in The Washington Post has an excellent summery of recent gun control efforts.
Rhetorical question: Why is it that the Republican party opposes gun control legislation and at the same time it claims to be be an advocate of the pro-life agenda?

About Covid-19

 US has a new dominant COVID-19 strain “A highly contagious sublineage of the BA.2 omicron subvariant is now the nation's dominant strain, according to the CDC's latest variant proportion estimates. 
The sublineage, BA.2.12.1, accounted for 57.9 percent of all U.S. COVID-19 cases in the week ending May 21, CDC data shows. BA.2, which became the nation's dominant strain in mid-March, now accounts for an estimated 39.1 percent of all cases.
BA.2.12.1 is estimated to have a 25 percent growth advantage over BA.2, which is already more transmissible than the original omicron strain.”

Post–COVID Conditions Among Adult COVID-19 Survivors Aged 18–64 and ≥65 Years — United States, March 2020–November 2021 “COVID-19 survivors have twice the risk for developing pulmonary embolism or respiratory conditions; one in five COVID-19 survivors aged 18–64 years and one in four survivors aged ≥65 years experienced at least one incident condition that might be attributable to previous COVID-19.
What are the implications for public health practice?
Implementation of COVID-19 prevention strategies, as well as routine assessment for post-COVID conditions among persons who survive COVID-19, is critical to reducing the incidence and impact of post-COVID conditions, particularly among adults aged ≥65 years.”

About health insurance

SCOTUS should stay out of False Claims Act dispute, says DOJ “The U.S. Supreme Court should not use a whistleblower’s complaint against a for-profit hospice provider to clarify the level of detail required to plead Medicare fraud under the False Claims Act, the Justice Department’s top lawyer has told the court.
U.S. Solicitor General Elizabeth Prelogar said no further clarification of the standard is necessary because there is no true circuit split…”

 New Study: No Surprises Act [NSA] Prevented Over Two Million Potential Surprise Bills for Insured Americans “AHIP and Blue Cross Blue Shield Association (BCBSA) released a survey and analysis which found that in the first two months of 2022, the NSA prevented more than two million potential surprise medical bills across all commercially insured patients. The analysis also found that should this trend hold, more than 12 million surprise bills will be avoided in 2022.”

Measuring progress in improving prior authorization[PA] Highlights from an AMA survey:
— “A strong majority (84% and 84%, respectively) of physicians report that the number of PAs required for prescription medications and medical services has increased over the last five years…
—A majority (65% and 62%, respectively) of physicians report that it is difficult to determine whether a prescription medication or medical service requires PA…
—An overwhelming majority (88%) of physicians report that PA interferes with continuity of care.”

Disparities in Health Care Use Among Low-Salary and High-Salary Employees “In this study, we found that lower-salary employees enrolled in an HDHP with an HSA through their employer spent significantly less on outpatient services and prescription fills compared with higher-salary employees. At the same time, low-salary employees spent significantly more on ED care. These results suggest that low-salary employees may be forgoing outpatient services and instead spending more in the ED compared with higher-salary employees when HDHPs are present. This pattern of health care utilization may lead to delayed diagnosis of health conditions and potentially miss the window and benefits of early diagnosis or prevention.”

8 recent payer mergers and acquisitions A good summary of recent activities.

New York attorney general $13.6M to consumers denied mental healthcare coverage by UnitedHealthcare “New York and federal law requires mental health and substance use disorder parity under all health plans. [Attorney general] James sued UnitedHealthcare under those laws, claiming two practices by the company violated behavioral health parity laws by improperly restricting coverage of psychotherapy. According to Ms. James, UnitedHealthcare had reduced reimbursement to members for psychotherapy and set arbitrary thresholds to trigger reviews of psychotherapy treatments, often leading to denials of coverage.”

About hospitals and healthcare systems

 Financial updates from 16 health systems  A good summary and links to individual results. Many systems had increased revenues but decreased operating margins- due to increased personnel and supply costs.

 Advocate Aurora hit with class action alleging anticompetitive behavior in eastern Wisconsin “Advocate Aurora Health has been hit with a class-action antitrust lawsuit alleging the system has used its market strength in eastern Wisconsin to suppress competition and drive ‘unreasonably high prices.’
Filed Tuesday, the case was brought by Uriel Pharmacy, based in Wisconsin, and its self-funded health plan…
Among the anticompetitive strategies plaintiffs alleged the large nonprofit employed were “all-or-nothing” clauses that require commercial health plans to include all Advocate Aurora facilities in their networks.
Advocate Aurora ‘aggressively’ blocks employers and payers from directing patients to competing facilities, according to the complaint, and ‘has gone to extraordinary lengths to suppress innovative insurance products, such as tiered plans, that would reduce costs for employers.’”
For example: “A colonoscopy with biopsy at Advocate Aurora Health would run employer health plans $10,700 compared to roughly $4,700 at Froedtert & the Medical College of Wisconsin, ‘a facility that is about 15 minutes away and has generally higher quality and safety ratings,’ plaintiffs wrote in a complaint filed Tuesday.”

