Today's News and Commentary

About the public’s health

The coronavirus pandemic has caused nearly 300,000 more deaths than expected in a typical year: An update. “The CDC said the novel coronavirus, which causes covid-19, has taken a disproportionate toll on Latinos and Blacks, as previous analyses have noted. But the CDC also found, surprisingly, that it has struck 25- to 44-year-olds very hard: Their “excess death” rate is up 26.5 percent over previous years, the largest change for any age group.”

WTO Holds Off On Waiving IP For COVID-19 Vaccines:”Member states of the WTO's Council for Trade-Related Aspects of Intellectual Property Rights on Friday declined to take an unprecedented step to waive provisions of the TRIPS Agreement, a global treaty governing international property rights, according to Amnesty International and other civil society organizations familiar with the talks.”

Government watchdog to investigate allegations of Trump interference at CDC, FDA: The Government Accountability Office (GAO) agreed to launch the investigation at the request of several Democratic senators.

Volunteers to be infected with coronavirus in world’s first ‘human challenge’ trials in London:”Up to 90 fit people aged 18-30 will be deliberately infected with virus in effort to accelerate vaccine development.”

Harvard-CU Boulder Portable Air Cleaner Calculator for Schools.v1.2: This calculator tells you how to choose an air filter given the size of the space in which it is placed.

American Society for Microbiology Finds Shortages of Testing Supplies in Labs: “The American Society for Microbiology (ASM) has announced that its online data collection tool has found crucial pandemic supply shortages, including a lack of commercial COVID-19 tests and routine laboratory diagnostics in clinical labs.
Of the 117 Clinical Laboratory Improvement Amendments (CLIA)-certified labs running the tool, 73 percent have a shortage of commercial testing kits for COVID-19, 65 percent of labs have a shortage of nonCOVID-19 testing supplies for routine bacteria and 70 percent of labs are short on supplies for testing for sexually transmitted infections, ASM said.”

STAT-Harris Poll: The share of Americans interested in getting Covid-19 vaccine as soon as possible is dropping:”“Overall, 58% of the U.S. public said they would get vaccinated as soon as a vaccine was available when asked earlier this month, down considerably from 69% who said the same thing in mid-August. That change suggests growing concern that the regulatory approval process for a Covid-19 vaccine has been politicized by the Trump administration in the run-up to the presidential election.”

About health insurance

CMS: Average ACA plan premiums to drop by 2% in 2021 as more insurers join exchanges: “The Centers for Medicare & Medicaid Services announced Monday that the premium decline is part of a larger trend with the insurance exchanges, where premiums for the average plan has declined by 8% since 2018.” This prediction contrasts with the 1% increase that the Kaiser Family Foundation reported yesterday.

Hospitals Denied Full Court Review in Medicare Drug Pay Suit: “Hospitals objecting to a Trump administration rule that cut their Medicare payments for certain drugs by billions of dollars per year failed to convince the full District of Columbia Circuit to rehear the case.
In an unsigned Oct. 16 order, the U.S. Court of Appeals for the District of Columbia Circuit denied a petition for en banc review filed by the American Hospital Association and several individual hospitals.”

Best Insurance Companies for Medicare Part D Prescription Drug Plans 2021: The ratings are from US News, based on Medicare data.

KFF Health Tracking Poll – October 2020: The Future of the ACA and Biden’s Advantage On Health Care: “The latest KFF Health Tracking Poll finds a large majority of the public – including majorities of Democrats (91%), independents (81%), and Republicans (66%), now say they do not want to see the Supreme Court overturn the ACA’s pre-existing condition protections. The share who do not want to see these protections overturned has increased by double digits from one year ago for each group.
Six in ten adults say they do not want to see the Supreme Court overturn the entire ACA, up 10 percentage points from one year ago. This includes majorities of both Democrats (89%) and independents (66%), but three-fourths of Republicans still want to see the entire law overturned. Overall views of the Affordable Care Act are slightly more positive this month, with 55% of the public saying they view the law favorably. This ties its highest favorability measured in ten years of KFF polling (tied with February 2020).”
Read the entire poll results.

About hospitals and healthcare systems

Healthgrades 2021: REPORT TO THE NATION: “The Healthgrades 2021 Report to the Nation analyzes the performance of nearly 4,500 hospitals as measured by risk-adjusted mortality and complication rates. The analysis shows wide performance gaps persist among hospitals…
Healthgrades’ recent assessment of 32 of the most common procedures and conditions in the country show that if all hospitals, as a group, performed similarly to 5-star rated hospitals, on average: 218,785 lives could potentially have been saved and complications in 148,681 patients could potentially have been avoided from 2017- 2019.” Much more information in this report and is worth reading.

About pharma

HHS lawyer: Trump’s drug cards could violate election law: “The health department’s top lawyer is warning in an internal memo that President Donald Trump's plan to give seniors $200 discount cards to buy prescription drugs could violate election law, according to three officials with knowledge of those legal concerns.
The lawyer’s objection, coupled with his advice to seek approval from the Department of Justice, is a significant blow to Trump’s hope to promote the hastily devised plan before Election Day.”

About healthcare IT

Nation's First Implant of Bluetooth-Connected Heart Device at St. Elizabeth[Edgewood, KY]: “The smartphone connectivity in this device is expected to substantially improve patient remote monitoring rates and patient engagement in monitoring. Research has shown that better patient engagement and compliance with monitoring translates into reduced hospitalizations, better clinical outcomes, and improvement in survival. The smartphone connectivity offers patients flexibility compared to traditional bedside monitors. The app allows easy transmission of data manually and access to device status such as battery longevity, all done in a cybersecure mode with enabled two-way authentication.”

American Telemedicine Association Partners with ORCHA to Launch Review Process in the U.S. to Ensure Patients Have Access to Safe and Effective Apps: “The American Telemedicine Association (ATA)… announced a new partnership with ORCHA (Organization for the Review of Care and Health Apps) to create a review process for the U.S. to enable healthcare providers, insurers, and employers to give patients access to safe and effective health apps. ORCHA’s automated, intelligent review engine allows healthcare organizations to assess thousands of apps against more than 300 measures in order to build and manage a health app program…
ORCHA has evaluated more than 4,000 health apps currently available in the U.S. against its criteria and found only 15% meet quality thresholds. Most apps fail to meet healthcare, security or usability standards established to safeguard patients.  Such quality standards apply across apps for all health conditions, from fitness to heart conditions.”

Research Report: COVID-19 Pandemic Shifts Innovation Priorities at Health Systems: Telehealth/virtual care has become, by far, the highest priority. But  only 20 percent said that they would continue providing these services if reimbursement rates returned to pre-COVID-19 levels. 

Today's News and Commentary

About pharma

WHO stands by COVID-19 study casting doubt on benefit of Gilead's Veklury: “Interim findings from the World Health Organization's (WHO) global Solidarity trial have been posted to the medRxiv preprint server, and the agency says Gilead Sciences' Veklury (remdesivir) and the other drug regimens tested had "little or no effect" on 28-day mortality or the in-hospital course of COVID-19 among hospitalised patients. The data appear to corroborate a recent report based on a copy of the study that was obtained by the Financial Times.”

