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.”

Today's News and Commentary

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.

Today's News and Commentary

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.”

Today's News and Commentary

About the public’s health

Covid-19 Vaccines Won’t Come With Copays, U.S. Health Official Says:”The U.S. government will pay for the vaccines and their distribution, and is working with commercial health insurers to offer the shots free of charge and without a copay, according to Paul Mango, deputy chief of staff for policy at the U.S. Department of Health and Human Services.”

2020’s Best & Worst States for Health Care: WalletHub’s annual report. At the top are Massachusetts and Minnesota. At the bottom are Georgia and Louisiana. Read the full article for the methodology.

HHS invests $6.5 million in diagnostic labs to expand COVID-19 testing:”The U.S. government is investing $6.5 million in two diagnostic laboratories to increase the country’s COVID-19 testing capacity and perform an additional 1 million tests each week by early October. 
The U.S. Department of Health and Human Services (HHS) said on Thursday the funding would enable the selected companies - Aegis Sciences Corp and Sonic Healthcare USA, a unit of Sonic Healthcare Ltd - expand capacity by increasing staffing and infrastructure.”

Top U.S. health official says COVID vaccines unlikely to be approved before November: NIH director Francis Collins “does not believe any potential COVID-19 vaccines backed by Operation Warp Speed are unlikely to be approved before November or December, given the time needed for large-scale clinical trials…”

Guideline: The American Thoracic Society provides recommendations on initiating pharmacologic treatment for tobacco-dependence: “The guideline panel formulated five strong recommendations and two conditional recommendations regarding pharmacotherapy choices. Strong recommendations include using varenicline rather than a nicotine patch, using varenicline rather than bupropion, using varenicline rather than a nicotine patch in adults with a comorbid psychiatric condition, initiating varenicline in adults even if they are unready to quit, and using controller therapy for an extended treatment duration greater than 12 weeks. Conditional recommendations include combining a nicotine patch with varenicline rather than using varenicline alone and using varenicline rather than electronic cigarettes.”

Systematic review with meta-analysis of the accuracy of diagnostic tests for COVID-19:

The takeaways:

RT-PCR followed by CT shows high sensitivity for detecting COVID-19.

Immunological tests should use a combination of IgG and IgM.

The genes E and RdRp present high analytical sensitivity to detect the virus.

Assays for molecular diagnosis should employ 2-target systems.

Studies of diagnostic tests for COVID-19 are of moderate methodological quality.

RT-PCR remains the gold standard for the diagnosis of COVID-19 in sputum samples. However, the combination of different diagnostic tests is highly recommended to achieve adequate sensitivity and specificity.

Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic — United States, June 24–30, 2020: From the CDC: “Overall, 40.9% of 5,470 respondents who completed surveys during June reported an adverse mental or behavioral health condition, including those who reported symptoms of anxiety disorder or depressive disorder (30.9%), those with TSRD symptoms related to COVID-19 (26.3%), those who reported having started or increased substance use to cope with stress or emotions related to COVID-19 (13.3%), and those who reported having seriously considered suicide in the preceding 30 days (10.7%).”

About hospitals and health systems

13 hospital construction projects costing $1B or more: Amazing that there are this many projects of this size given the economy.

Fitch maintains stable rating outlook for US nonprofit hospitals: “Fitch Ratings has maintained its stable rating outlook for US nonprofit hospitals and health systems and said it expects to keep it stable for the remainder of the year. 
While the rating outlook remains stable, Fitch revised the sector outlook to negative in March due to adverse effects from the pandemic and said it will maintain the negative sector outlook. Sector outlooks reflect business and economic conditions and while often correlated with rating outlooks they are more sensitive to changes in the economy.”

About health insurance

Oklahoma withdraws Medicaid block grant proposal: The state was going to be the first to test this method of payment being promoted by Republicans.

Today's News and Commentary

About the public’s health

U.S. reports fewer than 50K new COVID-19 cases for 3rd day in a row: However the large geographic differences remain. Also: American Academy Of Pediatrics: Number Of Coronavirus Cases Among Children In U.S. Has Increased 90 Percent In Last Month. And: U.S. reports highest number of covid-19 deaths in one day since mid-May.

Effect of mammographic screening from age 40 years on breast cancer mortality (UK Age trial): final results of a randomised, controlled trial: “Yearly mammography before age 50 years, commencing at age 40 or 41 years, was associated with a relative reduction in breast cancer mortality, which was attenuated after 10 years, although the absolute reduction remained constant. Reducing the lower age limit for screening from 50 to 40 years could potentially reduce breast cancer mortality.”
The problem of false positives remains. As far as cost/benefit, US costs would need to be used since mammograms are much more expensive here.

CareSource pledges $50M to support affordable housing: “Ohio's largest Medicaid managed care provider has pledged to invest millions of dollars to support affordable housing projects across the U.S.
The $50 million investment, announced Tuesday by Dayton-based CareSource, will be spread across its existing markets in Ohio, Indiana, Georgia, Kentucky and West Virginia, as well as new markets as the organization expands its footprint.”

Hahn: COVID-19 vaccine decision will be "deliberative": “The commissioner of the US Food and Drug Administration assured physicians and other healthcare providers that vaccine and therapeutics approvals for the COVID-19 pandemic will be ‘based on good science and sound data.’” Isn’t it sad that we need the reassurance?

Virucidal efficacy of different oral rinses against SARS-CoV-2:Look at Table 1 at the end of the article. The authors concluded that in particular, they “observed that three formulations (products c, e and f) containing different active compounds significantly reduced viral infectivity to undetectable levels.” Listerine cool mint (f) is the most recognizable name on the list.

About healthcare quality

85 hospitals with a 1-star CMS rating for patient experience: Yesterday the 5-star hospitals were referenced. Here is a list of the 1-star hospitals rated for patient experience. It seems to have many institutions that care for underserved populations.

UnitedHealth study: Primary care docs in value-based models achieve better patient outcomes: “Primary care physicians reimbursed in a global capitation model perform better on key quality metrics than those in a fee-for-service model, a new study from UnitedHealth Group shows…
For example, 80% of patients treated in the value-based arrangements were screened for breast cancer, compared to 74% of those in fee-for-service. More than 80% in global capitation were screened for colorectal cancer while 74% of fee-for-service patients were screened…
In addition, the study found that MA members treated in a global capitation arrangement had better blood sugar control levels, were more likely to be administered an eye exam and were provided functional status assessments and medication reviews more frequently.”

About healthcare IT

Health Experts Warn About Perils of New Virus Data Collection System: “Nearly three dozen current and former members of a federal health advisory committee, including nine appointed or reappointed by the health secretary, Alex M. Azar II, are warning that the Trump administration’s new coronavirus database is placing an undue burden on hospitals and will have ‘serious consequences on data integrity.’”

3.1M records tied to medical software company Adit found exposed online:”More than 3 million user records tied to a medical software company called Adit have been found exposed online and may have been stolen by malicious actors.
Discovered by security researcher Bob Diachenko, who revealed it today, the data included full names, email addresses, home and work phone numbers, marital status, sex and medical practice name. The database was completely unsecured with no password or other authentication required to access it.”

About pharma

COVID-19 vaccine players will split $100B in sales and $40B in profits, with Moderna leading the way: analyst: Evercore ISI pharma analyst Josh Schimmer predicted “that the total market for COVID-19 vaccines would be worth $100 billion in sales and $40 billion in post-tax profits. He assumed frontrunner Moderna would supply about 40% of the market, Novavax would take 20% and the other vaccine developers would split the rest.”

About health insurance

Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Laboratory Testing: This site updates the CPT coding for testing for SARS-CoV-2.

Today's News and Commentary

About the public’s health

One in Three Americans Would Not Get COVID-19 Vaccine: Update on the public’s attitude toward a COVID-19 vaccine: ”…many Americans appear reluctant to be vaccinated, even if a vaccine were FDA-approved and available to them at no cost. Asked if they would get such a COVID-19 vaccine, 65% say they would, but 35% would not.
The results are based on July 20-Aug. 2 polling in Gallup's COVID-19 tracking survey…”
The most striking differences are still along political affiliation.

LabCorp COVID tests free for three months to aid plasma donations:”Leading testing company LabCorp is offering a ‘no charge’ antibody COVID-19 testing program in the hope it will boost blood plasma donations.
A number of biopharmas, including the likes of Takeda, are hoping to use donated blood plasma from those who have recovered from COVID-19 and tap their antibodies as a potential therapy for the disease.”

US signs $1.5B deal for 100 million doses of Moderna's coronavirus vaccine candidate:”The U.S. federal government inked an agreement valued at up to $1.525 billion with Moderna Aug. 11 for 100 million doses of its COVID-19 vaccine candidate.
The vaccine candidate, mRNA-1273, will be manufactured while its clinical trials are underway. Moderna is developing the vaccine  with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.”

Facebook says it has taken down 7 million posts for spreading coronavirus misinformation: “Facebook said Tuesday that it took down 7 million posts pushing covid-19 misinformation from its main social media site and Instagram between April and June as the company tried to combat the rapid spread of dangerous information…”

Fauci: 'I seriously doubt' Russia's coronavirus vaccine is safe and effective: The headline speaks for itself.

