Today's News and Commentary

About Covid-19

 Covid-19 vaccines have saved more than 3 million lives in US, study says, but the fight isn’t over “The Covid-19 vaccines have kept more than 18.5 million people in the US out of the hospital and saved more than 3.2 million lives, a new study says – and that estimate is most likely a conservative one, the researchers say.”

About pharma

 Moderna says cancer vaccine reduces melanoma’s return by 44% “An experimental cancer vaccine being developed by the biotechnology firm Moderna and the drug giant Merck reduced the risk that melanoma would return after surgery or that patients would die by 44%, the company said.” 

About the public’s health

 Justices reject industry bid to block California’s ban on flavored tobacco “The Supreme Court on Monday turned down a request from a group of tobacco companies and retailers to block a California law that bans the sale of flavored tobacco. The state enacted the law in response to an increase in tobacco use by young people, but a group of tobacco companies argued that a 2009 federal law trumps state and local laws like California’s ban.
The justices did not provide any explanation for their decision, and there were no public dissents noted from Monday’s order.”

Judge rejects vaccine choice law in health care settings “A person's choice to decline vaccinations does not outweigh public health and safety requirements in medical settings, a federal judge ruled in a Montana case.
U.S. District Judge Donald Molloy last week permanently blocked a section of law the state said was meant to prevent employers — including many health care facilities — from discriminating against workers by requiring them to be vaccinated against communicable diseases, including COVID-19.”

About healthcare IT

‘Out of control’: Dozens of telehealth startups sent sensitive health information to big tech companies More and more information is coming out about hidden use of personal transactions and marketing. This article is the second excellent investigative report of this kind from STAT and The Markup.
”A joint investigation by STAT and The Markup of 50 direct-to-consumer telehealth companies like Workit found that quick, online access to medications often comes with a hidden cost for patients: Virtual care websites were leaking sensitive medical information they collect to the world’s largest advertising platforms…
On 13 of the 50 websites, STAT and The Markup documented at least one tracker — from Meta, Google, TikTok, Bing, Snap, Twitter, LinkedIn, or Pinterest — that collected patients’ answers to medical intake questions. Trackers on 25 sites, including those run by industry leaders Hims & Hers, Ro, and Thirty Madison, told at least one big tech platform that the user had added an item like a prescription medication to their cart, or checked out with a subscription for a treatment plan.”

 Longitudinal Associations Between Use of Mobile Devices for Calming and Emotional Reactivity and Executive Functioning in Children Aged 3 to 5 Years Findings  In this cohort study of 422 parents and 422 children, increased use of mobile devices for calming children aged 3 to 5 years was found to be associated with decreased executive functioning and increased emotional reactivity at baseline; however, only emotional reactivity had bidirectional, longitudinal associations with device use for calming at 3 and 6 months of follow-up. The associations were found to be increased in boys and children with higher temperamental surgency.
Meaning  The findings of this study suggest that, particularly in young boys or young children with higher surgency, the frequent use of devices for calming should be avoided.”

 8 largest healthcare data breaches of 2022 tied to vendors FYI

About health technology

 Plant power: Transplanted plant parts use photosynthesis to slow osteoarthritis progression  This discovery is one of the most fascinating I have ever seen. “…scientists at China’s Zhejiang University School of Medicine have harnessed plant power in mammalian cells to get them to produce energy when exposed to light. In a study published Dec. 7 in Nature, they described how they built tiny photosynthetic plant organelles called thylakoids and transplanted them into mammalian cells. They then demonstrated that the cells could stall disease progression in mouse models of osteoarthritis.”

100,000 newborn babies set to have their DNA fully decoded "One hundred thousand newborn babies in England will have their genomes sequenced, in a £105mn research programme that could pave the way for a full-scale neonatal screening plan to detect rare genetic conditions. Genomics England, a government-owned company, aims to read all the DNA carried by a representative national sample of babies shortly after they are born. The two-year project, to be carried out in partnership with the NHS, will begin late next year.”

Today's News and Commentary

About health insurance/insurers

11 states will offer health insurance for children without permanent legal status in 2023 “Eleven states will provide government health benefits to children without permanent legal status in 2023, Stateline reported Dec. 6. 
Connecticut and New Jersey will allow children without permanent legal status to enroll in Medicaid or the Children's Health Insurance Program in January, joining Maine, Rhode Island Vermont, Massachusetts, California, Illinois, New York, Oregon, Washington and the District of Columbia in extending these benefits.”

Oscar Health to stop accepting new members in Florida “Oscar Health will stop accepting new members through open enrollment on Dec. 13, the company said Dec. 12…
In third-quarter regulatory filings, published Nov. 9, Oscar Health said it had "proactively engaged" CMS to help the company keep its membership levels manageable following the exit of other carriers from certain markets.”

Unions suing Elevance Health for allegedly restricting access to claims data Labor unions contracted with Elevance Health for self-funded plans are suing the payer, alleging Elevance Health does not allow self-paid plans to access their own claims data and charged the self-pay plans higher rates than it had negotiated with hospitals. 
Law firm Berger Montague represents Bricklayers and Allied Craftworkers Local 1 Fund and Sheet Metal Workers Local 40 Fund, two unions who contracted with Elevance Health for access to the payer's network and negotiated rates.” 

About hospitals and healthcare systems

'We are in a crisis': Main Line anticipates 2nd straight $100M annual loss “Radnor Township, Pa.-based Main Line Health is anticipating its second consecutive $100 million annual loss as Philadelphia-area hospitals and health systems continue to face economic struggles, The Philadelphia Inquirer reported Dec. 12.
Through October, Main Line had already lost $62 million.”

About pharma

 Amoxicillin shortage worsens to 44 products, resupply dates pushed to 2023 “The number of amoxicillin products on back order has increased to 44 after months of the antibiotic being out of stock, according to the American Society of Health-System Pharmacists
Depending on the ASHP's website or the FDA's drug shortage database, between two dozen and three dozen oral presentations of amoxicillin have been in shortage because of high demand since late October. At the time, the shortage was expected to resolve by the end of 2022.”

Mark Cuban's drug company targets self-insured employer market “Mark Cuban Cost Plus Drug Company will offer prescription drug discounts to a coalition of 40 large private and public employers via a new platform called EmsanaRx Plus.
Cuban's drug company is partnering with pharmacy benefits manager EmsanaRx to expand access to lower-cost medicines to employers and employees. For Cost Plus Drugs, the partnership marks a strategic shift from operating exclusively in the direct-to-consumer market into the employer market.
EmsanaRx Plus is a supplemental drug discount product designed specifically for employers as a standalone pipeline for lower-cost medicines that have been contracted directly with drug manufacturers by Cost Plus Drugs, according to the company.”

About the public’s health

 Combo Vaccine Candidate for Influenza and COVID-19 Gets Fast Track Status “A phase 1 trial to investigate the immunogenicity and safety of the vaccine candidate has been initiated.
The Food and Drug Administration (FDA) has granted Fast Track designation to Pfizer-BioNTech’s mRNA-based combination vaccine candidate for the prevention of influenza and COVID-19 with a single injection.
The vaccine candidate utilizes BioNTech’s mRNA technology to combine Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), and Pfizer-BioNTech’s authorized Omicron-adapted bivalent COVID-19 vaccine.”

Catholic healthcare providers can't be forced to do gender surgeries: U.S. court “The Biden administration cannot force a group of Catholic healthcare providers and professionals to perform gender transition surgeries under an Obama-era regulation barring sex discrimination in healthcare, a U.S. appeals court ruled on Friday.
A unanimous three-judge panel of the 8th U.S. Circuit Court of Appeals agreed with a North Dakota federal judge who said the U.S. Health and Human Services (HHS) rule infringes on the religious freedoms of the plaintiffs, including a group of nuns who run health clinics for the poor and an association of Catholic healthcare professionals.”

Merck escapes nearly 1,200 Zostavax shingles vaccine lawsuits as plaintiffs' testimony falls short “Tuesday, a Pennsylvania federal judge threw out exactly 1,189 cases against Merck in the four-year-long group of cases.
The plaintiffs in the now-dismissed clutch of lawsuits argued Zostavax caused their shingles. But the medical expert attempting to back up that claim failed to consider whether the plaintiffs’ disease occurred naturally because they’d had chickenpox as kids, according to court filings published this week.”

Juul to Pay $1.7 Billion in Legal Settlement “Juul Labs Inc. has agreed to pay $1.7 billion in a broad legal settlement covering more than 5,000 lawsuits, according to people familiar with the matter.
Many of the lawsuits accused the e-cigarette maker of marketing its addictive products to children and teens. Juul has said it never targeted young people and that it has been working to regain the public’s trust.”

About health technology

 Thermo Fisher Bacterial Test Recall Now Deemed Class I “The FDA issued an update on Remel’s Oct. 20 recall of Thermo Fisher Scientific Gram Negative IVD AST Sensititre Plates, deeming it a Class 1 recall because of the risk of serious injury or death from potential false results.
The in vitro diagnostic test assesses the susceptibility of Gram-negative organisms towards certain antibiotics, enabling physicians to select appropriate treatments for infected patients.”

About healthcare finance

 Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war “Amgen is offering around $28 billion in cash for its proposed takeover of Horizon, the company said Monday. The drugmaker is paying a premium of approximately $47.9% on the closing share price of $78.76 per Horizon share on Nov. 29, 2022, the company said in its release.
The deal is expected to close in the first half of 2023, Amgen executives said on a conference call Monday morning.” 

Walgreens sells off more AmerisourceBergen stock “For the second time in as many months, Walgreens Boots Alliance has sold off shares in Pennsylvania-based AmerisourceBergen, this time getting $1 billion that it says it will use, in part, to fund the VillageMD purchase of Summit Health-CityMD.
Deerfield-based Walgreens said in a statement Thursday night that it has sold common stock publicly for about $800 million and that AmerisourceBergen repurchased about $200 million of Walgreens' holdings in the company.”

Today's News and Commentary

About Covid-19

 China’s disappearing data stokes fears of hidden Covid wave  “China is under-reporting coronavirus cases and fatalities, obscuring the scale and severity of the health crisis just as the world’s most populous country enters its deadliest phase of the pandemic, analysts warn. Official statistics on Friday revealed no new deaths and only 16,363 locally transmitted coronavirus cases in China, less than half the peak caseload reported last month.”

About health insurance/insurers

Employers estimate health benefits costs will rise 5.4% next year: Mercer “Analysts at Mercer polled more than 2,000 employers representing 124 million full-time and part-time employees and found that they expect benefits costs to increase by 5.4% next year. And they're expecting faster cost growth to continue in the near future, according to the survey.”

Florida physician gets 40 months for kickbacks, bribes “The former owner of a Sarasota, Fla.-based pain management clinic was sentenced to 40 months in prison for his role in a $4.5 million fraud scheme involving the fentanyl spray Subsys.
Steven Chun, MD, 59, was sentenced after being found guilty on six counts related to receiving kickbacks, according to a Dec. 7 Justice Department news release. Dr. Chun was found guilty in May along with Insys Therapeutics sales representative Daniel Tondre. 
he Justice Department said Insys, through Mr. Tondre, marketed Subsys to Dr. Chun by holding sham speaker events, paying him between $2,400 to $3,000 per event in return for him writing prescriptions for greater quantities and higher doses of the spray than necessary.”

3 providers to pay $22.5M to settle Medicaid fraud allegations in California “Three providers will pay out $22.5 million across two separate settlements to resolve false claims allegations in California, the Department of Justice (DOJ) announced.
Dignity Health and two Tenet Healthcare subsidiaries will settle allegations that they violated both federal and state false claims laws by submitting fraudulent claims to California's Medicaid program, Medi-Cal. Dignity Health will pay $13.5 million to the U.S. government and $1.5 million to the state to resolve the allegations.

About hospitals and healthcare systems

Hospitals in the US are the fullest they’ve been throughout the pandemic – but it’s not just Covid
“Hospitals are more full than they’ve been throughout the Covid-19 pandemic, according to a CNN analysis of data from the US Department of Health and Human Services. But as respiratory virus season surges across the US, it’s much more than Covid that’s filling beds this year.
More than 80% of hospital beds are in use nationwide, jumping 8 percentage points in the past two weeks.”

 U of Michigan Health to acquire, invest $800M in 6-hospital system “The University of Michigan Health's board of regents on Dec. 8 approved a proposed agreement that would see it acquire Lansing, Mich.-based Sparrow Health System to become a $7 billion-health system with more than 200 sites of care.
Ann Arbor-based University of Michigan Health said it will inject $800 million into Sparrow, a six-hospital system, through facility projects, operations and strategic investments over eight years.”

About pharma

 Gov. Jared Polis submits proposal to import prescription drugs from Canada “Gov. Jared Polis is taking action to try to save Coloradans money on their prescription medications. He submitted a proposal to the FDA to import prescription drugs from Canada on Monday. 
This is the first step in getting approval to operate Colorado's ‘Canadian Drug Importation Program.’ The plan aims to save Coloradans an average of 65% on imported medication. 
That could result in $53 to $88 million saved each year.”

Complementary and Alternative Medicines in the Management of Heart Failure: A Scientific Statement From the American Heart Association An excellent review. Go to the end and look at the Figure.

Homeopathic Products The FDA just updated its guidance on these products. In short: “Products labeled as homeopathic and currently marketed in the U.S. have not been reviewed by the FDA for safety and effectiveness to diagnose, treat, cure, prevent or mitigate any diseases or conditions.”
"While products labeled as homeopathic are generally labeled as highly diluted, some of these products have been found to contain measurable amounts of active ingredients and therefore could cause significant patient harm. Additionally, FDA has tested products that were improperly manufactured, which can cause incorrect dilutions and increase the potential for contamination. Further, some products labeled as homeopathic are marketed to treat serious diseases or conditions.”

About the public’s health

Texas state court throws out lawsuit against doctor who violated abortion law “A judge in San Antonio has thrown out a lawsuit filed against a Texas abortion provider who intentionally violated a controversial state abortion law.
The law, known as Senate Bill 8, allows anyone to bring a lawsuit against someone who “aids or abets” in an abortion after about six weeks of pregnancy. On Thursday, state District Judge Aaron Haas in Bexar County said people who have no connection to the prohibited abortion and have not been harmed by it do not have standing to bring these lawsuits.
Thursday’s ruling sets an important precedent but does not overturn the law, said Marc Hearron, senior counsel for the Center for Reproductive Rights.”

 EU Approves Takeda’s Dengue Vaccine “The European Commission (EC) has approved Takeda’s dengue Qdenga vaccine for individuals four years and older in preventing dengue, a mosquito-borne disease that can cause severe bleeding and shock.
The approval was supported by results from multiple clinical trials in which the vaccine prevented 80 percent of symptomatic dengue cases at 12 months after vaccination.”