Top critical access hospitals announced “The 20 highest-ranked critical access hospitals (CAHs) in the country, as determined by the Chartis Center for Rural Health, were recently announced by the National Rural Health Association (NRHA)…
The determining factors for the top 20 CAHs are based on the results of the Chartis Rural Hospital Performance INDEX and its eight indices of performance: inpatient market share, outpatient market share, quality, outcomes, patient perspective, cost, charge, and finance.”

About pharma

Pfizer to provide all patented drugs, vaccines to poor countries on no-profit basis “Pfizer announced Wednesday that it will provide all of its current and future patent-protected medicines and vaccines that are available in the US or Europe on a not-for-profit basis to 45 lower-income countries. The company noted that Rwanda, Ghana, Malawi, Senegal and Uganda have committed to join the programme and will help identify and resolve hurdles to inform the roll out in other countries.”

CVS Will Stop Filling Controlled-Substance Prescriptions for Cerebral, Done “CVS’s move is the most sweeping action by a major pharmacy chain on prescriptions by the telehealth companies in the wake of scrutiny of their prescription practices for attention-deficit hyperactivity disorder medication. Concern over those practices has also prompted an investigation by federal prosecutors, who subpoenaed Cerebral earlier this month and led Cerebral last week to replace its chief executive.
Cerebral and Done between them treat tens of thousands of patients for ADHD, prescribing stimulants such as Adderall.”

 FDA Approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years  The headline is the story.

 Teva, Allergan Strike $161M Deal With W.Va. AG In Opioid Case The headline is the story.

About the public’s health

 E-Cigarette use costs US $15 billion per year, reports UCSF in first study of its kind “Use of electronic cigarettes costs the United States $15 billion annually in health care expenditures — more than $2,000 per person a year — according to a study by researchers at the UC San Francisco School of Nursing. 
The study, published on May 23, 2022 in Tobacco Control, is the first to look at the health care costs of e-cigarette use among adults 18 and older.”
And in a related story: Use Patterns, Flavors, Brands, and Ingredients of Nonnicotine e-Cigarettes Among Adolescents, Young Adults, and Adults in the United States “This cross-sectional study of 6131 US residents aged 13 to 40 years found that 25.9% had ever used a nonnicotine e-cigarette, 16.7% had used one in the past 30 days, and 12.4% had used one in the past 7 days; 18.8% had ever co-used nonnicotine and nicotine e-cigarettes. The most-used flavors were sweet, dessert, or candy flavors; fruit flavors; and mint or menthol flavors; most common ingredients were tetrahydrocannabinol, cannabidiol, melatonin, caffeine, and essential oils.
Meaning  These findings suggest that a significant proportion of US residents are using nonnicotine flavored e-cigarettes marketed with unsupported health claims, which warrants further research, regulation, and prevention.”

Tedros Adhanom Ghebreyesus re-elected as director-general of World Health Organization The
re-election extends his tenure for another five years.

About healthcare IT

 CISA Adds 20 Known Exploited Vulnerabilities to Catalog “CISA has added 20 new vulnerabilities to its Known Exploited Vulnerabilities Catalog, based on evidence of active exploitation. These types of vulnerabilities are a frequent attack vector for malicious cyber actors and pose significant risk to the federal enterprise.”

Why Isn’t New Technology Making Us More Productive? “The growth in productivity since the pandemic hit now stands at about 1 percent annually, in line with the meager rate since 2010 — and far below the last stretch of robust improvement, from 1996 to 2004, when productivity grew more than 3 percent a year…
Seemingly small percentage gains in productivity can make a big difference in a country’s wealth and living standards over time. Even an additional 1 percent annual increase in productivity over a few years, to 2024, would generate an extra $3,500 in per-capita income for Americans, McKinsey & Company estimated in a report last year. The 3.8 percent average annual gain from 1948 to 1972 was the engine of the nation’s postwar prosperity.”
The article has many good examples, including Anthem (Elevance Health).