About the public’s health

bioLytical Receives CE Mark for One-Minute COVID-19 Test: “The portable test kit delivers results in one minute from a single drop of blood and doesn’t require any additional processing equipment, providing all the needed materials in a single pouch.” Testing is getting faster and faster.

Walgreens, CVS will offer free COVID-19 vaccines at long-term care facilities: “The vaccines will be free, and the partnership covers long-term care settings including skilled nursing facilities, nursing homes, assisted living facilities, residential care homes and adult family homes.” 

COVID-19 testing capacity outpacing desire to get swabbed: “The Trump administration says more than 120 million tests will be available in October nationwide. But far fewer Americans are actually being tested: only around 1 million per day, less than 30 million per month.”

State health officials tell Congress they need $8.4B for COVID-19 vaccination effort:”State public health officials are urging Congress to provide at least $8.4 billion in emergency funding for distributing a coronavirus vaccine, warning that they do not currently have enough money to carry out the immense logistical effort. 
The letter to bipartisan congressional leaders came from the Association of State and Territorial Health Officials (ASTHO), a group that represents state public health departments, and the Association of Immunization Managers (AIM), which represents states’ vaccination officials.”

Key coronavirus model predicts nearly 80 percent rise in deaths by February:”A key model foresees approximately 171,000 more coronavirus related deaths by February 2021, a number that would represent a spike of 78 percent.
The model from the Institute for Health Metrics and Evaluation at the University of Washington School of Medicine suggests there will be roughly 389,087 deaths by Feb. 1.
If all Americans use face masks, the model’s best-case scenario projects 314,000 deaths by that date. The model, however, foresees more than 477,000 deaths if mask mandates are eased.”

CMS data shows 21% of Medicare beneficiaries forego care: “The data showed that the most common type of care that beneficiaries delayed was going to the dentist (43%) followed by a regular checkup at 36%.
Another 36% reported not getting treatment for an ongoing condition and 32% for a diagnostic or medical screening.
CMS found that 45% of beneficiaries cited COVID-19 risk as the reason for not going to a medical facility.”
The data is a few months old so need a newer study to see if the trends are holding.

Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity — United States, 2001–2017: “Additional years of data show continued increases in the incidence of distant stage prostate cancer in the United States. The percentage of distant stage prostate cancer increased from 4% in 2003 to 8% in 2017. Five-year survival for distant stage prostate cancer improved from 28.7% during 2001–2005 to 32.3% during 2011–2016; for the period 2001–2016, 5-year survival was highest among Asian/Pacific Islanders (42.0%), followed by Hispanics (37.2%), American Indian/Alaska Natives (32.2%), Black men (31.6%), and White men (29.1%).”
The question is how often and in what populations do you need to screen. This period coincides with recommendations to decrease PSA testing.

About health insurance

Feds approve Georgia health insurance changes sought by Kemp:”Georgia will become the first state to offer federally subsidized health insurance to its residents only through private brokers under a plan being approved by President Donald Trump’s administration.
A separate part of the plan would offer Medicaid to some of the state’s poorest able-bodied adults, but only on the condition that they work, volunteer, receive job training or attend school.”

2021 Premium Changes on ACA Exchanges and the Impact of COVID-19 on Rates: “We find that the majority of rate changes for 2021 are still moderate, with increases or decrease of a few percentage points. Proposed rate changes range from a -42.0% decrease to a 25.6% increase, though half fall between a 3.5% decrease and 4.6% increase…” More details are in the survey.

About healthcare systems

Direct primary care provider to acquire 230 clinics: “Paladina Health, a Denver-based direct primary care provider, has signed an agreement to acquire Healthstat, a Charlotte, N.C.-based provider of onsite and virtual primary care. 
Paladina currently operates 120 clinics in 19 states. Through the Healthstat acquisition, Paladina will add 230 clinics in 13 additional states.” 

MOST HOSPITALS EXPANDING ASC INVESTMENTS: “In two years, the number of hospitals owning or affiliating with more than one ASC jumped 17 percentage points. In 2020, 75% of hospitals with 200-plus beds have more than one ASC. Payer pressures and other market forces have softened hospitals’ historically defensive posture toward ASCs, paving the way for overall growth, lower operating costs and heightened patient satisfaction.” 

The Impact of the COVID-19 Pandemic on Outpatient Care: Visits Return to Prepandemic Levels, but Not for All Providers and Patients: “Visits to ambulatory providers fell nearly 60 percent by early April. Since then visits have rebounded, returning in the past month to prepandemic levels.” Read this update from the Commonwealth Fund for more details.

Today's News and Commentary

About pharma

FDA extends pregnancy warning for common pain relievers: “Pregnant women should avoid a group of common pain relievers including Advil and Aleve for the last four months of pregnancy, federal health officials said Thursday, expanding the warning from three months.
The Food and Drug Administration said the fever-and-pain-reducing drugs can cause a rare but serious complication that can harm the fetus. They can lead to kidney problems in the fetus that can result in low levels of amniotic fluid that fills the womb.
The warning applies to a family of anti-inflammatory drugs that includes both over-the-counter ingredients like ibuprofen and prescription-strength drugs like Celebrex.”

Gilead questions WHO study that cast doubts on drug's COVID-19 benefits:”The American company told Reuters the data appeared inconsistent, the findings were premature and that other studies had validated the drug’s benefits.
In a blow to one of the few drugs being used to treat people with COVID-19, the WHO said on Thursday its “Solidarity” trial had concluded that remdesivir appeared to have little or no effect on 28-day mortality or length of hospital stays among patients with the respiratory disease.”

Pharma, take note: Millennials plan to spend more on meds, study says: “WPP's global media group, Mindshare, began surveying consumers in mid-March to find out what people were thinking about the then-emerging pandemic…
Overall, 77% of those surveyed planned to increase spending or spend the same amount on prescription medications.
However, when analyzed by generation, 26% of millennials—compared with only 9% of baby boomers—said they expect to increase their spending. It's not that boomers will spend less; 85% expect to spend the same amount. They just aren't likely to buy more. For comparison, 41% of millennials expect to keep their spending steady.”

About health insurance

Medicaid Enrollment & Spending Growth: FY 2020 & 2021: From the Kaiser Family Foundation:

• “After relatively flat enrollment growth in FY 2020 (0.04%), states responding to the survey expect Medicaid enrollment to jump in FY 2021 (8.2%) attributed to the FFCRA’s MOE requirements and to the economic downturn that started late in FY 2020.

• Across all reporting states, states were anticipating that total Medicaid spending growth would accelerate to 8.4% in FY 2021 compared to growth of 6.3% in FY 2020. Enrollment was the primary factor identified as putting upward pressure on expenditure growth in FY 2021.”

President Trump’s Medicare drug discount cards face uncertain path: “Three weeks after President Trump announced the government would send tens of millions of older Americans $200 to help pay for medicine, the election-season idea is mired in uncertainty over whether such drug discount cards are legal, proper or will ever exist.” Read the article for more details.

