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.”

Today's News and Commentary

About Covid-19

Moderna aims to launch a single-dose COVID-19 vaccine next year in India: report: “Moderna aims to launch a single-dose version of its mRNA COVID-19 vaccine in India next year and is in discussion with Mumbai-based pharmaceutical firm Cipla among others to supply it, according to the India news agency PTI.”

Inhalable Nanobody (PiN-21) prevents and treats SARS-CoV-2 infections in Syrian hamsters at ultra-low doses: “Intranasal delivery of PiN-21 [ Pittsburgh inhalable Nanobody 21] 0.6 mg/kg protects infected animals from weight loss and substantially reduces viral burdens in both lower and upper airways compared to control. Aerosol delivery of PiN-21 facilitates deposition throughout the respiratory tract and dose minimization to 0.2 mg/kg. Inhalation treatment quickly reverses animals’ weight loss after infection, decreases lung viral titers by 6 logs leading to drastically mitigated lung pathology, and prevents viral pneumonia. Combined with the marked stability and low production cost, this innovative therapy may provide a convenient and cost-effective option to mitigate the ongoing pandemic.”

Sinopharm's two COVID-19 shots effective, study says: “Two COVID-19 vaccines from China’s Sinopharm showed more than 70% efficacy against symptomatic cases, but it remains unclear how much protection they provide against severe or asymptomatic cases, according to the first detailed result of a large late-stage study published to the public.”

HHS and DOD will spend $27M to replenish medical supplies:”HHS and the U.S. Department of Defense announced this week that they will spend an additional $27.7 million to increase production of low dead-space syringes and needles, which are in short supply due to the pandemic.
LDS syringes and needles allow providers to extract every dose of vaccine vial upon injection.
This can help providers stretch out current vaccine supply by 20%.”

Resistance to vaccine mandates is building. A powerful network is helping: “Attorneys from Siri & Glimstad — a New York firm that has done millions of dollars of legal work for one of the nation’s foremost anti-vaccination groups — are co-counsel in a case against the Durham County Sheriff’s Office. They’ve sent warning letters to officials in Rock County, Wis., as well as to the president of Rutgers University and other schools.”
These lawyers should be ashamed of themselves.

DOJ Announces Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19: “The Department of Justice today announced criminal charges against 14 defendants, including 11 newly-charged defendants and three who were charged in superseding indictments, in seven federal districts across the United States for their alleged participation in various health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings…
The defendants in the cases announced today are alleged to have engaged in various health care fraud schemes designed to exploit the COVID-19 pandemic. For example, multiple defendants offered COVID-19 tests to Medicare beneficiaries at senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or blood sample. The defendants are alleged to have then misused the information and samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive laboratory tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests. In some cases, and as alleged, the COVID-19 test results were not provided to the beneficiaries in a timely fashion or were not reliable, risking the further spread of the disease, and the genetic, allergy, and respiratory pathogen testing was medically unnecessary, and, in many cases, the results were not provided to the patients or their actual primary care doctors. The proceeds of the fraudulent schemes were allegedly laundered through shell corporations and used to purchase exotic automobiles and luxury real estate.”

U.S. FDA gives emergency use approval for GSK-Vir COVID-19 antibody drug: “The antibody drug, Sotrovimab, is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy, the health regulator said on Wednesday.”

U.S. FDA may not review new COVID-19 vaccine EUA requests during pandemic:The headline is the message. Better to focus on permanent approval of current vaccines and ramp up production and delivery.

Eli Lilly's COVID-19 antibody halted in 6 more states as Regeneron's competing option sails along: “Within hours of granting emergency use approval to a COVID-19 antibody drug by GlaxoSmithKline and Vir, the United States has restricted the use of another COVID antibody treatment, this one from Eli Lilly.
The FDA has halted the distribution of Lilly’s combination of bamlanivimab and etesevimab in Arizona, California, Florida, Indiana, Oregon and Washington––all states where coronavirus variants from Brazil and South Africa account for more than 10% of those with the disease. The antibody combo had previously been paused in Illinois and Massachusetts. 
Providers in those states should use Regeneron’s antibody treatment of casirivimab and imdevimab, the FDA says. Lab studies have shown that option is more effective against the Brazilian (P.1) and South African (B.1.351) strains…”
In a related story: Eli Lilly hit with DOJ subpoena over New Jersey factory making COVID-19 drug: “Thursday, Lilly revealed the DOJ has issued a subpoena demanding documents relating to the site in Branchburg, New Jersey. The site produces doses of Lilly's COVID-19 antibody treatment, which has recently faced setbacks for its susceptibility to certain variants…
The findings included details about the production of bamlanivimab, which has been widely deployed in the U.S. to treat adult and certain pediatric COVID-19 patients with mild to moderate disease…”

Scientists claim to have solved Covid vaccine blood-clot puzzle: “Rolf Marschalek, a professor at Goethe university in Frankfurt who has been leading studies into the rare condition since March, said his research showed the problem sat with the adenovirus vectors that both vaccines use to deliver the genetic instructions for the spike protein of the Sars-Cov-2 virus into the body. The delivery mechanism means the vaccines send the DNA gene sequences of the spike protein into the cell nucleus rather than the cytosol fluid found inside the cell where the virus normally produces proteins, Marschalek and other scientists said in a preprint paper released on Wednesday.”
Another study linked the clots to an additive in the vaccines.

WHO reboots IP sharing scheme for Covid shots, drugs and tests: “The World Health Organization is moving to reboot its intellectual property sharing scheme as vaccine shortages threaten poorer nations’ attempts to emerge from the pandemic and as the debate over patents intensifies. In a letter published on Thursday, WHO director-general Tedros Adhanom Ghebreyesus and Costa Rican president Carlos Alvarado Quesada called on member states to engage with vaccine manufacturers to encourage IP sharing and tech transfer through the scheme.”

About the public’s health

A new tool tracks health disparities in the U.S. — and highlights major data gaps: “On Wednesday, a coalition of researchers and advocates launched a tool they hope will fill some of those gaps: the Health Equity Tracker, a portal that collects, analyzes, and makes visible data on some of the inequities entrenched in U.S. medicine…
Today, the tracker includes the 26 million lines from that restricted CDC database, each of which represents a single Covid-19 patient — including their state and county, race and ethnicity, sex, age, whether they were hospitalized, and whether they died. It combines that information with state-level health insurance and poverty data from the American Community Survey, and details on diabetes and COPD prevalence from America’s Health Rankings.”

2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association: Ten recommendations, many not new, e.g., lifestyle modifications.

Tobacco Cos. To Pay $200M To End Texas' Settlement Fight “Texas notified a federal court Wednesday that R. J. Reynolds Tobacco Co. and fellow tobacco company ITG Brands LLC have agreed to pay a total of more than $200 million to end the state's suit to enforce a 1998 tobacco settlement agreement. Reynolds agreed to pay Texas roughly $173 million in funds owed to the state under the 1998 tobacco master settlement for the years 2015 through 2020, plus $2. 5 million in attorney fees. ITG agreed to pay Texas about $19 million for payments owed to the state in 2020…”
I wonder what Texas will do with the money.

The effect of morning vs evening exercise training on glycaemic control and serum metabolites in overweight/obese men: a randomised trial: “Improvements in cardiorespiratory fitness were similar regardless of the time of day of exercise training. However, improvements in glycaemic control and partial reversal of HFD [High Fat Diet]-induced changes in metabolic profiles were only observed when participants exercise trained in the evening.”

About pharma

Truepill launches virtual primary care, diagnostics services to flesh out its white label digital pharmacy platform: “San Mateo, California-based digital pharmacy startup Truepill is building upon last year’s funding momentum with the formal launch of two new business lines: one focused on virtual primary care and another offering in-home and in-person diagnostic testing…
Designed for payer and employer customers, the Virtual Primary Care offering provides access to a network of primary care physicians able to take video calls or asynchronous text-based messages around the clock and across all 50 states.
Members or employees using the service can select an individual physician to become their primary care provider for all scheduled visits down the line and can receive referrals or other support from the company’s care coordination teams.”

CMS delays controversial best price requirement for drugmakers: “The Biden administration delayed part of a Trump-era rule requiring them to include the discounts they offer to patients when calculating the “best price” for drugs under Medicaid’s drug rebate program, according to a proposed rule on Wednesday.
Drugmakers were supposed to start reporting multiple best prices beginning Jan. 1, but CMS delayed the requirements until July 1, 2022. The agency said the additional time would allow the healthcare industry to address concerns over patient access and quality of care before the new requirements take effect.”

Teva Pharmaceutical to Settle Intuniv Lawsuit for $1.1 Million: “The 2016 lawsuit alleged that Actavis, which Teva acquired that year, had a pay-for-delay deal with Shire that delayed the launch of a generic of Shire’s attention deficit hyperactivity disorder (ADHD) drug Intuniv (guanfacine).”
Companies are still trying to use this method to retain market exclusivity. Although legal actions may curtail some of these activities, the penalties will have to be much larger to be truly effective.

Judge Clears Purdue Pharma’s Restructuring Plan for Vote by Thousands of Claimants: “A federal bankruptcy judge in New York indicated Wednesday that he would permit Purdue Pharma’s proposal to remake itself as a nonprofit company to be put to a vote by thousands of plaintiffs, who have sued to compel the maker of OxyContin to help pay for the terrible costs of the opioid epidemic.”

About health insurance

Health Insurance Trends May 2021: “This report, eHealth’s inaugural edition of its new biannual signature research series, presents an analysis of survey responses and first-hand interviews collected from more than 4,700 consumers and more than two dozen insurer representatives across three megatrends that dominate the health care market today: COVID-19, Technology and Innovation, and Public Policy Reforms.”
Look at page 4 for a summary of the findings. Some opinions are conditional. For example, “60% favor expanding access to Medicare in some form, whether that means making Medicare available to all Americans (28%), lowering the eligibility age to 60 (18%), or allowing adults age 50+ to buy in early (14%).”
But if you ask respondents if they are willing to pay for that option, you will probably get a different answer.

Premium Assistance for COBRA Benefits: From the IRS: This notice provides guidance on the application of… the American Rescue Plan Act of 2021… relating to temporary premium assistance for Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) continuation coverage.
Section 9501 of the ARP provides for a temporary 100 percent reduction in the premium otherwise payable by certain individuals and their families who elect COBRA continuation coverage through the Internal Revenue Code (Code), the Employee Retirement Income Security Act of 1974 (ERISA), or the Public Health Service Act (PHS Act) due to a loss of coverage as the result of a reduction in hours or an involuntary termination of employment.2 The temporary premium assistance is also available to individuals enrolled in continuation health coverage under State programs that provide for coverage comparable to COBRA continuation coverage, often referred to as ‘mini- COBRA.’”

Nurse Practitioner Sentenced to 20 Years, Ordered to Pay More Than $52 Million in Restitution: ”Mr. Reddy and co-conspirators created false patient bills using the provider numbers of six doctors as the treating physicians on the claims. All the claims were false and at no time did the six doctors provide billable services to any of Mr. Reddy’s medical clinics.”

[Nevada] Senate passes ‘public option’ health insurance plan: “SB420 aims to create health insurance policies for individuals that are at least as good as Medicare but provide the coverage at lower costs than Medicare.
The bill was passed on a party line vote with Democrats for it and Republicans unanimously opposed.
The legislation, which now goes to the Assembly, directs the head of Health and Human Services, the executive director of the Silver State Health Insurance Exchange and the Insurance Commissioner to apply to the U.S. Secretary of Health and Human Services for a waiver to obtain federal pass-through funding to pay for the program as well as other waivers to get funding to support the plan including potentially the Social Security Act.”
This legislation is an example of states acting on their own until/if Congress passes a federal public option.
In a related story: Leading Dems seek input on ‘public option’ health care plan: “The wide-ranging request from Sen. Patty Murray of Washington and Rep. Frank Pallone of New Jersey asks basic questions such as who should be eligible to enroll in a new federal health plan, how the benefits would be designed and what payments should look like for hospitals, doctors, drug companies and other medical providers.”

Cost Measures: Traditional MIPS Requirements: From CMS, the latest Merit-based Incentive Payment System payment activity category weights. Go to the bottom of the page and select the pdf.

