Today's News and Commentary

About health insurance

Medicaid Work Requirements In Arkansas: Two-Year Impacts On Coverage, Employment, And Affordability Of Care: Read the entire abstract. The aim of the requirement was to get people off Medicaid and back to work. However, “work requirements did not increase employment over eighteen months of follow-up.”

Insurers bearing the brunt of COVID-19 test costs. That might mean higher premiums: “Health insurers say providers are overcharging them for COVID-19 tests and the added costs could mean higher premiums for their plan members in the future.
The problem, insurers said, is providers can charge whatever they want for the tests and insurers must cover the full costs — no matter how high — under federal laws passed to address the coronavirus pandemic. One free-standing emergency room charged Blue Cross Blue Shield of Texas $4,800 for a nasal swab test, according to a redacted claim provided by the insurer.”

Coronavirus Tests Are Supposed to Be Free. The Surprise Bills Come Anyway:”Congress passed laws requiring insurers to pay for tests, and the Trump administration created a program to cover the bills of the uninsured. Cities and states set up no-cost testing sites…
About 2.4 percent of coronavirus tests billed to insurers leave the patient responsible for some portion of payment, according to the health data firm Castlight…
In some cases, the charges appear to violate new federal laws that aim to make coronavirus tests free for privately insured patients. In other cases, insurers are interpreting gray areas in these new rules in ways that work in their favor.”

About pharma

1,100 Hospitals Press HHS to Enforce 340B Pricing:”More than 1,100 hospitals in 46 states and the District of Columbia on Thursday urged the federal government to ensure that drug makers continue to provide discounts mandated under the 340B Drug Pricing Program for safety-net providers…
The petitioning hospitals noted that 340B hospitals provide 60% of uncompensated and unreimbursed care and 75% of hospital care to Medicaid patients…
The hospitals complained that several drug makers have cut off access to discounted drugs, and they singled out AstraZeneca, Eli Lilly (Azar's former employer), Merck, Sanofi, and Novartis as the most egregious offenders.”

Novartis, Roche fined $526M in France for alleged Lucentis marketing missteps: “ The [French] Competition Authority levied a fine of €385 million ($455 million) against Novartis and €60 million ($71 million) against Roche, according to several press reports in Europe. Lucentis was developed by Roche’s Genentech division and is marketed in Europe by Novartis.
The agency said the penalties were in response to allegedly anti-competitive practices by the companies in pushing Lucentis over Roche’s similar—and much less expensive—cancer drug Avastin, which can be used off-label to treat AMD [Age-related macular degeneration].”

Takeda's selloff spree continues with $562M deal with Germany's Cheplapharm:”With last month’s $2.3 billion Japanese consumer health sale to Blackstone Group, Takeda has arguably achieved its $10 billion divestment goal. But the Japanese pharma is showing no sign of stopping with the selloffs anytime soon.
Tuesday, Takeda said it had penned a deal to offload some noncore prescription drugs sold mainly in Europe and Canada to Germany’s Cheplapharm for $562 million…
the drugs changing hands fall outside of the company’s five key focus areas of gastroenterology, rare diseases, oncology, plasma-derived therapies and neuroscience. Takeda will use the cash to reduce the mountain of debt it incurred with its $59 billion Shire buyout and help lower its net debt/adjusted EBITDA ratio to the target of 2x, which it's aiming to hit between fiscal year 2021 and 2023.”

AbbVie puts $2B on the table for I-Mab cancer collab as biotech nabs $418M raise:”It’s a good day for Shanghai-based I-Mab, which has penned a $2 billion upfront-biobucks R&D deal with AbbVie while also nabbing $418 million from investors.” Read the article for details.

About healthcare IT

Taking the Pulse® 2020 Physician Survey Shows 4 in 5 U.S. Physicians Have Conducted Virtual Patient Consults Amid the COVID-19 Pandemic: “As of July 2020, 80% of U.S. physicians had conducted a virtual patient consultation in the previous three months – up from 39% in April and 9% in early March, when use of virtual consults was unchanged over 2019 levels…
However, barriers to telemedicine use remain – 58% of U.S. physicians have lingering reservations about the quality of care they can provide remotely.”

Telehealth is biggest threat to healthcare cybersecurity, says report: The headline speaks for itself. Read the article for more details.

About the public’s health

2020 Scorecard on State Health System Performance: Latest state rankings by the Commonwealth Fund. Hawaii, Massachusetts and Minnesota are again the top three.

20-second coronavirus screening test piloted at U.K.'s Heathrow airport: “Two British companies are preparing to launch a simple COVID-19 saliva screening test that aims to provide an accurate result within 20 seconds—following its first uses at London’s Heathrow airport, one of the busiest in the world.
The Virolens device, developed by iAbra, uses a digital microscope and artificial intelligence-powered software to visually search a mouth swab sample for signs of the novel coronavirus.
The machine provides a low-cost, repeatable and self-administered method of screening, allowing hundreds of cartridge-based tests to be performed each day, according to iAbra’s manufacturing partner TT Electronics. Validation studies by the University of Bristol have pegged the system’s false-negative rate of 0.2%, alongside a false-positive rate of 3.3%.”

New tool could 'help UK doctors spot high-risk Covid patients in seconds': “The researchers focused on eight metrics that play a key role in determining mortality risk – age, sex, number of underlying conditions, respiratory rate, blood oxygen concentration, level of consciousness, urea, and C-reactive protein (a chemical linked to inflammation).
These factors were combined into a model to give a score ranging from 0 to 21 points. Age, they concluded, is the biggest predictor, accounting for a third of the score. The calculations suggested patients with a score of at least 15 had a 62% chance of mortality compared with 1% mortality for those with a score of three or less. The tool, which is easily accessible on a smartphone or computer, takes seconds to generate a score and is expected to be rolled out in the NHS this week.”

COVID-19 study links strict social distancing to much lower chance of infection: Just a reminder: “Using public transportation, visiting a place of worship, or otherwise traveling from the home is associated with a significantly higher likelihood of testing positive with the coronavirus SARS-CoV-2, while practicing strict social distancing is associated with a markedly lower likelihood.”

Trends in Mortality From Drug Poisonings, Suicide, and Alcohol-Induced Deaths in the United States From 2000 to 2017: “During 2000 to 2017, 1 446 177 drug poisoning, suicide, and alcohol-induced premature deaths occurred in the US… totaling 451 596 more deaths than expected based on 2000 rates.”The concentration of each of those causes of death varied in different regions.

Today's News and Commentary

About hospitals and health systems

Care New England, Lifespan to merge: “Two Providence, R.I.-based health systems — Lifespan and Care New England Health System — have signed a letter of intent to combine into one nonprofit organization with Brown University…
If the transaction closes, the combined system would include seven hospitals and have more than 23,500 employees.” This is the second time the merger has been attempted.

13 health systems opening hospitals: The news here is that in this economy, these projects are going forward.

Association of Clinician Health System Affiliation With Outpatient Performance Ratings in the Medicare Merit-based Incentive Payment System: “Publicly reported data on 636 552 clinicians working at outpatient clinics across the US were used to assess the association of the affiliation status of clinicians within the 609 health systems with their 2019 final MIPS performance score and value-based reimbursement (both based on clinician performance in 2017), adjusting for clinician, patient, and practice area characteristics…
Whether this represents differences in quality of care or other factors requires additional research.”

About pharma

Mylan to Acquire Aspen's Thrombosis Business in Europe: Mylan announced “an agreement to acquire the related intellectual property and commercialization rights of Aspen Pharmacare Holdings Limited's thrombosis business in Europe for EUR 641.9 million, subject to customary closing conditions and European regulatory clearances. The transaction is expected to be immediately accretive to Mylan upon closing and is anticipated to be accretive to VIATRIS [a new company to be formed by the planned combination of Mylan and Upjohn, a division of Pfizer] upon the completion of Mylan's previously announced combination with Upjohn that is expected to close in the fourth quarter of 2020.”

Covid-19 vaccine trial participant had serious neurological symptoms, but could be discharged today, AstraZeneca CEO says: “The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.
The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said…
[And here is the news update today on this situation:] Soriot also confirmed that the clinical trial was halted once previously in July after a participant experienced neurological symptoms. Upon further examination, that participant was diagnosed with multiple sclerosis, deemed to be unrelated to the Covid-19 vaccine treatment, he said.”

GlaxoSmithKline earns FDA nod for triple-drug combo Trelegy in sought-after asthma patients: ”The FDA on Wednesday gave its thumbs-up to GSK's Trelegy as a maintenance therapy for asthma, making it the first once-daily, triple-drug inhaler approved in that indication, the British drugmaker said in a release. 
The agency based its review on findings from the phase 3 Captain head-to-head study, which showed Trelegy topped GSK's Breo Ellipta, known as Relvar in Europe, at improving lung function after 24 weeks in patients with uncontrollable asthma.”

Merck & Co. reports positive Phase III data for 15-valent pneumococcal vaccine V114:  “Merck & Co. on Wednesday unveiled top-line results from two Phase III studies, including the pivotal PNEU-AGE trial, which showed that V114, its experimental 15-valent pneumococcal conjugate vaccine, was non-inferior to Pfizer's Prevnar 13 for the 13 serotypes targeted by both vaccines. The company said it intends to apply for V114 approval in adults by year-end…

Merck said V114 was also superior for pneumococcal serotypes 22F and 33F, the two serotypes unique to its vaccine.“

Covid-19 drug rationed in the US is plentiful in developing countries: “A CNN investigation into remdesivir finds that doctors in several developing countries report ample supplies of the drug, while US patients have faced shortages -- even though the drug is made by a US pharmaceutical company and was developed with the help of US taxpayer money.” Read the article for more details.

About the public’s health

Substantial underestimation of SARS-CoV-2 infection in the United States: “We estimate 6,454,951 cumulative infections compared to 721,245 confirmed cases (1.9% vs. 0.2% of the population) in the United States as of April 18, 2020. Accounting for uncertainty, the number of infections during this period was 3 to 20 times higher than the number of confirmed cases. 86% (simulation interval: 64–99%) of this difference is due to incomplete testing, while 14% (0.3–36%) is due to imperfect test accuracy.”

Trump Administration Orders U.S. Diplomats to Curtail Contact With WHO: The headline speaks for itself, “even though the United States will remain a member of the global health agency until next summer…”

Scarcity of key material squeezes medical mask manufacturing: “Meltblown is spun out of plastic pellets made from oil, typically polypropylene or polyethylene. The pellets are fed into a heated metal extruder, and jets of hot air force the liquefied plastic through an array of extremely small holes, producing fine plastic fibers. As the fibers cool, they overlap and stick together, forming a dense mesh.
This year, American meltblown makers have been ramping up supply. But some say they need more government support to meet the demand.” The concern is that return on the investment in ramping up may not be long-lived, leading manufacturers with costly overcapacity.

USAID to shut down its coronavirus task force: “According to the aid agency’s note and people familiar with the issue, the responsibilities of the USAID task force will be handed to other agency bureaus and divisions. ‘As we approach the deactivation of the Task Force on Sept. 9, the entire team is focused on ensuring a smooth transition of key functions back to Bureaus and Independent Offices,’ the note read.” The story is more nuanced than it appears, so read the entire article.

Racial disparities in mortality for patients with prostate cancer after radical prostatectomy: “When adjustments were made for age and year of diagnosis only, Blacks had 51% higher mortality, AAPIs had 22% lower mortality, and Hispanics had 6% lower mortality than Whites. Overall, with adjustments for all clinical factors and nonclinical factors, the Black‐White survival disparity narrowed to 20%, whereas the AAPI‐White disparity increased to 35%. Among the controlled‐for factors, education, median household income, and insurance status contributed the most to the racial disparity.”

Some scientists spot 'unlikely' patterns in Russia vaccine data: letter:”Twenty-six scientists, most of them working at universities in Italy, have signed an open letter questioning the reliability of the data presented in the early-stage trial results of the Russian COVID-19 vaccine, named ‘Sputnik-V’…
The letter, published on the personal blog page of one of the signatories, said the Phase I/II trial results data showed multiple participants reporting identical antibody levels. 
‘On the ground of simple probabilistic evaluations the fact of observing so many data points preserved among different experiments is highly unlikely,’ the open letter said.”

How to talk about the COVID-19 Vaccine: “Across all demographic and geographic categories, the Personal Story message was most effective, and Economic Recovery, Safety and Community messages were least effective. But for some subgroups, the magnitude of effect was higher or lower. For example, for people who make less than $75K, Personal Story resulted in a 7% increase in intent, higher than the 5% for the overall sample…
Although personal stories were effective for both flu and COVID-19 vaccine messaging, the ‘community’ theme was most persuasive in the flu research, but ineffective for the COVID vaccine.”

About healthcare IT

Blackbaud security breach hits 11 systems: Atrium, NorthShore University, UK HealthCare & more:”The Blackbaud security breach affected more than 25,000 nonprofit organizations worldwide, including many health systems in the U.S.
Blackbaud is an organization that stores donor information for organizations. Most of the information exposed included the names, birth dates, addresses and phone numbers of donors and some patients. The breach occurred in between Feb. 7 and May 20, and the vendor notified organizations of the breach in July.
Blackbaud paid the ransom for the attackers to destroy their backup file of stolen information. So far, the breach is known to have affected more than 2 million individuals across at least 11 health U.S. health systems.”

7 things to know about VA's reboot of Cerner EHR go-live: An update in this continuing saga.

About health insurance

Cigna plans to expand its ACA exchange presence by 27% in 2021: “Cigna aims to expand its presence in the Affordable Care Act’s insurance exchanges by 27% in 80 new counties next year.
The insurer also announced that it will boost its plans sold on the exchanges, including offering new features intended to lower out-of-pocket costs. Cigna said it will grow its reach to more than 300 counties across 10 states.”

Humana launches value-based programs focused on heart surgery, shoulder replacements: “Humana is launching two new value-based care programs for members of its select Medicare Advantage (MA) plans, including one to cover coronary artery bypass grafting and another for total shoulder replacement procedures…
Under the new episode-based payment model, Humana provides data and analytics and financially incentivizes cardiothoracic clinicians to enhance patient care, deliver better coordinated care and reduce duplicative services, readmissions and complications…
The shoulder program also provides clinicians data and analytics, and it offers incentives for better health outcomes and lower costs derived from site of care selection, such as ambulatory surgical centers. Its inaugural facility participants in the program are located in Florida, Indiana, Kentucky, Ohio, North Carolina and Tennessee. 
The model is Humana’s third orthopedic value-based payment program, following those created for total hip and knee joint replacement surgeries and for spinal fusion procedures.”

Today's News and Commentary

About the public’s health

Major coronavirus vaccine trial is paused to investigate unexplained illness: One of today’s top news stories. “A major coronavirus  vaccine trial is on hold as an independent committee investigates whether a case of spinal inflammation in a single British participant is linked to the vaccine — a step that several experts said is a sign of the protections in place to ensure the safety of products ultimately used in millions of healthy people.
The hold on human testing of the vaccine candidate being developed by the pharmaceutical company AstraZeneca and the University of Oxford was confirmed by the company in a statement Tuesday evening, calling it a ‘routine action.’”

Woodward book: Trump says he knew coronavirus was ‘deadly’ and worse than the flu while intentionally misleading Americans: Another top news story. The headline speaks for itself. The evidence comes from recordings of interviews.

