Today's News and Commentary

About the public’s health

Scientists develop hand-held rapid test that can diagnose bacterial infections in less than ONE HOUR: If the technology pans out, it could be a huge public health benefit- cutting down on unnecessary antibiotics and the consequent drug-resistant bacteria.
The test “uses specially-designed molecules that can detect specific proteins, unique to a particular bacteria. 
The molecules are embedded in a microchip - making for a test that's small and easy to use.
The microchip is part of a handheld device, similar to a blood glucose monitor. Users can plug the device - which is about the size of a USB stick - into a smartphone to see their results.”

Helping Drug Users Survive, Not Abstain: ‘Harm Reduction’ Gains Federal Support: “Overdoses have surged during the pandemic. Now, for the first time, Congress has appropriated funds specifically for programs that distribute clean syringes and other supplies meant to protect users.”

Nine prohibited stimulants found in sports and weight loss supplements: deterenol, phenpromethamine (Vonedrine), oxilofrine, octodrine, beta-methylphenylethylamine (BMPEA), 1,3-dimethylamylamine (1,3-DMAA), 1,4-dimethylamylamine (1,4-DMAA), 1,3-dimethylbutylamine (1,3-DMBA) and higenamine: The headline is the story.

Juul agrees to pay North Carolina $40 million to settle vaping accusations: “E-cigarette company Juul agreed to pay North Carolina $40 million to settle allegations that the company aggressively marketed its products to young people, leading to addiction to its high-nicotine vapes, Attorney General Josh Stein announced Monday.”

About Covid-19

WHO recommends masks -- even for vaccinated people -- because of delta variant: “‘Vaccine alone won’t stop community transmission,’ Dr. Mariangela Simao, WHO’s assistant director-general for access to medicines and health products, said during a briefing in Geneva… ‘People need to continue to use masks consistently, be in ventilated spaces, hand hygiene ... the physical distance, avoid crowding. This still continues to be extremely important, even if you’re vaccinated when you have a community transmission ongoing.’”

Why Are People with Obesity More Vulnerable to COVID?: “In a healthy body, adipose tissue plays a positive role, serving as reservoir of energy in times of food scarcity. Fat tissue is also full of immune system cells. And in lean, healthy individuals, it secretes factors that are anti-inflammatory and protective.
If, however, the fat tissue becomes unhealthy, as often happens in people with obesity, it can become dysfunctional and secrete hormones and other chemical signals that promote chronic low-grade inflammation. This constant simmering state—often present in elderly as well as people with obesity—is not the same as normal inflammation, which is self-limiting and part of the body’s response to infection, damaged cells and other threats. Chronic inflammation raises the risk of a number of conditions, including autoimmune diseases, certain cancers and ailments of the heart, pancreas, lungs, stomach and reproductive system. It may also be the reason a high body mass index (BMI) is associated with poorer outcomes from infectious diseases, including COVID-19.
Researchers are still working out the mechanisms by which this inflammation occurs.”

OSHA Updates N95 Mask FAQs: “Internet rumors have been circulating for a while now that assert the N95 masks do not protect wearers from COVID-19 transmission. The main reason given is that the fabric used blocks few, if any, of the smallest virus particles.
OSHA’s addition to its COVID-19 FAQs regarding respirators and particle size posits states: “Will an N95 respirator protect the wearer from the virus that causes COVID-19?” OSHA’s answer is that yes, an N95 respirator is in fact effective in protecting workers from the virus that causes COVID-19.”

AstraZeneca kick-starts new COVID variant-busting vaccine test: “AZD2816 has been built using the same adenoviral vector platform as its existing vax, with minor genetic alterations to the spike protein based specifically on the so-called beta (B.1.351, South African) variant.”

About health insurance

Supreme Court upholds site-neutral pay cuts: “The U.S. Supreme Court on June 28 declined to hear an appeal challenging HHS' site-neutral payment policy, allowing reimbursement cuts to move forward…
In its final Outpatient Prospective Payment System rule of 2019, CMS made payments for clinic visits site neutral by reducing the payment rate for evaluation and management services provided at off-campus, provider-based departments.”
This decision will have a profound impact on hospital finances. One result will be a halt or slowdown in hospital purchases of physician practices. These acquisitions were heavily subsidized by the hospital’s ability to charge a higher rate for the same services the physicians provided while independent.

Few adults are aware of hospital price transparency requirements: About 10% of survey respondents were aware that price transparency was required. About 15% of respondents said they searched for hospital prices in the past year.

Kaiser, Molina, HealthNet accused of running 'ghost networks' in California: “San Diego's city attorney sued three health insurers June 25, accusing Kaiser Permanente, Molina Healthcare and HealthNet of misleading members with inaccurate provider directories. 
In her lawsuit, City Attorney Mara Elliott claimed that the provider directories of Kaiser and HealthNet, a subsidiary of Centene, have error rates of at least 35 percent. Molina's provider directory had an error rate as high as 80 percent, Ms. Elliott alleges.”

HHS Revokes Medicaid Work Requirements in Arizona, Indiana: “The Department of Health and Human Services continued its attack on work requirements in state Medicaid programs, informing Arizona and Indiana that it is withdrawing approval for must-work provisions approved during the Trump administration.
Requiring poor adults to work as a condition of receiving health care would likely decrease Medicaid enrollment without increasing employment, and would be especially inappropriate during the Covid-19 pandemic, the HHS said in the Thursday letters to Arizona and Indiana.”

About healthcare IT

Telehealth use falls 37% from pandemic highs, while demand for healthcare services projected to flatten: report: A report from Trilliant Health is well worth perusing, if not reading in detail. With respect to telehealth, it comment that the myth is everyone loves it. The truth is that less than 15% of the US population used it last year.

Calming Computer Jitters: Help for Seniors Who Aren’t Tech-Savvy: “A recent survey from AARP, conducted in September and October… found that older adults boosted technology purchases during the pandemic but more than half (54%) said they needed a better grasp of the devices they’d acquired. Nearly 4 in 10 people (37%) admitted they weren’t confident about using these technologies…
Before the pandemic, Generations on Line provided free in-person training sessions at senior centers, public housing complexes, libraries and retirement centers. When those programs shut down, it created an online curriculum for smartphones and tablets (www.generationsonline.org/apps) and new tutorials on Zoom and telehealth as well as a ‘family coaching kit’ to help older adults with technology. All are free and available to people across the country.”

Ohio health system employee snooped 7,000+ patients' EHRs for 11+ years: “Canton, Ohio-based Aultman Health Foundation recently began notifying around 7,300 patients that their protected health information had been inappropriately accessed by a former health system employee over the past decade..
The former employee accessed patient information outside the scope of their job responsibilities between Sept. 14, 2009, and April 26, 2021. The employee has not been identified but has been fired and no longer has access to patient data, the health system said. 
The employee accessed patients' names, Social Security numbers, health insurance information, addresses, birthdates and treatment information, according to the report.”

About pharma

J&J agrees to pay $230M to settle New York opioid claim: “Johnson & Johnson has agreed to pay $230 million to New York state to settle claims that the pharmaceutical giant helped fuel the opioid crisis, Attorney General Letitia James said on Saturday.
The drugmaker also agreed to permanently end the manufacturing and distribution of opioids across New York and the rest of the nation, James said in a statement announcing the settlement.”

3 Pharmacies Cut From NY Opioid Trial, CVS Reaches Deal: “Walmart, CVS and Rite Aid have been severed from New York state and two Long Island counties' swiftly approaching opioid trial, a spokesman for plaintiffs firm Simmons Hanly Conroy LLC told Law360 on Friday, while a CVS representative confirmed the counties had reached a deal with the pharmacy. The CVS representative did not state the amount of the deal with Suffolk and Nassau counties but said the settlement reflected the company's position that ‘opioid prescriptions are written by doctors, not pharmacists, and that opioid medications are made and marketed by manufacturers, not pharmacies.’”

Crispr gene-editing ‘revolution’ treats internal organ for first time: Crispr gene-editing has been performed on cells removed from the patient’s body and then re-infused. This new technique directly injects the gene-altering material.
“The Boston-based start-up, working with biotech company Regeneron, treated transthyretin amyloidosis, a devastating disease in which a build-up of a problematic protein hits a patient’s heart and nervous system, cutting their life expectancy…
In its phase 1 trial, a Crispr treatment was inserted in a lipid nanoparticle, which was picked up in the blood by the same tissue that grabs cholesterol globules, and transported to the liver. There, the one-off treatment inactivated the TTR gene and reduced the problematic protein 87 per cent in patients on the highest dose. There were no serious side effects by day 28.”

Novartis says it overpaid Roche's Genentech nearly $210 million in a licensing deal—and it wants its money back: “For years, Novartis said it dutifully shelled out tens of millions to Genentech as part of a patent licensing deal that dated back to 2005. Later, the Swiss pharma discovered it accidentally overpaid by nearly $210 million.
Those are the central arguments in a lawsuit filed by Novartis against its Swiss pharma counterpart seeking $209.5 million. In the suit, which recently made its way to California federal court, Novartis says Genentech isn't coughing up the dough.”

Sanofi offloads 16 consumer health brands to Stada amid CEO Hudson's refocusing effort: “As part of its quest to streamline consumer healthcare—and eventually spin off the unit as a standalone business—Sanofi will offload 16 consumer health products to Germany’s Stada Arzneimittel, the companies said Monday.”

About hospitals and health systems

Key hospital metrics showing recovery, Kaufman Hall says: “Hospitals across the U.S. have seen gains across key metrics in the first five months of 2021 when compared to last year, according to a new report from healthcare consulting firm Kaufman Hall. 
In particular, volumes, margins and revenues were up compared to 2020 levels. The volumes also are starting to approach pre-pandemic levels…
Not including federal relief payments, the median operating margin for hospitals in May was 2.6 percent. With the funding, the median operating margin was 3.5 percent. 
Compared to the first five months of 2020, hospital operating margin rose 95.2 percent year to date, according to the report.
Kaufman Hall attributed the increase in year-to-date margin to patient volume increases, especially compared to the volumes last year when there were national restrictions on elective procedures.”
And in a related article: Hospital Stocks’ Rally Points to Post-Covid Growth

Today's News and Commentary

About Covid-19

More than 1 in 10 people have missed their second dose of Covid-19 vaccine: “As of June 16, about 88% of those who received one dose of vaccine and were eligible for their second -- recommended 21 days after the first Pfizer/BioNTech shot or 28 days after the first Moderna shot -- had completed their two dose series, according to data shared with CNN by the US Centers for Disease Control and Prevention.
That's down from a 92% completion rate earlier in the year.”

U.S. approves Roche drug for emergency use against severe COVID-19: “U.S. health regulators have approved Roche's arthritis drug Actemra for emergency use to treat hospitalized COVID-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.
The U.S. Food and Drug Administration (FDA) said on Thursday it had issued an emergency use authorization (EUA) for Actemra to treat adults and pediatric patients hospitalized with COVID-19.”

Nearly all COVID deaths in US are now among unvaccinated: “An Associated Press analysis of available government data from May shows that “breakthrough” infections in fully vaccinated people accounted for fewer than 1,200 of more than 853,000 COVID-19 hospitalizations. That’s about 0.1%.
And only about 150 of the more than 18,000 COVID-19 deaths in May were in fully vaccinated people. That translates to about 0.8%, or five deaths per day on average.”

Lilly's COVID antibody combo halted nationwide, dealing huge blow to blockbuster program: “Eli Lilly's COVID-19 antibody cocktail has already been on the outs in several states over fears of reduced variant efficacy. Now, the U.S. has decided to extend that policy nationwide.
With a pair of troubling coronavirus variants on the rise, the U.S. is pausing the national distribution of Eli Lilly’s COVID-19 antibody combo of bamlanivimab and etesevimab until further notice, the HHS Assistant Secretary for Preparedness and Response said Friday.”

U.K. doubles down on Innova's rapid COVID-19 test, after FDA urged users to throw it away: “A week after the FDA urged anyone who had Innova Medical Group’s COVID-19 antigen test to stop using it and toss it in the trash, regulators across the pond have cleared the rapid diagnostic's use and extended its authorization.
The U.K. Medicines and Healthcare products Regulatory Agency said it found no problems in its own assessment of the test, which it carried out after the FDA delivered a warning letter to the company for pre-emptively delivering unreviewed products to a number of customers and making accuracy claims that did not match up with clinical data.”

Israel to reinstate indoor mask mandate next week as COVID-19 cases keep rising: “Coronavirus czar Nachman Ash announced Thursday that the indoor mask mandate, obligating people to cover their mouths and noses to prevent infections, will return early next week in an effort to stem the rise in COVID-19 cases.
In a briefing with journalists Thursday evening, Ash said the outbreak had spread to Kfar Saba, Ramla, Herzliya and other cities, as Health Ministry data showed 169 had been diagnosed Thursday by 6 p.m., the highest daily tally in months.
Ash recommended avoiding flights abroad, especially for people who have not been vaccinated.”

FDA greenlights its first saliva-based COVID-19 antibody test: ”Developed by Diabetomics, the rapid, lateral-flow diagnostic received an agency emergency authorization allowing it to be used at the point of care for adults and children. Designed to deliver a result within 15 minutes, the CovAb test also does not require any additional hardware or instruments.
When administered at least 15 days after the onset of symptoms, when the body’s antibody response reaches higher levels, the test demonstrated a false-negative rate of less than 3% and a false-positive rate of nearly 1%…”

About pharma

Sanofi, Translate Bio start seasonal mRNA flu vaccine trial, gaining early lead over Moderna and Pfizer: “Sanofi and Translate Bio have started a phase 1 clinical trial of an mRNA vaccine for seasonal influenza. The initiation of the study puts the partners ahead of Moderna and Pfizer in the race to show mRNA vaccines are as good or better at preventing flu than existing technologies. 
The validation of mRNA technology by vaccines against COVID-19 has ramped up interest in using the approach to protect against seasonal flu.”

Pfizer halts global distribution of smoking cessation pill as it tests for potential carcinogens: “After finding potential carcinogens in some lots of Chantix, Pfizer late last month halted worldwide distribution of its smoking cessation pill.
The drug maker, which is now running tests, took this step after finding nitrosamine levels that were above an ‘acceptable’ daily intake, according to the company. “

About the public’s health

Trends in Prevalence of Diabetes and Control of Risk Factors in Diabetes Among US Adults, 1999-2018: “In this serial, cross-sectional study of nationally representative data from 28 143 participants in the National Health and Nutrition Examination Survey (NHANES), the estimated age-standardized prevalence of diabetes increased significantly, from 9.8% in 1999-2000 to 14.3% in 2017-2018. Only 21.2% of adults with diagnosed diabetes achieved all 3 risk factor control goals in 2015-2018, including individualized hemoglobin A1c targets, blood pressure less than 130/80 mm Hg, and low-density lipoprotein cholesterol level less than 100 mg/dL.”

Estimated Cost-effectiveness of Solar-Powered Oxygen Delivery for Pneumonia in Young Children in Low-Resource Settings: Often low-cost solutions are first employed in other countries and then find their way to the US. This invention is one such innovation to watch. “The results of this economic evaluation suggest that solar-powered O2 is a cost-effective intervention for pediatric patients with hypoxemia in low-resource settings.”

About health insurance

Missouri judge strikes down state's Medicaid expansion, dealing blow to Centene and Biden admin: “State Judge Jon Beetem issued an opinion Wednesday that the ballot initiative to approve the expansion in August 2020 did not include any requirement for the state to appropriate funds for the expansion…
A federal court ruled in June 2020 before the Aug. 4 vote that the initiative didn’t create a revenue source nor direct the state’s legislature to appropriate funds, according to a release from the governor’s office.
[Gov. MIke] Parsons asked the legislature for $1.9 billion to fund the expansion but was denied.”

About healthcare IT

Startups using AI to tackle malaria, mental health and human trafficking take top awards, and cash, from IBM XPrize: “An Israeli startup that uses artificial intelligence and other tech tools to wipe out malaria took the top prize in IBM Watson's AI competition, nabbing $3 million to expand its operations.
ZzappMalaria, a subsidiary of Sight Diagnostics, developed an AI-powered mobile app and dashboard to tackle malaria on the eradication level, specifically in developing countries…
Aifred Health, a digital health company focused on clinical decision support in mental health, took second place in the AI competition, banking $1 million. The startup uses AI to learn from thousands of patients to help tailor treatment, reducing the time it takes for a patient to reach remission.”

States’ Actions to Expand Telemedicine Access During COVID-19 and Future Policy Considerations: A really good review of this topic from the Commonwealth Fund.

About medical devices

Boston Scientific shells out a hearty $295M for Farapulse's electric-field-generating afib treatment: “Boston Scientific has exercised an option to acquire Farapulse in full, per [a] September 2020 agreement. The company already holds a 27% stake in Farapulse and will put down about $295 million to pick up the remainder…
With Boston Scientific’s support, Farapulse will be able to accelerate its work toward FDA clearance for its ablation system for atrial fibrillation and other cardiac arrhythmias..”

About diagnostics

Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set: Evidence is growing that demonstrates the utility of cancer diagnosis from blood samples (so-called liquid biopsies): “A multi-cancer early detection (MCED) test used to complement existing screening could increase the number of cancers detected through population screening, potentially improving clinical outcomes. The Circulating Cell-free Genome Atlas study (CCGA; NCT02889978) was a prospective, case-controlled, observational study and demonstrated that a blood-based MCED test utilizing cell-free DNA (cfDNA) sequencing in combination with machine learning could detect cancer signals across multiple cancer types and predict cancer signal origin (CSO) with high accuracy. The objective of this third and final CCGA substudy was to validate an MCED test version further refined for use as a screening tool.”
The study concluded:
”In a validation study, an MCED test identified a diversity of cancer signals with high specificity.

The MCED test predicted the origin of the cancer signal with high accuracy across multiple cancer types.

Results support the use of this MCED test on a population scale as a complement [emphasis added] to existing single-cancer screening tests.”

Today's News and Commentary

About health insurers

Cigna to offer $500 incentive for members who switch to a biosimilar drug: “Under the new Shared Savings Program, members will be offered a one-time $500 debit card for healthcare services or medications if they make the decision to switch to a biosimilar…
The program will be made available first to eligible patients taking Remicade, a brand-name biologic that treats a number of inflammatory conditions such as Crohn's disease and psoriasis. Remicade infusion costs can vary, but Cigna claims data suggest the average regimen costs $30,000 per year, with expenses growing depending on the site of administration.”

Bipartisan bill requires Medicare to cover breakthrough devices after approval from FDA: “The legislation, introduced in the House on Wednesday, would require Medicare to cover all breakthrough products approved by FDA for four years. During that time, the Centers for Medicare & Medicaid Services (CMS) would determine whether coverage should be permanent. Sometimes it can take CMS up to three years after a device is approved to grant a national coverage determination that ensures Medicare reimbursement.”

Blues plans banking on Sempre Health's gamified approach to slash medication costs: “Sempre Health has locked up another $15 million in financing as it looks to expand the company’s program to trim costs for behavioral health medication and cut skyrocketing healthcare system losses when patients skip their medications.
The series B funding was led by the Blue Venture Fund—a collaboration of Blue Cross Blue Shield companies, the Blue Cross Blue Shield Association and Sandbox, to which 35 BCBS companies have committed more than $890 million across four funds…
The company provides a mobile text-based platform to insurers to offer large prescription copay discounts to members for filling their prescriptions on time.”

UnitedHealth to be investigated by Mississippi state auditor for overbilling Medicaid: “The Mississippi State Auditor's Office is investigating OptumRX, UnitedHealth Group's pharmacy benefits manager, for allegedly overbilling the state's Medicaid program for prescription drugs…
The investigation comes one week after Mississippi Attorney General Lynn Fitch announced a $55 million settlement with Centene, a payer also accused of overbilling Medicaid for prescriptions.”

Humana, Mom's Meals food delivery pilot boosts members' quality of life: study: “Here’s how it works: fully prepared, refrigerated meals across the nation are provided by Mom’s Meals, which also caters to the Medicaid, Medicare and individual markets.
By the time the year-long program wound down, some 86% of the participating members concurred: the home delivery of diabetes-friendly meals was paramount to their overall well-being, according to results released Monday.”

Express Scripts sues US for $43M: ”Express Scripts, the pharmacy benefit management arm of Cigna, filed a lawsuit June 22 against the United States, alleging that the Internal Revenue Service refused to pay the company $43 million in tax returns. 
According to the suit, the IRS erroneously denied Express Scripts' deductions and refused to refund the PBM more than $18 million in 2010 and nearly $25 million in 2011.”

About Covid-19

Officials note ‘likely association’ between Covid-19 vaccines and rare heart condition in young people: “…younger groups, particularly men under 30, have higher rates of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with the shots from Moderna or Pfizer-BioNTech. Most cases have occurred soon after the second shot of the two-dose regimens.” However: Top federal health officials, professional groups say COVID-19 vaccines safe for adolescents: “The joint statement from more than a dozen federal and professional groups on Wednesday followed a meeting of the Centers for Disease Control and Prevention's vaccine advisory panel regarding reports of heart inflammation in young adults after use of either the Moderna or Pfizer-BioNTech vaccine.
’The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment,’ the groups said.”
But, still: Pfizer, Moderna shots get new FDA safety warning: “The FDA will add a warning about rare instances of heart inflammation to the information sheets for the mRNA vaccines from Pfizer-BioNTech and Moderna.”

