Todays News and Commentary

About Covid-19

Fla. judge rules DeSantis administration cannot restrict school districts’ mask mandates: “Judge John C. Cooper of Florida’s 2nd Circuit sided with parents from six Florida counties who challenged DeSantis (R) and state education officials in court this week, arguing that the governor’s order infringes on classroom safety guaranteed by the state’s constitution.”

Warnings About the Sturgis Rally Have Come Tragically True: The story is as close to a controlled trial as you can ethically get. It compares the unprotected Sturgis motorcycle rally with the highly controlled Lollapalooza music festival with respect to Covid-19 cases.

Adults Reporting Symptoms of Anxiety or Depressive Disorder During COVID-19 Pandemic: Texas is 12 and Florida is 36. Maybe that finding is the problem- not worried enough about their health?

Coronavirus (COVID-19) Update: August 24, 2021: “FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months.”

About the public’s health

Seasonal Malaria Vaccination with or without Seasonal Malaria Chemoprevention: “Administration of RTS,S/AS01E [a vaccine] was noninferior to chemoprevention in preventing uncomplicated malaria. The combination of these interventions resulted in a substantially lower incidence of uncomplicated malaria, severe malaria, and death from malaria than either intervention alone.”

In talc case, reorg ruling goes Johnson & Johnson’s way, keeping bankruptcy in play: ”With 25,000 unresolved lawsuits alleging that its talcum products cause cancer, Johnson & Johnson is considering a legal maneuver sometimes referred to as the Texas two-step.  
On Thursday, a U.S. judge declined to block the move, giving the pharmaceutical giant the option to create a new business to absorb liabilities associated with the litigation and then seek bankruptcy protection.”

About pharma

Samsung Bioepis Scoops First EU Lucentis Biosimilar As 2022 Date Looms: “Samsung Bioepis has seen a positive opinion in the EU for its Byooviz (ranibizumab) biosimilar treatment for wet age-related macular degeneration turned into final approval by the European Commission. The company is also leading the pack in the US.” Lucentis is so expensive, many ophthalmologists use small doses of Avastin instead. Approval in the US of a biogenetic may change that practice depending on the new pricing dynamic.

About health insurance

Business Groups Withdraw Suit Challenging Health-Price Transparency Rule: “The U.S. Chamber of Commerce and a Texas affiliate withdrew a suit filed to block parts of a federal rule requiring insurers and employers to disclose prices they pay for healthcare services and drugs.
The withdrawal, in a filing late Wednesday, came after the Biden administration delayed enforcement of provisions of the rule that were the focus of the suit.”

Six things to know about prior authorization for ambulances: CMS plans to begin a six-phase rollout of prior authorization for non-emergency ambulance transportation on December 1; total implementation is expected by August 1, 2022.
In studies leading up to this plan, prior authorization “diminished pointless ambulance transportation and spending by over 70%…, reducing complete Medicare spending by 2.4%. There weren’t any notable results on well being outcomes…”

Mississippi Pharmacist and Louisiana Marketer Plead Guilty to More Than $180 Million Health Care Fraud Scheme: “According to court documents, Mitchell ‘Chad’ Barrett…participated in a scheme to defraud TRICARE and other health care benefit programs by distributing medically unnecessary compounded medications. Barrett is licensed as a pharmacist in Mississippi and was a co-owner of various compounding pharmacies. As part of this scheme, Barrett adjusted prescription formulas to ensure the highest reimbursement without regard to efficacy. He solicited recruiters to procure prescriptions for high margin compounded medications and paid those recruiters commissions based on the percentage of reimbursements paid by pharmacy benefit managers and health care benefit programs, including commissions on claims reimbursed by TRICARE. He further routinely and systematically waived and/or reduced copayments to be paid by beneficiaries and members, and utilized a purported copayment assistance program to falsely make it appear as if his pharmacy and its affiliate compounding pharmacies had been collecting copayments.”

Cigna to expand ACA exchange footprint to 3 new states, 93 counties: “Cigna is planning to expand its footprint on the Affordable Care Act's (ACA's) exchanges into three new states and 93 new counties for the 2022 plan year, the insurer announced Thursday.
Cigna said it plans to enter the markets in Pennsylvania, Georgia and Mississippi and new counties in Florida, Arizona and Virginia. The new regions could reach an additional 1.5 million customers, according to the announcement.
The new markets will bring the insurer's total footprint to 313 counties across 13 states.”

About healthcare IT

Alphabet's Verily, Mayo Clinic team up on decision support tech for cardiovascular care: “The two organizations struck a strategic two-year collaboration focused on the development of a digital point-of-care resource to support an individualized approach to patient care. The tool will provide contextualized and validated insight on disease management, care guidelines and treatment to help clinicians make decisions, the organizations said.
Teaming up with the Mayo Clinic, Verily will pull in the hospital's clinical content and apply advanced clinical analytics and user-centered design to deliver care insights that are integrated into the healthcare provider workflow, the companies announced…”

About medical devices

Medtronic's miniaturized, leadless implant improves long-term safety over traditional pacemakers in real-world study: “Through an analysis of Medicare claims data spanning more than 16,000 beneficiaries, researchers found the leadless device delivered a 38% drop in reinterventions and a 31% reduction in chronic complications compared to transvenous pacemakers, according to Medtronic, which described the effort as the largest evaluation of leadless pacemakers to date.”

About hospitals and health systems

New Jersey hospitals take rare step in merger fight with FTC: “Edison, N.J.-based Hackensack Meridian Health and Englewood (N.J.) Health are taking their case to the appellate court after their proposed merger was temporarily halted amid a challenge from the Federal Trade Commission. An appeal is a rare step at this stage of an FTC action…”

Ascension settles federal discrimination claims: “The settlement, announced Aug. 25, came after the Justice Department determined that Ascension automatically requested that its non-U.S. citizen employees present new documents to prove their continued work authorization even in situations where it wasn't required. The Justice Department said its investigation found that the health system improperly programmed software to send automated emails requesting proof of continued work authorization to all non-U.S. citizen employees. Ascension didn't program software to send emails to employees who were U.S. citizens, the Justice Department said.”

About hospitals and health systems

UPMC posts $605M profit in first half of 2021 as insurance business dips: “The University of Pittsburgh Medical Center (UPMC) posted a $605 million profit for the first half of the year, a massive $433 million increase compared to the same period in 2020.
The nonprofit system generated $12.1 billion in operating revenue for the first half compared with $11.1 billion in 2020 during the onset of the COVID-19 pandemic. But while patient service revenue increased in the first half as volumes rebounded, the system’s insurance business declined by $146 million in the first half compared to the same period in 2020 due to higher claims and expenses.”

Today's News and Commentary

Democrats have three weeks to get their health game on: A really good summary of the health content in the $3.5 trillion spending bill before Congress.

About Covid-19

U.S. administers 364.8 million doses of COVID-19 vaccines - CDC: “The agency said 202,500,853 people had received at least one dose while 171,773,370 people are fully vaccinated as of Wednesday.
The CDC tally includes two-dose vaccines from Moderna and Pfizer/BioNTech, as well as Johnson & Johnson’s one-shot vaccine as of 6:00 a.m. ET on Wednesday.”
”Those figures are up from the 363,915,792 vaccine doses that the CDC said had gone into arms by Aug. 24 out of 428,529,385 doses delivered.”

Moderna completes submission for full FDA approval of Covid-19 vaccine; Pfizer seeks approval for booster dose: “Moderna announced on Wednesday it has completed its submission to the US Food and Drug Administration for full approval of its Covid-19 vaccine for people age 18 and older, and Pfizer and BioNTech announced they have begun submitting data for full FDA approval of a third dose of their vaccine.
Moderna said it has requested priority review from the FDA. The company began submitting data for its Biologics License Application, or BLA, to the FDA in June.”

Japan suspends 1.6 million doses of Moderna shot after contamination reports: “Japan suspended the use of 1.63 million doses of Moderna Inc’s COVID-19 vaccine on Thursday, more than a week after the domestic distributor received reports of contaminants in some vials.
Both Japan and Moderna said no safety or efficacy issues had been identified and the suspension was just a precaution. But the move prompted several Japanese companies to cancel worker vaccinations planned for Thursday.”

Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting: “In this study in a nationwide mass vaccination setting, the BNT162b2 vaccine was not associated with an elevated risk of most of the adverse events examined. The vaccine was associated with an excess risk of myocarditis (1 to 5 events per 100,000 persons). The risk of this potentially serious adverse event and of many other serious adverse events was substantially increased after SARS-CoV-2 infection.”
It is important to note that the risk for myocarditis if infected with the virus is about 5X that of the vaccine.

‘I’m still not planning to get it’: FDA approval not swaying some vaccine holdouts: This quotation sums it up: “‘Most people have multiple reasons and concerns about getting vaccinated — it’s not just one thing,’ said Liz Hamel, a Kaiser Family Foundation director. ‘It may take some time for people to think about it.’”

Holes in reporting of breakthrough Covid cases hamper CDC response: “Forty-nine states are now regularly sending CDC information on hospitalized breakthrough patients. But more than a dozen told POLITICO that they do not have the capacity to match patients’ hospital admission data with their immunization records. Instead, those states rely on hospital administrators to report breakthrough infections. The resulting data is often aggregated, inaccurate and omits critical details for teasing out trends, such as which vaccine a person received and whether they have been fully vaccinated, a dozen state officials said.”

Covid protection for the fully vaccinated is waning, UK study finds: “An analysis from the UK's ZOE Covid app study of over 400,000 people who had received both shots of Pfizer-BioNTech's Comirnaty, showed that it was 88% effective a month after receiving both shots. However, efficacy fell to 74% five or six months after receiving both doses.
In the same study, an analysis of over 700,000 people who had received both doses of AstraZeneca's Vaxzevria showed its effectiveness fell from 77% after a month to 67% at the four- to five-month mark.
he data was collected after May 26, when the Delta variant became the dominant strain…”

COVID booster shots raise protection against severe illness to 97%: “Israeli health ministry figures suggest that after 16 days, a third dose of COVID-19 vaccine [Pfizer] boosts protection against severe illness from the virus to 97%…”

Delta Air Lines to impose $200 monthly surcharge on unvaccinated staff: “Ed Bastian, Delta chief executive, said the airline had decided to impose the $200 monthly surcharge from November to insulate its healthcare plan against the ‘financial risk’ of paying for employees sick with Covid. In a memo to staff seen by the Financial Times, Bastian said the average cost to Delta for an employee’s Covid-related hospitalisation was $40,000 per person and that all of its infected workers in recent weeks had not been fully vaccinated. In addition, a mask mandate will go into effect immediately for unvaccinated Delta workers, and beginning on September 12, employees who are not fully vaccinated must submit to a weekly test.”

FDA greenlights first smartphone-based home COVID-19 test: Developed by BD in collaboration with the digital testing company Scanwell Health, the Veritor rapid antigen test operates similar to a home pregnancy test, at first. After swishing a nasal swab in a tube of liquid reagents, drops on a testing strip trigger colored lines after about 15 minutes. There the smartphone takes over, using its camera to read and interpret the results more definitively.”

AHA wants OSHA to withdraw COVID-19 standard as ANA seeks to bolster it: “The American Hospital Association (AHA) wants the Biden administration to withdraw a COVID-19 emergency protection standard because it believes hospitals are already doing enough to protect front-line workers.
At the same time, the American Nurses Association (ANA) wants the standard to be even stronger, asking for vaccine mandates to be included in the Occupational Health and Safety Administration (OSHA) temporary standard, which requires employers to provide certain protections such as vital equipment like N95 masks.
The stark difference in views on the standard, which was open for comment until Aug. 20, comes as nurse unions and advocacy groups have charged that hospitals have not done enough to protect workers while facilities say they are following the latest policies and redoubled efforts to shield workers from the virus.”

Texas Governor Issues Order Banning Local Vaccine Mandates: The craziness continues.
”Gov. Greg Abbott issued an executive order on Wednesday banning any state or local mandates requiring people to be vaccinated against COVID-19, and he called on Texas legislators to vote it into law during their current special session.
The move came as Texas reported the most COVID-19 patients in its hospitals since the pandemic began.
Abbott issued his ban in an executive order to fill a loophole left by the full authorization of the Pfizer vaccine. He had previously banned the requirement of vaccinations under emergency use authorizations. He also has banned state and local government mandates for wearing masks.”

About the public’s health

Trends in Nicotine Product Use Among US Adolescents, 1999-2020: “This cross-sectional study, which included 16 years of survey data for between 15 000 and 36 000 students in grades 6 through 12 per year, found that exposure to nicotine products, as assessed by nicotine product days, decreased prior to the popularity of e-cigarettes. This decrease slowed and then reversed owing to the upsurge of vaping; however, adjusting for differential long-term risks of nicotine products, risk-adjusted nicotine product days may have decreased if the risk associated with vaping is sufficiently low compared with that of smoking.”

In 2021, the tobacco industry is projected to spend an estimated $105 million on Formula 1 sponsorship.: “The staggering amount confirms a concerning trend: Tobacco industry spending in F1 has increased, reaching its highest levels since 2006—the year tobacco companies were supposed to be banned from the sport.”

About behavioral health

Mental health giants Headspace and Ginger to merge into $3 billion company: “The new company, called Headspace Health, will have a reported value of $3 billion, placing it in the top echelon of companies vying to own significant chunks of the mental health market.
As investors have thrown huge sums into mental health, there’s been an increasing sense that consolidation must be on the horizon.”

Health Equity, Impact of Pandemic Among Large Employers’ Top Concerns, Says 2022 Health Care Strategy and Plan Design Survey: “Large U.S. employers noted five major areas of concern, including health equity and the pandemic’s long-term impact, as they modify benefits strategies and programs against the backdrop of the ongoing pandemic, according to Business Group on Health’s 2022 Large Employers’ Health Care Strategy and Plan Design Survey.
The survey, released today in Washington, D.C., also showed that top concerns include expanding access to mental health care, monitoring trends in health care delivery and preparing for an uptick in health care spending. The survey’s executive summary is located here.

About hospitals and health systems

US Nonprofit Hospitals’ Community Health Needs Assessments and Implementation Strategies in the Era of the Patient Protection and Affordable Care Act: “Among the 500 hospitals in our sample, 495 (99.0%) reported on their Internal Revenue Service 990 form that they had conducted a CHNA, and 412 (84.0%) of these CHNAs were identified online. A total of 491 hospitals (99.0%) reported that they adopted an implementation strategy, and 331 of these (75.0%) were identified on their website. In aggregate, 229 (60.0%) of the hospitals in our sample had both a CHNA and corresponding implementation strategy that could be found online.”

Amid rising expenses, Banner Health sees $179M operating income for H1 2021: “Banner Health credited federal pandemic support programs as a major lifeline to its financials during the pandemic.
The system said it has recognized $103 million in Provider Relief Funds during the first half of 2021 and a total of roughly $466 million in stimulus funds overall. In April, it also began recouping the $654 million in Medicare Accelerated and Advance Payments it received, roughly $587 million of which remained by June 30.”

About pharma

AstraZeneca's $39B Alexion buyout bears fruit, yielding late-phase win for potential blockbuster rare disease drug: “The study showed ALXN1840 is better than existing Wilson drugs—trientine, penicillamine, zinc or a combination of the medicines—at mobilizing copper from tissues. Wilson patients suffer from the loss of function in a copper-binding protein, causing the accumulation of the element. As copper accumulates, patients suffer outcomes including liver disease, neurological problems and psychiatric disturbances.”

Gilead wins reversal of $1.2B fine in CAR-T patent fight with Bristol Myer: “Thursday, a federal appeals court overturned a $1.2 billion fine on Gilead subsidiary Kite Pharma that was previously granted to Bristol Myers’ Juno Therapeutics unit and Memorial Sloan Kettering Cancer Center. The legal tussle focuses on whether Gilead’s CD19-targeted CAR-T therapy Yescarta infringed upon a Juno patent that’s licensed from MSK.”

About health insurance

Affordable Care Act’s Shared Savings Program Continues to Improve Quality of Care While Saving Medicare Money During the COVID-19 Pandemic: “The Centers for Medicare & Medicaid Services (CMS) announced today that Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (Shared Savings Program) in 2020 earned performance payments (shared savings) totaling nearly $2.3 billion while saving Medicare approximately $1.9 billion, marking the fourth consecutive year of net savings for Medicare.”
NOTE: While this CMS announcement is dated yesterday, the details are based on January 2020 data.

Today's News and Commentary

About Covid-19

Effectiveness of COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Frontline Workers Before and During B.1.617.2 (Delta) Variant Predominance — Eight U.S. Locations, December 2020–August 2021: From the CDC: “During December 14, 2020–April 10, 2021, data from the HEROES-RECOVER Cohorts,* a network of prospective cohorts among frontline workers, showed that the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines were approximately 90% effective in preventing symptomatic and asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19, in real-world conditions (1,2). This report updates vaccine effectiveness (VE) estimates including all COVID-19 vaccines available through August 14, 2021, and examines whether VE differs for adults with increasing time since completion of all recommended vaccine doses…
The VE point estimates declined from 91% before predominance of the SARS-CoV-2 Delta variant to 66% since the SARS-CoV-2 Delta variant became predominant at the HEROES-RECOVER cohort study sites; however, this trend should be interpreted with caution because VE might also be declining as time since vaccination increases and because of poor precision in estimates due to limited number of weeks of observation and few infections among participants. As with all observational VE studies, unmeasured and residual confounding might be present.”

FDA cautions against off-label use of Pfizer/BioNTech Covid-19 vaccine in younger children: The FDA joins the American Academy of Pediatrics in this recommendation. However, both organizations “strongly recommend that all eligible adolescents, ages 12 to 17, be vaccinated as soon as possible, especially as the highly transmissible Delta coronavirus variant continues to circulate nationwide.”

3 out of 4 pregnant people not yet vaccinated against COVID-19, CDC says: “Among pregnant Black people, nearly nine out of 10 are unvaccinated, according to the CDC.
Earlier this month, the CDC strengthened its recommendation for COVID-19 vaccination during pregnancy, citing new evidence of safety with the vaccines.”