2022 ANNUAL CONSUMER SENTIMENT BENCHMARK REPORT Lots of good information in this report, ranging from patient: 1)satisfaction about transparency to 2) trust in healthcare professionals and institutions to 3)sources of trusted information and more.

Today's News and Commentary

About Covid-19

 Evolution of neurologic symptoms in non-hospitalized COVID-19 “long haulers” Of the 52 patients completing this study: “Non-hospitalized COVID-19 ‘long haulers’ continue to experience neurologic symptoms, fatigue, and compromised quality of life 14.8 months after initial infection.”

As reports of ‘Paxlovid rebound’ increase, Covid researchers scramble for answers “Almost 90% effective at preventing hospitalizations from Covid-19, Pfizer’s antiviral pill has quickly become one of the most powerful additions to the pandemic arsenal since the advent of mRNA vaccines. But as it’s become more widely available, a growing number of people have found the drug only temporarily effective…
Already, there’s been debate over how to address a rebound. Pfizer’s CEO, Albert Bourla, has suggested that patients who experience one take another course of the drug, while the Food and Drug Administration has put out guidance telling physicians the opposite. On Tuesday morning, the Centers for Disease Control and Prevention issued its first official guidance, reiterating the FDA’s advice against re-treatment and telling rebounding patients to isolate for at least five days and mask for at least 10, as the agency currently advises for new infections.”

About health insurance

 Independence at Home Demonstration Performance Year 7 Results “The IAH Demonstration tests a payment incentive and service delivery model for home-based primary care for Medicare fee-for-service (FFS) beneficiaries with multiple chronic illnesses. The Demonstration tests whether home-based primary care that is designed to provide comprehensive, coordinated, continuous, and accessible care to high-need patients and to coordinate health care across all treatment settings reduces preventable hospitalizations, readmissions, and emergency department visits; improves health outcomes commensurate with beneficiaries’ stage of chronic illness; improves the efficiency of care; reduces the cost of health care services; and achieves beneficiary and family caregiver satisfaction…
In Performance Year 7 of the Demonstration (January 1, 2020 – December 31, 2020), the Centers for Medicare & Medicaid Services (CMS) found that the expenditures for IAH practices’ applicable beneficiaries were approximately 18.0 percent (equating to $42.3 million) below their spending targets, an average reduction of $6,585 per beneficiary. All 10 IAH participants (nine practices and one consortium) reduced the per-beneficiary-per-month (PBPM) expenditures relative to the practice’s PBPM spending target…
All 10 IAH participants met three or more of the six quality measures; three of those practices met the performance thresholds for all six quality measures.”
These findings were a change from the previous 6 years: “Mathematica’s evaluation of the first six years of IAH provided no compelling evidence that the IAH payment incentive reduced Medicare spending or hospital use for high-need patients of practices participating in the demonstration. When examining dually eligible beneficiaries who received home-based primary care from any provider, Mathematica’s analysis found lower expenditures on institutional care and higher expenditures on home-based services—but no reduction in total Medicare or Medicaid spending.”

About the public’s health

  Births: Provisional Data for 2021 From the CDC: “The provisional number of births for the United States in 2021 was 3,659,289, up 1% from 2020 and the first increase in the number of births since 2014. The general fertility rate was 56.6 births per 1,000 women aged 15–44, up 1% from 2020 and the first increase in the rate since 2014. The total fertility rate was 1,663.5 births per 1,000 women in 2021, up 1% from 2020. Birth rates declined for women in age groups 15–24, rose for women in age groups 25–49, and was unchanged for adolescents aged 10–14 in 2021.”
And in a related article:  Temporal Trends in Adverse Pregnancy Outcomes in Birthing Individuals Aged 15 to 44 Years in the United States, 2007 to 2019 “Adverse pregnancy outcomes (APOs) (hypertensive disorders of pregnancy [HDP], preterm delivery [PTD], or low birth weight [LBW]) are associated adverse maternal and offspring cardiovascular outcomes. Therefore, we sought to describe nationwide temporal trends in the burden of each APO (HDP, PTD, LBW) from 2007 to 2019 to inform strategies to optimize maternal and offspring health outcomes…
In aggregate, APOs now complicate nearly 1 in 5 live births. Incidence of HDP has increased significantly between 2007 and 2019 and contributed to the reversal of favorable trends in PTD and LBW. Similar patterns were observed in all age groups, suggesting that increasing maternal age at pregnancy does not account for these trends. Black–White disparities persisted throughout the study period.”