LabCorp to launch single home swab test spanning COVID-19, flu, RSV: “LabCorp announced plans to launch a new at-home COVID-19 diagnostic that allows people to also get tested for the flu and respiratory syncytial virus from a single sample.
The combined test is currently offered through doctors’ offices, hospitals and other healthcare providers, while the future, home-based version will be made available through LabCorp’s Pixel service, pending the FDA’s review and authorization.”

Operation Warp Speed promised to do the impossible. How far has it come?: A good overview of the progress of this initiative covering vaccines, treatments and diagnostics.

Sanofi France chief sees coronavirus vaccine priced below 10 euros: “A coronavirus vaccine that Sanofi is developing with Britain’s GlaxoSmithKline is likely to be priced at less than 10 euros ($11.80) per shot if it is approved for use…” Companies can afford to offer low prices because the volumes are guaranteed to be very high.

The Importance of Careful Patient Selection in the Use of Follow-up Bone Mineral Density Testing: An excellent review of this topic. The “bottom line” is that routine repetition every 2-3 years is not more predictive than baseline testing.

About health insurance

AMA announces new CPT codes as COVID-19 advancements expand: ”For quick reference, the two new Category I CPT codes and long descriptors are:
99072     Additional supplies, materials, and clinical staff time over and above those usually included in an office visit or other non-facility service(s), when performed during a Public Health Emergency as defined by law, due to respiratory-transmitted infectious disease
86413     Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) antibody, quantitative”

Association of Race, Health Insurance Status, and Household Income With Location and Outcomes of Ambulatory Surgery Among Adult Patients in 2 US States: “The study’s findings indicated that Black patients and patients with public health insurance were less likely to receive surgery at freestanding ambulatory surgery centers.”

About pharma

First trial of personalised care for children with asthma suggests benefits of prescribing according to genetic differences: Selecting treatments according to genetic differences could help children and teenagers with asthma, according to research presented at the European Respiratory Society International Congress…
The research involved 241 children aged between 12 and 18 years who were all being treated for asthma by their GPs. The children were randomly assigned either to receive treatment according to existing guidelines, or to receive treatment according to particular genetic differences (their genotype), an approach known as personalised medicine…using a test that costs less than €20.
The researchers were testing for a small difference in the gene that contains instructions for making the beta-2 receptor and they were looking for children who had either with one copy of the altered gene or with two copies of the altered gene…
Previous research suggests that the majority of children with asthma will benefit from standard treatment with an asthma preventer called salmeterol in addition to their regular steroid inhaler. However, around one in seven children have a small genetic difference that means using this medication could actually result in these children having more asthma symptoms. 
In this trial, children in the personalised medicine group who had this genetic difference were treated with an alternative asthma medicine called montelukast.
Researchers followed the children for a year to monitor their quality of life, with a score between one and seven according to how their symptoms were, whether their normal activities were limited by their asthma and how their asthma made them feel. 
They compared the average score of the group of children who had their medication decided on the basis of their genetics with the average score of children who were treated according to current practice that does not involve any genetic testing, and found only a small improvement of 0.16 with those who received personalised care.
However, when the researchers looked specifically at the children who were found to have two copies of the altered beta-2 receptor gene, they found a greater benefit, with children experiencing an average 0.42 improvement in their quality of life score. The researchers say this would translate to a noticeably better quality of life for the children with two altered gene copies…”

About healthcare IT

Association of Electronic Health Record Use Above Meaningful Use Thresholds With Hospital Quality and Safety Outcomes: “These findings suggest that advanced levels of electronic health record implementation are not consistently associated with patient satisfaction, spending, and safety, and in some cases depend on the outcome quantile.” 

Today's News and Commentary

About the public’s health

Experts project autumn surge in coronavirus cases, with a peak after Election Day: “Infectious-disease experts are warning of a potential cold-weather surge of coronavirus cases — a long-feared “second wave” of infections and deaths, possibly at a catastrophic scale. It could begin well before Election Day, Nov. 3, although researchers assume the crest would come weeks later, closer to when fall gives way to winter.”

Coronavirus in the U.S.: Latest Map and Case Count: “At least 261 new coronavirus deaths and 25,167 new cases were reported in the United States on Sept. 7. Over the past week, there have been an average of 38,915 cases per day, a decrease of 9 percent from the average two weeks earlier.
As of Tuesday morning, more than 6,317,200 people in the United States have been infected with the coronavirus and at least 189,000 have died, according to a New York Times database.”

Contributions Of Public Health, Pharmaceuticals, And Other Medical Care To US Life Expectancy Changes, 1990-2015: “Life expectancy in the US increased 3.3 years between 1990 and 2015…Forty-four percent of improved life expectancy was attributable to public health, 35 percent was attributable to pharmaceuticals, 13 percent was attributable to other medical care, and −7 percent was attributable to other/unknown factors.”

Assessment of Receipt of the First Home Health Care Visit After Hospital Discharge Among Older Adults: “Only… [54.0% of patients] discharged from the hospital with a home health referral received home health care services within 14 days of discharge. Of the remaining… [46% of discharged patients], 37.7%… never received any home health care, while 8.3%… were institutionalized or died within 14 days without a preceding home health care visit. Patients who were Black or Hispanic received home health at lower rates than did patients who were White… In addition, disadvantaged patients waited longer for their first home health care visit.”

The COVID-19 Global Response Index: With New Zealand as the global model of response (gaining a score of 100), the #2 country on the list is…Senegal (89.3). Not a statistical fluke, but the result of an early isolation policy starting with its top government officials acting as role models.

In EU, 1 in 8 deaths linked to pollution: report:”In the EU, 13 percent of deaths are linked to pollution, said a new report published on Tuesday by the European Environment Agency (EEA), which stressed the current pandemic put environmental health factors in the spotlight.
Europeans are constantly exposed to environmental risks like air pollution, noise and chemicals, and the COVID-19 pandemic provides an example of the links between ‘human health and ecosystem health.’
’The emergence of such zoonotic pathogens is linked to environmental degradation and human interactions with animals in the food system,’ the report said.”

Blue Shield of California launches interactive community health dashboard: “The dashboard, built in partnership with data company mySidewalk, combines information from dozens of sources to provide a look at health outcomes, care access and utilization, social risk factors and economic health conditions across California.
The goal, Blue Shield officials said, is to offer supports to community health organizations, health advocates providers and public health officials as they craft solutions targeting local needs. The data are not restricted to Blue Shield's members.”

About healthcare IT

OCR updates HIPAA resources for cloud computing, mobile health apps: ”HHS' Office for Civil Rights on Sept. 1 updated its previous Health App Developer Portal and changed it to a HIPAA resource page for cloud computing, mobile health apps and application programming interfaces.”

Children's Hospital Los Angeles launches 26-hospital pediatric digital innovation accelerator: “Children's Hospital Los Angeles is spearheading a new digital health accelerator that will link 26 hospitals across the U.S., U.K. and Australia with 10 tech companies focused on increasing digital innovations in pediatric healthcare. 
Applications for the 13-week program, dubbed KidsX, opened Sept. 1; the program will follow a reverse pitch model, which allows the participating hospitals to pitch their problems or challenges to the startup community and then work with the companies that have tech solutions to meet their needs.
Some of the problems on the KidsX wish list include wearables and bi-directional communication technologies for monitoring pediatric patients at home, tools to improve care transitions from pediatric to adult healthcare, and predictive analytics to identify potentially harmful clinical outcomes in pediatric patients.”

Data-sharing lawsuit against U of Chicago Medical Center, Google dismissed: “A federal judge in Illinois dismissed the class-action lawsuit against the University of Chicago Medical Center and Google, which alleged HIPAA violations.Former University of Chicago Medical Center patient Matt Dinerstein sued Google and the hospital in June 2019, alleging the partnership between the two organizations violated HIPAA. Under the partnership, which began in 2017, the University of Chicago Medical Center shared thousands of de-identified patient records with Google to help the tech giant improve predictive analytics.
The data included time stamps for dates of service and physician notes, which Mr. Dinerstein contended violated HIPAA. The University of Chicago denied any wrongdoing and the lawsuit didn't include evidence that Google misused the information.”

From big deals to bankruptcy, a digital health unicorn falls short. Here's what other startups can learn from Proteus: “Hundreds of startups are trying to succeed in a digital health market that is now flush with cash.
Investors poured $5.4 billion into healthcare technology startups in the first half of 2020, according to digital health venture capital firm Rock Health.
But having a breakthrough technology is not enough to succeed.”
This article is a good case study of one company, Proteus, that ultimately filed for Chapter 11 after a promising start.

About health insurance

A Doctor Went to His Own Employer for a COVID-19 Antibody Test. It Cost $10,984:”Physicians Premier ER charged Dr. Zachary Sussman’s insurance $10,984 for his COVID-19 antibody test even though Sussman worked for the chain and knows the testing materials only cost about $8. Even more surprising: The insurer paid in full…
The bill left him so dismayed he quit his job. And now, after ProPublica’s questions, the parent company of his insurer said the case is being investigated and could lead to repayment or a referral to law enforcement.”
A great case for discussion of what went wrong and what can be done to prevent similar situations.

Urgent care network to pay $12.5M in billing fraud case: “A company that owned and operated more than 30 urgent care centers has agreed to pay $12.5 million to resolve overbilling allegations, the Department of Justice…
UCXtra Umbrella, which did business in Arizona as Urgent Care Extra, previously admitted…that it had billing procedures in place that caused its providers to overstate the complexity of the medical services provided to patients…
The company also admitted that staff were encouraged to order tests and procedures that may not have been medically necessary to justify higher billing codes and reimbursement.”

Adjustment For Social Risk Factors Does Not Meaningfully Affect Performance On Medicare’s MIPS Clinician Cost Measures: “Medicare’s Merit-based Incentive Payment System (MIPS) …do not include risk adjustment for social risk factors. We found that adjusting for individual and community social risk did not have a meaningful impact on clinicians’ cost measure performance... Prior analyses have generally found higher health care costs for patients with increased social risk. MIPS episode-based cost measures are distinct from previous cost measures because they only include costs related to the specific condition being evaluated. This unique approach may explain why costs were similar for patients with high and low social risk before any risk adjustment”

Today's News and Commentary

About healthcare quality

CMS launches new Care Compare site that combines provider comparison tools into one place: “The Centers for Medicare & Medicaid Services (CMS) launched the updated Care Compare site…[which] combines the previously existing sites that allow consumers to comparison shop based on the quality metrics for hospitals, nursing homes, home health providers, dialysis facilities, long-term care hospitals, inpatient rehabilitation facilities, physicians and hospice.”

About pharma

The Rising Cost of Insulin for Pump Users: How Policy Drives Prices: This article emphasizes Medicare’s uncoordinated medication payments policies that vary by which part covers the drug. “Medicare reimbursement for insulin is based on the route of administration via syringe (Part D) or via pump (Part B). Recently, the Centers for Medicare & Medicaid Services (CMS) announced a voluntary model for Part D enhanced plans that lower out-of-pocket costs to a co-pay of ≤$35/month. Meanwhile, the 21st Century Cures Act and manufacturer price increases raised the cost of insulin for pump users by 304% in less than 2 years.“

FTC Approves Final Order Imposing Conditions on AbbVie’s Acquisition of Allergan: “Following a public comment period, the Federal Trade Commission has approved a final order settling charges that AbbVie's $63 billion acquisition of Allergan would violate federal antitrust law…
The final order requires AbbVie and Allergan to divest to Nestlé, S.A. Allergan's Zenpep and Viokase, which are currently sold to treat EPI. AbbVie and Allergan also are required to divest to AstraZeneca plc. Allergan's rights and assets related to brazikumab - an IL-23 inhibitor that is in development to treat moderate-to-severe Crohn's disease and ulcerative colitis.”

About the public’s health

Roche nets FDA authorization for combination COVID-19 and flu test: “Roche announced the launch of its second COVID-19 diagnostic of the week after securing an FDA authorization for a test that detects the novel coronavirus as well as influenza A and B.
The high-throughput laboratory test may prove especially useful as the pandemic collides with the annual flu season, allowing healthcare providers to tell the difference between patients showing similar sets of respiratory symptoms from a single sample.”

Today's News and Commentary

About the public’s health

Health Officials Worry Nation’s Not Ready for COVID-19 Vaccine: Among the disturbing fats in this article is: “The U.S. has committed more than $10 billion to develop new coronavirus vaccines but hasn’t allocated money specifically for distributing and administering vaccines.

Sharecare’s Community Well-Being Index 2019 State Rankings Report: New Hampshire and Hawaii head the list.

Farming partnership between St. Luke's, Rodale Institute hits major milestone: An interesting article about this hospital’s organic farm and its place in the community.

About healthcare financing

Private equity pushes into healthcare: 10 recent deals: FYI: the headline speaks for itself.

Today's News and Commentary

About hospitals and health systems

Charity Care: Do Nonprofit Hospitals Give More than For-Profit Hospitals?: “While the average for-profit hospitals spent less in total charity care than nonprofit hospitals, there was no significant difference between for-profit and nonprofit hospitals in charity care as percent of total expenses. When stratified by size, small for-profit hospitals spent less than small nonprofit hospitals while large for-profit hospitals spent more than large nonprofit hospitals.
We found no differences in charity care as percent of total expenses between for-profit and nonprofit hospitals located in lower-income zip codes, middle-income zip codes, or higher income zip codes.”

MedPAC: For-profit systems fare better than non-profits in weathering COVID-19 cash crisis: “For-profit health systems have been better able to weather a financial crisis caused by COVID-19 than their non-profit counterparts because they could reduce more expenses, a new analysis from the Medicare Payment Advisory Commission finds.”

About the public’s health

White House moves to halt evictions as fears of coronavirus-fueled housing crisis grow: The halt comes from the CDC as a measure to prevent COVID-19 spread.

Covid-19 vaccine delivery faces problems, warns DHL: A reminder from the delivery service that frozen vaccine transport will present problems.

Trump Administration Will Redirect $62 Million Owed to the W.H.O.:”As the United States withdraws from membership in the World Health Organization, the Trump administration will redirect $62 million still owed for this year’s dues to other health-related causes also under United Nations auspices, State Department officials announced on Wednesday.
Most of the redirected money will go to children’s immunization and influenza surveillance, officials said. But the United States Agency for International Development will continue with plans to give $68 million to the W.H.O. to support its work in Libya and Syria, and on polio eradication in Pakistan and Afghanistan.”

About pharma

Trial of Sodium Phenylbutyrate–Taurursodiol for Amyotrophic Lateral Sclerosis:”Sodium phenylbutyrate–taurursodiol resulted in slower functional decline than placebo as measured by the ALSFRS-R score over a period of 24 weeks. Secondary outcomes were not significantly different between the two groups. Longer and larger trials are necessary to evaluate the efficacy and safety of sodium phenylbutyrate–taurursodiol in persons with ALS.”

Civica Rx has 1,200 member hospitals, 40 medications under contract:”Civica Rx, a nonprofit organization created in 2018 to address the problem of chronic drug shortages, said it now consists of 1,200 hospitals and is contracted to supply 40 different medications. 
The organization, which is celebrating its two-year anniversary this month, said it has delivered over 11 million vials of drugs, more than 9 million of them to patients and about 2 million to the federal stockpile to help combat drug shortages caused by the COVID-19 pandemic.”