Georgia gets Trump approval for Medicaid work requirements, partial expansion: “The Trump administration has given Georgia the green light to partially expand Medicaid without federal support, and to impose work requirements on Medicaid beneficiaries.
The plan announced by Gov. Brian Kemp (R) Thursday stops short of the full-scale Medicaid expansion supported by Democrats, which would cover thousands more low-income adults regardless of their employment status.
Kemp’s plan, called "Pathways to Coverage," would cover adults who meet the work requirements and who earn no more than 100 percent of the federal poverty level — $12,760 a year for an individual.”

The Potential Effects of a Supreme Court Decision to Overturn the Affordable Care Act: Updated Estimates: “Using projections of coverage and spending in 2022 that account for an anticipated partial economic recovery from the COVID-19 recession, researchers estimate overturning the Affordable Care Act (ACA) would leave an additional 21 million people uninsured.”

Blue Shield of California’s Innovative Drug Cost Transparency Initiative Provides $10 Million in Prescription Savings: “Knowing that doctors treat dozens of patients per day, Blue Shield of California first released a tool that empowers doctors at the point of prescription – while the patient is still sitting in front of them during a visit. Integrated seamlessly into electronic records systems, this tool acts like an online shopping cost-comparison engine, displaying appropriate drug alternatives along with the patient’s copay and the total drug cost for each.”

Appeals court skeptical of AHA in lawsuit over HHS price transparency rule: “A trio of appellate judges was very skeptical of the hospital industry’s arguments that a controversial price transparency rule set to go into effect in January should be struck down…
The rule requires facilities to post payer-negotiated rates for 300 shoppable services. The idea is to give consumers a way to price shop among different hospitals for certain services.”

About the public’s health

Global Burden of Disease: This link is to tomorrow’s special issue of The Lancet. A great topical review.

The Third Coronavirus Surge Has Arrived: We worried about the second wave of the infection. Now, this article from The Atlantic explains we are experiencing the third wave: “After a month of warning signs, this week’s data make it clear: The third surge of the COVID-19 pandemic in the United States is under way. Outbreaks have been worsening in many states for more than a month, and new COVID-19 cases jumped 18 percent this week, bringing the seven-day average to more than 51,000 cases a day. Though testing rose by 8 percent nationally, that’s not enough of an increase to explain the steep rise in cases. Meanwhile, COVID-19 hospitalizations, which had previously been creeping upward slowly, jumped more than 14 percent from a week earlier.”

About hospitals and health systems

47 hospitals closed, filed for bankruptcy this year: A list of the casualties (so far) due to the decreased elective care volumes caused by the COVID-19 pandemic.

Today's News and Commentary

About health insurance

UnitedHealth Group Reports Third Quarter Performance: Updating yesterday’s post about increased revenue, UnitedHealth reported “earnings of $3.30 per share and adjusted earnings of $3.51 per share declined 10%, while care patterns disrupted by the pandemic moved closer to normal levels.”

Competition shrank in majority of health insurance markets where it is scarcest: “Between 2014 and 2019, the share of markets that were highly concentrated increased from 71% to 74%. Moreover, more than half (52%) of the markets that were highly concentrated in 2014 grew even more concentrated by 2019.”

CMS adds 11 new telehealth services to Medicare coverage: These services have been approved during the Covid pandemic. And in a related article: Blue Cross Blue Shield covers telemedicine permanently for federal workforce program.

FDA decision to stop quick review of lab developed tests [LDTs] raises payment concerns for labs:The FDA announcement “last week that it will no longer review COVID Emergency Use Authorization [EUA] submissions for laboratory-developed tests has created new uncertainty for laboratories amidst an already tumultuous environment.”
The decision “raises questions around reimbursement and liability protections for those tests moving forward. It could also impact the ability of new lab developed tests to compete in the market. That's because an EUA, which the new LDTs won't have, are seen by many clinicians and payors as a mark of quality.

Gen Re Announces U.S. Medicare Supplement Market Survey 2019 Results: “Key results from this year’s survey include:

• Across all participants, $23.3 billion in total Medicare Supplement in-force premium was reported for 2019, an increase of 5.8% over reported results for 2018.

• For companies actively selling and reporting premium and lives for both 2017 and 2018, sales premium and lives grew by 21.0% and 12.8%, respectively.

• Lapse rates averaged 10.6% for open blocks of business and 14.0% for closed blocks in 2019.

• Plan G was the most popular plan sold in 2019, accounting for 54.2% of new sales premium and 55.5% of new lives. [See the Medicare section of the Book for explanations of the different supplement choices.]

• Nearly 61% of the active companies who participated in the survey report selling Medicare Supplement plans on a direct-to-consumer basis (via phone, mail, online or a combination of these methods where a traditional agent receiving traditional paid compensation is not involved), and 6% are looking to develop this capability.”

About pharma

Walgreens Boots Alliance Reports Fiscal Year 2020 Results: Highlights:

• “Sales increased 2.0 percent to $139.5 billion, up 2.5 percent on a constant currency basis

• Operating income decreased 73.7 percent to $1.3 billion; Adjusted operating income decreased 24.9 percent to $5.2 billion, down 24.8 percent on a constant currency basis

• EPS decreased 88.0 percent to $0.52; Adjusted EPS decreased 20.8 percent to $4.74, down 20.6 percent on a constant currency basis; reflecting an estimated adverse COVID-19 impact of approximately $1.06

• Net cash provided by operating activities was $5.5 billion, a decrease of $109 million compared with fiscal 2019; Free cash flow increased 5.6 percent to $4.1 billion”

Rite Aid unveils new strategy, revamped stores to remain competitive with CVS, Walgreens: “The revamped stores, some of which will open this month, will feature a pharmacy that looks more like an Apple Store Genius Bar, virtual care rooms that will enable consumers to remotely connect with care teams and a new assortment of products with a focus on both traditional medicine and alternative ‘remedies’ like essential oils…”

About healthcare IT

Press Ganey acquires Doctor.com and majority stake in Binary Fountain:”Boston-based patient experience company Press Ganey acquired Doctor.com, a marketing automation platform for medical practices.
It also acquired a majority stake in Binary Fountain, which has an online reputation management platform. 
The combination of the two solutions will make its healthcare consumerism platform the largest in the industry… The platform will be aimed at helping health providers drive digital patient acquisition, retention and reputation management…”

Mayo Clinic, startup launch 'health passport' app with initial focus on COVID-19: “Mayo Clinic is partnering with Los Angeles-based Safe Health Group…  The venture will focus on testing for STDs and common ailments but will initially target COVID-19 through symptom tracking and testing by linking consumers, clinicians and test distribution into one digital solution, called HealthCheck.
HealthCheck is a smartphone and desktop app that's designed to provide real-time health status verification while also protecting consumer privacy, much like a health passport…”

Federal Electronic Health Record Connects With More Community Partners: “The Federal Electronic Health Record Modernization (FEHRM) program office announces the Department of Defense (DOD), Department of Veterans Affairs (VA) and Department of Homeland Security’s U.S. Coast Guard (USCG) significantly expanded their joint health information exchange (HIE) network with the private sector on Oct. 9 after connecting with the CommonWell Health Alliance.
CommonWell brings a nationwide network of more than 15,000 hospitals and clinics to the 46,000 community partners already part of the joint HIE.”

Alexa, do I have COVID-19?: A fascinating article from Nature that updates the emerging science of disease detection by voice recognition technology.