Physician Compensation Flattens due to the Pandemic’s Impact on Medical Groups: “Primary care physician compensation saw modest growth during 2020. With support for medical practices from the government, most notably the Paycheck Protection Program and the Provider Relief Fund, as well as a rebound in patient volumes in the latter part of the year, physician compensation stabilized as practices covered their overhead with federal assistance. Total compensation for primary care physicians increased by 2.6% between 2019 and 2020 compared to the three- and five-year cumulative increases of 5.27% and 10.15% respectively. Advanced practice providers (APPs) also experienced a slight increase in compensation during the same one-year timeframe…
Compensation changes for most specialties were very modest or essentially flat, and the decreases in compensation seen for certain specialties were not as large as expected. Surgical physicians, for example, whose patient volumes were significantly limited because of regional lockdowns and overwhelmed hospitals, experienced a compensation decrease of 0.89% in 2020. Nonsurgical specialists also reported a decrease of 1.29% despite the significant challenges faced by those specialists last year.”

About healthcare professionals

Best & Worst places to practice: From Medscape: best state to practice is Minnesota; worst is West Virginia.

Today's News and Commentary

About the public’s health

A LIFETIME OF DAMAGE: How Big Tobacco’s predatory marketing harms the health of women and girls: The title explains the article’s exposition of this problem. Most striking are the actual ads.

About Covid-19

HRSA to give nearly $5B to fund COVID-19 tests for uninsured: “The federal government will give a nearly $5 billion boost to a program that reimburses providers for testing uninsured individuals for COVID-19.
The program administered by the Health Resources and Services Administration will get $4.8 billion from the American Rescue Plan, the Department of Health and Human Services announced on Tuesday.”

U.S. to spend $4.8 billion to cover COVID-19 tests for uninsured Americans: “The Department of Health and Human Services announced Tuesday that it will spend an additional $4.8 billion so uninsured Americans will have more access to COVID-19 testing.
Money from the $1.9 trillion American Rescue Plan will go to pay for the additional testing.”

Surveys of Trust in the U.S. Health Care System [post-Covid-19]: “The American Board of Internal Medicine Foundation commissioned NORC to conduct surveys of trust in the U.S. health care system…
Key Findings:

  1. Trust in clinicians is greater than in the health care system as a whole

  2. Physician trust decreased during the COVID-19 pandemic; rebuilding trust is needed

  3. Physicians understand the importance of building trust with patients, but they do not always perform trust-building behaviors”

The entire report is worth reading.

C.D.C. Will Not Investigate Mild Infections in Vaccinated Americans: “The agency will carry out vaccine effectiveness studies that include data on breakthrough cases, but only in limited populations, such as health care workers and essential workers, older adults, and residents at long-term care facilities, a spokeswoman said.
Some scientists support the decision to focus on the illnesses that cause deaths, tax hospitals and overwhelm the health care system. Still, the move has been controversial.”

Effectiveness of Tocilizumab in Patients Hospitalized With COVID-19: “This follow-up analysis suggests that tocilizumab may be considered for treating patients with moderate-to-severe COVID-19–associated pneumonia and high CRP levels. Further studies will help determine which patients with COVID-19–associated pneumonia would benefit the most from a combination of tocilizumab and dexamethasone.”

About health insurance

Emory University Sues HHS Over Medicare Supplemental Pay Ruling: “Emory University and three other hospitals sued HHS in federal court in Washington to invalidate a policy that, they say, effectively ends their right to contest the amount of supplemental Medicare payments they get for treating poor people.
The complaint filed in the U.S. District Court for the District of Columbia involves Medicare disproportionate share hospital payments, which providers receive to offset costs of treating people who can’t pay their share of the bills.”

About pharma

UK regulator probes $39bn AstraZeneca tie-up with Alexion: “Biotech acquisition has been approved in 10 countries including the US…
The Competition and Markets Authority on Tuesday said it was investigating the deal signed in December when AstraZeneca — a key Covid-19 vaccine producer — agreed to buy US company Alexion, a biotech specialising in treatments for rare diseases. The UK regulator said the deal had met its test for a relevant merger — meaning there was a risk that the two companies would cease to be distinct, and had met the threshold for the CMA to investigate. The CMA has set a deadline of June 3 to receive views from interested parties and has until July 21 to decide whether to launch a more in-depth investigation.”

Insurers accuse CVS of overcharging for generic drugs: “Seven health insurers with businesses that span the nation have sued CVS Health Corp., alleging the Woonsocket, R.I.-based retail giant schemed with pharmacy benefit managers to overcharge health plans for generic drugs. 
These insurers’ federal class-action complaint, filed in Rhode Island district court, represents just one lawsuit accusing CVS of fraudulently hiding the real cost of medications, leaving insured customers paying more for drugs than those without insurance.”

Drugmakers Sue HHS Over Medicaid Drug Rebate Rule: “Drugmakers are suing the federal government over a new CMS rule that requires them to include the discounts they offer to patients when calculating the ‘best price’ for drugs under Medicaid’s drug rebate program, according to a lawsuit filed in the U.S. District Court for the District of Columbia on Friday.
The Pharmaceutical Research and Manufacturers of America said in its complaint that CMS didn’t have the power to issue the rule and seemingly reversed course on the agency’s longstanding interpretation of the law.”

Colorado Lawmakers Wage Multifront Assault on High Drug Costs: “Unable to set prices or change patent protections, the state is exploring creative legislative and administrative approaches to lower out-of-pocket costs on medications.
While none of the efforts alone would result in broad-based, deep cuts, state officials estimate the combined impact of the various measures could save Coloradans between 20% and 40% in out-of-pocket costs…
One bill would create a prescription drug affordability board, which could review prices of medications sold in the state to consumers and set payment limits. The legislation, backed by Democratic Gov. Jared Polis, has already passed the Colorado Senate and is making its way through the House. The board would be charged with ensuring those savings are passed on to consumers.”

Amazon considering building brick-and-mortar pharmacies, report says: “Amazon reportedly is considering delving deeper into the prescription drug business by either opening standalone retail pharmacies or adding pharmacies to its Whole Foods stores, Business Insider reported. 
The discussions are still in the exploratory stage, and if the company decides to move forward, it could take more than a year for it to start opening pharmacies, according to the article.”

Pharma and healthcare in merger buzz as two £1bn deals agreed: “The UK pharmaceuticals and healthcare sector was buzzing with merger activity on Wednesday as two £1bn deals were agreed by company executives. Ramsay Health Care swooped for Spire Healthcare that would create the UK’s largest private hospital group, while private equity’s Carlyle snapped up London-listed inhaler specialist Vectura.”

About healthcare IT

Google, HCA partner for health algorithms: 7 things to know: “HCA Healthcare inked a multi-year collaboration with Google Cloud focused on building a health data analytics platform to support the Nashville, Tenn.-based system's clinical and operational workflows, the organizations announced May 26... Under the partnership, HCA will use Google Cloud's healthcare data offerings, including the Google Cloud Healthcare application programming interface and BigQuery, a database that supports healthcare dating sharing standards Health Level Seven and Fast Healthcare Interoperability Resources.”

About hospitals and healthcare systems

The antitrust fallacy:Why busting up big health systems won't bring down hospital prices: A very thoughtful piece from Merrill Goozner, former editor of Modern Healthcare.

Today's News and Commentary

Happy Birthday!

Today is Professor Phillip Kotler’s 90th birthday.
Among his many accomplishments, he is the father of Social Marketing, which has been used to improve the health of countless people.
[For his latest writing on this subject, see: Strategic Marketing for Healthcare Organizations 2nd Edition (c)2021]

About Covid-19

Faster than a PCR test: dogs detect Covid in under a second: More on canine detection of Covid-19.

SARS-CoV-2 infection induces long-lived bone marrow plasma cells in humans: As we understand more about the natural history of Covid, this update on the longevity of immunity is important:
”Here we demonstrate that in patients who experienced mild infections (n=77), serum anti-SARS-CoV-2 spike (S) antibodies decline rapidly in the first 4 months after infection and then more gradually over the following 7 months, remaining detectable at least 11 months after infection. Anti-S antibody titers correlated with the frequency of S-specific BMPCs [long-lived bone marrow plasma cells] from bone marrow aspirates of 18 SARS-CoV-2 convalescent patients 7 to 8 months after infection.”

Moderna says its vaccine triggers immune response in teenagers, will seek FDA approval: “Biotechnology company Moderna announced Tuesday that its two-shot coronavirus vaccine produced the same immune response in teenagers as adults, and it plans to submit the data to U.S. regulators in early June.”

Push for vaccines reduced drug options for Covid patients: “While the Biden administration has committed to channeling billions of dollars into finding therapies, a key government agency that invests in drug development recently stopped reviewing requests for new treatments — in part because it doesn't have enough cash available, according to one senior health official…
The Health department’s agency to fund early countermeasures, the Biomedical Advanced Research and Development Authority, suspended calls for new therapies in May, partly because of tight budgets that one senior HHS official said could be refreshed with dollars from the American Rescue Plan, H.R. 1319 (117). And past trials yielded mixed results from a number of potential products. BARDA continues to fund nine ongoing projects, eight of which are aimed at more severe Covid cases. Only a single early project for potential antiviral formulas targets mild illness.”
In a related article: EU panel backs GSK, Vir's antibody sotrovimab for early COVID-19 treatment: “The European Medicines Agency (EMA) on Friday said its Committee for Medicinal Products for Human Use (CHMP) issued an opinion recommending GlaxoSmithKline and Vir Biotechnology's sotrovimab to treat COVID-19 in adults and adolescents aged 12 and older who do not require supplemental oxygen, but are still at risk of progressing to severe disease. The dual-action SARS-CoV-2 monoclonal antibody is also under review by the FDA to prevent at-risk patients with mild-to-moderate COVID-19 from getting worse.”

Pfizer study to investigate co-administration of COVID-19, pneumococcal vaccines: “The study's primary objective is the safety of both vaccines administered together, with follow-up six months after immunisation, while secondary goals include immune responses produced by each of the vaccines.”

COVID-19 Vaccine Breakthrough Infections Reported to CDC — United States, January 1–April 30, 2021: Published today from the CDC: “A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported from 46 U.S. states and territories as of April 30, 2021. Among these cases, 6,446 (63%) occurred in females, and the median patient age was 58 years (interquartile range = 40–74 years). Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died.”

Vaccine waitlist Dr. B collected data from millions. But how many did it help?: “Millions of users gave personal and health information to the US waitlist service.
Users say they were only offered appointments once eligibility was wide and appointments easy to come by.
The company refuses to say how many people it actually got vaccinated.”

About the public’s health

America’s Health Rankings® Annual Report: The 31st annual report on the status of our public health by the United Health Foundation in partnership with the American Public Health Association. In the report are:
74 measures to track current and emerging health issues at the state and national level.
Five categories of health in a new model: social and economic factors, physical environment, clinical care, behaviors and health outcomes.
20 data sources”
It is an excellent source to track the progress (or decline) of public health and associated measures (like education and income).

A megastudy of text-based nudges encouraging patients to get vaccinated at an upcoming doctor’s appointment: “We present a large field experiment (N = 47,306) testing 19 nudges delivered to patients via text message and designed to boost adoption of the influenza vaccine. Our findings suggest that text messages sent prior to a primary care visit can boost vaccination rates by an average of 5%. Overall, interventions performed better when they were 1) framed as reminders to get flu shots that were already reserved for the patient and 2) congruent with the sort of communications patients expected to receive from their healthcare provider (i.e., not surprising, casual, or interactive). The best-performing intervention in our study reminded patients twice to get their flu shot at their upcoming doctor’s appointment and indicated it was reserved for them. This successful script could be used as a template for campaigns to encourage the adoption of life-saving vaccines, including against COVID-19.”
A perfect example of social marketing research.

STATEMENT of the American Medical Association to the U.S. House of Representatives Committee on Oversight and Reform Re: Birthing While Black: Examining America’s Black Maternal Health Crisis: This document is the AMA’s Congressional testimony about the high rate of maternal complications and death among Black women. Knowledge of this disparity is not news; but what is important are the recommendations the report contains to address this severe problem.

Effects of Diet and Sodium Reduction on Cardiac Injury, Strain, and Inflammation: The DASH-Sodium Trial: “Combining a DASH dietary pattern with sodium reduction can lower 2 distinct mechanisms of subclinical cardiac damage: injury and strain, whereas DASH alone reduced inflammation. (Dietary Patterns, Sodium Intake and Blood Pressure.”