California may be the first state to develop its own generic drugs: “Lawmakers there approved a measure that would direct the state's top health agency to partner with one or more drug companies by January to make or distribute a broad range of generic or biosimilar drugs, including insulin.”

Eli Lilly to halt sales of 340B drugs to contract pharmacies with exception of insulin: “Eli Lilly became the latest drug company to restrict sales of drugs discounted under the 340B program to contract pharmacies, escalating a war with hospitals.
The company announced that starting Sept. 1 hospitals cannot get 340B discounted drugs through a contract pharmacy, a popular method used by most hospitals in the program, according to a notice first published on the site 340B Report.
Lilly noted that 340B hospitals can still get discounted insulin through their contract pharmacies, which are third party entities that dispense 340B drugs.”

Copay Savings Programs for Prescription Drugs: Who Saves and How Much?: Here is a summary of the results of this study by GoodRx:

• Almost 70% of copay savings programs are hard to access.

• Nearly 40% of copay savings programs are available for uninsured patients.

• Program eligibility isn’t always clear.

• Copay savings programs are available for some generic drugs.

• Average savings for copay savings programs tend to be higher for insured patients.

• Expensive-to-treat conditions like diabetes, psoriasis, and HIV have the largest number of copay savings programs.

• Certain manufacturers, such as Pfizer and Bausch, offer more copay savings programs than others.

• Copay savings programs are evolving with the rise of high-deductible health plans.

About health insurance

CMS' final inpatient payment rule for 2021: 7 things to know: The final rule is 2160 pages but this article hits the highlights. One rule deserves a comment: “Under the final rule, hospitals must report to CMS the median rate negotiated with Medicare Advantage organizations for inpatient services. CMS will begin collecting this data in 2021 and will use it in a new market-based methodology to set inpatient hospital payments beginning in 2024.” While the idea of lowering costs by benchmarking is laudable, managed care plans often pay for global episodes of care. For example, they may pay per diems for hospital days, while Medicare pays DRGs. Comparisons will be difficult.

How long can the state delay determining Medicaid eligibility?:”In a victory for patients and physicians, the California Supreme Court says a legal challenge that looks to hold the state accountable for taking no more than 45 days to decide whether an individual is eligible for the state’s Medicaid program, Medi-Cal, can go forward.
The ruling from the state’s high court overturns an appellate court decision in the case, Rivera et al. v. Kent et al., that said that the 45-day standard set by state and federal statutes and regulations was “merely a target, not an absolute requirement.”

About healthcare IT

Epic's focus today and what comes next: 5 updates from Judy Faulkner: A quick read about what Epic is planning.

Today's News and Commentary

About healthcare IT

Humana, Salesforce team on connected care platform:”Humana will deploy Salesforce’s Health Cloud platform as part of its new Enterprise Clinical Operating Model, which aims to boost care coordination between members, care teams and providers. 
The platform is designed to streamline collaboration, Humana said, by allowing care teams access to the member’s complete clinical history and insights on social, environmental and lifestyle factors that may impact their care.”

Multichannel Electrocardiograms Obtained by a Smartwatch for the Diagnosis of ST-Segment Changes: “The findings of this study suggest agreement between the multichannel smartwatch ECG and standard ECG for the identification of ST-segment changes in patients with acute coronary syndromes.”

Deep Learning Using Chest Radiographs to Identify High-Risk Smokers for Lung Cancer Screening Computed Tomography: Development and Validation of a Prediction Model: ”Lung cancer screening with chest computed tomography (CT) reduces lung cancer death. Centers for Medicare & Medicaid Services (CMS) eligibility criteria for lung cancer screening with CT require detailed smoking information and miss many incident lung cancers. An automated deep-learning approach based on chest radiograph images may identify more smokers at high risk for lung cancer who could benefit from screening with CT…
[The] CXR-LC [convolutional neural network] identified smokers at high risk for incident lung cancer, beyond CMS eligibility and using information commonly available in the EMR.”

Health tech funding snapshot—Withings nabs $60M to expand into healthcare; Ro raises $200M: Some updates on financing for IT and tech companies.

Konica Minolta will pay $500K to settle lawsuit alleging EHR software flaws: ”The complaint from the Department of Justice (DOJ) alleged that Viztek violated the False Claims Act by cheating on certification tests for its electronic health record (EHR) system. The company falsely represented that its EHR met the criteria for certification, which would allow it to receive incentive payments through the Electronic Health Record Incentive Program.
This resulted in providers filing false claims for incentive payments with the Medicare program…”

About the public’s health

The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Convalescent Plasma for the Treatment of COVID-19: In today’s top news story, the NIH declared: “There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19.” [Emphasis added.] Read the article for supporting details.

C.D.C. Tells States How to Prepare for Covid-19 Vaccine by Early November:”The Centers for Disease Control and Prevention has notified public health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups as soon as late October or early November…
Over the past week, both Dr. Anthony S. Fauci, the country’s top infectious disease expert, and Dr. Stephen Hahn, who heads the Food and Drug Administration, have said… that a vaccine may be available for certain groups before clinical trials have been completed, if the data is overwhelmingly positive.”

Federal panel lays out initial priorities for COVID-19 vaccine distribution:”Initial doses of a COVID-19 vaccine should go to front-line health workers, first responders and people at serious risk for infection, according to new draft guidelines released Tuesday by a federal advisory panel.
The draft guidelines were developed by the National Academies of Sciences, Engineering, and Medicine to help U.S. officials plan for an equitable allocation of an eventual vaccine.
The final report will be released later this fall.”

The Most American COVID-19 Failure Yet:This article from The Atlantic makes the case that we could have shut down COVID-19 if we had a coordinated national contact tracing strategy (for example, like New Zealand). A similar argument was made this weekend in an opinion piece in The Financial Times.

Florida cuts ties with Quest Diagnostics lab for 75,000 withheld coronavirus tests:”Gov. Ron DeSantis ordered the Florida Department of Health to no longer work with Quest Diagnostics after the laboratory violated state law and failed to report nearly 75,000 coronavirus tests that date back to April in a timely manner.”

White House to Target Hospitals for Uneven Covid-19 Data Reporting: “In a move expected as early as next week, the administration is planning to publicize the names of hospitals with data missing from the federal pandemic reporting system, according to people familiar with the discussions.”

US says it won’t join global effort to find COVID-19 vaccine:”The Trump administration said Tuesday that it will not work with an international cooperative effort to develop and distribute a COVID-19 vaccine because it does not want to be constrained by multilateral groups like the World Health Organization…
Some nations have worked directly to secure supplies of vaccine, but others are pooling efforts to ensure success against a disease that has no geographical boundaries. More than 150 countries are setting up the COVID-19 Vaccines Global Access Facility, or COVAX.”

Humoral Immune Response to SARS-CoV-2 in Iceland:”Our results indicate that antiviral antibodies against SARS-CoV-2 did not decline within 4 months after diagnosis. We estimate that the risk of death from infection was 0.3% and that 44% of persons infected with SARS-CoV-2 in Iceland were not diagnosed by qPCR.” Good news for lasting immunity- either natural or, hopefully, with a vaccine.

Two-thirds of healthcare experts plot virtual trial use as a result of COVID-19: report:”A new report from life science data analytics firm GlobalData has found that two-thirds of healthcare experts surveyed over the summer plan to use decentralized clinical trials.This is a direct result of COVID-19, during which the use of siteless tech related to home visits, deliveries and telehealth was actively encouraged by the FDA and a necessity in allowing trials to continue during the pandemic lockdown.”

Coronavirus may survive on outdoor surfaces for longer in autumn, US study suggests:”Researchers found that in lower temperatures and humidity, the virus could, for example, remain on a hiker’s jacket if it was outside for a week – and remain infectious for that time – whereas in summer its lifespan was estimated to be one to three days.
The prolonged survival of the virus on surfaces in autumn could “potentially contribute to new outbreaks”, the team led by Juergen Richt, professor of veterinary microbiology at Kansas State University, wrote in a non-peer-reviewed paper posted on preprint website bioRxiv.org on Monday.”

It’s time to talk about how toilets may be spreading covid-19: A really good review of this topic and what to do to mitigate risk in that setting.

Roche to launch 40M rapid coronavirus antigen tests per month, starting in Europe: “Roche plans to make a rapid antigen test for the novel coronavirus widely available in Europe later this month, while also submitting it to FDA reviewers for an emergency authorization in the U.S.
The point-of-care diagnostic aims to provide a result within 15 minutes, as a way to screen people with or without symptoms for COVID-19.
The Big Pharma said it will start off with 40 million tests in stock at launch and plans to ramp up production to more than twice that number, per month, by the end of the year.”
Perhaps with this test and the rapid Abbott test, the goal of more universal and continuous testing can be realized.

About pharma

Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19:A Meta-analysis: This recommendation comes from a meta-analysis done by the WHO: “In this prospective meta-analysis of clinical trials of critically ill patients with COVID-19, administration of systemic corticosteroids, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.” The article is one of several published online today in JAMA.
See, also, this editorial: Corticosteroids in COVID-19 ARDSEvidence and Hope During the Pandemic. It is a great review of the topic. It seems the type of steroid does not matter in producing a benefit.

U.S. House Oversight Committee to subpoena AbbVie in drug-pricing probe:”The U.S. House Oversight Committee on Tuesday decided to subpoena AbbVie Inc to seek documents on the drugmaker’s blockbuster treatments, Humira and Imbruvica, as part of its investigation into drug-pricing practices. 
The committee began the probe last year and had sought information from 12 drugmakers on price increases, corporate strategies to preserve market share and pricing power.”

Trump says he will meet with drugmakers this week over pricing: Despite this announcement, the “Pharmaceutical Research and Manufacturers of America (PhRMA)… is not aware of a meeting scheduled for this week, spokeswoman Nicole Longo said.”

About health insurance

AMA releases 2021 CPT code set: “The first major overhaul in more than 25 years to the codes and guidelines for office and other outpatient evaluation and management (E/M) services was included in [Tuesday’s] release of the 2021 Current Procedural Terminology (CPT®) code set published by the American Medical Association (AMA)….
The changes to CPT codes ranging from 99201-99215 are proposed for adoption by the Centers for Medicare and Medicaid Services on Jan. 1, 2021.
The E/M office visit modifications include:
Eliminating history and physical exam as elements for code selection.
Allowing physicians to choose the best patient care by permitting code level selection based on medical decision-making (MDM) or total time.
Promoting payer consistency with more detail added to CPT code descriptors and guidelines…
The revised E/M office visit codes are among 329 editorial changes in the 2021 CPT code set, including 206 new codes, 54 deletions, 69 revisions. 
See, also: Proposed 2021 Medicare pay schedule: 9 things doctors should know

DOD Releases Draft RFP for New $58 Billion Health Care Contracts: “The Pentagon released a draft request for proposal (DRFP) for the next generation of its massive healthcare contracts on Aug 28. The two contracts are potentially valued at more than $58 billion.
The DRFP is for the fifth-generation of managed-care support contracts, known as T-5, for the military’s TRICARE health services program. T-5, will deliver health care services for the approximately 9 million military personnel, retirees and dependents enrolled in the military’s TRICARE health system in the United States. Healthcare for about half a million people overseas is provided through a separate contract.”

Hospitals want redo in site-neutral payment case:”The American Hospital Association and dozens of individual hospitals filed a petition Aug. 31 asking a federal appeals court to rehear a case challenging HHS' site-neutral payment policy that cuts Medicare payments for hospital outpatient visits.” Read the article for a history of the suits.

About healthcare technology

Baxter nets FDA de novo clearance for a new class of dialysis filter, closer to the human kidney: “Baxter has received a green light from the FDA for a new type of dialysis filter that sifts out a wider range of molecules from the blood compared to traditional membranes—including those associated with the heightened inflammatory and cardiovascular disease seen in patients suffering from kidney failure.
The Theranova cartridge is designed to be used with existing dialysis machines with little change in treatment, while offering a filtration profile that more closely mimics the natural kidney, the company said.”

U.S. Medical Supply Shortage Plaguing More Than Just Tests for Covid-19: Such items include chemical reagents, gloves, pipettes and tests for a variety of diseases.

Syringe technology could enable injection of concentrated biologic drugs: A truly disruptive technology that would enable patients to self-inject the medication, rather than going to an infusion center or physician’s office. See the video in the article for the best explanation of how it works.

Today's News and Commentary

About the public’s health

Yet more data support COVID-19 aerosol transmission: “Two studies published late last week in Clinical Infectious Diseases highlight the role of airborne spread of COVID-19 and the importance of efficient ventilation systems. One study found that patients can exhale millions of viral RNA particles per hour in the early stages of disease, and the second tied an outbreak affecting 81% of residents and 50% of healthcare workers at a Dutch nursing home to inadequate ventilation.”

House suppressed coronavirus reports and downplayed virus, House panel says:

• “The House Select Subcommittee on Coronavirus published eight weeks of state coronavirus reports, which are prepared by the task force and sent privately to governors. 

• Each report contains data on confirmed cases, testing, the mobility of a state’s residents and more for every state. 

• The reports directly contradict optimistic messaging pushed by President Donald Trump and other administration officials over the summer, the Democrat-led committee said.”

How many people has the coronavirus killed?:”In times of upheaval — wars, natural disasters, outbreaks of disease — researchers need to tally deaths rapidly, and usually turn to a blunt but reliable metric: excess mortality. It’s a comparison of expected deaths with ones that actually happened, and, to many scientists, it’s the most robust way to gauge the impact of the pandemic. It can help epidemiologists to draw comparisons between countries, and, because it can be calculated quickly, it can identify COVID-19 hotspots that would otherwise have gone undetected. According to data from more than 30 countries for which estimates of excess deaths are available (see ‘Terrible toll’), there were nearly 600,000 more deaths than would normally be predicted in these nations for the period between the onset of the pandemic and the end of July (413,041 of those were officially attributed to COVID-19).”

Special Report: Six Months That Changed America: Excellent review by Harris Polls on the changing public opinions during the COVID-19 pandemic. For example, in the beginning, 54% of the public thought the national fear was irrational; now 75% think the fear is sensible. Also, 69% of respondents said they would get a vaccine as soon as it becomes available. Lots of other interesting opinions about work and consumer habits.
In a related Harris Poll: Americans see hospitals as more trustworthy than FDA or CDC on COVID-19 vaccine information, poll finds:”Nearly 9 in 10 (88%) said doctors and nurses were very or somewhat trustworthy sources of information.
They were immediately followed by nationally recognized health systems like Mayo Clinic or Cleveland Clinic, as well as scientists, with 84% of Americans indicating they saw both as trustworthy. Local hospitals are seen as highly trusted on the COVID-19 vaccine with 82% of Americans saying they were very or somewhat trustworthy sources.
Meanwhile, only 73% of Americans said they saw the CDC as somewhat or very trustworthy and 72% said they saw the FDA as highly trusted. That was just ahead of drug companies that work on vaccines in general, as well as those that are specifically working on COVID-19 vaccines (71%).
Meanwhile, 61% of Americans said their employers, as well as health insurance companies, were very or somewhat trustworthy.”