Seoul urges Biden to break vaccine IP deadlock: “Seoul is calling on the Biden administration to help Korean companies access intellectual property for producing Covid-19 jabs, as the highly infectious Delta variant prompts a reassessment of global vaccine requirements. South Korea’s failed attempts to gain access to US companies’ mRNA vaccine technology strikes at the heart of the rising divergence between the interests of pharmaceutical companies and the views of some international medical experts over jab supply shortages.”

Vax facts: San Diego researchers debunk 7 common COVID-19 vaccine myths: Good, clear explanations. Reprints would be good for physicians’ waiting rooms.

Booster dose of Johnson & Johnson vaccine yields stronger immune response than one shot, company says: “A second shot of the Johnson & Johnson coronavirus vaccine generates a protective response beyond the response from a single dose, the company said in a news release Wednesday.”
The preliminary results come from “two studies that have not gone through scientific peer review, submitted to the preprint site Medrxiv.”

CMS Ups Medicare Payment for At-Home COVID-19 Vaccinations, Again: “Medicare will pay an additional reimbursement of about $35 per dose administered for up to a maximum of five vaccine administration services per home unit or communal living space, as long as it is in a single group living location, CMS posted on its website earlier today.” See, also: Medicare Billing for COVID-19 Vaccine Shot Administration

Telling conservatives it’s a shot to ‘restore our freedoms’: How online ads are promoting coronavirus vaccination: A good example of how targeting can be effective social marketing.

About hospitals and health systems

Carbon Health scoops up 2 major clinic chains to expand primary care footprint: “Carbon Health, a primary care provider combining brick-and-mortar clinics with virtual services, bought two separate clinic chains to expand its national primary care footprint.
The company bought Southern Arizona Urgent Care’s nine clinics in Tucson, Arizona, and Med7 Urgent Care’s four clinics in Sacramento, California, bringing its total to 83 clinics across 12 states.
This acquisition underscores the company's goal of becoming the largest national healthcare provider, fueled by its recent $350 million funding news.”

August 2021 National Hospital Flash Report: From KaufmanHall: “steep increases in COVID-19 cases and hospitalizations spurred by rapid spread of the highly contagious Delta variant drove setbacks for u .s . hospitals and health systems in July .
Margins and volumes both were down across key metrics compared to pre-pandemic levels seen in 2019 . Revenues rose above 2019 levels, but those gains were offset by escalating expenses. Meanwhile, the data suggest that some healthcare consumers once again are postponing elective procedures and other outpatient care due to concerns of possible exposure to the virus.”
More details in the report.

Geisinger's operating income grows fivefold through first half of year: “The health system, which includes nine hospital campuses, saw its operating income hit $92.9 million in the first six months of 2021. In the same period last year, Geisinger's operating income was $17.4 million.
In the six months ending June 30, Geisinger posted revenue of $3.2 billion, up from $3.1 billion recorded in the same period last year. Expenses for the health system remained relatively flat year over year, growing just 0.1 percent to $3.1 billion. 
After factoring in investment gains, Geisinger ended the first six months of this year with a net income of $422.9 million. In the same period last year, Geisiger recorded a net loss of $180.7 million.”

Trends in Hospital Lawsuits Filed Against Patients for Unpaid Bills Following Published Research About This Activity: “In this cross-sectional analysis of 50 387 lawsuits filed by 67 Virginia hospitals, Virginia hospitals filed 59% fewer lawsuits in the year after a research article and subsequent media coverage exposed the practice compared with the year before publication. Overall, 11 hospitals banned the practice altogether.
These findings suggest that research and public health initiatives rooted in media exposure can increase public accountability for hospital billing practices and result in meaningful changes that benefit patients.”

About health insurance

AHIP: Adding dental, vision and hearing benefits could boost Medicare Advantage costs without benchmark changes: “Adding dental, vision and hearing benefits to traditional Medicare without adjusting Medicare Advantage payments could increase premiums for plans and lower rebates by up to 73%, according to a new insurer industry-funded report.
The analysis released Tuesday by top insurance lobbying group AHIP comes as Congress is considering adding the benefits as part of a $3.5 trillion infrastructure package. Payments to MA plans have also come under increased scrutiny as spending has outpaced traditional Medicare.
AHIP strongly urged the MA benchmark, which determines the payments for plans, to be adjusted if the new benefits are added.”

Today's News and Commentary

About Covid-19

Millions of Rapid Covid-19 Test Results Risk Going Uncounted: “Popular at-home Covid-19 tests from Abbott Laboratories and Quidel Corp., available without a prescription, were launched without a mechanism for reporting results to health officials, potentially leaving many cases uncounted by authorities as the delta variant spreads around the U.S.”

Labs unable to specify which COVID-19 variant patients have: “Despite recent COVID-19 surges largely due to the spread of the delta variant and vaccine hesitancy, most physicians and their patients are legally prevented from knowing which variant infected them because of regulatory hurdles…
That's because CMS requires genome-sequencing tests to be federally approved, a process that lab scientists say is too costly and time consuming to be done for every patient.”

Israel's COVID-19 vaccine boosters show signs of taming Delta: “The rate of disease spread among vaccinated people age 60 and over [the first group to receive a booster] - known as the reproduction rate - began falling steadily around Aug. 13 and has dipped below 1, indicating that each infected person is transmitting the virus to fewer than one other person. A reproduction rate of less than 1 means an outbreak is subsiding.”

Delta cases show 300 times higher viral load - S.Korea study: “People infected with the more transmissible Delta variant have a viral load 300 times higher than those with the original version of the COVID-19 virus, when symptoms are first observed, a South Korea study found.
But the amount gradually decreased over time - to 30 times in four days and over 10 times in nine days - and it matched levels seen in other variants after 10 days, the Korea Disease Control and Prevention Agency (KDCA) said on Tuesday.
The higher load means the virus spreads far more easily from person to person, increasing infections and hospitalisations, a health ministry official Lee Sang-won told a news conference.”

COVID-19 Transmission Dynamics Among Close Contacts of Index Patients With COVID-19: “In this cohort study of 730 index patients with a COVID-19 diagnosis and 8852 close contacts, transmission potential was greatest in the first 2 days before and 3 days after onset of symptoms in the index patient. When contacts received a diagnosis of COVID-19 infection, they were more likely to present asymptomatically if they had been exposed to an asymptomatic patient.”

It's Pronounced Koe-mir'-na-tee. How The Pfizer-BioNTech Vaccine's Name Came To Be: “The name ‘represents a combination of the terms COVID-19, mRNA, community, and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigor and efficiency — and with safety at the forefront — during this global pandemic,’ Pfizer and BioNTech said.”

American Academy of Pediatrics Cautions Against Off-Label Use of COVID-19 Vaccines in Children Under 12: “While the FDA is considering full approval of the vaccine for ages 12 through 15, it is available under emergency use authorization for this age group now, and AAP strongly recommends all eligible adolescents be vaccinated as soon as possible. The data from clinical trials and experience with the vaccine over the past four months in these adolescents show that it is safe and very effective in this age group, said Dr. Beers.
The dose of the adult vaccine is much higher than the doses being tested in children younger than 12.
Yvonne Maldonado, MD, FAAP, chair of the AAP Committee on Infectious Diseases, urged physicians to wait until the clinical trials are complete in children to give the vaccine to those under 12.”

Association of the COVID-19 Pandemic With the Prevalence of Homebound Older Adults in the United States, 2011-2020: “Between 2011 and 2020, the prevalence of homebound adults aged 70 years or older more than doubled, from approximately 5.0% from 2011-2019 to 13.0% in 2020. In 2020, an estimated 4.2 million adults aged 70 years or older were homebound compared with 1.6 million in 2019. The prevalence of being homebound in 2020 was greatest among Hispanic/Latino individuals (34.5% homebound compared with 12.6%-17.2% in prior years), followed by Black non-Hispanic individuals (22.6% homebound compared with 6.9%-9.9% in prior years) and White non-Hispanic individuals (10.1% homebound compared with 3.7%-6.0% in prior years).”

With Pfizer's COVID-19 vaccine approval, 145 health systems now require mandatory vaccination for their workforces: “Organizations that have taken the leap include major names like Kaiser Permanente, Trinity Health, Banner Health, Atrium Health and the Veterans Health Administration. Across the board, the policies of these and other providers include exemptions for medical, religious or other legally protected reasons.
At the same time, some health systems that are encouraging staff to vaccinate are holding back on making it a hard requirement.
Ballad Health CEO Alan Levine, for instance, told local press that forcing shots on the 22-hospital system’s remaining 38% of unvaccinated workers would likely exacerbate an ongoing nursing shortage.”
What if the federal government made hospital worker vaccinations a requirement of participation for Medicare, just as it does for nursing home personnel?

About hospitals and health systems

Advocate Aurora's net income, revenue bounce back in Q2: “Although much of its $739 million second-quarter net income came from its investments, Advocate Aurora Health also saw consistent gains across its operating income, overall revenue and operating margins.”
See the article for more details. Fortunately for hospitals, their investments buffered losses due to reduced volumes of profitable services caused by the pandemic.”

A Century of Care: This year is Cleveland Clinic’s 100th anniversary. It is worthwhile to review its history and mission on this site.

About pharma

FDA to Launch New Board to Improve Monitoring of Supply Chain: “The FDA’s Center for Drug Evaluation and Research (CDER) is setting up a new board to strengthen pharmaceutical supply-chain monitoring in the wake of COVID-19-related drug shortages.
The Pharmaceutical Supply Chain Governance Board, which will get under way next month, is tasked with coordinating all CDER supply-chain initiatives and providing guidance and fixes for major supply-chain issues.”

Pharma's reputation drops again. Could it foreshadow a return to the bottom?: “Pharma's reputation continues to slide, now down to 53% of consumers who still hold a positive view. The decline began after a February high of 62% approval, down to 60% in May and then 56% in June—and now down three more percentage points, according to The Harris Poll.
The steady drip, drip of approval drops now adds up to an overall nine-point decline in six months.”

About healthcare professionals

Survey Finds Slight Increase in Physician Compensation and Sharp Decline in Productivity in 2020: “Data from the 34th annual AMGA Medical Group Compensation and Productivity Survey demonstrates the profound effect of COVID-19 on physician compensation. Though the survey, conducted by AMGA Consulting, found very modest increases in compensation, there were significant decreases in productivity, which can be directly tied to the pandemic. The data reveals the devastating economic impact of COVID-19 on healthcare provider organizations and indicates that they may need to rethink their compensation models in order to remain resilient in the face of future disruptions.”
Look at the Figures for specifics by specialty.

About health insurance

COVID-19 Flexibilities Reminder: From CMS: “In light of the recent surge of the COVID-19 delta variant and increased hospitalizations across the country, the Centers for Medicare & Medicaid Services (CMS) strongly encourages all Medicare Advantage Organizations (MAOs) to waive or relax plan prior authorization requirements and utilization management processes to facilitate the movement of patients from general acute-care hospitals to post-acute care and other clinically-appropriate settings, including skilled nursing facilities, long-term care hospitals, inpatient rehabilitation facilities, and home health agencies. The ability of hospitals to transfer patients to appropriate levels of care without unnecessary delays or administrative burdens is critical to ensuring that hospitals have open acute-care beds to treat patients requiring emergent care.”

Majority of Health Insurers Concerned Over No Surprises Act’s Impending Transparency Requirements: Yesterday, Zelis “released findings from a survey conducted in July 2021 that polled healthcare insurers to assess their current readiness and preparation plans to meet the requirements set by the No Surprises Act (NSA). The NSA seeks to protect patients from surprise medical bills and includes transparency requirements, including an Advanced Explanation of Benefits (AEOB) for members that applies to both in- and out-of-network care. The way the law is currently written, for any healthcare service, a provider must send the patient’s insurer an estimate of expected charges. With that information, the insurer creates an AEOB, including the patient’s out-of-pocket estimates, and sends it to the patient before the scheduled service.
The poll of more than 100 healthcare executives revealed that a majority of insurers are concerned about the NSA’s transparency requirements. The results indicate that:

  • Three-quarters of respondents (74%) are concerned about meeting the Advanced Explanation of Benefits (AEOB) requirements.

  • Nearly two-thirds (63%) don’t know how they’re going to obtain the provider estimates required for AEOBs.

  • More than half (58%) expressed uncertainty about their ability to obtain the additional data required for AEOBs.”

About the public’s health

Screening for Prediabetes and Type 2 Diabetes: “The USPSTF recommends screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years who have overweight or obesity. Clinicians should offer or refer patients with prediabetes to effective preventive interventions. (B recommendation)”


Today's News and Commentary

Pfizer-BioNTech coronavirus vaccine wins full FDA approval, potentially persuading the hesitant to get a shot:
“In the end, the vaccine approval was the fastest in the agency’s history, coming less than four months after Pfizer-BioNTech filed for licensing on May 7. The individuals with knowledge of the decision spoke on the condition of anonymity because they were not authorized to speak publicly.”

About Covid-19

New Evidence Points To Antibodies As A Reliable Indicator Of Vaccine Protection: But the issue is a bit more complex than the headline leads us to believe. Read the article for a fuller explanation.

Unvaccinated COVID-19 hospitalizations cost the U.S. health system billions of dollars: “Based on our estimates…we find preventable COVID-19 cost the U.S. health system $2.3 billion in June and July 2021.” Read the article for the methodology that includes the finding that “each of these preventable hospitalizations cost roughly $20,000.”

Most U.S. teens, young adults want to get COVID-19 vaccine, survey finds: “About 75% of people ages 14 to 24 years in the United States who responded to the survey, conducted by the University of Michigan's Institute for Healthcare Policy and Innovation, said they would get the shot, the data showed.”

Morphological cell profiling of SARS-CoV-2 infection identifies drug repurposing candidates for COVID-19: “Repurposing of FDA-approved drugs is a promising strategy for identifying rapidly deployable treatments for COVID-19. Herein, we developed a pipeline for quantitative, high-throughput, image-based screening of SARS-CoV-2 infection in human cells that led to the identification of several FDA-approved drugs and clinical candidates with in vitro antiviral activity…
Notably, we discovered that lactoferrin, a glycoprotein found in secretory fluids including mammalian milk, inhibits SARS-CoV-2 infection in the nanomolar range in all cell models with multiple modes of action, including blockage of virus attachment to cellular heparan sulfate and enhancement of interferon responses. Given its safety profile, lactoferrin is a readily translatable therapeutic option for the management of COVID-19.”

Biden sees dip in support amid new COVID cases: AP-NORC poll: “A new poll from The Associated Press-NORC Center for Public Affairs Research finds that 54% of Americans approve of Biden’s job performance, down slightly from 59% last month.”

About health insurance

PRITZKER SIGNS PRIOR AUTHORIZATION LAW: “The [Illinois] law reduces the number of medically necessary services that are subjected to prior authorization requirements, and requires a decision to be made no later than 5 calendar days after obtaining the necessary information.
Prior authorization approvals will also remain valid for six months, or 12 months for chronic and long-term diseases.”

The Uninsurance Rate Held Steady During the Pandemic as Public Coverage Increased:
”Key Findings

  • Between March 2019 and April 2021, the share of nonelderly adults reporting employer-sponsored insurance declined from 65.0 percent to 62.3 percent, a decrease of approximately 5.5 million adults. Over the same period, the share reporting public coverage increased from 13.6 percent to 17.5 percent, an increase of approximately 7.9 million adults. The national uninsurance rate held steady at approximately 11 percent.

  • The share of adults reporting public coverage increased in all 50 states, however coverage gains were larger in states that expanded access to Medicaid. Such coverage increased from 14.9 percent to 19.2 percent in expansion states and from 10.7 percent to 14.3 percent in nonexpansion states.

  • More than 1 in 3 adults with low incomes in nonexpansion states (37.7%) were uninsured in 2021, compared with about 1 in 7 of such adults in expansion states (14.5%).”

Promise vs. Practice: the Actual Financial Performance of Accountable Care Organizations: “We found that overall, ACO programs roughly broke even from the CMS perspective. That is, when bonuses CMS paid to ACOs are subtracted from gross savings, the programs lost money or saved no more than a few tenths of a percent…
On the policy side, it is time to draw the ACO experiment to a close. We now have a decade of impressive empirical evidence demonstrating minimal if any benefit from ACOs of several designs.”

Biden can't rescind Texas' Medicaid waiver, court rules: “Texas has won a preliminary injunction barring President Joe Biden's administration from rescinding the previous administration's approval of changes to the state's Medicaid program, a move the state claims is intended to strong-arm it into expanding Medicaid under the Affordable Care Act.
U.S. District Judge J. Campbell Barker in Tyler, Texas, ruled Friday that the state was likely to succeed in proving that the administration's decision not to extenda waiver requiring Medicaid recipients to enroll in managed care, among other provisions, was arbitrary and capricious. The judge found that the Centers for Medicare and Medicaid Services failed to give Texas sufficient notice or chance to comment.”

About pharma

Pfizer swallows CD47 biotech Trillium in $2.3B takeover: “Trillium, like peers such as Forty Seven and Arch Oncology, has identified CD47 blockade as a way to unleash the power of the innate immune system against tumors. The two candidates are designed to block CD47 while simultaneously delivering an ‘eat me’ signal to macrophages and, in the case of TTI-621, activating natural killer (NK) cells.
Pfizer sees enough promise in the prospects to bet $2.26 billion on Trillium.”

Today's News and Commentary

About Covid-19 and vaccines

Texas Supreme Court rejects Abbott’s ban on school mask mandates — for now: “The move from the state’s high court happened the same day the Texas Education Agency suspended enforcement of Abbott’s ban in the state’s public school systems. The TEA noted in a public guidance letter that the ongoing court challenges pushed the agency to drop enforcement.”

AstraZeneca to seek approval for Covid antibody cocktail: “The Anglo-Swedish drugmaker said on Friday that its AZD7442 antibody combination showed a 77 per cent reduction in the development of symptomatic Covid compared with a placebo. There were no severe Covid cases or deaths in those treated with the drug, while the placebo arm accrued three cases of severe disease, including two deaths.”

Most private insurers are no longer waiving cost-sharing for COVID-19 treatment: While vaccination and testing costs are free to the public, “ 72% of the two largest insurers in each state and DC (102 health plans) are no longer waiving [treatment] costs, and another 10% of plans are phasing out waivers by the end of October.”