In the Debate Over ‘SIDS Monitors,’ Evidence Is Thin All Around: “…short of stronger evidence — ideally from a carefully controlled clinical trial — some pediatric experts continue to raise pointed questions about what, exactly, modern monitoring companies are selling. Ruey-Kang Chang, a pediatric cardiologist at Harbor-UCLA hospital who has published research on SIDS, said it’s clear that there is no clinical trial data or scientific evidence that shows these monitors can save babies from SIDS. Instead, he said, ‘I think they prey on parents’ anxiety.’”

About health insurance

Meet new CMS Administrator Chiquita Brooks-LaSure: 4 things to know: “The Senate has confirmed Chiquita Brooks-LaSure as the next CMS administrator. She will lead the trillion-dollar agency within HHS that manages Medicare, Medicaid and health insurance marketplace programs.”

Private payers to dole out over $2B in ACA rebates this fall: “Private insurance companies are expected to provide $2.1 billion in rebates to 10.7 million policyholders, the second-highest amount issued under the Affordable Care Act…”
The amounts are due to low Medical Loss Ratios that plans experienced last year due to decreases in elective care. Expect a rebound over “normal” this year.

Marketplace Premiums and Participation 2021: “In 2021, the ACA Marketplaces entered their eighth year of operation and premiums have stabilized. The national average benchmark premium fell again in 2021, following decreases in both 2019 and 2020. This decline is remarkable because it contrasts with premium increases in the employer-sponsored insurance market over the same period. However, the nationwide average belies the variation in premiums both across and within states…
We found that the number of insurers was a strong predictor of lower premiums; markets with only one or two insurers had substantially higher premiums than markets with five or more insurers. On the other hand, the presence of a Medicaid insurer was associated with lower premiums. Similarly, regions in states that expanded Medicaid or established state-based Marketplaces had lower premiums than regions in states that had not enacted such policies.”

Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Anthem Community Insurance Company, Inc. (Contract H3655) Submitted to CMS: “With respect to the seven high-risk groups covered by our audit, most of the selected diagnosis codes that Anthem submitted to CMS for use in CMS's risk adjustment program did not comply with Federal requirements. For 123 of the 203 enrollee-years, the diagnosis codes that Anthem submitted to CMS were not supported in the medical records and resulted in $354,016 of net overpayments for the 203 enrollee-years.
These errors occurred because the policies and procedures that Anthem had to detect and correct noncompliance with CMS's program requirements, as mandated by Federal regulations, were not always effective. On the basis of our sample results, we estimated that Anthem received at least $3.47 million of net overpayments for these high-risk diagnosis codes in 2015 and 2016.”
In a related article: Humana nets nearly $200M in overpayments, OIG audit finds: “Humana allegedly overcharged the federal government by nearly $200 million for submitting documentation that inaccurately showed some of its Medicare Advantage members were sicker than they actually were in 2015, according to an audit conducted by the HHS Office of Inspector General.
OIG is recommending Humana return $197.7 million and improve its policies to prevent such overpayments in the future.”

Time and Financial Costs for Physician Practices to Participate in the Medicare Merit-based Incentive Payment System: “In this qualitative study using interviews with leaders of 30 physician practices across the US, an average of $12 811 per physician was spent to participate in MIPS in 2019. Clinicians and administrators spent more than 200 hours per physician on MIPS-related activities.”

Lawmakers Propose Permanent Medicare Coverage Of Audio-Only Telehealth: “Medicare would permanently cover audio-only telehealth visits under a new bill introduced Monday by two members of Congress. 
The bill, introduced by Rep. Jason Smith (R-Mo.) and Josh Gottheimer (D-N.J.), would also remove a requirement that patients receive telehealth services at a health facility for it to be covered by Medicare.”

CMS: Prior authorization slashed ambulance transportation by 70%: “Prior authorization dramatically lowered the use of regular, non-emergency ambulance transportation among Medicare beneficiaries without affecting quality or beneficiaries’ access to care, according to a government report on Monday.
Those are the results of a CMS Center for Medicare and Medicaid Innovation experiment to test whether requiring ambulance service providers to get pre-approval for such services would reduce their use among Medicare beneficiaries with End-stage Renal Disease or pressure ulcers.
Researchers found that prior authorization reduced unnecessary use and spending by more than 70%, lowering total Medicare spending by 2.4%. The findings suggest that expanding prior authorization for regular non-emergency ambulance transportation could save Medicare even more money without affect beneficiaries’ health.”

About healthcare IT

UPMC Health Plan rolls out virtual concierge for Amazon Alexa, Google Assistant devices: “The insurer, headquartered in Pittsburgh, launched a new virtual concierge feature that will assist commercial plan members with some of their most frequently asked questions related to their benefits and coverage and how to access care and services. Members can also use the service to find out more about health insurance basics and how to access services like telehealth.
UPMC Health Plan is owned by the University of Pittsburgh Medical Center (UPMC).”

Humans Top Digital Scribes For Better EHR Documentation: “Human scribes still trump digital scribes in EHR documentation, according to a study published in the Association for Computing Machinery Digital Library.
A digital scribe is not currently capable of widespread adoption because of a lack of accuracy, completeness, and medical synthesis, clinician respondents said.”

Microsoft’s cloud boss says the company doesn’t want to compete with doctors: “Thanks to its pending acquisition of Nuance Communications, Microsoft will soon have a suite of software tools that doctors use to automatically keep notes on meetings with patients. But Microsoft isn’t interested in automating everything doctors do, said Scott Guthrie, the software company’s executive vice president for cloud and artificial intelligence.
The pending acquisition, worth $19.7 billion including debt, is an unusual case of a major technology company drawing from its cash pile to gain relationships in an individual industry. Microsoft’s rivals in the growing cloud computing market have not gone so far. If the move proves successful, Microsoft could convert Nuance customers into big users of Microsoft’s Azure cloud and strengthen its position relative to the market leader, Amazon.”

ONC Defines EHR Certification For SDOH Data To Pursue Health Equity: “ONC announced its health IT demographic EHR certification requirements to standardize race and ethnicity data collection in the pursuit of health equity.
ONC outlined that the agency’s “demographics” certification criterion requires health IT to record race and ethnicity at the same level of detail as the CDC’s Race & Ethnicity code technology. This system encompasses over 900 concepts for race and ethnicity, giving patients precise options for self-identifying their demographic information.”

Hospitals and health systems

Hospitals faced slight patient volume declines in April compared to March: “Hospital patient volumes in April saw a major increase compared to the same month in 2020 but were below March 2021’s levels, a new report from Kaufman Hall found.
The report, released Monday (PDF), shows the volatility and uncertainty the hospital industry still faces as facilities recover from the pandemic.”

Fintech takes aim at a $400B healthcare puzzle: Patients contract with companies for interest-free payments of hospital bills over time. The companies make their money by paying hospitals a discounted on the patients’ charges. Think of this scheme as the mirror image of paying premiums in advance of the event for traditional insurance coverage.

About diagnostics

Memorial Sloan Kettering AI spinout, Quest Diagnostics partner to expedite cancer diagnoses: “Paige, New York City-based Memorial Sloan Kettering's artificial intelligence spinout, teamed up with Quest Diagnostics May 25 to improve and expedite diagnoses for cancer and other diseases that need pathologic assessment..
Initially, the collaboration will focus on solid tumor cancers, such as breast, prostate, lung and colorectal.”

About pharma

CVS Health Introduces Clinical Trial Services: CVS is entering the Clinical Research Organization business and aims to increase recruitment for drug trials by tapping into each of its local markets.

Implantable piezoelectric polymer improves controlled release of drugs: Repeated tests showed a similar amount of drug release per activation, confirming robust control of release rate: “A membrane made from threads of a polymer commonly used in vascular sutures can be loaded with therapeutic drugs and implanted in the body, where mechanical forces activate the polymer's electric potential and slowly release the drugs.
The novel system, developed by a group led by bioengineers at UC Riverside and published in ACS Applied Bio Materials, overcomes the biggest limitations of conventional drug administration and some controlled release methods, and could improve treatment of cancer and other chronic diseases.”

Today's News and Commentary

About the public’s health

48 ORGANIZATIONS CALL FOR PHASING OUT SALES OF COMBUSTIBLE TOBACCO PRODUCTS: From the Action on Smoking and Health (ASH): “The vision to end the combustible tobacco epidemic is not new. Several countries have set themselves on a path to end smoking within a generation. Bhutan banned tobacco sales years ago, and two cities in California have already passed ordinances to end tobacco sales from 1 January 2021. Dutch lawmakers have passed laws aimed towards phasing out cigarette sales.”
The statement includes the list of organizations supporting the phase out.
Smoking kills more people annually than Covid-19. That fact should provide evidence for how deep political influence goes to keep tobacco products on the market.

Long-term Intake of Gluten and Cognitive Function Among US Women: There are many myths about the benefits of gluten-free diets in those without celiac disease. This research debunks one of them: “In this study, long-term gluten intake was not associated with cognitive scores in middle-aged women without celiac disease. Our results do not support recommendations to restrict dietary gluten to maintain cognitive function in the absence of celiac disease or established gluten sensitivity.”

About health insurance

White House budget plan set to leave out some health care proposals from campaign: “The White House jettisoned months of planning from agency staff as their initial plan could fuel criticisms that the administration is pushing new spending programs too aggressively. The budget will not include President Biden’s campaign pledge to enact a public option to create a government-run health insurance program, or his pledge to cut prescription drug costs, the people said. The people spoke on the condition of anonymity to describe internal administration deliberations.”
In cases like this one I always wonder what Lyndon Johnson would have done.

OptumRx analysts see more pharmacy fraud activity amid COVID-19: “The pharmacy benefit manager giant recovered $300 million in fraud, waste and abuse spend in 2020 and documented the largest ever increase in fraudulent claims, which were up 300% compared to 2019.
In addition, Optum's investigative audits led to an increase of 135% in fraud recoveries last year from 2019. The average audit recovery per case was also 70% higher in 2020 than in 2019, Optum found…
Optum found the fraudulent behavior concentrated among independent pharmacies and rarely found similar activity among retail chains…Due to the findings, the PBM axed 112 pharmacies from its network.”

State of Medicare Advantage [MA] REPORT MAY 2021: When comparing traditional Medicare with MA plans, the following findings should be kept in mind:

• “Enrollment in Medicare Advantage is growing year over year with over 26 million people, or 42 percent of all Medicare beneficiaries currently enrolled in Medicare Advantage. 
• Medicare Advantage beneficiaries report a 98 percent satisfaction rate with their coverage. 
•The Medicare Advantage population is increasingly diverse. 33.7 percent of Medicare Advantage beneficiaries identify as a racial or ethnic minority, compared to 16 percent in Traditional FFS Medicare. 
• Medicare Advantage beneficiaries report lower average annual individual spending compared to Traditional FFS Medicare, with consumer cost savings of $1,640. This savings is a 40 percent lower rate of cost burden for Medicare Advantage beneficiaries.
• Medicare Advantage has a 43 percent lower rate of avoidable hospitalizations for any reason, as compared to Traditional FFS Medicare, and higher rates of screening for conditions such as cancer and depression. 
• 99 percent of all Medicare beneficiaries have access to at least one Medicare Advantage plan and 96 percent of Medicare Advantage beneficiaries have access to at least one zero-dollar premium plan. 
• About 90 percent of Medicare Advantage plans offer wellness, dental, vision, or hearing coverage, which are not available in Traditional FFS Medicare, and approximately 68 percent offer all four benefits. More plans also offer supplemental benefits for chronically ill beneficiaries that address social determinants of health. 
• 52.7 percent of all Medicare Advantage beneficiaries live below 200 percent of the Federal Poverty Level, compared to 39.1 percent of beneficiaries in Traditional FFS Medicare.”

Laws to Curb Surprise Medical Bills Might Be Inflating Health Care Costs: “The concerns stem from guidelines states have established to help impartial arbitrators resolve disputes between providers and insurance carriers over how much should be paid for surprise, out-of-network bills.”
The problem is that these arbitrations rely on prevalent fees. Providers will anticipate these events and raise their prices to compensate.
The article has a helpful graph of which states have passed surprise billing legislation and an explanation of the arbitration process..