Most Americans believe the Covid-19 vaccine approval process is driven by politics, not science: “Seventy-eight percent of Americans worry the Covid-19 vaccine approval process is being driven more by politics than science, according to a new survey from STAT and the Harris Poll, a reflection of concern that the Trump administration may give the green light to a vaccine prematurely.
The response was largely bipartisan, with 72% of Republicans and 82% of Democrats expressing such worries…
just 46% of the public trusts the president or the White House to provide accurate information about the development of a Covid-19 vaccine, although views vary dramatically along partisan lines — with 71% of Republicans believing Trump and only 28% of Democrats believing him.
The public is not much more more confident in the media as a source of information on vaccine development, with 47% viewing national news outlets as trustworthy. Only social media fared worse as a source of information, with just 29% of respondents trusting information on the platforms.”

And in a related story to the three above:

HHS bids $250 million contract meant to 'defeat despair and inspire hope' on coronavirus: “As the presidential election fast approaches, the Department of Health and Human Services is bidding out a more than $250 million contract to a communications firm as it seeks to “defeat despair and inspire hope” about the coronavirus pandemic, according to an internal HHS document obtained by POLITICO…
The document also lists the goals of the contract: ‘defeat despair and inspire hope, sharing best practices for businesses to operate in the new normal and instill confidence to return to work and restart the economy,’ build a ‘coalition of spokespeople’ around the country, provide important public health, therapeutic and vaccine information as the country reopens, and give Americans information on the phases of reopening.”

About health insurance

U.S. Government Starts Making $12 Billion in ACA Risk Corridors Payments: Where the money goes depends on whether the insurers are still in business. One case was Land of Lincoln, “a small, nonprofit, member-owned, Illinois-based health insurer that failed in 2016, partly because it was unable to collect the ACA risk corridors program subsidy payments it was expecting to receive.
One document on the website of the Illinois Office of the Special Deputy Receiver shows that the Land of Lincoln liquidator needed an extra $69 million to meet all obligations.
The liquidator — the director of the Illinois Department of Insurance — used an open bidding process to sell some rights to the litigation proceeds to Juris Capital, a litigation finance company, in August 2019.
Under the deal between liquidator and Juris Capital, Juris Capital will get to keep $65 million of the litigation proceeds, and the estate of Land of Lincoln will get $64 million.”
Why the lawyers get the lion’s share is not clear since the state of Illinois needs the money and the federal government financed the startup of this organization.

Judge: Neither Anthem nor Cigna to receive damages in 'corporate soap opera' over failed merger: “A Delaware judge has ruled that neither Anthem nor Cigna can receive damages in the fallout from their failed $54 billion merger.”

Aetna launches new plan design that puts focus on CVS' health services: “The Aetna Connected Plan with CVS Health will be available to employers with 101 or more workers in three Missouri Counties and two in Kansas for the 2021 plan year. While the PPO plan will offer access to many regional providers, CVS' HealthHubs and MinuteClinics are deeply embedded in the plan design, Aetna said.
For instance, one of Aetna's care managers would book the member a HealthHub appointment to discuss their diabetes. They would then be referred to a provider through MinuteClinic, who will be able to consult with the member's primary care doc and prescribe medication.”
Is this plan more fragmented care?

About healthcare IT

Accurate patient matching is even more vital amidst the COVID-19 crisis, say industry groups: The article highlights the need for unique patient identifiers.

Nearly 800,000 health records breached in August: Those were only the ones reported to HHS.

HHS Appoints Perryn Ashmore Acting CIO After Arrieta Resignation: “Perryn Ashmore, currently Principal Deputy Chief Information Officer, will begin serving as Acting Chief Information Officer (CIO) following the resignation of Jose Arrieta.”

About pharma

GoodRx files to go public, boasting track record of profitability:”The startup, which helps consumers find deals on their prescription medications, is looking to raise up to $100 million in an IPO, according to a filing with the U.S. Securities and Exchange Commission (SEC) Friday.
The Santa Monica, California-based company, launched in 2011, said its stock will traded on Nasdaq under the symbol GDRX, according to an S-1 filing.”

Nestle gets peanut allergy treatment with $2 billion Aimmune buyout: “Nestle will pay $2 billion to buy the remaining stake in Aimmune Therapeutics Inc, gaining full ownership of the first U.S.-approved peanut allergy treatment which has struggled with a slow launch due to the COVID-19 pandemic.”

Mylan, Biocon undercut insulin competitors on price with launch of Lantus copycat: “Mylan and Biocon will launch Semglee, a copy of Sanofi's insulin injection Lantus, for a wholesale acquisition cost of $147.98 per package of five 3-milliliter pens and $98.65 per 10-milliliter vial, making it the lowest-priced basal insulin on the U.S. market, the partners said Monday.”

Assessment of Variation in State Regulation of Generic Drug and Interchangeable Biologic Substitutions: “In this cross-sectional study of all 50 states and Washington, DC, substantial variation was noted in generic substitution rules for small-molecule drugs, including whether substitution was mandatory or permissive, whether patient consent and notification were required before and after substitution, and whether pharmacists were protected from liability for substitution. Almost all states imposed heightened requirements for interchangeable biologic substitution.
 The findings of this study suggest a need for optimizing state drug product selection laws to improve medication adherence and reduce drug spending.”

Today's News and Commentary

About pharma

Most People Are Unlikely to See Drug Cost Savings From President Trump’s “Most Favored Nation” Proposal:”If a “most favored nation” approach was limited to setting prices for prescription drugs covered by Medicare Part B only, it could lower drug costs for approximately 4 million Medicare beneficiaries, based on the number of people who used Part B drugs in 2018 (just 7% of all 60 million beneficiaries covered by Medicare). However, it would have no direct impact on the lion’s share of drug spending under Medicare for prescriptions filled by the 45 million beneficiaries covered under Medicare Part D, nor would it lower drug costs for the 157 million people with employer coverage or for millions more with other insurance coverage or no coverage whatsoever.”

US government’s Darpa probes Moderna’s vaccine patents: In a report published last week, “researchers at Knowledge Ecology International (KEI), a patient advocacy group, said Moderna failed to disclose in its vaccine patents that it had received about $25m in grants from the DoD’s Defense Advanced Research Projects Agency, or Darpa, to develop its vaccine technology.” The disclosure will impact royalties due to the US government.

One shot of coronavirus vaccine likely won't be enough : The headline speaks for itself. The article is a nice update on the leading vaccine research companies.

FDA expands emergency use of Gilead's remdesivir in hospitalized COVID-19 patients: “U.S. Food and Drug Administration expanded the emergency use authorization of its experimental antiviral COVID-19 treatment, remdesivir, to allow its use in all hospitalized COVID-19 patients.” It had previously been authorized only in severe cases.

Researchers Eye Potential 'Broad-Spectrum' Antiviral Discovery for Covid-19: “Dubbed a ‘broad-spectrum antiviral strategy’ for Covid-19 and other viral infections, the finding by a team of microbiologists at the University of Hong Kong could eventually lead to a medicine that could stop a half-dozen known respiratory viruses as well as new threats the world has yet to encounter.
The discovery centers on a broad-spectrum antiviral peptide known as P9R that the researchers hope will lead to a possible defense against the novel coronavirus -- officially called SARS-CoV-2 -- as well as the viruses that cause MERS, SARS and the H1N1 flu. So far, the research has been limited to mice in the lab, but if effective, it could change the "one bug, one drug," approach to viral outbreaks, say the scientists…”
The research was  published in the Journal Nature Communications.

Eli Lilly, Boehringer's Jardiance slices CV events by 25% in Farxiga-matching heart failure trial: “AstraZeneca put the rest of the SGLT2 inhibitor class on notice when its Farxiga scored an FDA heart failure nod in patients with or without diabetes. One of its competitors, Eli Lilly and Boehringer Ingelheim's Jardiance, is fast on Farxiga's heels, though, and it's ready to bring its pivotal trial win in front of physicians. Jardiance, added to standard of care therapy, sliced the risk of cardiovascular hospitalizations or death by 25% over placebo in heart failure patients with or without Type 2 diabetes, according to late-breaking science set to be presented Saturday at the European Society of Cardiology virtual annual meeting.”
Also, see: AstraZeneca's Farxiga cuts kidney disease risks by 39% in trial that could 'rewrite' the treatment textbook.

Walgreens names former Rite Aid CEO as its new president:”Walgreens has named former Rite Aid CEO John Standley as its new president, effective immediately. 
Mr. Standley will lead all Walgreens operations and be responsible for the development, growth and management of the business. He previously served as president, CEO and chair of Rite Aid as well as CEO of the Pathmark supermarket chain and has held leadership roles in several other grocery and retail companies. 
Mr. Standley was also a former chair of the National Association of Chain Drug Stores.”

The top 10 global R&D institutes:”We ranked the top institutes using the Nature journal’s Index, rather than direct funding amounts, given that all these institutes have investments beyond life sciences.
The Index tots up the largest contributors to papers published by a subset of 55 journals among the 82 journals tracked by the Nature Index from January 2015 to December 2018.”
Harvard and the NIH top this global list.

About the public’s health

FDA commissioner says willing to fast-track COVID-19 vaccine: “The head of the U.S. Food and Drug Administration (FDA) is willing to fast-track a COVID-19 vaccine as quickly as possible, the Financial Times reported him as saying in an interview published on Sunday. 
Dr. Stephen Hahn, the FDA Commissioner, said his agency was prepared to authorize a vaccine before Phase Three clinical trials were complete, as long as officials are convinced that the benefits outweigh the risks…” And in a related article: UK to Allow Emergency Use of Any Effective COVID-19 Vaccine: “The UK has unveiled a proposal that would empower the Medicines and Healthcare Products Regulatory Agency (MHRA) to temporarily authorize effective COVID-19 vaccines while they are still under review.”
However: Covid vaccine rush could make pandemic worse, say scientists: “The experts say the world would be better served by waiting until comprehensive results showed vaccines with at least 30% to 50% effectiveness…”

U.S. coronavirus cases top six million as Midwest, schools face outbreaks: “U.S. cases of the novel coronavirus surpassed six million on Sunday as many states in the Midwest reported increasing infections, according to a Reuters tally.”

HHS cancels remainder of Philips' contract for 43K ventilators: This news goes along with the easing of COVID-19 related hospitalizations.

U.S. Will Revive Global Virus-Hunting Effort Ended Last Year: “The government agency that let Predict die last October has quietly created a $100 million program with a similar purpose as Predict, but it has a different name. The new program, set to begin in October, will be called Stop Spillover.
Predict, which was started in 2009 as part of the Obama administration’s Emerging Pandemic Threats program, was inspired by then 2005 H1N1 bird flu scare. Predict was run by the United States Agency for International Development, which is an independent foreign-aid agency overseen by the State Department.
Predict was an odd fit for USAID, experts said. Unlike the Centers for Disease Control and Prevention or the National Institutes of Health, the agency is not normally a home to cutting-edge science.
The American response to pandemics is strangely fragmented. The C.D.C. investigates outbreaks, while the National Institute of Allergy and Infectious Diseases pursues vaccines. Much research into tropical diseases and bioweapons is done by the military, legacies of the Spanish-American War and the Cold War, while the State Department coordinates global campaigns against AIDS.”

Empiric Antibacterial Therapy and Community-onset Bacterial Co-infection in Patients Hospitalized with COVID-19: A Multi-Hospital Cohort Study: “The prevalence of confirmed community-onset bacterial co-infections was low. Despite this, half of patients received early empiric antibacterial therapy. Antibacterial use varied widely by hospital. Reducing COVID-19 test turnaround time and supporting stewardship could improve antibacterial use.”

COVID-19 Not Likely to Be Transmitted by Breast Milk: Study:”No cases of an infant contracting COVID-19 from breast milk have been documented, but questions about the potential risk remain.
Researchers examined 64 samples of breast milk collected from 18 women across the United States who were infected with the new coronavirus (SARS-CoV-2) that causes COVID-19.
One sample tested positive for coronavirus RNA, but follow-up tests showed that the virus couldn't replicate and therefore, couldn't infect the breastfed infant…”

Clinical Characteristics and Viral RNA Detection in Children With Coronavirus Disease 2019 in the Republic of Korea: “In this case series of 91 children with COVID-19 in Korea, 22.0% were asymptomatic. Only 8.5% of symptomatic cases were diagnosed at the time of symptom onset, while 66.2% had unrecognized symptoms before diagnosis and 25.4% developed symptoms after diagnosis; SARS-CoV-2 RNA was detected for a mean of 17.6 days overall and 14.1 days in asymptomatic cases.” In other words, asymptomatic children can harbor the virus and be infectious for two weeks.

COVID-19 reinfection reported in Nevada patient, researchers say: First documented case of reinfection in the US. “The case involves a 25-year-old man living in Reno, Nevada, who first tested positive for COVID-19 in mid-April. He recovered, but got sick again in late May. The second time around, his illness was more severe, the case report said.”

About health insurance

Trump Program to Cover Uninsured Covid-19 Patients Falls Short of Promise: The headline speaks for itself and the article gives examples.

COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing: Latest update from CMS.

CMS rule aims to reduce lag time between FDA approval and Medicare coverage of new devices: “For devices approved under the new process, Medicare would give national coverage simultaneously with FDA approval. The coverage would extend for four years.” Other countries approve technology and pricing at the same time. But the process is not necessarily shorter, since costs need to be determined for Medicare passthrough payment purposes.

About healthcare IT

Vast majority of specialists increased use of telehealth tech during COVID-19 pandemic: ”Nearly 80% of cardiology, gastroenterology, pulmonology and respiratory physicians polled for a new survey said their use of virtual care technology has increased.”

Children’s National Study Ties Telehealth to Better Antibiotic Stewardship: “The study, published this week in the Journal of General Internal Medicine, found that providers using a virtual care platform with real-time access to their own prescribing statistics as well as practice-wide statistics reduced their prescribing rates. That would help reduce the estimated 2.8 million antibiotic resistant infections that occur each year in the US.”

Amazon unveils Halo to battle Apple Watch and Fitbit — tracks activity, body fat, emotions: More information on this new technology. One particularly interesting feature is “Tone.”
“Tone is an optional feature that listens to the user’s voice throughout the day and analyzes that information to present a picture of how they felt -- for instance, showing times they were feeling energetic, hopeful, or hesitant. For instance, the device might pick up on an argument, or a tense conversation at work, and indicate that the user felt elated at 10 a.m. but hesitant 30 minutes later. Amazon says none of the voice-based snippets are stored in the cloud and they’re automatically deleted once they’re processed. The company also said it won’t use the voice recordings for targeted advertising.”

About healthcare quality

Medical Errors Climb After Daylight Saving Time Switch: “Sleep medicine academy calls for DST to be abolished.
Medical errors increased the week after the spring switch to daylight saving time (DST) in a large healthcare system, an observational study showed.
Safety-related incidents stemming from human errors increased by 18.7% (95% CI 5.6%-33.6%, P=0.004) in the week after the spring time change, reported Bhanu Prakash Kolla, MD, of the Mayo Clinic in Rochester, Minnesota, and co-authors, at the virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine (AASM) and Sleep Research Society.”

Today's News and Commentary

About the public’s health

Reopened Schools Find Health Risks in Water After Covid-19 Lockdowns: “A number of schools found the bacteria that causes Legionnaires’ disease in their water, and experts say more should expect to see it.”

Pfizer, Moderna's coronavirus shot rollouts could freeze up, experts say, citing cold-storage needs:”A pair of frontrunner mRNA-based COVID-19 vaccines from Moderna and Pfizer could run into supply logistics issues over the ultra-cold storage needs for both shots, SVB Leerink analysts said in a pair of client notes Thursday. 
Citing discussion at a CDC advisory committee meeting Wednesday, analysts pointed out that experts expressed concern that the temperatures required to store mRNA vaccines were ‘severely limiting’ to distributors' ability to ship the shots and to clinics' ability to administer them to a wide swath of patients.”