HHS, Providers Drop Trump Health Worker Conscience Rule Appeals “The Second Circuit Thursday ended a fight over a Trump administration rule that threatened to strip health-care entities of federal money if they disciplined workers for refusing to provide services that violate their moral or religious beliefs.
The federal appeals court certified the parties’ stipulation withdrawing their challenge of a decision that vacated the rule from its review. The rule was touted as a means of strengthening health-care workers’ conscience rights, but never took effect, due to litigation that resulted in its invalidation.”

About healthcare IT

A Twitter data tracker inhabits tens of thousands of websites “Tens of thousands of websites belonging to government agencies, Fortune 500 companies and other organizations host Twitter computer code that sends visitor information to the social media giant, according to research first reported by The Cybersecurity 202 [Washington Post]. And virtually none of them have used a Twitter feature to put restrictions on what the company can do with that data, said digital ad analysis firm Adalytics, which conducted the study.”
Read the study! Many healthcare organizations are affected, including HHS.

More than 620,000 patients' data breached in CommonSpirit ransomware attack, new report shows “More than 620,000 patients of Chicago-based CommonSpirit Health had their data breached in the recent ransomware attack on the nation's second-largest nonprofit health system, according to a report to the HHS Office of Civil Rights.
That cyberattack led to widespread IT outages and appointment disruptions across the health system's nationwide network of hospitals beginning in early October.”

About healthcare finance

Deal volume remains resilient despite headwinds From PwC: “For select sectors, M&A volume retreated when compared to the historic levels experienced in 2021; however, the health services sector continued an impressive display of volume level through the last 12 months (LTM) ending November 15.
While traditional buy-side activity comprised a portion of this volume, an upcoming PwC study has identified the role divestitures can play in creating value in the healthcare sector.
PwC anticipates increased divestitures activity within health services for 2023 based on a variety of economic, regulatory and overall strategic repositioning.” 

Today's News and Commentary

About Covid-19

 Children as young as 6 months can now receive an updated Covid-19 vaccine “The US Food and Drug Administration on Thursday authorized updated Covid-19 vaccines from Moderna and Pfizer/BioNTech for use in children from ages 6 months through 5 years.
The bivalent vaccines target the original strain as well as the BA.4/5 Omicron strains. Bivalent vaccines were previously authorized as a booster for people age 5 and older.”

Vaccine hesitancy prospectively predicts nocebo side-effects following COVID-19 vaccination “Results show that a quantifiable and meaningful portion of COVID-19 vaccine side-effects is predicted by vaccine hesitancy, demonstrating that side-effects comprise a psychosomatic nocebo component in vaccinated individuals. The data reveal distinct risk levels for future side-effects, suggesting the need to tailor public health messaging.”

New Receptor “Decoy” Drug Neutralizes COVID-19 Virus and Its Variants “Scientists at Dana-Farber Cancer Institute have developed a drug that potently neutralizes SARS-CoV-2, the COVID-19 coronavirus, and is equally effective against the Omicron variant and every other tested variant. The drug is designed in such a way that natural selection to maintain infectiousness of the virus should also maintain the drug’s activity against future variants.
The investigational drug, described in a report published today in Science Advances, is not an antibody, but a related molecule known as an ACE2 receptor decoy. Unlike antibodies, the ACE2 decoy is far more difficult for the SARS-CoV-2 virus to evade because mutations in the virus that would enable it to avoid the drug would also reduce the virus’s ability to infect cells.  The Dana-Farber scientists found a way to make this type of drug neutralize coronaviruses more potently in animals infected with COVID-19 and to make it safe to give to patients.”

Federal judge declines 14 states' challenge to CMS vaccine mandate “A federal judge in Louisiana on Dec. 2 declined a case brought by 14 states challenging the Biden administration's rule that requires COVID-19 vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid programs.”

About health insurance/insurers

 UnitedHealth's LHC Group acquisition delayed until 2023 “Previously expected to close by the end of 2022, United Health Group's acquisition of home-health firm LHC Group will now likely be finalized in the first quarter of 2023, according to an LHC filing with the Securities and Exchange Commission.
The agreement was extended until March 28, according to the filing. UnitedHealth and LHC also certified to the FTC their substantial compliance with a June 10 request for additional information and documentation regarding the proposed acquisition.”

Value-Based Payment As A Tool To Address Excess US Health Spending An excellent review.
A couple takeaways: More Than Half Of Health Care Payments Are Still Based On Fee-For-Service
Savings Attributable To ACOs Range From Just Under 1 Percent To Just Over 6 Percent

About pharma

 RCTs with prognostic digital twins overcome the limitations of external control arms Digital twins are being used for a variety of purposes, including expedited drug development. This article is a good review of what it is and how it is being used.

About the public’s health

 FDA expected to decide on Pfizer RSV vaccine for older adults by May 2023 “KEY POINTS:
Pfizer, in a statement Wednesday, said the FDA has accepted its RSV vaccine candidate for review under an expedited process that reduces the approval process by four months.
The FDA is expected to make a final decision on whether to approve the vaccine by May 2023.
Between 60,000 and 120,000 older adults are hospitalized with RSV every year and 6,000 to 10,000 older adults die from the virus.
There currently is no vaccine.”
 About healthcare IT

Amazon shuts down support for Alexa HIPAA-compliant programs for hospitals, payers “Amazon will no longer support HIPAA compliance on its Alexa devices after launching a program three years ago for some hospitals and payers.
In April 2019, Amazon paved the way for Alexa to be used in healthcare when it announced its Amazon Alexa HIPAA-compliant skills kit for developers. The announcement paved the way for developers to build voice skills that can securely transmit private patient health information.”

Survey of Telehealth Use by Commercial Insurance Enrollees Highlights: 40% of respondents with commercial insurance used telehealth to access health services in the past year. 60% are satisfied with the care they received via telehealth.”
Obviously, convenience was the leading benefit users cites.

Digital Therapeutics Alliance and Curebase release publication setting the stage for a fit-for-purpose evidence standard for digital therapeutics (DTx) “The Digital Therapeutics Alliance (DTA), a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare, in collaboration with DTA Resource Partner, Curebase, a company committed to democratizing access to clinical studies, today released a publication to provide a fit-for-purpose evidence standard for DTx product regulatory, reimbursement, and clinical acceptance. 
The publication, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”, outlines foundational principles specific to the DTx category of medicine and baseline expectations for healthcare decision makers (HCDMs) related to the types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.”

A new coalition aims to close AI’s credibility gap in medicine with testing and oversight “The group, billing itself as the Coalition for Health AI, called for the creation of independent testing bodies and a national registry of clinical algorithms to allow physicians and patients to assess their suitability and performance, and root out bias that so often skews their results…
Like the many documents of its kind, the coalition’s blueprint is merely a proclamation — a set of principles and recommendations that are eloquently articulated but easily ignored. The group is hoping that its broad membership will help stir a national conversation and concrete steps to start governing the use of AI in medicine. Its blueprint was built with input from Microsoft and Google, MITRE Corp, universities such as Stanford, Duke and Johns Hopkins, and government agencies including the Office of the National Coordinator for Health Information Technology, the Food and Drug Administration, National Institutes of Health, and the Centers for Medicare & Medicaid Services.”

 Augmented Reality and Virtual Reality in Medical Devices A great review of the subject from the FDA.

Today's News and Commentary

About Covid-19

 Low neutralization of SARS-CoV-2 Omicron BA.2.75.2, BQ.1.1, and XBB.1 by parental mRNA vaccine or a BA.5-bivalent booster “The results showed that a BA.5-bivalent-booster elicited a high neutralizing titer against BA.4/5 measured at 14- to 32-day post-boost; however, the BA.5-bivalent-booster did not produce robust neutralization against the newly emerged BA.2.75.2, BQ.1.1, or XBB.1. Previous infection significantly enhanced the magnitude and breadth of BA.5-bivalent-booster-elicited neutralization. Our data support a vaccine update strategy that future boosters should match newly emerged circulating SARS-CoV-2 variants.”
In other words, the new bivalent vaccine does not work as well on the new, emerging variants.

CDC encourages people to wear masks to help prevent spread of Covid, flu and RSV over the holidays “KEY POINTS
CDC Director Dr. Rochelle Walensky said wearing a mask is an everyday precaution that people can take to reduce their chances of catching or spreading a respiratory virus.
Flu and respiratory syncytial virus are circulating at high levels at the same time Covid is picking up, straining hospital emergency departments.”

Pfizer countersues Moderna in COVID-19 vaccine patent infringement case “Pfizer and BioNTech filed a countersuit against Moderna Dec. 5 over their rival COVID-19 vaccines made from the same mRNA technology, court documents show. 
Moderna filed suit against Pfizer in late August and accused the drugmaker of infringing on patents and copying its mRNA technology ‘without ever requesting a license.’ 
About three months later, Pfizer submitted an 81-page document in the U.S. District Court in Massachusetts accusing the other pharmaceutical company of writing a ‘revisionist history not based on fact.’”

Paxlovid Has Been Free So Far. Next Year, Sticker Shock Awaits. “Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with covid-19 from being hospitalized or dying, and it may even reduce the risk of developing long covid. But the government plans to stop footing the bill within months, and millions of people who are at the highest risk of severe illness and are least able to afford the drug — the uninsured and seniors — may have to pay the full price.”

About health insurance/insurers

 FAQS ABOUT CONSOLIDATED APPROPRIATIONS ACT, 2021 IMPLEMENTATION - GOOD FAITH ESTIMATES (GFES) FOR UNINSURED (OR SELF-PAY) INDIVIDUALS Q1: Will CMS enforce the requirement that GFEs for uninsured (or self-pay) individuals include cost estimates from co-providers and co-facilities beginning on January 1, 2023?
A1:
No. HHS is extending enforcement discretion, pending future rulemaking, for situations where GFEs for uninsured (or self-pay) individuals do not include expected charges from co- providers or co-facilities.”

Trends In Treat-And-Release Emergency Care Visits With High-Intensity Billing In The US, 2006–19 “We performed an observational study of US treat-and-release ED visits using data from the Nationwide Emergency Department Sample. In 2006, 4.8 percent of treat-and-release ED visits exhibited high-intensity billing, and this figure rose to 19.2 percent by 2019. The proportion of visits for older patients, those with more comorbidities, and those with nonspecific but potentially serious diagnoses grew. Of the observed growth in high-intensity billing, 47 percent was expected, based on changes in administrative measures for patient case-mix and care services.”
The other conclusion is that 53% of the increase was not expected- in other words, overfilling using higher than warranted severity codes.

Trends in Episode-of-Care Spending for Cancer-Directed Surgery Among US Medicare Beneficiaries From 2011 to 2019 “This cross-sectional study revealed that 30-day episode spending for cancer-directed surgery decreased significantly among Medicare fee-for-service beneficiaries. This overall decrease was largely attributable to lower spending associated with inpatient procedures and a concomitant increase in the proportion of surgeries performed in the less-expensive outpatient setting.”

About hospitals and healthcare systems

Leapfrog Recognizes 2022 Top Hospital and Top ASC Recipients FYI

 Faced with costly discharge bottlenecks, hospitals want Congress to pay for patients' extended stays “The hospital lobby is looking to secure temporary per diem Medicare payments from Congress it says are needed to offset increased costs and missed revenues caused by patients who are ready to leave the hospital but have nowhere to go.
Per a new report (PDF) from the American Hospital Association (AHA), the average hospital length-of-stay has increased by 19.2% from 2019 to 2022 as well as by nearly 24% for patients being discharged to a post-acute care provider.
That increase isn’t just due to patients getting sicker during the course of the pandemic. When adjusting by case-mix index, average length-of-stay was still up 15.4% for discharges to post-acute care providers. Adjusted average stays were even higher when discharging to a skilled nursing facility (20.2%) or a psychiatric hospital (28.9%), according to data from Strata Decision Technology cited in AHA’s report.
Rather, acute care hospitals, long-term care hospitals and rehabilitation facilities alike are facing discharge logjams due to industrywide workforce shortages.”

About pharma

Unsubstantiated price hikes drove U.S. drug spending up $805 mln in 2021-report “Price increases spread among seven of the 10 drugs in 2021 behind an $805 million increase in U.S. spending from the prior year were not supported by clinical evidence, an influential U.S. pricing research firm said on Tuesday.
The Institute for Clinical and Economic Review (ICER) said the spending increase in 2021 was still less than the $1.67 billion rise in the previous year. This is the third year the group has looked at the top 250 drugs by spending and assessed if those driving U.S. spending increases were justified.”

 Drugmakers dodge US federal litigation over Zantac after judge tosses lawsuits “A judge in the US on Tuesday rejected the validity of scientific evidence used to back up claims that the withdrawn heartburn drug Zantac (ranitidine) causes a variety of cancers. The decision by US District Judge Robin Rosenberg in West Palm Beach, Florida, means companies such as GSK, Pfizer, Sanofi and Boehringer Ingelheim, which have all marketed the drug at different times, will not have to fight over 1700 lawsuits in federal court, although they still face tens of thousands of similar cases at the state level.”

About the public’s health

 Effects of Diet on 10-Year Atherosclerotic Cardiovascular Disease Risk (from the DASH Trial) “Using data from the original DASH (Dietary Approaches to Stop Hypertension) trial, we determined the effects of adopting the DASH diet on 10-year ASCVD risk compared with adopting a control or a fruits and vegetables (F/V) diet… In conclusion, compared with a typical American diet, the DASH and F/V diets reduced 10-year ASCVD risk scores by about 10% over 8 weeks. These findings are informative for counseling patients on both choices of diet and expectations for 10-year ASCVD risk reduction.”

UnitedHealth report: As mental health concerns rise, more providers are available to treat these needs “The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual "America's Health Rankings" report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%…
However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.”
Comment: The entire report is worth reading for its wealth of different kinds of information.

