Today's News and Commentary

About Covid-19

From the CDC: “The current 7-day moving average of daily new cases (136,558) decreased 12.7% compared with the previous 7-day moving average (156,341). The current 7-day moving average is 99.3% higher than the value observed approximately one year ago (68,527 new cases on July 20, 2020). The current 7-day moving average is 46.2% lower than the peak observed on January 10, 2021 (254,016) and is 1,076.0% higher than the lowest value observed on June 18, 2021 (11,613). A total of 40,523,954 COVID-19 cases have been reported as of September 8, 2021.”

HHS Announces the Availability of $25.5 Billion in COVID-19 Provider Funding: “This funding includes $8.5 billion in American Rescue Plan (ARP) resources for providers who serve rural Medicaid, Children's Health Insurance Program (CHIP), or Medicare patients, and an additional $17 billion for Provider Relief Fund (PRF) Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic.”

CNBC poll shows very little will persuade unvaccinated Americans to get Covid shots: “Among the 29% of U.S. voters who are unvaccinated, 83% say they do not plan to get the lifesaving shots, the survey shows.
Growing vaccine hesitancy could make it difficult to reach the up to 90% vaccination rate that some health officials have suggested is necessary to achieve nationwide herd immunity to Covid.”

Departing FDA officials say it's too soon for COVID-19 boosters as White House plans rollout next week: “Even with the wave of delta variant-driven coronavirus cases in the U.S., the authorized vaccines appear to be staving off severe infections, according to a paper published in The Lancet. The group of authors includes top officials with the World Health Organization.
The paper stands in stark contrast to the Biden administration’s own booster shot plan, which some have criticized for jumping ahead of federal regulators. The White House has been planning to roll out the extra doses to the general population as early as next week following the FDA’s meeting on Friday to discuss Pfizer’s application for an extra shot.“

U.S. could authorize Pfizer COVID-19 shot for kids age 5-11 in October -sources: “If Pfizer submits its EUA by the end of September, and the data support its use, ‘by the time we get to October, the first couple of weeks of October... the Pfizer product will likely be ready,’ Fauci said…
Fauci said that Moderna Inc  will likely take about three weeks longer than Pfizer to collect and analyze its data on children age 5-11... He estimated that a decision on the Moderna shot could come around November.”

Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial: “Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm—relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94–1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02–1.57, P = 0.034)…
Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.”

About healthcare IT

Hospital telehealth visits leveling off at 10%-20% of appointments as claims hit lowest level since pandemic: “About 40% of hospital executives report that up to 10% of their appointments are done virtually and the same percentage said 11% to 20% of their volume is virtual, according to a recent survey by KLAS Research and the Center for Connected Medicine.
The small handful of respondents (12%) are currently conducting more than 30% of their appointments virtually but note that their volumes are still inflated by the pandemic and expect their long-term volumes to be lower, the survey report said.
Telehealth use overall has stabilized at levels 38 times higher than before the COVID-19 pandemic, ranging from 13% to 17% of visits across all specialties, according to an analysis from McKinsey released in July.”

About the public’s health 

Young adult cannabis consumers nearly twice as likely to suffer from a heart attack, research shows: “Whether you smoke it, vape it or eat it as an edible, cannabis may be significantly increasing your risk of a heart attack. 
Adults under 45 years old, who consumed cannabis within the last 30 days, suffered from nearly double the number of heart attacks than adults who didn't use the drug, according to research… in the Canadian Medical Association Journal.”

About health insurance

Vermont All-Payer Model (VTAPM) Evaluation of the First Two Performance Years: 2018-2019: “The Vermont All-Payer Accountable Care Organization Model (VTAPM), launched on January 1, 2017 with an anticipated end date of December 31, 2022, aims to assess whether scaling an Accountable Care Organization (ACO) program across all payers in the state can reduce program expenditures while preserving or improving care quality by generating sufficient incentives and alignment across payers for broad delivery system transformation…
While the Vermont All-Payer Model failed to achieve its all-payer and Medicare scale target goals, in its first two performance years, the Model achieved statistically significant Medicare gross spending reductions at both the ACO and state levels, as well as Medicare net spending reductions at the state level.
There were declines in acute care stays (at the ACO and state levels) and in 30-day readmissions at the state level.
These decreases in utilization and spending may reflect rising spending in the comparison groups and relatively flat spending in the VTAPM groups that began in the baseline period and continued into the first two performance years.”
In a related article: State’s largest hospital, UVM Medical Center, asks for $204 million increase: “UVM Medical Center officials say the increased revenue would help the hospital recover from disruptions caused by Covid and hospital system failures, including a cyberattack that stalled patient services for six weeks and the closing of the Fanny Allen surgical center because of a persistent carbon monoxide contamination problem.”

Humana Expands Upon Its Bold Goal Initiative with $25 Million Affordable Housing Investment: “Humana’s Bold Goal social health initiative seeks to provide people with more Healthy Days and better lives by focusing on critical social determinants of health, including housing stability.
Humana’s national housing strategy aims to address members’ housing needs through a three-part approach, including interventions and investments that reduce health care costs and improve outcomes for vulnerable members and communities.
$25 million investment will help expand the supply of affordable housing in the states of Florida, Georgia, Illinois, Kentucky, Louisiana, Ohio, Oklahoma and Texas.”

Today's News and Commentary

About Covid-19

Sweeping new vaccine mandates for 100 million Americans: The big story is the President’s announcement of federal mandates/initiatives to require vaccination. A key to this requirement is using federal payments as a criterion. This link is to a clear, accessible article about the announcement.
But, of course: Republican governors threaten to sue over Biden’s sweeping vaccine mandates
And in another related article: Businesses Question Logistics, Cost of Biden Vaccine Plan: For example, “Betsy Booren, vice president of regulatory and technical affairs for the association, said packaged-goods companies now face pressing questions such as how to document compliance and how their performance will be tracked. Businesses are also dealing with ‘vaccine hesitancy’ in the workforce, which is compounded by the fact that only the Pfizer-BioNTech shot has been fully cleared by regulators. Industry-specific guidelines from different regulators will also be key, she said.”

Unvaccinated people were 11 times more likely to die of covid-19, CDC report finds: “People who were not fully vaccinated this spring and summerwere more than 10 times more likely to be hospitalized, and 11 times more likely to die of covid-19, than those who were fully vaccinated, according to one of three major studies published Friday by the Centers for Disease Control and Prevention that highlight the continued efficacy of all three vaccines amid the spread of the highly contagious delta variant.
A second study showed that the Moderna coronavirus vaccine was more effective in preventing hospitalizations than its counterparts from Pfizer-BioNTech and Johnson & Johnson. That assessment was based on the largest U.S. study to date of the real-world effectiveness of all three vaccines, involving about 32,000 patients seen in hospitals, emergency departments and urgent-care clinics across nine states from June through early August.”

An Anti-Vaccine Book Tops Amazon's COVID Search Results. Lawmakers Call Foul: “Amazon is under pressure from Democrats in Congress over how its algorithms promote hoax COVID-19 cures, including the livestock dewormer ivermectin, as well as anti-vaccination claims and other medical misinformation.”

Lilly's COVID-19 antibody combo cleared for nationwide use as feds say it can tackle the dominant delta variant: “Only a few days after Eli Lilly's COVID-19 antibody combo of bamlanivimab and etesevimab made its return to more than 20 states, federal officials are resuming distribution nationwide.
In a Thursday alert, officials said Lilly's drug "can be used in all U.S. states, territories, and jurisdictions" based on data about variants circulating nationwide. Since Eli Lilly's combo is expected to be effective against the delta variant—and because that variant is now dominant in the United States—officials are ready to again endorse the drugs.”

An average Covid-19 hospitalization costs Medicare about 150 times more than it does to vaccinate one beneficiary: “Covid-19 vaccines are provided at no direct cost to residents of the United States, but Medicare reimburses health care providers up to $150 to fully vaccinate beneficiaries with both doses of the two-dose regimen vaccines by Pfizer/BioNtech and Moderna, per billing documents published by the US Centers for Medicare and Medicaid Services. That's $40 for each dose administered and $35 to administer the shots at the individual's home or group living setting.
Meantime, the average cost to hospitalize a Medicare beneficiary with Covid-19 is $21,752 over an average stay of 9.2 days, according to research published in August in the Annals of Internal Medicine. That's approximately 145 times the cost of vaccinating a Medicare beneficiary.”