CDC director walks back testing guidance, but does not alter recommendations on website:”Disputed recommendations posted to the CDC website on Monday suggested people exposed to the coronavirus ‘do not necessarily need a test’ unless they're having symptoms, are older or are otherwise medically vulnerable.
In the new statement, the CDC's director, Dr. Robert Redfield, now says that ‘all close contacts of confirmed or probable COVID-19 patients’ may consider testing.”

US and UK are bottom of the pile in rankings of governments' handling of coronavirus pandemic:”A clear majority of people across the 14 countries said their own nation had handled Covid-19 well: 73% agreed, while 27% disagreed. 
But in the United Kingdom and the United States, the figures were much lower: 46% and 47% respectively. They're the only two countries where a minority of people said the government had done well. In every other country polled, most people said their government had done well, from Japan with 55% up to Denmark with 95%.” Opinions did differ substantially along political lines in several countries, including the US.

Chemical experts question EPA’s approval of coronavirus disinfectant: “With great fanfare, the Environmental Protection Agency on Monday gave emergency approval to a disinfectant it said would kill the coronavirus on surfaces for up to a week. Calling it ‘a major game-changing announcement,’ EPA Administrator Andrew Wheeler said the first to use the solution would be American Airlines and two sports clinics in Texas.
But health and chemical experts say the cleanser might actually harm passengers and flight attendants and do little to protect against the virus, which is mainly transmitted through the air in closed spaces…
The disinfectant is SurfaceWise2, made by Dallas-based Allied BioScience, whose main business is an earlier version of the cleanser.”

Asymptomatic Transmission of SARS-CoV-2 on Evacuation Flight: “Our research provides evidence of asymptomatic transmission of COVID-19 on an airplane. Further attention is warranted to reduce the transmission of COVID-19 on aircraft. Our results suggest that stringent global regulations for the prevention of COVID-19 transmission on aircraft can prevent public health emergencies.”

White House announces deal to provide 150 million rapid coronavirus tests: “The White House announced a deal Thursday with Abbott Laboratories to produce 150 million rapid coronavirus tests that will allow users to obtain results in 15 minutes from a small card.
The announcement of the $760 million agreement came just hours before President Trump was scheduled to deliver his nomination acceptance speech at the close of the Republican National Convention.”

Politics undermines COVID-19 vaccine confidence: “Health experts told National Journal they are concerned political pressure could influence the agency’s process to approve a COVID-19 vaccine. Trump has said he wants a vaccine by the end of this year…
More than 400 health experts, including many in public health and infectious disease, wrote to the FDA in early August urging the agency to wait until after Phase III trials to make vaccines widely available. The third phase of the trial provides most of the safety data while researchers also measure efficacy, according to the agency.”

Large U.S. covid-19 vaccine trials are halfway enrolled, but lag on participant diversity: “Moderna and Pfizer, the companies leading the U.S. race for a coronavirus vaccine, disclosed this week they have enrolled more than half the people needed for the 30,000-person trials that represent the final phase of testing. But only about a fifth of participants are from Black and Hispanic communities, which have been hit hardest by the virus — lagging what several experts said should be the bare minimum of diversity.”

About healthcare IT

9 health system malware, ransomware and phishing incidents this month:Read the summary for the types and scope of attacks.

About diagnostics

FDA Approves Foundation Medicine's FoundationOne®Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy Test with Multiple Companion Diagnostic Indications for Patients with Advanced Cancer: This information is from the company but it provides the best description of the test’s capabilities. “Liquid biopsies” are a significant breakthrough in screening.

About health insurance

12 million people have likely lost employer-sponsored health insurance since February: “For each person who is covered under their own employer’s plan, roughly two people on average are covered through employer-sponsored insurance (ESI) once spouses and dependents are included. This means that closer to 12 million people have been cut off from ESI coverage due to job losses in recent months.”

Today's News and Commentary

About the public’s health

COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card: The FDA issued “an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer…
A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result.
WHERE IT CAN BE USED:
This test could be used at point-of-care settings, like a doctor’s office, emergency room or some schools.  This test has been authorized for use in patients suspected of COVID-19 by their healthcare provider within seven days of symptom onset. Given the simple nature of this test, it is likely that these tests could be made broadly available. According to the test manufacturer, Abbott, it plans to make up to 50 million tests available monthly in the U.S. at the beginning of October 2020.“

Pence offers revisionist history of the coronavirus pandemic in the U.S.: Here is a good summary of the VP’s accounting of the COVID-19 pandemic and an accompanying fact check.

Individuals with obesity and COVID‐19: A global perspective on the epidemiology and biological relationships: The article is a good review of why obese persons do poorly when infected. One reason is: “Being an individual with obesity has modulatory effects on key immune cell populations critical in the response to SARS‐CoV‐2. Specifically, increased BMI is associated with greater frequency of the anti‐inflammatory CD4 T cell subsets Th2 and T regulatory cells. Increased anti‐inflammatory cells may inhibit the ability to reduce the infection, as inflammatory responses are needed to control viral spread.”

Covid-19 vaccine makers lobby EU for legal protection: The headline speaks for itself. We already have a vaccine harm compensation system in this country. Whether manufacturers will consider it enough protection remains to be seen.

New federal virus testing advice sparks criticism, confusion:”U.S. health officials sparked criticism and confusion after posting guidelines on coronavirus testing from the White House task force that run counter to what scientists say is necessary to control the pandemic. 
The new guidance says it’s not necessary for people who have been in close contact with infected people, but don’t feel sick, to get tested. It was posted earlier this week on the website of the Centers for Disease Control and Prevention. 
The CDC previously had advised local health departments to test people who have been within 6 feet of an infected person for more than 15 minutes. 
Across the country, public health experts called the change bizarre. They noted that testing contacts of infected people is a core element of public health efforts to keep outbreaks in check, and that a large percentage of infected people — the CDC has said as many as 40% — exhibit no symptoms.”

Covid-19 child cases in the US have increased by 21% since early August, new data shows: ”More than 70,000 new Covid-19 cases in children have been reported across the US since early August, new data shows.
Child cases increased by 21% between August 6 and August 20, according to an updated joint report from the American Academy of Pediatrics and the Children's Hospital Association. More than 440,000 children have been infected in the US since the start of the pandemic, the report said.”

Failure by WHO team to visit Wuhan sparks concerns over virus probe:”A recently concluded three-week trip to China by the two-person WHO team did not entail a visit to Wuhan, the central Chinese city where the first cases of novel coronavirus were detected in December 2019, the UN agency has confirmed. The WHO said the team was merely laying the groundwork in advance of a full international mission to investigate the virus but it was also vague on whether this larger task force would visit Wuhan.”

Sex differences in immune responses that underlie COVID-19 disease outcomes: “By focusing our analysis on patients with moderate disease who had not received immunomodulatory medications, our results revealed that male patients had higher plasma levels of innate immune cytokines such as IL-8 and IL-18 along with more robust induction of non-classical monocytes. In contrast, female patients mounted significantly more robust T cell activation than male patients during SARS-CoV-2 infection, which was sustained in old age. Importantly, we found that a poor T cell response negatively correlated with patients’ age and was associated with worse disease outcome in male patients, but not in female patients. Conversely, higher innate immune cytokines in female patients associated with worse disease progression, but not in male patients. These findings reveal a possible explanation underlying observed sex biases in COVID-19, and provide an important basis for the development of a sex-based approach to the treatment and care of men and women with COVID-19.”

Social Distancing Is a Lot More Complicated Than Staying 6 Feet Apart: The distancing and risk depend on indoors versus outdoors, length of exposure to others and their verbal activities (silent to singing). The article has an easy-to-read chart of risks under different circumstances.

About hospitals and health systems

These organizations are announcing second quarter (and first half) results for the year. Here are some examples that show the range of COVID-19’s impact.
Mayo generates $154M in operating income in Q2 despite sharp drops in volume due to COVID-19

Sutter Health posts $857M loss in first half of 2020 due to COVID-19

UPMC's revenue tops $11B in first half of year: “UPMC reported higher revenue in the first half of this year than in the same period of 2019, but the Pittsburgh-based health system's operating income declined year over year, according to unaudited financial documents.
UPMC reported revenue of $11.1 billion in the first six months of this year, up nearly $1 billion from the same period of 2019. A year-over-year decline in net patient service revenue attributed to volume declines linked to the COVID-19 pandemic was offset by gains in insurance enrollment revenue. Enrollment in UPMC's health plans grew to 3.9 million members as of June 30.”

About pharma

Anticoagulation [AC], Mortality, Bleeding and Pathology Among Patients Hospitalized with COVID-19: A Single Health System Study: “AC was associated with lower mortality and intubation among hospitalized COVID-19 patients. Compared to prophylactic AC, therapeutic AC was associated with lower mortality, though not statistically significant.”

Cassiopea scores FDA approval for Winlevi, the first novel acne med in decades:The medication works by targeting the androgen receptors directly in the skin.

FDA balks at recalls for 2 tuberculosis meds despite possible carcinogen contamination: “Despite finding elevated levels of possible carcinogens in tuberculosis meds rifampin and rifapentine, the FDA will not request a withdrawal from U.S. shelves over fears a recall would cause a supply shortage, the agency said Wednesday.”

6 recent drug, device recalls: Read the article for details.

FDA delays collecting drugmaker data required by CARES Act:”The FDA said this week that it won't begin collecting new data required from drugmakers under the Coronavirus Aid, Relief, and Economic Security Act…
Though the rule is set to take effect next month, the FDA says the electronic data submission portal it's developing for drugmakers to submit the information won't be ready by then…
The CARES Act sets new reporting requirements for drugmakers that are intended to improve the FDA's response to drug shortages. The rules require drugmakers to report shortages of drugs that are critical to public health during a public health emergency as well as the active pharmaceutical ingredients of those drugs. Drugmakers are also now required to report manufacturing volume data annually, including the amount of each drug that was manufactured, prepared, propagated, compounded or processed for commercial distribution…”

About health insurance

CMS needs another year to work on anticipated changes to the physician self-referral rule: “The Centers for Medicare and Medicaid Services is pushing back the timeline on anticipated modifications to the physician self-referral rule until August 2021, the agency revealed Wednesday. 
CMS first issued its proposed changes to the Stark Law—established to prevent docs from referring patients to entities in which they have a financial interest—back in October. Those revisions were meant to ‘modernize’ the law for the first time since its creation in 1989, carving out exceptions for providers in some value-based payment models.”

OIG warns Medicare Advantage encounter data have gaps in information critical to oversight: “A new watchdog report finds that Medicare Advantage encounter data often lack key information necessary to oversight.
The Department of Health and Human Services' Office of Inspector General found that MA encounter data are largely missing national provider identifiers (NPIs) for the providers ordering or referring services in the claims. 
Those data, according to the report, are crucial to tracking prescribing habits to catch any red flags as part of fraud and abuse oversight.”

Proposed 2021 Medicare Physician Payment and Quality Reporting Changes MGMA Member-Exclusive Analysis: A really good summary of proposed changes.

Trump admin alters key disaster policy for MA, Part D star ratings due to COVID-19: “CMS posts online star ratings on each MA and Part D plan based on a series of quality and performance measures. The rating is also used to determine the amount of quality bonus payments for plans…
The new emergency regulation changes a disaster policy that CMS implemented a few years ago to help plans that have a lot of beneficiaries in a natural disaster area.
The policy said that if 60% or more of a MA or Part D plan’s beneficiaries are in a federally designated disaster area then that plan’s star rating gets an adjustment to compensate. Over the past several years when the policy has been enacted, it has applied to a limited number of plans.
‘The disaster policy was not designed to address global pandemics,’ the rule said.
But the pandemic now counts as a disaster and most plans will be eligible for the disaster policy adjustments, CMS said in the rule. The agency said that if all U.S. plans are affected by the policy, then it will throw off the entire methodology for calculating and assigning star ratings.
So in the new rule CMS is removing the 60% policy for COVID-19 areas to ‘avoid having to exclude the vast majority of contracts from the methodology used to assign star ratings.’”

About healthcare professionals

Women in healthcare: Moving from the front lines to the top rung: 2nd annual McKinsey report found that: “Women account for 66 percent of all entry-level healthcare employees—an increase of three percentage points since last year—compared with 49 percent across all US industries. While the share of women declines in more senior roles, moving to 30 percent of C-suite positions, healthcare still outperforms all industries.”

About healthcare IT

Introducing Amazon Halo and Amazon Halo Band: “Amazon today introduced Amazon Halo, a new service dedicated to helping customers improve their individual health and wellness. Amazon Halo combines a suite of AI-powered health features that provide actionable insights into overall wellness via the new Amazon Halo app with the Amazon Halo Band, which uses multiple advanced sensors to provide the highly accurate information necessary to power Halo insights. Customers in the U.S. can request early access to Amazon Halo starting today, with the Amazon Halo Band and 6 months of Halo membership available for a special price of $64.99…
 Amazon Halo Band is purpose-built to focus on your health and wellness—unlike smartwatches and fitness trackers, it doesn’t have a screen or constant notifications. The small sensor capsule delivers highly accurate data, and includes an accelerometer, a temperature sensor, a heart rate monitor, two microphones, an LED indicator light, and a button to turn the microphones on or off, among other functions. Amazon Halo Band is water resistant for all-day wear and the comfortable fit means it won’t snag or irritate at night. Plus, the battery lasts up to seven days and fully charges in under 90 minutes. Customers can choose from three fabric band colors at purchase, with fabric and silicone sport accessory bands available in 15 additional colors.”

Today's News and Commentary

About the public’s health

Syringe shortage could hamper delivery of Covid-19 vaccine, experts warn:”US companies make roughly 663m syringes a year but the Trump administration has calculated that an extra 850m may be needed.”

Africa to be declared free of polio: Afghanistan and Pakistan are the last two places with wild polio virus.

Overview of Testing for SARS-CoV-2 (COVID-19): Latest recommendations from the CDC. For example:
”If you have been in close contact (within 6 feet) of a person with a COVID-19 infection for at least 15 minutes but do not have symptoms:

• You do not necessarily need a test unless you are a vulnerable individual or your health care provider or State or local public health officials recommend you take one.”

Mayo Clinic study finds uptick in chest pain searches online amid COVID-19, even as ED visits for heart problems drops: “Mayo Clinic researchers may lend more evidence that patients were trying to avoid a trip to the emergency room. In a study published this week in JMIR Cardio, the resesarchers found a correlation between online searches for chest pain symptoms and reports of fewer people going to the emergency department with acute heart problems.”

About hospitals

NRC Health Consumer Loyalty Award: See this site for award winners.

About pharma

10 most expensive drugs in the US (by annual list price): The list is headed by AveXis’ spinal muscular dystrophy drug Zolgensma, at $2,125,000.