Cardiometabolic benefits of micronutrient supplements vary “Supplementation of certain micronutrients benefited cardiometabolic health, but others did not, according to a systematic review and meta-analysis.
Specifically, supplementation with omega-3 fatty acids, folic acid and coenzyme Q10 conferred certain benefits, supplementation with vitamin C, vitamin D, vitamin E and selenium had no effect on CVD risk and supplementation with beta-carotene was harmful…”

Effect of Nudges to Clinicians, Patients, or Both to Increase Statin Prescribing Findings In this cluster randomized clinical trial of 4131 patients from 28 primary care practices, nudges to clinicians using electronic health record active choice prompts and monthly peer comparison feedback significantly increased statin prescribing by 5.5 percentage points relative to usual care. Nudges to patients by text message before the visit did not significantly increase statin prescribing, but the combination of nudges to clinicians and patients significantly increased statin prescribing by 7.2 percentage points relative to usual care.” [Emphasis added]

Deferral of primary care signals a troubled future for Americans’ health “Primary care visits are down 10.3% on average across U.S. cities relative to pre-pandemic levels. That, combined with more people with chronic diseases like diabetes, obesity, and cancer, and accelerating health care costs as inflation soars, signal a troubled future for the health of Americans…
Commercially insured women between the ages of 20 and 49 are the ones most likely to be resuming visits with their primary care providers. However, the demand is distributed unequally across various metro areas with demand greater in areas like Dallas and Miami compared to Los Angeles, New York City, Philadelphia, Houston, Seattle, and Washington, D.C.”

About healthcare IT

FDA Clears apoQlar’s Surgical Planning Software “The FDA has granted apoQlar 510(k) marketing clearance for its VSI HoloMedicine software device which helps surgeons plan complex procedures using 3D holograms created from flat imaging sources.
The software uses Microsoft’s HoloLens 2, a mixed-reality head-mounted display inside or outside the operating room. Computed tomography scans as well as magnetic resonance imaging and positive emission tomography scans can be used to create to the interactive 3D holograms.”

About health technology

 EU Tells Illumina How to Unwind Deal to Buy Cancer-Test Developer Grail “The European Union on Monday set out the details of a planned order requiring Illumina Inc. to unwind its $7.1 billion acquisition of cancer-test developer Grail Inc.
The European Commission, the bloc’s competition watchdog, said in a so-called statement of objections that it intends to require Illumina to swiftly return Grail to the same level of independence the company had before the acquisition. Grail must also be as competitive after the divestment as it was before the deal closed, the commission said.”

Today's News and Commentary

About Covid-19

 Pfizer asks FDA to clear updated COVID shot for kids under 5 “Pfizer is asking U.S. regulators to authorize its updated COVID-19 vaccine for children under age 5 — not as a booster but part of their initial shots.
Children ages 6 months through 4 years already are supposed to get three extra-small doses of the original Pfizer COVID-19 vaccine — each a tenth of the amount adults receive — as their primary series. If the Food and Drug Administration agrees, a dose of Pfizer’s bivalent omicron-targeting vaccine would be substituted for their third shot.”

US Won’t Back 2022 Patent Waivers for Covid Tests and Treatments “The US won’t agree to waive intellectual-property protections for Covid-19 treatments and tests this year -- aligning with developed-nation peers and delaying prospects for a World Trade Organization accord aimed at boosting global access to life-saving medicines. 
On Tuesday, US Trade Representative Katherine Tai said the agency needs more information about the market dynamics for Covid diagnostics and therapeutics, and plans to ask the US International Trade Commission to launch an investigation into the matter.”

About health insurance/insurers

Association of Medicare Advantage vs Traditional Medicare With 30-Day Mortality Among Patients With Acute Myocardial Infarction “Among Medicare beneficiaries with acute MI, enrollment in Medicare Advantage, compared with traditional Medicare, was significantly associated with modestly lower rates of 30-day mortality in 2009, and the difference was no longer statistically significant by 2018. These findings, considered with other outcomes, may provide insight into differences in treatment and outcomes by Medicare insurance type.”
And in a related editorial: How Much of an “Advantage” Is Medicare Advantage? This commentary provides a thoughtful analysis of differences between MA and FFS Medicare.

Association Between Individual Primary Care Physician Merit-based Incentive Payment System Score and Measures of Process and Patient Outcomes Question  Are higher scores for primary care physicians in the Medicare Merit-based Incentive Payment System (MIPS) associated with better performance on a broad range of clinical process and patient outcome measures?
Findings  In this cross-sectional observational study of 80 246 primary care physicians, MIPS scores were inconsistently related to performance on process and outcome measures, and physicians caring for more medically complex and socially vulnerable patients were more likely to receive low MIPS scores, even when they delivered relatively high-quality care.
Meaning  The MIPS program may not accurately capture the quality of care that primary care physicians provide.”
And in an accompanying editorial: Pay for PerformanceWhen Slogans Overtake Science in Health Policy: “In sum, theory and evidence tell us that quality of care is not as contractible through the payment system as the emphasis in policy would suggest. Talk of a fix that attaches stronger incentives to just the right measures—measures that somehow encompass what is valued and are impervious to the problems discussed above—is vague and fanciful. At some point, the slogans overtook the science, derailing a national conversation about quality improvement that will need to get back on track for progress to be made.”
The entire article is worth reading.

 9 Medicare Advantage plans audited for upcoding by OIG in the last 6 months FYI

The Impact of the COVID-19 Public Health Emergency Expiration on All Types of Health Coverage Key Findings
18 million people could lose Medicaid coverage when the COVID-19 public health emergency (PHE) ends, according to a new analysis.
While many who are currently enrolled in Medicaid will transition to other coverage options, nearly 4 million people (3.8M) will become completely uninsured.
19 states will see their uninsurance rates spike by more than 20 percent.
3.2 million children will transition from Medicaid to separate Children’s Health Insurance Program (CHIP) health plans.”

About hospitals and healthcare systems

Financial updates from 23 health systems: CommonSpirit, Tenet and more FYI

About pharma

Cigna’s PBM Express Scripts Latest To Put Less Pricey Biosimilars Of Abbvie’s Humira On Preferred Drug List “Cigna’s pharmacy benefit manager Express Scripts Monday said it will put ‘multiple’ biosimilar versions of Abbvie’s expensive rheumatoid arthritis drug Humira in the ‘same position as the brand’ on the PBM’s formulary in 2023.
Humira, approved by the U.S. Food and Drug Administration 20 years ago, has for years now been one of the nation’s most costly drugs generating more than $20 billion in sales for its maker, Abbvie in 2021 alone. Cigna and Express Scripts said Humira, which treats inflammatory and skin conditions, is one of the most widely used specialty medications.”

About the public’s health

Rising flu cases drive up U.S. hospitalizations, CDC says “The United States is experiencing the highest levels of hospitalizations from influenza that it has seen in a decade for this time of year, the head of the U.S. Centers for Disease Control and Prevention (CDC) said on Monday, adding that 14 children have died so far this flu season.
CDC Director Rochelle Walensky added that U.S. hospital systems also continue to be stressed with a high number of patients with other respiratory illnesses such as respiratory syncytial virus (RSV) and COVID-19.
There have been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu so far this season, according to CDC estimates. It urged people to get vaccinated.”

 mRNA vaccines take the sting out of malaria infection—and transmission “After nearly four decades of development, the world finally has a malaria vaccine. The first large-scale rollout of GlaxoSmithKline’s RTS,S, or Mosquirix, kicked off at the end of November.
And more are on the way. In September, Oxford researchers reported promising phase 2 results for R21/Matrix-M, which bumps up the efficacy rate against infection from Mosquinix’s 35% to as high as 80%. COVID-19 vaccine-maker BioNTech is working on its own version, too.”

About health technology

 Apple scores victory in dispute over heart monitoring technologies in Apple Watch “The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board, or PTAB, on Tuesday ruled that three AliveCor patents covering heart monitoring technologies for wearable devices were unpatentable. AliveCor alleged in federal court and before the International Trade Commission that Apple had copied the technologies with its Apple Watch, and over the summer an ITC judge found that Apple had infringed on two of three patents AliveCor asserted in its complaint.”

About healthcare finance

 Centene completes sale of Magellan Rx to Prime Therapeutics “Centene has completed its $1.35 billion divestiture of Magellan Rx to Prime Therapeutics.
The move adds Magellan's specialty drug management capabilities to Prime Therapeutics' suite of pharmacy benefit management tools, allowing it to enhance its collection of solutions. Prime is collectively owned by 19 Blues plans and affiliates.
Magellan Rx also brings 1.7 million new PBM members into the fold…”

Today's News and Commentary

About health insurance/insurers

Growth Of Value-Based Care And Accountable Care Organizations In 2022 An excellent update on the growth and types of these organizations.

Medicare Advantage Coverage is Rising for the Declining Share of Medicare Beneficiaries with Retiree Health Benefits From a KFF study: Based on the Survey, we find:

  • Half (50%) of large employers offering retiree health benefits to Medicare-age retirees offer coverage to at least some retirees through a contract with a Medicare Advantage plan, nearly double the share in 2017 (26%).

  • About 44% of large employers that offer Medicare Advantage coverage to their retirees do not give retirees a choice in coverage options.

  • Among larger employers with 1,000 or more workers that offer retiree health benefits through a Medicare Advantage plan, the most commonly cited reason they elected this option was the lower cost.

About hospitals and healthcare systems

Operating Margins Among the Largest For-Profit Health Systems Have Exceeded 2019 Levels for the Majority of the COVID-19 Pandemic The article covers HCA, Tenet and CHS.

About pharma

 Swiss Parliament Approves Motion to Allow FDA-Approved Medical Devices into Market “The Swiss Parliament has cleared the way for legislation to allow non-CE-marked medical devices — including those approved or cleared by the FDA — to be marketed in Switzerland, where only CE-marked medical devices are currently available.”
Comment: This action is a real breakthrough: it allows a device to be used in a European country with only FDA approval.

CVS, Walgreens, Walmart appeal Ohio $650M opioid ruling “Arguing in the U.S. Sixth Circuit Court of Appeals, lawyers for the three pharmacy chains said there was never any proof the companies had violated the federal Controlled Substances Act through dispensing the drugs. It was also unfair to target these companies and therefore allow other pharmacy chains not to contribute to any of the fines imposed, the report added.”

About healthcare IT

Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates Regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of PHI to tracking technology vendors or any other violations of the HIPAA Rules.For example, disclosures of PHI to tracking technology vendors for marketing purposes, without individuals’ HIPAA-compliant authorizations, would constitute impermissible disclosures.”[Emphasis in original].
These guidelines come after exposure that many hospitals have been using third-party tracking tools, such as Google Analytics or Meta Pixel, to perform analysis on their data.

About health technology

 Congress needs to update FDA’s ability to regulate diagnostic tests, cosmetics “The outdated framework has forced the agency to regulate a test based on where it is made — by a medical device manufacturer, for example, or in an academic or clinical laboratory — rather than its distinctive complexity or potential risks. The result is an obsolete and bifurcated approach that leaves patients and providers often overestimating the amount of oversight that’s been applied to tests that matter for increasingly important clinical decisions, and that leaves test developers facing both uncertainty and inefficient regulatory burdens.”
An excellent review of what is needed to correct this problem.

Today's News and Commentary

About Covid-19

 ‘The more you submit, the more we get paid’: How fintech fueled covid aid fraud A great piece of investigative journalism.

About health insurance/insurers

Assessment of Churn in Coverage Among California’s Health Insurance Marketplace Enrollees Findings  In this cross-sectional study of 5.4 million enrollees in California’s health insurance marketplace, from 2014 through 2021, many had short enrollment tenures, with a median tenure of 14 months. Survey data from 6474 members who terminated coverage in 2018, 2019, or 2021 indicated that most churn was associated with changes in eligibility; most disenrolled individuals took up other types of coverage (46% through an employer and 24% through Medicaid), with only 14% going uninsured.
Meaning  This study found that health insurance marketplace churn was largely the result of changes in eligibility to other sources of coverage rather than enrollees taking up coverage only when they needed care, suggesting that marketplaces should adopt policies to smooth the high volume of coverage transitions among its enrollees.”

Trends in and Factors Contributing to the Slowdown in Medicare Spending Growth, 2007-2018 Findings  In this analysis of individual-level Medicare spending data of more than 30 million beneficiaries, 44% of the decline in per-beneficiary spending growth from 2012 to 2015 and 63% from 2016 to 2018 could be attributed to lower increases in payment rates, sequestration measures, and shifts in beneficiary characteristics.
Meaning  Continued attention to Medicare payment policies and how to target them appropriately will be needed to maintain slow spending growth and extend the Medicare program’s sustainability.”

About hospitals and healthcare systems

 Trinity Health weathers $565M net loss, -2.9% operating margin to start its 2023 fiscal year “Revenue growth from Trinity Health’s recent MercyOne acquisition wasn’t enough to outpace volume struggles and rising expenses during the Catholic health giant’s first fiscal quarter of 2023.
Thursday, the 88-hospital system reported a $146.3 million operating loss (-2.9% operating margin) and a $565 million net loss for the quarter ended Sept. 30, 2022. The organization had notched a $106.3 million operating gain and a $378.8 million net profit at this time last year.”

About pharma

 Comparison of Uptake and Prices of Biosimilars in the US, Germany, and Switzerland Findings  This cohort study found that fewer biosimilars entered the market in the US between 2011 and 2020 compared with Germany and Switzerland and on average, the biosimilar market share at launch was highest in Germany yet increased at the fastest rate in the US. Monthly treatment costs of biosimilars were substantially higher in the US compared with Germany and Switzerland.
Meaning  These findings suggest that policies aimed against anticompetitive practices could allow biosimilars to enter the US market more quickly and could result in overall lower costs and that awareness of biosimilars should be promoted to increase uptake of biosimilars globally.”

About the public’s health

Biden administration poised to lift monkeypox emergency declaration “The Biden administration plans to end the public health emergency for monkeypox, officials said Friday, as new cases of the viral disease plummet.
Officials at the Department of Health and Human Services issued a 60-day notice to lift the emergency declaration, which had gone into effect in August.”

On World AIDS Day, Biden administration releases new global strategy to end HIV/AIDS by 2030 “On World AIDS Day, the Biden administration renewed its focus on ending the HIV/AIDS epidemic by 2030, releasing a new five-year strategy for the United States’ global response.
The administration said Thursday it is accelerating its response to HIV/AIDS with new global goals including reaching key treatment targets across ages, genders and population groups; supporting UNAIDS targets to reduce new HIV infections; and closing equity gaps for certain groups, including adolescent girls, young women and children.

About healthcare IT

 Telehealth department dissolving, Marshfield Clinic Health System facing financial difficulties “Another department within the Marshfield Clinic Health System has been dissolved as of Thursday. The Telehealth team of 18 employees was told in a meeting Oct. 27 that their positions were being eliminated due to “business reasons,” effective Dec. 1.” 

Today's News and Commentary

About Covid-19

 Coronavirus in the U.S.: Latest Map and Case Count As of the week closed 11/30:
Cases:45,21914 +15%
Test positivity:10% +26%
Hospitalized: 32,445 +16%
In I.C.Us: 3,794 +16%
Deaths: 262 (-7%) 

Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers This article has been quoted widely in the press with the conclusion that medical masks are just as good as N95 Respirators in preventing COVID-19. However, the results varied greatly among the countries where the study was carried out. N95s are still the safest choice for prevention.