Commentary: The FDA needs more information on supplements. Consumers’ safety is at risk “A national survey conducted for The Pew Charitable Trusts showed about half of adults overestimate the regulatory scrutiny that dietary supplements receive. The reality is that the FDA doesn’t know for certain what products are on the market or what’s in them. This is a serious challenge — one that Congress can address by passing Senate Bill 4090, known as the Dietary Supplement Listing Act of 2022, a bill recently introduced by U.S. Sen. Dick Durbin, D-Ill., and co-sponsored by Sen. Mike Braun, R-Ind…
[F]rom 2007 to 2019, the FDA found almost 1,000 products masquerading as dietary supplements that actually contained active and potentially harmful pharmaceutical compounds from prescription drugs, most commonly erectile dysfunction treatments, steroids and weight loss drugs — including one that was removed from the market in 2010 because it significantly increased risk of heart attack and stroke.”

Plasma Donation Rules Relaxed by FDA to Boost Blood Supply “People with blood pressure measurements outside of the normal range may still donate plasma without first getting a medical exam, the FDA said Monday in draft guidance.”

Screening for Impaired Visual Acuity in Older Adults “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for impaired visual acuity in older adults. (I statement).
And in a related article: Screening for Primary Open-Angle Glaucoma “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for primary open-angle glaucoma in adults. (I statement).”

Monkeypox likely isn't much of a threat to the public, a White House official says “Dr. Raj Panjabi, Senior Director for Global Health Security and Biodefense at the National Security Council, says the fewer than 10 cases seen in the United States so far have not been severe — ‘flu-like symptoms and a rash which can be painful but resolves in two to four weeks’ — and aren't likely to get much worse…
The virus usually spreads from person to person through sustained, skin-to-skin contact with someone with rashes or lesions.”
And in a related story: CDC releasing some smallpox vaccine doses for monkeypox “Jennifer McQuiston, the deputy director for the CDC’s Division of High Consequence Pathogens and Pathology, said during a press briefing that more than a thousand doses of the Jynneos smallpox vaccine are currently available in the U.S., with more doses expected to become available as production ramps up…
Apart from Jenneos, more than a million doses of the older-generation ACAM2000 smallpox vaccine are available, though CDC officials noted on Monday that this shot has some potential side effects that warrant discussion before widespread use.”

About healthcare IT

New AWS Healthcare Accelerator focuses on health equity “To help tackle health disparities, Amazon Web Services (AWS) is announcing the next AWS Healthcare Accelerator cohort—this time with a focus on health equity. The accelerator is one more way we are harnessing the power of the cloud to make access to healthcare equitable. It builds on other efforts we’ve launched in this area, including the AWS Health Equity Initiative, a $40 million, three-year global commitment designed to support innovations in this space. Both the Health Equity Initiative and the Healthcare Accelerator are part of AWS for Health, an offering of AWS services and AWS Partner Network solutions designed to help organizations increase the pace of innovation, unlock the potential of health data, and develop more personalized approaches to therapeutic development and care.”

The Era of Borderless Data Is Ending “Nations are accelerating efforts to control data produced within their perimeters, disrupting the flow of what has become a kind of digital currency…
France, Austria, South Africa and more than 50 other countries are accelerating efforts to control the digital information produced by their citizens, government agencies and corporations. Driven by security and privacy concerns, as well as economic interests and authoritarian and nationalistic urges, governments are increasingly setting rules and standards about how data can and cannot move around the globe. The goal is to gain ‘digital sovereignty.’”
A fascinating article in today’s The NY Times.

About healthcare personnel

 New Surgeon General Advisory Sounds Alarm on Health Worker Burnout and Resignation “There is a Projected Shortage of More than 3 Million Essential Low-Wage Health Workers in the Next Five Years and a Projected Shortage of Nearly 140,000 Physicians by 2033…
Topline recommendations to address burnout in the Surgeon General’s Advisory include:

  • Transform workplace culture to empower health workers and be responsive to their voices and needs.

  • Eliminate punitive policies for seeking mental health and substance use disorder care.

  • Protect the health, safety, and well-being of all health workers. [For example:]

    • Provide living wages, paid sick and family leave, rest breaks, evaluation of workloads and working hours, educational debt support, and family-friendly policies including childcare and care for older adults for all health workers.

    • Ensure adequate staffing, including surge capacity for public health emergencies, that is representative of the communities they serve. This is critical to protect and sustain health workers and communities.

  • Reduce administrative burdens to help health workers have productive time with patients, communities, and colleagues.

  • Prioritize social connection and community as a core value of the healthcare system.