About pharma

Comprehensive Plan for Addressing High Drug Prices: A Report in Response to the Executive Order on Competition in the American Economy: This report, released yesterday, “presents principles for equitable drug pricing reform through competition, innovation, and transparency; describes promising legislative approaches; and summarizes actions already underway or under consideration across the Department of Health and Human Services (HHS)…
The report identifies three guiding principles for drug pricing reform:

1. Make drug prices more affordable and equitable for all consumers and throughout the health care system - Support drug price negotiation with manufacturers and stop unreasonable price increases to ensure access to drugs that can improve health for all Americans

2. Improve and promote competition throughout the prescription drug industry - Support market changes that strengthen supply chains, promote biosimilars and generics, and increase transparency

3. Foster scientific innovation to promote better health care and improve health - Support public and private research and make sure that market incentives promote discovery of valuable and accessible new treatments, not market gaming

Support for Bold Legislative Action. The report highlights potential legislative policies Congress could pursue to advance the principles described above, including:

•   Drug price negotiation in Medicare Parts B and D, with those negotiated prices also available to commercial plans (including the Marketplace) and employers who want to participate

•   Medicare Part D reform, including a cap on catastrophic spending to protect beneficiaries from unaffordable out-of-pocket costs

•   Legislation to slow price increases over time on existing drugs

•   Legislation to speed the entry of biosimilar and generic drugs, including shortening the period of exclusivity, and policies in Medicare Part B to increase the prescribing of biosimilars by clinicians

•   Prohibition on “pay-for-delay” agreements and other anti-competitive practices by drug

  manufacturers

•   Investment in basic and translational research to foster innovation, including the President’s proposal to create the Advanced Research Projects Agency for Health (ARPA-H)”

GSK, Pfizer and Johnson & Johnson race toward $10B-plus RSV vaccine market: analyst: “GSK, Pfizer and GlaxoSmithKline are all in late-stage testing for their RSV shots. Sanofi, while it's a leading vaccine player worldwide, is taking another approach with its late-stage RSV program. The company and partner AstraZeneca are working on a prophylactic monoclonal antibody for infants, and they plan to file for approval next year.”

BMS, Pfizer Snag Appeals Court Victory for Blockbuster Eliquis: “The U.S. Court of Appeals for the Federal Circuit has upheld a prior victory for Bristol Myers Squibb and Pfizer covering two Eliquis (apixaban) patents, positioning the companies to keep exclusivity in the U.S. for the blockbuster oral anticoagulant until April 1, 2028. 
The case hinged on the drug’s composition of matter patent and a formulation patent. In a court ruling in August 2020, the U.S. District Court for the District of Delaware found that the two patents in question were valid and infringed.”

FDA Revises Q&A Guidance on Pandemic-Era Generic Drug Development: “The FDA has revised its guidance on generic drug development and application submission during the COVID-19 public health emergency, providing additional information and clarification of existing policies but no policy changes.
First published in April of this year, Development of Abbreviated New Drug Applications (ANDAs) During the COVID-19 Pandemic — Questions and Answers is a compilation of questions from industry and answers from FDA about generic drug product development and application assessment during the pandemic. Topics also include marketing and exclusivity.”

Amazon-backed biotech Mammoth raises $200m for diseases push: “Mammoth Biosciences, the biotech co-founded by Nobel Prize winner Jennifer Doudna and that counts Amazon as a backer, has raised almost $200m to expand its use of novel Crispr-associated proteins into an effort to cure genetic diseases. The California-based start-up is now valued at $1bn following a $150m round led by venture capitalists Redmile Group, with participation from Foresite Capital. It follows a $45m fundraising the company had in late 2020. Mammoth hunts the world for new versions of the bacterial immune system that can be used as a gene-editing tool known as Crispr, or clustered regularly interspaced short palindromic repeats.”

Bausch pays whopping $300M to settle Glumetza pay-for-delay lawsuit after 800% price hike: “Bausch Health, which industry watchers may remember by its former name Valeant, has been riddled in controversy for years over its defense of diabetes med Glumetza. Now, the company will pay millions to put those charges to rest. 
Bausch has agreed to dish out $300 million to settle a 2019 lawsuit that claimed the Canadian drugmaker paid off its generic rivals nearly a decade ago, allowing the company to jack up prices for the type 2 diabetes heavyweight by 800% shortly thereafter, according to a Wednesday court filing.”

About health insurance

Cigna, Oscar Health expanding cobranded plans into Illinois: “Cigna and Oscar Health are expanding their cobranded health plans in Illinois, the companies announced on Thursday.
The plans, which target small businesses, will be available in Chicago, as well as DuPage, Kane, Lake and McHenry counties. The expanded footprint is pending regulatory approval…
The plans, which are available for companies with between zero and 50 employees, are built on Cigna's provider network in tandem with Oscar's technology stack.
The partner plans have been scaling up its footprint at a rapid clip, expanding into additional areas of California and into Connecticut.”

UnitedHealth hit with class-action reimbursement suit: “A class-action lawsuit filed Sept. 7 accuses UnitedHealth of failing to fairly reimburse out-of-network providers by bypassing rates established by vendor contracts.
Specifically, the lawsuit points to member experiences that allege UnitedHealth ignored discounted rate agreements between vendors and providers, allegedly violating vendor contract plans.
The move is a violation of the Employee Retirement Income Security Act of 1974, the lawsuit alleges, as the uneven application of rates benefits the insurer and its employer customers, not members. 
The plaintiffs include three health plan members whose coverage is either administered or underwritten by UnitedHealthcare, all of whom are representing similar parties.”

About hospitals and health systems

Nonprofit hospitals provided $105B in community benefits in 2018: AHA: “Tax-exempt hospitals spent $105 billion on community benefits in 2018, according to a new report from the American Hospital Association.
Nonprofit hospitals are exempt from paying taxes. In return, they provide community benefits such as charity care, financial assistance programs, population health initiatives, underwriting medical research, among other benefits.
The new AHA analysis examined hospital and health systems' group and individual Schedule H tax filings submitted to the Internal Revenue Service for tax year 2018, the most recent data available.
The AHA report found that tax-exempt hospitals spent 13.9 percent of their total annual expense on community benefits. Further about half, 6.4 percent, of that expense involved offering financial assistance to patients and subsidizing underpayments from Medicaid and other government payers.”

HCA sells off dozens of its newly acquired home care locations to keep the focus on core networks: “HCA Healthcare just locked in its $400 million majority stake purchase of Brookdale Senior Living’s home health and hospice business in July, yet the hospital chain is already looking to trim off the fat with some extra dealmaking.
On Wednesday, the hospital chain announced that it has entered into a preliminary agreement with home care provider LHC Group to sell off nearly 50 home health locations, hospices and therapy agencies across 22 states.”

Challenges to Public Health Reporting Experienced by Non-Federal Acute Care Hospitals, 2019: An ONC Data Brief. Note the date of the study; it was published this month.
HIGHLIGHTS:

• “In both 2018 and 2019, half of all hospitals reported a lack of capacity to electronically exchange information with public health agencies.

• In 2019, seven in ten hospitals experienced one or more challenges related to public health reporting.

• Small, rural, independent, and Critical Access hospitals were more likely to experience a public health reporting challenge compared to their counterparts.

• The types of public health reporting challenges experienced by hospitals varied substantially at the state-level.”
  

Today's News and Commentary

BREAKING NEWS:
Justice Department sues Texas over a new law that bans nearly all abortions: “The Department of Justice on Thursday sued Texas over its restrictive new abortion law, saying the state’s legislature enacted the statute ‘in open defiance of the Constitution.’”
See: DOJ Live [Click on the arrow and view as soon as possible; it is unclear how long the video will last]

About healthcare finance

Healthcare bankruptcies at all-time low, new report finds: “Record-keeping began in 2010. The second quarter of this year was the lowest the Health Care Services Distress Research Index had ever recorded, according to the latest Polsinelli-TrBK Distress Indices Report. The index decreased more than 333 points since the last quarter and is more than 446 points lower than the same time last year. A lower index is likely in a strong economy, according to the report…
[T]he reason for this drastic shift is believed to be because of ‘substantial and continued government support for the most vulnerable of health care industries during the pandemic.’”

About Covid-19

Los Angeles mandates student vaccinations in nation’s second-largest school district: “The Los Angeles school board on Thursday voted without dissent to require mandatory coronavirus vaccinations for students ages 12 and up in the city’s public school system, with board members arguing that vaccination is the best way to protect students and keep schools open for in-person learning.”

SPREADING COVID-19 VACCINE MISINFORMATION MAY PUT MEDICAL LICENSE AT RISK: “The Federation of State Medical Boards’ Board of Directors released the following statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online and in the media:
’Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical
license.‘“

Novavax Begins Early-Stage Trial for Flu, COVID-19 Combo Vaccine: “Novavax has launched a phase 1/2 trial in Australia evaluating the safety and immunogenicity of a combination influenza and COVID-19 vaccine.
The study will assess Novavax’s COVID-19 vaccine candidate, NVX-CoV2373, plus its flu shot, NanoFlu, along with its Matrix-M adjuvant in 640 healthy adults aged 50 to 70.”
While convenient, is the two-in-one necessary? How many forms of the flu vaccine will be used, e.g., high dose for older recipients versus pediatric formulations?