Recovery of deleted deep sequencing data sheds more light on the early Wuhan SARS-CoV-2 epidemic: [This article has not been formally peer reviewed.] This story is all over today’s media. The data implications do not seem to support the theory that the virus was caused by a lab leak. But it certainly adds to the credibility challenges to Chinese transparency. Here is the Abstract:
”The origin and early spread of SARS-CoV-2 remains shrouded in mystery. Here I identify a data set containing SARS-CoV-2 sequences from early in the Wuhan epidemic that has been deleted from the NIH's Sequence Read Archive. I recover the deleted files from the Google Cloud, and reconstruct partial sequences of 13 early epidemic viruses. Phylogenetic analysis of these sequences in the context of carefully annotated existing data suggests that the Huanan Seafood Market sequences that are the focus of the joint WHO-China report are not fully representative of the viruses in Wuhan early in the epidemic. Instead, the progenitor of known SARS-CoV-2 sequences likely contained three mutations relative to the market viruses that made it more similar to SARS-CoV-2's bat coronavirus relatives.” Here is further analysis of the findings:
Claim that Chinese team hid early SARS-CoV-2 sequences to stymie origin hunt sparks furor


Covid Illness Anxiety Plummets Amid Some Unease Over Low Vax Rate: Highlights from Monmouth Poll: “Worries about a family member getting seriously ill from the coronavirus have plunged to an all-time low. Currently, 42% of the American public expresses concern about this happening. In prior polls since the pandemic started, that number ranged between 67% and 83%. Even more telling, the number who say they are very concerned about a serious illness in their family from Covid has dropped to 23% from 40% in March, after hitting a pandemic-era high of 60% in January. Prior to that, the number of adults who said they were very concerned ranged from 37% to 50% in polls taken throughout 2020.”

CDC group says there isn’t enough data yet to recommend Covid booster shots: “A booster shot of a Covid-19 vaccine may only be necessary for those most at risk of severe disease, according to a CDC vaccine safety group.
Residents of long-term care facilities, elderly people, health-care personnel and immunocompromised people may need boosters sooner.
The CDC working group said there currently isn’t enough data to recommend a booster shot in the general population.”

About the public’s health

Declines in Births by Month: United States, 2020: “The number of births declined in both the first and second 6 months of 2020 compared with 2019 for nearly all race and Hispanic-origin groups, with larger declines in the second half of 2020 compared with the first half of the year.”

The Pandemic Led To The Biggest Drop In U.S. Life Expectancy Since WWII, Study Finds: “A new study estimates that life expectancy in the U.S. decreased by nearly two years between 2018 and 2020, largely due to the COVID-19 pandemic. And the declines were most pronounced among minority groups, including Black and Hispanic people.” The decline is the largest since WWII.

Association of Meal and Snack Patterns With Mortality of All‐Cause, Cardiovascular Disease, and Cancer: The US National Health and Nutrition Examination Survey, 2003 to 2014: This study concludes it is not just what you eat, but when you eat it: “Fruit‐snack after breakfast, fruit‐lunch, vegetable‐dinner, and dairy‐snack after dinner was associated with lower mortality risks of CVD, cancer, and all‐cause; whereas Western‐lunch and starchy‐snack after main meals had greater CVD and all‐cause mortalities.”

About pharma

Viatris scores a win in long-running EpiPen antitrust lawsuit, but patent settlement charge : heads to trial: “Viatris, the newly-formed company that combined Mylan and Pfizer's Upjohn unit late last year, said it's "pleased" with the Kansas District Court's decision to rule in favor of the company's summary judgement motion in the case…
The judge's latest ruling dismissed all claims related to the Racketeer Influenced and Corrupt Organizations Act, including charges against the company's former CEO Heather Bresch, Viatris said. The court also dismissed the charge that Mylan prevented competition through rebate arrangements with PBMs. 
However, one claim related to patent settlements between Pfizer, which manufactured EpiPen, and Israeli drugmaker Teva remains outstanding and will go to trial, a Viatris spokesperson said. In the case, the plaintiffs claimed the companies abused "sham" patent litigation to forestall Teva's generic version from entering the market.”

Lilly to file for accelerated FDA approval of Alzheimer's drug after Aduhelm OK opens the floodgates: “Lilly plans to file for accelerated approval of its Alzheimer’s disease prospect donanemab later this year, a therapy the company once thought would need boat loads more data to get over the regulatory finish line.”
In a related story: Point32Health challenges Aduhelm, threatens coverage for 1.1M members: “Point32Health may not cover Biogen's new Alzheimer's treatment, Aduhelm, for its commercial members unless the price is reduced.
Point32Health CMO Michael Sherman, MD, told The Boston Globe that the drugmaker was favoring ‘excessive corporate profits’ with the $56,000 price tag over patient interests. Dr. Sherman believes the price of the treatment should be closer to $5,600, 10 percent of the current cost.”

Medicare Spent $2.1 Billion On Discarded Drugs From 2017 to 2019: “Our analysis of data provided by the Centers for Medicare and Medicaid Services (CMS) shows that more than $2.1 billion was wasted on discarded units of drugs from 2017 to 2019.
The majority of this wasted taxpayer money was spent on unused units of chemotherapy and cancer-treating drugs that were thrown away and unavailable for treating other patients in need of the drugs.
Most of this medication and financial waste is due to single-dose vials or containers of medications that include higher doses than are necessary to treat the average patient.” Emphases in the original.

Novartis bets on data, digital technologies to tackle global health challenges: “Novartis announced a collaboration Wednesday with Hewlett Packard that aims to accelerate the use of data and digital technologies in the Swiss drugmaker's global health initiatives, with the goal being to bolster access to healthcare and medicines. Financial terms were not disclosed, but the companies said they plan to start by developing a disease surveillance solution for dengue fever, initially focusing on India…
The initiative will concentrate on three ‘enablers’ of global health; namely identifying and integrating complex data sources related to health, applying artificial intelligence, machine learning and geo-spatial analytics to these data, and expanding access to technology in remote and underserved settings.”

About healthcare IT

It took a pandemic, but the US finally has (some) centralized medical data: “At the beginning of the pandemic, a group of researchers funded by the US National Institutes of Health, or NIH, realized that many questions about covid-19 would be impossible to answer without breaking down barriers to data sharing. So they developed a framework for combining actual patient records from different institutions in a way that could be both private and useful.
The result is the National COVID Cohort Collaborative (N3C), which collects medical records from millions of patients around the country, cleans them, and then grants access to groups studying everything from when to use a ventilator to how covid affects menstrual cycles…
The database is now one of the largest collections of covid records in the world, with 6.3 million patient records from 56 institutions and counting, including records from 2.1 million patients with the virus. Most records go back to 2018, and contributing organizations have pledged to keep updating them for five years. That makes N3C not just one of the most useful resources for studying the disease today, but one of the most promising ways to study long covid.”

Efficacy of Smartphone Active and Passive Virtual Reality [VR] Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A fascinating use for VR: “In this randomized clinical trial that included 90 pediatric patients with burns, participants in the active VR group had significantly lower scores for overall pain compared with participants in the standard care group and for worst pain compared with participants in the passive VR group and the control group.”

Regenstrief study shows EHRs underperforming for primary care: “The study traces the roots of the challenge to the fact that many EHRs were initially designed for specialists and hospitals – without much attention to the specific needs of primary care physicians, ‘whose effective decision-making is grounded in perception and comprehension of a patient's dynamic situation.’
For example, they note, an outpatient doc's choice to stop a patient's use of a particular medication will usually be informed by trends in that patient's blood pressure or cholesterol numbers, or other medications taken over the course of a month – all holistic information with implications for the patient's future health trajectory, but data that isn't always readily seen on a single EHR screen…
Instead, she said, ‘current EHRs are overloading primary care physicians with information in disparate files and folders rather than presenting comprehensive, actionable data in a context that gives meaning.’”

ONC Health IT Framework for Advancing SDOH Data Use and Interoperability: “ONC focuses on four key areas with respect to how health IT can be used to help achieve this: standards and data; infrastructure; policy; and, implementation.” Check the press release for more details.

Today's News and Commentary

About health insurance

Analysis of Medicare Advantage [MA] Plans’ Supplemental Benefits and Variation by County: This research letter provides a needed update on MA plans’ use of these benefits. In summary: “New supplemental benefits can be a tool to address MA beneficiaries’ health and social needs. However, only a relatively small proportion of MA plans (10.1%) are taking advantage of the most complex benefits.”

CMS Supports Modernizing Enrollment on State-Based Exchanges: “Twenty states with state-based exchanges are eligible to receive CMS grant funding, with each awardee receiving approximately $1.3 million…
As many as 21 cooperative agreement grants will be available to applicants. States that operate their exchanges on the federal health insurance marketplace website may still be eligible to apply.
CMS highlighted that these funds could go towards speeding up the eligibility determination process which assess whether individuals qualify for premium tax credits and cost-sharing reductions.
However, the funds may be used in a wide variety of ways to improve Affordable Care Act marketplace enrollment processes.”

4th Circ. revives dummy-code lawsuit against Aetna, Optum: “A federal appeals court on Tuesday reversed a ruling for Aetna Inc and OptumHealth Care Solutions, reviving a potential class action alleging that they agreed to use a ‘dummy code’ to disguise unbillable administrative fees as billable medical treatment.”
The case deals with a self-insured plan Aetna administered and for which it used Optum to subcontract certain services.

Time to pursue patient-centered payment models designed by doctors: A statement from the new AMA president. He makes many good points, however, if fully implemented, there would be an increased fragmentation in the healthcare system (hard to believe that is possible). Further, many of his recommendations would be implemented in a risk-based system, like Medicare Advantage plans that partner with physicians.

Blues plans team up to back new pharmacy solutions company, Evio: “Blue Cross Blue Shield of Massachusetts, Blue Cross Blue Shield of Michigan, Blue Shield of California, Highmark Health and Independence Blue Cross are backing Evio, according to an announcementreleased Tuesday.
The new company aims to establish outcomes-based arrangements with drugmakers, especially for high-cost therapies. In addition, Evio aims to collect and provide real-world evidence for medications to ensure the right product is getting to the right patient.
Evio will initially focus on providing these services to five founding health plans, according to the announcement. The plans collectively cover more than 20 million members nationwide.”

About hospitals and health systems

HCA to sell $2.4B in debt: “HCA Healthcare plans to offer two batches of senior notes worth nearly $2.4 billion to repay a portion of nearly $2.6 billion in senior secured term loans.”

Select Medical's latest deals amp up operations in acute care, outpatient clinics: “Select Medical Corporation announced a handful of new acquisitions and joint venture partnerships that will add seven long-term acute care hospitals and eight outpatient clinics to its already impressive collection of post-acute care facilities.
The company, which operates critical illness recovery, rehabilitation and occupational health locations across 46 states, said it expects the deals to close in the back half of 2021 pending regulatory approval.”

Hemmed In at Home, Nonprofit Hospitals Look for Profits Abroad: A good review of pros and cons of this strategy with examples.

About pharma

Calif. Jury Clears CVS In $121M Drug Overcharge Trial: “A California federal jury on Wednesday cleared CVS Pharmacy Inc. of claims by multiple classes of insured drug buyers that the pharmacy chain overcharged them by more than $121 million for generic drugs, in violation of multiple state consumer protection statutes, according to CVS and attorneys for the classes. After deliberating for less than a day, a unanimous jury cleared CVS of allegations brought by insured drug buyers from six states that the national pharmacy chain unfairly overcharged them for prescriptions under the company's now-defunct nationwide discount program called Health Savings Pass.”

Congress needs to fix the broken market for antibiotic development: “Unlike blockbuster cancer therapies or drugs that people take for years to control high blood pressure, antibiotics must be used judiciously to preserve their effectiveness. And their use is typically discontinued as soon as an infection is cured. That’s one reason antibiotics have not provided a strong return on investment for pharmaceutical companies. From 2014 to 2016, drug companies made more than $8 billion on cancer drugs, but lost $100 million on antibiotics. This poor return on investment also discourages private investment in new antibiotics. In 2019, investors poured $9.7 billion into oncology research, but committed only $132 million to antibiotics research.”
The article calls on Congress to “pass the Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act of 2021, also known as the PASTEUR Act, to stimulate the development of new drugs to fight deadly bacterial infections.”

Senior Democrat outlines new drug pricing plan as talks drag on: Here are the major points of Sen. Widen’s proposal.

CVS cut 72 drugs with 'hyperinflated' prices from its formulary last year: “Posaconazole, an antifungal medication, is priced at $4,500 for a 30-day supply—while an alternative, fluconazole, costs less than $14.
This is an example of a growing trend: medications, including many generics, with ‘hyperinflated’ prices, experts at CVS Caremark say. The pharmacy benefit manager giant culled 72 such drugs from its formulary in 2020 alone, leading to savings of $1.2 billion compared to 2018.”

Teva reaches $925K settlement with Mississippi in price-fixing case—and it hopes other states will follow suit: “The case dates back to 2019 when Mississippi, along with 43 other states, sued 20 generic drugmakers for divvying up markets and setting prices, the lawsuit alleged at the time. Investigations identified over 100 affected drugs for various maladies, including treatments for multiple sclerosis, HIV, ADHD and cancer, they claimed.
In some cases, price hikes that stemmed from backroom conversations were above 1,000%, former Connecticut Attorney General William Tong, who has led the investigation, said at the time.”

AI drug discovery start-up Insilico raises more than $255m: “Insilico, an artificial intelligence-based drug-discovery platform preparing to trial its first treatment in humans, has raised more than $255m from investors including Warburg Pincus and Sequoia Capital China. 
The Hong Kong-based start-up has 16 programmes in development, about half of which are for cancer and one of which is a potential antiviral for Covid-19. It plans to enter clinical trials this year with a novel drug for idiopathic pulmonary fibrosis, which scars the lungs, after discovering and validating the candidate in lab experiments in under 18 months.”

About medical devices

Masimo’s Radius Tº Wearable Thermometer Gets FDA 510(k) Clearance: “Masimo’s wearable, wireless thermometer branded Radius Tº has received 510(k) clearance from the FDA for both prescription and over-the-counter use in patients age five years and up.
Using a proprietary algorithm, Radius Tº provides continuous body temperature measurements that are approximations of sublingual temperatures captured from an oral probe.”

Portable dialysis machine maker Quanta lands $245M to boost U.S. reach: “After starting off 2021 with an FDA clearance for its portable dialysis machine, Quanta Dialysis Technologies has now raised a massive $245 million venture capital round to help roll out its next-generation device to both acute and chronic care settings.
The proceeds will also scale up the U.K.-based company’s operations internationally, with a special focus on boosting its U.S. manufacturing, sales and customer service divisions—in addition to setting the stage for a new clinical trial aimed at garnering an FDA green light for at-home use of its portable dialysis device.
Quanta’s SC+ hemodialysis machine is small enough to fit on top of a cart or tabletop and is currently cleared for use by healthcare professionals in hospitals and skilled nursing facilities.”

About the public’s health

Biden officials aim for the stars with new NIH research arm to push bold, risky biomedical ideas: “After the success of bringing COVID-19 vaccines to the masses in less than a year, U.S. officials are wondering how those lessons can be applied to spur breakthroughs across medicine.
President Biden is proposing a new research agency to sit within the National Institutes of Health, called the Advanced Research Projects Agency for Health (ARPA-H). It would be modeled after the Defense Advanced Research Projects Agency, or DARPA, which has led breakthroughs for the Department of Defense for more than 60 years.
The NIH requested an initial $6.5 billion in funding “to develop breakthroughs—to prevent, detect, and treat diseases like Alzheimer’s, diabetes, and cancer,” according to a paper from several NIH and White House officials published Tuesday in the journal Science.”

Radiology advocates update breast cancer screening guidance to reflect higher risk for minority women: “Breast cancer still looms as the second leading cause of cancer deaths, and two leading imaging groups say women should begin undergoing annual mammograms at age 40, particularly minority populations…
Minority women are 72% more likely to be diagnosed with breast cancer before they turn 50, and 58% more likely to suffer from an advanced stage of disease under the age of 50 compared to non-Hispanic white women. Such groups, which includes Hispanic, American Indian, Asian and non-Hispanic Black individuals among others, are also 127% more likely to die from breast cancer by their 50th birthday.”

Blood, Testing Supply Shortage To Persist Through 2021: “There has been at least a 10% increase in blood transfusions as patients resume care they deferred during the COVID-19 pandemic, many of whom are sicker.. Donations are also down, which have delayed some non-urgent procedures…
More than a third of community blood centers across the country reported having a one-day supply or less, according to America’s Blood Centers’ daily update from 59 community blood centers.”

Today's News and Commentary

About health insurance

Supreme Court declines to hear insurers' appeal seeking full reimbursement of CSR [cost-sharing reduction] payments: “The court declined Monday an appeal from Maine Community Health Options and Community Health Choice over an appellate court decision that plans that engaged in “silver loading” are not eligible to be repaid for lost CSR payments.
The court did not give a reason for not taking up the case, but the decision deals a blow to insurers looking to recoup CSR payments they believe they are owed by the federal government.
The Supreme Court had previously ruled in April 2020 that the federal government had to fully repay insurers for risk-corridor payments under the Affordable Care Act (ACA). The court ruled insurers were entitled to more than $12 billion in unpaid payments.”

About pharma

Blood-Brain Barrier Crossing Renin-Angiotensin Drugs and Cognition in the Elderly: A Meta-Analysis: Perhaps one more factor in considering tailored anti-hypertensive treatments:
”Older adults taking blood-brain barrier-crossing renin-angiotensin drugs exhibited better memory recall over up to 3 years of follow-up, relative to those taking nonpenetrant medications, despite their relatively higher vascular risk burden. Conversely, those taking nonblood-brain barrier-penetrant medications showed better attention over the same follow-up period, although their lower vascular risk burden may partially explain this result. Findings suggest links between blood-brain barrier crossing renin-angiotensin drugs and less memory decline.”

Roche's Alzheimer's antibody lowers biomarkers in inherited form of disease, though impact on symptoms is unclear: This study highlights the problem of using surrogate endpoints as the measure of success.
”In trial participants with dominantly inherited Alzheimer's disease (DIAD), which causes early onset of memory loss and other symptoms, Roche’s drug lowered biomarkers of the disorder and neurodegeneration in the brain, Washington University said in a study published in Nature Medicine.
The study did not show evidence of a cognitive benefit to people with DIAD [emphasis added], though it was not designed to measure the cognitive impact of gantenerumab on people who started taking the drug before they developed symptoms.”

BMS, Eisai Strike $3.1 Billion Deal for Cancer Drug: “Bristol Myers Squibb (BMS) and Eisai have inked a collaboration deal worth up to $3.1 billion focused on Eisai’s experimental cancer drug, MORAb-202, which is aimed at patients with advanced solid tumors.”

GSK to slash dividend in order to fuel growth at pharma unit: ”CEO Emma Walmsley is expected to unveil plans later this week to boost growth at GlaxoSmithKline's pharmaceutical division in an effort to appease investors who have become disillusioned with the company's recent performance. Reports suggested that the executive will unveil a large cut to the drugmaker's dividend at its capital markets day on June 23, with funds to be diverted into drug development, including through alliances and takeovers.”

AbbVie loses bid to have US high court intervene in AndroGel antitrust case: “US Supreme Court justices on Monday declined to hear AbbVie's challenge to a lower court ruling that it violated federal antitrust law by lodging a ‘sham’ patent complaint in order to stifle competition for AndroGel. Last year, a US appeals court said the "objective baselessness" of AbbVie's claims in its 2011 infringement lawsuit against Perrigo, showed that the drugmaker had no hope of winning the case, but rather intended to use the litigation process only to delay Perrigo's proposed generic version of the testosterone replacement treatment.”

Availability of Cost-effectiveness Studies for Drugs With High Medicare Part D Expenditures: “In this cross-sectional study of 250 drugs with the greatest Medicare Part D spending in 2016, cost-effectiveness analyses were unavailable for 46.0%, with these drugs representing 33.0% of Medicare Part D spending. For the 54.0% of drugs with available cost-effectiveness studies, many of the studies did not meet minimum quality standards.” This finding is only the first part of a problem. The other part is that, even if available, data cannot be used to approve/disapprove a therapy. This problem is one of the fundamental reasons prescription drugs cost more in this country than in others.

Merck's Keytruda extends life for cervical cancer patients in first-in-class win: “Adding Keytruda to chemotherapy with or without Roche’s Avastin for the first-line treatment of cervical cancer significantly extended patients’ lives in a phase 3 trial, Merck said Tuesday. The Keytruda regimen also performed better at staving off cancer progression in the study…”

Amgen dealt another blow in closely watched PCSK9 patent case against Sanofi, Regeneron: “In a Monday order (PDF), the U.S. Court of Appeals for the Federal Circuit declined Amgen's request for a rehearing of a prior patent loss on PCSK9 cholesterol drug Repatha. With the decision, Amgen can either try to appeal further or drop the issue.”

About Covid-19

U.S. administers more than 318 mln doses of COVID-19 vaccines - CDC: “The United States has administered 318,576,441 doses of COVID-19 vaccines in the country as of Monday, the U.S. Centers for Disease Control and Prevention said.
Those figures are up from the 317,966,408 vaccine doses the CDC said had gone into arms by June 20.
The agency said 177,342,954 people had received at least one dose while 150,046,006 people are fully vaccinated as of Monday.”
The distribution continues to be uneven with respect to geographic, demographic and political characteristics.

Desperate for Covid Care, Undocumented Immigrants Resort to Unproven Drugs: The headline is the story, but the intro paragraphs to the article exemplify the problem:
”FRESNO, Calif. — On a Tuesday afternoon in April, among tables of vegetables, clothes and telephone chargers at Fresno’s biggest outdoor flea market were prescription drugs being sold as treatments for Covid.
Vendors sold $25 injections of the steroid dexamethasone, several kinds of antibiotics and the anti-parasitic drug ivermectin. Chloroquine and hydroxychloroquine — the malaria drugs pushed by President Donald J. Trump last year — make regular appearances at the market as well, as do sham herbal supplements.”
If reporters can find these abuses, why can’t law enforcement officers remove these public health threats?