Federal court says HHS must recalculate years of Medicare payments to teaching hospitals: I previously reported this story, but now the financial impact of this decision is a bit clearer: “…plaintiff teaching hospitals said they were under reimbursed by millions of dollars for fiscal years dating as far back as 2005. One plaintiff, Milton S. Hershey Medical Center, said that its reimbursements were collectively reduced by more than $12.8 million due to the regulation.”

Commercial Savings Generated by Medicare Negotiation Under H.R. 3: “Title I and Title II of H.R. 3 address drug prices in two separate approaches. Title I, the ‘Lowering Prices Through Fair Drug Price Negotiation’ provision, would empower the Secretary of Health and Human Services (HHS) to negotiate prices directly with drug manufacturers for up to 250 of the costliest single-source brand drugs on the market. Negotiations would begin in 2023 and then each year thereafter HHS would establish a list of eligible drugs for which manufacturers would be required to negotiate prices. Title II, the ‘Medicare Parts B and D Prescription Drug Inflation Rebates’ provision, would require manufacturers to limit price increases to the rate of inflation by paying any greater price increase back as a rebate….
Under H.R. 3, West Health estimates that employers could see a $195 billion reduction in health care spending, while employees could see $61 billion in lower costs ($53 billion in lower premiums and $8 billion in lower out-of-pocket costs). Total costs for the ACA market could fall by $58 billion, including $34 billion in lower beneficiary premiums, $2 billion in lower cost-sharing, and $21 billion in federal savings through reduced Advance-Premium Tax Credits. Even though this scenario presumes that manufacturers will increase drug prices at a faster rate than current trends to make up for lower prices on negotiated drugs, the lower prices achieved under Title I of H.R. 3 outweigh these price increases.”

Biden admin to end Next Gen ACO model after this year: “The Biden administration has decided to not extend the Next Generation Accountable Care Organization Model, which is expected to end at the end of 2021.
The decision, announced late Friday, ends a program that called for ACOs to take on more financial risk than the Medicare Shared Savings Program (MSSP). The model was originally expected to end at the start of 2021 but was extended by the Trump administration due to the pandemic.”

About Covid-19

G-20 Health Accord Shows Split On Waiving COVID IP: “Leaders from the world's largest economies, including Vice President Kamala Harris, reached an agreement on Friday to support voluntary licensing of intellectual property covering COVID-19 vaccines, in a move that shows many countries are still reluctant to support a U.S.-backed World Trade Organization proposal to waive IP rights.
A declaration issued in Rome at the end of an international health summit failed to mention the proposal to waive aspects of the WTO's Council for Trade-Related Aspects of Intellectual Property Rights, or TRIPS, agreement, and instead focused on ways that G-20 members could work ‘consistently within’ the treaty's framework.”
The article is a good, current explanation of where the US currently stands on this issue vis-a-vis other countries.

Scientists zero in on long-sought marker of COVID-vaccine efficacy: “Triccas and his colleagues examined neutralizing-antibody data from trials of seven widely used vaccines. The team found a strong link between participants’ antibody levels recorded in early-stage trials and vaccine-efficacy results from late-stage trials. The researchers estimate that a vaccine has an efficacy of 50% even if it induces antibody levels 80% lower than those found, on average, in a person who has recovered from COVID-19.
Vaccines that generated the strongest neutralizing-antibody responses, such as the mRNA-based vaccines made by Moderna and Pfizer–BioNTech, were the most protective. Vaccines that induced a weaker response, which included the Oxford–AstraZeneca jab, provided lower levels of protection.
The researchers predict that because antibody levels wane over time, booster shots might be needed in about a year, but protection against severe disease could last many years even without them.”

Study finds Pfizer, AstraZeneca's COVID-19 vaccines "highly effective" against Indian variant: “An analysis by Public Health England (PHE) suggests that two doses of COVID-19 vaccines from Pfizer/BioNTech and AstraZeneca are "highly effective" against the B.1.617.2 coronavirus variant first identified in India, the UK government announced on Saturday.”

Pfizer, BioNTech to Distribute 2 Billion Doses to Lower-Income Countries: “The shipments to low- and middle-income nations would occur over the next 18 months, said Pfizer CEO Albert Bourla, adding that low-income countries would receive doses for free while middle-income countries would pay approximately half of what richer nations pay — an estimated $10 rather than $20 per dose.”

Americans favor vaccine mandates over vaccine passports, study shows: “Sixty-two percent of American adults said they support federal, state and local governments requiring citizens to get vaccinated against COVID-19, while just 27.5 percent said they supported businesses' use of vaccine passports, according to survey results released May 20 by the COVID States Project.”

Moderna taps Samsung for fill-finish duties on 'hundreds of millions' of COVID-19 vaccine doses: “Moderna has tapped Samsung Biologics for large-scale, commercial fill-finish duties on its mRNA-based vaccine, the companies said Saturday. Once the deal closes, tech transfer will kick off ‘immediately’ at Samsung's facilities in Incheon, South Korea, where the CDMO plans to leverage a finishing, labeling and packaging line to crank out ‘hundreds of millions’ of vaccine doses for countries other than the United States.”

About hospitals and healthcare systems

Mayo Clinic sees net income rebound to $782M in Q1: “Rochester, Minn.-based Mayo Clinic recorded a net income of $782 million in the first quarter of 2021, or a margin of 21.1 percent, according to recently released financial documents. In the same quarter one year prior, Mayo Clinic recorded a net loss of $623 million.” A good exercise is to review these statements and see what changed.

Advocate Aurora to make remote work permanent for 12,000 employees: “Under the new work model, dubbed WorkForward, the 12,000 non-clinical employees who have been working remotely throughout the COVID-19 pandemic will continue to do so permanently; these employees will 'no longer have dedicated workspaces’ like cubicles or offices at the health system's Milwaukee and Downers Grove, Ill.-based offices, the publication reports. 
Affected departments include finance and accounting, consumer experience and public affairs, strategy and business development, government relations and administration. Employees will be able to choose to work from home, at a coffee shop or other locations…”
Another example of how COVId-19 has accelerated business trends. While productivity changes with remote work have yet to be adequately studied, many businesses find that they are saving large amounts due to reduced rent/building ownership as well as on-site support services (cleaning, food service, etc.).

About healthcare IT

FBI warns Conti ransomware hit Ireland system, targeted 16 U.S. medical, emergency networks: “The same hackers that hit the Irish health system a week ago also targeted at least 16 U.S. medical and first responder networks in the past year, according to a federal law enforcement alert.
The Cyber Division of the Federal Bureau of Investigation (FBI) said cybercriminals using the malicious software dubbed 'Conti' have targeted law enforcement, emergency medical services, dispatch centers, and municipalities.
The alert didn't name specific victim organizations or offer details about the nature or severity of the breaches…”

21 telehealth platforms ranked by KLAS: “Swymed, Doximity and Caregility topped the list of telehealth companies ranked highest for provider satisfaction, according to a recent KLAS Research report. 
For its ‘Telehealth Ecosystem 2021’ report, KLAS Research analyzed customer-reported information on several telehealth platforms to generate overall performance scores for each platform.”

Hims & Hers Q1 revenue jumps 74% as company looks to expand virtual behavioral health services: “Hims & Hers, a consumer telehealth and wellness brand, saw its first-quarter 2021 revenue grow 74% to $52 million, beating both the company's expectations and Wall Street estimates…
The digital health company reported a net loss of $51 million for the first quarter of 2021 compared to a loss of $6 million for the first quarter of 2020. The year-over-year increase in net loss was primarily driven by one-time stock-based compensation and transaction bonus expenses related to the merger with Oaktree Acquisition Corp.”

Industry Voices—Digital twins of humans are closer than you think: Fascinating explanation of creating virtual human twins (digitally) so that treatments can be tried on the copy first.

Centering Equity In The Design And Use Of Health Information Systems: Partnering With Communities On Race, Ethnicity, And Language Data: A thoughtful discussion of the headline’s topic.

Today's News and Commentary

About Covid-19

Fauci says the U.S. will meet Biden's July 4 vaccination goal: “Around 160 million Americans have received at least one shot. Around half a million people need to receive their first shot over the next 44 days in order for Biden to meet his goal.”

U.S. reports fewer than 30,000 cases for five straight days, with the nation averaging 1.8 million daily vaccinations: “The U.S. has reported fewer than 30,000 cases for five straight days, bringing the seven-day average of daily new infections to about 30,300.
Roughly 1.8 million vaccinations have been reported on average each day over the past week, and 48% of the population has received at least one dose.”

FDA allowing longer refrigerator storage for Pfizer-BioNTech vaccines: “The agency moved to extend the storage time for thawed shots to up to one month between 35 and 46 degrees Fahrenheit, instead of the previous regulation of up to five days.”

CytoDyn shares plummet after FDA blasts the biotech for cherry-picking COVID-19 data: This case highlights the reason we need independent reviews:
“Back in March, a phase 3 clinical trial of CytoDyn’s leronlimab failed on the primary goal of reducing symptoms and all secondary goals, including one that questioned whether the therapy could reduce mortality. But the company instead focused its data release on a subgroup of 62 mechanically ventilated, critically ill COVID-19 patients, claiming that the drug spurred a 24% reduction in all-cause mortality and a six-day reduction in hospitalization, among other trial wins.
CytoDyn then issued a second press release after performing an ‘age adjustment’ analysis that claimed to show leronlimab reduced mortality in older patients.
Now, the FDA has broken its usual vow of silence on disclosing information on unapproved products to say that CytoDyn’s reshaping of the data is erroneous.”

About health insurance

Startup insurer Bright Health files to go public: “In its filing, Bright Health boasted $1.2 billion in revenue for 2020 and approximately 623,000 members in its commercial and Medicare Advantage plans. The insurer operates in 99 markets across 14 states.”

Single moms sue Missouri for refusing to expand Medicaid: ”Two single mothers are among a group of low-income adults who on Thursday sued Missouri Gov. Mike Parson’s administration for dropping plans to expand Medicaid. 
The two moms and a third woman asked a Cole County judge to force the state to give them coverage under the government health care program, as called for in a constitutional amendment approved by voters last year.”
To my knowledge, this law suit is unprecedented.

Kansas governor vetoes bill on short-term health insurance: ”Democratic Gov. Laura Kelly on Wednesday vetoed a bill favored by many Republican lawmakers that could have encouraged some people to stick longer with short-term health coverage that critics label ‘junk insurance.’
The bill’s backers said it simply would have given people who buy limited duration health insurance more protection against premium increases or coverage changes. Such plans, lasting up to a year, offer lower premiums than comprehensive plans but don’t cover pre-existing medical conditions and other items such as medications or maternity care.”

Cardiologist sentenced for decade-long healthcare scheme: “Asim Hameedi, MD, previously pleaded guilty to conspiracy to commit healthcare fraud. Dr. Hameedi was president and owner of a clinic in New York City called City Medical Associates.
According to the indictment, court filings and proceedings, Dr. Hameedi worked with co-conspirators to falsify patients' symptoms to get prior authorizations for medical tests and procedures. He also backdated bills to get around prior authorization requirements, submitted false claims to insurers and violated HIPAA by viewing patients' EHRs without authorization, among other actions, according to the Department of Justice.”
Why did it take so long to uncover this fraud? What would have happened if payments were global or capitated?

UnitedHealthcare introduces new initiative to improve health equity: “The payer is working with the Council of Large Public Housing Authorities, public housing agencies, federally qualified health centers and community-based organizations in a "mutual commitment" to close gaps in care, according to a May 19 news release.
The group will analyze claims, healthcare utilization and local data to address issues regarding food insecurity, health literacy, maternal and women's health, mental health, homelessness, healthcare access, and chronic disease management.”

About healthcare IT

CaptureRx data breach compromised 1.6M individuals' data: 13 hospitals, healthcare providers affected: “CaptureRx helps hospitals manage their 340B drug programs and said it discovered unusual activity in some of its files back in February. Compromised files contained patient records with protected health information, including names, birthdates and prescription details.
CaptureRX reported that there are 1,656,569 known victims affected by the breach.”