About hospitals and health systems

15 hospital building projects costing $1B or more: It is amazing that this much major construction is going on not only during the COVID-19 pandemic, but also as payment mechanisms are changing, e.g., more telemedicine and risk-based payments.

About the public’s health

COVID-19 in New Zealand and the impact of the national response: a descriptive epidemiological study: A great case study of successful handling of the COVID-19 pandemic: “Here, we investigate the impact of national suppression strategies on the epidemiology of the first wave of COVID-19 in New Zealand and measures of response performance.” Early shutdowns, quarantines and case tracing were among the key successful actions.

Today's News and Commentary

About the public’s health

Covid in the U.S.: Latest Map and Case Count: “At least 826 new coronavirus deaths and 54,512 new cases were reported in the United States on Oct. 13. Over the past week, there have been an average of 52,156 cases per day, an increase of 21 percent from the average two weeks earlier.” And in a related article: Coronavirus cases are rising in U.S., sparking worries the next big wave has begun

Rapid New Covid-19 Test From Access Bio Cleared in U.S.: “A new 10-minute Covid-19 test that doesn’t need added equipment to process has been cleared by the U.S. Food and Drug Administration, manufacturer Access Bio, Inc.said on Tuesday.” The test will cost less than $20.

New poll shows Black Americans see a racist health care system setting the stage for pandemic’s impact: A new nationwide poll by The Undefeated and the Kaiser Family Foundation (KFF) found that 7 in 10 African Americans believe that people are treated unfairly based on race or ethnicity when they seek medical care. It’s a feeling born of unequal history and intensified by the coronavirus pandemic, which is disproportionately ravaging Black lives  both physically and economically.” These findings tie into another study by the same organizations: Half of Black adults say they won’t take a coronavirus vaccine:”Overall, 65% of Black adults said they are not too confident or not at all confident that the development of a coronavirus vaccine is taking the needs of Black people into account.”

Pfizer to enroll kids as young as 12 in COVID-19 vaccine study: The headline speaks fro itself.

About health insurance

Hospitals can't use CARES Act grants to repay Medicare loans, HHS says: The headline speaks for itself.

Medicare Preparing Rule to Ensure Swift Access to Covid Vaccine: “The Centers for Medicare & Medicaid Services has a plan to ensure full payment for and speedy access to new Covid-19 vaccines and treatments for Medicare beneficiaries, agency Administrator Seema Verma said Tuesday at a virtual conference.Although Congress has made clear it wants Medicare to cover the cost of a Covid-19 vaccine without cost-sharing, Verma said it can take one to three years to work out payment issues for vaccines and other treatments…”

UnitedHealth Group rakes in $3.2B in Q3 profit: A followup to yesterdays post about health insurance profitability.

Verma says value-based care models haven't made good return on investment: “She did not elaborate on which models specifically did not perform well.
However, Center for Medicare and Medicaid Innovation Director Brad Smith pointed in a separate speech last month to bundled payment models that tie Medicare payments together for certain procedures into one bundle for a total cost of care. Smith said that the bundled models did not lead to significant quality and savings improvements, but he said the models did spur transformation among providers.
Smith said that models which focused on a global budget fared much better, giving Maryland’s Total Cost of Care model as an example. Under the model, Maryland has a per capita limit for Medicare costs in the state.
Verma also gave praise to CMS’ Pathways to Success model that overhauled the program managing accountable care organizations (ACOs).
Pathways required ACOs to take on financial risk at a shorter period than the Medicare Shared Savings Program created under the Obama administration. This meant that ACOs had to pay back Medicare if it did not meet certain savings targets.”

 About pharma

7 health systems form specialty pharmacy alliance: “Seven health systems are uniting to form the Health System Owned Specialty Pharmacy Alliance, or HOSP, to advocate for health system-owned specialty pharmacies. 
The group will advocate for the interests of integrated specialty pharmacies and promote best practices to deliver the best patient care and patient outcomes, the organization said in a news release.”

Study of Lilly's COVID-19 antibody LY-CoV555 paused over potential safety issue : No other information is available about this action.

J&J Strikes $5B Deal Pushing 3,000 Opioid Suits Toward End: “Johnson& Johnson on Tuesday disclosed that it's offering up to $5 billion to end a nationwide torrent of litigation accusing it of contributing significantly to America's opioid addiction crisis, a 25% increase on an earlier settlement proposal.”

About healthcare IT

 Dispute between telehealth giants heats up as Teladoc sues Amwell for patent infringement: “Teladoc has accused Amwell of infringing on its patents related to telehealth carts, a digital scope and stethoscope, according to a lawsuit filed Monday in the U.S. District Court for the District of Delaware.”

Google, Optum, Microsoft team up on $13M challenge to prevent next pandemic: “The Trinity Challenge, initially announced in September, will offer about $13 million in funding to recognize and reward insights and innovations across areas including economics, behavioral sciences and epidemiology. Founding members of the challenge span the public, private and social sectors including the Bill & Melinda Gates Foundation, Facebook, Tencent, GlaxoSmithKline, Cambridge University, Imperial College London and Northeastern University…
Solutions for identification could include building early-warning systems and developing new technologies to identify threatening pathogens before they cause great harm…”

About healthcare quality

Misclassification of Hospital Performance Under the Hospital Readmissions Reduction Program [HRRP]: “In this cross-sectional study of hospitals that participated in the HRRP in fiscal year 2019, the percentages of hospitals that should have been penalized by the program, but were not, was 20.9% for acute myocardial infarction, 13.5% for heart failure, and 13.2% for pneumonia. In contrast, the percentages of hospitals that were incorrectly penalized was 10.1% for acute myocardial infarction, 10.9% for heart failure, and 12.3% for pneumonia….
 These findings suggest that the hospital-level 30-day RSRR measure may not reliably distinguish hospital performance in the HRRP. This has important implications for CMS value-based programs that use risk-standardized outcomes to evaluate and compare hospital performance.”  

Today's News and Commentary

About the public’s health

Genomic evidence for reinfection with SARS-CoV-2: a case study:”The patient had two positive tests for SARS-CoV-2, the first on April 18, 2020, and the second on June 5, 2020, separated by two negative tests done during follow-up in May, 2020. Genomic analysis of SARS-CoV-2 showed genetically significant differences between each variant associated with each instance of infection. The second infection was symptomatically more severe than the first.” And in a related article: Dutch researchers report first death from COVID-19 reinfection: “An elderly woman in the Netherlands has died after getting COVID-19 a second time, researchers reported on Monday. It’s the first time a death has been reported from reinfection with coronavirus. 
The patient was an 89-year-old woman who was being treated for Waldenström’s macroglobulinemia, a rare type of white blood cell cancer which is treatable but incurable”

.Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant: The exact nature of the illness has not yet been revealed.

CMS Takes Action to Protect Integrity of COVID-19 Testing: “The Centers for Medicare & Medicaid Services (CMS) is taking every action to ensure U.S. laboratories are fit to deliver reliable, accurate and timely patient test results for coronavirus disease 2019 (COVID-19) by confirming Clinical Laboratory Improvement Amendments of 1988 (CLIA) certifications are up- to-date. A recent record check by CMS resulted in the issuance of 171 cease and desist letters to facilities that did not have proper CLIA certifications in place.”