U.S. officials reviewing possibility Moderna vaccine is linked to higher risk of uncommon side effect than previously thought: “Federal health officials are investigating emerging reports that the Moderna coronavirus vaccine may be associated with a higher risk of a heart condition called myocarditis in younger adults than previously believed, according to two people familiar with the review who emphasized the side effect still probably remains uncommon.”

Public Perspectives on Decisions About Emergency Care Seeking for Care Unrelated to COVID-19 During the COVID-19 Pandemic: “In this survey study of 933 US adults, we found that 16.9% and 25.5% of individuals confronted with scenarios consistent with myocardial infarction or appendicitis, respectively, prioritized avoidance of COVID-19 exposure in the emergency department over seeking appropriate care. Sociodemographics, political affiliations, and personal knowledge, attitudes, and beliefs regarding COVID-19 were not factors associated with decision-making regarding emergency care seeking.”

U.S. administers 359.6 million doses of COVID-19 vaccines - CDC: “The agency said 199,887,548 people had received at least one dose while 169,592,873 people were fully vaccinated as of Thursday.
The CDC tally includes two-dose vaccines from Moderna and Pfizer/BioNTech, as well as Johnson & Johnson’s one-shot vaccine as of 6:00 a.m. ET on Thursday.”

A natural pandemic has been terrible. A synthetic one would be even worse: “The Covid-19 pandemic has revealed the fragility of the U.S.’s public health preparedness infrastructure when faced with a moderately deadly and moderately transmissible respiratory pathogen. We cannot begin to imagine the devastation — possibly even a threat to civilization — if the country had to face a synthetic pandemic from a virus that had been intentionally engineered to spread as effectively as measles and had the virulence of filoviruses such as Ebola or Marburg.”
A really good article about weaponized viruses and our lack of preparedness to address such an attack.

The CDC Only Tracks a Fraction of Breakthrough COVID-19 Infections, Even as Cases Surge: “The nation is flying blind yet again, critics say, because on May 1 of this year — as the new variant found a foothold in the U.S. — the Centers for Disease Control and Prevention mostly stopped tracking COVID-19 in vaccinated people, also known as breakthrough cases, unless the illness was severe enough to cause hospitalization or death.
Individual states now set their own criteria for collecting data on breakthrough cases, resulting in a muddled grasp of COVID-19’s impact, leaving experts in the dark as to the true number of infections among the vaccinated, whether or not vaccinated people can develop long-haul illness, and the risks to unvaccinated children as they return to school.”

‘No one wanted to read’ his book on pandemic psychology – then Covid hit: This article is not a book review, but an interview with the author about “pandemic psychology.” One paragraph that especially stood out for me: “He [the author] interpreted that pandemics ‘are essentially a psychological phenomenon and about the behaviors, attitudes and emotions of people’ and that ‘the psychological footprint is bigger than the medical footprint’.” The entire article is well worth reading.

CDC director says we might not need annual Covid boosters after third shot: “CDC Director Dr. Rochelle Walensky said Thursday that Americans may not need yearly Covid-19 booster shots, suggesting that a third shot may sufficiently strengthen the long-term protection of Pfizer’s or Moderna’s vaccines.”
By comparison, the Hepatitis B vaccine requires 3 doses and a booster is not needed annually.

New study boosts hopes for a broad vaccine to combat COVID-19 variants and future coronavirus outbreaks: “Scientists from Duke-NUS Medical School and National Centre for Infectious Diseases (NCID) found that 2003 SARS survivors who have been vaccinated with the Pfizer-BioNTech mRNA vaccine produced highly potent functional antibodies that are capable of neutralising not only all known SARS-CoV-2 variants of concerns (VOCs) but also other animal coronaviruses that have the potential to cause human infection. This finding, published in The New England Journal of Medicine, is the first time that such cross-neutralising reactivity has been demonstrated in humans, and further boosts hopes of developing an effective and broad-spectrum next-generation vaccine against different coronaviruses.
Among the coronavirus family, one sub-group relies on the ACE2 molecule to enter human cells. Both SARS-CoV-1 and SARS-CoV-2 belong to this group as well as a number of coronaviruses circulating in animals such as bats, pangolins and civets. While the exact route of transmission remains unknown, these viruses have the potential to jump from animals to humans and could start the next pandemic. Collectively, this group of viruses is called sarbecovirus.
’We explored the possibility of inducing pan-sarbecovirus neutralising antibodies that can block the common human ACE2-virus interaction, which will be protective not only against all known and unknown SARS-CoV-2 VOCs, but also future sarbecoviruses,’ said Dr Chee Wah Tan, Senior Research Fellow with Duke-NUS’ Emerging Infectious Diseases (EID) programme and co-first author of this study.”

Israel extends COVID-19 vaccine boosters to people over 40, teachers: “Health Minister Nitzan Horowitz said on Twitter that ‘now even people aged 40 and over, and teaching staff, can get a third vaccine dose.’ Prime Minister Naftali Bennett, 49, said he intends to get the third dose as soon as Friday morning.”

CSL bets on self-amplifying mRNA to tackle seasonal, pandemic influenza: “Similar to existing mRNA technology, sa-mRNA instructs cells to make a protein, stimulating the immune response and leaving a blueprint able to recognise and fight future infections. However, as the name suggests, it also amplifies the amount of protein made. ‘This could enable vaccine manufacturers to potentially develop more effective vaccines with a smaller dosage and with lower rates of reactogenicity,’ according to Seqirus. It noted that in preclinical testing, sa-mRNA has shown ‘the potential to raise stronger cellular responses and generate significantly higher antibody titres at the same dose level as mRNA.’”

Pan-protective anti-alphavirus human antibodies target a conserved E1 protein epitope: “Alphaviruses are emerging, mosquito-transmitted pathogens that cause musculoskeletal and neurological disease in humans. Although neutralizing antibodies that inhibit individual alphaviruses have been described, broadly reactive antibodies that protect against both arthritogenic and encephalitic alphaviruses have not been reported. Here, we identify DC2.112 and DC2.315, two pan-protective yet poorly neutralizing human monoclonal antibodies (mAbs) that avidly bind to viral antigen on the surface of cells infected with arthritogenic and encephalitic alphaviruses…Treatment with DC2.112 or DC2.315 protects mice against infection by both arthritogenic (chikungunya and Mayaro) and encephalitic (Venezuelan, Eastern, and Western equine encephalitis) alphaviruses through multiple mechanisms…”

Philadelphia becomes latest archdiocese to reject religious exemptions for vaccine mandates: “Philadelphia joins at least five other dioceses that have given their priests similar guidance, including San Diego, New York, Los Angeles, Honolulu and Camden, N.J. Their stance sharply contrasts with the position of other bishops and Catholic organizations that have supported those seeking exemptions for reasons of conscience…
In a vaccine promotion campaign, Pope Francis on Wednesday called receiving a vaccine ‘an act of love.’”


About aging [Note: “aging” is the American spelling while “ageing” is the English spelling]

What an Older, Slower-Growing U.S. Population Means for the Economy: An “aging population with fewer births is intensifying structural forces underlying new problems spawned by the pandemic. Labor supply has been falling far short of demand as workers deal with child care issues, virus concerns linger, and unemployment benefits have been more generous than normal. The new census report highlights longer-term forces that will continue to weigh on the labor market as economists and investors bank on a return to normal this fall when children head back to school and the $300 in extra weekly jobless pay expires. Whether the Delta variant of Covid-19 and renewed infection rates dash those plans is unclear.”

Evidence that ageing yields improvements as well as declines across attention and executive functions: “Many but not all cognitive abilities decline during ageing. Some even improve due to lifelong experience. The critical capacities of attention and executive functions have been widely posited to decline. However, these capacities are composed of multiple components, so multifaceted ageing outcomes might be expected. Indeed, prior findings suggest that whereas certain attention/executive functions clearly decline, others do not, with hints that some might even improve. We tested ageing effects on the alerting, orienting and executive (inhibitory) networks... [W]hereas the efficiency of the alerting network decreased with age, orienting and executive inhibitory efficiency increased, at least until the mid-to-late 70s…The results suggest variability in age-related changes across attention/executive functions, with some declining while others improve.”

About healthcare IT

Google dismantling health division as chief departs for Cerner: “As Dr. Feinberg is set to leave Google on Sept. 1, it's splitting its health projects and teams across several different parts of the company, according to an Aug. 19 internal memo.
Jeff Dean, the head of Google's research division, sent the memo to employees and said Google Health would no longer function as a unified unit.
Google's CMO, Karen DeSalvo, MD, who leads its clinical initiatives, will now report to the chief legal officer. Google Health's clinician team, which is building an EHR tool, will now report directly to Mr. Dean and its artificial intelligence team, which is working on medical imaging, will report to Google's search and AI team.”

FDA Sends Alert Over Blackberry OS Flaw in Manufacturing Equipment: “Reports of a vulnerability in the Blackberry operating system used in some pharmaceutical manufacturing equipment as well as in certain medical devices and device manufacturing has prompted the FDA to issue a cybersecurity alert.
The software flaw, which affects certain versions of the BlackBerry QNX software development platform, could potentially allow a hacker to disable the software or have it do something it’s not supposed to do.”

About pharma

Prescription of Lipid-Lowering and Antihypertensive Drugs Following Pictorial Information About Subclinical Atherosclerosis: “The findings of this trial demonstrate that provision of pictorial information on vascular age and carotid plaques based on the results of ultrasonographic examination increased physician prescription of lipid-lowering drugs but not antihypertensive drugs within the following 465 days.”
Getting physicians to prescribe more appropriately is an ongoing issue. This method was a targeted solution. One must note, however, that it is a Swedish study, so applicability to other cultures needs to be demonstrated.

About medical malpractice

Redefining "cause of death" meaning would upend medical liability law: “In an opinion, the Superior Court of Pennsylvania said that ‘cause of death’ is ambiguous and interpreted it to mean the ‘conduct the plaintiff alleges led to the decedent's death.’ That definition would allow plaintiffs to file lawsuits beyond the two-year statute of limitations established in the bipartisan Medical Care Availability and Reduction of Error Act (MCARE).”
In other words, the Court said the cause of death is not a medical condition listed on a death certificate, but “conduct the plaintiff alleges led to the decedent's death.”

Today's News and Commentary

About healthcare quality

Apology Law Is Constitutional, Ariz. Appeals Court Finds: “An Arizona appeals court has ruled that a state law that a health care worker's apology can't be used as evidence of malpractice is constitutional in an appeal by a couple who said their obstetrician's conduct led to one of their twins suffering brain damage.” One of the basic tenets of “modern” quality processes is an apology for errors. But lawyers are often reluctant to allow their clients to make such statements. The affirmation of the constitutionality of this law can provide an impetus for other states to enact similar legislation.

About hospitals and health systems

Providence posts $94M loss in first half as higher staff expenses offset increases in volume: This article highlights two important points: Personnel-related costs are the single biggest institutional expense (in fact, the majority) and relying to a great degree on temp staff is not a financially stable policy.

About health insurance

Humana completes acquisition of Kindred at Home: “With the deal finished, Humana is now the country's largest provider of home healthcare services. Kindred at Home provides home health, hospice and personal care to more than 550,000 patients each year, Humana said.” This deal continues the trend of insurers buying provider organizations.

About Covid-19

Biden says US will require nursing homes get staff vaccinated or lose federal funds: “Biden said he is directing the Department of Health and Human Services to draw up new regulations making employee vaccination a condition for nursing homes to participate in Medicare and Medicaid.”
Many healthcare employers have been reluctant to require vaccines because, facing a tight labor market, they are afraid workers will quit. This action may force their hands. The question is what other leverage does the federal government have? Certainly, hospitals and other health facilities can be likewise compelled to vaccinate employees; but what about other institutions that receive federal monies- like public schools and universities that get research funding?

Third dose of Pfizer, BioNTech's COVID-19 vaccine 86% effective in over-60s: study: “According to initial results released by a large Israeli health maintenance organisation (HMO), a third dose of Pfizer and BioNTech's COVID-19 vaccine BNT162b2 was 86% effective in people aged over 60.”

Early Convalescent Plasma for High-Risk Outpatients with Covid-19: “Outcomes regarding worst illness severity and hospital-free days were similar in the two groups [antibody and placebo]…
The administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression.”

Vaccines still effective against Delta variant of concern, says Oxford-led study of the COVID-19 Infections Survey: “Obtaining two vaccine doses remains the most effective way to ensure protection against the COVID-19 Delta variant of concern dominant in the UK today, according to a study from the University of Oxford…
Two doses of either vaccine still provided at least the same level of protection as having had COVID-19 before through natural infection; people who had been vaccinated after already being infected with COVID-19 had even more protection than vaccinated individuals who had not had COVID-19 before.
However, Delta infections after two vaccine doses had similar peak levels of virus to those in unvaccinated people; with the Alpha variant, peak virus levels in those infected post-vaccination were much lower.”

About healthcare IT

CDC Stands Up New Disease Forecasting Center: “The center, with initial funding from the American Rescue Plan, will focus on three key functions:

  • Predict: Undertake modeling and forecasting; enhance the ability to determine the foundational data sources needed; support research and innovation in outbreak analytics and science for real-time action; and establish appropriate forecasting horizons.

  • Connect: Expand broad capability for data sharing and integration; maximize interoperability with data standards and utilize open-source software and application programming interface capabilities, with existing and new data streams from the public health ecosystem and beyond.

  • Inform: Translate and communicate forecasts; connect with key decision-makers across sectors including government, businesses, and non-profits, along with individuals with strong intergovernmental affairs and communication capacity for action.”

Biden-Harris Administration Invests over $19 Million to Expand Telehealth Nationwide and Improve Health in Rural, Other Underserved Communities: The “Biden-Harris Administration is announcing key investments that will strengthen telehealth services in rural and underserved communities and expand telehealth innovation and quality nationwide. These investments—totaling over $19 million—are being distributed to 36 award recipients through the Health Resources and Services Administration (HRSA) at the U.S. Department of Health and Human Services (HHS).”

HCA Healthcare to Sell PatientKeeper to Venture Firm General Catalyst’s Commure and Enter Into a New Strategic Collaboration: “HCA Healthcare…and General Catalyst, a global venture capital firm, today announced the sale of HCA Healthcare’s PatientKeeper to General Catalyst’s portfolio company Commure along with an investment in Commure and the formation of a new strategic collaboration to accelerate digital transformation.
PatientKeeper is a leading provider of intuitive software and mobile applications that help physicians and care teams access and work with patient information….
HCA Healthcare will continue to deploy PatientKeeper technology at its more than 180 hospitals across the country. For more than a decade, physicians at HCA Healthcare-affiliated hospitals have been using PatientKeeper to access a single view of their patients’ information across a variety of hospital systems, to streamline workflow, and to help improve patient care.”

About pharma

NICE changes to provide faster, fairer access to new drugs and devices: England’s National Institute for Health and Care Excellence (NICE) announced changes in its evaluation process to authorize new therapies. Since the organization is a model for rational technology evaluation, the announcement is worth reading.

Verily makes its first major acquisition as it looks to transform clinical trials: “On the heels of a series of prominent recent hires, Verily announced plans on Tuesday to make its first major acquisition by buying SignalPath, a North Carolina company which developed a clinical trial management platform. Verily, an Alphabet spinout founded in 2015, plans to use the acquisition to increase its appeal to clinical trial sites and to speed its efforts on decentralized research…”

About the public’s health

U.S. appeals court upholds Texas ban on second-trimester abortion procedure: “The 5th U.S. Circuit Court of Appeals upheld on Wednesday a Texas law effectively banning the most common abortion procedure for terminating second-trimester pregnancies, reversing a ruling last year by a three-judge panel of the same court.
Wednesday's decision marks the first time a U.S. federal court has upheld a prohibition on the standard abortion method used after 15 weeks of pregnancy - dilation and evacuation, or D&E - though some other states have acted to outlaw it…
Physicians found to have violated the measure would face a prison term of up to two years.
Nine judges on the New Orleans-based appeals court joined in ruling in favor of the Texas statute, with five judges dissenting and three recused from the case.
The newly re-instated law forbids D&E abortions unless the physician first performs a separate, additional procedure in the woman's body to bring about the demise of the fetus.”

About health technology

Microengineered perfusable 3D-bioprinted glioblastoma model for in vivo mimicry of tumor microenvironment: This 3-D printed tumor has the supporting structures and blood vessels if in-situ cancers. The authors conclude: “Our 3D-bioprinted model could be the basis for potentially replacing cell cultures and animal models as a powerful platform for rapid, reproducible, and robust target discovery; personalized therapy screening; and drug development.”

Today's News and Commentary

About Covid-19

U.S. reports more than 1,000 COVID deaths in single day: ”The United States reported more than 1,000 COVID-19 deaths on Tuesday, equating to around 42 fatalities an hour, according to a Reuters tally, as the Delta variant continues to ravage parts of the country with low vaccination rates.
Coronavirus-related deaths have spiked in the United States over the past month and are averaging 769 per day, the highest since mid-April, according to the Reuters tally.”

Biden administration to start offering vaccine booster shots to all Americans Sept. 20: “The plan, which applies only to the Pfizer and Moderna vaccines, calls for all Americans to get a booster shot eight months after receiving their second doses. The officials said they expect a booster shot will be needed for people who received the Johnson & Johnson vaccine, but they are still reviewing data and will announce plans at a later date.”

Most Americans support requiring masks in public places, yet few report experiencing actual employer or government mandates: “Two-thirds (64%) support their state or local government requiring masks to be worn in all public places.
However, there are significant partisan differences, with the vast majority of Democrats (88%) and less than half of Republicans (40%) in favor of state or local mask mandates.
Support for state and local mask requirements also varies based on where people live, with those living in urban areas (71%) being more supportive than those who live in rural areas (49%).
Despite this strong support for mask requirements, only a third (33%) say that their state or local government has required masks to be worn in all public places in the last few weeks.”

Texas Gov. Greg Abbott, who has sought to ban mask mandates in schools, tests positive for the coronavirus: He was vaccinated and is apparently asymptomatic. The positive test was part of regular screening. The problem is he does not wear a mask when in large groups.

What’s safe to do during summer’s Covid surge? STAT asked public health experts about their own plans: Interesting responses about their own preferences. The one unanimous reply was that: “None of 27 people who answered this question expressed a willingness to send an unvaccinated child to school without a mask.” The bar graph is a quick look at responses.