New COVID-19 approach exploits protein response in human cells to combat virus: “The mechanism, called the ‘unfolded protein response’ (UPR), is present in human cells infected with SARS-CoV-2... Combining two drugs targeting different prongs of the pathway significantly inhibited viral replication in human lung cell cultures to near undetectable levels, according to results published in the journal PLOS Pathogens.”

About healthcare IT

Algorithmic Bias Playbook: This report, from the University of Chicago, is a very well-done, clear explanation of the problem and steps to correct it:
This playbook will teach you how to define, measure, and mitigate racial bias in live algorithms. By working through concrete examples—cautionary tales—you’ll learn what bias looks like. You’ll also see reasons for optimism—success stories—that demonstrate how bias can be mitigated, transforming flawed algorithms into tools that fight injustice.”

External Validation of a Widely Implemented Proprietary Sepsis Prediction Model in Hospitalized Patients: “In this cohort study of 27 697 patients undergoing 38 455 hospitalizations, sepsis occurred in 7% of the hosptalizations. The Epic Sepsis Model predicted the onset of sepsis with an area under the curve of 0.63, which is substantially worse than the performance reported by its developer.”

Softbank-Backed Pear Therapeutics Plans To Go Public In $1.6 Billion SPAC Deal: “Pear Therapeutics, which has three FDA-authorized apps to treat psychiatric disorders, plans to go public in a $1.6 billion special purpose acquisition corporation, or SPAC deal, the company announced on Tuesday. Pear has raised more than $250 million to date with Softbank leading the startup’s Series D funding round…
The company, which launched in 2017, zeroed in on mental health quickly due to the high unmet need, says McCann, who has an MD and PhD in neurobiology. Pear’s flagship product reSET, developed out of Dartmouth, is a 90-day prescription app that provides cognitive behavioral therapy for the treatment of substance use disorder and is meant to be used alongside outpatient treatment. The list price for a 90-day prescription is $1,665.”

AWS [Amazon Web Services] announces AWS Healthcare Accelerator for startups in the public sector: “The AWS Healthcare Accelerator is a four-week technical, business, and mentorship accelerator opportunity open to U.S.-based healthcare startups or international healthcare startups that have existing U.S. operations. A cohort of 10 healthcare startup companies with an established product-market fit with existing customers and revenue, who seek to use AWS to help solve the biggest challenges in the healthcare industry, will be selected to participate in this new program. The program is tailored to accelerate growth in the cloud, with a focus on solutions like remote patient monitoring, voice technology, analytics, patient engagement, and virtual care. Applications are open today and proposals are due by July 23, 2021.”

The size and discovery delay of the following breaches are noteworthy.

Class action targets Scripps over data breach that exposed 147,000+ patients' info:”Scripps Health is being accused of failing to properly secure and protect patients' health information stored within the San Diego-based system's network, which a malware attack compromised April 29, according to court documents.”

Hacker removes files from New Mexico hospital's computers, exposes 69,000 patients' info: “San Juan Regional Medical Center in Farmington, N.M., recently began notifying nearly 69,000 patients that their protected health information was compromised by hackers. 
SJRMC reported the breach to HHS on June 4, saying it affected 68,792 individuals. The hospital said it discovered that an unauthorized individual accessed its network from Sept. 7-8, 2020, during which the unauthorized individual removed some information, according to a June 4 online notice. 
Some of the files the hacker removed contained patient information including names, Social Security numbers, birthdates, driver's license numbers, financial account numbers and medical record details.”

About healthcare systems

LifePoint Health Announces Agreement to Acquire Kindred Healthcare: “The transaction brings together LifePoint’s national network of community-based hospitals, providers and access points with Kindred’s expertise in delivering long-term acute care, rehabilitation services and behavioral health services…
LifePoint will invest $1.5 billion over the next three years to improve care for the communities that the combined organization will serve…the transaction is expected to be completed in the fourth quarter of 2021.”

About the public’s health

Trends and projections of caesarean section rates: global and regional estimates: “The use of CS has steadily increased worldwide and will continue increasing over the current decade where both unmet need and overuse are expected to coexist [emphasis added]. In the absence of global effective interventions to revert the trend, Southern Asia and sub-Saharan Africa will face a complex scenario with morbidity and mortality associated with the unmet need, the unsafe provision of CS and with the concomitant overuse of the surgical procedure which drains resources and adds avoidable morbidity and mortality. If the Sustainable Development Goals are to be achieved, comprehensively addressing the CS issue is a global priority.”

Today's News and Commentary

About health insurance

VA plans to offer gender-confirmation surgery to transgender veterans, reversing ban: “The Department of Veterans Affairs is moving to provide gender-confirmation surgery through its health-care coverage, reversing a 2013 ban, VA Secretary Denis McDonough announced Saturday.”
It appears the VA will outsource the procedures but pay for them.

Democrats seek new ways to expand Medicaid in holdout states: “There are currently 12 states where Republicans have refused to accept the expansion of Medicaid eligibility provided under ObamaCare, meaning 2.2 million low-income people are left without coverage they otherwise would have…
Efforts to entice the holdout states to expand the program with financial incentives have run into a wall, so Democrats are now turning to the idea of having the federal government step in and provide coverage.
The details of how to do that, however, are still up for debate and pose thorny questions of cost and potential health care industry opposition.”
In a related article: Pandemic Swells Medicaid Enrollment to 80 Million People, a ‘High-Water Mark’: “The latest figures show Medicaid enrollment grew from 71.3 million in February 2020, when the pandemic was beginning in the U.S., to 80.5 million in January, according to a KFF analysis of federal data. (KHN is an editorially independent program of KFF.)
That’s up from about 56 million in 2013, just before many states expanded Medicaid under the Affordable Care Act. And it’s double the 40 million enrolled in 2001.”

About COVID-19

Public is Relaxing its Pandemic Precautions: “Overall, 39% are satisfied with the speed in which local restrictions to prevent the spread of the coronavirus have been rescinded. Nearly as many, 34%, are concerned that the restrictions have been lifted too quickly, while 27% feel things haven’t been relaxed soon enough. But people in urban areas are much more likely to say restrictions have been lifted too quickly than those in the suburbs or rural areas. Democrats are also more likely to regard the restrictions as having been rescinded too quickly compared with Republicans.”
21% of Americans fear contracting COVID-19 from someone they know well, the lowest number since the pandemic began.

How vaccines stack up against CDC's 5 variants of concern: A really good summary. The good news is the vaccines are very protective.

About healthcare financing

23andMe rises in stock market debut after Branson-backed merger: “23andMe went public Thursday through a merger with Richard Branson's blank check company and raised nearly $600 million.
The deal values the personalized medicine and consumer genetic testing company at $3.5 billion.”

Physician social network Doximity plans IPO at $4B valuation: “Doximity, a social network for doctors, plans to raise nearly $536 million through an initial public offering.
At the midpoint of the proposed range, Doximity would command a fully diluted market value of $4.5 billion.”

About pharma

HHS pulls 340B advisory opinion after it fails to throw out AstraZeneca lawsuit: “The Department of Health and Human Services has pulled a controversial advisory opinion that stated drug makers must provide products discounted under the 340B program to contract pharmacies after a heated legal fight with AstraZeneca…
But HHS has not withdrawn a series of letters it sent to AstraZeneca and five other drugmakers last month calling for them to end the restrictions to contract pharmacies.
The Health Resources and Services Administration, which oversees 340B, does not mention the advisory opinion in the letters. The agency wrote that drug makers violated the federal 340B statute when they restricted sales to contract pharmacies.”

Amarin's Vascepa patent defense ends in a loss at the Supreme Court: “On Monday, the United States’ top court declined to take up Amarin’s challenge on a patent loss handed down last September, leaving the prior decision in place. Amarin’s stock was trading down about 10% on Monday morning. 
In September, the United States Court of Appeals for the Federal Circuit ruled in favor of Hikma and other generic challengers, finding that patents on Amarin’s fish oil-derived heart drug Vascepa were invalid based on obviousness.”

The top 10 ESG pharma companies in 2021: “Environmental, Social and Governance (ESG) is the new corporate sustainability yardstick. And investors are pushing ESG accountability—thanks in part to the pandemic—to the front page across industries, including pharma.” The article explains these three features and profile the top 10 pharma companies according to those measures. Boehringer Ingelheim tops the list.

About healthcare IT

Patients are looking to go back to brick-and-mortar post pandemic: “The research found that Gen Z and Millennials were the most likely to be open to telehealth, with 47% of millennials saying they would prefer telehealth over in-person visits once the pandemic has ended. Nearly three-quarters of younger generations reported that one reason they prefer telehealth is convenience.
The silent generation and the Baby Boomers were the least likely to favor in-person visits over telehealth.”

HIPAA and the Leak of “Deidentified” EHR Data: “Although the HIPAA Privacy Rule governs uses of identifiable data, it doesn’t apply to data that are considered deidentified, either as determined by experts or under the ‘safe harbor method,’ which requires removal of 18 specific identifiers (such as name, address, and date of birth)…
Even after many deidentification-related processes, individual patients can potentially be reidentified on the basis of only a handful of attributes. Deidentification technologies relying on encryption could be vulnerable to future advances in computing.
…the United States doesn’t have a comprehensive data-privacy law, and none of the various privacy-related laws or regulations protects patients from the potentially harmful use of deidentified data. There is no duty to report instances in which data have been reidentified or linked to external data sources, such as financial records, and patients have little or no opportunity for redress in cases of reidentification…
Broadly speaking, two approaches could help address the torrential leak of deidentified health record data. One approach would be to establish best practices for data protection among data providers. The other would be to strengthen legal and regulatory protections for patients.”

About the public’s health

AMA adopts guidelines that confront systemic racism in medicine: “Members of the AMA’s House of Delegates representing their peers from all corners of medicine voted to adopt guidelines addressing systemic racism in medicine, including discrimination, bias and abuse, including expressions of prejudice known as microaggressions. The AMA will recommend that health care organizations and systems use the new guidelines to establish institutional policies that promote positive cultural change and ensure a safe, discrimination-free work environment.”
If you read the recommendations, they appear to be identical to those for sexual harassment.



Today's News and Commentary

About health insurance

Fewer Medicare Advantage Plan Members Actively Managed Their Health during Pandemic, J.D. Power Finds: “Following are some of the key findings of the 2021 study:

  • Members’ active management of care declines in 2021: Slightly more than half (55%) of Medicare Advantage plan members actively managed their care in the past year, a decline of nine percentage points from 2019. The two most common ways in which plan members actively manage healthcare are checking whether a treatment or service is covered and asking their doctor or pharmacist for a generic drug instead of a brand name.

  • Communication still misses mark: Despite improvements in satisfaction with information and communication this year, it is the lowest-performing factor evaluated in the study. Overall satisfaction scores are 54 points higher (on a 1,000-point scale) when members successfully engage with their plan to ask a question or solve a problem than when they have no engagement at all.

  • New members cite worse health, lower income than established members: Just 34% of new Medicare Advantage plan members (those ages 65-68 or in their first year with the plan) say they are in “very good” or “better” health and 46% say they have an annual income of $50,000 or more. These compare with 39% of established plan members (ages 69+ and not in the first year of the plan) who say they are in “very good” or “better” health and 56% who earn $50,000 or more.

  • Health plan portals show promise: More than three-fourths (78%) of Medicare Advantage members are registered for their health plan’s member portal—up four percentage points from last year. Two-thirds of members have logged in to their health plan’s portal. Portal use is associated with higher levels of satisfaction and improved member engagement.

Study Rankings

Kaiser Foundation Health Plan ranks highest in Medicare Advantage plan overall satisfaction, with a score of 846. Highmark (834) ranks second and Cigna HealthSpring (822) ranks third.”

7 Fortune 500 health insurers by membership: The top 3:

1. UnitedHealth Group: 49.5 million members

2. Anthem: 43.5 million members

3. Centene: 25.1 million members

4 Philadelphia business owners charged in $10M Medicaid fraud: “Owners of three care coordination agencies allegedly conspired with a transportation company to bill Medicaid for $7.9 million in services from 2017-19 that were never provided to beneficiaries. Two of the companies, Brighter Care Services and Pennsylvania Service Coordination Agency, were accused of defrauding Medicaid an additional $2 million by charging for more services than were provided…”

Medicare Spending on Drugs with Direct-to-Consumer Advertising: Excellent analysis by the GAO:
”Drug manufacturers spent $17.8 billion on direct-to-consumer advertising (DTCA) for 553 drugs from 2016 through 2018, and spending was relatively stable at about $6 billion each year. Almost half of this spending was for three therapeutic categories of drugs that treat chronic medical conditions, such as arthritis, diabetes, and depression. GAO also found that nearly all DTCA spending was on brand-name drugs, with about two-thirds concentrated on 39 drugs, about half of which entered the market from 2014 through 2017.
Medicare Parts B and D and beneficiaries spent $560 billion on drugs from 2016 through 2018, $324 billion of which was spent on advertised drugs. Of the 553 advertised drugs, GAO found Medicare Parts B and D spending for 104 and 463 drugs, respectively. Among the drugs with the highest Medicare spending, some also had the highest DTCA spending. Specifically, among the top 10 drugs with the highest Medicare Parts B or D expenditures, four were also among the top 10 drugs in advertising spending in 2018: Eliquis (blood thinner), Humira (arthritis), Keytruda (cancer), and Lyrica (diabetic pain).”

About the public’s health

Hand Sanitizer Vapors Can Cause Nausea, Dizziness: The FDA is reminding consumers to use sanitizers in well-ventilated areas.

Nutrient Composition of a Selection of Plant-Based Ground Beef Alternative Products Available in the United States: “The percent Daily Value (DV) per 3-ounce cooked portion of each product was determined for nutrients with a DV. The median, interquartile range (IQR), minimum, and maximum nutrient values were calculated for all products by classification as vegan and nonvegan.
Results
The median saturated fat content of the plant-based ground beef alternatives products as a %DV was 4% (IQR 2%). Vitamin and minerals for which median %DV values for plant-based ground beef alternative products were 10% or higher included folate (10%, IQR 10%), niacin (21%, IQR 7%), iron (10%, IQR 5%), phosphorous (10%, IQR 4%), sodium (18%, IQR 7%), manganese (20%, IQR 20%), and copper (24%, IQR 10%). The median dietary fiber content of the plant-based ground beef alternative products was 15% of the DV (IQR 6%). Most of the products contained less protein, zinc, and vitamin B12 than ground beef.”

STDs reach all-time high for sixth consecutive year in the US.: “In 2019 alone, there were more than 2.5 million cases of chlamydia, gonorrhea and syphilis reported, according to the Centers for Disease Control and Prevention. This marks the sixth consecutive year of record-breaking cases of sexually transmitted diseases in the U.S.
The CDC's data looked at states with the highest cases of chlamydia, gonorrhea, syphilis and congenital syphilis. The following numbers were collected from cases in 2019, the most recent data on file, and show a large increase from the reported 1.4 million cases in 2014.”

Dirty Air in Pregnancy Might Raise Baby's Obesity Risk: “The researchers, from the University of Colorado at Boulder, analyzed air pollution data from the U.S. Environmental Protection Agency during the women's pregnancies and then assessed their babies.
Infants whose mothers were exposed to higher levels of air pollution during pregnancy grew unusually fast in their first six months, gaining excess fat that puts them at risk of obesity and related diseases later in life, according to the study.
Specific air pollutants seemed to affect male and female babies differently.”

About hospitals and health systems

Spectrum Health, Beaumont Health announce plans to form 22-hospital system: “Two of Michigan’s largest providers are exploring a potential merger that would yield a 22-hospital nonprofit system staffing more than 64,000 employees.
Spectrum Health and Beaumont Health have signed a letter of intent that places the health systems on track to combine by the fall, the organizations announced Thursday.
In addition to the hospitals, the merged system would also operate 305 outpatient locations and Spectrum’s Priority Health, the third-largest provider-sponsored health plan in the country.”
Recall Beaumont’s previous potential partner was Advocate-Aurora.

Ochsner to take over 7-hospital system: “Rush Health Systems, a seven-hospital system in Meridian, Miss., signed an agreement to join New Orleans-based Ochsner Health.
The organizations said June 17 that they signed a shared mission agreement and expect the deal to be finalized in mid-2022, following necessary regulatory approvals.”
Rush Health Systems is not to be confused with the Chicago-based system with a similar name.

State Supreme Court upholds legality of Colorado hospital fees: “The program requires collection of fees from Colorado hospitals, which are matched by the federal government and then redistributed to hospitals to help them cover Medicaid patients and people in rural areas. The initial provider fee program was started in 2009, a few years later there was a subsequent healthcare affordability and sustainability fee that was added.”
Many other states have used this method to raise monies to obtain federal Medicaid matching funds.

9 hospital construction projects costing $1B+: This list highlights the continuing building boom in this sector.

About healthcare professionals

Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products: “Every year, a torrent of cash and other compensation flows to these surgeons from manufacturers of hardware for spinal implants, artificial knees and hip joints — totaling more than $3.1 billion from August 2013 through the end of 2019, a KHN analysis of government data found. These bone specialists make up a quarter of U.S. doctors who have accepted at least $100,000 or more, and two-thirds of those who raked in $1 million or more, from the medical device and drug industries last year…”

Top 10 Paying Specialties in the PA Profession in 2020: Some policy experts claim that non-physician professionals could make up deficits in the numbers of primary care doctors. But if salaries for these other specialties are so high, PAs will not be attracted to primary care. Take a look at the list.

Today's News and Commentary

Supreme Court Upholds ACA

The Supreme Court decided (7-2) that the entire ACA stands. The reason is that the plaintiffs lacked standing to bring the suit because they could not show harm. The important issues, such as the severability with respect to the tax (penalty) provision, were not addressed by the majority. It leaves urther challenges open.

About pharma

US plays catch-up with Europe over biosimilar patents: “Europe’s more liberal approach to biosimilar drug patents is continuing to give it an edge over the US in producing lower cost medicines — despite moves by Washington to ease market access for generic manufacturers…
In Europe, the European Medicines Agency (EMA) will not approve a biosimilar in the first 10 years after approving the original drug. But, in the US, the Food and Drug Administration (FDA) will hold off for 12 years.
That difference in timing can be seen in the case of the drug bevacizumab — a treatment for colon and lung cancer and renal-cell carcinoma, sold as Avastin. This year, Europe approved a fifth Avastin biosimilar, whereas the US has approved just two biosimilars for bevacizumab overall, in 2017 and 2019…
Iqvia estimates that expanding the use of biosimilars could reduce the costs of medications in the US by $100bn over five years.”

New Alzheimer’s Drug is Projected to Increase National Health Expenditures [NHE]by More Than One Percent: “The contribution of Aduhelm to prescription drug spending and to NHE grows to more than $73 billion by 2028.”

AstraZeneca's lawsuit over 340B contract pharmacies survives after judge dismisses challenge from HHS: “A federal judge has dismissed the Department of Health and Human Services’ (HHS') bid to toss a lawsuit from drugmaker AstraZeneca over the 340B drug discount program.
The decision by Judge Leonard Stark, delivered Wednesday, ensures the lawsuit over AstraZeneca’s restriction of sales to 340B contract pharmacies will continue.
AstraZeneca and several other drug companies over the past year have restricted sales of 340B-discounted products to contract pharmacies, which are third-party entities that dispense the discounted drugs on behalf of covered entities.”

FDA launches global Generic Drug Cluster: “Described as ‘the first forum established for the world’s leading regulatory agencies to address generic drug development globally,’ the new cluster, wrote FDA, is meant to help harmonize approaches global regulators take to generic drug development through a variety of approaches. FDA announced the launch of the new body in a 14 June tweet from its FDA Drug Information Twitter account.”

GlaxoSmithKline awarded no restitution in high-profile trade-secrets theft case: This decision is odd and may have implications for other, similar, cases.
“The legal filing comes in the case of the U.S. vs. Yu Xue and Tao Li, Chinese nationals who previously pleaded guilty to trade secrets theft to benefit a company they founded, Renopharma…
In August 2018, Xue pleaded guilty to conspiracy to steal GSK’s trade secrets. And the following month, federal prosecutors secured a guilty plea from Li. 
While the government agreed to limit Li’s sentence to no more than seven years and drop other charges, the sides did not agree on any amount of financial loss, leaving the issue up to the court, the judge wrote this week. 
Now, despite arguments from the government that GSK lost more than $1 billion in the ‘fair market value’ of the trade secrets, the court is not awarding any restitution. In doing so, the court found that GSK ‘suffered no pecuniary loss.’”  

About health insurance

Colorado becomes 2nd state to create own public insurance option: “The legislation, signed by Democratic Gov. Jared Polis Wednesday, would create individual and small group health plans starting in 2023. It became the second state after Washington to pass a public insurance option, and several more could come after it.
The standardized plan must offer healthcare coverage on the bronze, silver and gold levels and offer all pediatric and other essential benefits.
Colorado’s insurance commission must also create rules regarding network adequacy for the public option plan.”

Feds sue to block Aon's $30 billion Willis Towers deal: “The U.S. Justice Department sued to block Aon’s proposed $30 billion acquisition of Willis Towers Watson, saying the deal to create the world’s largest insurance brokerage is anticompetitive.
The department’s antitrust division filed a lawsuit in federal court in Washington asking a judge to stop the deal, arguing that it would create too much concentration in the market and hurt businesses, their employees and retirees.”