Long Covid may be ‘the next public health disaster’ — with a $3.7 trillion economic impact rivaling the Great Recession “Long Covid has affected as many as 23 million Americans. It may cost the U.S. economy $3.7 trillion, roughly that of the Great Recession, according to one estimate.”

About health insurance/insurers

Highmark posts $268M loss across three quarters as investments, labor issues ding finances “Highmark Health posted a $268 million net loss through the first nine months of 2022 as multiple headwinds drag its finances.
Highmark reported $19.5 billion in revenue, up 22% year-over-year, and $594 million in operating gain. The performance of its equity investment portfolio is a key challenge facing the integrated system, as its financial report includes $670 million in unrealized investment impact driven by a decline in the portfolio…
Other major headwinds include ongoing supply chain issues, inflation and high labor costs, particularly at its Allegheny Health Network health system. Strong performance at its health plan arm is helping to bolster AHN as it weathers these challenges that providers nationwide are staring down.”

UnitedHealthcare loses to TeamHealth — again — over alleged underpayments “A three-judge arbitration panel in Florida ruled that UnitedHealthcare must award $10.8 million to a TeamHealth clinician group for underpayments from 2017 to 2020. 
The verdict is the latest in a contentious legal history between the payer and the Knoxville, Tenn.-based physician staffing company. A jury ruled in December 2021 that UnitedHealthcare must pay $60 million in punitive damages after losing a Nevada lawsuit against TeamHealth over thousands of provider underpayments for emergency services. TeamHealth medical groups have eight additional lawsuits pending across the country challenging the payer's alleged underpayment practices, according to a Nov. 30 TeamHealth news release.”

About hospitals and healthcare systems

 National Hospital Flash Report, November 2022 “Key Takeaways”

  1. Margins remain negative in October.
    October represented another month of negative operating margins for hospitals, with a slight downturn from September. As the year comes to a close, compounding months of poor performance could signal continued difficulties for hospitals in the near future.

  2. Expense pressures drive poor performance.
    Hospitals continue to face the significant weight of high expenses outpacing revenues, particularly when it comes to the cost of labor. Additionally, hospitals are turning to external sources for services like IT and human resources support, instead of keeping them in house at a lower cost. Finally, the high cost of materials due to inflation has not abated.

  3. Hospitals struggle to discharge patients.
    Hospitals struggled to discharge patients in October due to internal labor shortages and shortages in post-acute settings. The struggle to discharge patients led to a slight increase in length of stay. However, longer stays did not translate to additional revenue for hospitals.

  4. Emergency department visits and operating room minutes increase slightly.
    Hospitals experienced slight increases in both categories from September to October. However, the increase in emergency department (ED) visits put further strain on hospitals as many were unable to admit patients needing in-patient care due to staffing shortages. Many hospitals were forced to board patients in the ED leading to increased pressure on ED staff.” 

Mayo Clinic, Intermountain, HCA post quarterly incomes when many systems see losses “Labor challenges, rising costs, inflation and declining inpatient volumes are some of the key factors leading to many hospitals and health systems reporting third-quarter losses. However, Mayo Clinic, HCA Healthcare and Intermountain Healthcare are three systems that have bucked that trend.
While income did slip for these health systems, according to recent financial reports, the drops were not as significant as other healthcare organizations, with all three still reporting an income over a loss for the quarter.”

About the public’s health

 Drug Overdose Deaths in Adults Aged 65 and Over: United States, 2000–2020 

  • “Between 2000 and 2020, age-adjusted rates of drug overdose deaths for adults aged 65 and over increased from 2.4 to 8.8 deaths per 100,000 standard population.

  • For men aged 65–74 and 75 and over, rates of drug overdose deaths were higher among non-Hispanic Black men compared with Hispanic and non-Hispanic White men.

  • For women aged 65–74, drug overdose death rates were higher for non-Hispanic Black women compared with Hispanic and non-Hispanic White women, but for women aged 75 and over, non-Hispanic White women had the highest rates.

  • The age-adjusted rate of drug overdose deaths involving synthetic opioids other than methadone (such as fentanyl) for adults aged 65 and over increased by 53% between 2019 (1.9) and 2020 (2.9).”

 
CDC expands wastewater testing for polio to Michigan and Pennsylvania “The Centers for Disease Control and Prevention is expanding efforts to test wastewater to detect the polio virus in Philadelphia and the Detroit area, targeting communities at highest risk for the life-threatening and potentially disabling illness, officials said Wednesday.
The expansion of wastewater monitoring for polio comes amid pressure to increase efforts to fight the disease after the first U.S. polio case in nearly a decade was discovered in New York’s Rockland County in July.”

Is Spreading Medical Misinformation a Doctor’s Free Speech Right? “When Gov. Gavin Newsom signed into law a bill that would punish California doctors for spreading false information about Covid-19 vaccines and treatments, he pledged that it would apply only in the most “egregious instances” of misleading patients.
It may never have the chance.
|Even before the law, the nation’s first of its kind, takes effect on Jan. 1, it faces two legal challenges seeking to declare it an unconstitutional infringement of free speech. The plaintiffs include doctors who have spoken out against government and expert recommendations during the pandemic, as well as legal organizations from both sides of the political spectrum.”

About health technology

 U.S. FDA gives first-ever approval to fecal transplant therapy “The U.S. health regulator on Wednesday approved Switzerland-based Ferring Pharmaceuticals' fecal transplant-based therapy to reduce the recurrence of a bacterial infection, making it the first therapy of its kind to be cleared in the United States.
The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea. In the United States, the infection is associated with 15,000-30,000 deaths annually.”

About healthcare finance

GE board approves GE healthcare spinoff “GE said Nov. 30 its board approved the planned spin-off of its healthcare business, GE Healthcare. 
GE announced June 26, 2018, that it would spin off its healthcare business into a standalone enterprise as part of its plan to split into three public companies. Under the spinoff, shareholders will receive one share of the new company for every three GE shares they hold on Dec. 16, according to a press release from GE. 
The new company is also expected to begin trading on Nasdaq Jan. 4, under the symbol GEHC.”

Today's News and Commentary

About Covid-19

 BB variant's arrival won't cause a new deadly COVID surge, officials hope “The Centers for Disease Control and Prevention revealed Friday it is now tracking a new COVID-19 variant of concern around the U.S. known as XBB, which has grown to make up an estimated 3.1% of new infections nationwide. 
The strain's prevalence has grown furthest so far in the Northeast, according to the agency's weekly estimates. More than 5% of infections in the regions spanning New Jersey through Maine are linked to XBB…”

Twitter ends its ban on covid misinformation “Twitter will no longer enforce its policy against coronavirus misinformation, worrying experts who say the move could have serious consequences in the midst of a still-deadly pandemic.”  

About health insurance/insurers

AHIP says Medicare Advantage audit reports 'fail to provide context' “AHIP is pushing back on claims that Medicare Advantage plans are overcharging the government. 
In a Nov. 28 press release, the trade association rebutted a Nov. 21 story from Kaiser Health News detailing CMS audits of Medicare Advantage plans conducted between 2011 and 2013. 
The audits showed some plans overbilled an average of more than $1,000 per patient per year…
In the release, AHIP said the CMS audit process relies on physician records and suggested the agency create an ‘open, transparent and collaborative’ process for oversight.”

Humana shuttering most SeniorBridge home care locations “SeniorBridge offers services at 23 centers in nine states. The facilities in Arizona, Connecticut, Florida, Massachusetts, New Jersey, Ohio, Texas and Virginia will close, while seven sites in New York will remain in operation ‘until further notice,’ the Humana spokesperson wrote in an email.”

About hospitals and healthcare systems

How Elevance Health is working with NCQA and Harvard to advance its health equity work “Elevance Health, formerly Anthem, announced that 21 of its affiliated Medicaid plans earned full three-year accreditation for health equity from NCQA. The health equity accreditation provides an actionable framework to guide and evaluate organizations' health equity work, according to the nonprofit organization.
The accreditation was earned by Elevance Health affiliates in 20 U.S. states.”
The Health Equity accreditation is a relatively new NCQA process.

Cleveland Clinic's net losses reach $1.5B so far in 2022 “Cleveland Clinic has reported a more than $1 billion loss for the first nine months of 2022 as salaries increase and inflationary pressures mount.
The 20-hospital health system reported $469.2 million in third quarter net losses, a significant drop from $422.2 million net income last year. Cleveland Clinic's investment returns were nearly $682 million lower for the third quarter this year than last due to ‘unfavorable financial markets,’ according to the health system's financial report.
For the nine month's end, Cleveland Clinic reported $1.5 billion net loss compared to nearly $1.7 billion net income over the same period last year.”

About the public’s health

 Meal Skipping and Shorter Meal Intervals Are Associated with Increased Risk of All-Cause and Cardiovascular Disease Mortality among US Adults “In this large, prospective study of US adults aged 40 years or older, eating one meal per day was associated with an increased risk of all-cause and CVD mortality. Skipping breakfast was associated with increased risk of CVD mortality, whereas skipping lunch or dinner was associated with increased risk of all-cause mortality. Among participant with three meals per day, a meal interval of ≤4.5 hours in two adjacent meals was associated with higher all-cause mortality.”

 CDC awards over $3 bln to strengthen U.S. public health infrastructure “The Centers for Disease Control and Prevention (CDC) said on Tuesday it is awarding more than $3 billion to help strengthen public health workforce and infrastructure across the United States after the COVID-19 pandemic put severe stress on them.
The public health agency's funding includes $3 billion from the American Rescue Plan announced by President Joe Biden's administration last year, and would cover all state, local and territorial health departments across the country.
It also includes $140 million from a new appropriation to those jurisdictions and an award of $65 million to three public health entities to help provide training and technical assistance.”

Trends and Disparities in Firearm Fatalities in the United States, 1990-2021 “In this cross-sectional study of 1 110 421 firearm fatalities, all-intent firearm fatality rates declined to a low in 2004, then increased 45.5% by 2021. Firearm homicides were highest among Black non-Hispanic males, and firearm suicide rates were highest among White non-Hispanic men ages 70 years and older.”

Weekly U.S. Influenza Surveillance Report “Five influenza-associated pediatric deaths were reported this week, for a total of 12 pediatric flu deaths reported so far this season.
CDC estimates that, so far this season, there have been at least 6.2 million illnesses, 53,000 hospitalizations, and 2,900 deaths from flu.
The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 46 during every previous season since 2010-2011.”

Trends in Stage I Lung Cancer “Highlights:
The percentage of patients diagnosed with stage I lung cancer is increasing
This trend is observed in non-small cell lung cancer but not in small cell lung cancer
The staging shift may be due to lung cancer screening and a higher detection of incidental lung nodules
There are significant imbalances in the percentages of stage I lung cancer according to demographic characteristic”

 About health technology

THE BEST INVENTIONS OF 2022 From Time magazine. Many of the inventions are healthcare relayed.

Today's News and Commentary

About Covid-19

 COVID-19 cases to jump 80% by Dec. 7, Mayo forecasts The headline is the story.

Analysis of Failure Rates for COVID-19 Entrance Screening at a US Academic Medical Center “We found limited benefit in maintaining hospital entrance screening for COVID-19 symptoms, exposures, or travel. Of the nearly 1 million persons screened, less than 0.1% had a failed screening.”
Read the Discussion section for caveats.

About health insurance/insurers

 Providers in Direct Contracting Model saved Medicare $70M in 2021, CMS reports “The Direct Contracting Model saved Medicare $70 million in 2021 as the Biden administration plans a major overhaul to the value-based care program next year.
Recently released data from the Centers for Medicare & Medicaid Services (CMS) found that 53 direct contracting entities generated savings for Medicare and 38 organizations earned $47 million in shared savings in 2021, the first year of the model. In response to the public health emergency, the start of the performance year was delayed to April 1, 2021, leading to nine months of experience reflected in these results.
All 53 direct contracting entities received quality scores of 100 percent in areas such as patient satisfaction and unplanned admissions for patients with chronic conditions, according to an emailed announcement from CMS.”

Surprise Medical Billing Disputes Pile Up as Lawsuit Unfolds “Litigation over the Biden administration’s process for resolving surprise medical billing disputes threatens to exacerbate a growing backlog in claims and leave doctors without paychecks, health-care lawyers said.
A federal district court in Texas is slated to decide the validity of the Department of Health and Human Services’ revised process for settling disagreements between health insurers and providers over payment rates. It will hear arguments Dec. 20 in a case brought by the Texas Medical Association over a final rule outlining the independent dispute resolution process.”

Most common treatments subject to prior authorization Genetic testing and Specialty drugs top the list.

About the public’s health

WHO renames monkeypox as ‘mpox’ “The World Health Organization announced Monday that “mpox” is now the preferred name for monkeypox.
’Both names will be used simultaneously for one year while “monkeypox” is phased out,’ the organization said.”

Cervical Cancer Incidence Among US Women, 2001-2019 “Between 2001 and 2019, cervical cancer incidence declined or remained stable among US women except for the 30- to 34-year-old age group, in whom incidence increased 2.5% per year after 2012. The observed increase in incidence among 30- to 34-year-old women could be real as a result of a true increase in cervical cancer incidence or due to increased early detection with a stable disease occurrence. If the increase is real, it could be a result of missed screening opportunities at earlier ages, as suggested by the increase in squamous cell carcinoma and localized disease. It may also stem from a decrease in screening at younger ages.”

About healthcare IT

Prevalence and Sources of Duplicate Information in the Electronic Medical Record “In this cross-sectional analysis of 104 456 653 routinely generated clinical notes, 16 523 851 210 words (50.1% of the total count of 32 991 489 889 words) were duplicated from prior documentation. Duplicate content was prevalent in notes written by physicians at all levels of training, nurses, and therapists and was evenly divided between intra-author and inter-author duplication.”

Amwell exploring $200M buyout of online therapy provider Talkspace: media report The headline is the story.

Google Health strikes deal with iCAD to commercialize mammography AI “Google Health struck a deal with medical technology company iCAD to integrate its artificial intelligence technology into the company's breast imaging solutions.
It marks the first licensing and commercialization agreement for Google Health's mammography AI models and will integrate the technology into real-world clinical practice, according to the company. ICAD's tech is used in health systems and imaging centers across the U.S. and globally.”

Athenahealth looks to go public again “EHR vendor Athenahealth is looking to go public just 10 months after it was bought by Bain Capital and another private equity firm for $17 billion, the Boston Globe reported Nov. 28…
The company has gotten out of the hospital business, instead focusing on software and services for medical practices, adding more than 2,000 of them this year, according to the Globe. The vendor also sold its headquarters for $526 million to Alexandria Real Estate Equities in 2019.”