Judge says Ohio hospital cannot be forced to use ivermectin to treat Covid, reversing earlier decision: “A judge ruled Monday that an Ohio hospital cannot be forced to give a patient ivermectin for Covid-19, reversing an earlier decision that ordered it to administer a parasite medication that has not been approved to treat the disease.
In an 11-page decision, Hamilton County Common Pleas Judge Michael Oster Jr. wrote that there “was no doubt that the medical and scientific communities do not support the use of ivermectin as a treatment for Covid-19.”

A new study of dorm rooms shows how ventilation curbs virus levels: “Opening a window could reduce the amount of coronavirus in a room by half, according to a new observational study of infected college students in an isolation dormitory at the University of Oregon.
The study, which was posted online, is small and has not yet been published in a scientific journal. But it provides real-world evidence for several important principles, demonstrating that the virus spreads from infected people into the air in a room; that the more virus they’re carrying, the more virus builds up indoors; and that both natural and mechanical ventilation appear to reduce this environmental viral load.”

95 percent of US counties now seeing 'high' COVID-19 transmission rate: CDC data: “The CDC's COVID Data Tracker revealed on Tuesday that 95.19 percent of counties in the U.S. are seeing “high” rates of transmission, meaning there were at least 100 new cases reported per 100,000 people in the past seven days.
Around 2 percent of counties are seeing ‘substantial’ and ‘low’ rates of transmission, and less than 1 percent of counties are seeing ‘moderate’ rates of transmission.”

A COVID-19 vaccine in the nose? Cincinnati Children's will lead trial: “The vaccine has been engineered to express the COVID-19 spike glycoprotein, which is the same spike protein that's in the other vaccines, he said.
The vaccine is squirted into each nostril; then it replicates and generates an immune response, he said. 
The clinical trial at the Cincinnati Children's research center is expected to begin the week of Sept. 14, and recruitment is underway…”

Florida judge rules against DeSantis again, allows schools to require mask: “A Florida judge on Wednesday ruled against Gov. Ron DeSantis’s administration for a second time over school mask mandates, allowing school boards to require that students wear face coverings
Leon County Circuit Judge John C. Cooper again sided with parents who said an executive order from DeSantis (R) overstepped the state’s authority in restricting school districts from requiring masks.”

About the public’s health

Vaping Raises Blood Clotting Risks, Harms Small Arteries: Study: “’Our results suggest that using e-cigarettes that contain nicotine have similar impacts on the body as smoking traditional cigarettes,’ said study author Gustaf Lyytinen, a clinician at Helsingborg Hospital and researcher at the Karolinska Institute in Stockholm. His team presented the findings this week at the virtual annual meeting of the European Respiratory Society.”

Effect of Financial Incentives and Environmental Strategies on Weight Loss in the Healthy Weigh Study: “What is the relative effectiveness of financial incentives and environmental change strategies, alone and in combination, on initial weight loss and maintenance of weight loss in employees with obesity?...
In this randomized clinical trial, at the 18-month primary end point, participants in the incentives group lost a mean of 5.4 lb (2.45 kg), those in the environmental strategies group lost a mean of 2.2 lb (1.00 kg), and the combination group lost a mean of 2.4 lb (1.09 kg) more than the usual care group. None of the strategies was significantly more effective than usual care.”

Medical Journals Call Climate Change the ‘Greatest Threat to Global Public Health’: “In an editorial published in more than 200 medical and health journals worldwide, the authors declared a 1.5-degree-Celsius rise in global temperatures the ‘greatest threat to global public health.’ The world is on track to warm by around 3 degrees Celsius above preindustrial levels by 2100, based on current policies.
‘The science is unequivocal; a global increase of 1.5°C above the preindustrial average and the continued loss of biodiversity risk catastrophic harm to health that will be impossible to reverse,’ the authors wrote. ‘Indeed, no temperature rise is ‘safe.’”

Mexico's top court decriminalizes abortion in 'watershed moment': “Mexico's Supreme Court unanimously ruled on Tuesday that penalizing abortion is unconstitutional, a major victory for advocates of women's health and human rights, just as parts of the United States enact tougher laws against the practice.
The decision in the world's second-biggest Roman Catholic country means that courts can no longer prosecute abortion cases, and follows the historic legalization of the right in Argentina, which took effect earlier this year.”
Will Texans be traveling south for this service? See the Breaking News story above.

AmeriCorps partnering with CDC to recruit, train public health leaders: “The federal volunteering agency AmeriCorps has teamed up with the Centers for Disease Control and Prevention (CDC) to launch a program designed to recruit and train public health leaders as the pandemic rages on.
AmeriCorps unveiled its partnership with the CDC on Wednesday, saying the Public Health AmeriCorps program was funded by $400 million in the American Rescue Plan and is expected to support up to 5,000 AmeriCorps positions over the next five years.
Public Health AmeriCorps will mostly send AmeriCorps members to help in state, local, tribal and territorial public health departments, with a strong suggestion that at least two members be present at each location. Applicants for the positions have until Nov. 8 to submit their applications.”

FDA facing demands to snuff out Juul’s e-cigarettes: “The Food and Drug Administration is supposed to decide by Sept. 9 whether the embattled company — which has been widely blamed for igniting a surge in youth vaping — will be allowed to keep selling its products in the United States and, if so, under what conditions. The agency also is scrutinizing millions of other products made by hundreds of cigar, pipe and e-cigarette companies.”
UPDATE: U.S. FDA says it needs more time to decide on Juul, other e-cigarettes: “The U.S. Food and Drug Administration said on Thursday it needs more time to decide whether e-cigarette maker Juul Labs Inc and other major manufacturers can sell their products in the United States.”

France to give free access to contraception for women aged up to 25: “France will make access to birth control free for women aged up to 25 years old from January 1 onwards, in a new measure that will cost the state 21 million euros ($24.8 million) per year, French Health Minister Olivier Veran said on Thursday.
The policy announcement comes as President Emmanuel Macron’s government prepares for the 2022 election campaign.”

About medical devices

ICU Medical trumps US private equity with $2.7bn deal for Smiths’ medical unit: “Smiths Group has agreed to sell its medical division to California-based ICU Medical for $2.7bn, with the industrial conglomerate snubbing a lower offer made by US private equity suitor TA Associates…
US-headquartered Smiths Medical makes specialist medical equipment and single-use devices, reporting £918m in revenues in 2020. Its presence in the UK is small but it helped the country’s efforts to produce its own ventilators at the start of the first coronavirus wave last year.”

About health insurance

National brands sue Anthem, BCBS, cite 'continuing conspiracy' to stifle competition: “A cast of national brands — including the likes of FedEx, Boeing, Meijer, and Walgreens — filed an antitrust complaint against Anthem and Blue Cross Blue Shield, alleging that the insurers aimed to use their market leverage to influence employer-sponsored health insurance plans. 
The complaint, filed Sept. 4, alleges that the insurers charged rates that utilized their competitive advantage to clients, which include some of the challenging companies, thereby resulting in stifled competition.
The filing parties' complaints largely fall into the same narrative: Many use Blue Cross Blue Shield or Anthem self-insured or administrative services only plans, but costs are high and other options are limited due to noncompete agreements.”

Metros with the highest uninsured rates, by state: “The McAllen-Edinburg-Mission metro area in Texas has the highest uninsured rate at 35.7 percent when compared to other metro areas in the U.S
The ranking, published Sept. 4, used data from the U.S. Census Bureau on the share of uninsured residents in each metro area who didn't qualify for Medicare. Four states — Delaware, New Hampshire, Rhode Island and Vermont — only have one metro area, so those had the highest uninsured rate as a default.”

Home Health Agency Operator BAYADA to Pay $17 Million to Resolve False Claims Act Allegations for Paying Kickback: “BAYADA, BAYADA Home Health Care Inc., BAYADA Health LLC and BAYADA Home Care (collectively, the BAYADA Companies), headquartered in Moorestown, New Jersey, have agreed to pay $17 million to resolve allegations that they violated the False Claims Act’s Anti-Kickback Statute by paying a kickback to a retirement home operator by purchasing two of its home health agencies (HHAs) located in Arizona.
The United States alleges that the BAYADA Companies bought the two HHAs to induce referrals to BAYADA of Medicare beneficiaries from retirement communities operated by the seller throughout the United States, and that from Jan. 1, 2014 through Oct. 31, 2020, the BAYADA Companies submitted false claims for payment to Medicare for services provided to beneficiaries referred to BAYADA as a result of the kickback transaction.”

Today, CMS Administrator Chiquita Brooks-LaSure is releasing six pillars for how she envisions her agency operating: “She plans to focus on health equity; building on Obamacare; working with partners when crafting and implementing policy; promoting value-based care; keeping health programs afloat by using public funds responsibly; and creating an inclusive workplace.”