Comparison of Heart Team vs Interventional Cardiologist Recommendations for the Treatment of Patients With Multivessel Coronary Artery Disease: “The heart team’s recommended treatment for patients with multivessel coronary artery disease differed from that of the original treating interventional cardiologist in up to 30% of cases. This subset of cases was associated with a lower frequency of unanimous decisions within the heart team and less concordance between the interventional cardiologists; discordance was more frequent when percutaneous coronary intervention or medication therapy were considered.”
The article highlights the value of teams over individual decisions.

LabCorp, Quest Diagnostics say turnaround time for COVID-19 test results down to 1-3 days:The headline speaks for itself.

About health insurance

CMS launches new alternative payment model for rural healthcare providers: “The Centers for Medicare and Medicaid Innovation (CMMI) will use the model to test whether seed funding, predictable capitated payments, and operational and regulatory flexibilities will enable rural health care providers to improve access to high quality care while reducing health care costs, according to a release issued Tuesday.”
The initiative is called the Community Health Access and Rural Transformation (CHART).

Humana sues Trump administration over ACA cost-sharing reduction [CSR]payments: “Humana estimates that it [has] nearly $2 million in unpaid CSR payments from October, November and December 2017.”

Dawn of the Virtual Medicare Advantage Plan from Alignment Health : “Alignment will make its virtual plan available to eligible consumers, a plan which emphasizes digital, concierge-style solutions for primary care and specialty care services…
Although the plan promotes virtual care, members will not be restricted to the virtual platform if that is not the most effective channel for treatment. For patient interactions that require face-to-face engagement with a provider, the virtual plan will cover in-person visits.”

OIG’s Top Unimplemented Recommendations: Solutions To Reduce Fraud, Waste, and Abuse in HHS Programs: This annual report from the HHS OIG reviews unimplemented recommendations for all HHS programs, ranging from Medicare/Medicaid/CHIP to the NIH to the Indian Health Service. Well worth at least reviewing the list, which starts on page 4.

Patient and Plan Spending after State Specialty-Drug Out-of-Pocket Spending Caps: High out of pocket charges usually work to discourage unnecessary, discretionary care. However, specialty medications are usually used for serious conditions out of the patient’s control. So it is no wonder that putting caps on patient out-of-pocket spending saves them money and does not cost the plans more. Cost controls in these cases require different strategies (see the section in Chapter 7 covering cost containment strategies for specialty pharmaceuticals).

About healthcare quality

266 hospitals with 5 CMS stars for patient experience: When you read the list, notice the absence of teaching hospitals (except Mayo clinic).

About healthcare personnel

26 states will soon face shortage of ICU doctors: “The most recent update finds that 26 states will soon face shortages in ICU doctors, up from only five last week. Ten states are at risk of running low on critical care nurses. Seven face shortages in doctors trained to work in hospitals. Nine states will not have enough respiratory therapists, up from zero last week. Six states will face shortages in pharmacists.”

About hospitals and healthcare systems

Sentara, Cone Health to form $11.5B system: “Sentara Healthcare and Cone Health plan to merge in a deal that would create a 17-hospital system with more than 2,400 physicians and advanced practice clinicians…
The health systems also operate health plans. Sentara runs Optima Health Plan and Virginia Premier Health Plan, which serve 858,000 members, while Cone Health runs a Medicare Advantage plan with 15,000 members. Mr. Akin said the health systems plan to eventually combine their health plan operations.”

About healthcare IT

MIT’s AI system diagnoses chest conditions on x-rays, but knows when a radiologist could do better: Really interesting AI application. As the article notes: “Radiologists have largely moved past the idea that artificial intelligence is here to replace them. And a new platform released recently is a perfect example of how imaging experts and AI can coexist.”

The most dangerous health IT trends: Insights from 8 execs: Interesting opinions from 8 CIOs ranging from system vulnerability to lack of data integration.

Today's News and Commentary

About the public’s health

Scientists uneasy as Russia approves 1st coronavirus vaccine: “Russia on Tuesday became the first country to approve a coronavirus vaccine, a move that was met with international skepticism and unease because the shots have only been studied in dozens of people…
However, scientists in Russia and other countries sounded an alarm, saying that rushing to offer the vaccine before final-stage testing could backfire. What’s called a Phase 3 trial — which involves tens of thousands of people and can take months — is the only way to prove if an experimental vaccine is safe and really works.
By comparison, vaccines entering final-stage testing in the U.S. require studies of 30,000 people each. Two vaccine candidates already have begun those huge studies, with three more set to get underway by fall.”

Over 100 bln USD to be needed to ensure access to COVID-19 vaccines: WHO chief: “World Health Organization (WHO) director-general Tedros Adhanom said Monday that for the vaccines alone, over $100 billion will be needed to ensure everyone everywhere can access the tools to fight the COVID-19 outbreak, as reported Xinhua.”
By comparison, “$10 trillion that have already been invested by G20 countries in fiscal stimulus to deal with the consequences of the COVID-19 pandemic so far.’”

Citrus Flavoring Is Weaponized Against Insect-Borne Diseases:”Adding a new weapon to the fight against insect-borne illnesses like Lyme disease and malaria, the Environmental Protection Agency on Monday approved a new chemical that both repels and kills ticks and mosquitoes.
The chemical, nootkatone, an oil found in cedar trees and grapefruits, is so safe that it is used by the food and perfume industries.”

Low-cost measurement of facemask efficacy for filtering expelled droplets during speech: Duke researchers have come up with a method to test facemask performance. In short, N95 masks are very effective for the wearer but vented N95 masks do not protect others.. Handmade cotton masks were about as effective as surgical masks. Finally, neck fleece, bandanas and breathable neck gaiters were found to emit a higher droplet count than control tests involving no masks.

Filtration Efficiency of Hospital Face Mask Alternatives Available for Use During the COVID-19 Pandemic: “When new N95 respirators are unavailable, N95 respirators past their expiration date; sterilized, used N95 respirators; and other less common respirators can be acceptable alternatives.” Also, see the accompanying editorial here.

‘A Smoking Gun’: Infectious Coronavirus Retrieved From Hospital Air: “Skeptics of the notion that the coronavirus spreads through the air — including many expert advisers to the World Health Organization — have held out for one missing piece of evidence: proof that floating respiratory droplets called aerosols contain live virus, and not just fragments of genetic material…
A research team at the University of Florida succeeded in isolating live virus from aerosols collected at a distance of seven to 16 feet from patients hospitalized with Covid-19 — farther than the six feet recommended in social distancing guidelines.”

U.S. COVID-19 deaths drop for first time in four weeks:” The U.S. death toll from COVID-19 fell 16% to about 7,200 people last week, the first decline in deaths after four weeks of increases…”

Trends in Adiposity and Food Insecurity Among US Adults:”In this cross-sectional study, the estimated prevalence of food insecurity appeared to increase from 1999 to 2016 and across all levels of adiposity. These results suggest the need for multidisciplinary approaches to address the association between food insecurity and obesity in the US.”

About health insurance

Inadequate Edits and Oversight Caused Medicare to Overpay More Than $267 Million for Hospital Inpatient Claims with Post-Acute-Care Transfers to Home Health Services:”Medicare improperly paid most inpatient claims subject to the transfer policy when beneficiaries resumed home health services within 3 days of discharge but the hospitals failed to code the inpatient claim as a discharge to home with home health services or when the hospitals applied condition codes 42 (home health not related to inpatient stay) or 43 (home health not within 3 days of discharge). Of the 150 inpatient claims in our sample, Medicare properly paid 3; however, it improperly paid 147 with $722,288 in overpayments. Medicare should have paid these inpatient claims using a graduated per diem rate rather than the full payment. Based on our sample results, we estimated that Medicare improperly paid $267 million during a 2- year period for hospital services that should have been paid a graduated per diem payment.”

Humana sues Teva over recalled blood pressure drugs:”Humana filed a lawsuit against Teva Pharmaceuticals over its sale of since-recalled blood pressure medication that contained carcinogenic substances.
In 2018, the FDA said it was recalling valsartan medications because of their contamination with cancer-causing substances. Teva voluntarily recalled its valsartan drugs in 2018 for products distributed as early as October 2015.
In its lawsuit, filed Aug. 7 in the U.S. District Court for the District of New Jersey, Humana aims to recover ‘substantial’ costs the insurer said it incurred from recalling and replacing Teva's generic blood pressure medication for members.”

Costs higher for those who enroll on the ACA's exchanges during special enrollment periods: study:”Researchers at Harvard examined claims data from 2015 and 2016 on about 1.5 million individual marketplace enrollees and found that 20% signed up for plans during a special enrollment period [SEP]. Those people were more likely to be younger, and their costs were 34% higher, according to the study.
Members who enrolled in an SEP had inpatient care costs that were between 69% and 114% higher, and emergency care costs that were between 11% and 19% higher.”

About pharma

CVS, Walgreens & Costco sued for not filling opioid prescriptions: “A Florida mother filed a class-action lawsuit Aug. 6 against CVS, alleging its pharmacies have been wrongfully refusing to fill legitimate opioid prescriptions.
Edith Fuog’s lawsuit alleges that numerous CVS pharmacies have denied the opioid prescriptions she uses to manage the pain from her chronic conditions since 2017. 
The lawsuit claims CVS’ refusal to fill her prescriptions violates the American with Disabilities Act, the Rehabilitation Act of 1973 and the Affordable Care Act. The case was filed as a class-action lawsuit on behalf of the millions of legitimate opioid users nationwide….Ms. Fuog’s case comes after a similar one was recently filed against Walgreens and Costco by California mother Susan Smith.”