  • Invest in public health and our public health workforce.”

Today's News and Commentary

About Covid-19

Pfizer covid shot 80 percent effective in young kids, early data shows “Pfizer and its German partner, BioNTech, said Monday that an early analysis showed their three-dose coronavirus vaccine regimen triggered a strong immune response in young children, proving 80 percent effective at preventing symptomatic infections in children 6 months to 4 years old…
A few hours after Pfizer and BioNTech issued a news release announcing the data, which has not been peer reviewed, the Food and Drug Administration said its outside experts will meet June 14 and 15 to discuss the Moderna and Pfizer-BioNTech pediatric vaccines. Pfizer and BioNTech said they plan to finish filing data with the FDA this week — and warned that the efficacy number was fluid because results are still arriving.”

 COVID DATA TRACKER WEEKLY REVIEW “As of May 18, 2022, the current 7-day moving average of daily new cases (101,130) increased by 18.8% compared with the previous 7-day moving average (85,143). A total of 82,820,565 COVID-19 cases have been reported in the United States as of May 18, 2022.” 

About hospitals and healthcare systems

 Mayo Clinic posts $227M operating loss for Q1 as labor expenses shoot up “‘Workforce shortages and corresponding labor cost inflation, persistent supply chain disruptions and shortages, a higher interest rate environment and capital market volatility have all taken center stage for management attention,’ the earnings report said.”

Trinity Health's operating income slips 79% as labor costs soar “Higher labor costs put pressure on Trinity Health's margins in the first nine months of fiscal year 2022, according to financial documents released May 20. 
Livonia, Mich.-based Trinity Health posted revenue of $15.13 billion in the nine months ended March 31, up from $15.12 billion in the same period a year earlier. The health system said net patient service revenue was up 3.3 percent year over year, primarily because of increased volume and payment rates.”
In a related story: Trinity Health to build $1.5M pharmacy

About pharma

EU body calls for suspending some 100 generic drugs over flawed testing by CRO “The EMA's Committee for Medicinal Products for Human Use (CHMP) said "irregularities" were identified in how Synchron Research Services, which is located in Ahmedabad, conducted bioequivalence studies for drugs it tested on behalf of a slew of pharmaceutical firms…
 According to the EMA, the CHMP's review looked at all drugs that had been tested by Synchron for EU companies and found that a majority of them, roughly 100 drugs, had "no adequate bioequivalence data…available from other sources." Some of the companies whose products are affected include Viatris, Novartis' Sandoz and 1 A Pharma units, Johnson & Johnson, Teva, Accord Healthcare, Orifarm Generics, RIA Generics, STADA Arzneimittel, Wockhardt and Zentiva, among several others.”
According to the EMA:  “The list of concerned medicines can be found in the list of medicines concerned by the procedure.”

Bayer Backs Out of $670 Million Collaboration Deal With Atara “The collaboration included ATA3271, an allogeneic T-cell immunotherapy, and an autologous version, ATA2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small cell lung cancer.
The ending of the partnership follows the death of a patient in an early-phase clinical trial of ATA2271 at Memorial Sloan Kettering Cancer Center in February.”

About the public’s health

 CDC examines hepatitis cases and deaths in children “The CDC is examining 180 reported cases of hepatitis of unknown origin in kids across 36 states and territories, including six cases that resulted in deaths, officials told reporters in a briefing…
CDC is still trying to tease out whether these are part of a true increase in hepatitis among kids — or if the cases were identified as the result of improved pandemic-era surveillance…
The leading hypothesis for a root cause is adenovirus infections, which are common in childhood, officials said.”

CDC tells doctors to be on alert for monkeypox as global cases rise “The alert comes two days after the agency confirmed a monkeypox case in Massachusetts, where a patient with skin lesions associated with the rare virus was treated. New York City officials said Thursday they are investigating a potential case. Federal officials say they expect to identify additional infections in the coming days.”

About healthcare IT

MeMD rebrands as Walmart Health Virtual Care “Walmart announced in May 2021 that it would acquire MeMD, a multispecialty telehealth provider, in an effort to significantly expand its telehealth capabilities. The telehealth platform sits within the retailer's Walmart Health arm, which operates a slate of health clinics as well as other services.”

About health technology

 FDA Reports Thousands of Deaths, Injuries from Philips Respironics Device Breakdowns in Past Year “In a recently promised update on medical device reports (MDR) associated with suspected foam breakdown in certain Philips Respironics devices, the FDA reports it received more than 21,000 MDRs, including 124 reports of deaths, from April 2021 through April 2022.”