Price Differences To Insurers For Infused Cancer Drugs In Hospital Outpatient Departments And Physician Offices: “The prices paid in 2019 by Blue Cross Blue Shield health plans in hospital outpatient departments were double those paid in physician offices for biologics, chemotherapies, and other infused cancer drugs (99–104 percent higher) and for infused hormonal therapies (68 percent higher). Had these plans excluded hospital clinics from their networks, channeling all of the infusions to physician offices, they would have saved $1.28 billion per year, or 26 percent of what they actually paid.”
However, as the article points out, shifting to physician-office settings would increase patient out-of-pocket payments. A revised benefit schedule could help reduce insurance company costs while keeping patient financial responsibility low.
In a related story: UnitedHealth: Average of $684 saved when shifting common procedures outside of hospital: ”Moving routine procedures like colonoscopies and cataract removals away from a hospital outpatient department and to an ambulatory surgery center can save an average of $684 per procedure, UnitedHealth Group said in a report released Sept. 8.
UnitedHealth found that the average price of common procedures in a hospital setting was $7,716 in 2019, or 144 percent more than the same procedures in an ASC.”

CMS provides additional ARP funding to states to promote insurance affordability: “State-based reinsurance programs created through section 1332 waivers are designed to improve health insurance affordability and market stability by reimbursing issuers for a portion of healthcare provider claims that would otherwise be paid by some consumers and by the federal government through higher premiums. 
As a result, said CMS, these programs hold the potential to lower premiums for consumers with individual health insurance coverage, and may increase access to coverage and provide more health plan options for people in those reinsurance states, without increasing net federal costs.
The additional funds announced by CMS range from $2.5 million to $139 million per state – varying based on factors such as the size of the state's reinsurance program. The funds are the result of expanded subsidies provided under the ARP, which will result in new people enrolled, and will cover a portion of the states' costs for these reinsurance programs.”

Anthem signs on with Cleveland Clinic's, Amwell's virtual second opinions service: “Anthem is teaming up with The Clinic by Cleveland Clinic to offer virtual second opinions to members.
The Clinic is a digital health joint venture from Cleveland Clinic and Amwell that provides video consultations, digital record collection and concierge service to insurers, providers, employers and patients. Through the partnership, eligible members can seek online second opinions from the health system's 3,500 physicians.”

About healthcare IT

AMA releases more than 400 CPT code changes for 2022 to align with new tech services:  “The AMA made 405 changes in the 2022 Current Procedural Terminology code set, including 249 new codes, 63 deletions and 93 revisions. The changes will take effect Jan. 1. 
The CPT code set for 2022 incorporates a series of 15 vaccine-specific codes that are the model for efficiently reporting and tracking immunizations and administrative services against the coronavirus, the organization said.

More than Half of U.S. Broadband Households Own a Connected Health Device: “A study by research firm Parks Associates shows that 55 percent of U.S. households with a broadband Internet connection own at least one connected health device, such as a smart watch or a pulse oximeter.
The 55 percent figure is a 13 percentage point increase from 42 percent as of last year…Two years ago, fewer than four in 10 U.S. broadband households owned such a device.”

Ransomware attack wipes out Arizona clinic's EHR, corrupts 35,000 patients' records: “The clinic's IT system has been down since experiencing the May 21 ransomware attack, Desert Wells said in a Sept. 3 online notice to patients. After investigating the incident, the clinic discovered that the hacker who accessed its IT system corrupted its EHR data, making all records from before May 21 unrecoverable. 
The medical center did have the information backed up, but the hacker also corrupted that data, according to the notice.“

About pharma

Premier, 11 health systems acquire minority stake in Exela to lock down drug supply: “In a bid to head off drug supply shortages, healthcare improvement company Premier Inc. and 11 of its partner health systems have acquired a minority stake in the holding company of Exela Pharma Sciences, the organizations announced Wednesday.
The deal will see Premier’s health system members gain an uninterrupted supply of 19 pharmaceutical products developed and manufactured by the specialty pharma company at its Lenoir, North Carolina, location, according to the announcement. Of note, that includes Exela’s 503B pharmaceutical products and several injectables the companies said are often in short supply.”

Sanofi to buy Kadmon, beefing up transplant portfolio: “Sanofi on Wednesday announced a definitive merger agreement to acquire Kadmon for $9.50 per share in cash, representing a total equity value of approximately $1.9 billion. The deal, which has been approved by the boards of both companies, will expand Sanofi's transplant portfolio with the addition of the chronic graft-versus-host disease (GvHD) treatment Rezurock (belumosudil).”

Biopharma deals in review A look back at an energetic H1 and what to expect next: “Overall, the first half of 2021 is currently leading in the volume and value of financings and deals over every other year in the past decade. The amount of money being raised is impressive, and there is no sign of investment activity dropping off. Although none of the deals during H1 2021 met the $3.9 billion threshold to rank within the biopharma top 20 list, there were 30 deals that reached at least $1 billion. This is nearly four times as many as H1 2016 (eight deals) and continues the incremental increase we’ve observed since then: 11 in 2017, 12 in 2018, 18 in 2019 and 27 in 2020.”

SPAC Attack: The 10 biggest in biotech: A good review of this investment vehicle’s impact in biotech with links to the largest players.

10 most expensive drugs in the US: The most expensive is Zolgensma at $2,125,000.

About healthcare providers 

Amazon eyes expansion of in-person healthcare to 20 more cities: Amazon has plans to bring in-person healthcare to 20 major cities by the end of 2022… 
Amazon Care, the e-commerce giant's healthcare venture that offers telemedicine and in-person primary care, launched as a pilot program in 2019. It initially only was available to Amazon's Seattle employees and their dependents, but Amazon later expanded it to all employees in Washington state and announced plans in March to expand to other employers across the country. However, the in-person component of the venture was limited to Washington state, Washington, D.C., and Baltimore…
Now, Amazon is looking to bring both telehealth and in-person care to Philadelphia, Chicago, Dallas and Boston in 2021…
Additionally, the company plans to bring in-person Amazon Care to 16 cities in 2022. The cities are: Atlanta; Denver; Detroit; Houston; Indianapolis; Kansas City, Mo.; Los Angeles; Miami; Minneapolis; Nashville, Tenn.; New York City; Phoenix; Pittsburgh; San Francisco; San Jose, Calif.; and St. Louis.”

 

Today's News and Commentary

About health insurance

Drivers of 2022 Health Insurance Premium Changes: This monograph from the American Academy of Actuaries is a very thoughtful consideration of the complex factors that could influence healthcare costs (and hence premiums) in the next year. At minimum, read the Summary, which explains these potential factors.

Centene to consolidate its Medicare Advantage plan branding under Wellcare: “Centene is consolidating all of its Medicare Advantage (MA) brands under the Wellcare name, the government insurance giant announcedThursday.
Centene closed its acquisition of Wellcare Health Plans in January 2020, which led to a slew of disparate MA brands across 33 states, the company said. The $17 billion deal created one of country's largest sponsors of government insurance.”

MedPAC considers one-time funding boosts for Medicare in 2023 due to COVID-19 confusion: “A key Medicare advisory panel is debating one-time funding boosts to providers for 2023 due to questions on how COVID-19 has permanently impacted the healthcare industry.”
However, as previously reported in the past few days: Tens of billions of dollars in pandemic aid for hospitals and nursing homes not distributed and FAH calls for Congress to delay $36B in Medicare cuts set to go into effect in October. Is anyone in charge to coordinate these activities?

Florida Blue parent GuideWell to acquire Puerto Rico-based Triple-S Management: “GuideWell, the parent company of Blue Cross and Blue Shield of Florida, will acquire Triple-S Management, a health services firm based in Puerto Rico.
Once the deal is finalized, Triple-S will operate as a GuideWell subsidiary under its current branding, according to an announcement.”

United States Files Suit Against UPMC, Its Physician Practice Group, and the Chair of Its Department of Cardiothoracic Surgery for Violating the False Claims Act: “More specifically, the complaint alleges that Dr. Luketich – the longtime chair of UPMC’s Department of Cardiothoracic Surgery – regularly performs as many as three, complex surgical procedures at the same time, fails to participate in all of the “key and critical” portions of his surgeries, and forces his patients to endure hours of medically unnecessary anesthesia time, as he moves between operating rooms and attends to other patients or matters. According to the United States’ complaint, these practices violate the statutes and regulations governing the defendants, including those that prohibit “teaching physicians” (like Dr. Luketich) from performing and billing the United States for “concurrent surgeries.” As importantly, the United States’ complaint alleges that Dr. Luketich’s practices violate the standard of care and the patients’ trust, and heighten the risk of serious complications.”

Association of Cost Sharing With Delayed and Complicated Presentation of Acute Appendicitis or Diverticulitis: Out-of-pocket payments decrease utilization of health services.
However, they also discourage needed care. How much should these payments be and for what conditions?
We still do not have an answer. “In this cohort study of 151 852 patients, higher patient cost sharing was associated with lower odds of presenting with early, uncomplicated disease, receiving optimal surgical care, and receiving minimally invasive surgery.”

About Covid-19

The impact of coronavirus disease 2019 (COVID-19) on healthcare-associated infections [HAIs] in 2020: A summary of data reported to the National Healthcare Safety Network: “This report provides a national view of the increases in HAI incidence in 2020. These data highlight the need to return to conventional infection prevention and control practices and build resiliency in these programs to withstand future pandemics.”