Vaccines show declining effectiveness against infection overall but strong protection against hospitalization amid delta variant: “Three studies published Wednesday by the Centers for Disease Control and Prevention show that protection against the coronavirus from vaccines declined in the midsummer months when the more contagious delta variant rose to dominance in the United States.
At the same time, protection against hospitalization was strong for weeks after vaccination, indicating the shots will generate immune fighters that stave off the worst effects of the virus and its current variations.”

UK authorises Moderna's COVID-19 vaccine Spikevax for adolescents: “The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday extended the conditional authorisation for Moderna's mRNA COVID-19 vaccine Spikevax, allowing it to be given to 12- to 17-year-olds in Great Britain.”

About pharma

Walgreens Launches Industry-First myWalgreens Credit Card Program – The Credit Card That Pays Well to Stay Well®: The card offers customers discounts and cash rewards on purchases at Walgreens stores. Wonder why the company did not take this action sooner.

FDA new drug applications to cost more than $3M in 2022: “Starting in 2022, drugmakers filing new drug applications with clinical data will have to pay the FDA $3.1 million.
The FDA's fee for new drugs with clinical data has risen from a little more than $2 million in 2017 to $3.1 million in 2022.
The 2022 fee for FDA approval applications not requiring clinical data will be about $1.6 million in 2022, which is about $200,000 more than the previous two years.”

About health insurance

Association of Race and Ethnicity and Medicare Program Type With Ambulatory Care Access and Quality Measures: “Medicare Advantage, compared with traditional Medicare, was significantly associated with better outcomes for ambulatory care access and quality among minority beneficiaries, but minority beneficiaries nonetheless experienced worse outcomes for most of these measures compared with other beneficiaries within both Medicare programs.”

Higher and Faster Growing Spending Per Medicare Advantage Enrollee Adds to Medicare's Solvency and Affordability Challenges: “Medicare spending for Medicare Advantage enrollees was $321 higher per person in 2019 than if enrollees had instead been covered by traditional Medicare. The Medicare Advantage spending amount includes the cost of extra benefits, funded by rebates, not available to traditional Medicare beneficiaries.
The higher Medicare spending per Medicare Advantage enrollee, compared to spending for similar beneficiaries under traditional Medicare, contributed an estimated $7 billion in additional spending in 2019.
Growth in Medicare Advantage enrollment explains half of the projected increase in total Medicare Advantage spending between 2021 and 2029 and half is attributable to growth in Medicare payments per Medicare Advantage enrollee, after accounting for inflation.”

Evaluation of Clinical and Economic Outcomes Following Implementation of a Medicare Pay-for-Performance Program for Surgical Procedures: “The findings of this study suggest that the pay-for-performance program was associated with improvement on several dimensions of surgical care, including small reductions in surgical site infection and length of stay, and moderate reductions in hospital costs.”



Today's News and Commentary

About Covid-19

Biden administration to announce most Americans will need coronavirus booster shots: “Administration officials believe people should get additional shots eight months after being fully vaccinated…
Administration of boosters would not occur until mid- or late September, after an application from Pfizer-BioNTech for the additional shots is cleared by the Food and Drug Administration, the individuals said.” In a related article: COVID-19 CPT coding and guidance, the AMA reviews coding for the vaccines, including Pfizer and Moderna third shots. Further: Pfizer, BioNTech submit early data to FDA to support COVID-19 vaccine booster: “Pfizer and partner BioNTech announced Monday that they have submitted Phase I data to the FDA supporting the use of a third dose of their COVID-19 vaccine BNT162b2. The companies stated that these findings will also be submitted to the European Medicines Agency and other regulatory bodies in the coming weeks.” And finally: A million Israelis get third dose, with early data showing heightened protection: “According to health ministry figures, the results are very promising. Third-dose recipients appear to be 2.5 times more protected from infection than those who received two doses of the Pfizer vaccine. The added protection appears to reach its peak about a week after the third dose is given.
Amid rising cases, last month Israel became the first nation in the world to begin administering booster shots to those 60 and over. On Friday, Israel began giving third doses to people ages 50 and up.”

UPDATE ON ACTEMRA®(TOCILIZUMAB) SUPPLY IN THE U.S.: From Roche: “The dramatic emergence of the COVID-19 Delta variant, as well as the unexpected slowing of vaccination rates in the U.S., has led to an overwhelmingly high incidence of COVID-19 hospitalizations in certain areas of the country. This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV-- well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase…
[Despite efforts to increase the supply,] we are experiencing a temporary stockout of Actemra IV in the U.S. for 200mg and 400mg SKUs, as of Monday, August 16th, and have notified our customers. We currently have a short supply of the 80mg SKU, and we anticipate stockout by the end of the week. 
We expect the next scheduled replenishments to arrive by the end of August. However, if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”

Man shot 6 times waits more than a week for surgery after hospital is overwhelmed by covid:
A great ethics case. The shooting victim was an innocent bystander. The Covid patients at Ben Taub Hospital in Houston (where the ICU is at 103 % of capacity) could have prevented their disease if they were vaccinated. Who “deserves” the beds more?

Association of Vaccine Type and Prior SARS-CoV-2 Infection With Symptoms and Antibody Measurements Following Vaccination Among Health Care Workers: “Clinically significant symptoms following dose 1 were associated with prior SARS-CoV-2 infection, confirming prior reports. Clinically significant symptoms following vaccination were more frequent following dose 2 and receipt of the Moderna vaccine.”

GSK and CureVac’s second Covid vaccine yields stronger response: “The second-generation Covid-19 vaccine from GlaxoSmithKline and its partner CureVac induces a stronger immune response than the German biotech’s first vaccine, according to a new study. In an animal study, which has yet to be peer reviewed, the companies said the mRNA vaccine could induce antibodies capable of tackling several variants of concern, including Beta, Delta and Lambda. The new vaccine elicited a response more quickly and created a higher level of antibodies than CureVac’s first-generation vaccine. It was also better at activating B and T cells, other important elements of the immune system’s response. In a phase 3 trial, CureVac’s first vaccine had an average efficacy of 48 per cent. The partners plan to start a phase 1 clinical trial on humans of the second-generation vaccine in the fourth quarter.”

Association of Age and Pediatric Household Transmission of SARS-CoV-2 Infection: “This study suggests that younger children may be more likely to transmit SARS-CoV-2 infection compared with older children, and the highest odds of transmission was observed for children aged 0 to 3 years.”

Covid Vaccines Produced in Africa Are Being Exported to Europe: “South Africa is still waiting to receive the overwhelming majority of the 31 million vaccine doses it ordered from Johnson & Johnson. It has administered only about two million Johnson & Johnson shots. That is a key reason that fewer than 7 percent of South Africans are fully vaccinated — and that the country was devastated by the Delta variant.
At the same time, Johnson & Johnson has been exporting millions of doses that were bottled and packaged in South Africa for distribution in Europe, according to executives at Johnson & Johnson and the South African manufacturer, Aspen Pharmacare, as well as South African government export records reviewed by The New York Times.”

About pharma

Merck joins other drugmakers in cutting off sales to 340B contract pharmacies: “Merck became the latest drugmaker to cut off sales of 340B-discounted products to contract pharmacies, despite warnings from the federal government that similar moves by other companies violate the program’s statute.
The drug giant wrote to 340B entities last week that if they do not join the company’s program integrity initiative then it will cut off sales to most contract pharmacies starting on Sept. 1.”

Blues plans pass on including aducanumab on formulary: A short summary of which plans are not going to cover the drug.

FDA Requests Feedback on Older Approved Generic Drugs: “The FDA is asking for public comments on how it regulates generic drugs that were approved prior to the Hatch-Waxman Amendments of 1984, which established the current abbreviated new drug application (ANDA) process for generics.
Dubbed PANDAs (Pre-Hatch-Waxman ANDAs) by the agency, the drugs were first approved even earlier, between 1938 and 1962, when the agency only required drugs to be proven safe rather than both safe and effective.”

About healthcare IT

Bias and fairness assessment of a natural language processing opioid misuse classifier: detection and mitigation of electronic health record data disadvantages across racial subgroups: “We identified bias in the false negative rate (FNR = 0.32) of the Black subgroup compared to the FNR (0.17) of the White subgroup. Top features included “heroin” and “substance abuse” across subgroups. Post-hoc recalibrations eliminated bias in FNR with minimal changes in other subgroup error metrics. The Black FNR subgroup had higher risk scores for readmission and mortality than the White FNR subgroup, and a higher mortality risk score than the Black true positive subgroup (P < .05).”
AI can lead to both under- and over diagnosis of conditions due to model biases. The authors caution that: “From model design through deployment, bias and data disadvantages should be systematically addressed.”

TELEHEALTH RESEARCH INCUBATOR: Research Snapshots: A really good analysis of the costs and efficiency of telehealth visits. The report lays out a series of questions and then answers them.
For example, telehealth visits, on average, are several minutes longer and cost slightly more than in-person visits. But throughput is higher with telemedicine (no surprise). Telehealth also leads to more followup visits than in-person care.

About the public’s health

Biden administration approves largest increase to food assistance benefits in SNAP program history: “Benefits will rise by 25 percent on average, an infusion of cash that advocates say better reflects the modern cost of a basic diet.”

First Tick-Borne Encephalitis Vax Approved in the U.S.— TicoVac has been available abroad for 45 years: “It has been a long road to U.S. approval for TicoVac, which the manufacturer noted has been approved outside the country since 1976 -- over 170 million doses have been administered since that time. TicoVac, also marketed in Europe under the name FSME-Immun, is an inactivated whole virus vaccine that mimics the tick-borne encephalitis found in nature, and induces neutralizing antibodies against the virus, Pfizer said.”

‘Tainted’ Blood: Covid Skeptics Request Blood Transfusions From Unvaccinated Donors: “‘We are definitely aware of patients who have refused blood products from vaccinated donors,’ said Dr. Julie Katz Karp, who directs the blood bank and transfusion medicine program at Thomas Jefferson University Hospitals in Philadelphia.
In practical terms, blood centers have only limited access to donated blood that has not in some way been affected by covid. Based on samples, Katz estimated that as much as 60% to 70% of the blood currently being donated is coming from vaccinated donors. Overall, more than 90% of current donors have either been infected with covid or vaccinated against it, said Dr. Michael Busch, director of the Vitalant Research Institute, who is monitoring antibody levels in samples from the U.S. blood supply.
’Less than 10% of the blood we collect does not have antibodies,’ Busch noted.”

About healthcare professionals

ASA Position Statement on AANA Name Change: The American Society of Anesthesiologists (ASA) is gravely concerned with the American Association of Nurse Anesthetists’ (AANA) adoption of the new name ‘American Association of Nurse Anesthesiology.’ Medical title misappropriation, including AANA’s name change and their blatant encouragement of their members to use the term ‘nurse anesthesiologist,’confuses patients and creates discord in the care setting, ultimately risking patient safety. 
The term ‘anesthesiologist’ has always been used to differentiate physicians trained in the science and study of anesthesiology from non-physicians, including nurse anesthetists.”

About health insurance

More than half of medical practices report being forced to pay to receive electronic payments from insurers: From an MGMA poll:
”Of those who responded “yes” (57%) to being charged fees for EFT payments in the poll:

  • 10% stated they were charged a fee of 1% of their total reimbursement

  • 43% responded they were charged 2%

  • 43% stated they were charged 3%

  • 4% indicated they were charged 4% or more per EFT transaction…

The Association has called on CMS to repost prior industry guidance that was removed in 2017, or for CMS to clearly restate this guidance in a definitive manner. Additionally, MGMA believes if CMS will not provide clear guidance, the agency should clearly state why it is not using its authority to prohibit these abuses.”

Medicare Paid New Hospitals Three Times More for Their Capital Costs Than They Would Have Been Paid Under the Inpatient Prospective Payment System: From the HHS OIG: Medicare regulations require that established hospitals be paid for capital costs through the Inpatient Prospective Payment System (IPPS). These regulations also allow new hospitals to be exempt from the IPPS payment methodology for capital costs and, instead, to be paid for these costs on a cost reimbursement basis for their first 2 years of operation. The stated rationale for this IPPS exemption is that new hospitals may not have adequate Medicare utilization in those initial 2 years and may have incurred significant startup costs.
Our objective was to determine the potential cost savings to Medicare if the IPPS exemption were removed such that capital payments to new hospitals would be paid under the IPPS…
We identified significant potential cost savings to Medicare if the IPPS exemption were removed and capital payments to new hospitals were made through the IPPS. For the 112 new hospitals that we reviewed, Medicare paid a total of $283 million more for capital costs than it would have paid if these hospitals had been paid through the IPPS. The IPPS exemption resulted in new hospitals being paid three times more-or an average of almost $1.3 million more per cost report-under the reasonable cost methodology than if they had been paid for their capital costs under the IPPS…
We recommend that CMS review the findings in this report and, if it determines that a separate payment methodology for capital costs at new hospitals is no longer warranted, change its regulations to require new hospitals to have their Medicare capital costs paid through the IPPS with an option for payment adjustments or supplemental payments if necessary.”

Waste in the Medicare Program: a National Cross-Sectional Analysis of 2017 Low-Value Service Use and Spending: “We used Medicare claims and enrollment data for 100% of fee-for-service beneficiaries aged 65 and older continuously enrolled in parts A, B, and D for two years in 2017: 15,168,134 beneficiaries, requiring at least one and up to three years of claims history preceding the 2017 measurement year…
Among the included beneficiaries, 5,389,619 (35.5%) had at least one low-value service, accounting for 10 million distinct services... The three most frequent services were as follows: opioids for acute low back pain (2.8 million, 28.5%), preoperative baseline laboratory studies (2.6 million, 25.6%), and oral antibiotics for acute upper respiratory or external ear infections (1.4 million, 13.9%)—comprising over two-thirds of low-value services measured (68%).
Cumulative low-value service spending varied from $723 million ($48 per capita) at the claim-line-level to $2.1 billion ($140 per capita) at the claim-level... Spending per service varied from $6.32 for bleeding time testing at the claim-line-level to $7344.39 for renal artery revascularization at the claim-level..”
The total cost of all these unnecessary tests is ~$212.6 billion.

Health Disparities: This link is for an excellent special JAMA issue on this topic.

Today's News and Commentary

Here are 3 major policy areas that health industry groups are closely watching in $3.5T infrastructure bill: A good, concise review.

About Covid-19

Texas Supreme Court sides with governor and temporarily blocks mask mandates: The latest on a previously reported story:
”The Texas Supreme Court sided with Gov. Greg Abbott on Sunday in a ruling that temporarily blocks mask mandates recently issued in San Antonio and Dallas, though local officials said they will continue to enforce at least a portion of the mask mandates.
The Texas high court granted stay orders Sunday, but previously scheduled hearings on local mask mandates in lower courts in Bexar and Dallas counties will proceed as scheduled.”

Israel expands COVID vaccine booster campaign to over 50s, health workers: “Those eligible will be ‘people over 50, health care workers, people with severe risk factors for the coronavirus, prisoners and wardens,’ the health ministry said.
Israelis aged 60 and over started receiving the booster two weeks ago, ahead of any third-dose approval by the FDA. The US agency on Thursday authorised booster doses for people with compromised immune systems.” And in a related article: Biden administration plans for vaccine boosters, perhaps by fall

Does COVID cause babies to develop differently? - prelim data: “Children born during the coronavirus pandemic have significantly reduced verbal, motor and overall cognitive performance compared to children born before the pandemic, and this discrepancy is particularly pronounced in males, as well as in children in lower socioeconomic families, according to preliminary data presented in a preprint study. Researchers believe that this highlights that even in the absence of infection and illness, the pandemic has had a significant, negative impact on infant and child development.
In the study, not yet-peer reviewed and uploaded as preprint in medRxiv on Wednesday, researchers from Brown University examined data from an ongoing longitudinal study of child neurodevelopment, comparing scores in 2020 and 2021 to scores from 2011 to 2019.”

About health insurance

Updated Guidance Related to Planning for the Resumption of Normal State Medicaid, Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP) Operations Upon Conclusion of the COVID-19 Public Health Emergency [PHE]: “Specifically, CMS is revising the guidance in the December 2020 SHO in two key areas, as follows.
Extending the timeframe for states to complete pending eligibility and enrollment actions to up to 12 months after the month in which the PHE ends…
Completing an additional redetermination for individuals determined ineligible for Medicaid during the PHE” [Emphasis in the original]

Medicaid Programs Call for Medicare Coverage of Alzheimer’s Drug: “The National Association of Medicaid Directors (NAMD) is recommending that CMS approve Medicare coverage for Alzheimer’s disease therapies.
’The outcome of Medicare’s coverage decision for this therapy will have enormous ramifications for the Medicaid program,’ the Medicaid directors stressed. ‘Should Medicare not cover the drug, then Medicaid would become the primary source of coverage for duals and dramatically increase Medicaid spending.’
If Medicare does not cover aducanumab—an Alzheimer’s drug that has received FDA approval—then Medicaid spending could increase by approximately 250 percent nationwide, NAMD experts estimated. Some states could see spending increases of up to 500 percent.” And in a related article: Excellus BlueCross BlueShield Says It Won’t Cover Aduhelm

About diagnostics

New DNA Blood Test Could Pinpoint Cancer’s Source in the Body: Much has been written recently about so-called liquid biopsies- detecting tumors in the blood from DNA fragments. This “new test (called GETMap, for genetic-epigenetic tissue mapping) also measures a phenomenon called DNA methylation. Cells add molecular groups to certain DNA sequences to turn genes on and off; this so-called methylation fingerprint can reveal the original tissue source for the DNA.” Gene mapping most often does not pick up these crucial epigenetic changes.

About hospitals and health systems

Medicare Holds Off on Hospital Price Disclosure Fines for Now: CMS ”is giving hospitals time to adjust to its price transparency rule, so far refraining from penalizing providers despite recently proposing to increase sanctions for those that don’t comply…
The vast majority of hospitals—94.4%—haven’t met one or more of the requirements since the rule took effect Jan. 1, 2021, according to a recent sample of 500 hospital websites conducted by Patient Rights Advocate. Right now many hospitals are getting warning letters if they don’t comply.
Rather than rescinding or modifying the Trump-era rule, the Biden administration has also proposed tougher sanctions. The Centers for Medicare & Medicaid Services suggested increasing the penalty for noncompliant hospitals in a July proposed rule (RIN 0938-AU43) regulating outpatient payment rates for acute care hospitals. 
Hospitals can currently be fined up to $300 a day. If the proposal is finalized, the penalty would increase to at least $300 a day for smaller hospitals and $10 a bed a day for larger hospitals, but no more than $5,500 a day.”