Today's News and Commentary

About Covid-19

CDC recommends Pfizer booster shot for kids ages 5 to 11 as Covid cases rise across the U.S. The recommendation follows on the heels of FDA approval.

About health insurance

 Association Between Medicaid Expansion Under the Affordable Care Act and Survival Among Newly Diagnosed Cancer Patients “The 2-year overall survival increased from 80.58% pre-ACA to 82.23% post-ACA in expansion states and from 78.71% to 80.04% in nonexpansion states, resulting in a net increase of 0.44 percentage points (ppt) (95% confidence interval [CI] = 0.24ppt to 0.64ppt) in expansion states after adjusting for sociodemographic factors.”
In expansion states, certain cancer-specific overall survival rates were much higher than those averages (see the article for details).

Court tosses $300,000 hospital bill for promised $1,300 charge An important case for enforcement of “surprise medical bills.”
”Colorado's Supreme Court has ruled in favor of a woman who expected to pay about $1,300 for spinal fusion surgery but was billed more than $300,000 by a suburban Denver hospital that allegedly included charges it never disclosed she might be liable for.
This week's ruling in favor of Lisa French, who underwent two surgeries in 2014, follows efforts by many U.S. states and the federal government to help curb health care costs by restricting or eliminating so-called "surprise billing" and requiring increased price transparency for consumers.
In a unanimous opinion, the Colorado justices ruled Monday that agreements French signed before surgery at St. Anthony North Health Campus in Westminster don't compel her to pay the extra charges, which stemmed from a then-secret list of prices for services that hadn't been disclosed to her.”

Virginia’s ACA Section 1332 State Innovation Waiver “On May 18, 2022, federal reviewers issued a letter approving Virginia’s State Innovation Waiver application to establish the Commonwealth Health Reinsurance Program (CHRP) for an initial period of up to five years, beginning in 2023. Per enactment language, the remaining Virginia statutes establishing the CHRP will become effective on June 17, 2022, 30 days after the Commission provided notice of federal approval.
The CHRP is designed to operate as a traditional reinsurance program by reimbursing ACA individual market health insurers for a percentage of an enrollee’s claims costs exceeding a specified threshold (or “attachment point”) and up to a specified ceiling (or “reinsurance cap”). Specifically, in 2023, the approved program would reimburse claims between an attachment point of $40,000 and an estimated $155,000 cap with a coinsurance rate of 70%. This program is projected to reduce individual premiums in the ACA marketplace by 15.6% for plan year 2023.
The CHRP is designed to be funded in large part through pass-through funds provided by the federal government based on federal premium tax credit savings from lower premium costs in the Virginia marketplace.”

The Manatt State Cost Containment Update “Manatt examines how benchmarking programs can elevate the importance of primary care and behavioral health care investments and allow for the measurement of spending on these critical preventive services.”
The survey of state-specific initiatives is particularly interesting.

About hospitals and healthcare systems

 Mayo Clinic posts $142M operating gain, bucking national trend “Mayo Clinic ended the first quarter of this year with an operating gain of $142 million. In the same quarter last year, Mayo posted operating income of $243 million.
The health system also recorded nonoperating losses of $369 million in the first quarter of 2022. 
Despite losses from nonoperating items, Mayo Clinic ended the quarter with $17.5 billion in net assets, up from $13.2 billion recorded in the same period one year prior.”

About pharma

 Maine Joins Two Other States Considering Making Their Own Insulin  “The State of Maine has enacted legislation that will create a commission to assess whether the state has the resources to manufacture its own insulin…
Maine is the third state, along with California and Michigan, to consider producing its own insulin in an effort to make the essential drug more affordable.”

FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain “In 2019, in an effort to address the national drug shortage problem, the federal Drug Shortages Task Force released a report that called for the adoption of risk management plans to proactively assess risk and to predict and prevent supply disruptions that could potentially lead to a drug shortage. Then in 2020, Congress passed the CARES Act to require certain manufacturers to develop, maintain, and implement, as appropriate, risk management plans that identify and evaluate risks to a drug’s supply.
To further assist manufacturers with these requirements, we are issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans.
The draft guidance describes a framework for stakeholders to consider when developing risk management plans that aligns with principles stated in the International Council for Harmonisation guidance for industry, Q9 Quality Risk Management, and identifies risk factors to consider when developing the content of risk management plans. The steps needed to reduce risks of a disruption in drug supply may vary among the different manufacturers in the supply chain for a given drug.”