White House Announces $2.7 Billion to Boost Vaccine Production: “The U.S. government will allocate $2.7 billion to expand vaccine manufacturing, though it’s not yet clear which companies will receive the funds, President Joe Biden’s Covid response team announced Thursday. 
The money will be used to increase production of ingredients and supplies used to make vaccines. It will support the manufacturing of raw materials, vials and syringes, as well as the bottling process known as fill-finish, according to an official familiar with the plan.”

Rapid measurement of SARS-CoV-2 spike T cells in whole blood from vaccinated and naturally infected individuals: This study is extremely important in understanding Covid-19 immunity:
”Using this test, we observed a similar mean magnitude of T cell responses between the vaccinees and SARS-CoV-2 convalescents 3 months after vaccination or virus priming. However, a wide heterogeneity of the magnitude of spike-specific T cell responses characterized the individual responses, irrespective of the time of analysis. The magnitude of these spike-specific T cell responses cannot be predicted from the neutralizing antibody levels. Hence, both humoral and cellular spike–specific immunity should be tested after vaccination to define the correlates of protection necessary to evaluate current vaccine strategies.”[Emphasis added]

About the public’s health

Projected Association of Human Papillomavirus Vaccination With Oropharynx Cancer Incidence in the US, 2020-2045: “These results suggest that it will take more than 25 additional years to slow an increasing incidence of OPC by current HPV vaccination rates because most disease will be among older individuals who have not yet been vaccinated.”

Characteristics of Registered Clinical Trials Evaluating the Role of e-Cigarettes in Cessation or Reduction of Cigarette Smoking: “We identified 66 completed and ongoing registered trials examining the effects of e-cigarettes on smoking cessation or reduction. Completed and ongoing trials had similar characteristics, with modest sample sizes and duration, most lacking behavioral support to quit, and very few testing newer e-cigarette devices that are designed to deliver nicotine more similarly to cigarettes. Moreover, ongoing trials were less likely to evaluate outcomes at 6 months, which is a standard outcome used in meta-analyses. These findings support previously identified limitations of e-cigarette trials and highlight how ongoing studies may not address critical evidence gaps.”

Antibiotics Use and Subsequent Risk of Colorectal Cancer: A Swedish Nationwide Population-Based Study: This link is to the academic paper results summarized yesterday.
”This register-based study covering the entire population of Sweden found a robust association between antibiotics use and higher risk of proximal colon cancer and an inverse association with rectal cancer in women. This study strengthens the evidence from previous investigations and adds important insight into site-specific colorectal carcinogenesis.”

Cardiovascular Benefit of Lowering LDL Cholesterol Below 40 mg/dl: A lower limit target for LDL has been controversial. This prepublication article concluded that “these data support the ESC/EAS [European Society of Cardiology/European Atherosclerosis Society] recommendations and suggest that lowering LDL-C well below 40 mg/dl in a wider range of patients with ASCVD would further lower cardiovascular risk.”

Nomura bans smoking even for those working from home: “Nomura, Japan’s biggest brokerage, has split from the rest of the finance sector by asking its local staff to give up smoking during the working day, although Japan Tobacco said the move would not push it to change its longstanding business ties. The initiative has been privately described by some Nomura employees as ‘intrusive’ even though it has been imposed without a formal monitoring system or punishments for rule-breakers. It applies both to office staff and to the more than 50 per cent of staff in Japan working from home.”
Wonder how the company will enforce the at-home smoking ban.

About pharma

Sobi receives $8.1-billion buyout offer: “Swedish Orphan Biovitrum (Sobi) said Thursday that it received a takeover offer from private equity firm Advent International and Aurora Investment of SEK 235 ($27.40) per share in cash, valuing the drugmaker at approximately SEK 69.4 billion ($8.1 billion). Sobi added that its board unanimously recommended that shareholders accept the bid, which represents a premium of around 34.5% to its closing share price on August 25…
However, Handelsbanken analyst Mattias Haggblom said the proposal from Advent and Aurora was low, with shares in Sobi climbing above the offer price on Thursday to around SEK 244 ($28.35), spurring speculation that another bidder could emerge.”

Today's News and Commentary

About Covid-19

FDA calls meeting of its advisers to discuss Covid vaccine boosters: “The US Food and Drug Administration said Wednesday it has called a meeting of its vaccine advisers for September 17 to discuss booster doses of coronavirus vaccine.
That's three days before the September 20 target date to start offering booster doses announced by the White House last month.”
In three related articles:
WHO presses world leaders to hold off on Covid vaccine booster shots through September: “The World Health Organization asked world leaders again to hold off on giving Covid-19 booster shots so poorer nations can vaccinate more of their populations with first doses.”
EU health body says no urgent need for vaccine boosters:”The European Centre for Disease Prevention and Control (ECDC) said on Wednesday there was no urgent need for booster doses of COVID-19 vaccines for the fully vaccinated, citing data on the effectiveness of shots.
The comments follow a similar statement from the European Medicines Agency last month that more data was needed on the duration of protection after full inoculation to recommend using booster shots.”
Israel’s COVID-19 boosters are preventing infections, new studies suggest: “A report for the country’s Ministry of Health, posted Friday, showed a third dose reduced recipients’ risk of testing positive for SARS-CoV-2 by more than 10-fold 2 weeks later. And in a preprint posted yesterday, researchers used data from a health maintenance organization (HMO) to calculate that a third dose roughly halves a person’s chances of testing positive for the virus starting 1 week after the shot and further reduces it after the second week.”

Tens of billions of dollars in pandemic aid for hospitals and nursing homes not distributed: “As many hospitals bulge again with covid-19 patients, a wide swath of the health-care industry is exasperated that federal health officials have not made available any more of the aid since President Biden took office. About $44 billion from a Provider Relief Fund created last year remains unspent, along with $8.5 billion Congress allotted in March for medical care in rural areas…
Federal health officials declined to discuss reasons for the delay, but HHS said in a statement: ‘We continue to work expeditiously to get these funds out the door and will be announcing another distribution of funds soon. Plans are being finalized.’”

Axios-Ipsos poll: Vaccine hesitancy may be crumbling: “The 20% who say they're either not very likely (6%) or not at all likely (14%) comprise a new low in the survey, and down from a combined 34% in March and 23% two weeks ago.” See the survey for other findings.

Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app: a prospective, community-based, nested, case-control study: “Vaccination (compared with no vaccination) was associated with reduced odds of hospitalisation or having more than five symptoms in the first week of illness following the first or second dose, and long-duration (≥28 days) symptoms following the second dose. Almost all symptoms were reported less frequently in infected vaccinated individuals than in infected unvaccinated individuals, and vaccinated participants were more likely to be completely asymptomatic, especially if they were 60 years or older.”

WHO opens pandemic intelligence hub to look out for future crises: “A World Health Organization ‘pandemic intelligence hub’ launched by the UN agency’s director general, Tedros Adhanom Ghebreyesus, and Germany’s Angela Merkel in Berlin on Wednesday will try to help governments identify future pandemics at an earlier stage and improve monitoring of new variant strains of Covid-19.
The hub, which will host scientists and policymakers from around the globe on a project-by-project basis, is designed to make it easier for governments to compare notes on emerging infectious diseases and pull in additional relevant information on travel patterns, trade routes or human-animal interactions in agriculture.”

About pharma

FDA Regains Rulemaking Authority in Reversal of Trump-Era Move: “The Food and Drug Administration once again has the authority to issue its own regulations under a notice issued Wednesday that reverses a Trump-era change.
Former Health and Human Services Secretary Alex Azar issued a memo in September 2020, requiring that all rules coming out of the department’s agencies and offices would need to be signed by the secretary.”

Antibiotics increase the risk of colon cancer: “There is a clear link between taking antibiotics and an increased risk of developing colon cancer within the next five to ten years. This has been confirmed by researchers at Umeå University, Sweden, after a study of 40,000 cancer cases. The impact of antibiotics on the intestinal microbiome is thought to lie behind the increased risk of cancer.”
Another reason for judicious use of antibiotics.

About healthcare equipment/devices

Baxter to pay $10.5 billion in cash for Hillrom: “Baxter International and Hillrom said today that they have a deal in which Baxter has agreed to acquire Hillrom for $156 a share in cash, ‘for a total equity value of approximately $10.5 billion and a total enterprise value of approximately $12.4 billion, including the assumption of debt.’”

Tracking Your Premarket Submission’s Progress (Progress Tracker): New at the FDA: “The FDA built a secure, web-based tracker that displays the Center for Devices and Radiological Health’s (CDRH) progress in reviewing traditional 510(k) submissions.”