Today's News and Commentary

About health insurance/insurers

 Audits — Hidden Until Now — Reveal Millions in Medicare Advantage Overcharges “Newly released federal audits reveal widespread overcharges and other errors in payments to Medicare Advantage health plans for seniors, with some plans overbilling the government more than $1,000 per patient a year on average.
Summaries of the 90 audits, which examined billings from 2011 through 2013 and are the most recent reviews completed, were obtained exclusively by KHN through a three-year Freedom of Information Act lawsuit…”

Boost in people seeking HealthCare.gov coverage, HHS says “Nearly 3.4 million people have signed up for coverage — an increase of 17% compared to the same time last year. The boost in enrollment comes as the number of uninsured Americans this year reached a historic low of 8%.”

Medicare Advantage Premiums Rise, Zero-Dollar Premium Plan Uptake Declines “Medicare Advantage premiums rose to $7 per month on average for 2023 open enrollment season, an eHealth survey uncovered.
For the past four years, Medicare Advantage plan premium costs have been stable or falling. In 2019, the cost was $10 and by 2022 it had dropped to $4 per month. But now that trend is reversing and seniors will face, on average, a $3 premium hike…
During the 2022 open enrollment season, zero-dollar premium plans were responsible for keeping premium costs low. Zero-dollar premium health plans continue to be a significant share of Medicare Advantage plans. In fact, the number of Medicare Advantage plans with zero-dollar premiums has swelled from 59 percent in 2022 to 66 percent in 2023…Even though the number of plans with zero-dollar premiums grew in the past year, the percentage of beneficiaries who selected zero-dollar premium plans fell after four consecutive years of growth.”

Accounting for the Growth of Observation Stays in the Assessment of Medicare’s Hospital Readmissions Reduction Program [HRRP] Findings  In this cohort study including 8 944 295 hospitalizations, fully accounting for observation stays as both index hospital discharges and readmissions more than halved the apparent decrease in 30-day readmissions (−1.48 vs −0.66 percentage points). In addition, an association of the program with lower readmission rates identified when only inpatient hospitalizations were considered was not found.
Meaning  The findings of this study suggest that much of the estimated reduction in readmissions associated with the implementation of the HRRP can be attributed to reclassification of inpatient admissions to observation stays.”

Georgia moves ahead with Medicaid work requirement plan “he state plans to implement a new Medicaid expansion plan – Georgia Pathways — that includes work requirements next July after several years of legal wrangling over the controversial proposal.  
‘I can confirm that we are moving forward with implementing the Pathways plan,’ said Andrew Isenhour, a spokesman for Republican Gov. Brian Kemp. 
The limited Medicaid expansion plan will require enrollees to work, study or volunteer for at least 80 hours per month.”

About hospitals and healthcare systems

 Nonprofit health systems' Q3 earnings: Baylor Scott & White, Sutter Health's operations stand tall among the pack “Motley earnings numbers from more than a dozen major nonprofit health systems show third-quarter operating incomes landing on both sides of zero, though issues such as labor shortages, limited volume recovery and worsening payer mix look to be a constant across much of the sector.” 

About pharma

 FDA approves most expensive drug on market “The FDA approved a hemophilia B drug with a list price of $3.5 million — which could save the healthcare system millions per patient according to drug maker CSL Behring.
Hemgenix is the first and only onetime gene therapy treatment for adults with hemophilia B who ‘currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes,’ according to a Nov. 22 CSL release.”

Teva, AbbVie's Allergan lock in $6.6B deal to settle thousands of US opioid lawsuits “Under an agreement floated in July, Teva is on the hook to pay $4.25 billion—a sum that will be paid out over 13 years and includes up to $1.2 billion worth of Teva’s generic version of the overdose reversal drug Narcan. Allergan, for its part, will provide up to $2.37 billion to help state and local efforts to fight opioid addiction and substance use disorder in the U.S.”

‘Skinny labels’ on biosimilar medicines saved Medicare $1.5 billion over a recent five-year period “Ahotly contested provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare $1.5 billion from 2015 to 2020 — or nearly 5% of the $30.2 billion spent by the health care program — on just five medicines during that period, according to a new analysis.”

About the public’s health

The International Code of Medical Ethics of the World Medical Association “The World Medical Association (WMA) has developed the International Code of Medical Ethics as a canon of ethical principles for the members of the medical profession worldwide. In concordance with the WMA Declaration of Geneva: The Physician’s Pledge and the WMA’s entire body of policies, it defines and elucidates the professional duties of physicians towards their patients, other physicians and health professionals, themselves, and society as a whole.”

 Changes in Home Births by Race and Hispanic Origin and State of Residence of Mother: United States, 2019–2020 and 2020–2021 “Following average annual increases of 2% from 1990 (0.67%) to 2019 (1.03%), the percentage of home births rose 22% from 2019 to 2020 (1.26%), and another 12% from 2020 to 2021 (1.41%). The 2021 level was the highest since at least 1990, demonstrating a higher rate of increase in home births during the first 2 years of the COVID-19 pandemic. From 2020 to 2021, levels increased by 10% to 21% for each of the race and Hispanic-origin groups.” 

About healthcare IT

 Google rolls out search features that aim to make it easier to sign up for Medicaid, Medicare “When many people are looking to enroll in health benefits, they turn to Google as a source of key information on eligibility, the application process and in-network providers.
In this spirit, the Google Search team has quietly rolled out multiple features for its search engine that aim to make it easier for users to access key information about obtaining Medicaid and Medicare benefits, as well as which doctors locally accept those types of coverage.”

About health technology

 FDA classifies Baxter's hospital bed system recall as most serious “The U.S. health regulator on Wednesday classified the recall of hospital bed systems by Baxter International Inc as the most serious type, on concerns it could lead to life-threatening injuries or death…
The device was found to interfere with other nearby critical devices such as infusion pumps, insulin pumps, blood glucose sensors and bladder scanners, among others.The Food and Drug Administration said the interference from WatchCare may lead to erroneous reading or malfunctions on other devices, causing inappropriate medical treatment for patients.”

About healthcare finance

 Baxter's blunder with Hillrom raises questions about its future “Baxter International flubbed its biggest acquisition ever, tanking its stock price while raising doubts about CEO José Almeida’s growth strategy and potentially making Baxter itself a takeover target.
The Deerfield-based medical products manufacturer last month disclosed a $3.1 billion impairment charge related to the $10.5 billion purchase last year of Hillrom, confirming Almeida overpaid significantly for the Chicago-based maker of hospital equipment.”

Today's News and Commentary

About health insurance/insurers

 CENTENE SIGNS DEFINITIVE AGREEMENT TO DIVEST MAGELLAN SPECIALTY HEALTH “ Centene Corporation announced today that it has signed a definitive agreement to sell Magellan Specialty Health to Evolent Health, Inc. (Evolent). Subject to customary purchase price adjustments, Centene expects to receive over $750 million in the aggregate from the transaction.
Centene acquired Magellan Specialty Health, also known as NIA, in January 2022 as part of its acquisition of Magellan Health, Inc. Magellan Specialty Health is a leading specialty benefit management organization that offers industry-leading utilization management solutions to health plans, including radiology management, musculoskeletal management, physical medicine management, and genetic testing solutions.”

Federally-facilitated Exchange Improper Payment Rate Less Than 1% in Initial Data Release “The Centers for Medicare & Medicaid Services (CMS) announced today that the first improper payment rate for the Federally-facilitated Exchange (FFE) program was less than 1% for Benefit Year 2020, thanks in large part to the agency’s implementation of effective automated processes for the program’s eligibility determinations and payments. This finding highlights CMS’ commitment to being responsible stewards of public funds, and to ensuring the sustainability of its programs for future generations.”

About hospitals and healthcare systems

$2.4B Gundersen, Bellin merger to close Nov. 30 “The "merger of equals" was announced June 1 with the goal of both systems offering more resources and services to improve patient care. The health systems will have a balanced leadership structure, with CEOs and board chairs in both regions to have equal representation in decision making for the combined entity.”

 Mayo reports $157M Q3 income, salaries and benefits increase 3.5% “Rochester, Minn.-based Mayo Clinic reported a strong third-quarter operating margin despite challenges from workforce shortages and inflation. …
Mayo reported net operating income of $157 million on $4.12 billion for the third quarter of 2022. The health system's operating margin at the quarter's end was 3.8 percent.
Operating expenses hit nearly $4 billion for the quarter as well, a 7.1 percent increase over the same period last year. Salaries and benefits were up 3.5 percent to $2.3.”

Catholic Health suffers credit rating downgrade “Buffalo, N.Y.-based Catholic Health had its credit rating downgraded and is in danger of defaulting on its covenants, Moody's said Nov. 17.
The nonprofit health system, which serves residents in Western New York state with four acute care hospitals and several other facilities, saw its rating on approximately $364 million of debt drop from ‘B1’to ‘Caa2.’ Staffing costs, ongoing impacts from the pandemic and a prolonged labor dispute have resulted in ‘material cash flow losses,’ which are unlikely to go away anytime soon, Moody's said.”

Ascension creates foundation to address health inequities “Ascension, a 143-hospital nonprofit system based in St. Louis, has created a national philanthropic organization that will develop, support and promote health equity initiatives.
The Ascension Foundation will initially focus on programs that address generational poverty and help create economic stability for people, according to a Nov. 17 news release. The organization will also work on creating a diverse future healthcare workforce.”

No Surprises Act Prevents More than 9 Million Surprise Bills Since January 2022 “More than 9 million claims from health care facilities and providers were subject to the protections of the law, which limit out-of-pocket costs for consumers. The number of those claims disputed by providers or facilities has far exceeded the federal government’s initial prediction.”

About pharma

FDA approves Provention Bio's Tzield as first drug to delay onset of type 1 diabetes “The FDA granted clearance to Provention Bio's Tzield (teplizumab-mzwv), making it the first approved drug that can delay the onset of type 1 diabetes. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research, said Tzield's "potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease." 
The drug is designed to bind to CD3, a cell surface antigen present on T lymphocytes, and its mechanism is believed to involve partial agonistic signalling and deactivation of pancreatic beta cell autoreactive T lymphocytes. Specifically, Tzield, which is administered by intravenous infusion once daily for 14 consecutive days, is indicated to delay the onset of stage 3 type 1 diabetes in adults and paediatric patients 8 years and older who currently have stage 2 type 1 diabetes.”

About the public’s health

 Association of Residential Racial and Economic Segregation With Cancer Mortality in the US  “In this ecological study of 3110 US counties, age-adjusted mortality rates were statistically significantly higher for the most deprived counties for all cancers combined and for 12 of 13 selected cancer sites compared with the most privileged counties, with the largest magnitude occurring with lung and bronchus cancer.” 

Today's News and Commentary

Oregon will be the first state to make affordable health care a constitutional right “Oregon will be the first state in the nation to enshrine the right to affordable health care in its constitution.
Ballot Measure 111 narrowly passed, with nearly 50.7% of voters in favor and 49.3% of voters opposed. The measure’s long-term impact on Oregon health care is unclear because it doesn’t prescribe how the state should ensure that everyone has affordable health care.
Measure 111 amends the Oregon constitution by adding: ‘It is the obligation of the state to ensure that every resident of Oregon has access to cost-effective, clinically appropriate and affordable health care as a fundamental right.’
Comment: This measure is truly a landmark for Americans. Nowhere in our Constitution or federal laws is the right to healthcare guaranteed. [The exceptions are EMTALA’s requirement to treat and the rights of prisoners to health care services.] The implementation is going to be difficult and costly, but starts with the definitions of “cost-effective, clinically appropriate and affordable health care.”
Check this site to see how close the vote was and how the majority of counties voted “No.”

About health insurance/insurers

What Will UnitedHealth’s New Trove of Claims Data Mean for Consumers? A must-read article from ProPublica.

Extra Benefits Offered by Medicare Advantage Firms Vary Worth a quick read- especially the charts.

 Most Adults in Medicaid-Enrolled Families are Unaware of Medicaid Renewals Resuming in the Future 
”Key Findings

  • Most adults with family Medicaid enrollment were not aware of the return to regular Medicaid renewals when the PHE expires.

    • 62 percent of adults with family Medicaid enrollment reported hearing nothing at all about the forthcoming eligibility redeterminations, 16.2 percent reported hearing some, and 15.7 percent reported hearing only a little.

    • Only 5 percent of respondents reported hearing a lot about the return to regular Medicaid renewals.

  • The most common source of information for those who had heard about the resumption of renewals was media or social media (34.3%), followed by a state agency (30.6%), a health insurance company or plan (24.5%), a healthcare provider (17.8%), or somewhere else (6.5%).

  • Half of respondents (50.4%) who had heard from a state agency or health plan about the upcoming change received a notification about the need to renew coverage.

    • Just one in five (21.3%) were told how to get assistance with the renewal process.

    • Less than one-third (29%) were informed of the coverage options available to them if they become ineligible for Medicaid.”

About hospitals and healthcare systems

 Advocate Aurora posts $310M Q3 loss “1. Advocate Aurora reported a $310.8 million loss for the third quarter and reported a $911.6 million loss for the nine months ending Sept. 30. The results are in stark contrast to the $1.5 billion recorded for the nine months ending figure in 2021.
2. Total quarterly revenue reached $3.6 billion, up 3 percent year over year. The health system reported nearly $3 billion of the revenue came from patient services. In July, Fitch affirmed an AA rating and stable outlook for the system's long-term indebtedness, and since then S&P affirmed its AA rating and Moody's affirmed an Aa3 rating as well.”

CommonSpirit reports $227M quarterly loss: 6 details “The 138-hospital health system reported $23 million income for the three months ending Sept. 30, down from $34 million over the same period last year. However, CommonSpirit received $325 million as part of the California provider fee program under the CMS-approved state plan amendment; after normalizing for the program, CommonSpirit reported a $227 million loss for the quarter.”

About the public’s health

 Prevalence and global estimates of unsafe listening practices in adolescents and young adults: a systematic review and meta-analysis “Unsafe listening practices are highly prevalent worldwide and may place over 1 billion young people at risk of hearing loss. There is an urgent need to prioritise policy focused on safe listening. The World Health Organization provides comprehensive materials to aid in policy development and implementation.” 