About healthcare IT

Fraudulent HIPAA Communications: An Alert from the Office for Civil Rights: The Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) “sent an alert to its listservs regarding fraudulent communications that are being sent to health care organizations around the country. OCR states that it became ‘aware of postcards being sent to health care organizations disguised as official OCR communications, claiming to be notices of a mandatory HIPAA compliance risk assessment.’ The postcards have a Washington, D.C., return address, and the imposter uses the non-existent title description of ‘Secretary of Compliance, HIPAA Compliance Division.’ OCR further explains that these postcards are being addressed to HIPAA Privacy and Security Officers and indicates that recipients should visit a website link, call or email to take immediate action on HIPAA requirements. Importantly, the website link directs individuals to a non-governmental website.”

Today's News and Commentary

About the public’s health

Gates Foundation Teams Up With Vaccine Maker to Produce $3 Covid-19 Shots:”The Bill & Melinda Gates Foundation said it is backing the world’s largest vaccine maker, Serum Institute of India, to churn out 100 million doses of coronavirus vaccine for poorer countries and price them at less than $3.”

New CDC Guidelines Advise People to Wear Masks Without Vents, Valves: “The Centers for Disease Control and Prevention has released new guidance on wearing face coverings during the coronavirus pandemic, advising people not to use masks with vents or valves.” Check CDC mask recommendations here.

Young MSM [men who have sex with men] at high risk for HIV should be screened every 3 months, study suggests: “Screening young men who have sex with men every 3 months for HIV is cost effective and improves clinical outcomes compared with less frequent screening…”

Hospitalization Rates and Characteristics of Children Aged <18 Years Hospitalized with Laboratory-Confirmed COVID-19 — COVID-NET, 14 States, March 1–July 25, 2020: From the CDC: “Analysis of pediatric COVID-19 hospitalization data from 14 states found that although the cumulative rate of COVID-19–associated hospitalization among children (8.0 per 100,000 population) is low compared with that in adults (164.5), one in three hospitalized children was admitted to an intensive care unit…
Children are at risk for severe COVID-19. Public health authorities and clinicians should continue to track pediatric SARS-CoV-2 infections. Reinforcement of prevention efforts is essential in congregate settings that serve children, including childcare centers and schools.”

Scientists in spat over whether to infect people in coronavirus vaccine trials: The headline speaks for itself.

About healthcare technology

FDA approves Guardant’s tumor-sequencing blood test as a Tagrisso lung cancer diagnostic: ”Guardant Health received a milestone approval from the FDA for its cancer test, as the first liquid biopsy able to genetically profile solid tumors anywhere in the body through a single blood draw.|This can provide oncologists with biomarker and mutation information across 55 genes linked to multiple cancers, without needing to remove samples of the tumor tissue—but the Guardant360 CDx test has not been approved to direct patients toward a particular treatment, in all cases.
The agency did, however, grant the test a new, specific companion diagnostic approval for identifying patients with metastatic non-small cell lung cancer, who may benefit from AstraZeneca’s Tagrisso based on the presence of epidermal growth factor receptor, or EGFR alterations.”

FDA clears Siemens’ wheeled, bedside CT scanner: “Placed at a person’s bedside, the Somatom On.site allows for easier head exams of critically ill patients, including those within intensive care units.”

About pharma

Kodak's $765 million manufacturing loan on the rocks as red flags multiply: “The government put the $765 million loan on hold after "allegations of wrongdoing" on the company's part jeopardized its federally funded move into pharmaceuticals, the U.S. International Development Finance Corporation (DFC) said in a terse tweet Friday. “

Novartis to charge $2.1 million for Zolgensma following its US approval as first gene therapy for paediatric SMA patients: “Novartis' AveXis unit announced Friday that the FDA has approved Zolgensma (onasemnogene abeparvovec-xioi) for the treatment of patients under two years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the SMN1 gene. The company noted that Zolgensma is the first gene therapy approved in the US for the treatment of patients with SMA, including those who are pre-symptomatic at diagnosis…
Novartis has priced Zolgensma, which is administered via a single intravenous infusion, at a cost of $2.13 million.”

About health insurance

Kaiser's net income more than doubles to $4.5B in Q2: “After reporting a $1.1 billion net loss in the first quarter, Kaiser Permanente's revenue, operating income and net income for its nonprofit hospital and health plan units increased year over year in the second quarter of this year. 
The Oakland, Calif.-based healthcare giant reported operating revenues of $22.1 billion in the second quarter of 2020, up 3.3 percent from the same period a year earlier. Kaiser also saw expenses decline about 1.5 percent year over year to $20 billion.”

Trump teases order requiring insurers to cover preexisting conditions: President Trump “teased an executive order to require health insurers to cover all preexisting conditions, something already established under the Affordable Care Act, which his administration is suing to dismantle.
’Over the next two weeks I’ll be pursuing a major executive order requiring health insurance companies to cover all preexisting conditions for all companies,’ Trump said during a news conference at his Bedminster property in New Jersey.”

About healthcare IT

VA, Cerner restart $16B EHR overhaul with planned October go-live: “The Department of Veterans Affairs and Cerner are resuming a massive medical records project with a new go-live date in October.
In early April, the VA hit pause on its $16 billion electronic health record overhaul due to the COVID-19 pandemic. The agency is working to transition from its customized VistA platform to a Cerner EHR system.”

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About pharma

Pfizer, Amgen will rake in billions during ‘golden age’ for biosimilars: Analyst:”Pfizer’s global biosim sales grew 36% during the quarter to $289 million, driven largely by cancer drugs. The significance of that growth wasn’t lost on Bernstein analyst Ronny Gal. In a note to investors earlier this week, he singled out Pfizer, along with Amgen, as proof that the U.S. biosimilars industry has entered a ‘golden age.’”
The article details some of the products the companies have and the importance of biosimilars in the marketplace.

About the public’s health

Clinical Course and Molecular Viral Shedding Among Asymptomatic and Symptomatic Patients With SARS-CoV-2 Infection in a Community Treatment Center in the Republic of Korea: A reminder about the infectivity of asymptomatic persons: “Many individuals with SARS-CoV-2 infection remained asymptomatic for a prolonged period, and viral load was similar to that in symptomatic patients; therefore, isolation of infected persons should be performed regardless of symptoms.”

New FDA limits on arsenic levels in infant rice cereals don't adequately protect children, critics say: The content is self explanatory. Links to details are in the article. The question is: How low a level is safe?

Court sides with Trump administration effort to impose ‘public charge’ rule: “A federal appeals court on Wednesday sided with the Trump administration’s effort to implement regulations that make it harder for immigrants to seek permanent residency in the United States if they have relied on public assistance programs.
The split ruling from the U.S. Court of Appeals for the 4th Circuit reverses a lower-court injunction that had blocked the ‘public charge’ rule from taking effect.
The decision comes one day after a different appeals court ruled against the administration in a similar challenge brought by immigrant groups that argue the rule discourages legal immigrants from using any public benefits such as Medicaid, food stamps or housing assistance…
Despite the 4th Circuit’s decision Wednesday, the rule remains blocked for now because of a separate nationwide injunction issued by a New York judge in late July.”

‘It’s Kitchen Sink Time’: Fast, Less-Accurate Coronavirus Tests May Be Good Enough: “The best chance to rein in the sprawling outbreaks in the United States now, experts say, requires widespread adoption of less accurate tests, as long as they’re administered quickly and often enough.”

About healthcare providers

Oak Street Health goes public with $328 million offering: “Oak Street Health officially went public on Thursday with a $328 million initial public offering.
The tech-enabled, value-based care primary care start-up specifically targets Medicare-eligible patients, particularly those in underserved communities…
Backers include Humana, as well as General Atlantic and Newlight Partners.
Oak Street has 54 centers in 13 markets across eight states serving 85,000 patients with about 65% of those patients are under capitation agreements. The company has 2,300 employees including 250 primary care providers.”

Mental health startup Ginger lands $50M backed by Cigna, Kaiser Permanente:”The round, led by Advance Venture Partners and Bessemer Venture Partners, included participation from Cigna Ventures and existing investor Jeff Weiner, executive chairman of LinkedIn, as well as Kaiser Permanente Ventures.
The startup, which delivers evidence-based behavioral health coaching, therapy and psychiatry right from a smartphone, has raised more than $120 million to date.”

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About the public’s health

How the pandemic might play out in 2021 and beyond: A really good article from Nature that uses different scenarios in modeling simulations.

Do Americans Face Greater Mental Health and Economic Consequences from COVID-19? Comparing the U.S. with Other High-Income Countries: Among the comparison findings: “More than 30 percent of U.S. adults reported they’ve been faced with negative economic effects from the coronavirus pandemic, a significantly higher percentage than in any of the other countries. These effects include being unable to pay for basic necessities like food, heat, or rent; using up most personal savings; or borrowing money or taking out a loan.
Rates were also high in Canada (24%) and Australia (21%). Meanwhile, only 6 percent to 7 percent of German and Dutch respondents reported these financial hardships.”

‘Discrepancies’ in California’s case data cast doubt as deaths continue to rise: Yet another case of inaccurate data. “In the past week, daily deaths have increased 20%, while flawed data showed cases were down 17%.”