About health insurance

Medicare trustees project hospital fund to run out in 2026, same deadline as year before: “Medicare’s insurance trust fund that pays hospitals is expected to run out of money in 2026, the same projection as last year, according to a new report from Medicare’s board of trustees.
The report, released Tuesday, found Medicare spent $925.8 billion in 2020 and served 62.6 million people. It found that the COVID-19 pandemic had a major impact on the short-term financing for the program, but the financial status overall of the fund hasn’t significantly changed.”

FAH calls for Congress to delay $36B in Medicare cuts set to go into effect in October: “A key hospital group wants to ensure a 4% cut to Medicare spending doesn’t go into effect as facilities are still struggling with the financial impact of the pandemic.
The Federation of American Hospitals (FAH) is asking Congress to include a delay to the 4% cut as part of a government funding package that must be passed before current funding expires Sept. 30.”

Laboratory Owner Pleads Guilty to $73 Million Medicare Kickback Scheme: “A Florida man pleaded guilty yesterday in the Southern District of Florida for his role in a $73 million conspiracy to defraud Medicare by paying kickbacks to a telemedicine company to arrange for doctors to authorize medically unnecessary genetic testing. The scheme exploited temporary amendments to telehealth restrictions enacted during the COVID-19 pandemic that were intended to ensure access to care for Medicare beneficiaries.”

UnitedHealth Group To Expand Obamacare To Seven New States In 2022: “UnitedHealthcare is poised to capitalize by growing in even more markets for next year, filing for approval from state regulators to participate on insurance exchanges to offer coverage in Alabama, Florida, Georgia, Illinois, Louisiana, Michigan and Texas.”

About healthcare IT

FBI warns healthcare systems of Hive ransomware following Memorial Health System attack: “The cybersecurity division of the FBI is warning organizations of Hive ransomware, citing indicators of compromise and recent incidents. The ransomware is actively targeting healthcare systems.
The warning follows an attack by the same group on Memorial Health System in mid-August. While the healthcare system said employee and patient personal and financial information was not compromised, the attack shut its computer systems down on Aug. 15.
Hive ransomware was first observed in June 2021 and exhibits file encryption capabilities and terminates backup and file copying processes to carry out its attacks, the FBI said.”

Cyberattacks against outpatient, specialty clinics on the rise as data breaches double from 2018: “Healthcare breaches have nearly doubled since 2018 and continued to climb through the first half of 2021, according to a report by Critical Insight, a Seattle-based healthcare-focused cybersecurity firm…
The report shows that there were 43 breaches of hospitals and 74 breaches of outpatient, specialty clinics in the first half of 2021. “

Apple plans to add blood pressure monitoring, thermometer to smartwatch: report: “Apple is working on new health-related features for its smartwatch, including a tool for blood pressure measurement and a thermometer to help with fertility planning…
The company is expected to release its seventh version of the Apple Watch in the coming weeks, but most of its more ambitious health-related improvements aren’t expected before 2022.”

About hospitals and health systems

67 financial benchmarks for health system executives: Useful benchmarks from bond rating services.

Today's News and Commentary

About Covid-19

A New Report Says The COVID Recession Has Pushed Social Security Insolvency Up A Year: “The sharp shock of the coronavirus recession pushed Social Security a year closer to insolvency but left Medicare's exhaustion date unchanged, the government reported Tuesday in a counterintuitive assessment that deepens the uncertainty around the nation's bedrock retirement programs.
The new projections in the annual Social Security and Medicare trustees reports indicate that Social Security's massive trust fund will be unable to pay full benefits in 2034 instead of last year's estimated exhaustion date of 2035. For the first time in 39 years the cost of delivering benefits will exceed the program's total income from payroll tax collections and interest during this year. From here on, Social Security will be tapping its savings to pay full benefits.
The depletion date for Medicare's trust fund for inpatient care remained unchanged from last year, estimated in 2026.”

1 in 8 Nurses Say They Haven't Been Vaccinated and Don't Plan to: “A survey conducted between July 8 and 29 by the American Nurses Association (ANA) and American Nurses Foundation (ANF) found that among nearly 5,000 nurses, a quarter said they didn't trust the vaccines or were unsure about the safety and effectiveness of the shots.
Of those who don't intend on getting vaccinated, the main concerns included lack of information about long-term effects and vaccine safety, as well as mistrust in the information surrounding the vaccines' development and approval.”

Courts decide whether hospitals can deny ivermectin: Courts are deciding whether or not to force hospitals to use an unproven and potentially dangerous drug for Covid patients. REALLY???

More Americans getting vaccinated following full FDA approval of Pfizer COVID vaccine: “Just prior to the announcement, the U.S. rate of first doses had stagnated. Although the country experienced an increase in people initiating vaccination in July as new coronavirus cases surged across the country, the average number of Americans getting their first dose had then declined.
However, following Pfizer's full approval, the U.S. saw a 17% increase in the number of Americans getting vaccinated with their first dose.”

Moderna reveals source of COVID-19 vaccine contamination as Japan finds yet another suspect vial: “After yet another contamination report for a Moderna COVID-19 vaccine vial in Japan, the company on Wednesday said its contract manufacturer has identified the probable source of foreign materials.
After investigating, Spain's Rovi Laboratories has concluded that the particulates discovered are stainless steel. The contamination likely resulted from friction between two pieces of metal incorrectly installed in a production line, Moderna said.”

South Africa identifies new COVID-19 variant — 8 notes: “Researchers have identified a new COVID-19 variant called C.1.2. in South Africa that appears to have similar mutations as other variants of concern, according to research published Aug. 26 in preprint server medRxiv.”

FDA Reauthorizes Eli Lilly COVID-19 Antibody Cocktail, But Not Everywhere: “The FDA has reissued its Emergency Use Authorization (EUA) for Eli Lilly’s monoclonal antibodies bamlanivimab and etesevimab for treatment of mild-to-moderate COVID-19 infections — but only for certain states.
FDA Chief Scientist Denise Hinton said the antibodies can only be used in those states, territories or other U.S. jurisdictions “in which the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5 percent.” As of Aug. 27, only 22 states fit into that category.”

About pharma

Bankruptcy judge approves Purdue Pharma plan to resolve opioid claims, giving Sackler family civil immunity: “Negotiated until the 11th hour, the final terms of the settlement confirmed by federal bankruptcy Judge Robert D. Drain grant the family that owned Purdue Pharma, the Sacklers, broad protection from future litigation, despite objections from nine states and a branch of the U.S. Justice Department.
The family initially sought relief from any civil litigation whatsoever but Drain objected, shouting at one point over an attorney representing the Sacklers that the family should not be immune to legal claims related to the crisis they are contributing roughly $4.3 million to abate. The final settlement will grant relief specifically for claims related to the opioid epidemic.”

Johnson & Johnson scores an FDA first with nod for twice-yearly schizophrenia drug Invega Hafyera: “The FDA Wednesday approved J&J’s long-acting schizophrenia drug, previously known as paliperidone palmitate, for injection every six months. It's the first and only twice-yearly med for the condition. 
The new long-acting regime joins J&J’s existing one-month and three-month formulations, dubbed Invega Sustenna and Invega Trinza, respectively, plus a two-week injection known as Risperdal Consta.”

About diagnostics

Visby Medical Gets the FDA’s 510(k) Clearance for PCR Sexual Health Test: “The single-use polymerase chain-reaction diagnostic test is designed to detect sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis.
The test, which requires no additional instruments, analyzes self-collected vaginal swab samples in less than 30 minutes in the healthcare provider’s office, according to the company.”

About the public’s health

What The Texas Abortion Ban Does — And What It Means For Other States: “With the U.S. Supreme Court mum, a new law went into effect in Texas that bans abortions after about six weeks of pregnancy. That’s well before many women even know they are pregnant.
The law allows private citizens to sue abortion providers and anyone else who helps a woman obtain an abortion — including those who give a woman a ride to a clinic or provide financial assistance in obtaining an abortion. Private citizens who bring these suits don’t need to show any connection to those they are suing.
The law makes no exceptions for cases involving rape or incest.”

Incorporation of Social Risk in US Preventive Services Task Force Recommendations and Identification of Key Challenges for Primary Care: “This assessment of how social risks have been incorporated into the USPSTF recommendations is part of ongoing work to advance the goal of expanding the systematic inclusion of social risks in future recommendations but also identifies strategies that could be considered to improve USPSTF processes. Despite currently incorporating some social risks in its recommendations and focusing directly on certain social risks in other recommendations, there is the potential to systematically include more social risk evidence in all recommendations and aid the USPSTF to target social risks for preventive services when appropriate.”
In a related article: Screening and Interventions for Social Risk Factors: Technical Brief to Support the US Preventive Services Task Force: “Many interventions to address food insecurity, financial strain, and housing instability have been studied, but more randomized clinical trials that report health outcomes from social risk screening and intervention are needed to guide widespread implementation in health care.”

About hospitals and health systems

Hospital Merger Benefits: An Econometric Analysis Revisited: The American Hospital Association hired Charles River Associates to conduct this study. Below are summary findings:

• “Consistent with our previous analyses, hospital acquisitions are associated with a statistically significant 3.3 percent reduction in annual operating expenses per admission at acquired hospitals.