About pharma

Optum quietly revamps online pharmacy, sells virtual care for cash: “UnitedHealth subsidiary Optum is offering virtual care and discounted drugs to patients who pay with cash, presenting new competition to digital health startups and telehealth providers..

Today's News and Commentary

About Covid-19

FDA authorizes third vaccine dose for immunocompromised people: “The Food and Drug Administration (FDA) on Thursday authorized a third dose of COVID-19 for certain people with compromised immune systems, a narrow move into the realm of booster doses amid a growing debate over their use.
The move will allow a third dose of both the Pfizer-BioNTech and Moderna vaccines, and applies to certain immunocompromised people, including those with organ transplants and those ‘diagnosed with conditions that are considered to have an equivalent level of immunocompromise,’ the FDA said.
The agency emphasized that the general public does not need a third dose at the moment.”

Change in Saliva RT-PCR Sensitivity Over the Course of SARS-CoV-2 Infection: “Saliva was sensitive for detecting SARS-CoV-2 in symptomatic individuals during initial weeks of infection, but sensitivity in asymptomatic SARS-CoV-2 carriers was less than 60% at all time points. As COVID-19 testing strategies in workplaces, schools, and other shared spaces are optimized, low saliva sensitivity in asymptomatic infections must be considered. This study suggests saliva-based RT-PCR should not be used for asymptomatic COVID-19 screening.[Emphasis added]”

Gov. Abbott argues San Antonio’s mask mandate will ‘shatter’ Texas’ ability to respond to pandemic: “Texas Gov. Greg Abbott and Attorney General Ken Paxton filed an appeal Thursday seeking to reverse a Bexar County judge’s temporary restraining order that allowed the county to mandate masks in school…
The temporary restraining order against Abbott’s executive order is only in effect until Monday, when a local district judge will determine whether the local governments can continue mandating masks…
Lawyers for the statewide officials argued that the restraining order ‘will have shattered’ the state’s ability to ‘carry out an orderly, cohesive, and uniform response to the COVID-19 pandemic.’”
As far as I can tell, the only response the ruling has “shattered” is the ability to implement a science-based initiative.

Herd immunity is 'mythical' with the Covid delta variant, experts say: “Achieving herd immunity with COVID-19 vaccines when the delta variant is spreading is "not a possibility," said Andrew Pollard, head of the Oxford Vaccine Group..
Pollard said that while COVID-19 vaccines may slow the spread of the virus — because in studies fully vaccinated but infected people appeared to shed less virus, giving the virus less opportunity to spread — new variants were likely to emerge that would also spread.”
Speaks to the need to both vaccinate and wear masks.

WHO Broadens COVID-19 Study to Feature Three Licensed Drugs: “Expanding its existing Solidarity trial, the World Health Organization (WHO) will test three additional anti-inflammatory drugs as potential treatments for COVID-19.
Solidarity PLUS will determine whether artesunate, imatinib and infliximab — all of which are already approved for other indications — might reduce the risk of death or hospitalization in patients with the disease, WHO reported. An independent expert panel selected the candidate medications, which will be donated by the manufacturers.”

Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents: “The mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19.”

Despite obstacles, Native Americans have the nation’s highest COVID-19 vaccination rate: Despite poverty and remote living conditions, “data — collected by the U.S. Centers for Disease Control and Prevention — suggest that Native Americans are 24% more likely than whites to be fully vaccinated, 31% more likely than Latinos, 64% more likely than African Americans and 11% more likely than Asian Americans.”
The reason is the strong efforts by tribal leaders to promote the vaccine in the face of many deaths early in the pandemic.

About pharma

AHIP Letter Concerning National Coverage Determination Analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease: While the entire letter is a good summary of the issue, the insurance trade organization hedges its opposition with the following statement:
”While we do not believe CMS can conclude that aducanumab meets the Medicare coverage standard based on the risk of serious beneficiary harm and the lack of clinical benefit, we recognize that even if CMS agrees, CMS may still consider other statutory approaches that permit some degree of coverage under the Medicare program. In that context, an available approach under the Medicare statute would be for CMS to approve coverage only in connection with a CED [Coverage with Evidence Development]. As CMS has previously noted, an NCD involving CED is appropriate when CMS decides after a formal review of the medical literature that it will cover an item or service only in the context of an approved clinical study or when additional clinical data are collected to assess the appropriateness of an item or service for use with a particular beneficiary.”

Despite pharma's pandemic push, consumer trust in the industry still comes down to costs: study: “A new study from Accenture shows a boomerang back to a familiar topic—drug costs…
The top two answers specifically pointed to reduced medication costs (41%) and more transparency in pricing (39%) as measures that would make the respondents trust pharma companies more. Accenture surveyed 1,800 people in May and June about their healthcare experiences.”

About health insurance

Innovation At The Centers For Medicare And Medicaid Services: A Vision For The Next 10 Years: Chiquita Brooks-LaSure (Administrator, Centers for Medicare and Medicaid Services) is the lead author of this Health Affairs article. The beginning is a good review of recent CMMI initiatives and a call for simplification of its programs. It continues by offering areas for improvement for the future. Notably missing are implementation of evidence-based guidelines and reforms that would allow cost-benefit analyses to be used in care decisions.

Physician assistants will benefit with direct pay under CMS proposed rule: “In its proposed rule for the 2022 Physician Fee Schedule, CMS includes a section on billing for physician assistant services. It has people talking, but few know what it does – and does not – mean. 
If approved as a final rule, physician assistants (PAs) may choose to bill Medicare and be paid directly for their services, reassign their payment and incorporate as a solo or group practice comprised solely of PAs…
Section 403 of the Consolidated Appropriations Act of 2021 amends section 1842(b)(6)(C)(i) of the Social Security Act and removes the requirement that payment for services performed by PAs be made to their employer.”
The final rule is pending and awaits comment period closing on September 13.
If this provision is retained it could be one of the biggest changes in professional practice since physician licensure laws.

Oscar Health, Inc. Announces 2022 Market Expansion Plans, Culturally Competent Care Focus: “During the upcoming Open Enrollment period, the company plans to offer health insurance to individuals and families in 3 new states and 146 new counties.1 With this expansion, Oscar will have a footprint in a total of 22 states and 607 counties across its Individual & Family, Medicare Advantage, and Small Group (including Cigna+Oscar) plans.”

UnitedHealthcare loses Medicare overpayment appeal: 5 things to know: “In a 49-page opinion, the U.S. Court of Appeals for the District of Columbia Circuit reversed a 2018 decision that vacated Medicare's overpayment rule, which requires insurers to refund payment to CMS within 60 days if it learns a diagnosis lacks medical record support.
UnitedHealthcare had argued the overpayment rule was subject to "actuarial equivalence." However, the court ruled actuarial equivalence doesn't apply to the overpayment rule, and there's no legal basis for UnitedHealthcare's claim.”

UnitedHealth, Change Healthcare strike timing agreement with DOJ: 5 things to know: “UnitedHealth Group and Change Healthcare entered an agreement with the Department of Justice that dictates when the organizations can consummate their $13 billion proposed deal
UnitedHealth and Change agreed to wait at least 120 days after certifying compliance with the request for information to consummate the deal, according to an Aug. 7 filing with the Securities and Exchange Commission. Both organizations agreed to not certify compliance with the request before Sept. 15. 
The organizations could complete the acquisition before the 120-day period ends if they get a written notice saying the DOJ has closed its investigation into their deal.”

UnitedHealthcare to pay $15.6M in mental health parity settlement: “UnitedHealthcare will pay $15.6 million to settle federal and state investigations into mental health parity, the Department of Labor announced Thursday.
The settlement includes $13.6 million in payments to members for wrongfully denied claims as well as just over $2 million in penalties and lawyers fees, DOL said.
An investigation by DOL's Employee Benefits Security Administration found that UnitedHealth would reduce reimbursement rates for out-of-network behavioral health services and would flag members who were undergoing mental health treatment for utilization reviews.
UnitedHealthcare also failed to sufficiently disclose information about its practices to plan sponsors and members, according to DOL.”

Anthem partners with CareMax to open 50 medical centers: “Miami-based CareMax, a senior healthcare provider with an emphasis on value-based care, penned a partnership with Anthem that will lead to the duo opening 50 medical centers around the country.
The medical centers will primarily be created in areas where Anthem is focusing value-based care efforts, according to the Aug. 13 announcement. Some of the identified states include Indiana, Texas, Kentucky, Wisconsin, Georgia, Connecticut and Virginia.”

How Would Drug Price Negotiation Affect Medicare Part D Premiums?: “Under drug price negotiation, premium savings for Medicare beneficiaries are projected to increase from an estimated 9% of the Part D base beneficiary premium in 2023 to 15% in 2029. Medicare’s actuaries have estimated that the Part D base beneficiary premium, which covers the cost of basic Part D coverage, will increase from around $440 per year in 2023 to around $560 in 2029. The $14 billion in aggregate Part D premium savings from drug price negotiation over a decade translates into estimated per capita savings for Part D enrollees who pay premiums of $39 annually in 2023, increasing to $85 annually in 2029. This translates to savings of 9% of the base beneficiary premium in 2023 and 15% in 2029.”
See Figure 1 for a quick view of the impact.

About healthcare IT

Amwell expects fewer telehealth visits in fall, winter as delta variant creates uncertainty: “The company is projecting an $8 million impact on its 2021 revenue as a result of the drop in projected virtual care visits. Amwell adjusted its 2021 revenue guidance to between $252 million and $262 million from the previous range of $260 million to $270 million, executives said during the company's second-quarter 2021 earnings call Wednesday.
’The recent emergence of the delta variant has introduced some uncertainty to our second half visits outlook,’ said Ido Schoenberg, M.D., chairman and CEO of Amwell, during the call.”

Another big company hit by a ransomware attack: You know you are in trouble when your IT consultant is a ransomware victim: “Accenture, the global consulting firm, has been hit by the LockBit ransomware gang, according to the cybercriminal group's website. Accenture's encrypted files will be published by the group on the dark web on Wednesday unless the company pays the ransom, LockBit claimed, according to screenshots of the website reviewed by CNN Business and Emsisoft, a cybersecurity firm.”

About hospitals and health systems

Mississippi braces for ‘failure’ of hospital system due to covid-19 surge and lack of ICU beds: “A surge in coronavirus patients and a shortage of health-care workers and intensive care unit beds have pushed Mississippi’s hospital system to the brink of “failure,” state health officials warned Wednesday, saying drastic federal intervention was needed to help the state grapple with the thousands of new daily infections that have overwhelmed doctors and nurses.
Mississippi is averaging nearly 2,700 new covid-19 infections a day in the past week — a 54 percent spike in the past seven days…”

Former Broward Health director gets more than 3 years in prison for taking kickbacks: “In his role as procurement director, Mr. Bravo was responsible for deciding which vendors would provide Broward Health with products and services, including healthcare products, linens, compression sleeves and printer repair.
According to prosecutors, Mr. Bravo used his role to orchestrate a bribery and kickback scheme between 2008 and 2015 that involved four vendors.”

FTC’s Merger Review Process Change Muddies Deal-Closing Outlook: This article is in this section because most of the FTC’s scrutiny in healthcare has centered on hospital/health system mergers. “A shift in the Federal Trade Commission’s merger review process will add more risk management work for companies hoping to quickly wrap up mergers.
The FTC said this month it will tell some companies that it lacks resources to complete an initial review of their mergers and acquisitions within 30 days, as generally laid out in the Hart-Scott-Rodino (HSR) Act. 
The FTC will now send a letter to companies doing deals that can’t be fully reviewed within 30 days that its investigation remains open and their deal may be subsequently declared unlawful.”

Today's News and Commentary

About health insurance

Alignment Healthcare plans expansion into 16 new markets for 2022: “Startup Medicare Advantage insurer Alignment Healthcare is expanding into 16 new markets for the 2022 plan year, nearly doubling its footprint.
Alignment's plans will be available in 38 markets across Arizona, California, Nevada and North Carolina next year, reaching 6.9 million potential beneficiaries. The expansion is pending regulatory approvals.”

HHS sued over insurance price transparency rule: “The U.S. Chamber of Commerce and an affiliate are suing HHS to block the enforcement of a regulation that aims to increase insurance plan price transparency, according to court documents.
The U.S. Chamber of Commerce and Tyler Area Chamber of Commerce allege that HHS exceeded its authority by adopting provisions that they claim will reduce competition, raise costs to consumers and cost millions to implement.”

Kansas paid $1.3M to Medicaid contractors to care for dead people: “In the same release, the state inspector general said an audit also discovered over $1.6 million had been used to pay for claims for beneficiaries who exceeded the 12-month lifetime eligibility limit. These payments occurred between 2018 and 2021.”

About Covid-19

Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients: “We conclude that a third-dose booster Covid-19 vaccine should be considered, in conjunction with regulatory approval, for transplant recipients who have received two doses of mRNA-1273.”

A majority of Americans in highly vaccinated counties now live in covid hot spots, Post analysis finds: “Two-thirds of Americans in highly vaccinated counties now live in coronavirus hot spots, according to an analysis by The Washington Post, as outbreaks of the highly transmissible delta variant — once concentrated in poorly vaccinated pockets — ignite in more populated and immunized areas still short of herd immunity…
Living in a hot spot while vaccinated today is much safer than living in a hot spot while unvaccinated last summer. High-vaccination states have one-third the number of new cases per capita as low-vaccination states.
Hospitalization rates in states with less than 40 percent of their population fully vaccinated are four times higher than states that are at least 54 percent vaccinated, The Post found.”
The graphic maps are highly explanatory.

Breakthrough COVID-19 infection risk may differ with vaccine type, early Mayo Clinic research suggests: “People who received the Moderna COVID-19 vaccine may be less likely to experience a breakthrough infection compared to Pfizer vaccine recipients, findings published Aug. 8 in preprint server medRxiv suggest.”

Supreme Court won’t block Indiana University vaccine mandate as Justice Barrett rejects student plea: “Justice Amy Coney Barrett on Thursday rejected a plea from a group of Indiana University students to stop the university’s requirement that all students be vaccinated against the coronavirus.
Barrett, who received the request because she is the Supreme Court justice tasked with appeals from that region of the country, did not give a reason.”

About pharma

U.S. Veterans Health Administration turns down Biogen Alzheimer's drug: “The U.S. Veterans Health Administration (VHA) will not include Aduhelm, the $56,000-a-year Alzheimer's drug made by Biogen Inc and Eisai Co Ltd, on its list of approved drugs due to a lack of evidence that it is effective as well as safety concerns, the agency said on Wednesday.”

Affordable naloxone is running out, creating a perfect storm for more overdose deaths, activists say: “After a manufacturing issue halted Pfizer’s production of the single-dose injectable naloxone in April, groups that distribute a significant amount of the lifesaving medicine say they are facing an unprecedented obstacle to reverse drug overdoses as they reach an all-time high. Organizers say the insufficient supply has been felt unequally across the country.”

Pfizer halted Chantix distribution then recalled a dozen batches. Now, a generic's here to help fill the shortage: “Trying to fill a recent shortage for Pfizer’s smoking med caused by safety concerns, the FDA has approved Par Pharmaceuticals’ copycat version, also known as varenicline, “well ahead” of its expected review date, the agency said a statementon Wednesday.
Though Pfizer’s generic rival Par Pharmaceuticals received the FDA’s special expedited treatment, impending copycat competition wasn’t unexpected given Chantix lost its main patent in November last year.”

About healthcare IT

HIMSS21 Roundup—Epic rolls out customer story-sharing site; Young inventor's advice for health tech innovators

Today's News and Commentary

About health insurance

More than 2.5 Million Americans Gain Health Coverage During Special Enrollment Period: “New data released [yesterday] by the Centers for Medicare and Medicaid Services (CMS) shows more than 2.5 million people enrolled in health coverage on HealthCare.gov and state Marketplaces during the Biden-Harris Administration’s 2021 Special Enrollment Period (SEP), which will close in five days on August 15th. Additional data released by CMS today shows that a record high of nearly 81.7 million people are now receiving coverage through Medicaid and the Children’s Health Insurance Program (CHIP) as of March 2021.”

Senate passes infrastructure bill that restarts sequester cuts, delays rebate rule: “The package would reinstall starting in 2022 a 2% payment cut to all Medicare payments to providers. The cut was installed as part of sequestration, but Congress paused it last year at the onset of the pandemic.”

A Post-Merger Integration Agenda for Health Care Payers: From BCG: A good summary of the payer M&A activity over the past few years.

CMS pulls Medicaid work rules in 3 more states: “Health officials in Ohio, South Carolina and Utah received word from CMS on Aug. 10 that Medicaid work requirements would be revoked in their states…”

About Covid-19

Texas sees most COVID-19 hospitalizations in 6 months: “The third wave of COVID-19 in Texas continues to tax the state’s health care systems as 10,000 COVID-19 sufferers have been hospitalized for the first time since early February, state health officials reported.
Meantime, local governments and courts continue to chip away at Gov. Greg Abbott’s ban on mask and social distancing mandates as a state district judge in San Antonio granted a temporary restraining order to allow San Antonio and Bexar County to require public school students to mask up and quarantine unvaccinated students exposed to COVID-19.”

Novavax Says U.S. Will Pause Funding for Production of Its Vaccine: “Novavax, the Maryland firm that won a $1.75 billion federal contract to develop and produce a coronavirus vaccine, said on Thursday that the federal government would not fund further production of its vaccine until the company resolves concerns of federal regulators about its work.
The firm’s disclosure came in a quarterly filing with the Securities and Exchange Commission.”