New University of Chicago center will collect thousands of X-rays, CT scans to aid with COVID-19 research:”University of Chicago Medicine will be home to a new, massive database of medical images from COVID-19 patients that researchers can use to better understand and fight the illness, with support from a $20 million federal grant.
The images — such as X-rays and CT scans — will be collected at the University of Chicago and be open source, meaning they’ll be available to researchers around the world. The mainly virtual center created under the contract with the National Institutes of Health expects to collect more than 10,000 images in its first three months.”

Virus testing in the US is dropping, even as deaths mount: ”An Associated Press analysis found that the number of tests per day slid 3.6% over the past two weeks to 750,000, with the count falling in 22 states. That includes places like Alabama, Mississippi, Missouri and Iowa where the percentage of positive tests is high and continuing to climb, an indicator that the virus is still spreading uncontrolled.”

About hospitals and health systems

Indiana University Health to build $1.6B hospital: Many building projects have been scrapped or put on hold with the COVID-19 pandemic, making this announcement noteworthy. “Upon completion of the hospital, expected in 2026, operations of two IU Health adult hospitals in Indianapolis will be consolidated. 
IU Health said that by combining operations of IU Health Methodist and at IU Health University Hospital, the organization will eliminate costly duplication of high-acuity services.”

About pharma

Trump to order government to buy certain drugs solely from U.S. factories, setting up major shakeup for industry:”President Trump will sign an executive order Thursday directing the federal government to buy certain drugs solely from American factories…
It remains unclear, however, how broadly the order will be implemented — the executive order does not specify what drugs it covers. Instead, the order directs the Food and Drug Administration to decide which medicines will be subject to the new requirements, White House trade adviser Peter Navarro told reporters Thursday.”

New Rare Antibiotic Drugs Get Faster FDA Approval Pathway:”Companies making antibiotics for small patient populations will be able to use smaller, more streamlined clinical trials, the Food and Drug Administration said Wednesday. The guidance gives companies more clarity on what is expected when applying for the faster antibiotic approval process. The pathway is the agency’s latest push to generate more novel antibiotics, which typically aren’t high on companies’ priority lists because they don’t make a lot of money.”

Moderna will charge $32 to $37 for COVID-19 vaccine, CEO says: The headline speaks for itself.

Part D plans don't push beneficiaries to take brand-name drugs over generics: study: “Medicare Part D plans largely design their formularies to encourage use of generics, despite some criticism to the contrary, a new study shows.
Researchers led by a team at the Kaiser Family Foundation and Vanderbilt University analyzed more than 4.1 million Part D plan and product combinations, and found that in 84% of cases only the generic was covered by the insurer.
In 15% of cases, the plan covered both the generic and the brand-name product, according to the study published in Health Affairs.”

Mallinckrodt May File for Bankruptcy, Undercutting Opioid Settlement:”Drugmaker Mallinckrodt PLC said it is considering filing for chapter 11 protection over a clash with U.S. regulators and liabilities stemming from the opioid epidemic, potentially undercutting a proposed opioid settlement with state and local governments.
Mallinckrodt said Tuesday it has been in negotiations with creditors about a potential bankruptcy filing covering the parent company and most of its subsidiaries to address opioid-related liabilities, corporate debts and a dispute with regulators over its Acthar Gel medication.”

About health insurance

Major U.S. Health Insurers Report Big Profits, Benefiting From the Pandemic:”Some of the largest companies, including AnthemHumana and UnitedHealth Group, are reporting second-quarter earnings that are double what they were a year ago. And while insurance profits are capped under the Affordable Care Act, with the requirement that consumers should benefit from such excesses in the form of rebates, no one should expect an immediate windfall.”

Medicare payment rules for 2021: 11 notes for hospital execs: A good summary of the payment rules, some of which have been previously discussed here.

Fraudulent coding led CMS to overpay Cigna $1.4B, Justice Department says: “The U.S. Justice Department accused Cigna of using improper diagnostic codes to artificially inflate reimbursement for its Medicare Advantage plans by $1.4 billion in a lawsuit. 
The 64-page lawsuit, filed Aug. 4 in the U.S. District Court for the Southern District of New York, claimed that from 2012 until 2017, Cigna's HealthSpring unit, which runs Medicare plans, submitted false risk adjustment claims to CMS that led to improper reimbursement increases. The Justice Department accuses Cigna of submitting codes for conditions that its Medicare Advantage members didn't have, weren't recorded in medical records or weren't based on clinical data.”

About healthcare quality

CMS outlines long-awaited changes to hospital star ratings: “The proposed change was tucked into a proposed payment rule released by the Centers for Medicare & Medicaid Services on Monday for outpatient hospital departments and ambulatory surgical centers. The rule touches on the use of latent variable modeling (LVM, which combines and summarizes multiple pieces of information and is used to calculate a hospital's star rating…  
If finalized, the rule would discontinue use of the LVM for quality measure group scores and instead adopt a “simple average of measure scores to calculate measure group scores,” the proposed rule stated. “This method would average the measure scores a hospital reports within a given measure group, which have been standardized, to calculated the measure group scores."
See: Meaningful Measures/Patients Over Paperwork

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About health insurance

Deep red Missouri becomes 38th state to approve Medicaid expansion under Obamacare:”Voters on Tuesday made Missouri the 38th state to approve expanding Medicaid health care coverage to thousands more low-income adults.
Support for the constitutional amendment means that as many as 250,000 more adults could choose to be covered by government health insurance beginning in July 2021, according to estimates from the state auditor.”

CMS Announces a Temporary Policy for Premium Reductions: “…the Centers for Medicare & Medicaid Services (CMS) announced a policy that will allow issuers to offer temporary premium reductions for individuals with 2020 coverage in the individual and small group markets. CMS is providing this additional flexibility to help ensure that consumers struggling to pay their premiums can continue to be covered and receive the care they may need during this time.” Normally premiums are fixed after the start of the year.

About pharma

Blood-thinner with no bleeding side-effects is here: If this medicine pans out it will be a huge blockbuster:
”In a study led by EPFL (Ecole Polytechnique Fédérale de Lausanne) scientists have developed a synthetic blood-thinner that, unlike all others, doesn’t cause bleeding side-effects. The highly potent, highly selective, and highly stable molecule can suppress thrombosis while letting blood clot normally following injury.” The substance is an inhibitor of an enzyme called “coagulation factor XII” (FXII). “The only problem is that the inhibitor has a relatively short retention time in the body: it’s too small and the kidneys would filter it out. In the context of artificial lungs, this would mean constant infusion, since suppressing blood clotting for several days, weeks or months requires a long circulation time.” But researchers are working on a longer-lived version.

Gilead's COVID med remdesivir is scarce and costly, AGs say, urging feds to sidestep its patents: “Unhappy with the price and availability of Gilead’s remdesivir—the only drug with FDA clearance to treat COVID-19—dozens of state attorney generals have called for the federal government to exercise march-in rights to allow for broader production of the medicine.
In a letter to the heads of the FDA, HHS and NIH, 34 attorneys general wrote that Gilead has been unable to ensure “sufficient” supply and has priced the medicine out of reach for many patients who need it. Gilead is charging $3,120 per treatment course for patients with commercial insurance, Medicare or Medicaid, and $2,340 for patients on certain smaller federal programs. 
Federal laws allow the government to sidestep patents if the patent holder received taxpayer support and isn't meeting public health needs, the AGs wrote.”

FDA Updates Purple Book to Include All CBER-, CDER-licensed Biologics:”The FDA has updated its Purple Book to include information on all biologics approved by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).”

MedWatch to Manufacturer Program:”The U.S. Food and Drug Administration has discontinued the MedWatch to Manufacturers Program (MMP) as of July 31, 2020. This program allowed participating drug and biologic manufacturers to receive information from the FDA on serious adverse event reports that are submitted directly to FDA by voluntary reporters for new molecular entities and original biologics for the first three years after approval. 
Since the introduction of the FDA Adverse Event Reporting System (FAERS) Public Dashboard in 2017, manufacturers can now directly search and download publicly available information from adverse event reports in FAERS, including adverse event reports submitted voluntarily  to FDA.“

About the public’s health

6 states band together to secure rapid COVID testing: “Bipartisan governors of six states have entered into a first-of-its-kind agreement to jointly purchase rapid coronavirus testing kits.
The governors — from Virginia, Louisiana, Massachusetts, Michigan, Ohio and Maryland — said the goal of the compact is to show private companies that there is significant demand to scale up the production of these tests, which deliver results in 15 to 20 minutes.
The states will also coordinate on policies and protocols regarding the testing technology.”

A 50-State COVID-19 Survey from the The COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States (July): Summary:

  • “Most (63%) people are not getting results within the 1-2 days that would be optimal to aid contact tracing.

  • A substantial minority (21%) of individuals are receiving test results too late (5+ days) to be of any significant assistance in helping to control the spread of COVID-19.

  • The testing challenges are national in scope, with most states reporting a median waiting time of 3 days or more.

  • Waiting times are longer for African Americans (5 days) and Hispanic Americans (4.6 days) compared to white respondents.”