FDA may fine drugmakers, universities $10K for failing to report clinical trial results:”The FDA has released final guidelines for penalizing companies and universities that fail to report clinical trial results. 
According to the guidance, clinical trial sponsors that don't provide required information to ClinicalTrials.gov may face a $10,000 fine for each infraction. “

Teva indicted on U.S. price-fixing charges after walking away from settlement offers: “With the walls closing in around it on a yearslong generics price-fixing probe, Israeli drugmaker Teva faced two options: Reach a deal with prosecutors or gamble. Teva chose to roll the dice, and now it finds itself facing conspiracy charges—and a potentially bigger penalty on the horizon.
Federal prosecutors have charged Teva with conspiring to fix prices for a range of generic medicines between 2013 and 2015 as part of an industrywide scheme to overcharge consumers by more than $350 million, the U.S. Department of Justice (DOJ) said in a Tuesday release.”

Patients over 50 may take meds less if pill appearance changes a lot, study says: “A lack of consistency in the appearance of prescription drugs may contribute to medication nonadherence, a study conducted by researchers from Brigham and Women's Hospital and Harvard Medical school found.”

Celltrion taps Intract Pharma to develop world's first oral Remicade biosimilar:”South Korea's Celltrion has teamed up with U.K.-based drug delivery firm Intract Pharma to codevelop the world's first tablet version of infliximab, a biosimilar of Johnson & Johnson's immunology blockbuster Remicade. With intravenous and subcutaneous versions of the drug already under its belt, Celltrion hopes the tie-up will further secure its position in the Crohn's disease and ulcerative colitis fields. “
The development of an oral medication in this category is a huge innovation.

U.S. cities with the highest, lowest prescription drug costs: San Francisco, NY City and LA head the list.

Drugmakers deliver counteroffer to Trump international pricing plan: “The industry is offering to cut prices for physician-administered drugs in Medicare Part B by 10 percent. The administration estimated its original plan to link payments to lower costs abroad would save 30 percent.
Under the industry plan, Medicare’s Innovation Center would test a voluntary Part B model in which manufacturers would provide a ‘market-based’ discount for covered drugs that translates to a roughly 10 percent reduction in average sales price. The demo would also reduce cost sharing for those medicines to a set dollar amount between $15 and $20.”

About medical devices

Medtronic reports 44% drop in quarterly income as it begins to recover from COVID-19: This effect is from the reduction in elective procedures also causing revenue reductions in provider organizations.

About healthcare IT

What HIPAA law? Study finds future healthcare employees would consider violating privacy laws for cash: “A study of graduating students looking to go into the healthcare field found that close to half (46%) said they would violate federal privacy regulations for an amount of money ranging from $1,000 to more than $10 million.” The entire article is worth reading. Note the different scenarios the researchers presented for responses.

Interoperability can cut health costs by $30B. But this needs to happen first: Read the article for a list of what it will take to make interoperability happen. My #1 is to assure data security/confidentiality.

Innovation Improves Care Delivery Around the World: “Allscripts Healthcare Solutions was recently awarded five separate patents over the course of just eight days…
Each of the patents recently awarded contributes to streamlining and improving healthcare delivery. For example, one of the patents is for an application that connects electronic health records (EHRs) to various wellness applications to provide patients frictionless goal-tacking functionality, which directly leads to a higher level of patient engagement. Another application enables API calls from EHRs to initiate searches over genetic testing data stores. A patent was also issued for an application that helps organizations secure data in a HIPAA-compliant manner that will not cause performance issues that are often associated with typical encryption practices.”

About health insurance

Alphabet's Verily breaks into stop-loss health insurance market backed by Swiss Re: “Verily Life Sciences is expanding into the health insurance market with a focus on employer stop-loss insurance.
The Alphabet company will leverage its expertise in hardware, software and data science to offer a new data-driven solution for employers, the company said Tuesday.
The Verily subsidiary, called Coefficient Insurance Company, will be backed by Swiss Re Corporate Solutions, the commercial insurance unit of the Swiss Re Group, through a minority investment.”

Aetna fined for denying ER claims in California: “Aetna Health of California must stop using national standards to deny payment for emergency room claims, the California Department of Managed Health Care ordered Aug. 25. 
The department said the practice has led to Aetna wrongfully denying ER claims because California's broader standards on ER services aren't being applied. Aetna faces a $500,000 fine for repeatedly not following California law and failing to implement improvements.
Under California law, health plans must pay for emergency medical services unless there is proof the services didn't occur or an enrollee didn't need ER care. The department reviewed a sample of Aetna's denials for ER services and found 93 percent of the sampled claims were wrongfully denied.”

Today's News and Commentary

About the public’s health

Some Trump administration claims on effectiveness of convalescent plasma are wrong or dubious, scientists say: The head of the FDA mixed up relative and absolute risk. If the absolute risk goes down from 3 in 100 to 2 in 100, the relative risk is reduced by 33%. He said the equivalent of: the risk reduction is 33 in 100. (The number he used was 35.)

WHO says 172 countries engaging with global COVID-19 vaccine plan: The headline speaks for itself.

Heterogeneous trends in burden of heart disease mortality by subtypes in the United States, 1999-2018: observational analysis of vital statistics: “Heart failure and hypertensive heart disease account for the greatest increases in premature deaths and the largest black-white disparities and have offset declines in ischemic heart disease. Early and targeted primary and secondary prevention and control of risk factors for heart disease, with a focus on groups at high risk, are needed to avoid these suboptimal trends beginning earlier in life.”

EPA approves coronavirus cleanser for emergency use in Texas: “The Environmental Protection Agency gave emergency approval Monday for the application of a cleanser intended to kill the novel coronavirus on surfaces for up to seven days, and the state of Texas said it would allow American Airlines and two branches of Total Orthopedics Sports & Spine to start using the new product.
The agency said it hoped the product — called SurfaceWise2 and made by Allied BioScience — would provide longer-lasting protection in public spaces and increase consumer confidence in air travel, which has suffered a big hit during the covid-19 pandemic.”

About hospitals and health systems

Changes in Hospital Income, Use, and Quality Associated With Private Equity Acquisition: “Hospitals by private equity were associated with larger increases in net income, charges, charge to cost ratios, and case mix index as well as with improvement in some quality measures after acquisition relative to nonacquired controls. Heterogeneity in some findings was observed between HCA and non-HCA hospitals.”

And in a related article, see: Private equity pushes into healthcare: 5 latest deals.

Beaumont loses confidence of more than 650 nurses: More potential problems for the merger with Advocate Aurora.

About health insurance

 Insurers' EBITDA up 87% year over year in Q2: “Insurers posted "unusually strong" financial performance in the second quarter, according to a new analysis from Moody's Investors Service.
Payers' earnings before interest, taxes, depreciation and amortization (EBITDA) was up 87% year over year, largely due to significant declines in care utilization, the analysts said. However, while the firm maintains the stable outlook for the industry, there are several trends threatening to shake things up in the second half of the year.
For one, deferred services are returning and volumes are stabilizing.”

Humana files suit against telehealth company QuivvyTech over millions in alleged false claims: “Humana has filed suit against Florida-based telehealth company QuivvyTech, saying it was defrauded out of millions of dollars.
According to the suit, filed in Southern Florida district court, QuivvyTech telemarketers would cold-call Humana members and ask them questions about common ailments. They would then wire that information to physicians who were in the scheme to secure prescriptions for pricey, unneeded creams.
The physicians would prescribe these creams without ever speaking to the patient directly, according to the lawsuit. The prescriptions would then be wired to pharmacies that were also active participants in the scheme to be dispensed to members, Humana said.”

About healthcare IT

3 new health features part of Fitbit's latest smartwatch rollout: “Fitbit has rolled out more advanced health monitoring features including an ECG app and sensors to track stress levels and changes in skin temperature.
It's part of the wearable giant's transition from fitness tracking to being a platform that puts consumers in control of their health, said James Park, Fitbit co-founder and CEO, during a virtual presentation for reporters Monday.”

Ascension move to outsource IT will eliminate 'a few hundred' jobs:”The health system has created ‘digital studios’ in three locations and investing in data sciences as part of those capabilities…”

About pharma

The 10 prescriptions most frequently filled at pharmacies: These medicines are commonly prescribed generics.

Today's News and Commentary

About pharma

Is Avoidable Experiment Expenditure Draining Billions from COVID-19 Research?: Really good review of the costs of drug development and avoidable experiment expenditures [AEE] that needlessly increase that cost. “Multiple factors contribute to AEE, including inappropriate reagents, poor experimental design, unreliable or variable protocols, lack of details in reporting, and lack of transparency in internal data. However, inappropriate reagents are the most significant individual contributor, responsible for over a third of AEE, or more than $17 billion.”

Trump hails FDA's authorization of plasma treatment for coronavirus, after slamming agency:”The FDA, explaining its decision, cited early evidence suggesting blood plasma can decrease mortality and improve the health of patients when administered in the first three days of their hospitalization.” The bottom line on this treatment is that it may help and probably doesn’t cause harm (like hydroxychloroquine). But randomized controlled trials still have not been done.

Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: “Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.”

About the public’s health

One in three U.S. high school students vaped in 2019, CDC says:”That figure is more than twice that of 2017, the last time the [CDC"] assessed vaping among teens, when 13% reported using these tobacco products, the data showed…
Roughly 37% of high school students surveyed identified as "current users" of tobacco products in 2019, up from 20% in 2017, while 8.2% acknowledged using two or more tobacco products last year, the CDC said.”

Covid-19 Live Updates: Researchers Document First Case of Virus Reinfection: “Researchers in Hong Kong are reporting the first confirmed case of reinfection with the coronavirus.
‘An apparently young and healthy patient had a second case of Covid-19 infection which was diagnosed 4.5 months after the first episode,’ University of Hong Kong researchers said Monday in a statement.”

Travel during the COVID-19 Pandemic: An update from the CDC.

About healthcare IT

Telehealth Skyrocketing Among Older Adults: “During the first three months of the pandemic, one in four patients over 50 years of age used telehealth -- way up from the 4% who did so in 2019.”

Billions in Hospital Virus Aid Rested on Compliance With Private Vendor:”The Trump administration tied billions of dollars in badly needed coronavirus medical funding this spring to hospitals’ cooperation with a private vendor collecting data for a new Covid-19 database that bypassed the Centers for Disease Control and Prevention.
The highly unusual demand, aimed at hospitals in coronavirus hot spots using funds passed by Congress with no preconditions, alarmed some hospital administrators and even some federal health officials.”

About healthcare professionals

July survey shows more physicians are meeting patients face-to-face:”Our latest survey of 1107 physicians (conducted by Medefield across 10 countries between July 25 and Aug 5) shows that over 90% of respondents are now consulting with patients face-to-face, compared to a rate of 70% in May. Concurrently there has been a drop off in the number of physicians engaging with patients by telephone or video call over this period.”

About hospitals and health systems

Hospital operating margins down 96% compared to last year, Kaufman Hall finds: “Without federal relief aid, hospital operating margins have fallen 96 percent in the first seven months of 2020, compared to the same period last year, according to a new Kaufman Hall report.
However, even including funding from the Coronavirus Aid, Relief, and Economic Security Act, hospital operating margins still are down 28 percent from January to July.”

Today's News and Commentary

About health insurance

Covid-19 Vaccination Costs to Strain State Medicaid Programs: “Getting millions of Covid-19 vaccine doses to the poorest adults in the country will require budget-conscious Medicaid plans to get creative with dwindling resources and a patchy health-care system not designed for mass inoculation.”

Many Private Insurers Offer Financial Relief for COVID-19 Treatment, but Cost-Sharing Waivers Are Expiring:”About 88% – nearly nine in ten – enrollees in the individual and fully-insured group markets are covered by plans that have taken action to limit out-of-pocket costs for patients undergoing treatment for COVID-19 since the start of the pandemic. However, after accounting for waivers that have already expired (20%) or are scheduled to expire by the end of September (16%), just over half of enrollees in these plans will still be eligible for waived cost-sharing in October and beyond.
The estimates do not include the 61% of group market enrollees in self-insured plans through their employers.”

UC Health settles Medicare fraud allegations: “Cincinnati-based UC Health has agreed to pay $3.1 million to settle Medicare fraud allegations, according to The Cincinnati Enquirer. 
The settlement, announced Aug. 20, resolves allegations brought in 2018 by Donald Lynch, MD, an interventional cardiologist employed by the health system. He alleged the system illegally billed Medicare for trascatheter aortic valve replacements. UC Health needed to have performed at least 50 of the surgeries the year prior to bill for the procedures, and it had allegedly performed about half that amount, a lawyer representing Dr. Lynch told The Cincinnati Enquirer. 
UC Health did not admit to the allegations as part of the settlement.”

Centene underpaid physicians affiliated with TeamHealth, court says:”Under the verdict, a six-person jury in the U.S. District Court for the Eastern District of Arkansas found Centene and its subsidiaries breached their contract with Southeastern Emergency Physicians by underpaying ER claims and delaying reimbursement. The jury found Centene and its affiliates are liable for $9.4 million in underpayments to the ER physicians.”

About the public’s health

For Joe Biden, it's all about fixing the coronavirus pandemic: A good summary of his acceptance speech last night.

What if We Worried Less About the Accuracy of Coronavirus Tests?: Nothing new in this article but it is a good explanation of the advantage of testing pooled samples.

Ultraviolet UVC sanitizers can be dangerous and have limited use against coronavirus, warns FDA: “‘The effectiveness of UVC lamps in inactivating the SARS-CoV-2 virus is unknown because there is limited published data about the wavelength, dose, and duration of UVC radiation required to inactivate the SARS-CoV-2 virus,’ the FDA said in a newly posted statement.”

Trump administration bars FDA from regulating some laboratory tests, including for coronavirus:”The new policy stunned many health experts and laboratories because of its timing, several months into a pandemic. Some public health experts warned the shift could result in unreliable coronavirus tests on the market, potentially worsening the testing crisis that has dogged the United States if more people get erroneous results. They argued the change is unlikely to solve current testing problems, which at this point are largely due to shortages of supplies such as swabs and chemical reagents.”

About healthcare IT

HHS denies report COVID-19 hospital data going back to CDC:”The Department of Health and Human Services is denying a report by the Wall Street Journal which stated that hospitals would return to the practice of sending critical COVID-19  data to the Centers for Disease Control and Prevention. Data collection was moved to HHS in July.
‘HHS made repeated attempts to explain to the Wall Street Journal that the process for COVID-19 data reporting has not and is not changing,’ said Michael Caputo, HHS Assistant Secretary for Public Affairs in a statement to TEGNA. ‘This false reporting will sow more confusion and only undermines the public health response.’”

About hospitals and health systems

Two systems report financial results:

Mayo Clinic's operating income drops 48.7%: “Rochester, Minn.-based Mayo Clinic recorded a net operating income of $154 million in the second quarter of 2020, a decrease of 48.7 percent compared to the same period last year, according to recently released financial documents.”

Sutter Health posts net income in second quarter after $1B first-quarter loss:”Sacramento, Calif.-based Sutter Health saw its financial picture improve in the second quarter of 2020, after  posting a $1.1 billion loss in the first quarter, according to recently released financial documents.
Sutter Health recorded a net income of $220 million in the second quarter of 2020. This compares to a net income of $113 million in the same quarter one year prior.”

About healthcare technology

Agile mobile robotic platform for contactless vital signs monitoring: “To eliminate the need for in-person contact for vital signs measurement in the hospital setting, we developed Dr. Spot, an agile quadruped robotic system that comprises a set of contactless monitoring systems for measuring vital signs and a tablet computer to enable face-to-face medical interviewing. Dr. Spot is teleoperated by trained clinical staff to facilitate enhanced telemedicine. Specifically, it has the potential to simultaneously measure skin temperature, respiratory rate, heart rate, and blood oxygen saturation simultaneously while maintaining social distancing from the patients.”