GAO tells Congress to halt expanding telehealth until there's more research: “The Government Accountability Office testified in front of Congress that government agencies should wait until after the pandemic, when there is more research, before expanding telehealth coverage for Medicare and Medicaid programs, according to a May 19 report.
Telehealth capabilities were vital during the start of the pandemic, but now it's deemed safe to return to a physician's office. Some officials from GAO are concerned that there have not been enough studies proving that virtual visits are just as effective as in-person visits. 
In addition, telehealth visits can increase CMS' spending if virtual visits are reimbursed the same as in-person visits. There is also an increased risk of fraud, waste and abuse that GAO has previously noted because some program safeguards have been suspended.”

About pharma

NICE Rejects J&J’s Oral Prostate Cancer Drug Over Costs: A reminder that other countries make cost/benefit decisions on drug coverage: “The cost-appraising body said the drug’s price, approximately $ 3,879 per pack of 112 tablets, was too expensive and that patients had other oral prostate cancer treatment options, including Bayer’s Nubeqa (darolutamide).”

Bill Ending Orphan Drug Exclusivity Loophole Clears House: A bit more clarification on this Bill (passed two days ago): “H.R. 1629, the Fairness in Orphan Drug Exclusivity Act, which amends existing legislation to require drugmakers who receive seven years of market exclusivity for a drug that treats a nonrare disease to provide regular updates to the FDA explaining why they can’t reasonably expect to recoup research and development costs from sales within 12 years of launch.
If companies are unable to provide adequate justification to the agency, H.R. 1629 gives the FDA the power to revoke orphan drug exclusivity for the nonrare disease drugs.”

Magellan Rx Management’s Medical Pharmacy Trend Report Unlocks the Latest Trends and Emerging Strategies to Manage Rising Medical Benefit Specialty Drug Spend: This annual report has some very specific details about drugs as well as overall trends. A major finding that exemplifies the basis for increased costs is: “The oncology pipeline had more than 700 drugs in clinical trials in 2019 and is forecasted to increase 105% in PMPM spend from $52 in 2019 to $106 in 2024.”

About hospitals and healthcare systems

Colorado Will Pay Hospitals to Close Expensive Free-Standing ERs: “Colorado health officials so abhor the high costs associated with free-standing emergency rooms they’re offering to pay hospitals to shut the facilities down.
The state wants hospitals to convert them to other purposes, such as providing primary care or mental health services.
At least 500 free-standing ERs have set up in more than 20 states in the past decade. Colorado has 44, 34 owned by hospitals.
The trend began a decade ago with hopes these stand-alone facilities would fill a need for ER care when no hospital was nearby and reduce congestion at hospital ERs.
But that rarely happened.”

HCA to fund $50M in community projects: “The "Healthier Tomorrow Fund" will support grants to nonprofit organizations that run health and workforce projects. Up to $5 million will be distributed in the fund's first year to support high-priority community needs and health equity efforts. 
The 25 communities include cities in Texas, Florida, Missouri, Colorado and North Carolina. HCA plans to eventually expand the fund to additional communities.”

About healthcare technology

FDA drafts guidance on cutting-edge devices for controlling Type 2 diabetes: “A new draft guidance (PDF) from the agency is aimed at hardware designed to directly improve HbA1c levels in people with Type 2 diabetes mellitus, regardless of whether or not they are taking insulin or another drug regimen—an area where no devices have yet been approved. 
The FDA’s new recommendations for study design do not apply to software programs and devices used to monitor blood sugar, calculate doses and deliver insulin, such as continuous glucose monitors or digitally connected pens and pumps…
For interventions involving higher-risk surgical or endoscopic procedures or implants, the agency urged a follow-up period of at least one year and recommended that companies limit their use to patients whose diabetes has not come under control despite the use of at least two non-insulin medications, including one at its maximum dose.”

FDA finalizes ‘leapfrog’ guidance on use of thought-controlled tech in paralysis patients, amputees: ”The agency issued the final version of its guidanceon brain-computer interface technology, outlining best practices for clinical and nonclinical testing of implanted devices that use brain activity to restore motor and sensory capabilities in patients with paralysis or amputation…
The draft guidance offered recommendations about these devices’ electrical and electromagnetic safety needs, plus their long-term biocompatibility with users’ blood, cerebrospinal fluid and nerve tissue. It also advised technology developers on using nonclinical testing to mitigate any potential risks before beginning carefully designed clinical studies.”

The top 10 medtech VC rounds of 2020: FYI

ASCO Abstracts: The American Society of Clinical Oncology meets June 4-8, but the abstracts have been released and are available at this web address.



Today's News and Commentary

About Covid-19

CDC expects Covid vaccine data on pregnant women in summer, kids under 12 in fall: The message is the headline.

100 Million Vaccine Doses Held Up Over Contamination Concerns, Firm Reveals: “The chief executive of Emergent BioSolutions, whose Baltimore plant ruined millions of coronavirus vaccine doses, disclosed for the first time on Wednesday that more than 100 million doses of Johnson & Johnson’s vaccine are now on hold as regulators check them for possible contamination.
In more than three hours of testimony before a House subcommittee, the chief executive, Robert G. Kramer, calmly acknowledged unsanitary conditions, including mold and peeling paint, at the Baltimore plant. He conceded that Johnson & Johnson — not Emergent — had discovered contaminated doses, and he fended off aggressive questions from Democrats about his stock sales and hundreds of thousands of dollars in bonuses for top company executives.”

UK launches extensive trial of third booster shots of Covid vaccines: “The UK is laying the scientific foundations for giving third booster shots of Covid-19 vaccines in the autumn, with a wide-ranging clinical trial that will assess the effects of seven different jabs on people who have already received two Oxford/AstraZeneca or BioNTech/Pfizer doses. The new Cov-Boost study will ‘provide data on immunogenicity and side-effects to inform the government’s decision on whether people should be revaccinated later this year and, if so, which vaccines to use in what doses for different age groups’, said Saul Faust of Southampton university, the trial’s chief investigator.”

Access, not hesitancy, now biggest barrier to COVID-19 vaccination: “The biggest impediment to getting more people fully vaccinated for COVID-19 is access, not vaccine hesitancy, according to Thomas R. Frieden, MD, MPH, former director of the Centers for Disease Control and Prevention during the Obama administration.”

It's official: Pfizer, BioNTech ink enormous deal with Europe to provide 1.8B more COVID-19 vaccine doses: “The companies made it official on Thursday, saying they will deliver up to 1.8 billion doses to the bloc through 2023.
Earlier this month, European Commission president Ursula von der Leyen tweeted about the enormous deal, signaling that the mRNA shot had become the bloc’s vaccine of choice. Many of the doses under the new deal are expected to be used as boosters.”

Change Healthcare Launches No-Fee, Privacy-Protecting, Portable Vaccination Record: “Change Healthcare today announced the launch of its Vaccination Record solution. This digital solution gives Americans the ability to access a durable, security-enabled, and trusted record of their vaccinations and/or testing results to be used when and where they choose. The solution is based on the open standards designed by the Vaccination Credential Initiative™.
Vaccination Record allows vaccination and testing providers to quickly and easily provide their customers a security-enabled and durable record of their vaccinations, and allows those consumers to easily see, save, and share their vaccination information with whomever they choose. It allows authorized parties to verify that information, if allowed by the consumers. To bring this solution to Americans, Vaccination Record can be accessed on all types of devices, including feature phones, smart phones, and computers, and, like a boarding pass, can be printed for convenience. The record and the credentials are fully under the consumer’s control.”

About health insurance

Medicare Expansion Could Have a Mixed Impact on Premiums: A study from Avalere concludes that:
”Under an expansion of the Medicare program, individuals who turn 60 would be eligible to enroll in Medicare and forgo their existing forms of coverage or, in the case of the uninsured, newly enroll in health insurance. An expansion of Medicare eligibility, depending on the exact parameters of the policy, could lead to as many as 24.5M additional individuals receiving Medicare coverage… primarily shifting from some form of commercial market coverage.
Importantly, simply expanding Medicare eligibility does not guarantee premium affordability. The current design of the Medicare program could lead to some low-income beneficiaries—particularly those who switch from subsidized exchange coverage—spending more on premiums in Medicare than they currently spend. For lower-income individuals (e.g., those at 138% of the federal poverty level [FPL]), current exchange subsidies are consistently more generous than the subsidies available to Medicare beneficiaries. For higher income individuals above 400% FPL, Medicare can offer significant premiums savings relative to exchange subsidies.”

Texas sets public hearings as it tries to convince federal government to extend health funding for the uninsured: This story highlights the complexity and political nature of the Medicaid waiver process. “Last month, federal health officials rescinded the Trump-era extension to the 1115 waiver agreement — which Texas has had with the U.S. Centers for Medicare and Medicaid Services since 2011 and is up for review every few years — and ordered Texas to collect public input, as the agreement requires, while it renegotiates the new extension beyond its current October 2022 expiration date.
The decision did not stop funding for the current waiver, which will continue to provide $3.87 billion in annual funding for 2021 and 2022 to partly offset free care provided by Texas hospitals to the uninsured, and to pay for innovative health care projects that serve low-income Texans, often for mental health services.
The extension granted in the final days of Trump’s administration would have continued hospital reimbursements until September 2030 but allowed the innovation fund to expire.”

Digital health company Babylon acquires 700-physician group in California: “Babylon, a digital health company in London, recently acquired a Novato, Calif.-based medical group with 700 physicians.
Babylon said it acquired Meritage Medical Network in April, according to a May 11 news release. The acquisition comes as the company further expands its U.S. presence. Babylon said it now serves 100,000 Americans and recently announced new U.S. offices in Palo Alto, Calif. Business in the U.S. reflects 70 percent of Babylon's revenue. 
The company uses artificial intelligence and virtual care services to provide patients with 24/7 access to information, health monitoring and clinicians through their mobile devices.”

Failed New York health insurer gets $220M settlement from US: “A liquidated New York health insurer will recover $220.8 million from the U.S. to resolve a lawsuit alleging that the federal government failed to distribute payments under an ACA program.
Health Republic Insurance of New York was a nonprofit health insurer that participated in a number of federal ACA programs, including its risk corridors program. Under the program, the government collected payments from insurers with lower-than-expected claims on the health insurance exchanges and made payments to insurers with higher-than-expected claims. However, the balances collected were insufficient to cover what insurers were owed. 
Health Republic will use the settlement to pay all claims in full…
The settlement resolves a 2017 lawsuit filed by New York's superintendent in her capacity as liquidator of the health plan.”

JPMorgan launches healthcare company, Morgan Health: “JPMorgan Chase on May 20 unveiled its new healthcare company, dubbed Morgan Health, which its top executive told Becker's Hospital Review can be viewed as a continuation of Haven, an ambitious healthcare venture that recently disbanded
’We learned a lot from the Haven experience,’ Dan Mendelson, CEO of Morgan Health, said. ‘The Haven experience focused us on primary care, digital medicine and specific populations. … You can see this as a continuation of the work that was started at Haven.’
However, Mr. Mendelson said there are several key differences between Morgan Health and Haven, the healthcare venture launched by Amazon, Berkshire Hathaway and JPMorgan Chase in 2018. For one, it has a much more simplified business structure, as it is a unit of JPMorgan Chase. Second, it has a philosophy of striking partnerships to meet its goals rather than working from the ground up.”
I was skeptical about Haven’s success when it launched, mainly because of lack of insurance and big company experience of its CEO.
Now, a much smaller entity with employees distributed all over the country wants to get into the same business. Its success will depend on what “striking partnerships “ actually means. Morgan Health could certainly use the help.

Clover Health's stocks skid as startup insurer posts $48.4M loss in Q1: “Clover Health posted a $48.4 million loss in the first quarter of 2021, nearly doubling its year-over-year losses as medical costs jumped under the pandemic.
The startup insurer reported a $28.2 million loss in the first quarter of 2020, according to the company's earnings report released this week. Clover's stock values took a nosedive following the financial reporting, dropping from about $7.70 per share at 10:30 a.m. Monday to $6.82 per share at market close…
Clover executives said they believe its medical care ratio is often higher than competitors' due to its benefit offerings and lower out-of-pocket costs for members.”