• At the same time, performance on key indicators of quality is improved: our empirical analysis continues to show a statistically significant reduction in inpatient readmission rates and a composite readmission/mortality outcome measure. Mortality rates at acquired hospitals also decline, but not by a statistically significant amount. The lack of statistical significance of the mortality outcome may be related to the inclusion of recent hospital transactions in our analyses; for recent transactions, it is difficult to measure quality improvements over the short post-acquisition time period reflected in our data.

• Revenue per admission at acquired hospitals also decline relative to non-merging hospitals by a statistically significant 3.7 percent. These results are suggestive that savings that accrue to merging hospitals are passed on to health plans.”

With respect to the last item, many respected economists as well as Justice Department activities have consistently shown that these mergers raise prices.

Today's News and Commentary

About Covid-19

Unraveling the Mystery of Why Children Are Better Protected from COVID Than Adults: “The immune system uses a special mechanism to protect children from novel viruses—and it typically saves them from a severe course of COVID-19 in two different ways. In the mucous membranes of their airways, it is much more active than that of adults. In children, this system reacts much faster to viruses that it has never encountered, such as pandemic pathogens. At least, that is what a recent study by Irina Lehmann of the Berlin Institute of Health at Charité and her colleagues suggests.”
Read the article for more details.

CDC panel says more evidence needed for booster recommendation: “Members of the CDC's Advisory Committee on Immunization Practices (ACIP) said the evidence on boosters is not clear and indicated it would likely consider a risk-based approach that would prioritize residents of long-term care facilities and health workers rather than all eligible Americans at once.”
In related articles:
Immunity To COVID-19 Could Last Longer Than You'd Think: Very readable presentation of why we may have long-lasting immunity. Note: It might take 6 months to develop that protection.
New data confirm Covid vaccines provide strong protection against hospitalization: Om Monday, “Dr. Sara Oliver, a C.D.C. scientist, presented unpublished data from Covid-Net, a hospital surveillance system. All three vaccines used in the United States remained highly effective at preventing hospitalizations from April through July, when Delta became dominant, the data suggested.
For adults under the age of 75, the shots were at least 94 percent effective at preventing hospitalizations, a rate that has remained steady for months, Dr. Oliver said. Protection against hospitalization did decline in July for adults 75 or older, but still remained above 80 percent.”

Factors Associated With Household Transmission of SARS-CoV-2: “In this updated systematic review and meta-analysis of 87 studies representing 1 249 163 household contacts from 30 countries, the estimated household secondary attack rate was 19%. An increase in household transmission was observed over time, perhaps owing to improved diagnostic procedures and tools, longer follow-up, more contagious variants, and different study locations.”

FDA approval of Pfizer's COVID-19 vaccine spurs American confidence: Harris Poll: “A Harris Poll survey over the weekend found that 80% of Americans who were aware of the approval now have more confidence in it. Even more encouraging? Almost half (49%) of unvaccinated people who heard about the approval said they will “probably” or “definitely” get vaccinated.Overall awareness of the Pfizer approval was high—79% of those surveyed by The Harris Poll were aware of the FDA thumbs-up.”

About the public’s health

Acute Consumption of Alcohol and Discrete Atrial Fibrillation [AF] Events: “Individual AF episodes were associated with higher odds of recent alcohol consumption, providing objective evidence that a modifiable behavior may influence the probability that a discrete AF event will occur.”

U.S. mortality rates to remain elevated, childbearing to lag through 2023 because of pandemic, new government report predicts: “The federal government expects U.S. mortality rates to be elevated by 15 percent over pre-pandemic norms in 2021 and not return to normal levels until 2023, according to a report released Tuesday by the Trustees of the Social Security and Medicare programs.
The trustees concluded that these elevated mortality rates, along with lower immigration and depressed fertility rates, have had a significant effect on the trust funds supporting Medicare in the short term. But the report found that Medicare’s main trust fund will still be able to pay out full benefits until 2026, a timeline unchanged since last year.”

About hospitals and health systems

Fitch: COVID-19 resurgence threatens nonprofit hospitals' margins, credit ratings: “The group said smaller, lower-rated hospitals will be less capable of fending off the rising expenses and declining reimbursement that comes with ICUs full of labor-intensive COVID-19 patients.
Highly rated hospitals, on the other hand, ‘should have sufficient financial cushion to absorb an increase in operating costs and a shift in volume type without meaningfully affecting credit,’ Fitch wrote.”

Hospitals to face new emission goals, and potential penalties for noncompliance, under new HHS office: “The Department of Health and Human Services (HHS) aims to roll out new requirements for hospitals and health systems to cut greenhouse gas emissions and could potentially levy penalties to facilities for failing to do so.
HHS announced Monday the creation of the new Office of Climate Change and Health Equity tasked with taking on the health impacts of climate change and its effects such as extreme weather. The new office plans to roll out specific goals for emissions levels at hospitals at a later date.”

Federal judge grants final approval of $575M settlement against Sutter Health: “A federal judge has granted final approval for a $575 million settlement with Northern California-based hospital system Sutter Health that settles allegations of price gouging.
The settlement judgment, announced late Friday, requires Sutter to not only pay $575 million but also to adopt several reforms aimed at curbing anti-competitive practices.”

Cleveland Clinic posts $339M profit in Q2 after major patient revenue rebound: “The Cleveland Clinic generated $339 million in operating income for the second quarter of the year as its patient service revenue saw a massive 50% rebound compared to the same period in 2020 when the system faced major strain from the pandemic.
The hospital system generated $3.2 billion in operating revenue for the second quarter compared to $2.3 billion for the second quarter in 2020. A major reason was the boosted $2.7 billion in net patient service revenue, up from $1.8 billion over the same period last year.
The Cleveland Clinic used a series of measures to reduce costs including “restricting travel, reducing purchased/administrative service expenses and other controllable costs, suspending annual pay increases for caregivers in 2020 and postponing certain non-critical capital expenditures,” according to its earnings report.”

About healthcare IT

Electronic Health Record Interoperability—Why Electronically Discontinued Medications Are Still Dispensed: “Electronic prescriptions (e-prescriptions) are transmitted using the National Council for Prescription Drug Programs SCRIPT standard, which has been widely implemented by EHRs and pharmacy systems. Electronic medication discontinuation (e-discontinuation) is included in this standard. Therefore, the functionality exists to send a request from a prescriber to a pharmacy to discontinue a medication (a CancelRx message) via a health information network, most commonly the Surescripts network. Although most EHRs have this functionality, it is often not ‘turned on,’ as that would entail additional costs for health care professionals and networks, including costs for software licensing and integration, as well as ongoing network fees and maintenance costs.”

DuPage Medical Group reports data breach: “The largest independent physicians group in Illinois is notifying more than 600,000 patients whose information may have been compromised in a recent breach, DuPage Medical Group said in a statement today.
Through an investigation, the company determined that a July network outage was caused by unauthorized actors gaining access to its network, the statement says.
Patient information that may have been compromised includes names, addresses, dates of birth and diagnoses, according to the statement. Financial account numbers were not included, but social security numbers for a ‘small subset of individuals’ may have been affected.”

Where the US stands on telehealth coverage: 13 states that let orders expire or kept expansions: A good summary about this issue. Many states are extending or making telemedicine coverage permanent while others have let provisions expire.

About health insurance

Uber Health Expands Access to Transportation Options for Medicaid Recipients in Texas: “Uber Health today announced Texas Medicaid recipients will now have access to non-emergency medical transportation (NEMT) options to and from medical appointments through the Uber Health platform. Following legislation in 2019 to update the state’s Medicaid program to allow non-emergency ridesharing solutions to Medicaid recipients across the state, the Texas Health and Human Services Commission recently made changes to facilitate the seamless integration of transportation network companies. This decision will allow Uber Health to open up access to its NEMT solutions to Texas’ nearly 4.4 million Medicaid enrollees, directly addressing barriers to care, reducing costs for the state government, and streamlining population health management at scale.”

About 1.6 mln more Americans had health insurance in 2020 - CDC: “Estimates based on a household survey by the statistics division of the U.S. Centers for Disease Control and Prevention showed on Tuesday that a total of 31.6 million, or 9.7% of Americans of all ages, were uninsured last year, down from 33.2 million in 2019.
Among Americans of all age groups, the number of people with public health plan coverage grew by 2.1 million to 123.5 million in 2020, while those that had private health insurance grew by 1.9 million to 200.6 million.”

About pharma

Biogen Offers Free Alzheimer’s Drug as Medicare Coverage Remains Uncertain: “Biogen is offering its Alzheimer’s drug, Aduhelm (aducanumab), free to certain patients as uncertainty remains about how Medicare will reimburse the drug, which costs $56,000 a year.
The drugmaker is reportedly providing Aduhelm to a neurology center in Florida free of charge. Supplying free drugs to patient assistance programs is often used as part of a promotional strategy.”
The objection to the drug has been about its safety profile almost as much as its cost- so even if free, it may not show the growth the company expected.