KFF COVID-19 Vaccine Monitor: Parents and the Pandemic: Among the highlights:
— “As children around the country head back to school, nearly half of parents of children ages 12-17, the age group currently eligible to receive a COVID-19 vaccine, say their child has already been vaccinated (41%) or they will get the vaccine right away (6%)…
— A majority (58%) of parents of 12-17 year-olds say their child’s school should not require students to be vaccinated for COVID-19, and a similar share (54%) of parents of all school-age children say schools should not require vaccination even once the FDA has fully approved the use of a COVID-19 vaccine in children.
— More than six in ten (63%) of all parents of children who attend school think their child’s school should require unvaccinated students and staff to wear masks at school, although most Republican parents (69%) oppose such a requirement and parents of unvaccinated children are evenly divided.”

3rd COVID shot highly potent in Israel's immunocompromised, early study shows: “According to early results from research carried out at Beilinson Medical Center in Petah Tikva, the COVID-19 vaccine booster shot is highly effective among immunocompromised people, doubling the number of people who developed antibodies among patients who have received heart, lung or kidney transplants…” In a related article: Israel’s Covid infections surge as government rolls out booster shots: “Almost 80 per cent of the adult population has been fully vaccinated, one of the highest rates in the world, but more than 6,000 people tested positive for Covid-19 on Monday, according to the health ministry. Nearly 650 people were in hospital and 400 of them were in serious condition, it said, without indicating how many had already been vaccinated. Just under 5 per cent of coronavirus tests were coming back positive, in a sign that the nation was in the midst of a major Covid increase…”

How to reach the unvaccinated: the risks of bribery and coercion: A good overview of what countries are doing and the pros and cons of the approaches. A couple comments: “ ‘As vaccine supplies increase in the developed world, governments are rushing to introduce incentives and mandates to increase uptake — without always thinking through the consequences that it might harden the views of those who are hesitant,’ says Professor Heidi Larson, founding director of the Vaccine Confidence Project at the London School of Hygiene & Tropical Medicine.
[Stephen Reicher, a professor of psychology at the University of St Andrews] notes that incentives also come with risks. ‘Some scientific literature suggests that they can decrease what is called your intrinsic motivation,” he says. “In other words, you get vaccinated because you get a reward for it, not because you believe it is the right thing to do.’”

BD and CerTest Biotec Gain CE Mark for Test for COVID-19 Variants: “The test, which runs on the BD MAX real-time PCR platform, can distinguish between the original COVID-19 virus and three variants, Alpha, Beta and Gamma, the companies said.
The test kit also includes three options for specimen collection: nasopharyngeal, oropharyngeal and saliva.”

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021: Published yesterday from the CDC:
“Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome (GBS) and thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination…
[However], continued COVID-19 vaccination will prevent COVID-19 morbidity and mortality far exceeding GBS, TTS, and myocarditis cases expected.”

COVID-19 vaccine safety update: The European Medicines Agency (EMA) has requested more data from BioNTech about possible certain possible vaccine-related conditions: erythema multiforme, glomerulonephritis, nephrotic syndrome, and “menstrual disorders.” All are rare and not a reason to avoid the vaccine.

At least 1 million people got unauthorized third booster shot: “The Centers for Disease Control and Prevention estimates that more than 1 million people who have received the Moderna or Pfizer vaccine have gone back for an unauthorized third booster shot.
Florida is among the states reporting the highest number of people opting for a booster shot, followed by Ohio, California, Illinois and Tennessee.”

CDC guidance now official: Pregnant women should get coronavirus vaccine: “The Centers for Disease Control and Prevention recommended Wednesday that pregnant women be vaccinated against the coronavirus, updating its advice after it found no increased risk of miscarriage among those who have been immunized.”

Alabama Just Tossed 65,000 Vaccines. Turns Out It's Not Easy To Donate Unused Doses: While Alabama is in the headline, the article discussed how many states need to dispose of outdated vaccines and why donating them is not easy.

About healthcare professionals

High trust in doctors, nurses in US, AP-NORC poll finds: “At least 7 in 10 Americans trust doctors, nurses and pharmacists to do what’s right for them and their families either most or all of the time, according to the poll from the University of Chicago Harris School of Public Policy and The Associated Press-NORC Center for Public Affairs Research.
The poll shows high levels of trust among both Democrats and Republicans; men and women; and white, Black and Hispanic Americans…
Polling from the nonprofit Kaiser Family Foundation in June also showed people trusted doctors for information about the vaccine more than other sources like the Centers for Disease Control and Prevention and Dr. Anthony Fauci, the U.S. government’s top infectious disease expert.”

About the public’s health

Screening for Gestational DiabetesUS Preventive Services Task Force Recommendation Statement: “The USPSTF recommends screening for gestational diabetes in asymptomatic pregnant persons at 24 weeks of gestation or after. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for gestational diabetes in asymptomatic pregnant persons before 24 weeks of gestation. (I statement)”

Perceptions on Barriers and Facilitators to Colonoscopy Completion After Abnormal Fecal Immunochemical Test Results in a Safety Net System: “In this qualitative study of 21 primary care physicians (PCPs) and staff members, barriers to follow-up colonoscopy completion included environmental factors (ie, social determinants of health and organizational factors) and patient cognitive factors. Resources that addressed these barriers (eg, insurance assistance, appointment reminders, and bowel preparation education) were associated with improved colonoscopy completion.”

Trends in Consumption of Ultraprocessed Foods Among US Youths Aged 2-19 Years, 1999-2018: “In this serial cross-sectional study of nationally representative data from 33 795 US youths aged 2-19 years, the estimated percentage of total energy consumed from ultraprocessed foods increased from 61.4% to 67.0%, whereas the percentage of total energy consumed from unprocessed or minimally processed foods decreased from 28.8% to 23.5%.”

Religious Groups Win Pass On Abortions, Transgender Care: “A Texas federal judge has ruled that several religious medical providers can't be punished by the federal government for refusing to provide abortions or gender transition-related care, despite an anti-bias provision in the Affordable Care Act.”

About pharma

Groups make own drugs to fight high drug prices, shortages: A good overview of how non-pharma companies are producing drugs to fight shortages and high costs.

Judge Limits Attorney Contingency Fees to 15 Percent in $26 Billion Opioid Settlement: “A federal judge has capped contingency fees at 15 percent for lawyers representing plaintiffs poised to earn large amounts from the pending $26 billion opioid lawsuit settlement by the three largest U.S. drug distributors and Johnson & Johnson (J&J).”

Ex-Roche Employee Sentenced to Prison for Cheating the Drugmaker Out of Nearly $10 Million: “The defendant and an accomplice pleaded guilty to commercial fraud, document forgery and commercial money laundering, after being charged with embezzling the funds from January through August 2017.”

Big Pharma’s Q2 growth, ranked: Regeneron, Pfizer lead the way as sales rebound from pandemic depths: “More than half of Big Pharma companies reported revenue increases greater than 15% over the same quarter in 2020, which was marred by lockdowns and the shock to the economic system that ensued at the start of the pandemic…
Companies that registered the most dramatic revenue growth were the ones that have developed COVID-19 treatments. In fact, this was the case for all six of the firms that exceeded a 20% increase, including Regeneron (up 163%) with $2.59 billion in sales for its antibody drug REGEN-COV and Pfizer (92%) with $7.8 billion in COVID-19 vaccine sales.”
Check the graphic for data on specific companies.

Perfect packaging? J&J's latest innovation challenge crowdsources single dose ideas:
“…Johnson & Johnson Innovation looks to crowdsource the best ideas in single-dose packaging for its latest JLABS Quickfire challenge.
The contest focuses on single-dose packages but also aims for ideas that incorporate child safety measures, environmentally friendly materials and adherence helpers…
The new unit-dosing challenge follows up on a Pill Protect safer medicine storage challenge that ended in July. Gatekeeper Innovation won with its solution for a child-resistant prescription pill minder. J&J kicked off that challenge with an eye toward making over the popular multiday pill boxes that people fill weekly with their meds…”
A great example of “listening to the voice of the customer.”

About healthcare IT

Telemedicine company owner indicted in $784M fraud scheme: Another Medicare, multi-year scam:
”According to prosecutors, Mr. Harry and his co-conspirators solicited kickbacks and bribes from durable medical equipment suppliers and marketers in exchange for orders. His telemedicine companies also allegedly paid physicians to write orders for braces and other equipment regardless of medical necessity. The scheme resulted in the durable medical equipment suppliers fraudulently billing Medicare more than $784 million, of which Medicare ended up paying about $247 million. 
Prosecutors also say Mr. Harry directed suppliers not to pay his telemedicine companies but instead to pay shell companies opened in straw owners' names in the U.S. and foreign countries in an effort to conceal the scheme. Mr. Harry committed income tax evasion between 2015 and 2018 by receiving the proceeds in the accounts of shell companies, according to the indictment.”

TytoCare Launches New Integration with Epic for Seamless Asynchronous Telehealth Exams: TytoCare, the global health care industry's first all-in-one modular device and examination platform for AI-powered, on-demand, remote medical exams, has expanded its integration within MyChart enabling frictionless asynchronous workflow. The integrated workflow enables health systems to easily access TytoCare-generated data in a patient's EHR (Electronic Health Record), clinicians to access TytoCare exam data directly within Epic, and seamless remote patient monitoring.
The new integration was developed as a result of a collaboration between TytoCare and University of Miami Health System in June 2020.”

Fitbit moves deeper into healthcare with LifeScan deal to combine diabetes devices, consumer wearables: “Smartwatch maker Fitbit inked a deal with LifeScan to integrate its health tracking apps with the company's glucose monitoring devices to help patients with diabetes management.”

HIMSS21 Update

About healthcare quality

NCQA launches program to streamline quality reporting: “The National Committee for Quality Assurance announced a program this week geared toward ensuring the validity of clinical data used for quality reporting and other initiatives.  
The Data Aggregator Validation program is aimed at giving health plans, government entities and care delivery organizations confidence in the validity of their clinical data. It does so, says the NCQA, by evaluating how organizations ingest, transform and output that data. “

Today's News and Commentary

About the public’s health

Association of State Opioid Prescription Duration Limits With Changes in Opioid Prescribing for Medicare Beneficiaries: “This cohort study found that in the Medicare population, total days of opioid prescribed per enrollee decreased from 2013 to 2018, with a slightly greater reduction in states with laws restricting initial opioid prescriptions to 7 days or less, suggesting a significant but limited outcome for such legislation.”

About hospitals and health systems

Mass General Brigham posts $2.9B gain over 9 months: “Looking at the first nine months of 2021, revenues were up nearly 18 percent year over year. Mass General Brigham ended the first three quarters of this year with operating income of $507.9 million, including $232 million in Coronavirus Aid, Relief and Economic Security Act funds to reimburse the system for lost revenue and higher expenses tied to the pandemic as well as $30 million in ACA risk corridor program subsidies for insurance coverage provided from 2014-16. In the first nine months of 2020, the system reported an operating loss of $506 million. 
Mass General Brigham reported a nonoperating gain of $2.39 billion in the first nine months of 2021 and an overall gain of $2.9 billion. In the same period last year, the system reported a nonoperating loss of $192.2 million and an overall loss of $698 million.”
The results do show attention to efficiencies, but also highlight the importance of government funds as well as non-operating income, like investments. (The S&P was up 19% the first three quarters of this calendar year.)

About pharma

Pharmacies Face Extra Audit Burdens That Threaten Their Existence: “According to data from PAAS National, a pharmacy audit assistance service, while the number of pharmacy audits in 2020 declined nearly 14% from the year before, the overall number of prescriptions reviewed went up 40%. That meant pharmacies had to provide more documentation and stood to lose much more money if auditors could find any reason — even minor clerical errors — to deny payments.
The average audit in 2020 cost pharmacies $23,978, 35% more than the annual average over the previous five years, the PAAS data shows. And the number of prescriptions reviewed in September and October was fourfold over what PAAS members had seen in previous years.”

Performance evaluation of a prescription medication image classification model: an observational cohort: A fascinating look at the use of AI in making sure the medication filling process is accurate. One finding, however, was that a major source of mistakes was “system error”… “medications that share similar color, shape, and imprints with at least one common character accounted for almost 50% of the errors.” If the FDA reviewed such features before allowing manufacture, it would cut down on errors by both machines and humans.

About health insurance

CVS Health launches first nationwide virtual primary care solution: “Aetna Virtual Primary Care is available for self-funded employers and provides eligible members access to health services remotely and in person…”
Among its features are $0 co-pay for virtual primary care visits and select in-person services at MinuteClinic® and CVS® HealthHUB™ locations (which starts after the deductible is met) and in-person visits with in-network health care providers with no referral requirements.
”This new care experience is powered by Teladoc Health's longitudinal, physician-led care team model…”

Insurers came back down to Earth in Q2 following sky-high profits a year ago: A good, short overview of the top six companies in this sector.

Health Care Service Corporation Launches Biggest Expansion of Medicare Advantage Plans in Company's History: “Health Care Service Corporation (HCSC), which operates health plans in Illinois, Montana, New Mexico, Oklahoma and Texas, announced the company is increasing its footprint in the Medicare Advantage market to serve more than 90 new counties, increasing access to new coverage options for more than 1.1M additional Medicare-eligible individuals. The expansion is the company's largest service area and product expansion in its history, particularly in rural and underserved areas.”

About healthcare IT

This week is the HIMSS annual conference. People are attending in person, though in reduced numbers. For free updates subscribe to STAT. Here is another update.

Cigna Launches World's First Voice-Activated Stress Test: Test your stress level through the links provided in this article.

New Salesforce Care from Anywhere Innovations Improve Patient Access and Deepen Relationships: Interesting to read what this company is doing in the healthcare space.

Today's News and Commentary

About Covid-19

Myocarditis and Pericarditis After Vaccination for COVID-19: “Two distinct self-limited syndromes, myocarditis and pericarditis, were observed after COVID-19 vaccination. Myocarditis developed rapidly in younger patients, mostly after the second vaccination. Pericarditis affected older patients later, after either the first or second dose.”
The purpose of the article is to define two groups for these rare complications.

CDC: Reinfection more likely for unvaccinated who had COVID-19 than for vaccinated: “People who were infected with COVID-19 earlier in the pandemic, but who opt to not get vaccinated against the virus, are more than twice as likely to get sickened again compared with those who receive the shot, according to data released Friday by the Centers for Disease Control and Prevention.”

Coronavirus booster shots for the immunocompromised expected to be authorized soon: “The extra shots are expected to be authorized within days or weeks, according to federal officials who spoke on the condition of anonymity because the plan has not been announced.”

U.S. Military Will Mandate Vaccine for Troops: “The Pentagon will seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than next month, the Biden administration announced Monday.”

The social network for doctors is full of vaccine disinformation: “Doctors on the industry networking site Doximity are finding their news feed inundated with anti-vaccine comments from fellow physicians.”

About the public’s health

Bronchitis the Leader at Putting Children in the Hospital: ”More children admitted to hospitals in 2018 had acute bronchitis than any other diagnosis, according to a recent report from the Agency for Healthcare Research and Quality.” It was the #1 diagnosis for males and #2 for females (after depression).

Prevalence of bacterial contamination of touchscreens and posterior surfaces of smartphones owned by healthcare workers [HCWs]: a cross-sectional study: “Eighty-four HCWs participated in this study. The touchscreen and posterior surface were contaminated in 27 (32.1%) and 39 (46.4%) smartphones, respectively, indicating that the posterior surface was more frequently contaminated (p = 0.041). Bacillus species and coagulase-negative staphylococci were isolated from each surface of the smartphones.”

Humans have pushed the climate into ‘unprecedented’ territory, landmark U.N. report finds: Today, the Intergovernmental Panel on Climate Change “issued its latest and most dire assessment about the state of the planet, detailing how humans have altered the environment at an ‘unprecedented’ pace and cautioning that the world risks increasingly catastrophic impacts in the absence of rapid greenhouse gas reductions.
The landmark report, compiled by 234 authors relying on more than 14,000 studies from around the globe, bluntly lays out for policymakers and the public the most up-to-date understanding of the physical science on climate change. Released amid a summer of deadly fires, floods and heat waves, it arrives less than three months before a critical summit this November in Scotland, where world leaders face mounting pressure to move more urgently to slow the Earth’s warming.”

About health insurance

The Impact of the COVID-19 Pandemic and Recent Federal Policies on Small Business Health Insurance:

  • “Small businesses’ health coverage offerings remained relatively stable amid the COVID-19 pandemic, contrary to some early predictions.

  • The share of small employers offering comprehensive health benefits has steadily declined over the last two decades, but employers that continue to offer benefits recognize its importance in attracting and retaining skilled employees.

  • Many small employers are shifting to coverage exempt from Affordable Care Act rules in response to rising costs, resulting in an unsettled market.”

Democrats reintroduce legislation to create Medicaid-based public option: “Nearly 20 Senate Democrats reintroduced legislation Friday to create a new Medicaid-based public option, reinforcing their commitment to a key priority.
But the legislation isn't certain to become law, as it has not been added to a $3.5 trillion infrastructure package that includes other reforms on drug pricing and expanding Medicare benefits.”

About healthcare IT

Digital Health Trends 2021: From Iqvia, this report is well-worth reading, especially if you are involved or interested in this sector.
Here are some overall highlights:
”Health-related mobile applications available to consumers on top app stores worldwide now surpass 350,000, with more than 90,000 digital health apps added in 2020 — an average of more than 250 apps per day.... Mental health, diabetes and cardiovascular disease-related apps now account for almost half of disease-specific apps. 
Digital therapeutics (DTx) and digital care (DC) products and tools — which incorporate software as a means to treat, prevent or manage specific diseases or conditions — have been proliferating, and more than 250 such products are now identified, including about 150 products that are commercially available… 
At least 25 DTx products have been granted market authorization through regulatory processes and another 23 are commercially available, with indications predominantly in the mental health and behavior modification areas, and an additional 89 are in earlier stages of development and evidence generation.”

GE Healthcare moves imaging, clinical analytics platforms to Amazon Web Services cloud: “GE Healthcare will begin moving several of its software platforms to the AWS cloud, making it easier for healthcare providers and artificial intelligence developers alike to access clinical data to improve patient care.
First to make the jump to the cloud are GE’s Edison Health Services platform and its newest AI-powered imaging tool, the Edison True PACS picture archive and communication system, which was specifically designed to be hosted on the cloud in order to reduce data storage costs and speed up the process of integrating AI into under-resourced clinics.”