Dr. Fauci says U.S. faces ‘a whole lot of trouble’ as coronavirus cases rise heading into winter: “The U.S. reported more than 44,600 new cases on Sunday and the seven-day average rose to over 49,200 new cases per day, up more than 14% compared with a week ago, according to a CNBC analysis of data compiled by Johns Hopkins University. Average daily cases were up by more than 5% in 36 states and the District of Columbia, CNBC’s analysis shows.
Similarly, the number of people currently hospitalized with Covid-19 rose by at least 5% in 36 states, according to CNBC’s analysis of data from the Covid Tracking Project, a volunteer project founded by journalists at The Atlantic magazine.”

Economy-Sensitive Conditions: Are Some Pediatric Hospitalizations Triggered By Economic Recessions?:”…a 1 percent increase in unemployment was associated with a 5 percent increase in hospitalizations for substance abuse, a 4 percent increase for diabetes mellitus, and a 2 percent increase both for children with medical complexity and for poisoning and burns. Mean pediatric all-cause hospitalizations increased by 2 percent for every 1 percent increase in unemployment…”

The COVID-19 Pandemic and the $16 Trillion Virus: Economists David Cutler and Lawrence Summers estimate the cost of the COVID-19 crisis will be $16.12Trillion, with about half attributable to loss of GDP.

Excess Deaths From COVID-19 and Other Causes, March-July 2020:”Although total US death counts are remarkably consistent from year to year, US deaths increased by 20% during March-July 2020. COVID-19 was a documented cause of only 67% of these excess deaths.”

Proposal to hasten herd immunity to the coronavirus grabs White House attention but appalls top scientists: Three scientists with distinguished academic appointments are promoting a strategy, which they call Focused Protection. “Martin Kulldorff is an epidemiologist at Harvard University. Sunetra Gupta is an epidemiologist at the University of Oxford. Jay Bhattacharya is a physician and health economist at Stanford Medical School.” They “argue that their approach would decrease the undesirable public health effects of restrictions and closures, which disproportionately affect lower-income people. The declaration does not mention wearing masks, engaging in social distancing, avoiding crowds and indoor environments, or any of the other recommendations pushed by most government and scientific experts.” This policy “has been denounced by other infectious-disease experts and has been called ‘fringe’ and ‘dangerous’ by National Institutes of Health Director Francis Collins.” Also opposing the approach is WHO Director General Tedros Adhanom Ghebreyesus.

Found: genes that sway the course of the coronavirus: “…a U.K. group studying more than 2200 COVID-19 patients has pinned down common gene variants that are linked to the most severe cases of the disease, and that point to existing drugs that could be repurposed to help.”

About pharma

AstraZeneca, U.S. gov't sign deal for COVID-19 antibody treatment: “Pharmaceutical company AstraZeneca has reached a $486 million deal with the U.S. government to supply as many as 100,000 doses of its experimental COVID-19 antibody treatment, if it's ultimately approved.”

Walgreens COO says pandemic has been an 'accelerator' for VillageMD plans: “In the months after Walgreens announced a $1 billion partnership with VillageMD to build hundreds of primary care clinics next to its retail pharmacy stores, there are still only a few locations in Houston.
But that will be changing quickly, said Walgreens' co-Chief Operating Officer Alex Gourlay.
Within the next fiscal year, the company plans to have at least 40 locations open, Gourlay said, speaking at the HLTH 2020 virtual conference Monday. The company has previously said it expects to have at least 500 locations open within the next five years.”

About health insurance

Health Insurer Financial Performance Amid the Coronavirus Pandemic: Profitability has increase for insurers as the Medical Loss ratios have mostly dipped. The individual market MLR is steady at 72% while the Group and Medicare Advantage rates are 78% and 80%, respectively. Net income was not measured. (Recall MLR only includes specified patient care costs, not SG&A expenses.)

About healthcare IT

ROI for pop health IT still not quite in view: “A report from KLAS and CHIME finds that hospitals and health systems are still investing in population health management tools, but many are ‘becoming less optimistic’ about the near-term prospects for value-based reimbursement.”

Comcast's Quil Health launches in-home sensor technology for aging seniors: “Digital health company Quil Health is expanding its reach into home health care with a new sensor-based technology platform aimed at aging seniors and their caregivers.
Quil—the healthcare joint venture of telecom giant Comcast NBCUniversal and Independence Health Group—is offering new technology that combines ambient sensors and voice-activated technology in the home to help caregivers monitor patients' movements…”

IBM Watson launching blockchain 'health pass' to return to public spaces: “IBM's Watson Health division leveraged blockchain technology to develop its digital health pass to be used by employers, schools, stadiums or airline companies.
The digital tool was designed for an organization to establish their own criteria such as COVID-19 test results and temperature scans so that a verified health pass can be generated for an individual, IBM said…
he IBM Digital Health Pass will allow users to share their verified health pass without exposing any of the underlying data used to generate it to ensure privacy protections, the company said.
 IBM Digital Health Pass uses IBM Blockchain and sophisticated cryptographic techniques so that data exchange can be verifiable and trusted, IBM said.”

New services and solutions company, Tegria, to streamline health care delivery: “Tegria, a new company designed to provide next generation technologies and services to the health care sector, launched today with support from Providence, one of the nation's largest health systems. Tegria combines select Providence investments and acquisitions into a comprehensive portfolio of solutions to accelerate technological, clinical and operational advances in health care.” This article is a great example of how a health system has branched into the IT sector as a diversification strategy.

Today's News and Commentary

About pharma

Mallinckrodt files for Chapter 11 bankruptcy: “Opioid claims against the company are to be channeled into one or more trusts which would receive $1.6 billion in structured payments. The company also agreed to pay $260 million over seven years to settle claims it knowingly underpaid Medicaid for Acthar. 
In the bankruptcy filing, Mallinckrodt listed both assets and liabilities in the range of $1 billion to $10 billion. 
The company will continue to operate as normal as it restructures for bankruptcy.”

Health officials scrambling to produce Trump's ‘last-minute’ drug cards by Election Day:”Caught by surprise by President Donald Trump’s promise to deliver drug-discount cards to seniors, health officials are scrambling to get the nearly $8 billion plan done by Election Day, according to five officials and draft documents obtained by POLITICO.”

About health insurance

Trends in Subsidized and Unsubsidized Enrollment [for ACA Exchange Plans]: Among the findings in this report from CMS:

• “From plan years 2016 to 2019, unsubsidized enrollment declined by 2.8 million people, representing a 45 percent drop nationally. At the state level, the percentage change in unsubsidized enrollment over this period ranged from a 4 percent drop in Rhode Island to a 90 percent drop in Iowa.

• The most recent year of enrollment data shows that average monthly enrollment across the individual market nationally decreased by 3 percent between 2018 and 2019.”

Fewer Medicare Advantage plans scored high quality ratings :”Of the 400 Advantage plans with prescription drug coverage that received a rating, roughly 49% earned four stars or higher on a scale of one to five stars, with five being the highest. For 2020 plans, 52% scored four stars or more.” This data is on number of plans as opposed to numbers who enroll in high quality plans (see October 9’s health insurance section).