For those affected by dementia, the pandemic has been especially grim: “…there is evidence in some rich countries that the age-specific incidence of dementia is declining, even as the overall prevalence increases as societies get older.”
“… as many as 40% of dementia cases might in theory be delayed or prevented by tackling 12 ‘modifiable’ risk factors.” Among the most important are: smoking, high blood pressure, obesity, hearing loss, a low level of education, diabetes, excessive drinking in middle age, head injuries (also in middle age), and exposure to air pollution in later life.

Johnson & Johnson pledges 100M coronavirus vaccine doses to U.S. for $10 each: The headline speaks for itself.

Ancestry rolls out more advanced DNA testing to flag risk of heart disease, breast cancer: “Ancestry is stepping up its consumer DNA testing using next-generation sequencing developed by Quest Diagnostics.
The family history and consumer genomics company is relaunching its AncestryHealth service with more advanced genetic testing technology to flag cutsomers' risk for developing certain inheritable diseases.
The sequencing-based tests replace Ancestry's previous microarray-based tests, the company said in a release. The tests are physician-ordered, are not diagnostic and have not been reviewed or approved by the Food and Drug Administration (FDA).”

About healthcare IT

Teladoc to take over Livongo in $18.5B digital health deal:”Telehealth giant Teladoc has moved to absorb the digital disease management company Livongo through a deal worth as much as $18.5 billion, reflecting the growing importance of virtual healthcare platforms as the world is caught in the wake of the COVID-19 pandemic.
The massive medtech acquisition takes the crown not two days after Siemens Healthineers announced a $16.4 billion offer for the cancer radiotherapy player Varian Medical Systems.”

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About the public’s health

Pennsylvania suspends requirements for childhood immunizations, and that has pediatricians worried: The Pennsylvania Department of Health quietly announced late last month that it was temporarily suspending requirements for children’s immunizations, a move that could send mixed signals to parents about the importance of preventing disease, and could mark a return for vaccine-preventable diseases like measles, doctors fear.
The coronavirus pandemic has made it difficult for families to make scheduled checkups. In Philadelphia, routine immunizations have fallen substantially since March. As a result, many children in Pennsylvania may not have the required immunizations to enter and attend school this fall.”

Health illiteracy is nothing new in America. But the pandemic magnifies how troubling it is.:This article explains how health illiteracy is causing confusion among vulnerable populations. “Health literacy is not about reading skills or having a college degree. It means you know how to ask a doctor the right questions, read a food label, understand what you’re signing on a consent form, and have the numeric ability to analyze relative risks when making treatment decisions.”

Fauci explains the 'insidious increase' that has officials worried about new COVID surges: “Top infectious disease expert Anthony Fauci, M.D., warned the signs indicate more states could experience serious jumps in COVID-19 cases in the next month, following in the footsteps of a handful of southern states that have been hit with surges of the virus in recent weeks.”

The FDA's list of dangerous hand sanitizers has now grown to more than 100: The headline speaks for itself. The list is here.

3C-like protease inhibitors block coronavirus replication in vitro and improve survival in MERS-CoV-infected mice: “We describe herein the structure-guided optimization of a series of inhibitors of the coronavirus 3C-like protease (3CLpro), an enzyme essential for viral replication…These results suggest that this series of compounds has the potential to be developed further as antiviral drugs against human coronaviruses.”

The six strains of SARS-CoV-2 :”SARS-CoV-2 mutation rate remains low. Across Europe and Italy, the most widespread is strain G, while the L strain from Wuhan is gradually disappearing. These mutations, however, do not impinge on the process of developing effective vaccines.
The virus causing the COVID-19 pandemic, SARS-CoV-2, presents at least six strains. Despite its mutations, the virus shows little variability, and this is good news for the researchers working on a viable vaccine.”

About health insurance

Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2021: “With the budget neutrality adjustment to account for changes in RVUs, as required by law, the proposed CY 2021 PFS [physician fee schedule] conversion factor is $32.26, a decrease of $3.83 from the CY 2020 PFS conversion factor of $36.09.” Recall that the professional feee is the service RVU (determined by the CPT code) x Conversion Factor. Other changes include expansions in telehealth; refinements in coding for extended visits; supervision of diagnostic tests by certain Non-physician Practitioners (NPPs); clarification that physicians and NPPs, including therapists, can review and verify documentation entered into the medical record by members of the medical team for their own services that are paid under the PFS; allowing teaching physicians to use audio/video real time communications technology to interact with the resident through virtual means; and more.

About pharma

Sanofi, GlaxoSmithKline under investigation for possible carcinogen in Zantac: The U.S. Justice Department launched an investigation into whether Sanofi and GlaxoSmithKline failed to report information about a potential carcinogen to the federal government…”

About healthcare IT

Trump signs order to expand access to telehealth services in rural areas:”U.S. President Donald Trump on Monday signed an executive order expanding access to telehealth services for 57 million Americans in under-served rural areas and elsewhere, after virtual visits soared during the coronavirus pandemic.”

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About health insurance

Cuts to 340B payments are legal, appeals court rules:”An HHS policy that will cut Medicare outpatient drug payments by nearly 30 percent at 340B hospitals in the U.S. is legal, an appellate court panel ruled July 31. The ruling overturns a lower court decision. 
Under the 340B program, eligible hospitals can buy outpatient drugs at a discount. A hospital typically pays  20 percent to 50 percent below the average sales price for the drugs….HHS argued that Medicare should not reimburse hospitals more than they paid to acquire the drugs.”

Health Care Spending and the Medicare Program (July 2020):Perhaps the best comprehensive explanation of annual Medicare spending. It is prepared by MedPAC.

Texas, Other States Lose $479 Million in Obamacare Provider Fees: “The Fifth Circuit Friday upheld the Obamacare provider fee that states pay to the IRS on behalf of Medicaid Managed Care Organizations in order to receive federal reimbursement for MCO payments.
The fee is a valid federal tax that doesn’t violate the U.S. Constitution’s spending clause, it said.”

Florida physician charged in $681M billing fraud scheme: “Dr. Ligotti allegedly served as the medical director for more than 50 addiction treatment facilities and signed more than 135 standing orders authorizing fraudulent tests. In exchange for his signature on the standing orders, he allegedly required the treatment centers to have their patients treated at Whole Health. Some patients were allegedly charged between $10,000 and $20,000 by Dr. Ligotti and Whole Health for one visit.”

CMS Finalizes $750M Medicare Payment Boost for Nursing Homes in Fiscal 2021: “The federal government on Friday finalized a previously proposed rule that will bring a 2.2% Medicare payment bump to the nation’s skilled nursing facilities.”

CMS finalizes 3 payment rules for 2021: 5 things to know: “CMS finalized three Medicare payment rules July 31, including updates for psychiatric facilities, skilled nursing facilities and hospices.”

About the public’s health

Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov: The quality of research studies on COVID-19 has been generally poor. This research was a cross-sectional study using ClinicalTrials.gov information. The researchers “found that despite the marked rise in COVID-19 studies, only 29.1% of those registered in ClinicalTrials.gov have the potential to result in OCEBM [2011 Oxford Centre for Evidence-Based Medicine] level 2 evidence. Of the RCTs, only 29.3% are placebo-controlled, blinded studies. Global decline in new cases could also stall enrollment. Even before results are known, most studies likely will not yield meaningful scientific evidence at a time when rapid generation of high-quality knowledge is critical.”

SARS-CoV-2-reactive T cells in healthy donors and patients with COVID-19: Researchers “detected SARS-CoV-2 S-reactive CD4+ T cells in 83% of patients with COVID-19 but also in 35% of HD [healthy donors].” Meaning that T cell immunity (not just antibody- producing B cell immunity) plays an important part in fighting COVID-19. It is another potential mechanism for vaccine development. Also, the 35% mentioned means healthy people can have cross reactivity and possible protection from previous exposure to other similar viruses.

6 reasons why COVID-19 medical liability shield critics are wrong: One of the differences between Democratic and Republican proposals for COVOD-19 relief is whether there is a liability exemption for employers whose employees become ill. (The former want the liability, the latter want the exemption.) This article from the AMA is a thoughtful analysis of the issue.

COVID-19 Hospital Data System That Bypasses CDC Plagued By Delays, Inaccuracies: This article is a great summary of how the new reporting system is in trouble. In a related article: CDC director says he wasn't involved in decision to reroute COVID-19 hospitalization data

‘The Biggest Monster’ Is Spreading. And It’s Not the Coronavirus: TB is “the biggest infectious-disease killer worldwide, claiming 1.5 million lives each year.” The point of the article is that TB, HIV infection and malaria, all on the decline, have been making a comeback as resources and attention have been focused on COVID-19.

Here are some updates on COVID-19 testing that offer faster/better or easier testing:
Sorrento Licenses COVID-19 Saliva Test;
90 minute COVID-19 tests: [UK]Government orders 5.8 million DnaNudge kits;
Oxford researchers say new artificial intelligence test could identify coronavirus within one hour;
NIH picks seven COVID-19 diagnostic tests in 'Shark Tank' competition, unlocking $248.7M in scale-up funding; and
FDA authorizes first tests for measuring COVID-19 antibody amounts

Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study: “Compared with the general community, front-line health-care workers were at increased risk for reporting a positive COVID-19 test (adjusted HR 11·61, 95% CI 10·93–12·33). To account for differences in testing frequency between front-line health-care workers and the general community and possible selection bias, an inverse probability-weighted model was used to adjust for the likelihood of receiving a COVID-19 test (adjusted HR 3·40, 95% CI 3·37–3·43). Secondary and post-hoc analyses suggested adequacy of PPE, clinical setting, and ethnic background were also important factors.”