Changes in Home Births by Race and Hispanic Origin and State of Residence of Mother: United States, 2019–2020 and 2020–2021 “Following average annual increases of 2% from 1990 (0.67%) to 2019 (1.03%), the percentage of home births rose 22% from 2019 to 2020 (1.26%), and another 12% from 2020 to 2021 (1.41%). The 2021 level was the highest since at least 1990, demonstrating a higher rate of increase in home births during the first 2 years of the COVID-19 pandemic. From 2020 to 2021, levels increased by 10% to 21% for each of the race and Hispanic-origin groups. For all women and non-Hispanic White women, increases occurred generally for most months of the year, although not all increases were significant. Although less pronounced and consistent, increases also were seen in home births for most months for non-Hispanic Black and Hispanic women. Between 2020 and 2021, home births increased in 41 states (changes in 11 states were not significant) and declined in 9 states and D.C. (changes in 7 states and D.C. were not significant).”

Lung cancer screening rates in US ‘simply unacceptable’ “An estimated 14.2 million Americans meet the U.S. Preventive Services Task Force recommendation for lung cancer screening. The task force recommends annual screening with low-dose CT scan for individuals aged 50 to 80 years who have a 20 pack-year smoking history and either currently smoke or quit within the past 15 years.
Only 5.8% of Americans who meet those criteria have undergone lung cancer screening, according to the report. Analyses by state show rates are lowest in California (1%) and Nevada (1.3%) and highest in Massachusetts (16.3%)…
White individuals appeared more likely to be diagnosed at an early stage (27%) than Black (23%), Latino (23%), Asian/Pacific Islander (22%) and American Indian/Alaska Native (23%) individuals.”

Chest CT Findings in Marijuana Smokers “Airway inflammation and emphysema were more common in marijuana smokers than in nonsmokers and tobacco-only smokers, although variable interobserver agreement and concomitant cigarette smoking among the marijuana-smoking cohort limits our ability to draw strong conclusions.”

FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon Characters “Today, the U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product is packaged to look like toys, food, or cartoon characters and is likely to promote use by youth. None of the manufacturers submitted a premarket application for any of the unauthorized products.”

Mode of delivery modulates the intestinal microbiota and impacts the response to vaccination “Here we assess the association between mode of delivery, gut microbiota development in the first year of life, and mucosal antigen-specific antibody responses against pneumococcal vaccination in 101 infants at age 12 months and against meningococcal vaccination in 66 infants at age 18 months. Birth by vaginal delivery is associated with higher antibody responses against both vaccines. Relative abundances of vaginal birth-associated Bifidobacterium and Escherichia coli in the first weeks of life are positively associated with anti-pneumococcal antibody responses, and relative abundance of E. coli in the same period is also positively associated with anti-meningococcal antibody responses.”

About healthcare IT

 Mental Health Apps Are Not Keeping Your Data Safe “We surveyed 132 studies that tested automation technologies, such as chatbots, in online mental health initiatives. The researchers in 85 percent of the studies didn’t address, either in study design, or in reporting results, how the technologies could be used in negative ways. This was despite some of the technologies raising serious risks of harm. For example, 53 studies used public social media data—in many cases without consent—for predictive purposes like trying to determine a person’s mental health diagnosis. None of the studies we examined grappled with the potential discrimination people might experience if these data were made public.” 

About healthcare personnel

 Healthcare employment in 20 numbers FYI

Today's News and Commentary

Global population hits 8 billion as growth poses more challenges for the planet

About Covid-19

Cost of COVID-19 hospital admissions among people with private health coverage “We find that, in 2020, COVID-19 hospitalizations cost an average of $41,611, including an average out-of-pocket payment of $1,280 for people with large employer coverage. In 2020, many private insurers and employers temporarily waived out-of-pocket costs for COVID-19 treatment (this is generally no longer the case). For COVID-19 hospitalizations with some cost-sharing expense, an average of $1,880 was spent out-of-pocket by individuals with large employer coverage.”

Biden requests $9.25 bln for COVID, $37.7 bln for Ukraine from Congress -officials “The Biden administration is asking Congress for $9.25 billion to fight COVID-19…
The administration is also requesting $750 million to fight other infectious diseases and will be seeking additional money for natural disaster relief, the officials said.”

NICE recommends 3 treatments for COVID-19 in draft guidanceThree treatments for COVID have been recommended in draft NICE guidance released today for public consultation.
The recommended treatments are:

  • Nirmatrelvir plus ritonavir (also called Paxlovid and made by Pfizer).

  • Tocilizumab (also called RoActemra and made by Roche).

  • Baricitinib (also called Olumiant and made by Eli Lilly and company, subject to it receiving a marketing authorisation in Great Britain for treating COVID-19).”

Post–COVID-19 Symptoms 2 Years After SARS-CoV-2 Infection Among Hospitalized vs Nonhospitalized Patient Findings  This cross-sectional study found that the proportion of patients with at least 1 post–COVID-19 symptom 2 years after acute infection was 59.7% for hospitalized patients and 67.5% for those not requiring hospitalization. No significant differences in post–COVID-19 symptoms were seen between hospitalized and nonhospitalized patients.
Meaning  Similar rates of post–COVID-19 symptoms between hospitalized and nonhospitalized patients suggest that, among all patients who contract COVID-19, these sequelae deserve attention.”

About health insurance/insurers

 Working full time doesn’t always make it easier to get health insurance at the job “Though the number of full-time, year-round workers ages 19 to 64 jumped by 10.4 million last year, the uninsured rate of this group also rose – by 0.6 percentage points to 9.1%, according to Census Bureau data.
That’s partly because the occupations that had the largest increases in the share of full-time, year-round workers last year were service and construction, which are less likely to provide job-based health benefits. Only about 62% of service workers and 56% of construction workers have employer-sponsored insurance.
At the same time, the share of employees in professional and management occupations – which have the highest rates of workplace coverage at 89% and 85%, respectively – declined somewhat last year. This also contributed to the drop in coverage among all full-time, year-round workers.”

About hospitals and healthcare systems

Midwest nonprofits Sanford Health, Fairview Health Services target a 58-hospital merger for 2023 “The nonprofits have signed a nonbinding letter of intent as they proceed with due diligence and regulatory antitrust reviews, they said in a press release. Each would maintain their own regional presence, leadership and regional boards but operate as a single integrated system under Sanford Health’s banner.
The organizations said they anticipate closing their deal sometime next year.”

CommonSpirit Health kicks off its fiscal 2023 with a $397M net loss, 0.3% operating margin “The system’s $23 million operating income (0.3% margin) for the three months ended Sept. 30 represents a slight decline from the $34 million (0.4%) recorded during the same time last year.
Operating revenue for the quarter rose to about $9.01 billion from the previous year’s $8.55 billion (5.4% year-over-over increase).”

 Leapfrog Group Releases New Hospital Safety Grades, Marking 10th Anniversary “Highlights from the fall 2022 Leapfrog Hospital Safety Grade include:

  • Thirty percent of hospitals received an "A," 28% received a "B," 36% received a "C," 6% received a "D," and 1% received an "F.”

  • The top ten states with the highest percentages of "A" hospitals are New Hampshire, Virginia, Utah, Colorado, Idaho, New Jersey, North Carolia, Maine, Pennsylvania, and Florida.

  • There were no “A” hospitals in the District of Columbia, North Dakota, or Vermont.” 

About pharma

 Optum to add biosimilars to formulary to tackle the massive cost of Humira “Optum Rx, the pharmacy benefit management subsidiary of UnitedHealth Group, manages more than 66 million members and is one of the three largest PBMs that dominate the market, alongside CVS Health's Caremark and Cigna's Express Scripts.
The company said it will place those biosimilars on its formulary at parity with Humira, meaning they'll be on the same tier. The first biosimilar to compete with Humira will arrive next year and will be the first added to the formulary. 
The goal, CEO Heather Cianfrocco said at a HLTH session Tuesday, is to make a dent in rising specialty drug costs, which represent just 2% of prescriptions but 50% of costs. Optum Rx said Humira alone accounts for $20 billion in sales each year.”

AbbVie Reaches $54.4 Million Settlement Over Its Alzheimer’s Drug “AbbVie has agreed to a $54.4 million settlement for alleged anticompetitive abuse of the generic pharmaceutical approval process involving Namenda (memantine hydrochloride), an FDA-approved drug to treat Alzheimer’s.”

Deductibles and Coinsurance Drive High Out-Of-Pocket Costs For Commercially Insured Patients Taking Brand Medicines “As new data shows, this discriminatory practice can lead to higher costs for patients at the pharmacy. For commercially insured patients taking one or more brand medicines in 2021, the sponsored health care data analytics firm IQVIA found that:

  • Patients with deductibles or coinsurance spent six times ($261) more out of pocket, on average, for their brand and generic medicines than patients with only copays.

  • Insurers and PBMs subjected two-thirds of patients to the medicine’s full list price through the use of deductibles or coinsurance.

  • Deductibles and coinsurance accounted for 60% of patients’ out-of-pocket spending on brand medicines.

  • Patients filling a brand prescription in the deductible paid eight times more for their medicine than patients filling a brand prescription with copays.

  • Patients were nearly four times more likely to abandon newly prescribed brand medicines filled in the deductible compared to those filled with copays.

  • Patients using cost-sharing assistance to access their brand medicines reduced their annual out-of-pocket costs by nearly 60%, leading to average savings of nearly $500.”

About the public’s health

 Screening for Obstructive Sleep Apnea in Adults “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for OSA in the general adult population. (I statement)”

FDA moves to boost access to overdose reversal med with preliminary over-the-counter endorsement “In a Federal Register notice issued Tuesday, the U.S. drug regulator released its preliminary assessment that certain naloxone products “may be approvable”—i.e., safe and effective—for over-the-counter use. The decision—while not a formal OTC approval determination—is many years in the making and could ease development and approval of nonprescription naloxone, the agency said in a release. This could include transforming the approvals for existing prescription naloxone products into OTC nods.”

Notable Survey: 61% of Patients Skip Medical Appointments Due to Scheduling Hassles The headline is the story.

Judge overturns Georgia’s six-week abortion ban “A Fulton County judge has overturned Georgia’s six-week abortion ban, ruling that two key parts of the law “were plainly unconstitutional when drafted, voted upon, and enacted” and writing that the law cannot be enforced.
The 15-page ruling by Fulton County Superior Court Judge Robert McBurney stemmed from a lawsuit that argued the state’s “heartbeat bill” violated pregnant people’s liberty and privacy rights under Georgia’s constitution. The plaintiffs also argued that the law violatedthe U.S. Constitution at the time it was enacted — in 2019, when Roe v. Wade was still the law of the land.”

About healthcare IT

 Best Buy expands push into home healthcare with investment in remote patient monitoring firm “Best Buy has made an initial investment in remote patient monitoring company Coeus h3c as the tech retailer looks to expand in the home healthcare market.
Coeus h3c offers a cloud-based platform that automates technology and logistics processes for remote patient monitoring vendors.”

Mayo Clinic launches digital referee for spotting potential bias in healthcare AI programs “Dubbed Platform_Validate, the program is designed to put an algorithm’s credibility to the test, and act as a third party to confirm the AI’s efficacy in meeting its intended clinical purpose. 
By generating standard reports on specificity and sensitivity, the Mayo Clinic said it aims to address some of the skepticism of implementing AI programs in healthcare and diagnostics—especially where programs may inadvertently reinforce inequities in the current system, by underlining disparities present in potentially poor-quality data used to construct and train the algorithm in the first place.”

Teladoc Health Reaches 50 Million Visit Milestone The headline is the story.

About healthcare finance

 DispatchHealth raises $330M led by Optum Ventures “Home healthcare company DispatchHealth has raised $330 million in a funding round led by Optum Ventures, Home Health Care News reported Nov. 15.
DispatchHealth offers on-demand in-home acute care delivered by emergency and internal medicine teams. Blue Shield of California was among the other investors.

Today's News and Commentary

About health insurance/insurers

Trends in Social Spending by Private Health Insurers “Between 2017 and 2021, total identifiable social spending for the top 20 private health insurers was at least $1.87 billion. The top 6 insurers by market share made up 72% of total social spending. As a percent of net income, these six insurers, on average, spent 0.11% of dollars on SDoH in 2017, 1.6% in 2020, and 0.67% in 2021. Most funds went to housing ($1.2 billion) and food security ($238 million) programs. $247 million were allocated towards “general SDoH.” The least amount of funding was directed to transportation ($13.4 million), followed by social and community context ($49.7 million), education ($57.2 million), and employment ($58.6 million).”

About hospitals and healthcare systems

 Illinois OKs Atrium, Advocate Aurora merger “The Illinois Health Facilities and Services Review Board unanimously approved a plan to change ownership for 10 Advocate Aurora facilities in the state covered by the system's plan to merge with Charlotte, N.C.-based Atrium Health…”

AHA: Drugmaker 340B restrictions are harming safety net hospitals financially “A new hospital industry report charges that safety net and charity care hospitals are losing millions due to drug companies cutting off sales of pharmaceuticals discounted under the 340B program to contract pharmacies.
The report, released Monday and conducted by the American Hospital Association (AHA), focuses on the impact of restrictions conducted by nearly 20 drugmakers. The federal government and some of the companies have been battling in court over the moves.”

Cleveland Clinic to bill up to $50 for MyChart messages “Cleveland Clinic will begin to bill for Epic MyChart messages requiring a provider's clinical time and expertise beginning Nov. 17.
Patients have been able to send MyChart messages for free, and providers typically respond within three business days. But now the health system plans to bill for messages about medication changes, new symptoms, changes to long-term medical conditions, checkups on long-term conditions and requests to complete medical forms sent through MyChart, according to a news release from Cleveland Clinic.
Messages to schedule an appointment, get prescription refills and ask questions that could lead to an appointment will remain free. Patients can also give providers health updates without any extra charges.”
Other systems are also starting to implement these types of charges.

Oracle Cerner, Labcorp partner to manage hospital labs in 10 states “Oracle Cerner has partnered with life sciences company Labcorp to manage hospital-based laboratories in 10 states. 
Under the partnership, Cerner's laboratory information system will help Labcorp centralize operations and streamline processes within the hospital-based labs at a leading health system, according to a Nov. 14 press release from Oracle Cerner. The aim is to enhance patient care and improve lab efficiency. 
The partnership also allows Labcorp to build and expand upon the labs' existing technologies to standardize and optimize workflows for better efficiency as well as support information sharing across the health system.”

Providence's operating loss grows to $1.1B for 2022 “Providence, a 51-hospital system headquartered in Renton, Wash., ended the first nine months of 2022 with an operating loss of $1.1 billion, according to financial documents released Nov. 14. 
The system said in a Nov. 11 news release that its third quarter financial results showed the ‘ongoing impact of inflation, the national healthcare labor shortage, delayed reimbursement from payers, global supply chain disruptions and financial market weakness.’”