Supreme Court review of appellate decision on site-neutral payments is unnecessary, HHS says in new filing: “The Biden administration has asked the Supreme Court to take a pass on an appeals court decision upholding the agency’s authority to bring Medicare payments to off-campus clinics in line with independent physician practices.
In a recent filing (PDF), the Department of Health and Human Services (HHS) argued opponents of the site-neutral payments policy, which is a long list of provider industry stakeholders headlined by the American Hospital Association (AHA), “have not identified any ‘specific prohibition in the statute that is clear and mandatory’ that HHS’ action contravenes.” Rather, the appellate court had correctly determined that ‘the reduction was a permissible exercise of HHS’ statutory authority,’ the agency wrote…
HHS’ 2019 Outpatient Prospective Payment System rule aims to remove payment disparities where hospital-affiliated clinics receive more Medicare reimbursement than physicians' offices providing the same services. Critics and studies have suggested disparity has helped drive greater consolidation within the provider landscape.”

Amazon Introduces New Mental Health Benefit for All U.S. Employees and Their Family Members: “Amazon today launched a new mental health benefit, Resources for Living, that provides every U.S. employee, their family, and their household with a single place to start for personalized, convenient, and confidential support for mental health and daily life assistance. These services are available 24 hours a day, seven days a week, and include access to free counseling sessions in-person or through the phone, video, or text.”

Humana Taps NowPow to Address Social Needs for Medicare & Medicaid Members in Chicago: “As part of the partnership, Humana will leverage NowPow’s personalized community referral platform to help extend the digital infrastructure for its population health strategy supporting Humana Medicaid and Medicare members in Chicago. This effort aims to improve members’ health by meeting needs like food insecurity, loneliness and social isolation, and transportation.”

About the public’s health

US cervical cancers fall but other sex-related cancers rise: “Screening and the HPV vaccine have led to drops in cervical cancers over the last two decades in the U.S., a new study finds, but the gains are offset by a rise in other tumors caused by the virus. 
Oral sex is helping fuel more cases of mouth and throat cancers in men. For older women, anal cancer and a rare type of rectal cancer caused by HPV may be more common than cervical cancers by 2025.”

Near-Complete Ban on Abortion Is Signed Into Law in Texas: “Gov. Greg Abbott of Texas signed into law on Wednesday one of the nation’s most restrictive abortion measures, banning the procedure after six weeks of pregnancy…
The legislation, also known as the ‘heartbeat law,’ amounts to an outright ban on abortion, as many women are not aware they are pregnant at the six-week mark. It also would allow any private citizen to sue doctors or abortion clinic employees who would perform or help arrange for the procedure.”

Merck, locked in next-gen pneumococcal vaccine race with Pfizer, strengthens its lead in childhood use: “Merck's V114 passed safety and efficacy bars in two phase 3 trials, the company said Thursday, giving it a timing advantage over the Pfizer rival. The readout sets the stage for Merck to submit an application for its shot in kids by the end of the year, potentially offering an edge over Pfizer, which doesn't expect late-stage pediatric data on its pneumococcal candidate until 2022. 
In adult use, both rivals have won priority reviews at the FDA. The agency is set to make a decision on Pfizer's 20-valent shot in June and Merck's 15-valent candidate in July.”

About healthcare IT

Irish government says it will not pay ransom over 'significant' cyberattack on health system: “Ireland’s health service shut down its IT systems Friday to protect them from a "significant" ransomware attack the government said was carried out by an international cybercrime gang.
The country's health service, called Health Service Executive (HSE), posted on Twitter Friday morning that it shut down its IT systems following the attack in order to assess the situation with its security partners.”
Successful targeting of non-US healthcare entities is rare, if lack of reporting in the media is any indication.

About hospitals and health systems

FTC Too Busy To Scrutinize All Hospital Mergers, Sens. Told: “The Federal Trade Commission's hospital merger group is overworked and operating on outdated antitrust guidelines that make it hard for the agency to keep the rapidly consolidating industry in check, the Senate's antitrust subcommittee heard Wednesday. FTC employees often work 14-hour days and still have to ‘regularly pass on transactions due to lack of staffing,’ Brian Miller, an ex-FTC official who is now a Johns Hopkins School of Medicine professor, testified. Some extra funding would definitely help, Miller told Sen. Amy Klobuchar, D-Minn. , after she asked if additional resources would help hospital enforcement.”

Health system financial results for Q1: An updated list of financial Q1 stats for some major systems. The list mostly highlights the importance of non-operating income to the “bottom line.”

Today's News and Commentary

About Covid-19

Fauci says the public is ‘misinterpreting’ the CDC’s latest mask guidance: “‘I think people are misinterpreting, thinking that this is a removal of a mask mandate for everyone. It’s not,” he told Axios. ‘It’s an assurance to those who are vaccinated that they can feel safe, be they outdoors or indoors.’
Fauci emphasized that the health agency did not explicitly tell unvaccinated people to go without masks but instead communicated to vaccinated individuals that they won’t get infected indoors or outdoors.”

Brussels seeks to regain initiative on Covid vaccine patent debate: “Valdis Dombrovskis, executive vice-president of the European Commission, said World Trade Organization members should use existing rules to make it easier to share intellectual property for coronavirus jabs, rather than expand the ability of governments to override patents, as proposed by the US. Given the pandemic represents a national emergency, the requirement to negotiate with rights holders to license the production of Covid-19 vaccines could be waived, he said in prepared remarks to the European Parliament. The intervention was a plea for countries to increase access to vaccine technology under the existing WTO agreement known as Trips, rather than create a major new loophole in the IP regime by waiving patents.”

Oxford/AstraZeneca booster works well, study finds: “A study has found that the Oxford/AstraZeneca Covid-19 vaccine works well as a third booster shot, despite concern that the immune system might fight off the adenovirus used as a delivery mechanism. A third dose was shown to boost participants’ antibodies to the coronavirus’s spike protein in an upcoming study by Oxford university, according to people familiar with the matter.”

Troubled Vaccine Maker and Its Founder Gave $2 Million in Political Donations: “When Fuad El-Hibri, founder and executive chairman of Emergent BioSolutions, appears Wednesday before a House subcommittee to explain how the company’s Baltimore plant ruined millions of doses of coronavirus vaccine, he will be questioned by lawmakers he and his employees spent tens of thousands of dollars helping to elect.
Since 2018, federal campaign records show, Mr. El-Hibri and his wife, Nancy, have donated at least $150,000 to groups affiliated with the top Republican on the panel, Representative Steve Scalise of Louisiana, as well as Mr. Scalise’s campaigns. At least two other members of the subcommittee received donations during the 2020 election cycle from the company’s political action committee, which has given about $1.4 million over the past 10 years to members of both parties.”

About pharma

Judge OKs classes in case accusing Ranbaxy of delaying generics: “A federal judge has approved multiple classes in litigation accusing Indian generic drugmaker Ranbaxy Laboratories Ltd of delaying the launch of generic drugs by submitting false applications to U.S. regulators.
In an opinion issued Friday, U.S. District Judge Nathaniel Gorton in Boston certified classes of both direct purchasers, including drug wholesalers, and indirect purchasers, such as health plans and insurance companies.”

Big Pharma spent a record $92M on lobbying in Q1— for what?: “The pharmaceutical industry is on track to break its annual lobbying spending record for the second year in a row, with most of the $92 million it spent during 2021's first quarter going toward efforts to block Medicare reform and protect patents
The pharmaceutical lobby spends more than any other industry, according to a May 8 Truthout report. During the first three months of 2021, Pfizer alone spent $3.7 million on lobbying. PhRMA, a prevalent industry trade group, spent $8.7 million on lobbying during the same time period.“

COVID-19 impact on oncology clinical trials: a 1-year analysis: From Nature: “The pandemic affected all trials during the earlier waves, but the impact on oncology trials has been less severe compared with non-oncology trials. As vaccines continue to be rolled out, we expect this impact to continue to lessen.”
The chart provides a good graphical explanation of what happened to the trials over the past year.
And in a related monograph from IQVIA: Global Trends in R&D:

  • Funding for early- and late-stage R&D and strategic transactions increased significantly in 2020; aggregate R&D spend for the top 15 companies reached a record high.

  • The number of first-time launches of novel active substances (NAS) reached an all-time high of 66 in 2020 – with success for treatments in oncology and rare diseases.

  • Clinical trial starts increased 8% in 2020, similar growth to the prior three years, with oncology trial starts reaching historically high levels.

  • Overall, clinical trial activity recovered from mid-year 2020 to levels above 2019 – even without COVID-19 trials.

Health Plans Win Class Cert. In CVS Price-Gouging Suit: “A Rhode Island federal judge granted certification to multiple classes of insured health plans that say CVS schemed with pharmacy benefit managers to overcharge the plans for generic drugs while providing discounted prices for uninsured customers, according to an order unsealed Tuesday. In a partially redacted decision that was filed under seal May 11, U. S. District Judge William E. Smith allowed certification for four classes of health plans in two consolidated suits, encompassing thousands of health plans.”

Triple vs Dual Inhaler Therapy and Asthma Outcomes in Moderate to Severe Asthma: A Systematic Review and Meta-analysis: “Among children (aged 6 to 18 years) and adults with moderate to severe asthma, triple therapy, compared with dual therapy, was significantly associated with fewer severe asthma exacerbations and modest improvements in asthma control without significant differences in quality of life or mortality.”
This study could change the way these patients are treated from the start- as opposed to step therapy.

Bristol-Myers pays up to $1.2bn to enter artificial-intelligence pact: “Bristol-Myers Squibb has agreed to pay up to $1.2bn to enter a drug discovery collaboration with artificial intelligence start-up Exscientia as the Big Pharma company bets on the power of the technology to turbocharge drug development. The agreement comes as the biotech industry deploys AI to speed up the process of screening molecules that can then be tested as drugs to tackle illnesses ranging from cancer to heart disease.”

About healthcare IT

Anthem, Epic team to enhance data sharing with providers: “The insurer announced Wednesday that the partnership would harness Epic's Payer Platform, which will be embedded directly into Anthem's Health OS and thus into providers' workflows. The platform will allow the payer and providers to share clinical data and information at discharge from the hospital, for example.”

Johns Hopkins spinout Emocha Health closes $6.2M series A for video-based medication adherence: “Emocha’s approach to medication adherence looks to scale directly observed therapy (DOT), the gold standard approach to ensuring medication adherence. But rather than require patients to meet in person with nurses or other practitioners on a regular basis, the company allows patients to record themselves taking a medication and send it off for review.”

Cerner slips 2nd year but holds dominance alongside Epic for EHR market share: “While Cerner's hold of the EHR market share dropped for the second consecutive year, the EHR vendor still maintained the second largest share after Epic for acute care hospitals in 2020. 
For its ‘U.S. Hospital EMR Market Share 2021’ report, KLAS Research examined EHR purchasing activity and contracts across the country from Jan. 1 to Dec. 31, 2020.”
Here are the top 5 EHRs measured by market share:
—Epic: 31 percent
—Cerner: 25 percent
—Meditech: 16 percent
—CPSI: 9 percent
—Allscripts: 5 percent

Ro will acquire women's health startup Modern Fertility in $225M deal: “Digital health company Ro is adding reproductive health to its growing platform with plans to acquire Modern Fertility.
The deal, announced Wednesday, is valued north of $225 million, according to sources familiar with the deal.
Modern Fertility launched in 2017 offering at-home fertility tests for women.”

About hospitals and health systems

One of America's largest hospital chains has been suing thousands of patients during the pandemic: “Hospitals owned by Community Health Systems, Inc., one of America's largest hospital chains, have filed at least 19,000 lawsuits against their patients over allegedly unpaid medical bills since March 2020, even as other hospitals around the country have moved to curtail similar lawsuits during the coronavirus pandemic, a CNN investigation found.
The company's 84 hospitals, which are concentrated in the South and stretch from Alaska to Key West, Florida, have taken their patients to court for as little as $201 and as much as $162,000. They say litigation is a last resort.”

Hospitals Serving The Poor Struggled During COVID. Wealthy Hospitals Made Millions: “This past year, the nation's more than 300 safety-net hospitals found themselves on the front lines of the coronavirus pandemic, which disproportionately affected the communities that safety-net hospitals are most likely to serve. They took on a greater share of the patient burden, even as other hospitals emerged from the pandemic with huge profits, an investigation by NPR and the PBS series Frontline has found…”

Financial reports:
Sutter Health posts $49M operating loss in Q1 after rough 2020 and
CommonSpirit Health accelerates COVID-19 rebound with $539M in operating gains

About health insurance

Dual Eligibles in Medicare Advantage Faced Fewer COVID-Related Disruptions in Care than Those in Traditional Medicare: “Despite being older and sicker, dual eligibles in MA were less likely to report difficulty accessing care during the COVID-19 pandemic. Only 35 percent of dual eligibles in MA said they were unable to get a regular check-up during the pandemic, compared to 51 percent in FFS. Similarly, dual eligibles in MA were less likely to report that they were unable to get diagnostic or medical screening tests, treatment for ongoing conditions, and urgent care for accidents or illnesses during the pandemic.”