HHS commits $300M to global accelerator targeting antibiotic-resistant bacteria “The Department of Health and Human Services announced Thursday morning a $300 million commitment to supporting a public-private antibiotic-resistant bacteria accelerator over the next decade.
Called the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the accelerator was jointly launched in 2016 by HHS’ Biomedical Advanced Research and Development Authority (BARDA), the National Institute of Allergy and Infectious Diseases (NIAID) and global health charity Wellcome.
The Boston University-led program funds and offers technical, regulatory and business support to private companies in the early stages of developing new products to address antimicrobial-resistant infections.”

 About the public’s health

Oklahoma lawmakers pass bill banning abortions after ‘fertilization’ Oklahoma lawmakers on Thursday passed a bill that would ban abortions from the moment of ‘fertilization,’ effectively prohibiting almost all abortions in the state…
The Oklahoma bill is similar in its enforcement mechanism to the one that was signed into law in Texas last year, allowing civilians to file lawsuits against those who perform or help facilitate an abortion…
The bill states a lawsuit cannot be brought against a woman who had or seeks to have an abortion…
It explicitly allows for the use of the Plan B pill, a widely used form of emergency contraception, but would prohibit medical abortions using pills. The bill exempts from its definition of abortion any procedure to ‘save the life or preserve the health of the unborn child,’ to ‘remove a dead unborn child caused by spontaneous abortion’ or to remove an ectopic pregnancy, in which the fetus grows outside the uterus.”

HHS announces $1.5B grant for states to address ongoing opioid epidemic “The grant funding opportunity will be available through the Substance Abuse and Mental Health Services Administration (SAMHSA)…
The funding will be made available to those increasing access to medications for opioid use disorder (OUD) and supporting prevention, harm reduction, treatment and recovery support services for OUD and other substance use disorders. A portion is earmarked for those with the highest mortality rates. States and territories will also be asked to develop naloxone distribution plans to increase access.” 

HHS Announces $2 Million Funding Opportunity to Establish National Center of Excellence on Social Media and Mental Wellness “U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), is announcing $2 million in funding to establish a national center of excellence (CoE) on social media and mental wellness. The purpose of the CoE will be to develop and disseminate information, guidance, and training on the impact—including benefits and risks—that social media use has on children and youth, especially the risks to their mental health. This CoE will also examine clinical and social interventions that can be used to mitigate the risks. Social media use can be associated with negative mental health outcomes, and children and youth are particularly vulnerable.”

Trends in Cancer Mortality Among Black Individuals in the US From 1999 to 2019 “In this cross-sectional study of 1 361 663 deaths from cancer among Black individuals, although cancer mortality decreased considerably among Black individuals from 1999 to 2019, the cancer mortality rate was higher among Black men and women than in other racial and ethnic groups in 2019.”

AMA, Brigham and Women's, Joint Commission's new peer network helps health systems embed equity in care “The American Medical Association (AMA), Brigham and Women’s Hospital and the Joint Commission have launched a new network designed to teach health systems how to better incorporate racial justice equity into their quality and safety practices.
Announced Thursday, the so-called Advancing Equity through Quality and Safety Peer Network is a one-year mentorship and networking program that will be piloted by eight hospitals and health systems including the Dana-Farber Cancer Institute and Vanderbilt University Medical Center.”

Federal judge blocks HHS gender transition coverage requirement after challenge from Christian group “A federal judge in North Dakota has temporarily blocked HHS and the Equal Employment Opportunity Commission from requiring the Christian Employers Alliance and its members to provide health plans that cover employees' gender transition procedures.
The U.S. District Court for the District of North Dakota ruled May 16 that the requirement adopted in 2021 by the two federal agencies applying to most health plans would force the Christian group and its members to violate their religious beliefs and cause irreparable injury.”

 About health technology

 Anti-Mullerian Hormone [AMH] as Predictor of Future and Ongoing Bone Loss During the Menopause Transition AMH below 100 pg/mL will detect [higher risk for bone loss] with sensitivity of 50% in premenopause, 80% in early perimenopause, and 98% in late perimenopause. These findings suggest that AMH measurement can help flag women at the brink of significant bone loss for early intervention.”

Today's News and Commentary

About Covid-19

 Nearly every state expected to see increase in COVID-19 hospitalizations, forecast shows “As the nation's COVID-19 resurgence reaches its highest point since mid-February, daily hospital admission levels and new COVID-19 related deaths in the U.S. are projected to continue increasing over the next four weeks, according to newly updated forecast models used by the Centers for Disease Control and Prevention (CDC).
The forecast now predicts that nearly every U.S. state and territory is projected to see increases in new hospitalizations over the next two weeks.”