Democrats devise a way to finally expand Medicaid in resistant states: This morning, Rep. Lloyd Doggett (D-Tex.) introduced “legislation, co-signed by more than 40 House Democrats, that would let cities and counties bypass the states still refusing to expand their Medicaid programs…
Cities, counties or even hospital districts could get special permission from the Centers for Medicare and Medicaid Services to expand Medicaid within their own jurisdiction. The permission, granted through what are known as ‘demonstration projects,’ would last for five years, with an option to extend for an additional five years. It would provide the same federal assistance provided to states; localities would have all of their expansion costs covered for the first three years, with the federal subsidies phased down to 90 percent of costs by the seventh year.”

UnitedHealth Group Releases 2020 Sustainability Report: “The report includes three long-term commitments UnitedHealth Group is making to expand access to care, improve health care affordability and achieve better health outcomes. These commitments are to:

  • Ensure that 85% of members receive preventive care services annually by 2030.

  • Ensure more than 55% of outpatient surgeries and radiology services among members are delivered at high-quality, cost-efficient sites of care by 2030.

  • Close 600 million gaps in care for members by the end of 2025.”

About Covid-19
Despite progress in this country, the virus continues to spread globally. Below are a few articles examining this problem.

WHO says delta Covid variant has now spread to 80 countries and it keeps mutating: “The variant now makes up 10% of all new cases in the United States, up from 6% last week. Studies have shown the variant is even more transmissible than other variants. WHO officials said some reports have found that it also causes more severe symptoms, but more research is needed to confirm those conclusions.”
The good news is that current vaccines are very effective against infection by this variant.

Coronavirus infections rising exponentially in England - REACT study: “The number of people infected with the coronavirus is increasing rapidly in England, doubling every 11 days…
Most infections are happening in children and young adults, but they are rising in older people too, increasing at a similar rate in the over 50s and the under 50s.

Africa sees 44% spike in new Covid infections, 20% increase in deaths: “Weekly cases jumped 44% while fatalities rose 20% over the previous week across Africa, according to the World Health Organization.
African countries currently have the lowest share of vaccines in the world.

U.S. buys 200 mln more Moderna COVID-19 vaccine doses: “The additional Moderna doses, which brings total U.S. orders to 500 million, could be used for primary inoculation, including of children, or as a possible booster shot, the company said.”

Pfizer’s arthritis drug Xeljanz shows lifesaving benefits in hospitalized COVID-19 patients: “Xeljanz reduced the risk of death or respiratory failure among hospitalized patients with COVID-19 pneumonia who didn’t require ventilation, according to data published in the New England Journal of Medicine.

About healthcare IT

CVS Health database leak left 1B user records exposed online: “More than 1 billion search records belonging to CVS Health were accidentally posted online and accessible to the public earlier this year.
The database belonging to the healthcare and retail giant, which was not password protected, was discovered at the end of March by independent cybersecurity researcher Jeremiah Fowler, according to a report published by Website Planet, which conducts research into unsecured internet data.
The database, which was approximately 204 gigabytes in size and totaled 1.1 billion records, had no form of authentication in place to prevent unauthorized entry, the researchers said.
The data exposed online included customer email addresses, user IDs and customer searches on CVS Pharmacy websites for COVID-19 vaccines and other medications, according to the report.”

Penn Medicine releases bedside Epic tool to share EHR data with patients: “Philadelphia-based Penn Medicine has released a digital tool, MyChart Bedside, to share scheduling and updated health information with patients…
The Epic-hosted tool gives patients access to educational materials, descriptions of hospital staff assisting with their treatment, their medications, and other information through hospital iPads.”

About the public’s health

A randomized controlled trial to isolate the effects of fasting and energy restriction on weight loss and metabolic health in lean adults: “Even with net energy intake restricted to that of daily dieters, alternate-day fasting less effectively reduced body fat content and offered no additional short-term improvements in metabolic or cardiovascular health compared to daily energy restriction.”


Today's News and Commentary

About pharma

AHA urges Express Scripts to rescind 340B claims reporting policy: “The American Hospital Association (AHA) wants Express Scripts to rescind a policy that would require contract pharmacies to apply a unique code for claims under the 340B drug discount program…
In a letter to the PBM sent Tuesday, the AHA argues that because the 340B program has stringent government oversight, the policy ‘raises significant questions about Express Scripts' true motivations.’
The organization added that compliance with the policy could add to the burden on providers already struggling as a result of COVID-19. Complying with the requirement requires significant investment in system upgrades and staff, the AHA said.”

Anthem joins generic drug initiative Civica Rx: “Civica Rx, a nonprofit organization created in 2018 to address the problem of chronic drug shortages, said June 16 that Anthem will join the CivicaScript unit as a new health insurance partner. Anthem joins CivicaScript's insurance co-founders: the Blue Cross Blue Shield Association and 17 independent BCBS companies.”

HHS proposes nixing rule affecting insulin and EpiPen discounts for community health centers: “The Department of Health and Human Services (HHS) proposed rescinding a Trump-era rule that required community health centers to fully pass along discounts they received from the 340B drug program for insulin and EpiPens.
HHS said in a notice that the rule finalized by the Trump administration in December 2020 created too much of an administrative burden on community health centers. Back in March, the agency had delayed implementation of the rule until July.”
This action is a bit of a puzzle. Usually Democrats favor lowering drug costs by such methods and are not concerned with bureaucratic expenses.

About health insurance

MedPAC: Part D spending grew 26% from 2013 to 2018 thanks to higher launch prices: “The analysis was part of a report from MedPAC sent to Congress on Tuesday. The analysis found that while Part D spending increased, spending on services covered under the physician fee schedule remained flat…
MedPAC found a wide variation in the per capita drug use from 2013 to 2018.
‘Growth in per capita drug use during this period ranged from -22% in the Kansas portion of the St. Joseph, Missouri-Kansas geographic area, to 40% in the El Centro California, geographic area,’ the report found.
While spending on Part D rose in the five-year period, MedPAC found a slight decline in the use of clinician services in Parts A and B.”
And in a related article about this annual MedPAC Report: MedPAC to Medicare: Cut Down on Those Alternative Payment Models: “The strategy of implementing a plethora of models over the last decade has given the agency an opportunity to build up the evidence base about what works and what does not. While this strategy has yielded valuable information, the commission contends that continuing to test a large number of independent APMs is likely to inhibit the ability of APMs to reach their full potential. We therefore recommend that CMS now take a more holistic approach that involves implementing a smaller, more harmonized portfolio of APMs."

MedPAC's 6 latest spending recommendations to Congress: A quick overview of other MedPAC recommendations. Remember, MedPAC is a strictly advisory body; Congress is not obligated to follow recommendations.

Tufts-Harvard Pilgrim name combined company: “Point32Health is the name of a new health insurance organization formed by the merger of Tufts Health Plan and Harvard Pilgrim Health Care. 
The name was inspired by the 32 points on a compass.”

UnitedHealth: $320B could be saved in next decade by reducing ED visits: “Treating common conditions, including bronchitis and the flu, in primary care settings instead of emergency rooms could save health systems up to $320 billion over the next 10 years, according to UnitedHealth Group's 2020 Sustainability Report.
Two-thirds of visits to hospital emergency departments by patients with private insurance are avoidable, the report said.”

Medical-Debt Charity to Buy, Wipe Out $278 Million of Patients’ Hospital Bills: “RIP Medical Debt, which uses donations to wipe out unpaid medical bills, has reached a deal with nonprofit Ballad Health, a dominant hospital system in Tennessee and Virginia, to buy debt owed by 82,000 low-income patients. Many likely qualified for free care under Ballad’s policy but didn’t get it, executives at Ballad involved in the agreement said. The patients lacked applications, they said.”

About the public’s health

Association Between Childhood Consumption of Ultraprocessed Food and Adiposity Trajectories in the Avon Longitudinal Study of Parents and Children Birth Cohort: News Flash: Children who eat junk food get fat! So glad resources were spent on this study as opposed to helpful interventions. And here is another similar one: Association of a Sweetened Beverage Tax With Purchases of Beverages and High-Sugar Foods at Independent Stores in Philadelphia: While the specifics may be new, the findings are very old: Increase taxes (on sugared drinks, tobacco products, etc.) and use will go down. The only place such action does not work is for luxury items (think: gas guzzler tax for your Ferrari).

Fluorinated Compounds in North American Cosmetics: “These compounds are precursors to PFCAs [per- and polyfluoroalkyl substances] are known to be harmful. The ingredient lists of most products tested did not disclose the presence of fluorinated compounds exposing a gap in U.S. and Canadian labeling laws. The manufacture, use, and disposal of cosmetics containing PFAS are all potential opportunities for health and ecosystem harm. Given their direct exposure routes into people, better regulation is needed to limit the widespread use of PFAS in cosmetics.”
In a popular press article related to the research: More Than Half of Cosmetics Used in U.S. and Canada Contain Cancerous Chemicals, Study Shows According to the Washington Post, on Tuesday, Senators Susan Collins (R-Maine) and Richard Blumenthal (D-Conn.) plan to introduce a new bill titled the No PFAS in Cosmetics Act.

59% OF U.S. ADULTS SAY HEALTH CARE SYSTEM DISCRIMINATES AT LEAST “SOMEWHAT,” NEGATIVELY AFFECTING TRUST: The study, conducted by NORC, is part of the Building Trust initiative of the American Board of Internal Medicine. Among the findings: “Fifty-nine percent (59%) of adult consumers say the health care system discriminates at least “somewhat,” with 49% of physicians agreeing.  
About one in every eight adults (12%) say they have been discriminated against by a U.S. health care facility or office, with Black individuals being twice as likely to experience discrimination in a health care facility compared to white counterparts.”

About Covid-19

CureVac, the latest experimental coronavirus vaccine, proved just 47 percent effective amid spread of variants, preliminary analysis shows: This result highlights why you need to do the field research. “A closely watched coronavirus vaccine invented by the German company CureVac was just 47 percent effective in a large trial at its interim analysis, a disappointing result that may highlight the challenge posed by virus variants.
The results of the 40,000-person trial, announced by news release Wednesday, mark a setback for a promising vaccine based on messenger RNA technology, the same approach at the core of the Pfizer-BioNTech and Moderna vaccines authorized late last year for use in the United States.”

Novavax to File for Emergency Use for COVID-19 Vaccine: ”Novavax said it plans to file for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in the third quarter.”

American COVID-19 Vaccine Poll: “The American COVID-19 Vaccine Poll is a partnership between the African American Research Collaborative and The Commonwealth Fund. The Robert Wood Johnson Foundation supported an expansion of the poll in the Native American community and the W.K. Kellogg Foundation supported expansion in New Mexico.
We surveyed over 12,000 Americans to better understand their access to and opinions about the vaccines, as well as messages and messengers that encourage different groups to get vaccinated.”
This really interesting, interactive site also includes most effective messages/messengers for those reluctant to get vaccinated. Example: Most effective message overall for the unvaccinated: “Getting a COVID-19 vaccine can protect the lives of my family, friends, and those I love.” 43.5% effective.

Most U.S. employers will not require workers to be vaccinated before entering the workplace: “As U.S. employers continue their efforts to encourage workers to get the COVID-19 vaccine, most (72%) will not require or do not plan to require vaccination before entering the workplace, according to a new survey by Willis Towers Watson... Among employers requiring or considering requiring vaccination, more than half (56%) will require documented proof of vaccination. Nearly one in five (19%) will require or consider requiring vaccinations for certain workplace privileges such as indoor gyms and cafeterias.”

Amazon kicks off new role as diagnostics provider by making COVID test available online: ”Using a proprietary COVID-19 test first developed to screen its own workers during the pandemic, Amazon has now made its at-home sample collection kit available to the public online.
The kit can be purchased without a prescription by anyone 18 years and older, retails for $39.99 and can be delivered in one day in some areas.
Each comes with a nose swab and collection tube, as well as a specimen bag and a prepaid shipping label to ship the sample back to one of Amazon’s labs around the country.”

Today's News and Commentary

About Covid-19

Trends in Number of COVID-19 Cases and Deaths in the US Reported to CDC, by State/Territory Reported COVID-19 cases in the U.S. are no longer dropping and began to plateau around June 8.

FDA panel split on approach to COVID-19 vaccines for younger children: “Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.
Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as the fall and flu season approach and the risk of contracting respiratory infections increases…
Some members of the committee who were wary of EUAs in younger age groups said there was insufficient justification and safety data to support emergency use in this population and were concerned about recent reports from Israel that cited elevated cases of myocarditis, or inflammation of the heart, in males ages 16 to 30 who received both doses of Pfizer-BioNTech’s mRNA-based vaccine Comirnaty.”

Diabetes mainstay metformin tamps down lung inflammation in COVID models: “The researchers tested metformin in a mouse model of severe lung inflammation that can result from COVID-19—a dangerous condition called acute respiratory distress syndrome (ARDS). The drug inhibited the onset of ARDS and relieved its symptoms, they reported in the journal Immunity.”

AstraZeneca's COVID-19 antibody combination fails post-exposure prevention trial: “AstraZeneca’s anti-SARS-CoV-2 antibody combination has failed a phase 3 clinical trial designed to assess its ability to prevent symptomatic COVID-19 in people recently exposed to the pandemic coronavirus.
While the Storm Chaser study missed its primary endpoint, a subgroup analysis of people who tested negative for COVID at baseline offered encouragement to AstraZeneca.”

Many Post-Covid Patients Are Experiencing New Medical Problems, Study Finds: “The study, tracking the health insurance records of nearly two million people in the United States who contracted the coronavirus last year, found that one month or more after their infection, almost one-quarter — 23 percent — of them sought medical treatment for new conditions.
Those affected were all ages, including children. Their most common new health problems were pain, including in nerves and muscles; breathing difficulties; high cholesterol; malaise and fatigue; and high blood pressure. Other issues included intestinal symptoms; migraines; skin problems; heart abnormalities; sleep disorders; and mental health conditions like anxiety and depression.”

NIH study suggests coronavirus may have been in U.S. as early as December 2019: “The new report, published in the journal Clinical Infectious Diseases, bolsters earlier studies indicating that the virus entered the country under the radar and may have been spreading in the first two months of 2020, well in advance of warnings to that effect from the Centers for Disease Control and Prevention.
A volunteer in Illinois who gave blood on Jan. 7, 2020 — in a study unrelated to the emergent virus — tested positive for antibodies to SARS-CoV-2, according to the NIH report. It noted that the antibodies typically take 14 days, on average, to develop, and this ‘suggests the virus may have been present in Illinois as early as December 24, 2019.’”

About pharma

Mississippi becomes the first state to jointly sue drug makers and PBMs over the cost of insulin: “In a first-of-its-kind move, the Mississippi attorney general last week filed a lawsuit accusing several drug makers and pharmacy benefit managers of conspiring to set prices for insulin, the life-savings diabetes treatment that has become a poster child for the high cost of prescription medicines.
The lawsuit alleged that the manufacturers benefited from a scheme in which prices were ‘artificially’ inflated to win placement on formularies, the list of medicines for which insurance is provided.”

Teva Files Lawsuit Against Eli Lilly Over Patents for Migraine Drug: “Teva Pharmaceuticals has filed a new patent infringement complaint against Eli Lilly over competing migraine drugs.
Teva’s latest suit in an ongoing battle with Eli Lilly came just hours after the U.S. Patent and Trademark Office issued two new patents on Teva’s migraine drug, Ajovy (fremanezumabin).”

Divisive Drug Patent Proposal From Trump Era Is on Biden Agenda: “The Biden administration is forging ahead with a divisive, Trump-era regulatory proposal that would limit the government’s ability to control prices on drugs developed from federally funded research.
The National Institute of Standards and Technology set an October deadline to update the Bayh-Dole Act, the 1980 law that enables universities to retain patent rights on inventions discovered from government-funded research. The proposal would clarify the law—which allows the government to step in and license federally funded inventions to third parties in certain circumstances—can’t be exercised by an agency primarily to lower costs.
The government has consistently rebuffed calls to use “march-in rights” to control the price of certain medicines. But pressure to do so has mounted during the pandemic, with lawmakers and activists urging the Biden administration to seize control of Covid-19 treatments to ensure more widespread availability.”

Association of California’s Prescription Drug Coupon Ban With Generic Drug Use: “Drug manufacturers sometimes offer co-payment coupons to offset patient out-of-pocket costs. Although coupons can help patients afford necessary medications, they increase overall drug spending by encouraging use of expensive brand-name drugs over less expensive generics. Coupons are prohibited by Medicare and Medicaid, but they are available for commercially insured patients. Several states are considering restricting coupon use to promote generic substitution and control drug spending. In October 2017, California passed a law that banned use of co-payment coupons for brand-name drugs once interchangeable generic versions of those products have become available…
[The law] banning use of co-payment coupons for brand-name drugs with direct generic competitors was associated with no significant increase in generic substitution in its first year.”

About healthcare devices

Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices: “Following the company update on April 26, 2021, Royal Philips… provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.” The foam can degrade into a carcinogen.

Do Magnets in Consumer Electronics Disable Implanted Medical Devices?: “‘We believe the risk to patients is low and the agency is not aware of any adverse events associated with this issue at this time,’ Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. Yet as more products containing strong magnets are expected to come on the market, the agency offered precautions for consumers who have implanted devices including pacemakers and implantable defibrillators.”

About health insurance

AMERICAN RESCUE PLAN IMPACT: MORE THAN 1M CONSUMERS PAY LESS THAN $10 PER MONTH: “The Centers for Medicare & Medicaid Services (CMS) released a report Monday morning that found more than 1 million consumers have coverage through HealthCare.gov that costs $10 or less per month.
The findings underscore the financial impact of the advance payments of premium tax credits (APTC) introduced through the American Rescue Plan (ARP), which President Joe Biden signed into law in March.”

Humana to acquire onehome in bid to expand value-based home care: “Humana will acquire One Homecare Solutions, or onehome, in a bid to grow its value-based home healthcare offerings…
The home health company has provided care to Humana members since 2015 and has pioneered a value-based model in both Texas and Florida.”

Centene to pay more than $140M to settle Medicaid overpayment allegations in Ohio, Mississippi: “Centene will pay $143 million to settle allegations from attorneys general in two states that a pharmacy benefit manager subsidiary misrepresented costs to obtain Medicaid overpayments.”


About hospitals and health systems

Hospitals held for ransom by flood of robocalls: 5 details: “Robocalls are the No. 1 consumer complaint filed with the Federal Communications Commission, and robocalls to hospitals are a significant portion of the problem, creating a new type of ransomware attack on hospitals and a threat to public safety.
The illegal calls flood hospital networks and are often perpetuating fraud. The nonstop flow of calls undermines hospitals' ability to perform patient care by keeping staff on phone lines unnecessarily and impairing operational capacity, according to a June 11 FCC news release.

How America’s top hospitals hound patients with predatory billing: A really good investigative piece in Axios. Some highlights:
—”Just 10 hospitals are responsible for 97% of court actions against patients” By far, the most actions are by VCU Medical Center in Richmond, VA
—”The top 100 hospitals, on average, charged patients 7x the cost of service, with markup calculated from the American Hospital Directory's cost-to-charge ratio. And private, for-profit hospitals average nearly a 12x markup.”
Check the Figures as well.

Best Children’s Hospitals by Specialty: From US News.

Early Hospital Compliance With Federal Requirements for Price Transparency: “As of March 2021, a small proportion of US hospitals were compliant with the major requirements of the new federal rule requiring disclosure of negotiated prices. Hospitals exhibited selectively higher compliance with the requirement of a price estimator for patients to view personalized out-of-pocket costs for shoppable services; a smaller proportion made their data fully accessible to the public by posting a machine-readable file with payer-specific negotiated rates.
Selective compliance was especially pronounced for the 100 highest-revenue hospitals, a low proportion of which fully disclosed their negotiated rates despite high compliance with the price estimator tool requirement.”

California lawmakers blast HCA-owned hospital, allege dangerous staffing levels, hostile management: “The letter, signed by state Sen. Dave Cortese, Assemblyman Ash Kalra and Assemblyman Alex Lee, accuses Good Samaritan of having dangerous staffing levels despite its parent company reporting a $3.7 billion profit last year.”

About healthcare IT

Health Union Acquires WEGO Health: From the press release: “ Health Union, the leader in building online health solutions for people living with chronic conditions, today announced that it has acquired WEGO Health, the world's largest network of patient leaders - advocates, community leaders, creators and influencers. Combining Health Union's targeted scale and depth in the condition experience with WEGO Health's breadth of patient leaders in nearly all health conditions, Health Union aims to change the face of social health, connecting people in meaningful and innovative ways.”



Today's News and Commentary

This issue is #600!
Thanks to all the readers from around the world for your support.

About Covid-19

Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial: This piece is a company press release. The two-shot vaccine is not FDA approved, even for emergency use. The protection is due to immunity derived from injection of a modified spike protein, rather than injection of the coding (mRNA) to produce the spike protein.
”—93% efficacy against predominantly circulating Variants of Concern and Variants of Interest
—91% efficacy in high-risk populations
—100% efficacy against variants ‘not considered Variants of Concern/Interest’
—All COVID-19 hospitalizations/death occurred in the placebo group”

A dangerous Covid-19 variant on the rise could cause outbreaks in US states with lower vaccination rates, expert says: “Currently 10% of Covid-19 infections in the US can be attributed to the variant, also called the B.1.617.2 variant, but that proportion is doubling every two weeks, said Scott Gottlieb, a former commissioner of the US Food and Drug Administration, said in a CBS interview Sunday.
He added that it probably will become the dominant strain in the US.”
Current vaccines offer good protection against this strain, also known as delta; obviously it is a problem for those who are not vaccinated. In a related article:
G7 leaders commit to plan to tackle next global health crisis: “The rise of the Delta variant has put more pressure on G7 leaders to address the global gap in COVID-19 vaccinations. Public health officials in Britain have said that two shots of vaccine were still highly effective against the Delta variant, especially in preventing severe illness. However, only a fraction of people in developing countries have had even one shot, leaving ample opportunity for the variant to spread, especially as countries begin to ease lockdown measures…
During their meeting in Carbis Bay, England, the G7 leaders — from Canada, Britain, the United States, France, Germany, Italy and Japan — agreed on a plan to cut the time it takes to develop vaccines and to bolster global surveillance networks to track viruses. The G7 has also committed to donating more than one billion doses of vaccine to low-income countries over the next year.”