Hospital acquired infections were on the rise in 2021, says CDC “Several healthcare acquired infections (HAIs), such as central line-associated bloodstream infections and ventilator events, showed increased prevalence in 2021, according to new data released by the Centers for Disease Control and Prevention.
Four of six common infections increased over 2020, with the biggest increase occurring with Methicillin-resistant Staphylococcus aureus (MRSA), which showed a 14% year-over-year increase. 
Following that were ventilator-associated events (VAEs) at 12%; central line-associated bloodstream infections (CLABSIs) at 7%; and catheter-associated urinary tract infections (CAUTIS) at 5%.”

About pharma

 Walmart Agrees to Pay $3.1 Billion to Settle Opioid Lawsuits “Walmart, the largest retailer in the United States, has agreed to pay $3.1 billion to resolve thousands of lawsuits over its pharmacies’ roles in the opioid crisis, the company and lawyers for states, local governments and tribes announced Tuesday.” 

About the public’s health

More than 100 healthcare organizations have signed on to climate resilience pledge, HHS says “More than 100 health systems, payers, drug manufacturers, associations and other industry organizations have signed on to the Biden administration’s greenhouse gas and climate resilience pledge, according to a Department of Health and Human Services (HHS) announcement timed with the United Nations Climate Change Conference (COP27).

Inappropriate outpatient antibiotics linked to adverse drug events, excess health care costs “Of nearly 3.3 million eligible adults (median age, 43 years; 41% male), 43% and 56% received inappropriate antibiotics for sinusitis and pharyngitis, respectively. For viral infections, 7%, 32%, 52%, and 66% received inappropriate antibiotics for influenza, viral upper respiratory infection, nonsuppurative otitis media, and bronchitis, respectively.”

The FDA has banned certain vapes and medicines. We still bought these 13 products in its backyard From a STAT investigation: “The Food and Drug Administration, as the name suggests, is supposed to police the United States’ food and drug supply.
But there are still illegal products available for easy purchase at gas stations and convenience stores all over the country — including in the FDA’s own backyard. We know, we bought them.
Some of the products STAT found around the FDA’s suburban Maryland campus are outright dangerous, like an unapproved cough medicine linked to childrens’ deaths. Others, like CBD gummies and vapes, have become ubiquitous at convenience stores, but are still illegal nonetheless.”

About healthcare IT

 Consolidated telemedicine implementation guide From the WHO: In response to the global increase in demand, this guide provides an overview of key steps and considerations for implementing telemedicine and optimizing its benefits and impact. The guide aims to be an evolving document that harnesses learnings emerging from the COVID-19 pandemic, while synthesizing key considerations from WHO resources relevant developed over the past decade. Overall, this consolidated guide provides a comprehensive overview of the key planning, implementation and maintenance processes to inform a costed investment plan and support countries across different stages in their telemedicine journey.” 

Amazon Clinic makes debut “Amazon is expanding its healthcare presence with a new virtual offering called Amazon Clinic.
Amazon Clinic, unveiled on Nov. 15, will allow patients in 32 states to message clinicians through a secure portal to seek personalized treatments and prescriptions for common conditions such as urinary tract infections, dandruff and migraines. Patients can also seek birth control options, according to a press release from Amazon.”

About healthcare personnel

Primary Care Physician Supply by County-Level Characteristics, 2010-2019 “The number of PCPs per 100 000 population did not meaningfully increase across US counties by poverty quartile or racial and ethnic minority concentration between 2010 and 2019. However, counties with the second-highest poverty level experienced a decline in PCP supply, potentially due to federal policies preferentially allocating resources to counties with the highest poverty level. The number of PCPs per capita also declined in counties in rural areas and in the South. As a result, the rural-urban difference in PCP supply widened over the study period.
Despite recent federal investments, PCP supply has remained unchanged or even worsened among communities that face unmet health needs.”

 Average Appointment Wait Times Across 15 Metro Markets “The average appointment wait time, measured across five specialties in 15 metropolitan areas, is 26 days in 2022. This represents an increase of 8% over 2017 – the last time wait times were measured in the same survey…

Of the five different specialties included in the survey, average wait time was as follows:

  • dermatology: 34.5 days

  • OB-GYN: 31.4 days

  • cardiology: 26.6 days

  • family medicine: 20.6 days

  • orthopedic surgery: 16.9 days”

Today's News and Commentary

About Covid-19

U.S. COVID public health emergency to stay in place “The public health emergency was initially declared in January 2020, when the coronavirus pandemic began, and has been renewed each quarter since for 90 days. But the government in August began signaling it planned to let it expire in January.
The U.S. Department of Health and Human Services (HHS) has promised to give states 60 days' notice before letting the emergency expire, which would have been on Friday if it did not plan on renewing it again in January. The agency did not provide such notice…”

Moderna says new booster increases protection against omicron subvariants “In blood drawn from people who received the bivalent booster, omicron-blocking antibody levels shot up 15 times higher than their pre-booster levels, Moderna said in a news release. The findings, which are not yet peer-reviewed, are similar to results Pfizer and its German partner, BioNTech, presented this month about their bivalent coronavirus vaccine booster.”

Lifting Universal Masking in Schools — Covid-19 Incidence among Students and Staff “Among school districts in the greater Boston area, the lifting of masking requirements was associated with an additional 44.9 Covid-19 cases per 1000 students and staff during the 15 weeks after the statewide masking policy was rescinded.”

Repeat COVID is riskier than first infection, study finds “Reinfected patients had a more than doubled risk of death and a more than tripled risk of hospitalization compared with those who were infected with COVID just once. They also had elevated risks for problems with lungs, heart, blood, kidneys, diabetes, mental health, bones and muscles, and neurological disorders, according to a report published in Nature Medicine.”

 Some Employers Still Require COVID-19 Vaccines “Employer vaccination requirements decreased this year from 34 percent in 2021 to 32 percent, Mercer found in a survey of more than 700 employers. Fewer employers required one booster (16 percent) or two (11 percent).
If a spike in COVID-19 infections occurs this winter, 52 percent of surveyed businesses said they are providing additional paid time off for employees recovering from COVID-19.”

About health insurance/insurers

 U.S. judge rejects Biden administration's LGBT health protections “A federal judge in Texas ruled on Friday that President Joe Biden's administration had wrongly interpreted an Obamacare provision as barring health care providers from discriminating against gay and transgender people.
U.S. District Judge Matthew Kacsmaryk in Amarillo ruled that a landmark U.S. Supreme Court decision in 2020 holding that a law barring workplace discrimination protects gay and transgender employees did not apply to the healthcare law.”

About hospitals and healthcare systems

Hospital double whammy: Less cash in, more cash out “A nationwide healthcare worker shortage has increased the need for hospitals to rely on contract labor, resulting in a 37% increase per patient in labor costs for hospitals between 2019 and March 2022…
According to Crowe research, in the summer of 2021, hospitals on average had collected 97% of their expected cash within six months. During the same period in 2022, that percentage dropped to 94%. The three-percentage-point decrease in cash coupled with a more than 9% increase in expenses creates a minimum of a 12% negative impact on a health system’s finances…
Prior-authorization denials on inpatient accounts are a key driver behind the dollar value of denials increasing to 2.5% of gross revenue in August 2022 from 1.5% of gross revenue in January 2021. That’s an increase of 67%.”
And in a related article: Health system cash reserves plummet

 Best Hospitals and Surgery Centers for Billing Ethics “…Money and The Leapfrog Group’s Best Hospitals and Surgery Centers for Billing Ethics… selected the facilities that are most likely to play fair with your bill.”

About pharma

 Eli Lilly lost billions after fake Twitter account promotes free insulin “On Nov. 10, a verified Twitter account posed as Eli Lilly wrote in a viral tweet, "We are excited to announce insulin is free now." By the next day, the drugmaker's shares plunged by about $22 billion. 
The fake account, which has since been taken down, had a verified blue check and a copy of the Indianapolis-based company's logo as its profile picture. Eli Lilly responded within two hours, but the tweet that stayed on the app for less than a day accumulated thousands of retweets.”  

About the public’s health

 Tobacco Product Use Among Middle and High School Students — United States, 2022  “In 2022, nearly one in nine (11.3%) middle and high school students reported current tobacco product use, including 13.5% of non-Hispanic American Indian or Alaska Native students; 16.0% who identified as lesbian, gay, or bisexual; 16.6% who identified as transgender; 18.3% who reported severe psychological distress; 12.5% with low family affluence; and 27.2% with low academic achievement.”

Trends in inequalities in the prevalence of dementia in the United States “The age-adjusted prevalence of dementia decreased from 12.2% in 2000 (95% CI, 11.7 to 12.7%) to 8.5% in 2016 (7.9 to 9.1%) in the 65+ population, a statistically significant decline of 3.7 percentage points or 30.1%. Females are more likely to live with dementia, but the sex difference has narrowed. In the male subsample, we found a reduction in inequalities across education, earnings, and racial and ethnic groups; among females, those inequalities also declined, but less strongly. We observed a substantial increase in the level of education between 2000 and 2016 in the sample. This compositional change can explain, in a statistical sense, about 40% of the reduction in dementia prevalence among men and 20% among women, whereas compositional changes in the older population by age, race and ethnicity, and cardiovascular risk factors mattered less.”

About healthcare personnel

 Association of State Share of Nonphysician Practitioners With Diagnostic Imaging Ordering Among Emergency Department Visits for Medicare Beneficiaries Question  Are emergency department (ED) nonphysician practitioner (NPP) encounters associated with more imaging studies than physician encounters?
Findings  In this cross-sectional study of 16 922 274 ED visits by Medicare fee-for-service beneficiaries in 2005-2020, the presence of NPPs in the ED compared with no NPPs was associated with 5.3% more imaging studies per ED visit.”

About health technology

 Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents The FDA is redefining “Device” and introducing the “Counterfeit device”. Prior to this action, the latter could fit the device definition and technically be “legal.”

About healthcare finance

 Opiant, maker of Narcan, to be acquired in $145 million deal “Shares of Opiant Pharmaceuticals Inc. OPNT, 111.89% soared 120.8% in premarket trading on Monday after the company, which is best known for selling the opioid overdose treatment Narcan, said it will be acquired by Indivior PLC INDV, +2.36% for $145 million. The deal also includes additional potential milestone payments tied to revenue for a still investigational opioid overdose treatment.”

Ionis, Metagenomi pen Big Pharma-sized genetic target pact that could total almost $3B “Ionis Pharmaceuticals and budding gene editing company Metagenomi have penned a multi-target research collaboration that could total almost $3 billion in biobucks. 
The gargantuan financial deal is astounding for two companies that are not heralded as large pharmas, but nonetheless, the announcement shows just how much the industry is betting on gene editing. The agreement is essentially split into two groups of four possible genetic targets—Ionis is paying $80 million for the first batch of four, with two of the targets being co-developed with Metagenomi.”

Lantheus promises up to $2B for 2 of the biotech's cancer radiopharmaceutical therapies “Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1.8 billion tied up in biobucks.
Under the agreements, POINT will continue to fund and complete its phase 3 SPLASH trial for PNT2002, a prostate-specific membrane antigen (PSMA)-targeting 177Lu-based radiopharmaceutical therapy for metastatic castration-resistant prostate cancer. After that, Lantheus will work with POINT to file the therapy for FDA approval.
The other candidate is PNT2003, a somatostatin receptor-targeted radioligand in development for gastroenteropancreatic neuroendocrine tumors.”

Today's News and Commentary

About Covid-19

WHO reports 90% drop in world COVID-19 deaths since February “Director-General Tedros Adhanom Ghebreyesus said that last week just over 9,400 deaths linked to the coronavirus were reported to the WHO. In February of this year, he said, weekly deaths had topped 75,000 globally.” 

About health insurance/insurers

 Americans must work 504 hours to cover typical hospital stay “Workers making the average American salary of $26.22 an hour need to work 504 hours to cover the cost of a typical 4.6-day hospital stay, according to an Oct. 17 report from the personal finance site ValuePenguin.”

Elevance Health to acquire specialty pharmacy BioPlus “The insurer, formerly Anthem, has entered into an agreement with CarepathRx to pick up BioPlus, which offers a range of specialty pharmacy options for patients with chronic conditions such as cancer, multiple sclerosis, autoimmune conditions and hepatitis C. BioPlus will enable Elevance Health to better meet the specialty drug needs of its patients in a whole-person manner, in collaboration with other services across the health plan and its Carelon portfolio.
BioPlus will be folded into Elevance's pharmacy benefit management arm, IngenioRx.”

About pharma

 Walgreens Faces $10B Opioid Trial Threat Despite $5B Deal New Mexico and Walgreens have submitted written closing arguments in the Land of Enchantment's opioid trial, and the state said it wants nearly $10 billion in damages — twice as much as Walgreens offered last week to settle opioid litigation across the entire country…”  

About healthcare IT

 Hospitals Should Be Wary of Using Meta Pixel & Other Third-Party Analytics Tools “ECRI recently issued an alert warning hospitals about the cybersecurity risks associated with the use of third-party analytics tools, such as Meta Pixel, Google Analytics and Adobe Analytics. When providers install these tools on their websites and patient portals, they may be exposing patient data — which tech companies can use to target medical-related ads to consumers as they browse the Internet.”

The lawsuit that could rewrite the rules of AI copyright “Microsoft, its subsidiary GitHub, and its business partner OpenAI have been targeted in a proposed class action lawsuit alleging that the companies’ creation of AI-powered coding assistant GitHub Copilot relies on “software piracy on an unprecedented scale.” The case is only in its earliest stages but could have a huge effect on the broader world of AI, where companies are making fortunes training software on copyright-protected data.
Copilot, which was unveiled by Microsoft-owned GitHub in June 2021, is trained on public repositories of code scraped from the web, many of which are published with licenses that require anyone reusing the code to credit its creators. Copilot has been found to regurgitate long sections of licensed code without providing credit — prompting this lawsuit that accuses the companies of violating copyright law on a massive scale.”

Amazon’s leaked ‘Clinic’ would connect patients to telemedicine “Amazon might have a new healthcare offering coming soon, according to a leaked video. A video published to the company's YouTube page Tuesday — and then quickly taken down — described ‘Amazon Clinic,’ an online care program that would offer treatment for ‘common conditions’ like allergies and acne.
As described in the video, people could fill out a questionnaire about their symptoms and pay a fee. A clinician would review their answers and provide a diagnosis and prescriptions as needed. ‘Telehealth services are offered by third-party healthcare provider groups,’ according to the text in the video.”

About healthcare personnel

 Physician Flash Report “ Key Takeaways

  1. Expenses for providers (including physicians) are outpacing revenues.

    While revenue for physicians and other providers increased in Q3 2022, expenses rose at a faster rate.