App-Based Feedback for Rehabilitation Exercise Correction in Patients With Knee or Hip Osteoarthritis: Prospective Cohort Study: “Motion Coach (Kaia Health GmbH) provides audiovisual feedback on exercise execution in real time on conventional smartphones…
There was no detectable difference in levels of interrater agreement between Motion Coach vs physiotherapists and between physiotherapists in any of the 6 exercises…
The results demonstrated that Motion Coach is noninferior to physiotherapist evaluations…These results confirm the ability of Motion Coach to detect user form during exercise and provide valid feedback to users with musculoskeletal disorders.”

Altoida's Alzheimer's-predicting smartphone app snags FDA breakthrough status: “Altoida’s technology uses artificial intelligence to analyze cognitive test results to determine whether a case of mild cognitive impairment will escalate into Alzheimer’s within a year…
The system is the product of more than 20 years of cognitive research, Tarnanas said. It comprises a slate of neurological tests for users aged 55 and up and AI software to analyze the results of those tests.
The assessment portion of the system takes 10 minutes to complete and can be accessed on a user’s own smartphone or tablet. It focuses on measuring 11 specific areas of the brain research has suggested are linked to the onset of Alzheimer’s.”

These Algorithms Look at X-Rays—and Somehow Detect Your Race: “The study authors and other medical AI experts say the results make it more crucial than ever to check that health algorithms perform fairly on people with different racial identities. Complicating that task: The authors themselves aren’t sure what cues the algorithms they created use to predict a person’s race.”

Allscripts reports double-digit growth in its Veradigm analytics business as it eyes potential M&A: “Allscripts reported a particularly strong quarter in its life sciences data business within the Veradigm segment, both for in-quarter revenue as well as new partnership development, Poulton said.
The company's Veradigm business has the largest linked electronic health records claims patient database available for research, sourced from and directly connected to clinical platforms.
Allscripts expects those double-digit gains to continue for the rest of 2021.”

About pharma

CMS proposes pulling model that ties Part B drug prices to those paid overseas: “The Biden administration has pulled a Trump-era regulation that ties Medicare Part B prices for certain products to prices paid overseas.
The proposed rule, released Friday by the Centers for Medicare & Medicaid Services, comes in response to a series of legal defeats that the Biden administration faced over the controversial model.
The model would tie the prices for certain Part B single-source drugs and biologics to the average price paid by several overseas countries.”

GoodRx inks deal with Surescripts to provide information on cash prices for drugs: “The partnership with GoodRx will enable Surescripts to deliver drug discount price information to prescribers when they are prescribing medications for uninsured patients and patients whose price information isn’t already available from their pharmacy benefit manager (PBM) or health plan, according to the companies.
Surescripts' real-time prescription benefit technology delivers cost information in the electronic workflow so prescribers can make more informed decisions and address patient prescription cost concerns at the point of care.”

About healthcare quality

CMS maintains patient safety measure after pushback from Leapfrog: “The ‘Death Among Surgical Inpatients with Serious Treatable Complications’ safety measure, also known as Patient Safety Indicator 4, or PSI-4, will remain in place for now, per CMS Inpatient Prospective Payment System final rule for 2022.”

About healthcare professionals

2021 REVIEW OF PHYSICIAN AND ADVANCED PRACTITIONER RECRUITING INCENTIVES: From Merritt Hawkins, their 28th annual report. Note it also includes PAs and NPs.

Today's News and Commentary

About Covid-19

California to mandate COVID-19 vaccines for health workers: “California will require all of its roughly 2.2 million health care workers and long term care workers to be fully vaccinated by Sept. 30 as the nation’s most populous state is losing ground in the battle against new infections of a more dangerous coronavirus variant.
The order, issued Thursday by the California Department of Public Health, is different than what Democratic Gov. Gavin Newsom said last month when he announced health care workers would have the choice of either getting vaccinated or submitting to weekly testing.”
Many healthcare facility managers are concerned that if they require employee vaccination, they will lose employees in a tight job market. If the state requires all such businesses to vaccinated employees, it substantively removes that threat.

South African study shows high COVID protection from J&J shot: “…the single-shot J&J vaccine offered 91% to 96.2% protection against death, while offering 67% protection against hospitalisation when the Beta coronavirus variant dominates and about 71% protection against hospitalisation when the Delta variant dominates.”

Vaccine Mandates Are Lawful, Effective and Based on Rock-Solid Science: This is an excellent summary and a “must read.”
“The DOJ and EEOC specifically stated that employer mandates may occur even under an EUA…
States have long had the constitutional authority to mandate vaccinations, which the Supreme Court has upheld twice, first in 1905 and then in 1922. The federal government, however, has limited power to mandate vaccines. It can only require them to prevent transmission of a dangerous infectious disease across state lines or international borders. The federal government has never sought to require nationwide vaccinations, and the courts probably would not allow it. To date, all state government mandates have been for fully approved vaccines. Thus, it is likely cities and states would wait to mandate COVID-19 vaccines until they are fully licensed.”

A giant trial of COVID-19 treatments is restarting. Here are the drugs it’s betting on: “After months in the doldrums, one of the world’s largest trials of COVID-19 treatments is finally restarting. Solidarity, a global study led by the World Health Organization (WHO), will test three new drugs in hospitalized COVID-19 patients: the cancer drug imatinib, an antibody named infliximab that is used to treat autoimmune diseases, and artesunate, an antimalarial.
The medicines have been shipped to Finland, the first country to have all approvals in place, says John-Arne Røttingen of the Norwegian Institute of Public Health, who chairs the study’s executive group. ‘I expect that the first patients will probably be recruited there any day,’ he says. Other countries could soon join SolidarityPlus, as the new phase has been dubbed; more than 40 are in the process of getting ethical and regulatory approvals.”

FDA Covid-19 Vaccine Booster Plan Could Be Ready Within Weeks: “The Food and Drug Administration expects to have a strategy on Covid-19 vaccine boosters by early September that would lay out when and which vaccinated individuals should get the follow-up shots, according to people familiar with discussions within the agency.
The Biden administration is pushing for the swift release of a booster strategy because some populations—people age 65 or older and people who are immunocompromised, as well as those who got the shots in December or January shortly after they were rolled out—could need boosters as soon as this month, two of the people said.”

Moderna's COVID-19 vaccine sales surge to $4.2 billion during Q2: “Moderna said Thursday that it generated sales of $4.2 billion for its COVID-19 vaccine mRNA-1273 during the second quarter, delivering 199 million doses in the period, for a total of 302 million doses so far this year. The vaccine comprised the bulk of Moderna's quarterly sales, which totalled $4.4 billion in all when grant revenues were taken into account, coming in slightly ahead of analyst expectations and towering over the $67 million it made in the prior-year period.
Company profit surged to $2.8 billion in the second quarter, beating estimates of $2.5 billion, whereas it had recorded a loss of $117 million the same time last year.”

Novavax's latest COVID-19 vaccine delay sends shares tumbling nearly 20%: “The latest roadblock—which will advance the timeline by just a couple weeks—spurred a 17.25% drop in Novavax's shares to about $195 apiece as of 10:41 a.m. ET Friday morning. It seems investors are fed up with delay after delay.”

About pharma

Surprise! Pfizer jumps the queue and leaps into RSV vax contention as COVID helps turbochar”ge work: “In data dropped rather quietly during second-quarter earnings this week and to little fanfare, Pfizer said a challenge study, where vaccines were given to 62 adults under 50 who were then intentionally infected with RSV to see if the shot worked, showed ‘100% observed efficacy against mild to moderate symptomatic infection resulting from RSV.’
This is only a peek from the phase 2a test, which is set up to assess the immunogenicity and efficacy of the bivalent protein-based vaccine candidate, RSVpreF.”

Express Scripts Awarded 7-Year TRICARE Pharmacy Program Contract: “The U.S. Department of Defense today awarded Express Scripts, an Evernorth company, a contract for the administration of the TRICARE Pharmacy Program, Fifth Generation. Under the new contract, Express Scripts will serve 9.6 million active-duty service members, their family members, and retirees through 2029.”

Class-action lawsuit alleges 4 drugmakers colluded to restrict insulin sales to 340B contract pharmacies: “The class-action lawsuit alleges that Sanofi, Eli Lilly, Novo Nordisk and AstraZeneca colluded in the summer of 2020 to restrict offering discounted products to 340B contract pharmacies.”

Gilead cracks down on fake versions of popular HIV drugs Biktarvy, Descovy being sold at US pharmacies: “Counterfeit versions of two of Gilead Sciences’ most popular HIV drugs are circulating in the U.S., threatening the health of people taking them.
Gilead’s original Biktarvy and Descovy have been replaced by fake versions at some pharmacies, Gilead warned Thursday. Unauthorized distributors were able to sell fake drugs to retailers; and then, ‘genuine Gilead bottles’ were filled with fake tablets, the company said.”

GSK again scores $235M in 'skinny label' case, but court admits it's 'unclear what Teva even did wrong': Read the whole story. It is a crazy, confusing exposition of the application of drug patent regulations.

About health insurance

Innovative Approaches to Addressing Social Determinants of Health for Medicare Advantage Beneficiaries: “On behalf of the Better Medicare Alliance's Center for Innovation in Medicare Advantage, NORC at the University of Chicago (NORC) assessed the current landscape of SDOH services within Medicare Advantage…
The new supplemental benefit authorities have been well received by health plans, with an explosion of participation in SSBCI’s [Special Supplemental Benefits for the Chronically Ill]-primarily health-related benefits to 845 separate plans in 2021, up from 245 in 2020 (the first year of SSBCI benefit availability).xxiv The top benefits offered in 2021 included Meals, Food and Produce, Social Needs Benefit, Pest Control, and Non- Medical Transportation. All health plans interviewed for this report described participating in SSBCI, with many enthusiastic about the results.”

Ascension Michigan to Pay $2.8 Million to Resolve False Claims Act Allegations: “Ascension Michigan and related hospitals… have agreed to pay $2.8 million to resolve claims that they violated the False Claims Act by submitting or causing the submission of false claims for payment to federal health care programs related to alleged medically unnecessary procedures performed by a gynecologic oncologist (‘the Doctor’)…
Ascension Michigan knowingly submitted false claims for payment to federal health care programs and improperly retained payment for professional and facility fees related to medically unnecessary radical hysterectomies that the Doctor performed, chemotherapy services that the Doctor administered or ordered that were not medically necessary, and evaluation and management services by the Doctor that were not performed or not rendered as represented.”

About the public’s health

Tennessee can enforce abortion waiting-period law, 6th Circuit rules: “The full 6th U.S. Circuit Court of Appeals, split largely along partisan lines, on Thursday revived a 2015 Tennessee law requiring a 48-hour waiting period for abortions, reversing a lower court decision blocking the law.
Circuit Judge Amul Thapar wrote in the 9-7 majority opinion that the law was constitutional because it did not place a ‘substantial obstacle’ in the way of a ‘large fraction’ of women seeking abortions before fetal viability.”

About healthcare IT

Allscripts Announces Second Quarter 2021 Results: “On a GAAP basis in the second quarter of 2021, income from operations was $10 million compared with a GAAP loss from operations in the second quarter of 2020 of $25 million. Non-GAAP income from operations in the second quarter of 2021 was $33 million compared with $25 million in the second quarter of 2020.”

About medical devices

llumina posts 78% revenue growth as cancer, DNA testing ramp back up: “Illumina’s sales (PDF) of consumables alone were up 82% year-over-year, totaling $704 million, with oncology testing showing three consecutive quarters of growth and the National Institute of Health’s All of Us program moving forward at full scale toward its goal of sequencing the genomes of at least one million people in the U.S.
About $189 million in Instrument sales set a new record, up 7% compared to the first quarter of this year, including about $20 million from COVID-19 tracking initiatives.”

Medtronic boosts ear, nose and throat portfolio with $1.1B bid for sinus implant maker Intersect ENT: “The medtech giant has set its sights on Intersect ENT, which has developed two types of steroid-eluting implants to treat cases of chronic rhinosinusitis, where symptoms like facial pain, pressure and nasal drainage or obstruction last for more than 12 weeks at a time, often requiring years of costly surgeries and other treatments.
Both companies’ boards of directors have approved the buyout, which will see Medtronic putting up $28.25 in cash for each of Intersect’s outstanding shares, pricing the transaction at about $1.1 billion.”

Today's News and Commentary

About Covid-19

Global COVID-19 cases surpass 200 mln as Delta variant spreads: “Coronavirus cases worldwide surpassed 200 million on Wednesday, according to a Reuters tally, as the more-infectious Delta variant threatens areas with low vaccination rates and strains healthcare systems.
The global surge in cases is highlighting the widening gap in inoculation rates between wealthy and poor nations. Cases are rising in about one-third of the world's countries, many of which have not even given half their population a first dose.”

Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19: “Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load.”

Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19: “In noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis.”

CDC: Delta variant accounts for 93 percent of all infections: “For the two-week period ending July 31, all the different lineages of the delta variant made up about 93 percent of cases that were sequenced.
In some parts of the country with low vaccination rates, especially the Midwest, the percentages are even higher.”

Moderna says its COVID-19 vaccine is 93% effective after 6 months, weaker against delta: “The new trial data was released just before an Aug. 5 earnings call. In the slides prepared for the call, Moderna said booster shots will most likely become necessary before winter to combat the rapid spread of the delta variant, which became widespread in the U.S. after the trial results were recorded.”

U.S. COVID-19 cases hit six-month high, Florida grapples with surge: “The United States hit a six-month high for new COVID cases with over 100,000 infections reported on Wednesday, according to a Reuters tally, as the Delta variant ravages areas where people did not get vaccinated.
The country is reporting over 94,819 cases on a seven-day average, a five-fold increase in less than a month, Reuters data through Wednesday showed. The seven-day average provides the most accurate picture of how fast cases are rising since some states only report infections once a week or only on weekdays.”

About health insurance

Biden Stimulus Increase Cut Obamacare Plan Premiums by 40%: “Average premiums for returning customers in the 36 states using the federal marketplace dropped from $104 a month to $62 a month, according to data from the Department of Health and Human Services.
The $1.9 trillion American Rescue Plan expanded the number of people eligible for subsidies for ACA marketplace coverage. It also bolstered the tax credits for those already purchasing coverage to make the plans more affordable.
For the first time it extended subsidies to people making more than 400% of the federal poverty level -- $106,000 for a family of four -- a group that had faced steep costs for insurance coverage. Their costs are now capped at 8.5% of income.
The expanded premium assistance is set to expire after 2022, but Democrats are seeking to extend it. The provision is projected to cost $34 billion, according to the Congressional Budget Office.”
The problem is not always premiums but the rapidly rising out-of-pocket expenses.

OIG audit targets Aetna's Medicare Advantage plans as government cracks down on fraud: “Federal regulators are auditing Medicare Advantage plans sold by CVS Health's payer arm Aetna as the government continues to crack down on inaccurate or fraudulent risk-adjustment scores in the program.
In a financial filing with the Securities and Exchange Commission on Wednesday, CVS disclosed HHS' Office of the Inspector General was looking at its MA business, amid a slew of recent whistleblower lawsuits and audits finding improper practices in the program.”

Cigna anticipates elevated claims costs for rest of 2021, execs say: “Cigna is bracing for elevated claims costs through the remainder of 2021, executives told investors Thursday morning.
Brian Evanko, Cigna's chief financial officer, said on the company's earnings call that costs associated with COVID-19 were higher than anticipated, and non-COVID utilization grew at a more rapid clip than was expected.”

Morgan Health Makes $50 Million Investment in Vera Whole Health: “Morgan Health, the JPMorgan Chase & Co. business focused on improving the quality, cost, and equity of employee healthcare, is investing in an innovative healthcare company that offers patients coordinated care and an enhanced primary care experience. Morgan Health announced today a $50 million investment in Vera Whole Health, its first investment in a coordinated care model.”

About hospitals and health systems

Public Payment Rates For Hospitals And The Potential For Consolidation-Induced Cost Shifting: “After controlling for many confounders, we found that hospitals with a higher share of Medicare patients had lower and more rapidly declining profits and an increased likelihood of closure or acquisition compared with hospitals that were less reliant on Medicare. This is consistent with the existence of consolidation-induced cost shifting and implies that reductions in public prices must be undertaken cautiously.”

About the public’s health

NRC Health 2021 Mid-Year Healthcare Consumer Trends Report: A few highlights:
”The good news is that the rate at which consumers are resuming services has risen by 5% from Q3 2020 to the first half of 2021. Not only is delayed healthcare decreasing…, many service lines and specialties are returning to normal levels, and… telemedicine and urgent-care visits are remaining the same. What’s interesting to note is that months before the pandemic, deferment rates were approaching a five-year low.
3 out of 4 consumers would choose a provider who shares prices over one who doesn't.

Moderna Gains Fast-Track Designation for mRNA-Based RSV Vaccine: “The FDA has granted Moderna Fast-Track designation for mRNA-1345, its investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults older than age 60.
Moderna’s RSV vaccine candidate uses the same lipid nanoparticle as the company’s authorized COVID-19 vaccine and contains optimized protein and nucleotide sequences.”

About healthcare IT

25 hospitals completing the most telehealth visits during the pandemic + what they charge: “Among all the hospitals offering telehealth, hospital outpatient clinic visits (CPT G0463) occurred the most, accounting for more than 47 percent of total telehealth claims.”
Interesting variation on charges across the country.
Note the CPT code is a temporary (G) code.

About pharma

Review of the FDA's Accelerated Approval Pathway: Form the HHS Office of the OIG: “The FDA's approval of Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee's vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA's use of the accelerated approval pathway. In response to these concerns, we will assess how the FDA implements the accelerated approval pathway.”
The report is expected in 2023.

Bayer bets $1.5B that Vividion will help it target the 'undruggable' and make 1+1=3: Instead of a public offering, Vividion is partnering with Bayer and will retain R&D independence.

Today's News and Commentary

About Covid-19

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month: “President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had ‘taken an all-hands-on-deck approach’ to the work.”

Covid Live Updates: W.H.O. Calls for Moratorium on Covid Vaccine Boosters: “The World Health Organization called on Wednesday for a moratorium on coronavirus vaccine booster shots until the end of September to help all countries vaccinate at least 10 percent of their populations, appealing to the world’s wealthiest nations to address dramatic disparities in global vaccination rates.”

Who Can Make You Get a Covid Vaccine?: A really good review of the topic and what is currently being done.