About the public’s health

The Sweden Myth— How did the country outperform everybody on COVID-19? That's easy -- it didn't: The headline speaks for itself but the article has specifics.

Coronavirus survives for almost a month on cash and phones, study finds: “Australian agency says pathogen stays infectious for ‘significantly longer’ on smooth surfaces.”

Two Black university leaders urged their campuses to join a Covid-19 vaccine trial. The backlash was swift: “The episode illustrates the challenges historically Black colleges and universities face as they seek to leverage their legacies of trust within African American communities to bolster lagging Black enrollment in Covid-19 vaccine clinical trials. Their recruitment efforts will need to overcome the deep-seated suspicions many Black Americans hold toward medical researchers, pharmaceutical companies, and the government that stem from long-standing racial injustices perpetrated by those institutions.
Now, as the four HBCU medical colleges prepare to host Covid-19 vaccine trials on their campuses, there’s hope their efforts will have more success.”

Today's News and Commentary

About healthcare IT

Trump Administration Invests $72 Million in Distance Learning and Telemedicine Infrastructure in 40 States, Puerto Rico and the Virgin Islands: This time the funds are coming from the Dept. of Agriculture.

Telehealth Patient Satisfaction Surges During Pandemic but Barriers to Access Persist, J.D. Power Finds:  “The overall customer satisfaction score for telehealth services is 860 (on a 1,000-point scale), which is among the highest of all healthcare, insurance and financial services industry studies conducted by J.D. Power…
Though telehealth has been pitched as a solution to improve access to healthcare for everyone, more than half (52%) of telehealth users say they encountered at least one barrier that made it difficult to use telehealth. The most common hurdles are limited services (24%); confusing technology requirements (17%); and lack of awareness of cost (15%). Additionally, 35% of telehealth users indicate they experienced a problem during a visit. Tech audio issues (26%) are the most common problem…
Overall satisfaction is 117 points lower among patients with the lowest self-reported health status than among patients who consider themselves to be in excellent health. Similarly, healthier patients are significantly more likely to understand the information provided during the visit, receive clear explanations, feel their visits are highly personalized and obtain a high-quality diagnosis…
Among patients who used a telehealth offering this year, 46% say their top reason for choosing telehealth was safety. That compares with just 13% in 2019.”

About health insurance

HCA to return $6B in CARES Act funding, including more than $4B in Medicare accelerated payments: “In a release, officials at the Nashville, Tennessee-based health system giant said they took a conservative approach to address operational and financial challenges presented by the COVID-19 pandemic. Using available cash and future cash flows from operations, officials said they plan to repay the $1.6 billion in Provider Relief Funds HCA received and $4.4 billion in Medicare accelerated payments.”

CMS alerts providers to changes to Medicare advance loan repayments, giving hospitals more time: “Now, providers have until one year after the first payment was issued to start repaying. Once that first year ends, Medicare will automatically recoup 25% of the Medicare payments otherwise given to a provider or supplier for 11 months.
At the end of that 11-month period, the recoupment will increase to 50% for another six months.
If a provider or supplier can’t repay the total amount during this 29-month period, CMS will issue letters calling for the repayment of any outstanding balance with an interest rate of 4%.”

Average Family Premiums Rose 4% to $21,342 in 2020, Benchmark KFF Employer Health Benefit Survey Finds: “Annual family premiums for employer-sponsored health insurance rose 4% to average $21,342 this year, according to the 2020 benchmark KFF Employer Health Benefits Survey. On average, workers this year are contributing $5,588 toward the cost of family coverage, with employers paying the rest.” Look through the executive summary and graphics for this report. It is an excellent summary of employer sponsored health insurance.

High-Quality Care for Medicare Beneficiaries Continues as Medicare Health and Drug Plans Receive Star Ratings: “Most Medicare beneficiaries – about 77 percent – who enroll in Medicare Advantage plans with drug coverage will be in plans with four or more stars in 2021. That compares with 69 percent of beneficiaries enrolled in such plans in 2017…
[Also}, Medicare beneficiaries will have access to higher-quality stand-alone Medicare Part D prescription drug plans. Based on current enrollment, about 98 percent of beneficiaries enrolled in stand-alone prescription drug plans for 2021 will be in plans with 3.5 stars or higher, an increase from about 70 percent in 2020.”

About pharma

Final Results of National Institute of Allergy and Infectious Diseases’ ACTT-1 Trial Published in New England Journal of Medicine Expand Clinical Benefits of Veklury (remdesivir) for the Treatment of COVID-19: “Overall, treatment with Veklury Resulted in Five Days Faster Recovery and Reduced Disease Progression Compared with Placebo. Veklury Reduced Mortality by 70 Percent at Day 29 in Patients on Low-Flow Oxygen at Baseline in Post-Hoc Analysis.”

As Trump touts his ‘great’ COVID drugs, the pharma cash flows to Biden, not him: “Reversing a trend in which contributions from drugmakers’ political committees and their employees have gone largely to Republican candidates  for president and Congress, so far for 2020 the industry has tilted toward Democrats.”

Trump pushes FDA to quickly clear coronavirus antibody treatments, erroneously calling them a ‘cure’: The headline speaks for itself. Of note is that the treatment was made from stem cells derived from aborted fetuses, which the Trump administration bars for use (the ones used were from before the ban, so are “allowed.”). See: Trump’s antibody treatment was tested using cells originally derived from an abortion.

Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19: From the RECOVERY Collaborative Group: “Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care.” Can we finally put this issue to rest?

About the public’s health

COVID-19 Is Now the Third Leading Cause of Death in the U.S.:”COVID-19 became the third biggest cause of deaths in the week of March 30 to April 4, trailing heart disease and cancer. It killed more people than stroke, chronic lower respiratory disease, Alzheimer’s, diabetes, kidney disease or influenza.”

The bizarre abortion order just handed down by the Supreme Court, briefly explained: You will need to read the details to fully appreciate the issue. Briefly, the case hinges on whether relaxation of dispensing abortion medication during the COVID-19 pandemic should be allowed. The SCOTUS punted.

New test detects coronavirus in just 5 minutes:”Researchers have used CRISPR gene-editing technology to come up with a test that detects the pandemic coronavirus in just 5 minutes. The diagnostic doesn’t require expensive lab equipment to run and could potentially be deployed at doctor’s offices, schools, and office buildings”

.About healthcare quality

Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: “Compared with the control group, different financial incentives improved measured statin adherence but not LDL-C levels. This result points to the importance of directly measuring health outcomes, rather than simply adherence, in trials aimed at improving health behaviors.” The study emphasizes the importance of measuring actual versus surrogate outcomes.

Ambulatory Follow-up and Outcomes Among Medicare Beneficiaries After Emergency Department Discharge: “In this cohort study of Medicare beneficiaries discharged from the ED, nearly 30% lacked ambulatory follow-up at 30 days, with variation in follow-up rates by patient and hospital characteristics. Having an ambulatory follow-up visit was associated with higher risk of subsequent hospitalization but lower risk of mortality. Ambulatory care access may be an important driver of clinical outcomes after an ED visit.” There needs to be actual, not presumed, handoffs to assure continuity of care.