  2. Investment/subsidies grew in Q3.

    The gap between expenses and revenues translated to higher rates of investment/subsidy in physicians and other providers by health systems.

  3. Volumes for providers (including physicians) were up in Q3.

    Volumes and a corresponding increase in provider productivity could not close the gap on growing expenses. Going forward, simply increasing volume may not be the solution to the negative operating margins that it was in previous years.

  4. Health systems must assess how service lines affect margins.

    Health systems must evaluate and think carefully about where to grow volume, focusing on balancing service lines that positively affect their margins with their mission. 

Today's News and Commentary

Election overview: Some specific outcomes are explained below. As of this writing, the Republicans have narrowly captured the House. The Senate, however could end up in a 50-50 split, depending on the Georgia runoff in December.
The implications for healthcare are, as usual, uncertain. The House Republicans may not do much of anything beyond trying to impeach the President and hold hearings about the (post-Trump) handling of Covid.
Even if both houses flip “red”, the President still has a veto that cannot be overridden, as well as the power of executive orders.
For now…wait and see.

About Covid-19

 COVID-19 cases to jump 39% by Nov. 17, Mayo forecasts “COVID-19 cases are projected to increase by nearly 40 percent over the next two weeks, though it's still unclear whether hospitalizations and deaths may follow suit in November, according to national disease modeling.”

Comparative Risk of Myocarditis/Pericarditis Following Second Doses of BNT162b2 and mRNA-1273 Coronavirus Vaccines Myocarditis/pericarditis following mRNA COVID-19 vaccines is rare, but we observed a 2- to 3-fold higher odds among individuals who received mRNA-1273 [Moderna] vs BNT162b2 [Pfizer/BioNTech]. The rate of myocarditis following mRNA-1273 receipt is highest among younger men (age 18-39 years) and does not seem to be present at older ages. Our findings may have policy implications regarding the choice of vaccine offered.”

About health insurance/insurers

Person-Centered Innovation – An Update on the Implementation of the CMS Innovation Center’s Strategy
”In October 2021, the Center for Medicare and Medicaid Innovation (Innovation Center) launched a renewed vision focused on five objectives to support and help execute CMS’ vision and priorities . This report provides an update on the Innovation Center's progress in the implementation of the new strategy, describes areas of focus for the coming year, and begins the process of measuring progress against the five objectives.”
The five objectives are:
DRIVE ACCOUNTABLE CARE
ADVANCE HEALTH EQUITY
SUPPORT INNOVATION
ADDRESS AFFORDABILITY
PARTNER TO ACHIEVE SYSTEM TRANSFORMATION”
For the media’s take on this document, see: Medicare eyes changes to pay for specialty care

 Cigna: Tracking 'vitality' is the key to measuring whole-person health “Cigna's Evernorth has launched a new index aimed at tracking patients' vitality, which the company is touting as the ‘next-generation measure of health.’
Evernorth said it's calculating vitality using eight elements of health: physical, spiritual, emotional, environmental, social, occupational, financial and intellectual. The index also accounts for how people feel about their own ability to manage their life across those factors, or their autonomy, relatedness and competence, Cigna said.”
The highest score is for those over 65 and the lowest is for those 18-24.

South Dakota votes to expand Medicaid “South Dakota voters on Tuesday approved a measure to expand the state’s Medicaid program under the Affordable Care Act.
The program, which takes effect in July and is expected to cover more than 40,000 people, passed with about 56 percent support.”

Oscar Health largely abandons Medicare Advantage “Oscar Health has largely abandoned its Medicare Advantage business, opting to focus on ACA exchange plans, CEO Mario Schlosser told investors on a Nov. 9 call. 
Mr. Schlosser said the company has exited MA markets in New York and Texas. The company's lone remaining plan is a partnership with Holy Cross Health and Memorial Healthcare system in Broward County, Fla.”
Do check the financials. Revenues and membership are up, loss ratio is down; however expenses are up.
If companies can’t make money on Medicare advantage, something is wrong with management.

Assessment of Immigrants’ Premium and Tax Payments for Health Care and the Costs of Their Care Question  Do insurers and US government programs pay more for the care of immigrants than immigrants contribute to the health care system in insurance premiums and taxes?
Findings  In this cross-sectional analysis of 210 669 respondents to the Medical Expenditure Panel Survey and the Current Population Survey, immigrants contributed $58.3 billion more in premiums and taxes in 2017 than insurers and government paid for their health care, and US-born citizens incurred a net deficit of $67.2 billion. Undocumented immigrants accounted for most (89.0%) of the surplus.”
From an accompanying editorial: The broad strokes of this analysis are (1) immigrants generally use fewer health care services than similar US-born citizens and therefore have lower medical expenditures, and (2) immigrants typically pay taxes and health insurance premiums like most citizens, but (3) federal policies make it more difficult for many immigrants, particularly undocumented immigrants, to receive governmental health assistance from programs such as Medicaid, Medicare, and the Affordable Care Act health insurance marketplaces.”
Another myth about immigration debunked.

About hospitals and healthcare systems

 Mass General Brigham turning away offensive, violent patients under new 'Patient Code of Conduct' “Mass General Brigham (MGB) unveiled the new policy last week in an email notice to existing patients and an update to its online resources for patients and visitors. Physical copies of the policy will also be posted in MGB hospitals…
The notices outlined five specific examples of patient, family, visitor or research participant behaviors that will no longer be tolerated at its care locations:

  • Offensive comments about others’ race, accent, religion, gender, sexual orientation or other personal traits

  • Refusal to see a clinician or other staff member based on these personal traits

  • Physical or verbal threats and assaults

  • Sexual or vulgar words or actions

  • Disrupting another patient’s care or experience

MGB said patients believed to have violated the code will have a chance to plead their case before we make any decisions about future care at [MGB].’”

About pharma

 Statins may prevent people from losing eyesight in later life “Experts, led by a team from University Hospital Bonn in Germany, examined 14 studies involving almost 40,000 people from the UK, France, Germany, Greece, Ireland, Italy, Norway, Portugal and Russia.
They found that people taking statins were 15% less likely to go on to develop age-related macular degeneration (AMD).”

Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical TrialQuestion  Is mindfulness-based stress reduction noninferior to escitalopram for the treatment of anxiety disorders?
Findings  In this randomized clinical trial of 276 adults with anxiety disorders, 8-week treatment with mindfulness-based stress reduction was noninferior to escitalopram.”

Amazon Pharmacy is scooping up payer contracts A good summary about how this Amazon business is expanding.

About the public’s health

 California bans flavored tobacco products, including vapes “The move makes California by far the largest state to ban such products, which are already illegal in a smattering of smaller states, including Rhode Island, New Jersey, and Massachusetts.
Regulators have targeted flavored products in particular because they are overwhelmingly preferred by young people. More than 84% of young people who vape reported using flavored products, according to recently released survey data by the Centers for Disease Control and Prevention.”

Michigan, Vermont, and California affirm abortion rights, as Kentucky voters shoot down anti-abortion amendment “Voters in Kentucky shot down a proposal that would have explicitly denied abortion as a right in its constitution, though the procedure still remains all but banned in the state. In a closely watched fight in Michigan, voters passed a measure that would protect abortion access in the state constitution. Voters in California and Vermont also voted to codify abortion as a constitutional right, while in Montana, voters weighed in on a measure requiring care for fetus born alive after an abortion attempt. That measure was largely expected to pass but remains in close contention with 80% of votes counted.”

About healthcare IT

 Hims & Hers bucks health tech's downward trend, boosts 2022 revenue guidance “The telehealth company, which sells prescription and over-the-counter drugs online as well as personal care products, reported better-than-expected revenue growth in the latest quarter, reporting its top line grew 95% to reach $144.8 million mostly due to its online business segment. The company's top line beat Wall Street estimates as analysts expected revenue of $130.3 million in the third quarter.
This was the company's third consecutive quarter posting more than $100 million in revenue.
Hims & Hers also netted 70,000 new subscribers during the quarter, bringing the total subscriber count to 991,000, up 80% year over year.”

About healthcare finance

 Healthcare Dealmakers—UHG wraps up Change Healthcare deal; Rural systems eye 25-hospital merger and more A good review of activities in several health sectors.

Walgreens cuts AmerisourceBergen stake by $2 billion “The sale priced early Tuesday at $155.20 per share, a 4.2% discount from Monday’s closing trade, according to a person familiar with the matter, who asked not to be named. AmerisourceBergen shares hit an intraday high on Friday, jumping the most in nearly two years on an outlook that surpassed Wall Street estimates.”

Today's News and Commentary

About health insurance/insurers

 UnitedHealth continues to lead the way on insurer profits in Q3. Here's how its competitors fared “In the third quarter, UHG reported $5.3 billion in profit. It's next-closest competitor, Cigna, posted $2.8 billion in profit. UnitedHealth is also comfortably out in front on profit through the first three quarters of the year, with the healthcare giant reporting $15.35 billion in profit through the first nine months of 2022.
Cigna also reported the second-highest profit through the first nine months of this year, posting $5.5 billion.
UnitedHealth Group edges out CVS Health for the highest revenue through the first three quarters of 2022, reporting $241.4 billion. CVS Health posted $238.6 billion in revenue through Sept. 30 of this year.”

About pharma

Patent wars: Moderna’s battle for the spoils of Covid vaccines “In autumn 2020, as drugmakers raced to get vaccines to market in the face of the biggest public health crisis in a generation, Moderna made a bold pledge: it would not enforce its patents against rivals developing Covid-19 jabs. This year, however, almost two years after Pfizer and BioNTech beat it to the first approved mRNA jab, Moderna fired back with a lawsuit over patents for a technology that could open the door to many more vaccines. If Moderna wins, it could gain a slice of billions of dollars in revenues from the BioNTech/Pfizer Covid jab. Perhaps more importantly, it would also signal to investors and Big Pharma that the Massachusetts-based company is primed to dominate the future mRNA market.”

 Gilead dodges Supreme Court review—and a $1.2B fine—in CAR-T patent feud with Bristol Myers “After years of courtroom drama and amid a market clash, Bristol Myers Squibb has failed to open a new legal front in its cell therapy war with Gilead Sciences.
Monday, the U.S. Supreme Court declined to hear BMS’ case to resurrect a $1.2 billion win in the five-year dispute over a BMS CAR-T patent and Gilead’s cell therapy Yescarta.”

 Troubled Lupin suspends manufacturing of drugs bound for US “Indian generics manufacturer Lupin has suspended production of drugs bound for the U.S. from a troubled active pharmaceutical ingredient plant in India, according to an FDA warning letter.”

About the public’s health

 Physician Attitudes About Using Life Expectancy to Inform Cancer Screening Cessation in Older Adults—Results From a National Survey ”This study found that approximately a quarter of physicians did not consider life expectancy a reasonable criterion for stopping cancer screening in older adults. Together with a study showing that older adults do not perceive life expectancy as relevant in cancer screening,4 our findings question whether reframing guidelines away from the life expectancy label may be more acceptable to physicians and patients. For example, life expectancy and age-specific cancer mortality have been combined to estimate the risk of dying from that cancer in one’s remaining lifetime.1 Although this calculation fundamentally relies on life expectancy, framing screening cessation as when cancer mortality risk is too low to justify the harms involved may be more acceptable.”

Don’t bother with dietary supplements for heart health, study says “Some people believe that common dietary supplements – fish oil, garlic, cinnamon, turmeric, plant sterols and red yeast rice – will lower their ‘bad’ cholesterol. ‘Bad’ cholesterol, known in the medical community as low-density lipoproteins or LDL, can cause the buildup of fatty deposits in the arteries. The fatty deposits can block the flow of oxygen and blood that the heart needs to work and the blockage can lead to a heart attack or stroke…
None of the people who took the supplements saw any significant decrease in LDL cholesterol, total cholesterol or blood triglycerides, and their results were similar to those of people who took a placebo. While there were similar adverse events in all the groups, there were a numerically higher number of problems among those who took the plant sterols or red yeast rice.”

Express Scripts to shell out $3.2M in prescription drug pricing case “Express Scripts agreed to settle for $3.2 million in a Massachusetts case that accused the pharmacy benefit manager of overcharging for some injured workers' prescriptions. 
Attorney General Maura Healey said Express Scripts allegedly "billed and obtained payment for prescription drugs from payers of workers' compensation claims in excess of amounts" permitted by state law at CVS, Walgreens and Rite Aid locations, according to a court document filed Nov. 7.”

About healthcare IT

 Telehealth Utilization in Nation as a Whole Remained Relatively Stable “Telehealth utilization in the nation as a whole, as measured by telehealth’s share of all medical claim lines, remained relatively stable in August 2022, as it had in July. Nationally, telehealth utilization increased 1.9 percent, from 5.3 percent of medical claim lines in July to 5.4 percent in August. In the Midwest and Northeast there was no change in telehealth utilization. In the South, telehealth utilization increased 4.7 percent and, in the West, it decreased 1.4 percent.” 

About healthcare personnel

 Oak Street reports $130M net loss even as revenues rise significantly “Oak Street Health, which operates a network of over 160 primary care clinics for Medicare patients across 21 states, reported a net loss of $130.4 million for the third quarter ending Sept. 30. The net loss for the first nine months of the year was $375.3 million.
Those numbers come as the company reported revenues rising to total $545 million for the third quarter and almost $1.6 billion for the nine month period. Those figures compare with revenues of $388.7 million and $1.04 billion in the respective periods in 2021.”

About health technology

 First ever clinical trial of laboratory grown red blood cells being transfused into another person “Red blood cells that have been grown in a laboratory have now been transfused into another person in a world first clinical trial.
The manufactured blood cells were grown from stem cells from donors. The red cells were then transfused into volunteers in the RESTORE randomised controlled clinical trial.
This is the first time in the world that red blood cells that have been grown in a laboratory have been given to another person as part of a trial into blood transfusion.”

Air power: UConn researchers charge neurostim implants by collecting electricity from breaths “Somewhat similar to a pacemaker, a deep brain stimulator delivers pulses to the brain multiple times per second to regulate its electrical activity. The implants can help patients with Parkinson’s disease better control their motor muscles or potentially reduce the symptoms of severe depression.
But while a pacemaker’s batteries can last as long as a decade under certain conditions, brain stimulators use much more power and typically require surgery to swap them out every two to three years.
But according to the UConn researchers, their implant never needs its batteries changed. It relies on a small device that uses the expansion and contraction of the chest each time the user takes a breath to generate and store small amounts of electricity.”

About healthcare finance

 Oracle Sells $7 Billion of Debt to Help Fund Cerner Purchase “Oracle also increased its previous term loan by $1.3 billion
Acquisition was funded with $15.7 billion of bridge loan debt