AMA survey shows over 96% of doctors fully vaccinated against COVID-19: FYI

Judge dismisses lawsuit filed by Houston hospital system employees who refused coronavirus vaccine: The complaint, filed last month, argued that the mandate is unlawful and forces “employees to be human ‘guinea pigs’ as a condition for continued employment.” The real crux of these protests is that the vaccines are only approved for emergency use. When the FDA gives them full approval, the cases for refusal will greatly diminish.

UK insurers pay out over £750m in business interruption claims: The reason for bringing this article to your attention is to contrast the UK with the US, where many insurers are refusing to pay for such claims.

About healthcare IT

Biden Orders Software Developers to List Third-Party Components: “To improve the security of the software supply chain, the administration is introducing a Software Bill of Materials that will require a formal record of the sources of all components used in developing software.”

Personalized machine learning [ML} of depressed mood using wearables: Wearables have been touted for detection of physical illnesses like atrial fibrillation or diabetes-related problems. This article demonstrates their use to detect parameters associated with depression.
The authors found ”distinct feature determinants of depression over time for each person ranging from co-morbid anxiety, to physical exercise, diet, momentary stress and breathing performance, sleep times, and neurocognition. In future, these personalized features can serve as targets for a personalized ML-guided, multimodal treatment strategy for depression.”

Astronomy meets pathology to identify predictive biomarkers for cancer immunotherapy: “A new platform, called AstroPath, melds astronomic image analysis and mapping with pathology specimens to analyze microscopic images of tumors.” The article provides a good explanation of how the algorithm works.

Doctor on Call? Lawmakers Debate How Much to Pay for Phone Appointments: A good discussion of this issue, with a special focus on California.

About health insurance

Primary care group buys Miami's University Health Care for $600M: “Cano Health, a primary care provider for seniors and underserved communities, acquired Miami-based University Health Care for $600 million, the organization said June 14. 
The deal, financed through cash on hand and a common equity issued to University's shareholders, includes $540 million in cash and $60 million in equity. 
Cano Health, backed by billionaire Barry Sternlicht, operates value-based primary care centers and supports affiliated medical practices that support primary care for seniors in Florida, Texas, Nevada and Puerto Rico. University Health Care has been providing comprehensive primary care in Florida for 25 years.”
The acquisition was to increase Cano’s Medicare Advantage business.

About pharma

Investor behind Moderna raises $3.4bn biotech-focused fund: “Flagship Pioneering, the venture capital company behind Moderna, has raised its largest fund as it aims to build the next generation of biotech companies. The $3.4bn fund is one of the biggest amassed in the pharmaceutical industry and comes at a time when investment is flooding into the sector, fuelled by the numerous early-stage companies racing to make treatments and vaccines to tackle Covid-19…
Rather than hunting for existing early-stage biotechs to finance, the Massachusetts-based group invests in developing technologies and establishing companies within its own four walls. Teams are built around specific areas of interest with the aim of spinning out to form individual companies as the research develops.”



Today's News and Commentary

About diagnostics

Grail launches long-awaited Galleri blood test, its groundbreaking multi-cancer screening diagnostic: “Designed to trace back the original organ location of as many as 50 different cancers by decoding fragments of tumor DNA found in the bloodstream, Galleri could be Illumina's ticket to a deep foothold in the clinical testing market. The company has estimated the test could help screen as many as 50 million people after its initial debut, before Grail pursues a full FDA approval in 2023.”

Oxford spinout spies the hidden mechanics of DNA and disease with single-pair resolution method: “Nucleome Therapeutics is working on a method known as micro-capture-C, or MCC, to provide a three-dimensional view of the famously twisting double-helix structure, with the ability to zoom in on individual base pairs…
Its latest work on 3D genome mapping was published this week in Nature.

About health insurance

UnitedHealthcare delays ER coverage policy amid provider backlash: “Amid significant backlash from providers, UnitedHealthcare is delaying its new emergency department coverage policy, which would allow the insurer to retroactively deny ED claims it determines are nonemergent.”

Social Determinants of Health [SDoH] Geographic Variation in Medicare per Beneficiary Spending: “In this cross-sectional study, SDoH were associated with 37.7% of variation in price-adjusted Medicare per beneficiary spending between counties in the highest and lowest quintiles of spending in 2017, including both direct contributions and indirect contributions through other factors. SDoH’s direct contribution accounted for 5.8% of the variation after controlling for patient demographic characteristics, clinical risk, and supply of health care resources.
 These findings suggest that addressing SDoH is important for reducing geographic spending variation and improving the value of health care.”

About healthcare IT

Amazon Care has inked deals with multiple companies for telehealth services, executive says: “Amazon has signed on multiple employers to its healthcare service, called Amazon Care, as part of the national expansion of its virtual health service benefit…
The service offers virtual visits, in-person primary care visits at patients' homes or offices and prescription delivery. The on-demand healthcare service enables employees to connect with medical professionals via chat or video conference, typically in less than 60 seconds, and eliminates lengthy wait and travel times to get medical attention, according to Amazon executives…
The service also can deliver medications to users within 120 minutes…”

Meet the ransomware gang behind 235 attacks on US hospitals: 7 things to know: A good summary of this growing problem.

About Covid-19

Coronavirus deaths this year surpass 2020 total: “The coronavirus pandemic has already killed more people this year than in all of 2020, according to a Wall Street Journal analysis of data collected by Johns Hopkins University.
The newspaper found that about 1.883 million people have died from the virus in 2021, compared with 1.88 million last year.”

FDA accuses company of distributing unapproved Covid test and using falsified data: “The Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test, accusing the company that makes the tests of distributing them without regulatory approval and using falsified data that inflates their performance.
The agency announced a ‘Class 1 recall’ — its most serious type, indicating that use of the tests may cause serious injuries or death — and fired off a warning letter to Innova Medical Group of Pasadena, Calif., saying an FDA investigation revealed serious problems in the company’s data, but also in its making unapproved rapid tests available to consumers in the United States.”

Chinese researchers find batch of new coronaviruses in bats: “According to the researchers, their discoveries in a single, small region of Yunnan province, southwestern China show just how many coronaviruses there are in bats and how many have the potential to spread to people…
‘In total, we assembled 24 novel coronavirus genomes from different bat species, including four SARS-CoV-2 like coronaviruses,’ the researchers wrote in a report published in the journal Cell.

Community-level evidence for SARS-CoV-2 vaccine protection of unvaccinated individuals: ”On average, for each 20 percentage points of individuals who are vaccinated in a given population, the positive test fraction for the unvaccinated population decreased approximately twofold. These results provide observational evidence that vaccination not only protects individuals who have been vaccinated but also provides cross-protection to unvaccinated individuals in the community.”

The F.D.A. tells Johnson & Johnson that about 60 million doses made at troubled plant cannot be used: “Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation.”

About pharma

Third member of U.S. FDA advisory panel resigns over Alzheimer’s drug approval: “Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel.
’My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees ... because I didn’t think that the firm recommendations from the committee in this case ... were appropriately integrated into the decision-making process,’ Kesselheim said in an email…
On Tuesday, a member of the advisory group who voted against the approval, Washington University neurologist Dr. Joel Perlmutter, resigned from the committee, citing the FDA's approval of Aduhelm.
Mayo Clinic neurologist Dr. David Knopman said he resigned on Wednesday.”

FDA approves omadacycline for treatment of community-acquired bacterial pneumonia: “Omadacycline (Nuzyra, Paratek Pharmaceuticals) is a novel antibiotic with once-daily oral and IV formulations for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. The once-daily oral-only dose has an initial dose of 300 mg twice on the first day followed by 300 mg once daily for 7 to 14 days, according to the release…
Omadacycline is a modernized tetracycline designed to overcome tetracycline resistance and exhibit activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative and atypicals including other drug-resistant strains, according to the release.” And in two related articles:
WHO reveals new global antibiotic resistance data, more concerns: “The WHO's fourth Global Antimicrobial Resistance and Use Surveillance System (GLASS) Report includes information on more than 3 million laboratory-confirmed bacterial infections caused by pathogens of concern in 70 countries in 2019. That's more than a sixfold increase in the number of infections reported to GLASS when sites first began reporting AMR surveillance data in 2017.
Although WHO officials caution that the data are limited and more research is required to draw firm conclusions, among the findings are high rates of resistance in common pathogens to first-line antibiotics used to treat urinary tract infections (UTIs) and extremely high resistance to last-resort antibiotics in some healthcare-associated pathogens.”
Making drug-resistant bacteria susceptible to antibiotics: “When exposed to antibiotics, some bacteria switch to a dormant state to survive in a process that’s mediated by the production of the molecule hydrogen sulfide (H2S). The NYU team previously showed that this mechanism is present in a wide variety of bacterial species, including Staphylococcus aureus and Pseudomonas aeruginosa, which have produced many multidrug-resistant strains. Previous studies have shown that genetic disruption of H2S could sensitize these pathogens to antibiotics and to the host immune response.”

Bayer pledges $300M to boost production in world's 'contraceptive capital’: “The company has designs on a €250 million ($303 million) investment for a new production plant in Turku, Finland, which it's pegged to become "one of the most modern" factories in the world thanks to its heavy use of automation and robotics…”

About the public’s health

'Miraculous' mosquito hack cuts dengue by 77%: A novel strategy: “The trial used mosquitoes infected with Wolbachia bacteria…
Wolbachia doesn't harm the mosquito, but it camps out in the same parts of its body that the dengue virus needs to get into. 
The bacteria compete for resources and make it much harder for dengue virus to replicate, so the mosquito is less likely to cause an infection when it bites again…
Wolbachia are also spectacularly manipulative and can alter the fertility of their hosts to ensure they are passed on to the next generation of mosquitoes. 
It means once Wolbachia has been established, it should stick around for a long time and continue to protect against dengue infection.”

CDC warns about spike in RSV cases across South: The CDC issued a Health Advisory Network warning to doctors and other health care providers to be on alert for the virus, which can cause pneumonia, especially in very small children and babies.”

About healthcare professionals

The Complexities of Physician Supply and Demand: Projections From 2019 to 2034: From the AAMC: “By 2034, we project:

  •   A shortage of primary care physicians of between 17,800 and 48,000.

  •   A shortage across the non- primary care specialties of between 21,000 and 77,100 physicians.”

Today's News and Commentary

About health insurance

CMS Increases Medicare Payments for At-Home COVID-19 Vaccinations: ”Prior to this announcement, at-home vaccine administration warranted a $40 reimbursement for providers per dose; providers will now receive $75 per dose, or $150 for a two-dose vaccine. The increase in payment covers any costs associated with at-home vaccinations and accounts for the time a provider needs to monitor the beneficiary after the shot. The payment rates will be adjusted geographically…
Difficulty with vaccine storage temperatures and travel make administering at-home vaccines a significant challenge for many providers. In conjunction with CMS’ announcement, the Centers for Disease Control and Prevention (CDC) released guidelines for providers who are administering at-home vaccines.”

Nevada becomes 2nd state with ‘public option’ insurance law: “The new law requires insurers that bid to cover Medicaid recipients and state employees to also bid to offer a so-called public option plan. State officials would select certain providers to be in-network for the public option plan and mandate that they charge 5% less in monthly premiums than the average plan on the state insurance marketplace created by the Affordable Care Act and 15% less four years after it is first offered.” And in a related article:
New health insurance plan aimed at cutting costs is headed to Colorado governor’s desk: “Under the bill, the state will require insurers to offer the Colorado Health Benefit Option by Jan. 1, 2023, in all 64 counties. It’ll be available for the individual and small group marketplaces, which cover about 15% of Coloradans, and by 2025, its premiums will have to be 15% less than the rates insurers offered in 2021 (adjusted for medical inflation). It will also set benchmarks for the types of care covered under the plan, including pediatric care and other essential benefits.”

About the public’s health

Tobacco Use Prevalence and Transitions From 2013 to 2018 Among Adults With a History of Cardiovascular Disease: “Among adults with CVD who are current tobacco users, the most commonly used product was cigarettes (82.8%), followed by any type of cigar (23.7%), and e‐cigarette use (23.3%). E‐cigarette use without concurrent cigarette use among participants with prevalent CVD was uncommon (1.1%).Factors associated with tobacco use were younger age, male sex, had lower education level, and lack of knowledge about the association between smoking and CVD…
Despite known harmful cardiovascular effects, over one fourth of adults with prevalent CVD use tobacco products and few quit smoking over the 4 waves of the PATH [Population Assessment of Tobacco and Health] set.”

Effect of Matching Therapists to Patients vs Assignment as Usual on Adult Psychotherapy Outcomes Albert Schweitzer allegedly said that medicine is not only a science but also the art of letting our own individuality interact with the individuality of the patient. “In this study, mental health care was enhanced by prospectively assigning patients to empirically good-fitting therapists, which requires minimal disruptions within a mental health care system.”

About Covid-19

The COVID lab-leak hypothesis: what scientists do and don’t know: From Nature, this article is the best one I have read about the lab-leak hypothesis.

Latest Data on COVID-19 Vaccinations Race/Ethnicity: “These recent trends suggest a narrowing of racial gaps in vaccinations at the national level, particularly for Hispanic people, who have recently received a larger share of vaccinations compared to their share of the total population (28% vs. 17%). While these data provide helpful insights at a national level, to date, CDC is not publicly reporting state-level data on the racial/ethnic composition of people vaccinated.”

Immunogenicity of Ad26.COV2.S vaccine [J&J vaccine]against SARS-CoV-2 variants in humans: ”These data show that neutralizing antibody responses induced by Ad26.COV2.S were reduced against the B.1.351 and P.1 variants, but functional non-neutralizing antibody responses and T cell responses were largely preserved against SARS-CoV-2 variants. These findings have implications for vaccine protection against SARS-CoV-2 variants of concern.”

U.S. signs $1.2 bln deal for 1.7 mln courses of Merck's experimental COVID-19 drug: “Merck & Co Inc said on Wednesday the U.S. government has agreed to pay about $1.2 billion for 1.7 million courses of its experimental COVID-19 treatment, if it is proven to work in an ongoing large trial and authorized by U.S. regulators.
The oral antiviral treatment, molnupiravir, aims to stop COVID-19 from progressing and can be given early in the course of the disease, similar to Tamiflu to treat influenza.
The treatment course being tested in the trial is an oral dose given every 12 hours for five days.”

FDA's vaccine advisers to discuss rules for authorizing Covid-19 shots for kids: “Vaccine advisers to the US Food and Drug Administration will meet [today] to discuss what information the agency should ask for in considering the go-ahead for vaccinating children under 12 -- including how many children need to be enrolled in clinical trials and how much safety data will be needed.
Members of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will not be asked to discuss specific vaccines or to vote on any issues, but instead will weigh in on what specific extra information companies will have to provide in seeking authorization or approval for children.”

Coronavirus: US has distributed $395bn in stimulus payments since March, IRS says: FYI

Prime Day deal? Amazon lands FDA go-ahead to sell COVID-19 tests directly to consumers: “The FDA’s emergency use authorization allows the retail giant’s subsidiary STS Lab Holdco to sell its Amazon Real-Time RT-PCR test kits to anyone 18 years or older without requiring buyers to obtain a prescription or show proof of any COVID symptoms or recent contact with the virus.
The EUA also allows for pooled testing, in which up to five individual samples may be combined and tested at the same time, exponentially increasing the reach of Amazon’s lab resources.
After each nasal swab kit is sent to one of Amazon’s processing labs using the included prepaid shipping label, users will receive notifications via text message and email once their test results are ready. The results can then be accessed through an online portal located at AmazonDx.com…”

DOL Issues Long-Awaited COVID-19 Safety Rule: “The ETS [Emergency Temporary Standard] issued by OSHA, the DOL's workplace safety arm, will require employers in the health care sector to maintain social distancing protocols, make sure that patients are properly screened for virus symptoms and give workers paid time off to get vaccinated and recover from vaccine side effects as encouragement to get the shot. The ETS includes a carve-out for certain workplaces where all workers are fully vaccinated and people who may have COVID-19 are barred.
OSHA also issued a series of voluntary guidelines for employers that operate outside of the health care context to protect unvaccinated workers, particularly industries like meatpacking and high-volume retail where close contact between people is common.”

Meet the influencers making millions by dealing doubt about the coronavirus vaccines.: A great expose’ about who is making money by spreading misinformation about vaccines.

Moderna files for FDA authorization of its COVID-19 vaccine for adolescents: “Moderna said June 10 it has requested emergency use authorization from the FDA for its COVID-19 vaccine for use in children ages 12 to 17. 
The drugmaker already filed for approval for the age group in Canada and Europe.”

Federal agencies can lift caps on number of employees working on-site, Biden administration announces: “The Biden administration Thursday told federal agencies that they no longer have to limit the number of employees allowed in the workplace, but kept in place an expansive telework policy that was instituted during the coronavirus pandemic, an approach that could slow the return to federal buildings.
The long-awaited guidance, the first major announcement on pandemic staffing the administration has issued since January, reversed a previous 25 percent cap on capacity inside federal offices.”

Johnson & Johnson's COVID-19 vaccine scores longer shelf life just as millions of doses were set to expire: “The U.S. FDA has extended the shelf life for J&J’s single-shot vaccine from three months to four and a half, the drugmaker said Thursday. The agency based its decision on ongoing stability studies that found the vaccine could last longer when kept at refrigerated temperatures.”

About pharma

35 top over-the-counter health products recommended by pharmacists: FYI

Pharma funded more than 2,400 state lawmaker campaigns in 2020, new STAT analysis finds: “In the last two years, at least 2,467 state legislators — over one-third of all state lawmakers nationwide — used pharmaceutical industry cash to fund their campaigns, according to a new STAT analysis of campaign finance records that spans the full 2020 election cycle. The industry wrote over 10,000 individual checks totaling more than $9 million.”
If you look at the interactive map, many of the donations were a few hundred dollars. But some state legislatures had overwhelming percentages of recipients of such funds.

About healthcare devices

Facebook plans first smartwatch for next summer with two cameras, heart rate monitor: “Facebook is taking a novel approach to its first smartwatch, which the company hasn’t confirmed publicly but currently plans to debut next summer. The device will feature a display with two cameras that can be detached from the wrist for taking pictures and videos that can be shared across Facebook’s suite of apps, including Instagram…”

As more devices come on the market, it is a good opportunity to review the International Medical Device Regulators Forum Strategic Plan 2021 - 2025: “While technology has opened up opportunities to incorporate new features and functionalities in modern medical devices to enhance their performance, it has also posed additional regulatory challenges such as:

  • accessibility,

  • cybersecurity,

  • interoperability,

  • data integrity, and

  • data security etc…

Personalised medical devices that deliver targeted or patient specific therapy for better clinical outcomes are gaining popularity. Personalised treatments including:

  • personalised digital therapies (e.g. cognitive behaviour therapy software for treatment of insomnia) and

  • personalised implants (e.g. orthopaedic implant designed and manufactured to fit an individual patient’s anatomy)

These necessitate additional considerations to traditional clinical evaluation requirements and clinical study designs. “

About hospitals and health systems

Rural hospitals may get paid to become standalone ERs:”Rural hospitals that close inpatient beds and revamp as standalone emergency rooms may receive more funding under a proposal buried in the almost 6,000-page stimulus act signed late last year..
The measure included in the act, sponsored by Sen. Chuck Grassley, R-Iowa, calls for these rural hospitals to revamp their service offerings to obtain the rural emergency hospital designation. Hospitals that obtain this designation will receive more funding.
Rural hospitals with fewer than 50 beds can apply for the designation, which takes effect in 2023.”

About healthcare IT

Announcing Avaneer Health: Accelerating Healthcare Delivery and Powering the Next Generation of Care Experiences: See if you agree with this assessment: Reading this press announcement is like going through a thesaurus of business buzz words without understanding what the product is. This statement is as close as it gets to an explanation: “Avaneer Health is a member-based, secure and open network supporting utilities developed for and by the healthcare industry.” The owners include “Aetna, Anthem, Cigna, Cleveland Clinic, HCSC, IBM, The PNC Financial Services Group, Inc. and Sentara Healthcare. Avaneer Health incorporated in 2020 as the Health Utility Network, Inc. and is now known as Avaneer Health.”

Mayo joins $32M funding round to boost cybersecurity of healthcare communication platform: “Nuvolo, a cloud-based workplace communication platform, secured $32 million to improve its cybersecurity technologies, the company announced June 9. 
Rochester, Minn.-based Mayo Clinic is the latest company to join the series C financing round, investing $1 million to support Nuvolo's cybersecurity developments.”

Today's News and Commentary

Medical cost trend: Behind the numbers 2022: “PwC's Health Research Institute (HRI) is projecting a 6.5% medical cost trend in 2022, slightly lower than the 7% medical cost trend in 2021 and slightly higher than it was between 2016 and 2020. Healthcare spending is expected to return to pre-pandemic baselines with some adjustments to account for the pandemic’s persistent effects.”