About pharma

Ohio pharmacy board reverses hydroxychloroquine ban: Politics wins out over science: “Ohio's board of pharmacy has reversed its ban on hydroxychloroquine for use in COVID-19 patients and said it will reexamine the issue — just a day after announcing its plan to ban the drug — following a request from Gov. Mike DeWine.
The board had announced July 29 a plan to ban medical institutions from prescribing hydroxychloroquine for use in COVID-19 patients as of July 30, saying it was a "patient safety issue." The drug would still have been allowed in clinical trials.”

The day the music died? FDA fields request to ban background music in DTC ads:”While the petition is lengthy, its argument is simple. Music played in the background during the reading of risks distracts consumers and makes it more difficult to understand and remember those risks.”

About hospitals and health systems

Hospitals must start paying back billions borrowed from government during pandemic: Unlike many PPP “loans,” hospitals received advances on Medicare payments which they will need to start paying back soon. This article is a good discussion of the details and issues behind this upcoming major stress.

About healthcare IT

Healthcare groups cheer House move to overturn ban on nationwide patient identifier: Now if the Senate can agree…
”On Thursday, the U.S. House of Representatives passed the six-bill FY2021 minibus package that includes the Labor-Health and Human Services appropriations bill. As part of the bill, the House approved by voice vote the bipartisan Foster-Kelly Amendment, which strikes Section 510 of the Labor-HHS bill and removes the ban on using federal funding to create patient identifiers.

Allscripts sells EPSi business to Strata Decision Technology for $365M: “EPSi is a provider of financial decision support and planning tools for hospitals and health systems.”

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About health insurance

CMS announces two payment initiatives for COVID-19 drug treatment and counseling:”CMS will make payment available to physicians and providers to counsel patients at the time of COVID-19 testing about the importance of self-isolation after they are tested and prior to the onset of symptoms. The agency is also implementing new procedure codes to allow Medicare and other insurers to identify the use of the therapeutics remdesivir and convalescent plasma for treating hospital inpatients with COVID-19. 
These new codes are being implemented into the International Classification of Diseases Procedure Coding System, ICD-10-PCS. They go into effect on August 1. “

Medicare coverage for Alzheimer brain scans in question:”A big study to help Medicare officials decide whether to start covering brain scans to check for Alzheimer’s disease missed its goals for curbing health care costs, calling into question whether the pricey tests are worth it. 
The results announced Thursday are from a $100 million study of more than 25,000 Medicare recipients. It’s been closely watched by private insurers too, as the elderly population grows and more develop this most common form of dementia, which currently has no cure…
The study missed its goal of curbing hospitalizations by 10% in the year after the scan: Rates were 24% among those scanned versus 25% of the others. 
However, among those scanned, there were fewer hospitalizations for those with Alzheimer’s versus those without the disease.”

Oscar Health unveils $0 Virtual Primary Care program, 2021 expansion plans: “The expansion will bring the startup health plan's geographic footprint to 19 states and 47 markets, pending regulatory approvals…
Alongside the plans to further expand its reach, Oscar unveiled its new $0 Virtual Primary Care, which will offer a slew of digital and in-home services to its individual and family plan members in 10 markets, including Houston, Miami, New York City and Los Angeles, at no cost.”

About the public’s health

Age-Related Differences in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Levels in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19): VERY IMPORTANT RESEARCH FINDING THAT CHANGES HOW WE HANDLE THE COVID-19 PANDEMIC: “Our analyses suggest children younger than 5 years with mild to moderate COVID-19 have high amounts of SARS-CoV-2 viral RNA in their nasopharynx compared with older children and adults. Our study is limited to detection of viral nucleic acid, rather than infectious virus, although SARS-CoV-2 pediatric studies reported a correlation between higher nucleic acid levels and the ability to culture infectious virus. Thus, young children can potentially be important drivers of SARS-CoV-2 spread [emphasis added] in the general population, as has been demonstrated with respiratory syncytial virus, where children with high viral loads are more likely to transmit. Behavioral habits of young children and close quarters in school and day care settings raise concern for SARS-CoV-2 amplification in this population as public health restrictions are eased.” 

Yesterday, a reporting problem in New Mexico was provided as an example of what probably nationwide issues getting an accurate assessment of COVID-19. Today, two more reporting problems are in the news:

Florida health department says it doesn't collect COVID-19 healthcare worker death data; former employee says it does and
Missouri COVID-19 data backlog cleared, but delays persist, health officials say 

Observations of the global epidemiology of COVID-19 from the prepandemic period using web-based surveillance: a cross-sectional analysis: “Cases with travel links to China, Italy, or Iran accounted for almost two-thirds of the first reported COVID-19 cases from affected countries. Among cases with age information available, most were among adults aged 18 years and older. Although there were many clusters of household transmission among early cases, clusters in occupational or community settings tended to be larger, supporting a possible role for physical distancing to slow the progression of SARS-CoV-2 spread.”

Use of Chest Imaging in the Diagnosis and Management of COVID-19: A WHO Rapid Advice Guide: “The World Health Organization (WHO) undertook the development of a rapid guide on the use of chest imaging in the diagnosis and management of COVID-19…he rapid guide includes three diagnosis recommendations and four management recommendations. The recommendations cover patients with suspected or confirmed COVID-19 with different levels of disease severity, throughout the care pathway from outpatient facility or hospital entry, to home discharge”

Netflix’s Wellness Programming Is Irresponsible and Misleading: The headline is self explanatory and the article has many examples to back up the assertion.

About pharma

Moderna stock sinks as patent case spurs concern for COVID-19 vaccine:”A patent court has sided with Arbutus Biopharma in its dispute with Moderna, raising concerns that the intellectual property dispute could stymie COVID-19 vaccine development. The news sent shares in Moderna down 9% despite it being unclear whether the patent is relevant to its COVID-19 vaccine. 
The case centers on an Arbutus patent covering lipid formulations for the delivery of nucleic acids. In filing the patent, Arbutus said the technology is based on a ‘surprising discovery.’ Moderna disputed the novelty of the idea and took Arbutus to court on the grounds that it would have been obvious at the time of the invention.
The decision is the third ruling in a series of cases brought by Moderna against Arbutus with mixed, but largely unnoticed, results.”

AstraZeneca, Lilly, GSK and more will share COVID-19 antibody secrets to speed manufacturing scale-up:”Eli Lilly, AstraZeneca, Roche's Genentech unit, Amgen, GlaxoSmithKline and Lilly partner AbCellera can now share manufacturing information that could help speed up coronavirus antibody production, thanks to a business review letter [reported here last week] from the Justice Department's antitrust division…Two things those drugmakers can't collaborate on, though? Production costs and pricing.”

US to pay Sanofi, GlaxoSmithKline up to $2.1B for development, 100M doses of coronavirus vaccine:”The majority of the funding will go to Sanofi, which is developing the vaccine candidate based on recombinant protein-centric technology used in its influenza vaccine. Sanofi is partnering with GlaxoSmithKline to incorporate its adjuvant technology into the vaccine for improved efficacy.
More than half of the funding is apportioned for the vaccine's development, and the rest will go to manufacturing costs and an initial supply of 100 million doses. The U.S. has the option to obtain an additional 500 million doses later on.”

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About the public’s health

Operation Warp Speed: a timeline so far: A good summary of the activity from May 15-July 15. Lots of activity, no results.

Patients Evaluate Visit Notes Written by Their Clinicians: a Mixed Methods Investigation: The majority of patients understand their physician’s notes. This finding runs counter to many claims to the contrary and implications from studies of patient health literacy, The researchers found: “Nearly all patients (96%) reported they understood all or nearly all of the self-selected note, with few differences by clinician type or specialty. Overall, 93% agreed or somewhat agreed the note accurately described the visit, and 6% reported something important missing from the note. The most common suggestions for improvement related to structure and content, jargon, and accuracy.”

Cost-effectiveness of Breast Cancer Screening With Magnetic Resonance Imaging for Women at Familial Risk: This study from the Netherlands “suggests that MRI screening every 18 months between the ages of 35 and 60 years for women with a family history of breast cancer is cost-effective within the National Institute for Health and Care Excellence threshold for all densities. Higher thresholds would favor annual MRI screening. These outcomes support a change of current screening guidelines for this specific risk group and support MRI screening.”
It is important to look at the numbers they used in their calculations. Among the figures, a Quality Adjusted Life Year was valued at $24, 795.87 while the mammogram cost was $322.09 (both converted form Euros). In the US, the CPT code for an MRI mammogram without contrast with computer aided reading is 77049 (global charge). Perusal of the Medicare fee schedule (https://www.cms.gov/apps/physician-fee-schedule/search/search-results.aspx?Y=0&T=0&HT=0&CT=3&H1=77049&M=1 ) shows an approximate average charge of at least $400 (though some localities are as low as $360s). Commercial rates are undoubtedly much higher. So while the cost/benefit of this imaging works in Europe, our costly healthcare system changes the recommendation to a much less affordable option.