Patients charged hundreds of dollars to get Covid drugs already paid for by taxpayers “Doctors and hospitals are charging fees to give Evusheld, the only drug that works to prevent Covid-19 for many immune-compromised people, even though the government is distributing the drug for free.
Evusheld, a monoclonal antibody, is the only Covid prevention option for many people with weak immune systems, as vaccines failed to give them antibodies…
But have offered no plan, at least not publicly, to fix the situation, leaving some immune-compromised people hit with sticker shock when they go to the doctor to get Evusheld.”

NIH announces antiviral drug development awards | National Institutes of Health (NIH) “The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $577 million to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.
The AViDD centers will conduct innovative, multidisciplinary research to develop candidate COVID-19 antivirals, especially those that can be taken in an outpatient setting, as well as antivirals targeting specific viral families with high potential to cause a pandemic in the future. These include paramyxoviruses, bunyaviruses, togaviruses, filoviruses (including Ebola viruses and Marburg virus), picornaviruses (including enteroviruses and other cold-causing viruses), and flaviviruses (including the viruses that cause yellow fever, dengue and Zika).”
See the article for details about the awardees.

Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986–2020 “To better understand the strategies that brand-name inhaler manufacturers have employed to preserve their market dominance, we analyzed all patents and regulatory exclusivities granted to inhalers approved by the Food and Drug Administration between 1986 and 2020. Of the sixty-two inhalers approved, fifty-three were brand-name products, and these brand-name products had a median of sixteen years of protection from generic competition. Only one inhaler contained an ingredient with a new mechanism of action… Manufacturers augmented periods of brand-name market exclusivity by moving active ingredients from one inhaler device into another (“device hops”). The median time from approval of an originator product to the last-to-expire patent or regulatory exclusivity of branded follow-ons was twenty-eight years (across device hops on fourteen originator products). Regulatory and patent reform is critical to ensure that the rewards bestowed on brand-name inhaler manufacturers better reflect the added clinical benefit of new products.”

About health insurance

 CMS rolls out changes to Medicare website aimed at usability “One of the key new features is to redesign the Medicare.gov home page to add more detailed information on Medigap policies and plan costs. Other new information on the homepage aims to improve how to compare and select drug coverage.
The changes also include new messages on the homepage that highlight the information most requested by people on Medicare, people nearing eligibility or family members.”

The Children’s Health Insurance Program at 25 A good review of the program’s history and current status.

About pharma

Merck to pay up to $1.4B in cancer deal with Kelun, but details are scarce “Merck & Co. is plucking a cancer project from the branch of Chinese-based Kelun Pharmaceutical for up to $1.4 billion, but details from the New Jersey-based Big Pharma have been hard to come by. 
The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing over $47 million in upfront cash in exchange for ex-China rights to a “macromolecular tumor project.” However, what exactly is being exchanged remains unknown; Kelun has more than a dozen oncology assets, with 11 in clinical trials and three in preclinical testing.”

Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020 “This cohort study of 49 drugs approved by the FDA in 2020 found that they were supported by 75 pivotal trials, of which nearly two-thirds were double-masked, more than three-fourths had a randomization component, nearly half used a surrogate measure as a primary end point, and more than one-fourth used a historical, external, or other control. Surrogate measures and historical controls were much more common among oncology drug approvals than among nononcology drug approvals.
Meaning  In this study, the cohort of 2020 novel drug approvals continued a trend of new drugs being supported by smaller numbers of preapproval pivotal trials and fewer features traditionally associated with rigor.

About the public’s health

 Derivation and Validation of the UCAP-Q Case-finding Questionnaire to Detect Undiagnosed Asthma and COPD “Many people with asthma and COPD remain undiagnosed. We developed and validated a new case-finding questionnaire to identify symptomatic adults with undiagnosed obstructive lung disease.”

Biden invokes Defense Production Act for formula shortage “President Joe Biden on Wednesday invoked the Defense Production Act to speed production of infant formula and authorized flights to import supply from overseas, as he faces mounting political pressure over a domestic shortage caused by the safety-related closure of the country’s largest formula manufacturing plant.
The Defense Production Act order requires suppliers of formula manufacturers to fulfill orders from those companies before other customers, in an effort to eliminate production bottlenecks. Biden is also authorizing the Defense Department to use commercial aircraft to fly formula supplies that meet federal standards from overseas to the U.S…”