Bayer to pay $1.6 billion to resolve U.S. claims for Essure birth-control device: “…Bayer said on Thursday it will pay around $1.6 billion to settle the majority of U.S. claims involving its Essure birth-control device…
Bayer said the Essure settlement is for around 90% of the nearly 39,000 claims by women alleging injury from the devices and that it was in discussion with counsel for the remaining plaintiffs.”

About pharma

Efficacy of Remdesivir in COVID-19: A JAMA editorial that is a good summary of the topic. Conclusion: “First, the optimal patient population is unclear. Second, the optimal duration of therapy is unclear. Third, the effect on discrete clinical outcomes is unclear. Fourth, the relative effect of the drug if given in the presence of dexamethasone or other corticosteroids is unclear. Some of the RCT findings suggest remdesivir could improve recovery for many millions of individuals around the world who may be hospitalized with COVID-19. However, the costs to produce and distribute remdesivir at such scale are considerable, and, most importantly, whether remdesivir offers incremental benefit over corticosteroids, which are widely available and inexpensive, is unknown. It therefore seems prudent to urgently conduct further evaluations of remdesivir in large-scale RCTs designed to address the residual uncertainties and inform optimal use.”

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About employer-sponsored care

2021 Large Employers’ Health Care Strategy and Plan Design Survey: This survey includes businesses with 9 million employees. Among the key findings:

More than ever, employers consider healthcare strategy and integral part of workforce strategy.

The top three areas on which employers are focusing are: virtual care; expand access to behavioral health services; and high cost claims.

About health insurance

Supreme Court to hear arguments on pivotal case that decides fate of ACA after election: “The Supreme Court will hear oral arguments in a lawsuit over the constitutionality of the Affordable Care Act (ACA) on Nov. 10, a week after the presidential election.” The appearance was going to be after the election, so this news just sets a date.

HHS Quietly Makes It Easier to Sign Up for Obamacare: “The Department of Health and Human Services recently changed a question on the application for Affordable Care Act insurance to indicate that losing coverage since the start of the year allows people to sign up outside of the normal open enrollment period, according to people following ACA coverage.
Previously, the application for such coverage on the federal HealthCare.gov website used in 38 states asked if people had lost their coverage in the last 60 days—and the agency hasn’t made any announcement of the change."

About emerging technology

Research delivers new insight into how skin can regenerate after severe burns or injuries: By altering a burn’s microenvironment, certain regenerative cells’ genes can be turned on to promote normal skin healing instead of scarring. The article has an easily understandable explanation of how this process works.

About pharma

Drugmakers Take Own Steps to Narrow Drug Discount Program: “The program, known as 340B, requires drug companies to offer steep discounts on their products to hospitals with primarily low-income patients. Patients can also get the discounts at multiple pharmacies as long as they are associated with the 340B hospital.
AstraZeneca PLC will limit discounts to the hospitals themselves and only one pharmacy per 340B facility, the company said this week. And starting Oct. 1, Novartis will require 340B facilities to submit drug claims data to a third-party vendor to ensure they aren’t getting duplicate discounts…
The latest actions mirror similar changes Sanofi, Merck & Co. Inc., and Eli Lilly and Co. made earlier this summer.”

Drug costs for COVID-19 patients plunge at U.S. hospitals, but may rise: “Research by the health data firm IllumiCare and exclusively shared with Reuters found that hospitals spent $1,090 per COVID-19 patient on medication in July. That was down from $3,011 in May among more than 50 hospitals in 10 states that were analyzed.

Several factors drove down the number. The average length of stay for COVID-19 patients declined by nearly 30%, from 9.6 days in April to 6.8 days in July, the hospital data show. And the number of medications used dropped by 22%, from nearly 20 individual drugs in April to 15.4 drugs in July.”

Takeda to sell OTC drug business to US private equity firm for $2.37B: “Japan-based Takeda Pharmaceutical will sell its over-the-counter drug business to Blackstone Group, a U.S. private equity firm, for $2.37 billion…”

Democrats say the Postal Service is delaying prescription deliveries, but pharmacies don't agree: The headline speaks for itself. This issue is the other side of the politics of slowing down the mails.

About the public’s health

Pharmacists can give childhood shots, U.S. officials say: “Pharmacists in all 50 states are now allowed to give childhood vaccinations under a new directive aimed at preventing future outbreaks of measles and other preventable diseases.
Alex Azar, the head of the U.S. Department of Health and Human Services, took the step using emergency powers he has during the U.S. coronavirus epidemic, which was declared a public health emergency. The directive announced Wednesday will temporarily preempt restrictions in 22 states starting this fall.
The move is designed to help prevent vaccination rates from falling during the pandemic, Azar said.”

COVID Testing Choke Points: An interesting article with useful graphics that looks at testing logistics and bottlenecks.

About diagnostics

FDA Removes Need for Confirmatory Testing for 23andMe Pharmacogenetics Report: “California-based genetic testing company 23andMe has received an expanded 510(k) clearance from the FDA for its pharmacogenetics report for clopidogrel, a drug prescribed for certain heart conditions, and citalopram, a depression med.” The significance is that a strictly family-search/ancestry company is now a legitimate genetic testing firm.

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About pharma

J&J to buy Momenta for $6.5 billion: “Johnson & Johnson announced Wednesday that it entered into a definitive agreement to acquire Momenta Pharmaceuticals for $52.50 per share in cash, or approximately $6.5 billion, a deal it says broadens its position in immune-mediated diseases and allows it an opportunity to expand into autoantibody-driven diseases.”

Report shows Medicare spent more than $1.4 billion on discarded drugs during 2017 and 2018: “Medicare spent more than $1.4 billion on drugs that would eventually be wasted or discarded between 2017 and 2018, according to a report from MedicareAdvantage.com.
The majority of the medications that went unused were chemotherapy and cancer-treating drugs. In 2018, Medicare spent $392.3 million and $115.1 million, respectively, on discarded chemotherapy and anti-cancer drugs. They were wasted because the single-dose vials of medication had a higher dose than necessary to treat the average patient, according to the report from the company that bills itself as one of the largest Medicare sellers in the country.”

Famotidine linked to improved outcomes in COVID-19: “In hospitalized patients with COVID-19, famotidine was correlated with a lower mortality risk, lower risk for combined mortality and intubation outcomes and lower serum markers for severe disease, according to a study published in the American Journal of Gastroenterology.”

Novartis and Roche tee up self-injected Xolair option with FDA filing for prefilled syringe: “Novartis and Roche have struggled to keep their aging asthma blockbuster Xolair relevant, especially as competition from rival drugs—like Sanofi and Regeneron's blockbuster Dupixent—mop up sales.
But now, the drugmakers are advancing a prefilled syringe version that would allow patients and caregivers to inject the drug themselves, padding the case for Xolair's convenience in the pandemic era. The self-administration option is under review at the FDA, with a decision due early next year.”
The self-administered product would be covered by prescription drug benefit instead of the office benefit.

About the public’s health

Just for fun, check this website.

HHS Releases Healthy People 2030 with National Disease Prevention and Health Promotion Objectives for the Next Decade: The U.S. Department of Health and Human Services “released Healthy People 2030, the nation's 10-year plan for addressing our most critical public health priorities and challenges. Since 1980, HHS's Office of Disease Prevention and Health Promotion has set measurable objectives and targets to improve the health and well-being of the nation.
This decade, Healthy People 2030 features 355 core – or measurable – objectives with 10-year targets, new objectives related to opioid use disorder and youth e-cigarette use, and resources for adapting Healthy People 2030 to emerging public health threats like COVID-19. For the first time, Healthy People 2030 also sets 10-year targets for objectives related to social determinants of health.”

FDA halts COVID-19 blood plasma emergency approval: “As the FDA was prepping to allow emergency use of blood plasma donation from recovered COVID-19 patients, government officials have put pay to that.  
The authorization is on hold for now as more data are reviewed, and H. Clifford Lane, M.D., clinical director at the National Institute of Allergy and Infectious Diseases, said an emergency approval could still be issued in the near future, as quoted by The New York Times.
This comes after National Institutes of Health leader Francis Collins, M.D., and COVID-19 response leader Anthony Fauci, M.D., recently questioned how efficacious treatments from it could be.”

New U.S. ethics board rejects most human fetal tissue research proposals: “An ethics board convened by the Trump administration today recommended that the United States refuse to fund all but one in a group of applications to do medical research using human fetal tissue donated after elective abortions. The applications, made to the U.S. National Institutes of Health (NIH), had already been recommended for funding by scientific reviewers and had met existing legal requirements for ethical use of the tissue."
The Human Fetal Tissue Research Ethics Advisory Board, appointed by Health and Human Services (HHS) Secretary Alex Azar, reviewed the 14 proposals last month. Its recommendations that 13 of them be rejected, delivered to Azar and Congress today, were the first under a new regime implemented last year by the Trump administration, in which projects by extramural, NIH-funded scientists using human fetal tissue need to pass an extra layer of ethics review.”

Coronavirus in the U.S.: Latest Map and Case Count: An update: “At least 1,349 new coronavirus deaths and 43,226 new cases were reported in the United States on Aug. 18. Over the past week, there have been an average of 49,102 cases per day, a decrease of 17 percent from the average two weeks earlier.
As of Wednesday morning, more than 5,498,300 people in the United States have been infected with the coronavirus and at least 171,800 have died, according to a New York Times database.”

More infectious coronavirus mutation may be 'a good thing', says disease expert: “An increasingly common mutation of the novel coronavirus found in Europe, North America and parts of Asia may be more infectious but appears less deadly, according to a prominent infectious diseases doctor.”

ClearMask Receives FDA OK for Transparent Surgical Mask: “The FDA has granted ClearMask 510(k) clearance for its fully transparent surgical mask, the first one to be fully cleared by the agency.
The transparent mask helps improve visual communication, ‘which may help avoid costly errors and adverse outcomes,’ the company said.”

Many Americans may not comprehend COVID-19 information as agencies fail to meet health literacy guidelines, study says: “The U.S. Centers for Disease Control and Prevention, the White House and state health departments failed to meet guidelines when communicating vital information about COVID-19 to the public, according to a study released Tuesday.
The CDC, the American Medical Association and the National Institutes of Health all recommend that medical information for the public be written at no higher than an eighth-grade reading level. 
But after studying 137 federal and state web pages, Dartmouth College researchers found that public information about the coronavirus averaged just over an 11th-grade reading level.”

Facebook funnelling readers towards Covid misinformation - study: “Websites spreading misinformation about health attracted nearly half a billion views on Facebook in April alone, as the coronavirus pandemic escalated worldwide, a report has found.
Facebook had promised to crack down on conspiracy theories and inaccurate news early in the pandemic. But as its executives promised accountability, its algorithm appears to have fuelled traffic to a network of sites sharing dangerous false news, campaign group Avaaz has found.
False medical information can be deadly; researchers led by Bangladesh’s International Centre for Diarrhoeal Disease Research, writing in The American Journal of Tropical Medicine and Hygiene, have directly linked a single piece of coronavirus misinformation to 800 deaths.”

Mexico moves to ban junk food sales to children, citing obesity as coronavirus: “Spurred by growing evidence that being overweight increases the risk of serious illness with an infection by the novel coronavirus, a number of Mexican states are moving to ban the sale of junk food to children.
On Monday, legislators in Tabasco voted to prohibit the sale of sugar-sweetened beverages and highly processed foods to anyone under 18, just 12 days after Oaxaca took similar action.”

About health insurance

Cleveland Clinic, Aetna partner to curb employer health spending by 10%: “Cleveland Clinic and Aetna are forming an accountable care organization that includes the launch of a co-branded insurance plan designed for employers in Northeast Ohio and expanded access to the health system for second opinions and heart care.  
The health system and payer say employers that enroll in their new Aetna Whole Health – Cleveland Clinic co-branded commercial plan could save as much as 10 percent in healthcare spending compared to a current Aetna broad network plan. Members of the health plan can receive care from the Cleveland Clinic Quality Alliance network of employed and independent community physicians or at any Cleveland Clinic facility, and the system will be rewarded for meeting quality and cost targets.”

U.S. Health Insurance Coverage in 2020: A Looming Crisis in Affordability: From the Commonwealth Fund, a couple highlights from the report:

• “In the first half of 2020, 43.4 percent of U.S. adults ages 19 to 64 were inadequately insured. This is statistically unchanged from the last time we fielded the survey in 2018.

• The adult uninsured rate was 12.5 percent. In addition, 9.5 percent of adults were insured but had a gap in coverage in the past year and 21.3 percent were underinsured. These findings are also statistically unchanged from 2018.”

Aetna and Lyft to give schools access to essential rides for families: ”Aetna… announced it will give $100,000 in essential rides for families in school districts around the country such as Chicago, Denver, Baltimore and Seattle, in collaboration with the National School Boards Association (NSBA) and Lyft to help families this school year.”

HHS extends application deadlines for financial assistance programs: “HHS announced that Medicaid, Medicaid managed care, Children's Health Insurance Program and dental providers as well as certain Medicare providers experiencing financial difficulty stemming from COVID-19 now have until Aug. 28 to apply for funding relief.”

About health IT

Fitbit posts early findings showing its trackers can identify cases of COVID-19 before symptoms take hold: “Since launching a study to see whether its wearable activity trackers could pick up on the early signs of a COVID-19 infection, Fitbit has enrolled over 100,000 participants across the U.S. and Canada and is now delivering its first, preliminary results 90 days later.
That includes at least 1,100 users who have tested positive for the novel coronavirus. By tracking subtle changes in a person’s heart rate, breathing, physical activity and quality of sleep, Fitbit aims to develop an algorithm that can highlight potential cases before symptoms start.
So far, the company said its devices have been able to detect nearly half of COVID-19 cases at least one day before the participant reported any of the disease’s symptoms, such as fever, cough or muscle aches.”

Hospital adoption of electronic health record functions to support age-friendly care: results from a national survey: “Despite significant national investment in EHRs, hospital EHRs do not yet include key documentation, exchange, and communication functions needed to support evidence-based care for the older adults who comprise the majority of the inpatient population.”

COVID-19–Related Infodemic and Its Impact on Public Health: A Global Social Media Analysis: “We identified 2,311 reports of rumors, stigma, and conspiracy theories in 25 languages from 87 countries. Claims were related to illness, transmission and mortality (24%), control measures (21%), treatment and cure (19%), cause of disease including the origin (15%), violence (1%), and miscellaneous (20%). Of the 2,276 reports for which text ratings were available, 1,856 claims were false (82%).” Also, see above Facebook funnelling readers towards Covid misinformation - study

How did Novo Nordisk's Sophia chatbot become a pharma industry standard? Empathy, timing and relevance: experts: Interesting insight into Voice User Interface (VUI).

About hospitals and health systems

Assessment of Costs of Avoidable Delays in Intensive Care Unit Discharge: “In this study, potentially avoidable discharge delay occurred for most patients admitted to ICUs across a large integrated health system and translated into substantial associated health care costs.”
In addition to costs, the delays tie up beds needed for critically ill patients.