Trump launches "Embers Strategy" in coronavirus hotspots:”The Trump administration is sending increased personal protective equipment, coronavirus test kits and top health officials like Drs. Anthony Fauci and Deborah Birx to coronavirus hotspots across the U.S. as part of a campaign called the ‘Embers Strategy,’ White House officials tell Axios…
Its name, the ‘Embers Strategy,’ is meant ‘to highlight the risk level of “‘embers'‘“to decrease the likelihood of “'fires,'" a senior White House official said.”

57% of New Mexico hospitals didn't report COVID-19 data last week: 4 things to know: The article highlights reporting deficiencies that are probably happening nationwide.

Mapping the Spread of the Coronavirus Outbreak Around the U.S. and the World: Time magazine announced its “one-stop dashboard” to keep track of COVID-19 statistics. One interesting feature is the ability to look at trends in new cases by state.

California cuts off coronavirus aid to two cities that refuse to shut down: The cities weigh the balance of losing state aid versus lost revenue from businesses staying closed.
”At their city council meetings on Monday, leaders in Atwater, a city of 29,000 off Highway 99 in Merced County, and Coalinga, a city of 17,000 in the southwest corner of Fresno County, stood by resolutions they passed this spring allowing all businesses in their communities to reopen.
The Governor’s Office of Emergency Services warned the cities last week that they could collectively lose about $600,000 of federal coronavirus relief unless they come into compliance with state health requirements.”

About pharma

Drug Price Forecast 2020: This monograph is Vizient’s forecast for the coming year. Among the findings are a 3.29 percent increase in hospital pharmaceutical costs and the continuation of specialty drugs as the main driver of increasing prices.

Moderna proposes coronavirus vaccine will cost $50 to $60 per course: “The price is higher than the $19.50 per dose price agreed upon by Pfizer and BioNTech for their experimental vaccine in a pre-order deal with the U.S., Financial Times reported. 
AstraZeneca has signed a deal with some European countries to supply its COVID-19 vaccine at $3 to $4 per dose.”

GlaxoSmithKline employs 'new way of thinking' by using 23andMe's genetic data to launch cancer drug trial:”Early-stage trials for a new cancer drug developed by the two companies are now underway. They developed the antibody drug to block CD96, a protein that causes overactivity of another molecule in malignant tumors.”

AstraZeneca bucks industry trend with rise in first-half profits:”UK drugmaker AstraZeneca has increased first-half revenues and profits, bucking a trend at other large pharmaceutical groups that have begun to suffer from the coronavirus-related global economic slowdown. Revenue for the first six months of the year rose 14 per cent at constant currencies to $12.63bn, the company said on Thursday, while its core earnings per share jumped 26 per cent to $2.01. “

How a secretive Pentagon agency seeded the ground for a rapid coronavirus cure: For the past decade, the Defense Advanced Research Projects Agency (DARPA) has been funding technology aimed at “producing antibodies for any virus in the world within 60 days of collecting a blood sample from a survivor…
DARPA’s antibody program, which is known as the Pandemic Prevention Platform, or P3… has already led to the world’s first study in humans of a potential covid-19 antibody treatment.”
Fascinating article about DARPA and this process.

About health insurance

Trump Administration Continues to Keep Out-of-Pocket Drug Costs Low for Seniors: This article is the CMS announcement that the “average basic Part D premium will be approximately $30.50 in 2021.” Also significant is the previously announced $35 per month cap on spending for insulin.

Cigna saw utilization 'closer to normal' in June, expects similar trends in July despite COVID-19 spikes:”Cigna executives said that health utilization crept back up toward the end of Q2, with June appearing ‘much closer to normal.’
And early trends suggest that trend will continue through July, despite spikes in pandemic cases in several regions across the country. Cigna's utilization rate declined between 30% and 35% in April, but has climbed back up steadily since…”

Healthcare investments

State Of Healthcare Q2’20 Report: Sector And Investment Trends To Watch:
“REPORT HIGHLIGHTS:

  1. Global healthcare funding saw significant growth in Q2’20, setting a new quarterly record. Deals climbed slightly quarter-over-quarter. 

  2. Healthcare & digital health funding in Asia and Europe rebounded from the previous quarter, likely due to reopening efforts amid the pandemic. 

  3. Telehealth deals skyrocketed during the quarter, while funding declined slightly. Q2’20 also saw a record number of exits in the telehealth space. 

  4. The medical device sector reached new heights in both funding and exit volume during the quarter. 

  5. Healthcare AI startups received more than $1B in funding across 84 deals. Though up compared to the previous quarter, financing activity was below the record-setting levels seen in Q3’19. “

Today's News and Commentary

About the public’s health

Discriminative Accuracy of Plasma Phospho-tau217 for Alzheimer Disease vs Other Neurodegenerative Disorders: This blood test could be very useful distinguishing Alzheimer’s from other types of dementia. The research concluded: “Among 1402 participants from 3 selected cohorts, plasma P-tau217 discriminated AD from other neurodegenerative diseases, with significantly higher accuracy than established plasma- and MRI-based biomarkers, and its performance was not significantly different from key CSF- or PET-based measures. Further research is needed to optimize the assay, validate the findings in unselected and diverse populations, and determine its potential role in clinical care.”

Geographic Variation in Overscreening for Colorectal, Cervical, and Breast Cancer Among Older Adults:”In a large, nationally representative, cross-sectional telephone survey with 176 348 participants, more than 45% of older adults in the US reported being screened for colorectal, cervical, or breast cancer after the recommended upper age limit, and overscreening for cervical and breast cancer was more common in metropolitan areas. Life expectancy was not associated with overscreening.”

There May Be 6 Types of COVID-19: Results in a preprint indicate there may be 6 distinct types of COVID-19 clinical illness.

“The six symptom groups in a sequence from least to most severe are: 

  • Headache, loss of smell, muscle pains, cough, sore throat, chest pain, no fever. 

  • Headache, loss of smell, cough, sore throat, hoarseness, fever, loss of appetite. 

  • Headache, loss of smell, loss of appetite, diarrhea, sore throat, chest pain, no cough.

  • Headache, loss of smell, cough, fever, hoarseness, chest pain, fatigue. 

  • Headache, loss of smell, loss of appetite, cough, fever, hoarseness, sore throat, chest pain, fatigue, confusion, muscle pain. 

  • Headache, loss of smell, loss of appetite, cough, fever, hoarseness, sore throat, chest pain, fatigue, confusion, muscle pain, shortness of breath, diarrhea, abdominal pain.”

'Spectacular': Trump praises doctor who dismissed face masks after viral video: I thought this story was from The Onion. Just read it and see if you are amused or appalled.

Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19): “In this cohort study including 100 patients recently recovered from COVID-19 identified from a COVID-19 test center, cardiac magnetic resonance imaging revealed cardiac involvement in 78 patients (78%) and ongoing myocardial inflammation in 60 patients (60%), which was independent of preexisting conditions, severity and overall course of the acute illness, and the time from the original diagnosis…
These findings indicate the need for ongoing investigation of the long-term cardiovascular consequences of COVID-19.”

A desk-based job may lower the risk of cognitive decline: “The research study found that that those with desk jobs — which are typically sedentary roles — have a lower risk of cognitive decline. Moreover, people with lifelong desk-based careers were most likely to be among the study’s top 10% of cognitive performers. 
Conversely, people whose jobs involve manual work have nearly three times the risk of developing poor cognition.”
The researchers warn that: “The relationship between inactivity and cognition is strongly confounded by education, social class and occupation. Physical activity during leisure may be protective for cognition, but work-related physical activity is not protective. A greater understanding of the mechanisms and confounding underlying these paradoxical findings is needed.”

Minnesota Republican county official resigns after posting image comparing mask wearing to Nazi Germany: And we wonder why we are still having a pandemic? “A Minnesota Republican Party county official has resigned after posting an image on Facebook comparing mask mandates to Jews being forced to wear Stars of David in Nazi Germany, the state party said on Tuesday.”

US officials: Russia behind spread of virus disinformation: ”Russian intelligence services are using a trio of English-language websites to spread disinformation about the coronavirus pandemic…
Two Russians who have held senior roles in Moscow’s military intelligence service known as the GRU have been identified as responsible for a disinformation effort meant to reach American and Western audiences, U.S. government officials said…
Between late May and early July, one of the officials said, the websites singled out Tuesday published about 150 articles about the pandemic response, including coverage aimed either at propping up Russia or denigrating the U.S.”

Young people are infecting older family members in shared homes:”…evidence is growing that young people who work outside the home, or who surged into bars and restaurants when states relaxed shutdowns, are infecting their more vulnerable elders, especially family members.”

Preliminary Medicare COVID-19 Data Snapshot: This CMS website provides “current” demographic data about Medicare patients (including Medicare Advantage) with COVID-19 infections. YTD through June 20 there were 550,000 affected Medicare beneficiaries.

XPrize launches $5M COVID-19 testing competition backed by Amazon, Google, Anthem:”XPrize has launched a Rapid Covid Testing competition that will award $5 million to teams that develop faster, cheaper and easier-to-use COVID-19 testing methods at scale.”

Sorrento picks up color-changing COVID-19 saliva test built by Columbia University fertility clinic:”Sorrento Therapeutics has picked up a saliva-based coronavirus test developed by fertility researchers at Columbia University that aims to provide an easy-to-read result in less than 30 minutes.
The entirety of the single-step test, to be dubbed COVI-TRACE, is contained within a small tube—it requires no laboratory equipment and can be used just about anywhere.”