About the public’s health

Political Declaration on HIV and AIDS: Ending Inequalities and Getting on Track to End AIDS by 2030: From UNAIDS: “The political declaration calls on countries to provide 95% of all people at risk of acquiring HIV within all epidemiologically relevant groups, age groups and geographic settings with access to people-centred and effective HIV combination prevention options. It also calls on countries to ensure that 95% of people living with HIV know their HIV status, 95% of people who know their status to be on HIV treatment and 95% of people on HIV treatment to be virally suppressed.”

Women Now Drink As Much As Men - Not So Much For Pleasure, But To Cope: “For nearly a century, women have been closing the gender gap in alcohol consumption, binge-drinking and alcohol use disorder. What was previously a 3-1 ratio for risky drinking habits in men versus women is closer
to 1-to-1
 globally, a 2016 analysis of several dozen studies suggested.
And the latest U.S. data from 2019 shows that women in their teens and early 20s reported drinking and getting drunk at higher rates than their male peers — in some cases for the first time since researchers began measuring such behavior.
This trend parallels the rise in mental health concerns among young women, and researchers worry that the long-term effects of the COVID-19 pandemic could amplify both patterns.”

About pharma

Walmart launching drug discount offering in membership program: “Walmart is rolling out a new prescription savings offering as part of its membership program, Walmart+.
Walmart+ is the retail giant's equivalent to Amazon Prime, for a $98 annual fee members can gain access to free shipping for delivery orders as well as gas discounts and other benefits. Now, members can look up their medications to secure discounts, with thousands of drug products at $0 or up to 85% off.
The program works in lieu of insurance. If a member would save more on the medication through the Walmart+ discount card, they will instead pay that price, according to the announcement. Eligible prescriptions can also be submitted electronically by providers, Walmart said.”

FDA okays Pfizer's Prevnar 20 pneumococcal conjugate vaccine:FYI

AbbVie's Botox rolls out the red carpet for real people in new documentary-style ads: Look at the video ads in the article; do you think they are effective?

About Covid-19

Pfizer to test Covid vaccine in larger group of children below 12: “Pfizer said on Tuesday it will begin testing its Covid-19 vaccine in a bigger group of children under age 12 after selecting a lower dose of the shot in an earlier stage of the trial.
The study will enroll up to 4,500 children at more than 90 clinical sites in the United States, Finland, Poland and Spain, the company said.”

Lives and Costs Saved by Expanding and Expediting COVID-19 Vaccination: “When achieving a given vaccination coverage in 270 days (70% vaccine efficacy), every 1% increase in coverage can avert an average of 876,800 (217,000–2,398,000) cases, varying with the number of people already vaccinated. For example, each 1% increase between 40%-50% coverage can prevent 1.5million cases, 56,240 hospitalizations, 6,660 deaths, gain 77,590 QALYs, save $602.8 million in direct medical costs and $1.3 billion in productivity losses .”

Pentagon closing majority of COVID-19 mass vaccination sites:”The Pentagon by the end of Tuesday will shutter all but five of the COVID-19 mass vaccination sites it opened alongside the Federal Emergency Management Agency (FEMA) as the demand for the shot slows, according to the Department of Defense’s (DOD) top spokesman.
Earlier this year, as many as 35 mass vaccination sites were operated by thousands of active-duty and National Guard troops, but the number has since dropped to eight, with three of those locations to close by Tuesday’s end, Pentagon press secretary John Kirby told reporters.“

About healthcare IT

Datavant, Ciox Health ink $7B deal for wide-ranging access to medical research data: “With the goal of making data a facet of every healthcare decision—and spinning that information back into life science research—Datavant and the medical records platform developer Ciox Health, plus their VC backers, have agreed to lay out $7 billion to combine their enterprises. 
The deal promises to expand Datavant's reach to thousands of U.S. clinics. The resulting company plans to offer a joint technology ecosystem that brings disparate health records together and allow for secure, anonymous exchanges among patients, providers and biopharma companies alike.
It's the largest transaction by far among recent deals in the space, which focuses in part on de-identifying patient data so researchers can easily—and legally—use it.”
Here are summaries of the large number of deals that took place in this sector last month.

Humana sued over wrongful records access data breach: 7 details: “Louisville, Ky.-based Humana is being sued over a data breach last fall that exposed the personal information of about 65,000 of its health plan members, according to court documents.”

Top 20 smart hospitals in the world, ranked by Newsweek: Mayo Clinic leads the list.


Today's News and Commentary

Biden Admin Replaces 'Mothers' With 'Birthing People' in Maternal Health Guidance: “‘The United States has the highest maternal mortality rate among developed nations, with an unacceptably high mortality rate for Black, American Indian/Alaska Native, and other women of color. To help end this high rate of maternal mortality and race-based disparities in outcomes among birthing people [emphasis added],’ reads the 2022 White House fiscal year budget proposal…
The pro-choice nonprofit NARAL defended use of the term, tweeting, ‘When we talk about birthing people, we're being inclusive. It's that simple. We use gender neutral language when talking about pregnancy, because it's not just cis-gender women that can get pregnant and give birth. Reproductive freedom is for *every* body.’ "
It is a complex issue. Additionally, not all mothers have given birth (e.g., Kamala Harris). But I doubt the reason for the change was linguistic precision. Are there any liberals who will push back on this change?

About pharma

The big health story the news continues to be the approval yesterday of Biogen’s Alzheimer’s drug. The Fierce website has several good articles that summarize the issues around this controversial decision:
Biogen's shockingly broad Aduhelm label—and $56K price—set up a $10B launch, analysts say: “Biogen didn't just win the most closely watched FDA green light of the year. Its newly minted Alzheimer's disease drug, Aduhelm, snared an approval that covers all Alzheimer's patients, not just a select group of them, meaning millions could be eligible.
And it set an aggressive price tag, in the words of one analyst, that's several times higher than market watchers had predicted—roughly $56,000 for the average patient.The upshot? Some $10 billion in peak sales, analysts say. And ‘one of the biggest launches in biopharma history.’”
Ready, set, prescribe? Doctors detail why they'll deploy Biogen's new Alzheimer's drug—or not: “So why would most physicians plow ahead? Because the reality in the neurology, gerontology and even primary care practices where Alzheimer’s patients are treated is that Aduhelm is the now the only drug approved to target the underlying disease process…
Then there's the practical matter of administration: Only about 600 medical centers are able to treat at launch. Those are key considerations in what is expected to be a long runway toward establishing Aduhelm use in practice.
And of course, not all clinicians and researchers agree with the FDA nod for use with any group of patients…
Neither of Biogen’s phase 3 trials completed; the potential benefits are small and come at a high price; and the risks are high, with one-third of patients having developed swelling in the brain.”
FDA's 'intellectually insulting' aducanumab decision opens up a regulatory foothold for leading competitors: “Many analysts and industry watchers spent the hours after the FDA announcement opining about what Biogen's triumph meant for everyone else—and whether the new standard set by the FDA was a good one.
Aducanumab was submitted on data from a pair of conflicting trials that spurred an FDA advisory panel to give the medicine a thumbs-down in November. Patients in one trial saw a modest improvement in dementia symptoms, while the other study showed patients taking aducanumab actually fared worse than those on placebo.
Rather than approve the controversial therapy outright, the FDA opted to give a tentative green light under its accelerated approval pathway, which is for drugs that could provide meaningful benefit over existing treatments for a serious or life-threatening disease. Data to support these approvals can be based on a surrogate endpoint.”
Biogen unveils collaborations with CVS Health, Cigna to boost access to its Alzheimer's drug: “The pharmaceutical company is teaming with CVS Health to launch a new program on brain health, highlighting the importance of screenings and disease education. Screenings will be made available through CVS' Project Health program, which focuses on minority and underserved communities.
The testing will be made available in select markets including Atlanta, Philadelphia, New York City and the District of Columbia beginning in September…
Cigna is the parent company of Express Scripts, the largest pharmacy benefit manager in the U.S. Through the agreement, the insurer and drugmaker will streamline the process of getting patients access to the drug while monitoring the effectiveness against several patient outcome metrics.”
Costly New Alzheimer Disease Medications on the Horizon—Financing Alternatives for Medicare: This article is from last September and is an analysis of projected costs of Aducanumab.
”A simple, informal calculation, which assumes a minimum aducanumab market of 5 million (2 million people with mild AD and 3 million people with MCI, both with amyloid plaque burden), modest uptake of 50%, and a pricing estimate of $40 000 annually, yields direct costs of around $100 billion per year.” The actual price is $57,000. Other costs, such as diagnostics and treatment of complications, can be added to the total. I have not seen a good analysis of savings from using the drug, such as delays in institutional care and complications of Alzheimer’s disease.

Bayer's billon-dollar Parkinson's disease bets land in the clinic: “The first dose of DA01, which the German Big Pharma refers to as pluripotent stem cell-derived dopaminergic neurons, was given out in a phase 1 test through its biotech subsidiary, BlueRock Therapeutics.
Bayer has also kicked off a gene therapy trial in Parkinson’s disease, this time through Asklepios BioPharmaceutical, an adeno-associated virus (AAV) gene therapy unit also known as AskBio. That trial is a phase 1b.”

After COVID-19 spotlighted supply chain weaknesses, Biden unveils plan to resurrect U.S. drug manufacturing: “Under the plan, the White House is establishing a public-private partnership to select 50 to 100 essential medicines ‘to be the focus of an enhanced onshoring effort,’ the plan says. Further, the government is committing around $60 million to research new technologies to boost domestic API [active pharmaceutical ingredient] production.”
The blueprint follows a February executive order demanding a multi-industry review of key American supply chains. The fact that much of America’s drug production is based overseas isn’t exactly news, but the pandemic put those problems into sharp relief.”

Biosimilars And Follow-On Products In The United States: Adoption, Prices, And Users: “Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the US and worldwide…Using monthly sales data from the period 2005–19 for ten drug classes, we examine how quickly biosimilars/follow-on products gained market share and the subsequent trajectory of prevailing (national average invoice) prices. Our analysis suggests that although uptake has been slower than what is typically seen in generic drug markets, the most recent entrants have captured market share more rapidly than comparable earlier biosimilars/follow-on products. We also document that from biosimilar/follow-on products’ time of entry, their lower prices help offset the overall trend in average annual reference-product price increases.”

About health insurance

Where Does Your Health Care Dollar Go?: The latest breakdown from AHIP of how the premium dollar is spent. The largest single portion is $0.21 for pharmaceuticals. It should be noted that these percentages differ from those for national health expenditures. See: National Health Expenditures, 2019: Steady Spending Growth Despite Increases in Personal Health Care Expenditures in Advance of the Pandemic: Published by the AMA in May. For example, see Exhibit 1 on Page 13.

Medicaid is a hassle for doctors. That’s hurting patients: “A recent study by researchers from the US Bureau of Economic Analysis, the University of Chicago, and the Federal Reserve Bank in San Francisco found providers run into more obstacles when trying to bill Medicaid than they do with other insurers, and that these administrative hurdles explain the access problems experienced by Medicaid patients as much as the program’s payment rates.”
Medicaid pays little and late. Not news. Question is what is being done to correct the problem. Some states’ pay parity initiatives would be a temporary fix until/if federal conditions of participation mandate it.

About Covid-19

Spread of Misinformation About Face Masks and COVID-19 by Automated Software on Facebook: “Scientific journals are easy targets of automated software. Possible approaches to prevent misinformation due to dissemination of articles by automated software include legislation that penalizes those behind automation; greater enforcement of rules by social media companies to prohibit automation; and counter-campaigns by health experts.”

“Nanotraps” Designed to Capture and Clear SARS-CoV-2: “An interdisciplinary team led by University of Chicago researchers is designing biodegradable nanomedicines to capture and clear the novel coronavirus. The ‘nanotraps’ are dotted with angiotensin-converting enzyme 2 (ACE2) receptors or SARS-CoV-2 neutralizing antibodies that bind the virus and prevent it from infecting cells.”

Americans Getting Out More, but Cautiously: From Gallup:

  • Less than a quarter of Americans now practicing strict social distancing

  • More than four in 10 still avoiding large crowds; 26% avoiding small gatherings

  • Visits to grocery stores, restaurants and pharmacies jumped in May

About healthcare professionals

AAPA Responds to National Medical Organizations: This statement was presumably directed at the AMA and AOA, which last week published opposition to changing the name of Physician Assistant to Physician Associate. “We are writing to inform you that AAPA’s House of Delegates recently passed a policy affirming physician associate as the official title for the PA profession. We believe that this title more distinctly articulates the role and responsibilities of PAs in continuing to deliver quality healthcare, while reaffirming our commitment to team-based patient care. We kept “physician” in our title to demonstrate the value we place on our longstanding relationship with our physician colleagues and our historic roots within the physician community.”

About the public’s health

FDA can continue regulating e-cigarettes after Supreme Court declines to hear a case arguing that the agency has too much authority over the vaping industry: “Regulation of e-cigarettes by the U.S. Food and Drug Administration (FDA) can continue after the Supreme Court declined to hear a case on Monday that would have limited the government's authority to oversee the vaping industry.
The appeal from Big Times Vapes Inc, a Mississippi vape shop, centers around the 2009 Tobacco Control Act (TCA), in which Congress gave the FDA broad authority to regulate tobacco products.”

Rural-Urban Disparity in Mortality in the US From 1999 to 2019: “Rural residents experienced greater mortality and the disparity between rural and large metropolitan areas tripled from 1999 to 2019. Even though there were reductions in AAMRs for all ages, there was a 12.1% increase in the AAMR [age-adjusted mortality rates] rural residents aged 25 to 64 years, which was driven by an increasing AAMR among non-Hispanic White people. However, non-Hispanic Black people had greater AAMRs across all 3 US Census–categorized areas than all other racial/ethnic groups. These trends could be further exacerbated by rural hospital closures and the COVID-19 pandemic.”

General Health Checks in Adult Primary Care: The latest study on the utility of the annual/routine physical exam. “General health checks were not associated with reduced mortality or cardiovascular events, but were associated with increased chronic disease recognition and treatment, risk factor control, preventive service uptake, and improved patient-reported outcomes.”

About healthcare IT

Apple announces new features to share health data with doctors, track trends over time: “At its annual technology showcase known as the Worldwide Developers Conference on Monday, Apple revealed a new feature for users who have opted to share their medical records on their devices. Users can now choose the types of information they would like to share — such as an elevated cholesterol level or their physical activity history — and identify specific people to send it to, such as family members or clinicians.
Apple said the data is privacy-protected and secured during the upload and download process and will not be shared beyond the selected individuals, including Apple itself. The company is also making it possible for doctors using electronic health records made by Cerner, Allscripts, DrChrono, and others to view their patients’ information from Apple devices within the EHR, without having to download or open another app or tab.”

About hospitals and healthcare systems

Trinity Health generates nearly $700M in profit over 9 months thanks to strong investment gains: “Hospital chain Trinity Health generated $694 million in operating income for a nine-month period ranging from July 2020 through March 2021 as the system continues to weather volume declines due to COVID-19….
The improved results were ‘driven by higher operating revenue and strong cost controls on discretionary spending compared to the same period of fiscal 2020,’ Trinity said in its earnings report released Friday. “In addition, strong investment returns drove non-operating gains higher.
But Trinity has also experienced higher expenses handling the pandemic, like other hospital systems across the country. The system reported $14.4 billion in expenses in the nine-month period, an increase of $97.6 million compared to the same period the year before.”

Cleveland Clinic's net income grows to $350M in Q1: “Cleveland Clinic recorded a net income of $350.3 million in the first quarter of 2021, compared to a net loss of $830.6 million in the same period last year, according to recently released financial documents
The 19-hospital system saw its net revenue reach $2.8 billion in the three-month period ending March 31, up from $2.6 billion recorded in the same period one year prior. 
Expenses for the health system also rose to $2.6 billion in the first quarter of this year, an increase of 5.5 percent from the same period last year.”

8 hospital mergers, acquisitions called off: A good summary of the past year’s failed activities.

2021 Impact of Change® Forecast Highlights: From Sg2. Some highlights:

  • Hospital Outpatient Departments (HOPD) and Ambulatory Surgery Centers (ASCs) will continue to experience rapid patient growth (19% and 25% by 2029, respectively), experiencing a patient volume that is 15 million higher in 2029 than in 2019. This will help drive down the cost of surgical procedures. [Comment- are surgical procedures scalable at these numbers?]

  •   This shift will accelerate as the Centers for Medicare & Medicaid Services (CMS) eliminates all of the procedures listed on their In-Patient Only List (more than 1,700 codes) and expands the number of ASC-covered procedures by 278 by the end of CY 2023. [Comment- there will still be some only-inpatient services, though increased technology has allowed more to be done on an ambulatory basis.]

  •   Physicians Offices and Clinics will see 18% growth by 2029, much of which driven by procedures formerly done in hospitals like cataract surgery and endovascular procedures. [Comment- cataract surgeries have been done for decades in ophthalmologists’ offices/surgicenters. Likewise, many endovascular procedures are being done in the outpatient setting…but in a doctor’s office?]

  •  There will be shift of admissions to the home toward the end of the decade with home-based services increasing by 15% to an estimated volume of 474.9 million.[Comment- this prediction continues a long trend to home care.]

  • Part of the growth in hospital-at-home will be attributable to a reimagining of senior care that moves patients out of skilled nursing facilities, which will see a 5% reduction in patient volume by 2029, despite an aging population.

Today's News and Commentary

Private equity group reaches deal to buy Medline for $34bn: “A consortium of private equity groups, comprising Blackstone, Carlyle and Hellman & Friedman, has reached a deal to buy a majority stake in US medical supply group Medline for about $34bn, including debt, in what is the largest buyout of the year. The transaction, announced by Medline on Saturday, is the largest buyout involving a club of private equity investors since the 2007 financial crisis. It ranks as one of the largest-ever private equity deals, behind the $44bn buyout of US energy group TXU Corporation in 2007…
Medline said that after the transaction it would continue to be led by the Mills family, which would remain its largest shareholder.”

About Covid-19

COVID-19 Vaccine-Reluctant in U.S. Likely to Stay That Way: From Gallup: “As of the May 18-23 survey, 60% of U.S. adults report they have been fully vaccinated against COVID-19, 4% have been partially vaccinated, 12% plan to be vaccinated and 24% do not plan to be vaccinated.
Among those not planning to be vaccinated, 78% say they are unlikely to reconsider their plans, including 51% who say they are "not likely at all" to change their mind and get vaccinated. That leaves one in five vaccine-reluctant adults open to reconsidering, with 2% saying they are very likely and 19% saying they are somewhat likely to change their mind and get vaccinated -- equivalent to 5% of all U.S. adults.”

A New Type Of COVID-19 Vaccine Could Debut Soon: “The first protein subunit COVID-19 vaccine to become available will likely come from the biotech company, Novavax. In contrast to the three vaccines already authorized in the U.S., it contains the spike protein itself — no need to make it, it's already made — along with an adjuvant that enhances the immune system's response, to make the vaccine even more protective.”

Complete protection by a single dose skin patch delivered SARS-CoV-2 spike vaccine: “Here, we use the high-density microarray patch [HD-MAP] to deliver a SARS-CoV-2 spike subunit vaccine directly to the skin. We show the vaccine, dry-coated on the patch is thermostable, and delivery of spike via HD-MAP induced greater cellular and antibody immune responses, with serum able to potently neutralize clinically relevant isolates including those from the B.1.1.7 and B.1.351 lineages. Finally, a single dose of HD-MAP-delivered spike provided complete protection from a lethal virus challenge, demonstrating that HD-MAP delivery of a SARS-CoV-2 vaccine is superior to traditional needle-and-syringe vaccination and has the potential to greatly impact the ongoing COVID-19 pandemic.”

Antibody-laden nasal spray could provide COVID protection — and treatment: “A nasal spritz of a designer antibody offers strong protection against variants of the coronavirus SARS-CoV-2 — at least in mice.”

About health insurance

Now Is The Time For Payvider Adoption & Growth: “In this report, the Guidehouse Center for Health Insights identifies markets where payvider [Payer/Provider] models are best positioned to disrupt incumbent hospitals, health systems, and health plans. The analysis is based on projected growth in health plan membership under capitated payment arrangements, relative to current utilization, cost, and quality performance.” Graph 1 on page 9 is worth a look even if you do not read the entire piece.

Biden turns to Obama to help boost health care enrollment: “The [HHS] report says 11.3 million people are covered through the health law’s marketplaces, where subsidized private plans are offered. An additional 14.8 million are covered through expanded Medicaid, the report adds. All but a dozen states have accepted the law’s Medicaid expansion, which mainly serves low-income working adults. And 1 million are covered by so-called basic health plans, an option created by the law and offered in a limited number of states.
That accounts for enrollment of about 27 million people. But the Biden administration is also claiming credit for four million people who would have been eligible for Medicaid without Obama’s law.”

CMS Announces $80 Million Funding Opportunity Available for Navigators in States with a Federally-Facilitated Marketplace: “The Centers for Medicare & Medicaid Services (CMS) issued the 2021 Navigator Notice of Funding Opportunity (NOFO), which will make $80 million in grant funding available to Navigators in states with a Federally-Facilitated Marketplace (FFM) for the 2022 plan year. This is the largest funding allocation CMS has made available for Navigator grants to date. With the additional funding, CMS encourages current and past Navigators to apply, especially those that focus on education, outreach and enrollment efforts to underserved and diverse communities.”