HHS Must Redo Medicare Pay for Physician Training Programs: “Hundreds of hospitals throughout the country will receive a boost in their Medicare reimbursements for training medical residents, as the government unlawfully changed how those payments are calculated, a federal court said.
The Secretary of Health and Human Services acted arbitrarily and capriciously, and in contravention of the Medicare Act, when he adopted a regulation that effectively changed the weighting factors statutorily assigned to residents and fellows, the U.S. District Court for the District of Columbia said.”

Cancer Outcomes Among Medicare Beneficiaries And Their Younger Uninsured Counterparts: “The main outcomes were survival at one, two, and five years for sixteen cancer types in 1,206,821 patients. We found that uninsured patients ages 60–64 were nearly twice as likely to present with late-stage disease and were significantly less likely to receive surgery, chemotherapy, or radiotherapy than Medicare beneficiaries ages 66–69, despite lower comorbidity among younger patients. Compared with older Medicare patients, younger uninsured patients had strikingly lower five-year survival across cancer types.”

About the public’s health

HHS Announces $3 Billion in American Rescue Plan Funding for SAMHSA Block Grants to Address Addiction, Mental Health Crisis: “The Substance Abuse and Mental Health Services Administration (SAMHSA) is distributing $3 billion in American Rescue Plan funding — the largest aggregate amount of funding to date for its mental health and substance use block grant programs. 
The Community Mental Health Services Block Grant (MHBG) Program and Substance Abuse Prevention and Treatment Block Grant Program (SABG) will disperse $1.5 billion each to states and territories (with the latter also awarding money to a tribe). This follows the March announcement of supplemental funding of nearly $2.5 billion for these programs. SAMHSA, an operating division of the U.S. Department of Health and Human Services, has expedited federal funding to grantees to help communities grappling with mental health and substance use needs during the COVID-19 pandemic.”

SCOTUS Dismisses Title X Family Planning Cases to AMA Applause: “The Supreme Court of the United States has dismissed Title X cases, a move that will likely amount to overturning a Trump-era rule that some industry leaders, like the American Medical Association, said is akin to a gag clause in patient-provider communication.
The Court’s dismissal of the cases means it will not hear the cases arguing against the prior Administration’s rule.
It is up to the Biden Administration to ultimately overturn the rule…
The Title X Family Planning rule issued out of the Trump Administration’s Department of Health & Human Services (HHS) withdrew any federal funding from medical providers offering family planning counseling, including referral to abortion services.
The rule also pulled federal funding from Title X clinics that provide abortion service referrals or counseling about abortion services; got rid of requirements that Title X care sites offer multiple family planning methods and counseling on those methods; and funneled new funding opportunities toward faith-based or other groups that promote fertility awareness and abstinence-based family planning education.”

About diagnostics

Amazon may expand into diagnostics: “Amazon is planning to launch a business that will offer at-home medical tests…
The new brand, Diagnostics, would first offer testing kits for COVID-19. Eventually, Amazon plans to expand the business to offer testing kits for other diseases, such as sexually transmitted infections.
People familiar with the new brand said Amazon's long-term goal is to offer clinical genomics and launch a third-party marketplace that sells medical tests from other companies.

Today's News and Commentary

About Covid-19

The Future of Virus Tracking Can Be Found on This College Campus: A really interesting article explaining how Lookout, Colorado Mesa University’s digital Covid-19 dashboard, was used to track and contain Covid-19 cases and gather symptom profiles. The system was developed by the Broad Institute of M.I.T. and Harvard.

Forget throat swabs: Dutch company claims its breathalyzer can help sniff out COVID-19: “SpiroNose isn’t meant to definitively diagnose infection; instead it aims to rule it out in as many cases as possible. For the remainder, the test yields an ‘inconclusive,’ and those people receive a polymerase chain reaction (PCR) or antigen test.”

As more Americans get vaccinated, 41% of Republicans still refuse COVID-19 shots: A good recent summary about who is refusing vaccination and what incentives are being offered by states.
In a related story: Vaccine-hesitant Americans list false side effects among concerns: poll: “Among the 1,061 people in the survey who say they are unlikely to get vaccinated against COVID-19 and listed side effects as a concern, 60 percent named blood clots, which have indeed been reported in extremely rare cases. But 24 percent listed infertility, and just as many cited potential birth defects, which are not considered possible from any of the vaccines that have been approved. 
Twenty-two percent said they were concerned about potentially getting cancer from their coronavirus vaccine, another false side effect.”

Mid-stage results prompt GSK, Sanofi to move ahead with pivotal COVID-19 vaccine study: “GlaxoSmithKline and Sanofi announced Monday that their adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralising antibody responses in adults in a Phase II study, paving the way for a late-stage trial to start in the coming weeks and potential regulatory authorisation in the fourth quarter.”

The 60-Year-Old Scientific Screwup That Helped Covid Kill: Is there a difference between droplets and aerosols and does it matter? Yes (to both questions). If transmission of a virus is by droplets, 3-6 feet distancing will help prevent spread. But if it is aerosolized you need a much longer safe distance. (Masks in both cases obviously also help.) This article provides background on how we got the nature/nomenclature of spread wrong.

About the public’s health

Short-term air pollution, cognitive performance and nonsteroidal anti-inflammatory drug use in the Veterans Affairs Normative Aging Study: “Air pollution, especially fine particulate matter (PM2.5), may impair cognitive performance but its short-term impact is poorly understood. We investigated the short-term association of PM2.5 with the cognitive performances of 954 white males measured as global cognitive function and Mini-Mental State Examination (MMSE) scores and further explored whether taking nonsteroidal anti-inflammatory drugs (NSAIDs) could modify their relationships. Higher short-term exposure to PM2.5 demonstrated nonlinear negative associations with cognitive function… Such adverse effects were attenuated in users of NSAIDs [non-steroidal anti-inflammatory drugs] compared to nonusers. This study elucidates the short-term impacts of air pollution on cognition and warrants further investigations on the modifying effects of NSAIDs.”

Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement: This statement applies only to the following population:
“Asymptomatic adults 45 years or older at average risk of colorectal cancer (ie, no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease; no personal diagnosis or family history of known genetic disorders that predispose them to a high lifetime risk of colorectal cancer [such as Lynch syndrome or familial adenomatous polyposis]).”

“The USPSTF recommends screening for colorectal cancer in all adults aged 50 to 75 years. (A recommendation) The USPSTF recommends screening for colorectal cancer in adults aged 45 to 49 years. (B recommendation) The USPSTF recommends that clinicians selectively offer screening for colorectal cancer in adults aged 76 to 85 years. Evidence indicates that the net benefit of screening all persons in this age group is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the patient’s overall health, prior screening history, and preferences. (C recommendation)…”
See Table 1 in the article “for characteristics of recommended screening strategies, which may include combinations of screening tests.”

About medical devices

CMS’ rule granting speedy coverage to FDA-designated ‘breakthrough’ devices delayed again: “CMS delayed the start date of its rule that would provide expedited Medicare coverage for products the FDA deems "breakthrough devices" from May 15 to Dec. 15. CMS wants more time to examine concerns expressed about the rule, including that devices may gain coverage despite limited evidence of their use among seniors.”

About pharma

US Supreme Court refuses to hear Novartis' appeal over Enbrel patents: “The US Supreme Court on Monday declined to hear Novartis' challenge to two patents on Amgen's Enbrel (etanercept), upholding a Federal Circuit Appeals Court decision from last year. The Supreme Court snub means Novartis continues to be barred from launching Erelzi, its biosimilar version of Enbrel, in the US despite the FDA having  approved it in 2016.
The Enbrel patents in question cover its active ingredient and a process to make the drug, and are set to expire in 2028 and 2029, respectively.”

AbbVie repeatedly hiked Humira, Imbruvica prices and abused patents to keep competitors at bay: report: “AbbVie owns two of the best-selling drugs in the world in Humira and Imbruvica. But to build and defend its market monopoly for the two heavyweights, the company has repeatedly raised prices and exploited the U.S. patent system, a congressional probe found.
In the 48-page report released ahead of AbbVie CEO Richard Gonzalez’s appearance on Capitol Hill on Tuesday, the House Committee on Oversight and Reform found that Humira is the nation’s top-selling drug “due in large part to AbbVie’s price increases.” Those costs have ‘placed significant strain on U.S. patients and their families’ who have been left with greater out-of-pocket expenses. “

About healthcare IT

Doctors Now Must Provide Patients Their Health Data, Online and On Demand: This article discusses the pros and cons of making information instantly available to patients when it becomes available.

About hospitals and health systems

Advocate Aurora Health reports $352M gain for Q1 2021 even without COVID relief funds: “Advocate Aurora Health has started its fiscal year in the black, reporting this week nearly $352 million in earnings for the quarter ending March 31 despite receiving no financial support from the government’s COVID-19 relief efforts during that time.
The performance is a stark contrast to the same period last year when the pandemic hit and the nonprofit system lost more than $1.3 billion after expenses.”

About healthcare professionals

Contributions of US Medical Schools to Primary Care (2003-2014): Determining and Predicting Who Really Goes Into Primary Care: “The commonly used Residency Match Method predicted a 41.2% primary care output rate. The actual primary care output rate was 22.3%. The proposed new method, the Intent to Practice Primary Care Method, predicted a 17.1% primary care output rate, which was closer to the actual primary care rate.”
This more accurate predictive method highlights the shortage of primary care physicians.



Today's News and Commentary

About health insurance

Biden reverses Trump order barring immigrants who cannot afford healthcare: “President Biden on Friday revoked a 2019 proclamation signed by then-President Trump that prevented immigrants from obtaining visas unless they proved they could obtain health insurance or pay for health care.”

Pandemic accelerates employer voluntary benefit offerings, Willis Towers Watson survey finds: From a Willis Towers Watson survey: “The Emerging Trends in Health Care Survey found that employer interest in offering voluntary benefits has been burgeoning, with 94% of employers finding voluntary benefits to be important to their employee value proposition and Total Rewards strategy three years from now, compared with just 36% of employers deeming them to be important in 2018.”
Growth was seen in critical illness, identity theft and pet insurance benefits.

House bill mandates Medicare Advantage [MA] plans adopt electronic prior authorization: “New legislation in Congress would require Medicare Advantage plans to create an electronic prior authorization process, targeting a major source of administrative burden for providers.
The House legislation, introduced Thursday, would also create a process for payers to quickly clear items and services that are routinely approved and improve transparency on the extent of prior authorization used by MA payers.”

About healthcare IT

Cancer Treatment Centers of America Announces 105,000-Record Data Breach: “Cancer Treatment Centers of America is alerting 104,808 patients of its Midwestern Regional Medical Center that some of their protected health information was contained in an email account that was accessed by an unauthorized individual.”

Telehealth Firms Continue To Report Revenue Growth, Net Losses In Q1: “Telehealth companies continued to see revenue gains in 2021’s first quarter as they prepare their business for a world not dominated by the COVID-19 crisis.
Amwell posted $57.6 million in revenue for the quarter, up 7.2% from the year-ago period, while Teladoc Health, a market leader in the telehealth space, continued to see sizeable growth with $453.7 million in quarterly revenue, up 150.9% year-over-year. SOC Telemed, which focuses on the acute-care sector, posted $14.8 million, up 0.1%. 
The three companies, all of which reported net losses, are working to differentiate themselves in a crowded market—in part by convincing investors they can be a single vendor for all or many of their customers’ virtual care needs.”
And in a related article: Modernizing Medicare Coverage Pathways For Prescription Digital Therapeutics: A really good discussion of Medicare coverage for telehealth services

About Covid-19

U.S. administers 273.5 million doses of COVID-19 vaccines: CDC: “The United States has administered 273,545,207 doses of COVID-19 vaccines in the country as of Sunday morning and distributed 344,503,495 doses, the U.S. Centers for Disease Control and Prevention (CDC) said.
Those figures are up from the 270,832,342 vaccine doses the CDC said had gone into arms by Saturday out of 344,503,395 doses delivered.