Beaumont delays vote on Advocate Aurora merger to address physician complaints: “The board of trustees of Southfield, Mich.-based Beaumont Health agreed last week to postpone voting on a planned merger with Advocate Aurora Health until physician grievances are addressed. 
The trustees decided to delay the vote after physicians presented the results of a seven-question survey completed by 1,500 of Beaumont's 5,000 physicians. The results of the survey, which was developed by physician leaders, were critical of Beaumont's management and proposed merger with Advocate Aurora…”

Today's News and Commentary

About health insurance

Judge blocks HHS from rolling back LGBT anti-discrimination protections:”A New York federal judge blocked the Department of Health and Human Services from lifting anti-discrimination protections for LGBT patients. 
In June, HHS announced a finalized rule (PDF) to eliminate protections for transgender individuals provided under the Affordable Care Act (ACA). During the Obama administration, HHS announced it would bar providers that receive federal funding from discriminating on the basis of gender identity under a part of the ACA known as Section 1557.”

Pennie'-pinching states take over Obamacare exchanges from feds: “Pennsylvania is one of six states shifting in the next several years from the federal insurance exchange to run their own online marketplaces, which determine eligibility, assist with enrollment and connect buyers with insurance companies. They will join 12 states and the District of Columbia with self-contained exchanges.”

‘A Disconnect’: Insurer Sees Loophole In Trump Policy On Pooled Tests: “Insurers may have found a loophole in Congress' COVID-19 diagnostic testing coverage requirements: pooled test results. Trump administration officials have hailed pooling COVID-19 testing samples as a way to increase testing capacity while conserving supplies, but at least one insurer [Cigna] tried to exempt themselves from paying for any sort of pooled testing under a standard set in guidance from the Trump administration.”

Court Affirms CSR [Cost Sharing Reduction] Reimbursement, But Amount Still Questionable: This article is a good explanation/update of this issue. While the court ruled the CSR payments must be made, a “lower court will have to determine how much the government should pay in 2017 cost-sharing reduction reimbursement while accounting for 2018 premium tax credits.”

CMS Hikes Medicare Inpatient COVID-19 Payments 20%: The headline speaks for itself. To qualify for payments:
”Medicare patients must have a verifiable positive COVID-19 lab test within 14 days of admission, either at the hospital or before admission [and]
Only the results of viral testing (i.e., molecular or antigen) that are consistent with Centers for Disease Control and Prevention guidelines can be used.”

Hospitals must repay Medicare for $100B pandemic lifeline: This total is only through May.

About the public’s health

Cardiorespiratory Fitness in Youth: An Important Marker of Health: The problem the article addresses is : Cardiorespiratory fitness (CRF) “is an important marker of physical and mental health and academic achievement in youth. However, only 40% of US youth are currently believed to have healthy CRF.”
Read the article for more information about interventions.

Association Between Bisphenol A Exposure and Risk of All-Cause and Cause-Specific Mortality in US Adults:”Bisphenol A (BPA) is a major public health concern because of its high-volume industrial production, ubiquitous exposure to humans, and potential toxic effects on multiple organs and systems in humans….
In this nationally representative cohort of US adults, higher BPA exposure was significantly associated with an increased risk of all-cause mortality. Further studies are needed to replicate these findings in other populations and determine the underlying mechanisms.”

Racial Disproportionality in Covid Clinical Trials: The headline speaks for itself. The article contains more details. We know different populations respond differently to treatments, so the need for diversity is more than a social equity issue.

Coronavirus now third leading cause of death in U.S.: former CDC official: “As the coronavirus pandemic continues to hemorrhage 1,000 lives daily in the U.S., COVID-19 now ranks third for cause of death in this country.
The leading causes of death in the U.S. are heart disease and cancer, but COVID-19 is gaining fast, CNN reported Monday.”

How climate change could expose new epidemics: Read the article for more information about how climate change is enhancing the likelihood of new epidemics.

What if ‘Herd Immunity’ Is Closer Than Scientists Thought?: “In interviews with The New York Times, more than a dozen scientists said that the threshold is likely to be much lower: just 50 percent, perhaps even less. If that’s true, then it may be possible to turn back the coronavirus more quickly than once thought.”

Coronavirus Doctors Battle Another Scourge: Misinformation: “Doctors on the front lines of the global pandemic say they are fighting not just the coronavirus, but also increasingly combating a never-ending scourge of misinformation about the disease that is hurting patients.”

About pharma

5 biggest FDA drug approvals of 2020: Read the article for the list.

Merck plans to build £1bn UK research hub in central London: The headline speaks for itself.

U.S. states seek $2.2 trillion from OxyContin maker Purdue Pharma: filings: “U.S. states claimed they are owed $2.2 trillion to address harm from OxyContin maker Purdue Pharma LP’s alleged role in America’s opioid epidemic, accusing the drugmaker in new filings of pushing prescription painkillers on doctors and patients while playing down the risks of abuse and overdose.
In filings made as part of Purdue’s bankruptcy proceedings that were disclosed on Monday, the states said Purdue, backed by the wealthy Sackler family, contributed to a public health crisis that has claimed the lives of roughly 450,000 people since 1999 and caused strains on healthcare and criminal justice systems. The filings cited more than 200,000 deaths in the U.S. tied directly to prescription opioids between 1999 and 2016.”

Moderna stands to earn $300M for quick vaccine approval, up to $6.6B for extra doses: filing: “Moderna's coronavirus vaccine deal with the U.S., announced last week with a $1.525 billion price tag, would be worth far more if all options are exercised—and if the mRNA biotech meets an aggressive timeline for the shot's arrival.
The company stands to gain up to a whopping $8.125 billion, according to a Moderna securities filing that details the price for follow-up doses and the windfall for an early FDA approval.
The base agreement calls for 100 million doses of the company’s COVID-19 vaccine candidate, mRNA-1273, for $1.225 billion. But the drugmaker is eligible for a $300 million bonus if it’s able to score an FDA emergency use authorization or full approval by Jan. 31, the filing shows. “

Teva funneled kickbacks through copay assistance charities for MS med Copaxone: DOJ: “Federal prosecutors accused Teva in a new lawsuit of paying kickbacks to two patient copay assistance charities as part of a scheme to pump up prescriptions of multiple sclerosis med Copaxone, Reuters reported. 
The filing in a Boston district courthouse alleged the company paid more than $300 million to those third-party organizations and defrauded Medicare of "hundreds of millions" in reimbursements, Reuters said.”

 About healthcare IT

HHS chief information officer abruptly resigns: “HHS' chief information officer, José Arrieta, resigned unexpectedly Friday.
Arrieta told senior leaders that he would stay on for up to a month to help with the transition, said two individuals with knowledge of his plans. He departs just four months after the department stood up the public data sharing hub HHS Protect, and a little over a year since he took over as chief information officer.”

COVID-19 data will go back to CDC when 'revolutionary new data system' is complete, Dr. Deborah Birx says: COVID-19 data reporting responsibility will transition back to the CDC, Deborah Birx, MD, White House coronavirus task force coordinator said at a roundtable discussion on Aug. 17. 
CNN reported that during the discussion, hosted by Arkansas Gov. Asa Hutchinson, Dr. Birx referred to the current COVID-19 reporting system as an "interim system" focused on gathering daily reports from hospitals. In July, the federal government updated the COVID-19 data reporting process, requiring hospitals to send data directly to HHS instead of the CDC.”

About healthcare quality

CMS Announces Resumption of Routine Inspections of All Provider and Suppliers…: “Today, the Centers for Medicare & Medicaid Services (CMS) announced it will resume routine inspections of all Medicare and Medicaid certified providers and suppliers to improve the safety and quality of life of patients and residents. CMS had previously suspended certain routine inspections as part of its response to the coronavirus disease 2019 (COVID-19) pandemic to prioritize infection control and immediate jeopardy situations and to give health care providers and suppliers time needed to respond to the spread of COVID-19.”

ECRI and the Institute for Safe Medication Practices (ISMP) Launch New Patient Safety Organization: “Leaders of ECRI and its affiliate, the Institute for Safe Medication Practices (ISMP), announce the launch of a joint Patient Safety Organization (PSO), an important step in making medication, medical devices, and healthcare practices safer for patients across all care settings, now during the COVID-19 pandemic, and into the future. The nonprofit organizations had each been federally designated PSOs since the program began in 2008…
By combining their two PSOs, ECRI and ISMP create one of the largest patient safety entities in the world. ECRI has more than 3.5 million analyzed events, including 10,000 related to COVID-19, submitted by the nation's most respected health systems and providers across all care settings. ISMP is the worldwide leader in determining system-based causes of medication errors across the continuum of care, disseminating lessons learned, and creating impactful change in practice.”

About emerging science

Protein Produced by the Nervous System May Help Treatments for Inflammatory Diseases: “A Rutgers-led team may have found the key to treating inflammatory diseases like asthma, allergies, chronic fibrosis and chronic obstructive pulmonary disease (COPD).
In a study published in the journal Nature Immunology, researchers discovered that neuromedin B (NMB), a protein produced by the nervous system, was responsible for preventing overactive immune responses and damaging inflammation.”

About diagnostics

Researchers at Facebook AI, NYU Langone Push Speed Limits of MRI:  The results of the joint effort, which originated at Facebook, show that accurate MRIs can be produced more quickly as AI functions with less data, researchers said…
’Our goal is a five-minute MRI. This has the potential to be a new paradigm,’ he said. ‘We really want to improve patient care.’”

Today's News and Commentary

About healthcare technology

FDA clears new version of Hyperfine’s portable MRI scanner-on-wheels: “Six months after netting the FDA’s green light for its groundbreaking portable MRI machine, Hyperfine Research has secured a second clearance for a newer generation of the device.
The Swoop system brings point-of-care imaging to the patient’s bedside, with a scanner-on-wheels that plugs into a standard electric wall outlet and fits in an elevator. 
Designed to scan a person’s head and brain, the latest clearance expands the system’s use to young toddlers, infants and neonates, after it was initially available to patients ages 2 and older.”

About hospitals and health systems

HHS to distribute $1.4 billion to freestanding children's hospitals: “Eligible hospitals will receive 2.5% of their net revenue from patient care” starting this week.
“The money will go to certain free-standing children's hospitals that are not affiliated with larger hospital systems, as financial relief to offset revenue losses.”

About the public’s health

U.S. to make coronavirus strain for possible human challenge trials:”U.S. government scientists have begun efforts to manufacture a strain of the novel coronavirus that could be used in human challenge trials of vaccines, a controversial type of study in which healthy volunteers would be vaccinated and then intentionally infected with the virus…
The work is preliminary and such trials would not replace large-scale, Phase 3 trials such as those now under way in the United States testing experimental COVID-19 vaccines from Moderna Inc and Pfizer Inc, according to a statement emailed to Reuters by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.”

Updated Isolation Guidance Does Not Imply Immunity to COVID-19: From the CDC: “On August 3, 2020, CDC updated its isolation guidance based on the latest science about COVID-19 showing that people can continue to test positive for up to 3 months after diagnosis and not be infectious to others.  Contrary to media reporting today, this science does not imply a person is immune to reinfection with SARS-CoV-2, the virus that causes COVID-19, in the 3 months following infection.  The latest data simply suggests that retesting someone in the 3 months following initial infection is not necessary unless that person is exhibiting the symptoms of COVID-19 and the symptoms cannot be associated with another illness.People with COVID-19 should be isolated for at least 10 days after symptom onset and until 24 hours after their fever subsides without the use of fever-reducing medications.”

The U.S. has already invested billions in potential coronavirus vaccines. Here’s where the deals stand: “Key Points:

• So far, the federal government has struck deals with a handful of pharmaceutical giants that have topped roughly $10.79 billion as part of Operation Warp Speed. 

• The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

• Moderna, Johnson & Johnson, Pfizer and BioNTech, Sanofi and GlaxoSmithKline, Novavax and AstraZeneca have all received funding from the operation for their vaccines.”

Texas-based McKesson tapped to help get coronavirus vaccines into American communities: ”The U.S. government has chosen medical supplier McKesson to be a centralized distributor for future COVID-19 vaccines, a crucial step in creating a pipeline to get any eventual vaccines into American arms and stop the pandemic…
Several of the current candidate vaccines must be kept at extremely low temperatures — as much as -112 degrees Fahrenheit. That temperature requirement will add to the complexity of distribution.”

FDA creates first-ever medical supply shortage list including masks, swabs and ventilators: ”The Food and Drug Administration (FDA) announced on Friday that it has created its first list of medical supplies that are facing a shortage.” Click on that site and you can ask about:

• Personal Protective Equipment

• Testing Supplies and Equipment

• Ventilation-Related Products

New saliva-based Covid-19 test could be a fast and cheap 'game changer': “Researchers from the Yale School of Public Health created the SalivaDirect test, which received emergency use authorization from the Food and Drug Administration on Saturday…
SalivaDirect test doesn't require a specific swab or collection device. It can also be used with reagents from multiple vendors.
’We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample,’ said Nathan Grubaugh, a Yale assistant professor of epidemiology…
Yale plans to publish its protocol as "open-source," meaning designated labs could follow the protocol to perform their own tests according to Yale's instructions, the FDA said.”

FDA: Don't use rapid COVID tests on people without symptoms:More sensitive PCR tests should be used on these individuals instead.: The headline speaks for itself.

Can Air Conditioners Spread COVID-19?: The quick answer is: “there's a possibility that air conditioning may be a potential route of transmission…” But read the entire article. It is very informative.

Fast Food Intake Among Children and Adolescents in the United States, 2015–2018:
”Key findings:

Data from the National Health and Nutrition Examination Survey

• During 2015–2018, over one-third (36.3%) of children and adolescents consumed fast food on a given day.

• During 2015–2018, children and adolescents consumed on average 13.8% of their daily calories from fast food on a given day. Adolescents aged 12–19 consumed a higher percentage of calories from fast food than children aged 2–11 years.

• Non-Hispanic white adolescents aged 12–19 consumed a lower percentage of calories from fast food on a given day than both non-Hispanic black and Hispanic adolescents.

• The percentage of calories from fast food in children and adolescents decreased from 14.1% in 2003–2004 to 10.6% in 2009–2010, and then increased to 14.4% in 2017–2018”

Disparities in Incidence of COVID-19 Among Underrepresented Racial/Ethnic Groups in Counties Identified as Hotspots During June 5–18, 2020 — 22 States, February–June 2020: These disparities continue to be a problem and reports are coming in daily about their extent. This report is from the CDC and concludes: “Long-standing health and social inequities have resulted in increased risk for infection, severe illness, and death from COVID-19 among communities of color…
Among 79 counties identified as hotspots during June 5–18, 2020 that also had sufficient data on race, a disproportionate number of COVID-19 cases among underrepresented racial/ethnic groups occurred in almost all areas during February–June 2020.”

About pharma

Sanofi enters $3.7-billion deal to buy Principia Biopharma: “Sanofi announced Monday a definitive agreement to acquire all of Principia Biopharma's outstanding stock for $100 per share in cash, representing an equity value of around $3.7 billion, boosting the French drugmaker's core research areas of autoimmune and allergic diseases.”

About diagnostics

Anthem and Quest Diagnostics Form Strategic Relationship: “Anthem and Quest will work together to improve efficiency in care delivery and reduce overall costs by leveraging a broad range of tools and programs to drive operational improvements, create pricing transparency, and enhance health care consumer engagement and outcomes.  The strategic relationship will focus on consumers in California, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, New Hampshire, New York, Ohio, Virginia, and Wisconsin.”