About hospitals and health systems

Atrium, Wake Forest Baptist merge to create 42-hospital system:”With the transaction complete, Wake Forest Baptist Health and Wake Forest School of Medicine will become the "academic core" of Atrium Health. The health system said it plans to build a second campus of the school of medicine in Charlotte.”

About healthcare technology

CurveBeam’s CT Imaging System Gets CE Mark: “The system, which can scan anywhere along the lower extremity from the hip and pelvis to the feet, allows patients to stand naturally on both feet during a CT scan. It requires minimal patient radiation shielding and is designed for ease of use.”

Today's News and Commentary

Campaigns spar over debate timing after Trump rejects virtual event: “Trump rejected a decision by a nonpartisan panel to hold a town-hall-style event on Oct. 15 virtually instead of in person.”

About health insurance

Verma doubles down on supporting Medicaid work requirements as enrollment swells: “The head of Centers for Medicare & Medicaid Services reiterated support for Medicaid work requirements as enrollment in the program swells this year…
Her remarks come less than a month after a study in Health Affairs found that work requirements in Arkansas did not lead to more employment.”

How Many Americans Have Lost Jobs with Employer Health Coverage During the Pandemic?: From the Commonwealth Fund: “We estimate that as many as 7.7 million workers lost jobs with ESI [Employer Sponsored Insurance] as of June 2020 because of the pandemic-induced recession. The ESI of these workers covered 6.9 million of their dependents, for a total of 14.6 million affected individuals. Only with time will we know how many job losses are ultimately permanent, resulting in loss of ESI for workers and their dependents.”

Cigna won't cover some hospital-based MRIs, CT scans under new policy: “Cigna will not cover MRIs and CT scans performed in a hospital setting if they don't meet new medical necessity requirements, according to a policy that took effect Aug. 1. 
Other commercial insurers, including Anthem, have similar policies in place. The policies aim to direct patients to less pricey freestanding facilities for imaging services.” Plans have been using utilization review for costly diagnostics for quite a while, e.g., Anthem’s division AIM.

How Much Would Trump’s Coronavirus Treatment Cost Most Americans?: The short answer is: “For someone who isn’t president, that would cost more than $100,000 in the American health system.” Read the article for more details.

 About pharma

AstraZeneca vaccine document shows limit of no-profit pledge: The pledge is only good during the pandemic. AZ decides when it is over and can do so as soon as July, 2021. See also: Moderna Vows to Not Enforce Covid-19 Vaccine Patents During Pandemic: “Moderna Inc. said it wouldn’t enforce patents related to its experimental Covid-19 vaccine while the pandemic continues and is willing to license the patents to others after the pandemic.”

Lilly seeks FDA emergency use for LY-CoV555 in higher-risk COVID-19 patient : “Eli Lilly said Wednesday that it submitted a request to the FDA for emergency-use authorisation (EUA) of LY-CoV555 monotherapy for higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. The neutralising IgG1 monoclonal antibody, also known as bamlanivimab, is being  co-developed with AbCellera.”

Statement on REGN-COV2 Emergency Use Authorization Request: From Regeneron: “Subsequent to our discussions with regulatory authorities, we have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for our REGN-COV2 investigational antibody combination for COVID-19. Under our agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.”

Dexamethasone price has increased 137% in recent months: “The price of the steroid spiked from $0.59 per unit to $1.39 per unit and is currently listed in shortage from both the FDA and the American Society of Health-System Pharmacists.”

 About the public’s health

Renewal of Determination That A Public Health Emergency Exists: From the HHS secretary:
”As a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) pandemic, on this date and after consultation with public health officials as necessary, I, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby renew, effective October 23, 2020, my January 31, 2020, determination, that I previously renewed on April 21, 2020 and July 23, 2020, that a public health emergency exists and has existed since January 27, 2020, nationwide.”

The vice presidential debate: 6 healthcare takeaways: A good summary of the major healthcare points from last night’s debate. VP Pence said the Administration has a healthcare plan, but the question is: Where is it?

Survival of SARS-CoV-2 and influenza virus on the human skin: Importance of hand hygiene in COVID-19: “The 9-h survival of SARS-CoV-2 on human skin may increase the risk of contact transmission in comparison with IAV [Influenza A Virus], thus accelerating the pandemic. Proper hand hygiene is important to prevent the spread of SARS-CoV-2 infections.”

About healthcare professionals

Latest $20 billion round of CARES Act physician relief now open:”The Department of Health and Human Services (HHS) is disbursing another $20 billion in financial relief for physician practices and other health care delivery organizations and clinicians that is part of the Coronavirus Aid, Relief and Economic Security (CARES) Act.”

About healthcare technology

Heritable Human Genome Editing: From the National Academy of Sciences, Engineering and Medicine: “Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues…
From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses.”
The report is free to download.

Today's News and Commentary

About the public’s health

Trump’s determination to attend next week’s debate seen as part of pattern of recklessness: I was wrong when I predicted the second debate would be canceled. But it will take a lot of energy (and breath) to achieve the same level of interruption we saw in the last contest.

Prestigious medical journal calls for US leadership to be voted out over Covid-19 failure “In an unprecedented move, the New England Journal of Medicine on Wednesday published an editorial written by its editors condemning the Trump administration for its response to the Covid-19 pandemic -- and calling for the current leadership in the United States to be voted out of office.”

White House Agrees to FDA’s Guidelines for Vetting Covid-19 Vaccines: The article is a good explanation of the chronology of the President’s reversal in opposing FDA guidelines for vaccine approval.

Forget October. Warp Speed chief says first COVID shot data—from Pfizer and Moderna—won't appear till later this year: “Operation Warp Speed head Moncef Slaoui said early efficacy data on vaccines will be available over the next several months, with Pfizer and Moderna's in a first wave in November or December…”

Face masks: what the data say: You know what the data says…but the article is a great summary of research findings.

In the U.S., states — not science — decide what counts as a coronavirus outbreak “The nation’s patchwork pandemic response has led to wide disparities in data reporting and even in definitions for basic medical concepts. In the absence of federal standards, states have adopted divergent and sometimes scientifically questionable approaches to disease control, which experts say have allowed the virus to spread.”

Trends in the Age of Cigarette Smoking Initiation Among Young Adults in the US From 2002 to 2018: Some bad news: “In this repeated cross-sectional study including 71 756 young adults aged 22 to 23 years, the proportion of ever smokers who initiated cigarette smoking in early adulthood more than doubled between 2002 and 2018, and the proportion of daily cigarette smokers who transitioned to daily smoking in early adulthood also increased from 38.7% in 2002 to 55.9% in 2018.”

The Surgeon General’s Call to Action to Control Hypertension: Click on the website and scroll down to this title for a full list of documents. Briefly, the Surgeon General’s publications have two sections:: Section 1 ”summarizes the current state of hypertension control, including the economic costs and disparities between different population groups…
Section 2 presents three overall goals to support improvements in hypertension control: 
Goal 1. Make hypertension control a national priority.
Goal 2. Ensure that the places where people live, learn, work, and play support hypertension control.
Goal 3. Optimize patient care for hypertension control.”