Scientists tracking coronavirus variants struggle with global blind spots: The article highlights the need for world-wide monitoring of variants. Ten (rich) of 152 countries for which data is available account for 82% of the reported sequences.

National Nurses United 'outraged' over CDC's rolled-back mask guidance: “National Nurses United, the country's largest nurses union, is condemning the CDC's decision to roll back indoor mask guidance for fully vaccinated people. 
The agency's new guidance, announced May 13, says fully vaccinated Americans no longer need to wear masks or follow social distancing guidelines in most indoor settings. 
‘This newest CDC guidance is not based on science, does not protect public health, and threatens the lives of patients, nurses, and other frontline workers across the country,’ Bonnie Castillo, RN, executive director of the union, said in a May 14 statement. ‘Now is not the time to relax protective measures, and we are outraged that the CDC has done just that while we are still in the midst of the deadliest pandemic in a century.’”

723 Epidemiologists on When and How the U.S. Can Fully Return to Normal: From a survey by The NY Times. Take a look at the graphics for the “bottom lines” on the opinions.

Johns Hopkins launches pandemic data initiative: “Johns Hopkins University launched a pandemic data initiative to address the lack of a consistent real-time health data infrastructure, the Baltimore-based university announced May 17.
Throughout the pandemic, the university's Coronavirus Resource Center has served as a resource for healthcare professionals and public health officials to better understand how COVID-19 is affecting communities, as it tracks positivity rates, new cases and other trends.
However, the resource center's researchers, as well as data scientists worldwide, have struggled to effectively and accurately compile COVID-19 data, as it is often inconsistent, incomplete and lagging. Johns Hopkins' new data initiative will establish a standardized system to collect, confirm, report and share data in near-real time so that countries can be better equipped to deploy rapid, unified responses to the next public health crisis.
The university said it hopes the new data infrastructure will allow rapid communication between researchers so federal, state and local governments can make data-informed decisions.”

About the public’s health

Biden hopes to dig up the nation’s lead water pipes. This city wants his help.: “The Biden administration wants to spend $45 billion via grants and low-interest loans to replace more than 6 million lead-pipe service lines across the country. The measure is one of the most popular parts of his $2.3 trillion infrastructure proposal — a CBS News poll showed 85 percent approval — and may help overcome Republican lawmakers’ resistance to the package.”

U.S. Supreme Court takes up major challenge to abortion rights: “The U.S. Supreme Court on Monday agreed to consider gutting the 1973 Roe v. Wade ruling that legalized abortion nationwide, taking up Mississippi's bid to revive a Republican-backed state law that bans the procedure after 15 weeks of pregnancy.
By hearing the case in their next term, which starts in October and ends in June 2022, the justices will look at whether to overturn a central part of the landmark ruling, a longstanding goal of religious conservatives.
The eventual ruling by the conservative-majority court, expected next year, could allow states to ban abortions before a fetus is viable outside the womb, upending decades of legal precedent. Lower courts ruled against Mississippi's law.”

About medical devices

Large Medicare study finds no increased death risk with paclitaxel-coated balloons, stents: “Remember the FDA’s cautions on paclitaxel-laden devices? Think again: An audit of nearly four years of Medicare data spanning more than 168,000 beneficiaries found no evidence of additional harm with balloons and stents coated with the chemotherapy drug compared to bare ones.”

About pharma

GoodRx to acquire discount drug company for $50M: “Pharmacy discount company GoodRx is acquiring its competitor RxSaver for $50 million…”

6 drugmakers in violation of 340B statute, HRSA says: “Six drugmakers are in violation of the 340B statute and must immediately begin offering their drugs at discounted prices to hospitals participating in the federal drug-pricing program, Diana Espinosa, acting administrator of the Health Resources and Service Administration, said. 
Ms. Espinosa sent letters to six drugmakers May 17 stating that HRSA determined their policies that place restrictions on the 340B drug pricing program for hospitals that dispense drugs through contract pharmacies have resulted in overcharges and are in direct violation of the 340B statute…
The letters were sent to AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics.”

Health care and prescription drug costs top voter concerns in new poll: “In the Morning Consult-Politico poll, 88 percent of Americans said that Congress should make lowering health care costs a priority, including 59 percent who said it should be a top legislative priority. Eighty-five percent said lawmakers should prioritize passing a bill to bring down prescription drug costs, with 50 percent saying it should be a top priority. 
Reducing health care and prescription drug costs, moves that enjoy support across party lines, outrank all other issues surveyed, including stimulating the economy during the coronavirus pandemic, at 84 percent; reforming immigration policy, at 71 percent; regulating tech companies, at 57 percent; and legalizing marijuana, at 43 percent.”

About healthcare quality

An Evolving Hospital Quality Star Rating System From CMS: A very thoughtful explanation and critique of CMS’ Star Rating System. Read the entire article.

Today's News and Commentary

The 8 greatest healthcare leaders in 2021, per Fortune: Not household names because it is a global list. No Fauci!

About Covid-19

U.S. to bolster public health workforce to fight COVID-19, future pandemics: “Of the $7.4 billion, $4.4 billion will go to states and local public health departments to address disease outbreaks and hire school nurses. It will also be used to expand the U.S. Centers for Disease Control and Prevention's ability to track outbreaks and to create a service corps dedicated to public health. The remaining $3 billion will boost local public health workforces ahead of future challenges, with an emphasis on recruiting diverse candidates, the White House said.”

Hundreds of Epidemiologists Expected Mask-Wearing in Public for at Least a Year: “When federal health officials said on Thursday that fully vaccinated Americans no longer needed to wear masks in most places, it came as a surprise to many people in public health. It also was a stark contrast with the views of a large majority of epidemiologists surveyed in the last two weeks by The New York Times.
In the informal survey, 80 percent said they thought Americans would need to wear masks in public indoor places for at least another year. Just 5 percent said people would no longer need to wear masks indoors by this summer.
In large crowds outdoors, like at a concert or protest, 88 percent of the epidemiologists said it was necessary even for fully vaccinated people to wear masks.”

Delaying second Pfizer vaccines to 12 weeks significantly increases antibody responses in older people: “Antibody response in people aged over 80 is three-and-a-half times greater in those who have the second dose of the Pfizer COVID-19 vaccine after 12 weeks compared to those who have it at a three-week interval, finds a new study led by the University of Birmingham in collaboration with Public Health England. 
The study, supported by the UK Coronavirus Immunology Consortium, of 175 people who were aged over 80 and living independently is the first direct comparison of the immune response in any age group between those who are given the second Pfizer vaccine at a three-week interval and those at a 12-week interval.”

Immunogenicity of COVID-19 mRNA Vaccines in Pregnant and Lactating Women: “In this exploratory analysis of a convenience sample, receipt of a COVID-19 mRNA vaccine was immunogenic in pregnant women, and vaccine-elicited antibodies were transported to infant cord blood and breast milk. Pregnant and nonpregnant women who were vaccinated developed cross-reactive antibody responses and T-cell responses against SARS-CoV-2 variants of concern.”

Blood Expert Says He Found Why Some Covid-19 Vaccines Trigger Rare Clots: “Andreas Greinacher of the University of Greifswald in Germany believes viral vector vaccines, which use modified adenoviruses to convey genetic material into vaccine recipients to fight COVID-19, could cause an autoimmune response that leads to blood clots…
According to Greinacher, that reaction could be tied to stray proteins and a preservative he has found in the AstraZeneca vaccine.
He and his team have just begun examining Johnson & Johnson's vaccine, but has identified more than 1000 proteins in AstraZeneca's vaccine derived from human cells, as well as a preservative known as ethylenediaminetetraacetic acid (EDTA).
Their hypothesis is that EDTA, which is common to drugs and other products, helps those proteins stray into the bloodstream, where they bind to a blood component called platelet factor 4 (PF4), forming complexes that activate the production of antibodies.
The inflammation caused by the vaccines, combined with the PF4 complexes, could trick the immune system into believing the body had been infected by bacteria, triggering a defense mechanism that then runs out of control and causes clotting and bleeding.”

About health insurance

You’ve Added Your Kids to Your Health Plan. What About Mom?: “…a California lawmaker is pushing a bill that would require private health plans regulated by the state to extend coverage to some subscribers’ parents. Business groups and others fear the legislation could jack up insurance premiums, but the bill has strong backing from health advocacy and immigrants’ rights organizations, as immigrants make up a sizable portion of California’s uninsured population.”
This proposal is a great subject for policy discussions ranging from classrooms to statehouses.

Oscar Health posts $87.4M loss in first quarter of 2021: “Oscar Health posted an $87.4 million loss in the first quarter of 2021, the insurer reported Thursday, marking an improvement from its $96.9 million loss in the first quarter of 2020…
Revenue rose significantly year over year, the company said in its earnings report, reaching $389 million compared to $88.4 million in the first quarter of 2021
Oscar Health officially went public in March. While its reach has continued to grow in terms of membership, the company has historically struggled to turn a profit.”

About healthcare devices

Magnets in Cell Phones and Smart Watches May Affect Pacemakers and Other Implanted Medical Devices: “Some consumer electronic devices, such as certain cell phones and smart watches, include high field strength magnets. Recent studies have shown that consumer electronic devices with high field strength magnets may cause certain implanted medical devices to switch to ‘magnet mode’ and suspend normal operations until the magnet is moved away from the medical device.
Many implanted medical devices are designed with a ‘magnet mode’ to allow for safe operation during certain medical procedures such as undergoing an MRI scan. These safety features are typically engaged by physicians with the use of a high field strength magnet that is placed near the implanted device placing it into a ‘magnet mode.’ Removal of the magnetic field causes the device to return to normal operation.”

Becton Dickinson’s Self-Collection HPV Test Receives CE Mark: “Becton Dickinson has received CE mark certification for its Onclarity HPV Assay, a human papillomavirus test that can also help screen for cervical cancer.
Using the assay, women can collect vaginal samples at home and send them to a laboratory for processing on the company’s Viper LT or COR systems.”

About hospitals and health systems

3 Ascension Texas hospitals to pay $20.9M for alleged kickbacks: “Three Ascension hospitals in Texas agreed to pay $20.9 million for allegedly paying multiple physician groups above fair market value for services, according to a recent news release from the HHS' Office of Inspector General.”

Atrium Health posts $18M loss in Q1 due to higher expenses: “Atrium Health posted a $18 million loss of operating revenue for the first quarter due to higher operating expenses.
But the 42-hospital system did post net operating revenue of $1.9 billion for the first quarter, slightly above the $1.98 billion that it budgeted, according to an earnings report released during the system’s board meeting Tuesday.”

About pharma

Heron's newly-minted opioid alternative for post-surgical pain headed for blockbusterland, analysts say: “The FDA this week cleared Zynrelef to help patients manage pain for up to 72 hours after a bunionectomy, groin hernia repair or total knee replacement. The approval will allow Heron to target around 2.1 million procedures at launch, the company said in an approval presentation Thursday.
At a wholesale acquisition price of $267.50 for a 400 mg/12 mg vial and $135.50 for a 200 mg/6 mg vial, Zynrelef could be looking at a market worth some $300 million for those three procedures, analysts at Evercore ISI wrote in a note to clients this week.
Still, Heron was expecting a wider label.”

About healthcare IT

Health Interoperability Outcomes 2030: The ONC is soliciting comments about what will/should/can change as a result of interoperability.

Background Press Call by Senior Administration Officials on Executive Order Charting a New Course to Improve the Nation’s Cybersecurity and Protect Federal Government Networks: This document is the text of Wednesday’s White House Press Briefing about the President’s Executive Order [EO] addressing cybersecurity: “[T]oday’s executive order makes a down payment towards modernizing our cyber defenses and safeguarding many of the services on which we rely. It reflects a fundamental shift in our mindset — from incident response to prevention, from talking about security to doing security — setting aggressive but achievable goals to make the federal government a leader in cybersecurity, and improve software security and incident response.”
For example, tools “like multi-factor authentication, encryption, endpoint detection response, logging, and operating in a zero-trust environment will be rolled out across government networks on a tight timeline as you’ll see in the EO.”