Coronavirus tracker: Do-it-yourself vaccine raises questions; Sanofi's Dupixent 'resilience': This article is a really good update on COVID-19 over the past 10 days. It also mentions that: “A group of scientists in Boston formed a group to create a do-it-yourself experimental vaccine that's administered through the nose, raising legal and ethical questions, MIT Technology Review reports. At least 20 people have given themselves the unproven vaccine.”

About healthcare IT

Pharmacies are also sources of data breaches as evidenced by two stories in today’s news:
CVS Pharmacy loses 21,289 patients' information after vandalism: “CVS Pharmacy reported vandalism at stores in several markets between May 27 and June 8 resulted in the loss of some patient information.
The HHS Breach Portal shows the incident affected 21,289 individuals. The missing information included paper prescriptions, filled prescriptions that had been held in pharmacy waiting bins and vaccine consent forms. Information affected during the vandalism included names, birth dates, addresses, medication names and prescriber information in addition to information about primary care providers. CVS Pharmacy has notified impacted patients.”

Walgreens says 180 stores affected by potential patient data breach: “Walgreens has sent letters to customers telling them that stores nationwide were affected by a potential breach of patient data between May 26 and June 5 and their prescription information may have been compromised. 
The company said that between those dates, thieves stole filled prescriptions and paper records with health information, potentially exposing data including customer names and ages, medication names and dosages, prescription numbers and prescriber names, health plan names and group numbers, and vaccination information, as well as patients' addresses, phone numbers and email addresses.” 

IBM Report: Compromised Employee Accounts Led to Most Expensive Data Breaches Over Past Year: “IBM Security announced today the results of a global study examining the financial impact of data breaches, revealing that these incidents cost companies studied $3.86 million per breach on average, and that compromised employee accounts were the most expensive root cause.” However, healthcare breaches cost the most-$7.13 million.

About health insurance

Anthem earns $2.28B in Q2 profit as payers continue to see strong financial performance amid COVID-19: “Anthem's profits doubled year over year in the second quarter, reaching $2.28 billion, according to the insurer's earnings report released Wednesday morning.
In the second quarter of 2019, Anthem earned $1.14 billion in profits, making it the latest national health plan to report massive financial gains so far this year amid the COVID-19 pandemic.”

The COVID-19 Downturn Triggers Jump in Medicaid Enrollment:”Medicaid enrollment was 72.3 million in April, up from 71.5 million in March and 71 million in February, according to the latest enrollment figures released last week by the Centers for Medicare & Medicaid Services. The increase in March was the first enrollment uptick since March 2017.
About half of the people enrolled in Medicaid are children.”

About pharma

House passes $3.2B FDA budget giving agency power to recall drugs: While only a House bill, if passed by the Senate as well, this measure could be one of the highest impact pharma laws in the decade. The reason is that currently, while the FDA can recall defective products, it cannot require that drugs be taken off the market.

Kodak Shifts Into Drug Production With Help of $765 Million U.S. Loan:”Eastman Kodak Co. has won a $765 million government loan under the Defense Production Act, the first of its kind. The purpose: to help expedite domestic production of drugs that can treat a variety of medical conditions and loosen the U.S. reliance on foreign sources.”

About hospitals and health systems

Systems are now reporting 2nd quarter results. They must repay federal loans and Medicare advances, so these reports must be viewed with caution. Among the reports:

UHS generates $251M in profits thanks to help from COVID-19 relief funds:”The system reported late Monday that its net revenue declined by 4.4% to $2.7 billion in the second quarter compared with $2.85 billion for the same time period in 2019. The earnings reflect other hospital systems that have relied on a massive $175 billion relief fund to help recover from losses sparked by COVID-19.
UHS found that the $251.9 million in profits was slightly above the $238.5 million it generated in the second quarter of 2019.”

HS generates $70M in profits in Q2, got $448M in COVID-19 relief funds:”Community Health Systems generated $70 million in profits in the second quarter of 2019 as government relief funding helped soften the blow of COVID-19…
The second-quarter earnings also represent a significant boost year over year, as CHS suffered a net loss of $167 million in the second quarter of 2019.
CHS generated net operating revenue of $2.5 billion for the quarter.”

Today's News and Commentary

About health insurance

New bill seeks to boost participation in advanced payment models, ACOs via several reforms:”The Value in Health Care Act introduced on July 24 proposes several changes to Medicare’s alternative payment models. It would boost payments for not only ACOs but also extend bonus payments to clinicians working in advanced APMs.”

About healthcare quality

2020-21 Best Hospitals Honor Roll and Medical Specialties Rankings: Annual US News rankings.
Mayo is overall #1.

About pharma

Potent neutralizing antibodies directed to multiple epitopes on SARS-CoV-2 spike: Researchers “report the isolation of 61 SARS-CoV-2-neutralizing monoclonal antibodies from 5 infected patients hospitalized with severe disease.” The implication is that vaccines and treatments may need to have multiple components to successfully prevent or fight SARS-CoV-2.

Identification of an Anti-diabetic, Orally Available Small Molecule that Regulates TXNIP Expression and Glucagon Action: Researchers found the small molecule SRI-37330 inhibits expression of the gene TXNIP in mouse and human pancreatic islet cells that are responsible for glucose regulation. Oral SRI-37330 decreases glucagon secretion (which increases blood sugar), blocks hepatic glucose output and reverses obesity. This potential drug represent s a new mechanism for diabetes treatment.

Disrupting the platelet internal membrane via PI3KC2α inhibition impairs thrombosis independently of canonical platelet activation: Antiplatelet therapy to prevent strokes and heart attacks impairs platelets’ ability to form clots and can lead to bleeding disorders. Researchers found a more targeted mechanism that prevents clotting related only to impaired flow. If a workable drug can be found that achieves this effect it would be a safer alternative to current therapies.

Generic drug trade group loses bid to block California pay-to-delay law:”A federal appeals court denied a bid by generic drug trade group Association for Accessible Medicines to block a California law banning pay-to-delay deals between drugmakers….
Pay-to-delay deals happen when a brand-name drugmaker pays a generic drugmaker to delay launching a generic version of a drug so the brand-name drugmaker can continue selling it without competition for a longer period of time. 
The Federal Trade Commission has said such deals cost U.S. consumers about $3.5 billion annually. 
California became the first state to outlaw such deals in October 2019.”

Drugmakers refuse to attend White House meeting after Trump issues executive orders on costs: “A White House meeting with top pharmaceutical executives that President Donald Trump promised for Tuesday is off, five industry sources familiar with discussions told POLITICO. Three said the drug-pricing discussion was canceled because the major drug lobbies, reeling from Friday’s cluster of executive orders on the topic, refused to send any members.”

President Trump announces $265 million award to Fujifilm for coronavirus vaccine manufacturing: “The Department of Health and Human Services awarded the contract, which reserves manufacturing capacity  through the end of 2021, to the Fujifilm Texas A&M Innovation Center in College Station, Texas.”

AstraZeneca, Daiichi Sankyo in $6B oncology deal: “AstraZeneca PLC said Monday that it has entered into an oncology collaboration with Daiichi Sankyo Co. worth up to $6 billion that it said could redefine treatment standards in lung, breast and multiple other cancers.
The British pharmaceutical giant said it and Daiichi Sankyo will jointly develop and commercialize a new antibody drug conjugate, DS-1062, world-wide, except in Japan. The drug is currently in development, AstraZeneca said.”

Indivior to pay $600 million to settle U.S. opioid treatment marketing claims:”The indictment alleged Indivior deceived doctors and healthcare benefit programs into believing the film version of Suboxone, which has an opioid component, was safer and less susceptible to abuse than similar drugs…
The company is also settling related civil lawsuits the Justice Department joined in 2018… to resolve claims by the Federal Trade Commission that it impeded competition from generic equivalents of Suboxone.”

Pfizer, BioNTech start their COVID-19 vax phase 3, squaring off with Moderna:”Moderna announced early Monday that, alongside a near half-billion extra in Biomedical Advanced Research and Development Authority dollars, it has started a boosted 30,000-patient phase 3 for its vaccine; not to be left out, Pfizer and BioNTech announced after-hours that they too were starting a late-stage attempt.”

About the public’s health

Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration: Not that this study will change the opinions of anti-vaxxers, but researchers found that: “Over a 20-year period, vaccines were found to be remarkably safe. A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance. These findings confirm the robustness of the vaccine approval system and postmarketing surveillance.”

Effectiveness of surgical masks against influenza bioaerosols: Masks have been recommended to prevent the wearer from spreading a contagion. In this study, researchers developed a model to gauge the effectiveness of protection for the wearer. They found: “Live influenza virus was measurable from the air behind all surgical masks tested. The data indicate that a surgical mask will reduce exposure to aerosolised infectious influenza virus; reductions ranged from 1.1- to 55-fold (average 6-fold), depending on the design of the mask.”

Florida judge upholds coronavirus ordinance requiring masks:”A Florida judge on Monday upheld a county’s coronavirus ordinance that requires masks be worn in public places like stores, saying government officials have the authority to protect their residents from the spread of infectious diseases.”

FDA expands list of potentially deadly hand sanitizers:”The US Food and Drug Administration has expanded its list of potentially deadly hand sanitizer products, warning a Mexican-based company about selling products that contain methanol, a dangerous form of alcohol that can poison people through their skin.”