UnitedHealthcare may not cover ER care it deems nonemergent: “ED claims will be evaluated based on many factors, including:

  • The patient’s presenting problem

  • The intensity of diagnostic services performed

  • Other patient complicating factors and external causes”

This action is a significant trend back to the original operation of these commercial plans. They never intended ERs to be places of first contact for non-urgent/emergent care. This change will not affect some states’ beneficiaries (such as Illinois) where laws say insurers have to cover almost all of these visits regardless of reason.

Effect of the Million Hearts Cardiovascular Disease Risk Reduction Model on Initiating and Intensifying Medications: “In this prespecified secondary analysis of a cluster randomized, pragmatic trial that included 125 436 Medicare patients, the rate of initiation or intensification was 37% for patients enrolled by organizations paid to assess and reduce cardiovascular risk vs 32% for patients enrolled by organizations that were not, indicating a statistically significant difference.”

About the public’s health

Despite pandemic, level of carbon dioxide in the atmosphere hits historic levels: “Economies worldwide nearly ground to a halt over the 15 months of the coronavirus pandemic, leading to a startling drop in global greenhouse gas emissions.
But that did little to slow the steady accumulation of carbon dioxide in the atmosphere, which reached the highest levels since accurate measurements began 63 years ago, scientists said Monday.
‘Fossil fuel burning is really at the heart of this. If we don’t tackle fossil fuel burning, the problem is not going to go away,’ Ralph Keeling, a geochemist at the Scripps Institution of Oceanography…”

Fake patient reviews are making it increasingly hard to seek medical help on Google, Yelp and other directory sites: “Posting fraudulent reviews may be illegal under federal and state laws if there is financial gain involved. But enforcement is scattershot, and it is hard to find cases of disciplinary action from professional bodies for review fraud…
Although there is no easy way to quantify how many physicians and health-care providers are faking reviews, Curtis Boyd, the CEO and founder of Objection Co., which specializes in identifying fake local business reviews for business owners, estimated that as many as 20 percent of businesses in the health-care industry including doctors have suspicious review activity on Google and Yelp.”

Association of Opioid Agonist Treatment [OAT] With All-Cause Mortality and Specific Causes of Death Among People With Opioid Dependence: “Among the cohort studies, the rate of all-cause mortality during OAT was more than half of the rate seen during time out of OAT (RR, 0.47; 95% CI, 0.42-0.53). This association was consistent regardless of patient sex, age, geographic location, HIV status, and hepatitis C virus status and whether drugs were taken through injection. Associations were not different for methadone (RR, 0.47; 95% CI, 0.41-0.54) vs buprenorphine (RR, 0.34; 95% CI, 0.26-0.45)…
However, access to OAT remains limited, and insurance coverage remains low. Work to improve access globally may have important population-level benefits.”

About pharma

FDA approves first drug to slow decline of Alzheimer’s disease: “The Food and Drug Administration on Monday approved the first Alzheimer’s treatment to slow cognitive decline, a move likely to be hailed by patients and advocates but sharply criticized by others who argued there was not sufficient evidence the drug works.
The medication, called aducanumab, is for people with mild cognitive impairment or early-stage dementia both caused by Alzheimer’s. It is the first drug cleared that is designed to alter the course of the disease by slowing the deterioration of brain function — not just to ease symptoms. No Alzheimer’s treatment has been approved since 2003, reflecting the extraordinarily high failure rate of drugs developed for the illness.”

U.S. FDA approves Novo Nordisk's semaglutide as obesity treatment: “The drugmaker said it was expecting to launch the drug, which would be sold under the brand name Wegovy, in the United States later in June 2021.”

ASCO21 round-up: Things that got our attention...: “The American Society of Clinical Oncology (ASCO) annual meeting officially kicked off on Friday…” Check this article for “a few notable presentations that caught our eye.”

Bristol Myers Squibb faces $6.4B lawsuit over delaying cancer drug’s approval: “Bristol Myers Squibb was sued for $6.4 billion June 3 for allegedly delaying the FDA approval of its cancer drug Breyanzi so it could avoid making a milestone payment to the shareholders of Celgene, which the drugmaker acquired in 2019.
The lawsuit was filed by UMB Bank, acting as a trustee for ex-Celgene shareholders. It said Bristol Myers Squibb delayed Breyanzi's approval so it wouldn't have to make a $6.4 billion milestone payment tied to the approval. It alleged the drugmaker failed to fulfill its contract with Celgene because it did not employ ‘diligent efforts’ to win the drug's approval by the Dec. 31, 2020, deadline laid out in the agreement.”

Trends in Retail Prices of Brand Name Prescription Drugs Widely Used
by Older Americans, 2006 to 2020
: From the AARP: “Retail prices for widely used brand name
prescription drugs increased substantially faster • than general inflation in every year from 2006 to 2020. Between 2019 and 2020, retail prices for 260 brand name prescription drugs widely used by older Americans, including Medicare beneficiaries, increased by an average of 2.9 percent. In contrast, the general inflation rate was 1.3 percent over the same period.” Brand name drug prices rose much faster than average.
Read the article for more details. Check Figure B-1 on page 21 for an interesting finding.

About healthcare IT

Walmart Health files plans to expand virtual care into 16 more states: “Walmart told Insider the filings are related to the retail giant's telehealth push, not for its physical primary care clinics. Walmart Health's deal to buy virtual care provider MeMD, announced in May, is pending.”

Google reassigns global head of diversity and research over 2007 blog about Jews: FYI.

Before attacking IT systems, hackers stole information from 147K patients, Scripps Health says: “Before deploying ransomware on Scripps Health's computer network, cybercriminals stole data on close to 150,000 patients.
The San Diego-based health system said it is notifying 147,267 patients that hackers acquired some health and personal financial information during last month's ransomware attack.
The information could include names, addresses, dates of birth, health insurance information, medical record numbers, patient account numbers, clinical information and treatment information, the health system said.”

One Medical to acquire Iora Health in $2.1B all-stock deal: “Tech-enabled primary care provider One Medical has entered into an agreement to acquire Iora Health, another primary care competitor focused on Medicare patients, in a $2.1 billion deal.
One Medical has largely focused on care for the commercially insured, so a union with Iora Health will broaden its reach in the Medicare space, the two companies announced Monday morning. The deal would expand One Medical's potential market opportunity to $870 billion.”


Today's News and Commentary

About Covid-19

Vulnerable people may need vaccine boosters this year, scientists say: “People most vulnerable to Covid-19 could require a booster of the BioNTech/Pfizer vaccine later this year, according to scientists who said the shot elicited a lower antibody response against the Delta variant first identified in India.”

EU trade chief pushes for more Covid jab production not patent waivers: “Europe’s trade chief has called for a rapid increase in global vaccine production as the best way to fight the pandemic, arguing ahead of crunch talks next week against a narrow focus on patent waivers that has been backed by the US.”

Incidence of SARS-CoV-2 infection according to baseline antibody status in staff and residents of 100 long-term care facilities[LTCFs] (VIVALDI): a prospective cohort study: “In this cohort study done in 100 LTCFs, the risk of PCR-positive SARS-CoV-2 infection was substantially lower in residents and staff who were positive for SARS-CoV-2-specific antibodies at baseline. Our findings suggest that previous infection reduced the risk of reinfection by approximately 85% in residents and 60% in staff members. We identified only 14 cases of possible reinfection, mainly affecting staff, and although almost all of these individuals reported symptoms, none required hospital treatment. These findings suggests that previous SARS-CoV-2 infection provides a high degree of protection against a second infection and is broadly consistent with findings from longitudinal studies.”

During The Pandemic Lockdown, Traffic Deaths Soared To The Highest Level In 13 Years: “U.S. traffic deaths rose 7% last year, the biggest increase in 13 years even though people drove fewer miles due to the coronavirus pandemic, the government's road safety agency reported Thursday.
The National Highway Traffic Safety Administration blamed the increase on drivers taking more risks on less-congested roads by speeding, failing to wear seat belts, or driving while impaired by drugs or alcohol.”

AI for radiographic COVID-19 detection selects shortcuts over signal: “Artificial intelligence (AI) researchers and radiologists have recently reported AI systems that accurately detect COVID-19 in chest radiographs. However, the robustness of these systems remains unclear. Using state-of-the-art techniques in explainable AI, we demonstrate that recent deep learning systems to detect COVID-19 from chest radiographs rely on confounding factors rather than medical pathology, creating an alarming situation in which the systems appear accurate, but fail when tested in new hospitals. We observe that the approach to obtain training data for these AI systems introduces a nearly ideal scenario for AI to learn these spurious ‘shortcuts’.”

Regeneron leaps ahead in COVID-19 antibody race, scoring FDA nod for lower dose and subcutaneous injection: “Friday brought news that the FDA has made Regeneron’s monoclonal antibody cocktail more user friendly, allowing it to be administered by subcutaneous injection in addition to its original administration form of intravenous infusion. The agency also approved a lower dose of the Regeneron drug, 1200 mg, allowing the company and officials to stretch available supply.”

About scientific innovation

Genetic code breakthrough opens door to advanced materials: A great article about the next step in genetic reengineering.

About pharma

Lynparza yields significant invasive DFS benefit in early breast cancer study: “Study results released ahead of presentation at the American Society of Clinical Oncology (ASCO) annual meeting showed that adjuvant use of AstraZeneca's Lynparza (olaparib) reduced the risk of breast cancer recurrence, other new cancers or death by a significant 42% versus placebo in patients with germline BRCA-mutated, high-risk HER2-negative early breast cancer, who have completed surgery and chemotherapy.”

Surprise! Amgen's hot KRAS drug seals early FDA approval, winning a shot against 'undruggable' cancer: “The agency approved Lumakras…as the first treatment for non-small cell lung cancer (NSCLC) with a particular genetic mutation called KRAS G12C.
Once considered an undruggable target, KRAS mutations and drugs to treat them are among the most talked-about subjects in cancer research these days. Amgen is first to get a new therapy to the FDA finish line, but other companies, most notably Mirati Therapeutics, are on the company’s heels.”

‘Next big wave’: Radiation drugs track and kill cancer cells: “After about two years, those who received the drug did better, on average. The cancer was kept at bay for nearly nine months compared to about three months for the others. Survival was better too — about 15 months versus 11 months.”

Walgreens closes $6.3B sale of Alliance Healthcare to AmerisourceBergen: “AmerisourceBergen has completed its nearly $6.3 billion acquisition of Walgreens' Alliance Healthcare, one of Europe's largest drug wholesalers.
Amerisource will pay $6.27 billion in cash and turn over 2 million shares of its common stock in the deal, the wholesale giant announced this week. The companies said they also plan to expand and extend other commercial agreements to drive further growth and synergy.”

About healthcare IT

Digital health player Babylon Health to go public via $4.2B merger with blank check company: “The London-based health tech startup plans to become a public company through a $4.2 billion merger with Alkuri Global Acquisition Corp., led by Groupon’s ex-chief executive officer Rich Williams and former chief operating officer Steve Krenzer…
Founded in 2013, Babylon offers a digital healthcare app for AI-powered diagnosis and video appointments that covers 24 million people across four continents, according to company executives. The company raised $550 million in August 2019 in an effort to launch an expansion into the U.S. It has raised $631 million to date.”

47,000 BCBS Kansas City members exposed through vendor breach: “BlueCross BlueShield of Kansas City began notifying 47,034 members that their data was exposed in a cyberattack on its cloud vendor, LogicGate, according to a May 26 data breach notification letter.

About health insurance

CMMI director: Expect more mandatory value-based care payment models: “The Biden administration is exploring making more payment models mandatory in the future as it implements a more patient-centric vision for value-based care.
Center for Medicare and Medicaid Innovation (CMMI) Director Liz Fowler detailed parts of this vision on Thursday …” Read the article for details.
In a related article: Lawmakers call for CMMI to be more transparent and accountable as model review continues: “A group of bipartisan lawmakers wants the Center for Medicare and Medicaid Innovation (CMMI) to be more transparent in its handling of value-based care models as the center continues a major overhaul of its demonstrations.
The 24 lawmakers sent a letter to CMMI Director Liz Fowler on Wednesday seeking for more insight into the center’s decision-making process on value-based care models it oversees. The letter comes less than a month after Democrats were concerned over several parts of the Direct Contracting Model.”

About healthcare devices

Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped: From the FDA website, a Class I recall. Abbott has said it will be able to pick up the slack.

About hospitals and health systems

Hospitals gain jobs after 4 straight months of losses: “Hospitals added 2,900 jobs in May, after four months of job losses this year, according to the latest jobs report from the U.S. Bureau of Labor Statistics.
The May count compares to 5,800 hospital jobs lost in April, 600 jobs lost in March, 2,200 jobs lost in February and 2,100 jobs lost in January. Before January, the last job loss was in September, when hospitals lost 6,400 jobs.”

About pharma

After breakout year, Moderna on track to generate $15B+ in 2022 thanks to more demand, higher prices: analysts: “Moderna is hard at work ramping up production of its mRNA COVID-19 vaccine, which is projected to reap over $19 billion for the company by year’s end. But given that the pandemic is easing in parts of the world, what’s less certain is how 2022 will play out.
After a breakout year, Moderna sees strong reason to believe 2021 won't be a one-off boom year. That's thanks to the predicted need for booster shots and additional supply deals coupled with stronger pricing power…”

Today's News and Commentary

About the public’s health

Cicadas are related to shrimp – don't eat them if you have a seafood allergy, FDA warns: The headline is the message.

About Covid-19

Why you shouldn’t get a COVID antibody test after a vaccine: “…antibody tests don’t paint a full picture. They are not an effective way of making sure your vaccine and immune system are on task, said Dr. Jesse Goodman, who formerly directed the Food and Drug Administration’s Center for Biologics Evaluation and Research and is a senior scholar with the O’Neill Institute for National and Global Health Law. 
‘I definitely would not recommend it,” he said. “For most people, if you’ve been vaccinated with an authorized vaccine, you’re going to have antibodies, and we understand what your protection would be.’”

Moderna plans mix of COVID-19 vaccine doses with new Lonza deal: “Moderna is gearing up to halve the dose of its COVID-19 vaccine, the U.S. drugmaker said on Wednesday, so that it can also be used to combat variants and inoculate children.”
It has agreed a deal with Swiss-based drugmaker Lonza which said a new drug substance production line in Geleen, Netherlands, will have capacity to make ingredients for up to 300 million doses annually at 50 micrograms per dose.”

U.S. details global coronavirus vaccine plan, with 25 million doses headed to Asia, Latin America, Caribbean, Africa: “The Biden administration on Thursday announced a plan to share 25 million vaccine doses globally by the end of June, routing about three-quarters through international public health organizations while reserving the remaining 25 percent for direct donations to handpicked nations.”

Masks have stopped disease spread for centuries. Here’s why they may catch on in the U.S.: Good review of the issue.

About hospitals and health systems

New Harmony Healthcare Survey of Hospital Leaders Finds More Than 30% of Hospitals Near Danger Zone of Denial Rates: “Across the nation, the average denials rate is between 6% and 13%, and over 1/3 of hospital reimbursement executives surveyed responded that their organizations are nearing the denials danger zone of 10%…
Research shows that approximately 85% of denials are preventable, but successfully preventing them requires strengthened leadership and improved skills of hospitals’ prevention and recovery teams… Key findings include:

  • 32% of respondents reported their top concern as coding

  • 30% of respondents reported their top concern as medical necessity acute IP

  • 20% of respondents reported their top concern as front end

  • 18% of respondents reported their top concern as clinical validation denials”

About pharma

MorphoSys to buy Constellation Pharmaceuticals for $1.7 billion: FYI

Sackler Family Empire Poised To Win Immunity From Opioid Lawsuits: “According to legal documents filed as part of the case, that immunity would extend to dozens of family members, more than 160 financial trusts, and at least 170 companies, consultants and other entities associated with the Sacklers…
In addition to contributing money from their personal fortunes, the Sacklers have agreed to give up control of Purdue Pharma. They will, however, retain ownership of other companies, admit no wrongdoing and will remain one of the wealthiest families in America.”

F.D.A. Approves Pricey Pill to Treat Vaginal Yeast Infections: A perfect case for discussion about value-added.
”The drug, Brexafemme (ibrexafungerp) made by SCYNEXIS, is a one-day oral treatment and the first of a new class of triterpenoid antifungal drugs. The company said the new drug kills candida — the yeast that can cause an infection.
The standard oral medication, Diflucan (fluconazole), inhibits the growth of yeast but does not kill it.
But the treatment most likely wouldn’t be prescribed widely at first for common vaginal yeast infections. Dr. David Angulo, the company’s chief medical officer, estimated that the list price of the drug would range from $350 to $450 for the four-tablet treatment. By comparison, GoodRx lists the average retail price of fluconazole as $29.81.”

About health insurance

Medicare Advantage Plans Lose Skirmish Over Quality Ratings Data: “Three Medicare Advantage plans lost their attempt to require the CMS to collect data on patient care and satisfaction during the Covid-19 pandemic, as a federal court said the agency hadn’t exceeded its statutory authority in suspending the collection.
The U.S. District Court for the District of Columbia on Tuesday granted the Health and Human Services Department’s motion for summary judgment and denied AvMed Inc.'s motion for summary judgment and preliminary injunction due to its finding that the agency action wasn’t arbitrary and capricious.”

Expanding Insurance Coverage Is Top Priority for New Medicare-Medicaid Chief: A brief interview with new CMS head Chiquita Brooks-LaSure. Not a lot new but worth a quick read.

About medical technology

Magnetic Interference on Cardiac Implantable Electronic Devices From Apple iPhone MagSafe Technology: “Magnet wireless charging is being utilized increasingly in current generation smartphones. Apple's MagSafe is a proprietary wireless charging technology with an array of magnets that has the capacity to generate magnet fieldstrength >50 gauss (G). We hypothesize that there is clinically significant magnet interference caused by Apple's MagSafe technology on cardiac implantable electronic devices (CIED).”

About healthcare IT

J&J experiences 15.5B cybersecurity incidents per day, CISO says: “Ransomware is just one type of cybersecurity incident, in a continuous cycle of attacks. Johnson & Johnson experiences around 15.5 billion cybersecurity incidents each day, Marene Allison, J&J's chief information security officer said.”
I had to look at the number several times!

About healthcare personnel

AMA joins opposition to 'physician associate' rebrand: The AMA joins the AOA in opposition to the name change. See yesterday’s post.

National Health Service Corps:Program Directs Funding to Areas with Greatest Provider Shortages: From the GAO: “The Health Resources and Services Administration estimates that about 25% of the U.S. population lives in an area with too few primary care physicians. Its National Health Service Corps programs offer scholarships and loan repayments to primary, dental, or mental health care providers in exchange for working in areas where there are shortages.

Our review of the programs for FY 2020 found:

  • About 14,000 recipients provided care at about 7,000 sites

  • Recipients were most commonly nurse practitioners (26%), physicians (15%), and licensed clinical social workers (12%)

  • About 57% of new applicants received funding”

Today's News and Commentary

JAMA editor-in-chief stepping down amid fallout of 'No physician is racist' controversy: “Howard Bauchner, M.D., has held the role for almost a decade but was placed on administrative leave in late March roughly a month after the medical journal released a controversial podcast featuring then-Deputy Editor Ed Livingston, M.D., and Mitchell Katz, M.D., deputy editor for JAMA Internal Medicine and CEO of NYC Health + Hospitals.
The episode kicked off a discussion on structural racism by questioning its existence in healthcare. It was promoted with a tweet that read: ‘No physician is racist, so how can there be structural racism in healthcare?’”
“I remain profoundly disappointed in myself for the lapses that led to the publishing of the tweet and podcast,” Dr. Bauchner said in a statement. “Although I did not write or even see the tweet, or create the podcast, as editor in chief, I am ultimately responsible for them.”
The AMA issued this statement: AMA announces transition in JAMA editorial leadership

Johnson & Johnson to pay $2.1bn in talc cancer case after Supreme Court rejection: “Johnson & Johnson must pay $2.1bn in damages to women who blamed their ovarian cancer on asbestos in the drugmaker’s baby powder, after the US Supreme Court refused to review the case. The judgment was the largest against the company, which has battled a wave of litigation and lost several cases as thousands of people claimed the products led to cancer. The appeal that was denied on Tuesday related to a case filed in Missouri in 2018 involving 22 women.”

About hospitals and health systems

A couple financial reports from large systems.
Banner Health joins recovering nonprofits with $63M operating income, $3B total revenue: “That increase in revenue was, however, paired with a rise in costs. The system reported a year-over-year increase from $2.4 billion to almost $3 billion, nearly half of which was attributed to higher salaries and benefits payouts…
To date, Banner said it has received about $465 million in CARES Act funding. It also received $654 million in Medicare Advance and Accelerated Payments, which will be recouped over 12 to 18 months beginning in April.”
Cleveland Clinic posts $61M profit in Q1 thanks to strong patient service revenue: “But the system still is facing higher expenses for supplies and salaries for workers, which have shot up for hospitals across the country throughout the pandemic. Cleveland Clinic spent $1.5 billion on salaries and benefits for the first quarter compared with $1.48 billion for the same period last year. Costs for supplies also increased to $297 million, slightly above the $269 million it paid in the first quarter of 2020…
Another bright spot is an increase in patient volumes. Total surgical cases for Cleveland Clinic increased 6.5% for the first quarter compared to the first quarter of 2020. Inpatient admissions also increased by 1.1% for the quarter.”

About Covid-19

For the first time in over a year, the US records a daily average of fewer than 20,000 new Covid-19 cases: The headline is the story.

Covid-19 Prevention Measures Are Keeping Childhood Diseases Like Chickenpox at Bay: “The disinfecting and hand-washing that became common during the Covid-19 pandemic have also served as powerful tools against a host of childhood ailments such as chickenpox, stomach viruses and strep throat, recent data suggest.”