Initial treatment with a single pill containing quadruple combination of quarter doses of blood pressure medicines versus standard dose monotherapy in patients with hypertension (QUARTET): a phase 3, randomised, double-blind, active-controlled trial: Standard blood pressure treatment usually starts with one drug that is titrated up in dose as needed. If that one medication does not work, it might be changed to a different class of drugs or a second class of medication is added to the first. In this study, a combination of 4 drugs was used to begin treatment.
”A strategy with early treatment of a fixed-dose quadruple quarter-dose combination achieved and maintained greater blood pressure lowering compared with the common strategy of starting monotherapy. This trial demonstrated the efficacy, tolerability, and simplicity of a quadpill-based strategy.”

Today's News and Commentary

About Covid-19

Coronavirus booster shots 'not a luxury', WHO Europe head says: “A third-dose booster shot of the COVID-19 vaccination is a way to keep the most vulnerable safe and ‘not a luxury"‘ the World Health Organization said on Monday.
The WHO said earlier this month data did not indicate a need for booster shots, while topping up already fully vaccinated people would further widen a vaccine-availability gap between rich and lower-income countries.”

Antibody Tests Should Not Be Your Go-To For Checking COVID Immunity: “On an individual level, antibody tests can be useful for picking up evidence of a past SARS-CoV-2 infection. They're also helpful to researchers studying the prevalence of the virus across a population or tracking the degree to which antibody levels wane over time. And the decline in antibody levels against the coronavirus among some people who got vaccinated late last year were cited as part of the scientific case for why millions of Americans need booster shots.
But scientists in the field say there's still considerable uncertainty about what these levels of detectable antibodies really mean when it comes to protection. And a lack of standardization among the commercially available tests for antibodies makes it even harder to decipher the results.”

Fauci backs COVID-19 vaccine mandate for U.S. school children: “Currently, children under 12 are not eligible to receive the COVID-19 vaccine. But Fauci, in a separate interview on ABC’s ‘This Week’ program, said there should be enough data by early October for the U.S. Food and Drug Administration to consider whether the shot is safe for children under that age.” And in a related article: Half of the adolescents in the U.S. have received at least one dose of a coronavirus vaccine, White House says.

Covid-19 hospitalizations top 100,000 as delta variant surges: “More than 100,000 people are hospitalized with Covid-19, according to data released Friday morning by the U.S. Department of Health and Human Services. That means 1 in every 6 hospital beds nationwide has a Covid patient, according to NBC News data.
New admissions of patients with confirmed Covid-19 cases are at their highest levels since the start of the pandemic for all age groups under 50 years old, according to the Centers for Disease Control and Prevention.”

High Pay for Covid-19 Nurses Leads to Shortages at Some Hospitals: “Fueled by intense demand, and paid for in part with federal emergency funding to hospitals, travel-nurse pay has skyrocketed. In December 2019, average gross weekly wages for a travel nurse were around $1,600 a week, according to data from Vivian Health, a healthcare recruiting company. One year later, average pay was more than $3,500 a week.”
The article has many examples of how wage disparities influence where nurses are going for jobs during the pandemic.

Comparison of SARS-CoV-2 Antibody Response Following Vaccination With BNT162b2 and mRNA-1273: “This study demonstrated a significantly higher humoral immunogenicity of the SARS-CoV-2 mRNA-1273 vaccine (Moderna) compared with the BNT162b2 vaccine (Pfizer-BioNTech), in infected as well as uninfected participants, and across age categories. The higher mRNA content in mRNA-1273 compared with BNT162b2 and the longer interval between priming and boosting for mRNA-1273 (4 weeks vs 3 weeks for BNT162b2) might explain this difference.”

About pharma

Four new drugs to watch in 2021: From Optum. The treated conditions range from rare to common.

Who's getting the most out of their R&D engine? Pharma's top 11, ranked: “Fierce Pharma took a close look at the recent approvals for 11 of the world's biggest drugmakers by revenue. Specifically, we're highlighting the dollar value of the industry's launches from the last five years and analyzing how the new meds fit into each company's overall portfolio…
On the value metric, the crown goes to Roche, which has eight launches to its name in the last five years worth a whopping $99.78 billion. Others with even fewer launches, such as AbbVie and AstraZeneca—each with five—boast similarly impressive net present values.”
Check the graphic for more details.

In reopening Tennessee penicillin plant, Jackson Healthcare relieves the US' dependence on China-made antibiotics: “Jackson Healthcare of Georgia is reopening the Bristol plant, which was formerly owned by Neopharma, under the name of USAntibiotics. The 360,000-square foot factory will churn out enough Amoxil and Augmentin to stockpile the U.S. for five years, the company said in a release. In all, it'll produce 2 billion tablets and 300 million capsules annually.
Last August, Neopharma of the United Arab Emirates declared bankruptcy and shuttered the 43-year-old plant, leaving the U.S. dependent solely on penicillin from China.”

Biotech co-founders admit to stealing trade secrets from Roche's Genentech, face possible prison terms: “After two former staffers at Roche’s Genentech pleaded guilty to stealing biologics trade secrets, their co-conspirators didn’t put up much of a fight before admitting to their roles in the scheme. The pair, former execs at Taiwanese company JHL Biotech, could now face prison sentences and hefty fines for the crimes.
Racho Jordanov and Rose Lin, the two co-founders and former top execs at JHL, pleaded guilty to charges of conspiring to steal trade secrets from Genentech and wire fraud, the U.S. Department of Justice (DOJ) said.”

About health insurance

ACA navigators expected to quadruple in 2022 after $80M increase in funding: “The Department of Health and Human Services announced Friday it will provide $80 million in grant awards to 60 navigator organizations, which will be able to hire more than 1,500 navigators to aid consumers. The announcement comes as the Biden administration has made moves to bolster the ACA, including holding a special open enrollment period for those affected by the pandemic through Aug. 15.”

About the public’s health

How a once-obscure government database turned into a weapon for anti-vaxxers: “You may not be familiar with the Vaccine Adverse Event Reporting System, or VAERS. Co-managed by the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration, VAERS was established in 1990 to detect possible safety problems with vaccines.
Unfortunately, the anti-vaccine movement has used this once-obscure database to spread misinformation about the Covid-19 vaccine.
VAERS is ripe for exploitation because it relies on unverified self-reports of side effects. Anyone who received a vaccine can submit a report. And because this information is publicly available, misinterpretations of its data has been used to amplify Covid-19 misinformation through dubious social media channels and mass media, including one of the most popular shows on cable news.”

The Best & Worst Cities for Mental Health in America: At the top are Denver and Salt Lake City.
4 of the bottom 10 cities are in Texas and another 4 in Florida. Look at the criteria for evaluation.

Report: 91% of Pennsylvania schools that tested drinking water found lead—only 9% removed it: “The report, published this month by the Pittsburgh-based health advocacy nonprofit Women for a Healthy Environment, looked at testing and cleanup practices for environmental health hazards including lead and other contaminants in drinking water; lead in paint and dust; radon; and mold in a randomized sample of 65 public school districts serving about 175,000 students across the state.
That's a small sample size—Pennsylvania's K-12 education system has about 500 school districts, so it represents about 10% of total school districts—but among the schools sampled, the report found that testing and cleanup procedures for environmental hazards are not performed consistently or uniformly as the state still lacks legal requirements.”
I am sure Pennsylvania is not alone in having this problem.

Effect of Salt Substitution on Cardiovascular Events and Death: The role of extra salt in the diet has, at times, been controversial. This study adds to the substantial literature that says lower salt intake is healthier.
”Among persons who had a history of stroke or were 60 years of age or older and had high blood pressure, the rates of stroke, major cardiovascular events, and death from any cause were lower with the salt substitute than with regular salt.”

About healthcare equipment

Baxter Is in Advanced Talks to Buy Hill-Rom for About $10 Billion: These talks resume recent conversations which were not successful.

CellMax Life’s Cancer Blood Test Designated FDA Breakthrough Device: “Molecular diagnostics company CellMax Life’s FirstSight pre-cancer and cancer detection blood test has received the FDA’s Breakthrough Device designation.
The test is designed to detect and measure colorectal neoplasia-associated epithelial cells and DNA markers in human blood. The results, combined with age and gender, are integrated into a proprietary algorithm to generate a result of either low or high-risk for advanced neoplasia.”
The question that needs answering are: Will it replace fecal testing and/or screening colonoscopies?

About healthcare IT

Overbooked and Overlooked: Machine Learning and Racial Bias in Medical Appointment Scheduling: “We demonstrate that state-of-the-art scheduling systems cause the black patients in our data set to wait about 30% longer than nonblack patients. Our race- aware methodology achieves both goals of eliminating racial disparity and obtaining a similar schedule cost as that obtained by the state-of-the-art scheduling method, whereas the race-unaware methodologies fail to obtain both efficiency and fairness.”

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