Biden tells Florida, Texas leaders: Help on COVID-19 or 'get out of the way': Further information from the White House press conference reported here yesterday: “U.S. President Joe Biden on Tuesday urged Republican leaders in Florida and Texas - home to roughly a third of all new U.S. COVID-19 cases - to follow public health guidelines on the pandemic or ‘get out of the way’ as the country struggles to contain the rapid spread of the disease's Delta variant…
Florida Governor Ron DeSantis has opposed strict COVID-19 restrictions. On Friday, he issued an order blocking mask mandates in the state's schools. Texas Governor Greg Abbott issued an order last spring that would impose fines for mask mandates.”

Korea confirms first two cases of delta plus: “Delta plus is a sub-lineage of delta with an extra mutation in the spike protein called K417N -- the same mutation found in beta and gamma, variants of concern first spotted in South Africa and Brazil, respectively. South Africa stopped using AstraZeneca’s vaccine in February after a study showed it did not work well against the beta variant.”

After Nearly 9 Million Pfizer Shots for U.S. Teens, Serious Side Effects Rare: CDC: “As of July 16, close to 9 million teens, aged 12 to 17, had received the Pfizer-BioNTech vaccine — the only one okayed for that age group. Among roughly 9,240 reported side effects, 91% were minor, such as soreness near the vaccination site. 
But 9% were serious, with 4% developing a heart problem known as myocarditis…”

About healthcare quality

Mirror, Mirror 2021: Reflecting Poorly: Health Care in the U.S. Compared to Other High-Income Countries: From the Commonwealth Fund:

  • Key Findings: The top-performing countries overall are Norway, the Netherlands, and Australia. The United States ranks last overall, despite spending far more of its gross domestic product on health care. The U.S. ranks last on access to care, administrative efficiency, equity, and health care outcomes, but second on measures of care process.

  • Conclusion: Four features distinguish top performing countries from the United States: 1) they provide for universal coverage and remove cost barriers; 2) they invest in primary care systems to ensure that high-value services are equitably available in all communities to all people; 3) they reduce administrative burdens that divert time, efforts, and spending from health improvement efforts; and 4) they invest in social services, especially for children and working-age adults.”

Differences in Cancer Care Expenditures and Utilization for Surgery by Hospital Type Among Patients With Private Insurance: A good example of the need to analyze methodology before assessing usefulness of a study’s findings.
“In this cross-sectional study, surgery at NCI centers vs community hospitals was associated with higher insurer spending for a surgical episode without differences in care utilization [length of stay, ED use, or hospital readmission within 90 days of discharge] patients with private insurance undergoing cancer surgery.” However…
”while every attempt was made to adjust for differences in case mix, our claims-based analysis did not allow for complete adjustment of clinical factors such as stage at diagnosis, surgical complexity, and pathologic status, which limited our ability to judge surgical quality.”
Further, longterm outcomes were not assessed.

Association Between the Physician Quality Score in the Merit-Based Incentive Payment System and Hospital Performance in Hospital Compare in the First Year of the Program: “Are higher scores on the Merit-Based Incentive Payment System (MIPS) for physicians associated with hospital-level patient outcomes?…
The MIPS quality score was not associated with the hospital composite rate of postoperative complications.”
Read the article for more information, the results for all surgical specialties are not straightforwardly uniform.

Majority of nursing homes missing broad safety, quality inspections due to the pandemic: “While the standard surveys, which check for quality and federal compliance, are required at least every 15 months, 71% of Centers for Medicare & Medicaid Services-certified nursing homes nationally had gone at least 16 months without one as of May 2021, according to a report from the Office of Inspector General.
Though it kept in place more narrow surveys such as infection control and targeted complaint investigations, CMS had suspended standard surveys due to the COVID-19 pandemic in March 2020. However, despite announcing in August 2020 that states should resume the surveys, resources allowing, the backlog grew from 8% in June of 2020 to 71%, the OIG’s latest examination of CMS administrative data found.”

About healthcare IT

FDA clears Abbott’s iPhone app for FreeStyle Libre 2: A reminder that such devices need FDA approval.

Envisioning a world of big, AI-ready—and free—healthcare data, a top medical school leads by example: “The academic medical institution that maintains the world’s best-stocked library of curated, patient-deidentified and AI-ready data is going 100% open source with its digital riches. 
Stanford Health announced…it already has nine available datasets containing more than 1 million useable assets—specifically annotated medical images—and is likely to hit 2 million within the next year.
As part of the expansion, the Center for Artificial Intelligence in Medicine and Imaging (AIMI) at Stanford University School of Medicine is partnering with Microsoft’s AI for Health program.”

About the public’s health

Effect of Graphic Warning Labels [GWL] on Cigarette Packs on US Smokers’ Cognitions and Smoking Behavior After 3 Months: “Although there was a significant increase in cognitions about quitting in the GWL group, there was no evidence of increased quitting or reduced consumption, and this was biochemically validated at the postintervention visit.”

About pharma

Amgen vows to fight after IRS demands $3.6B in back taxes—and a bigger bill could be on the way: “Amgen’s tax revelation came amid a mixed quarter for the drugmaker, which raked in $6.5 billion during the period. While that was a 5% increase compared with last year, the COVID-19 recovery has been gradual and will likely hit sales for the rest of the year, Amgen forecasted.”

About healthcare devices

Philips faces 2nd Class I recall in a month, this time for high-flow therapy ventilators: “At the core of the issue is a safety mechanism in the ventilators that caps the oxygen flow delivered to a patient and issues a low-priority alarm when the system reaches a default maximum pressure limit. A blockage to the flow of oxygen could raise the pressure, therefore triggering the safety cutoff and preventing the device from reaching the necessary level of oxygen flow.”

About health insurance

Aetna, CVS to enter ACA marketplace in 8 states: “The first Aetna CVS Health hybrid-branded product will be available in Arizona, Florida, Georgia, Missouri, Nevada, North Carolina, Virginia and Texas, according to a series of Aug. 4 news releases, and confirmed by a CVS spokesperson.”

CVS Health sees profit dip to $2.8B in Q2: “While profits are down slightly compared to the second quarter of 2020, the company is still on par for the first half of the year, bringing in $5 billion in profit. It also reported $5 billion in profit for the first half of 2020.”

Nationwide out-of-pocket spending jumped 10% in 2021. Expect that growth to continue through 2026: “Consumer out-of-pocket spending on healthcare is set to hit an estimated $491.6 billion, or about $1,650 per person, in the U.S., according to a recent report.
The number is a roughly 10% increase over last year’s total and is expected to maintain a continual annual growth rate of 9.9% for the next five years…”

About hospitals and health systems

Hospitals with higher credit ratings weathered greater margin deterioration, Fitch says: “In contrast, hospitals with ‘BBB’ ratings below investment grade categories saw incremental improvements in operating margins. 
Fitch said hospitals with lower ratings likely saw some improvement for several reasons, including that many took immediate expense reduction efforts and recognized stimulus funding quickly. Fitch also said the smaller sample size may have contributed.”

CMS' final inpatient payment rule for 2022: 7 things to know: A good summary of the rule.

MUSC wraps up purchase of 3 South Carolina hospitals from LifePoint Health: The headline is the story.

Today's News and Commentary

3 key health policies in the Senate's $1T infrastructure package:

  • “Providers got a win in the package when lawmakers agreed to not raid unallocated COVID-19 Provider Relief Fund monies. However, the legislation does deal a blow to the industry’s efforts to halt a 2% cut to Medicare payments from resuming.

  • Requiring drugmakers to refund Medicare for any discarded drugs
    The requirement applies to drugs dispensed under Medicare Part B, which reimburses for drugs administered in a doctor’s office such as chemotherapy. The requirement applies to single-dose containers or single-use package drugs.

  • The legislation demands that any federal contract to buy PPE must be for two years and go to a domestic manufacturer. The two-year time frame will give the domestic PPE maker enough financial security to stay in the market.”

2021's Best & Worst States for Health Care: WalletHub’s annual ranking based on Cost, Access and Outcomes. [The classic triad of cost/quality/access]. Massachusetts, RI and Minnesota are the top 3; Arkansas, Louisiana and Alabama [lowest] are at the bottom. The various measures are worth a look.

About devices

FDA Regulation and Approval of Medical Devices: 1976-2020: A good review of the topic, highlighted by a concise timeline of regulatory actions.

About Covid-19

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials: Transcript of yesterday’s press conference. A great summary of what is happening with Covid-19.

Don’t Want a Vaccine? Be Prepared to Pay More for Insurance.: The Federal government requires waiver of out of pocket expenses for Covid-19 testing and vaccination, but not treatment. This policy raises the question of who pays for treatment if the vast majority (97%) of hospitalizations are non-vaccinated persons. Will/should health plans charge higher premiums and fees to those who refuse the vaccine? Can it apply to anyone who is unvaccinated for other diseases- like influenza, pertussis, and pneumococcal vaccines?

US hits 70% vaccination rate -- a month late, amid a surge: “The U.S. on Monday finally reached President Joe Biden’s goal of getting at least one COVID-19 shot into 70% of American adults -- a month late and amid a fierce surge by the delta variant that is swamping hospitals and leading to new mask rules and mandatory vaccinations around the country.”

NYC Becomes Largest U.S. City To Require Proof Of Vaccination For Indoor Activities: “New York City will require workers and patrons at indoor businesses to show proof of vaccination starting on Sept. 13, becoming the first major U.S. city to take such action amid a surge of new cases nationwide driven by the highly transmissible delta variant.
The new mandate announced Tuesday, dubbed the ‘Key to NYC Pass,’ will apply to indoor dining, gyms and entertainment venues.”

Rates of SARS-CoV-2 transmission and vaccination impact the fate of vaccine-resistant strains: The conclusion of this simulation was that masking must be done with aggressive vaccination. The reason is that viral transmission from vaccinated persons gives the virus a chance to mutate.

11 bans on vaccine mandates — What states have them & which might soon: A good summary.

Germany Will Offer Vaccine Booster Shots Starting in September: “As concerns grow over the highly contagious Delta variant of the coronavirus, Germany on Monday became the biggest Western country yet to announce that it will offer vaccine booster shots to a wide range of people considered potentially vulnerable, adding to growing momentum in rich nations to give additional shots to fully vaccinated people.
The move by Germany came even as a top European Union official criticized the bloc as falling far short of its promises to donate vaccine doses to Africa and Latin America. And with a limited global vaccine supply, health experts say the top priorities should be distributing doses to poor countries that lag far behind in inoculations, and persuading vaccine-resistant people in wealthy countries to get their first shots.”

Insurer filings suggest COVID-19 pandemic will not drive health spending in 2022: “Of the 75 insurer filings submitted in these states [13 states and DC], only 13 say the COVID-19 pandemic will have an upward effect on their costs, with most of those stating that the impact would be less than 1%. This includes seven plans in New York, three plans in Connecticut, one plan in Tennessee, one plan in Michigan, and one plan in Vermont. Three insurer filings said the pandemic would have a downward impact on their costs. About half (37 insurers) say the pandemic will have no net impact on their 2022 costs. The remaining insurers either did not specify a COVID-19 cost impact or redacted it.  
Among the 13 plans that specified cost increases due to COVID, reasons included costs related to ongoing COVID-19 testing, treatment, and vaccinations (8 insurer filings), and anticipated vaccination boosters (7 insurer filings).”

Eli Lilly's COVID-19 antibody sales crater as variants, vaccines take a toll: “Lilly’s COVID-19 antibodies raked in $148.9 million during the quarter, an 82% drop from the $810.1 million the drugs generated during the first quarter this year. That includes sales of bamlanivimab, plus Lilly’s combo treatment that pairs that drug with etesevimab. 
Neither of Lilly’s treatments, however, are being deployed in the U.S. amid the rapid rise of variants. In early April, the FDA revoked its authorization for bamlanivimab alone after the mutations proved resistant to the solo treatment.”

About healthcare IT

4.5 million affected by data breaches in July: 10 hospitals hit: Why people don’t trust the healthcare system to keep records safe: “In July, 4,584,411 patients and employees across 39 healthcare organizations were hit by data breaches.”

A COVID-19 Telehealth Impact Study—Exploring One Year of Telehealth Experimentation: A good of telehealth utilization, reasons for use and satisfaction through December 2020. The standout is use of behavioral health.

Modernizing Public Health Data SystemsLessons From the Health Information Technology for Economic and Clinical Health (HITECH) Act: Some recommendations from Google- worth a quick read.

About hospitals and health systems

CMS finalizes $2.3B pay bump for hospitals in federal fiscal 2022: “The Biden administration has finalized a rule that gives hospitals an overall $2.3 billion for the 2022 fiscal year that begins in October and scraps a proposal for hospitals to disclose Medicare Advantage rates. 
The final Hospital Inpatient Prospective Payment Services rule, released Monday by the Centers for Medicare & Medicaid Services (CMS), also includes a 1.1% hike for long-term care hospitals. The regulation also extends an add-on payment for new COVID-19 treatments through the end of the fiscal year where the public health emergency ends and requires hospitals to submit data on several public health measures to identify emerging outbreaks.”

Three notices of system sales:
HCA sells 4 hospitals to Piedmont
Ascension sells 7 Wisconsin hospitals, 21 clinics
Tenet sells 5 Florida hospitals

National Hospital Flash Report: Monthly report from KauffmanHall. Read the repot for details. Overall: “While overall metrics indicate continued recovery for hospitals and health systems nationwide, the uptick in COVID-19 cases could hinder progress in the coming months.”

About pharma

Quantifying The Economic Burden Of Drug Utilization Management On Payers, Manufacturers, Physicians, And Patients: “Based on a compilation and analysis of the existing peer-reviewed and professional literature, this article estimates that payers, manufacturers, physicians, and patients together incur approximately $93.3 billion in costs annually on implementing, contesting, and navigating utilization management. Payers spend approximately $6.0 billion annually administering drug utilization management, and manufacturers spend approximately $24.8 billion supporting patient access in response. Physicians devote approximately $26.7 billion in time spent navigating utilization management, whereas patients spend approximately $35.8 billion annually in drug cost sharing, even after taking advantage of manufacturer and philanthropic sources of financial support.”

Sanofi to buy partner Translate Bio for $3.2bn in mRNA push: “French pharmaceutical group Sanofi will acquire its partner Translate Bio for $3.2bn, as it makes a big bet on the future of messenger RNA as a transformative technology for vaccines and therapeutics.”

Today's News and Commentary

About COVID-19

U.S. CDC chief says there will be no federal mandate on COVID-19 vaccine: “U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said on Friday there will be no nationwide mandate for Americans to get a COVID-19 vaccine, clarifying comments she made earlier during a televised interview.”

FDA vows ‘all hands on deck’ effort to get Pfizer coronavirus vaccine full approval as quickly as possible: “With coronavirus cases surging, the Food and Drug Administration’s top vaccine official said Friday the agency is redeploying staff and adding computer and other technical resources to accelerate an effort to grant the Pfizer coronavirus vaccine full approval as rapidly as possible.
‘We have rolled out an all hands on deck’ strategy to identify ways to expedite approval of the vaccine, which is currently being administered under the FDA’s emergency use authority, said Peter Marks, director of the Center for Biologics Evaluation and Research, in an interview.”

About pharma

FTC drops antitrust case against AbbVie, but still decries the company's 'ill-gotten gains': “Appealing a $448 million judgement in an antitrust case has ultimately paid off for AbbVie.
On Friday, the U.S. Federal Trade Commission withdrew its complaint that AbbVie (then under the umbrella of Abbott Laboratories) used sham litigation in 2011 to illegally block generic competition for its testosterone drug AndroGel. While the agency still thinks AbbVie engaged in ‘anticompetitive conduct,’ an official said current laws don't support the agency's efforts to recoup money for consumers.”

The Top 10 Most Expensive Popular Generic Drugs in the US (and How to Save): From Good Rx. Two of the top 10 are erectile dysfunction drugs.

FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway: “Since the US Food and Drug Administration established its accelerated approval pathway for drugs in 1992, nearly half (112) of the 253 drugs authorised have not been confirmed as clinically effective, an investigation by The BMJ has found.
Of these 112 drugs approved in the past 28 years, a fifth (24) have been on the market for more than five years and some for more than two decades—often with a hefty price tag, shows an in-depth analysis of FDA data to 31 December 2020, conducted by The BMJ.
The accelerated pathway allows drugs onto the market before efficacy has been proved. As part of this approval, however, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to ‘verify the anticipated clinical benefit.’ If these trials show no benefit the drug’s approval can be cancelled.
Further analysis of FDA data shows that only 16 drugs approved through the pathway have ever been withdrawn. Most of these were shown to lack efficacy, but in some cases the confirmatory trials were never done. Celecoxib (Celebrex), which was given accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because the efficacy trials were never done.”

About health insurance

DOJ joins false claims suit against Kaiser Permanente: “According to the lawsuits, Kaiser Permanente pressured its physicians to include addenda on patient records to additional diagnoses. These updates were at times made months or more than a year later, for conditions the patient did not have or that were not considered at the time of their visit, the DOJ said.
The false claims allegations were initially filed in a series of whistleblower suits, the DOJ said.”

NPs get prison time for telemedicine fraud: “Two nurse practitioners have been sentenced to prison and ordered to pay restitution for conspiring to defraud Medicare, the U.S. Justice Department announced July 30. 
Janae Harper, NP, 34, of Kalispell, Mont., was sentenced to 12 months in prison and ordered to pay $4.3 million in restitution. Mark Hill, NP, 54, of Edinburg, N.D., received a nine-month prison sentence and was ordered to pay $5.1 million in restitution. The sentences were handed down after both defendants pleaded guilty to conspiracy to commit healthcare fraud. 
The government alleged Ms. Harper worked with staffing and telemedicine companies to commit healthcare fraud from late 2017 through July 2019. She allegedly received money to sign brace orders that were prepared by telemarketers who had no medical training. She allegedly signed 7,673 brace orders, which resulted in $8.3 million billed to Medicare, according to the Justice Department. 
The government alleged Mr. Hill also worked with telemedicine and staffing companies to commit fraud. He was allegedly paid to sign brace orders for Medicare beneficiaries from October 2017 through April 2019. He allegedly signed 7,097 brace orders, which resulted in $10.1 million billed to Medicare.”