Moderna applies for full F.D.A. approval for its Covid vaccine.: “Moderna on Tuesday became the latest pharmaceutical company to apply to the U.S. Food and Drug Administration for full approval for its Covid-19 vaccine for use in people 18 and older. F.D.A. approval would allow the company to market the shot directly to consumers, and could also help raise public confidence in the vaccine.
Full approval could also make it easier for schools, employers, government agencies and the U.S. military, which has encountered resistance to coronavirus vaccines, to mandate vaccinations.”

Israel reports link between rare cases of heart inflammation and COVID-19 vaccination: “The COVID-19 vaccine made by Pfizer and BioNTech appears to put young men at elevated risk of developing a heart muscle inflammation called myocarditis, researchers in Israel say. In a report submitted today to the Israeli Ministry of Health, they conclude that between one in 3000 and one in 6000 men ages 16 to 24 who received the vaccine developed the rare condition. But most cases were mild and resolved within a few weeks, which is typical for myocarditis.”

U.S. begins study testing mix-and-match Covid vaccine booster shots: “The NIH said it started a trial looking at what happens when an adult who is fully vaccinated with one type of Covid vaccine, like Pfizer’s, is boosted with a different shot about three to four months later.
The trial will include about 150 adults who have been fully vaccinated with the Johnson & Johnson, Moderna or Pfizer Covid vaccines, according to the agency.
Federal health officials said people who have not yet received an authorized vaccine are also eligible to enroll in the trial in a separate group.”

Cancer patients show good COVID immune response to vaccine, infection: This article explains the data behind the headline. For more detail, see the JAMA Oncology editorial commenting on the research.

19 Vaccination and Nonpharmaceutical Interventions [NPIs] With Infections, Hospitalizations, and Mortality: “A decision analytical model of North Carolina found that removing NPIs [such as face masks] while vaccines were distributed resulted in substantial increases in infections, hospitalizations, and deaths. Furthermore, as NPIs were removed, higher vaccination coverage with less efficacious vaccines contributed to a larger reduction in risk of infection compared with more efficacious vaccines at lower coverage.”

Coronavirus: West Virginia gives residents chance to win guns with a Covid-19 shot: No comment needed.

WHO grants emergency listing to Sinovac's coronavirus vaccine: “The World Health Organization (WHO) on Tuesday issued an emergency-use listing for Sinovac's inactivated COVID-19 vaccine CoronaVac in adults aged 18 and over, the second such authorisation it has granted to a Chinese company, and the seventh listing overall. Sinopharm became the first non-Western COVID-19 vaccine developer to be endorsed by the UN agency after its inoculation BBIBP-CorV won WHO backing last month.”

Protection Because of Prior SARS-CoV-2 Infection: As research is looking into the longevity of protection from Covid-19 due to natural infection or vaccination, there are some caveats to findings. Read this short editorial from JAMA Internal Medicine for a good explanation of these interpretation qualifications.

On a roll, Moderna taps Thermo Fisher for fill-finish duties and Lonza for booster shot manufacturing: The headline is the story.

About health insurance

Industry Voices—Delay in codifying 'reasonable and necessary' undermines healthcare enforcement: “In a rule issued in the waning days of the last administration, the Centers for Medicare & Medicaid Services sought to codify for the first time a definition of “reasonable and necessary” for purposes of determining whether an item or service is eligible for Medicare reimbursement.
That codification, embedded in the Medicare Coverage of Innovative Technology rule, appears required by the logic of the Supreme Court’s decision in Azar v. Allina Health Services. However, CMS recently prevented this regulation from going into effect, leaving the definition of “reasonable and necessary” to continue residing solely in sub-regulatory guidance.
The failure to codify a definition, in violation of the Medicare Act as interpreted by Allina, gives new ammunition to defendants in healthcare enforcement actions, including False Claims Act matters, that rely on the sub-regulatory definition of ‘reasonable and necessary.’”

Major rulings including Obamacare loom for U.S. Supreme Court: A reminder that the Court has still not decided on the validity of the ACA.

PAHCF [The Partnership for America’s Health Care Future] Medicare Expansion, Suggests Extending ACA Policies: “‘Not only would opening up seniors’ Medicare to younger Americans mainly absorb those who are already covered or have access to coverage, research shows the unaffordable costs would be passed on to taxpayers and could hasten the Medicare program’s bankruptcy, all while threatening patients’ access to quality care,’ Lauren Crawford Shaver, executive director of the PAHCF, said in the statement.”

CenterWell Senior Primary Care Extends its Value-Based Care to People with Original Medicare: In the past, offering Medicare beneficiaries additional benefits for a reduced or no cost was considered an illegal inducement. Then CMS allowed Medicare Advantage plans to offer extended services (transportation, meals, etc.) without legal consequences. Now, under a CMS Direct Contracting Model, Humana-owned CenterWell Senior Primary Care is able to offer those same extra benefits. “Under this new Direct Contracting Model, CenterWell’s reimbursement will be dependent on the quality of care it provides; CenterWell will share financial responsibility for patients’ medical costs with CMS.”

U.S. Consumers Often Lack Literacy In Healthcare Finances: Not a new finding; but what is newsworthy is that this problem still exists. For example: “Two-thirds of Americans can’t correctly define concepts such as healthcare insurance premiums, co-payments and deductibles. And, a majority of Americans isn’t familiar with basic elements of the Affordable Care Act (ACA), such as when the open enrollment period is, if there is a tax penalty for foregoing coverage, and whether health plans must enroll those with pre-existing conditions.”

Access to Care, Cost of Care, and Satisfaction With Care Among Adults With Private and Public Health Insurance in the US: “In this survey study of 149 290 individuals residing in 17 states and the District of Columbia, individuals with employer-sponsored and individually purchased private insurance were more likely to report poor access to health care, higher costs of care, and less satisfaction with care compared with individuals covered by publicly sponsored insurance programs.”

About the public’s health

China reports human case of H10N3 bird flu, a possible first: “A man in eastern China has contracted what might be the world’s first human case of the H10N3 strain of bird flu, but the risk of large-scale spread is low, the government said Tuesday.” Where have we heard that?

A pandemic anniversary: 40 years of HIV/AIDS: This Lancet article is a reminder that the first CDC article on what we now recognize as HIV/AIDS was published 40 years ago this month.

Best and Worst States for Elderly Healthcare: At the top are Minnesota and North Dakota. At the bottom are Georgia (50) and Oklahoma (51).

The Fastest-Growing U.S. States Have the Worst Health Care: “The fastest-growing states in terms of population over the last decade, including Texas, Florida, and Georgia, consistently rank last when it comes to health and health care. This is because these states have large numbers of uninsured adults, high levels of premature death from treatable conditions, less investment in public health, too many people with mental illness unable to get the care they need, and residents facing mounting insurance costs that make health care less affordable than in many other parts of the country, according to the Commonwealth Fund.”

About healthcare technology

Rapid Response Revival Defibrillator Gains CE Mark: “The small, portable defibrillator is designed so that “someone with no medical training can use it quickly in a high-stress situation,” the company said, adding that the product will be priced at one-tenth of the cost of a traditional AED.” The key point is the price, which will allow more widespread availability.

Illumina hits yet another legal snag as clock ticks on $8B deal for Grail: “Illumina's multibillion-dollar deal for cancer blood test developer Grail was already under an antitrust microscope in the U.S. and Europe. Now, the watchdogs have raised a new threat.
A federal court allowed U.S. regulators to potentially postpone their action to block the deal, pending legal outcomes across the pond—all while the deal runs up against a deadline set to expire before the end of this year.”

About healthcare IT

New Device That Connects To Computer, Combined With Telehealth Visit, Can Help Parents Get To Bottom Of Children’s Ear Pain: I wonder if the inventors ever examined a squirming, crying child?

1 in 4 hospitals can't send patients' EHR data to third parties, ONC finds: “While 90 percent of hospitals have the certified EHR technology patients need to view, download and transmit their health information electronically, only 3 out of every 4 hospitals have enabled the tech function, according to a June ONC data brief.” The number is actually worse: 90 percent of hospitals have the certified EHR technology X .75 (3 out of every 4 hospitals have enabled the tech function) = 67.5% can perform the function.

Brain-computer interface allowing 'locked-in' ALS patients to communicate earns European approval: “The dream of a device converting nonverbal amyotrophic lateral sclerosis (ALS) patients’ brainwaves into speech could finally become a reality now that a neural signal processing platform designed to do just that has received regulatory clearance in Europe.
The NeuroKey platform was developed by the Wyss Center for Bio and Neuroengineering, a nonprofit research institute in Switzerland.”

About pharma

Sanofi looks to take Mylan to court, again, over EpiPen antitrust allegations: “Sanofi is requesting a new trial to argue that Mylan blocked competition to its EpiPen competitor Auvi-Q, leveraging price hikes and steep rebates to maintain a U.S. epinephrine ‘monopoly.’ The move comes after a Kansas District Court in December ruled in Mylan’s favor.”

Today's News and Commentary

About healthcare costs

Milliman Medical Index: Cost of healthcare for a family of four decreases for first time in report history, to $26,078 in 2020, but costs are projected to rebound in 2021: “For the first time in the 16-year history of the MMI, healthcare costs decreased by 4.2% as a result of the COVID-19 pandemic. Based on restated claims data, healthcare costs for a hypothetical family of four in 2020 were $26,078, compared to $27,233 in 2019.
’Eliminated care in 2020 more than offset the cost of COVID-19 testing and treatments,’ said Dave Liner, co-author of the MMI. ‘In fact, all categories of healthcare costs – inpatient, outpatient, and professional and other services – were lower in 2020 compared to 2019, except for prescription drug costs.”

About healthcare IT

Increasing Telehealth Utilization and Digital Contact Help Health Plans Score Points with Members During Pandemic, J.D. Power Finds: “The following are key findings of the 2021 study:

  • Digital contact and telehealth adoption increase significantly: Telehealth utilization increases 27 percentage points, with 36% of U.S. health plan members saying that they accessed telehealth services, up from just 9% a year ago. Digital contact with insurers also has increased, with 32% of members saying they connected with their health plans via web, mobile app or text message in the past year.

  • Overall satisfaction, Net Promoter Score© and trust increase: Overall satisfaction improves 10 points year over year, up from a 6-point increase in 2020 and a 1-point increase in 2019. The year-over-year rise in satisfaction has been driven largely by significant improvement in scores in the cost, information and communication and website factors/subfactors. Net Promoter Scores1also improve, having risen 7 points during the past two years. Similarly, perceived levels of trust in health plans have increased 2 percentage points during the past two years.

  • Member contact significantly higher among younger generations: Members of Gen Z2 and Gen Y have the highest levels of contact with their health plan, with 62% of Gen Z and 52% of Gen Y members accessing their health plan’s customer service channel at least once during the past year. That number falls to 49% among Pre-Boomers/Boomers. While contact lifts satisfaction for all members, the effect is 20 points higher among Gen Y/Z members than among older members.

  • Despite improvement, many had no engagement with their health plan: More than one-third(37%) of health plan members had no engagement with their health plan. Nearly half (44%) of Pre-Boomers/Boomers had no engagement with their health plan, the highest percentage of any generational group.”

Frazier Healthcare Partners brings in $1.4B to invest in healthcare IT, data analytics: FYI

Digital physicians network Doximity files for a $100M IPO: “It plans to list under the symbol DOCS, but has yet to select an exchange. No pricing terms were disclosed in the filing.”

About Covid-19

The E.E.O.C. explains how companies can mandate vaccines for workers.: “Companies can require vaccines only of employees returning to the workplace, and not those who work outside the office, the E.E.O.C. said in guidance released on Friday. But doing so still counts as a mandate, so companies must give the same legally required considerations that companywide vaccine requirements would entail, like making accommodations under the Americans with Disabilities Act for employees who can’t receive the vaccine. That means allowing for exceptions for those who may be unable to take the vaccine for health reasons, like an allergy.”

KFF COVID-19 Vaccine Monitor: May 2021: “The latest KFF COVID-19 Vaccine Monitor shows continued steady progress in vaccine uptake, with 62% of U.S. adults saying they’ve gotten at least one dose of a vaccine (up from 56% in April) and the share saying they will “wait and see” down slightly from 15% to 12%. This leaves few remaining eager to get vaccinated, while the shares saying they will get vaccinated “only if required” (7%) or will “definitely not” get a vaccine (13%) essentially unchanged over the last several months…
One potential avenue for further increasing vaccine uptake is full FDA approval of one of the vaccines currently authorized for emergency use, with about one-third (32%) of unvaccinated adults saying such approval would make them more likely to get vaccinated. In addition, one in five (21%) employed adults who have not gotten a vaccine say they would be more inclined to do so if their employer gave them paid time off to get vaccinated and recover from side effects.”

The name game for coronavirus variants just got a little easier: From the WHO: “Each variant will be given a name from the Greek alphabet, in a bid to both simplify the public discussion and to strip some of the stigma from the emergence of new variants…
Under the new scheme, B.1.1.7, the variant first identified in Britain, will be known as Alpha and B.1.351, the variant first spotted in South Africa, will be Beta. P.1, the variant first detected in Brazil, will be Gamma and B.1.671.2, the so-called Indian variant, is Delta.”

Accessibility and Usability of State Health Department COVID-19 Vaccine Websites-A Qualitative Study: “State health department COVID-19 vaccine website accessibility and usability challenges create frustration, may promote health disparities, and contribute to overall ineffective and inequitable distribution. Accessibility issues included a lack of support for smartphone access, English-only text, and poor readability. Usability issues compound the problems by failing to provide critical information, such as the last time or date the site was updated, web-based scheduling, a wait-list or follow-up process, and requiring users to check multiple locations for availability.”

Covid-19 vaccines burnt as shelf-life complicates global rollout: “Inefficiencies in the global distribution of vaccines and the relatively short shelf-life of the leading jabs have meant that doses have arrived in some countries too late for the shots to be used. The southern African nation of Malawi publicly burnt almost 20,000 doses of the Oxford/AstraZeneca vaccine last month, despite having one of the lowest vaccination rates in the world.”

Covid-19 cases and deaths in the US will fall over the next four weeks, forecast predicts: “The US Centers for Disease Control and Prevention is predicting that Covid-19 cases, hospitalizations and deaths will fall over the next four weeks. The CDC ensemble forecasts conclude that there will be a total of 596,000 to 606,000 Covid-19 deaths by June 19.
As of Friday, Covid-19 has killed at least 593,364 people and infected more than 33 million in the US, according to Johns Hopkins University.
The improved outlook can be attributed to the continuing efforts by states to get people vaccinated. Already, 10 states have reached the Biden administration's goal of vaccinating 70% of adults by July 4 with at least one dose.”

Samsung Biologics looking to offer "end-to-end" mRNA vaccine production next year: “According to the company, the addition will allow it to provide ‘end-to-end mRNA vaccine manufacturing services, from bulk drug substance to aseptic fill/finish, including labeling and packaging, as well as cold-chain storage.’”

HHS launches $50M venture capital partnership to develop tech for pandemic response: “The U.S. Department of Health and Human Services (HHS) announced Tuesday a public-private partnership with nonprofit organization Global Health Investment Corporation to develop and commercialize technologies and medical products that aid the U.S. in responding effectively to future health security threats.
BARDA Ventures, the venture arm of the Biomedical Advanced Research and Development Authority (BARDA), is spearheading the initiative and plans to provide GHIC with a minimum of $50 million over five years with potential for up to $500 million over 10 years.”

COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting Updated May 27, 2021: Implementation Date: June 10, 2021: “The below changes will have an implementation date of Thursday, June 10, 2021.

  •   Influenza fields (fields 33-38) are now OPTIONAL. Notably, after October 1, 2021 the fields may become mandatory again in some form when acute respiratory illness activity is anticipated to increase.

  •   Fields for inventory and usage for Therapeutic B (bamlanivimab when administered alone,

    fields 39c-d) are now OPTIONAL. This is consistent with the FDA revocation of the emergency use authorization for bamlanivimab when administered alone2 on April 16, 2021.

About the public’s health

74th World Health Assembly: The WHO conducted this event the past weekend. A large number of issues (from addressing SDOH to coordinating global pandemics) were discussed. Check the website and daily updates for resolutions. "The one recommendation that I believe will do most to strengthen both WHO and global health security is the recommendation for a treaty on pandemic preparedness and response," [WHO Director-General] Tedros said. "This is an idea whose time has come."

Nestlé document says majority of its food portfolio is unhealthy: “Internal company presentation acknowledges more than 60% of products do not meet ‘recognised definition of health.’”

Biden Budget Requests Steep Increases for NIH, CDC, SAMHSA: “The NIH's discretionary budget authority would rise by about 22%, or $9.03 billion, to $50.5 billion in fiscal 2022, which starts in October, from $41.5 billion in the current budget year, fiscal 2021.
The budget authority for the Centers for Disease Control and Prevention (CDC) would rise by $1.5 billion (about 21%) to $8.54 billion, and that for the Substance Abuse and Mental Health Services Administration (SAMHSA) would rise by $3.72 billion (about 63%) to $9.59 billion.”
In a related article: Biden's $6T budget: 7 takeaways for healthcare leaders

About healthcare professionals

Bill proposes allowing more foreign physician residents: “Lawmakers reintroduced a plan to allow more international physician candidates attend residency in the U.S. and stay in the country after their training if they agree to work in underserved areas.
The legislation was reintroduced Thursday and would increase the number of slots in the Conrad 30 program. Sen. Amy Klobuchar (D-Minn.) first introduced the bill in 2019 with bipartisan support, but it failed to pass the Senate Judiciary Committee.
Minor changes were made to the bill to drum up a broader coalition of supporters, including reauthorizing the Conrad 30 program for three years following the bills enactment, language clarifying hospital malpractice concerns, and a mandate that directs U.S. Citizenship and Immigration Services and HHS to keep track of how the J-1 visa program is being used by states.”

Physician assistant title change opposed by American Osteopathic Association: “A recent push to change physician assistants' professional title could cause confusion about medical roles and undermine the importance of a physician-led care team model, thereby threatening patient safety, the American Osteopathic Association said May 28.
On May 24, the American Academy of Physician Assistants voted to adopt "physician associate" as the official title for the PA profession. The change comes about three years after the academy hired a healthcare marketing research and branding firm to determine the best title and marketing strategy for the profession.”

About health insurance

Democrats plot Medicaid expansion backdoor in red states refusing program: “However, the new effort carries risks that Democratic lawmakers, White House officials and health care advocates have been struggling to resolve in behind-the-scenes discussions over the past few months, say people involved in those talks. One challenge is designing a program that won’t invite backlash from a health care industry ready to battle Democrats on other sweeping changes. Another concern is inadvertently rewarding states that blocked Medicaid expansion for years. Any plan would also come with a steep price tag.”

Putting Medicare Spending for COVID-19 Into Perspective: “The researchers' analysis indicated, perhaps surprisingly, that COVID-19 did not have a major financial impact on Medicare in 2020. They found that the average cost of treatment was considerable among those who were hospitalized, but the costs for milder cases—which represented the majority—were relatively small. In total, the study estimated that traditional Medicare spending for COVID-19–related hospital and outpatient care was $6.3 billion, or $5334 per person presenting for treatment of COVID-19. The estimate does not include spending for patients in Medicare Advantage plans because Medicare Advantage claims data are not available.”

About pharma

White House urges court to toss lawsuit preventing states from importing prescription drugs: “The Biden administration on Friday asked a federal court to toss a lawsuit that is seeking to prevent states from importing cheap prescription drugs from Canada.
The White House said in a court filing that a lawsuit being brought by pharmaceutical companies was premature since no decision has yet been formalized over whether to give the green light to any import programs.”

ViewPoints: Post-pandemic, half of doctors would like to see fewer drug sales rep meetings: “In the current climate, half of the doctors we surveyed said they are not prioritising meetings with sales reps at all (16%) or are only making this a low priority (34%).
By comparison, 42% of respondents said meeting drugs reps is of moderate priority to them at the moment, but just 8% described these interactions as a high priority.”

About healthcare devices

Wyss Center Earns CE Mark for Brain-Computer Interface Software:”The Wyss Center has earned CE mark certification for its NeuroKey brain-computer interface (BCI), a neural signal processing software platform that works with implantable devices.
The software decodes neural signals acquired from implanted electrodes in the patient’s brain and runs an auditory feedback speller that prompts the user to select letters to form words and sentences.”
In a related article: FDA Issues Guidance on Implanted Brain-Computer Interface Devices: “Sponsors need to ensure that the failure of any single component of the implanted BCI device doesn’t cause an unacceptable risk during use, the agency advised.
Developers also need to consider electrical safety and electromagnetic compatibility, because the implanted devices may expose the operator and patient to electrical energy hazards, the FDA said.”

Abbott takes an ax to sales forecast as COVID testing dries up faster than expected: “While the need for lab-based PCR tests has dropped steadily since the start of the year, Abbott had anticipated demand to remain high for its rapid, point-of-care tests—such as its card-based BinaxNow antigen diagnostic—thanks to continued coronavirus surveillance and screening programs meant to help people return to work or school.
However, the success rates of today’s vaccines have led many to forgo testing altogether.”

About healthcare quality

Association of Low-Value Care Exposure With Health Care Experience Ratings Among Patient Panels: “Do primary care professional (PCP) patient panels who receive more low-value care rate their health care experiences more favorably?…
With 1 exception (waiting room time), all observed associations between low-value care exposure and health care experience ratings (overall health care, timely access to nonurgent care, timely access to urgent care, personal physician, and interactions with personal physician) were small and/or lacked statistical significance.”