About healthcare technology

Nobel Prize in chemistry goes to CRISPR pioneers Doudna, Charpentier: “The 2020 Nobel Prize in chemistry was awarded to Jennifer Doudna, Ph.D., and Emmanuelle Charpentier, Ph.D., for their 2012 discovery of the genome-editing tool CRISPR-Cas9. It was the first time two women have won a science Nobel Prize.
Charpentier, now director of the Max Planck Unit for the Science of Pathogens in Berlin, stumbled upon a previously unknown RNA while studying the bacterium Streptococcus pyogenes. That RNA turned out to play a role in CRISPR-Cas9, a mechanism that bacteria use to defend against viruses. She published her findings in 2011 and then teamed up with Doudna, a biochemist at the University of California, Berkeley.”

Cleveland Clinic’s Top 10 for 2021: Their annual listing of top 10 influential technologies. Always worth a read.

STERIS Expands Healthcare Consumables Offering with Acquisition of Key Surgical for approximately $850 million: The headline speaks for itself.

About healthcare IT

HHS threatens to withhold federal funding from hospitals that fail to report coronavirus data:”…hospitals will be given 14 weeks to comply with the requirements before enforcement is implemented…”

2020 breaks record in digital health investment with $9.4B in funding: “With $9.4 billion invested up through the third quarter, 2020 will be the largest funding year for digital health to date.
The sector is on track to hit $12 billion in funding by the end of the year, compared to $7.4 billion invested in 2019 and $8.2 billion invested in 2018, according to investment firm Rock Health's latest digital health funding report.”

CHIME names 2020 'Most Wired' hospitals: Read the article for the list.

Modest increases in physician productivity can offset the cost of medical scribes:”New research led by Neda Laiteerapong MD, Associate Professor of Medicine at the University Chicago Medicine, indicates the real value of adding this healthcare professional to a medical practice. It gives physicians more time to treat patients, add new ones, and schedule more return visits. This research also indicates that the initial cost of employing a medical scribe can be offset in a year or less, after which the possibility of increased profit follows.
‘We did an economic evaluation, a pretty common technique for healthcare administrators,’ Laiteerapong said. ‘And we did it for a total of 30 specialties, plus physician assistants and nurse practitioners.’ The study was published October 6, 2020, in Annals of Internal Medicine.”

Facebook, Twitter Take Action After Trump Falsely Claims Flu Deadlier Than COVID-19:”Facebook and Twitter took measures to screen against misinformation after President Trump put posts on both sites that falsely claimed COVID-19 is less deadly than the flu in ‘most populations.’
Facebook took down Trump's post, saying that users are not allowed to make false claims about the severity of the pandemic. The social network says the post broke its rules against harmful misinformation.
Twitter allowed the president's tweet to stay up with a warning label. The company said it is in violation of Twitter's ‘rules about spreading misleading and potentially harmful information related to COVID-19.’ But it added that the company "has determined that it may be in the public's interest for the Tweet to remain accessible."

Here's how Google, Amazon, Facebook and Apple are targeting the health insurance market: “Google, Facebook, Apple and Amazon have invested heavily in personal health monitoring devices and virtual care and have been able to integrate these capabilities into health insurance offerings relatively easily.” The article provides a nice summary of what the companies are doing.

Effect of Passive Choice and Active Choice Interventions in the Electronic Health Record to Cardiologists on Statin Prescribing: “In passive choice, cardiologists had to manually access an alert embedded in the EHR to select options to initiate or increase statin therapy. In active choice, an interruptive EHR alert prompted the cardiologist to accept or decline guideline-directed statin therapy. Cardiologists in the control group were informed of the trial but received no other interventions…
The passive choice and active choice interventions did not change statin prescribing. In the subgroup of patients with clinical ASCVD [arteriosclerotic cardiovascular disease], the active choice intervention led to a small increase in statin prescribing at the optimal dose, which could inform the design or targeting of future interventions.”

About pharma

Mississippi pharmacy owners charged in $18M healthcare fraud scheme:”Dempsey Bryan Levi and Jeffrey Wayne Rollins, owners of Garden's Pharmacy in Ocean Springs, Miss., allegedly wrote prescriptions for compounded pain creams based on how much money they'd bring in and not for medical need. They fraudulently billed insurers, including the military insurer Tricare, out of millions of dollars, the U.S. Justice Department lawsuit claims.” The case points out the ongoing problems with compounding pharmacies.

FDA ad watchdog slaps two pharmas with warning letters for promo emails, Google link: “The Office of Prescription Drug Promotions (OPDP) reprimanded Nephron for emails promoting budesonide, while Nalpropion’s warning centered on a Google link promoting Contrave. Warning letters are OPDP’s strongest rebuke for improper pharma promotions.” Budesonide was promoted as helping treat COVID-19 and the FDA was “concerned that Nalpropion is continuing promotion of Contrave in a manner that… fails to adequately convey risk information.”

About health insurance

Humana saved $4B through its value-based care programs last year:”The insurer released its annual look at its value-based care initiatives Wednesday, which found Humana's Medicare Advantage (MA) members would have incurred those additional costs had they been enrolled in traditional, fee-for-service Medicare plans.
Humana said that 67% of its MA members, or 2.41 million beneficiaries, are treated by primary care physicians who are enrolled in value-based arrangements.”

Startup Medicare Advantage insurer Clover Health is going public: ”The payer, which offers tech-enabled Medicare Advantage plans, will become publicly traded by merging with Social Capital Hedosophia Holdings Corp., a special purpose acquisition company.
Through the deal, Clover will be valued at $3.7 billion in enterprise value.”

Blue Cross Blue Shield Association Names Kim A. Keck As New President And Chief Executive Officer: Read the article to learn more about her.

With MA open enrollment on the horizon, Walmart formally launches insurance brokerage: “Walmart is formally launching its new insurance brokerage ahead of Medicare open enrollment kicking off next week.
Walmart Insurance Services is licensed in all 50 states and the District of Columbia, according to a blog post from the retail giant, and will offer Part D, Medicare Advantage and Medicare supplement plans from a slew of insurers including UnitedHealthcare, Humana, Anthem and WellCare Health Plans, which is now a subsidiary of Centene Corporation.
It will also include plans from Amerigroup, Simply Health, Clover Health and Arkansas Blue Cross and Blue Shield. [As mentioned yesterday] Walmart will also be teaming up with Clover to offer its own co-branded MA plans.”

About hospitals and health systems

Hospital groups demand CMS halt expansion of certain physician-owned hospitals in payment rule: “Several major hospital groups and systems are pushing for the Trump administration to halt a proposed expansion of certain physician-owned hospitals in an upcoming payment rule.
Several groups posted comments on the Centers for Medicare & Medicaid Services’ (CMS') proposed hospital payment rule for 2021, furious about the change. Hospitals also opposed the elimination of the Inpatient Only Procedure List that details which procedures aren’t payable under the Outpatient Prospective Payment System (OPPS).”

Today's News and Commentary

About the public’s health

White House Blocks New Coronavirus Vaccine Guidelines: This action is the reason many people will not trust the vaccine when it comes out. “Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.
Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.”

Trump health official meets with doctors pushing herd immunity: This article is a great explanation of a strategy to open society to the least vulnerable and let COVID-19 spread in order to achieve “heard immunity.” Do you agree?

WHO: 10% of world’s people may have been infected with virus: “The head of emergencies at the World Health Organization said Monday the agency’s ‘best estimates’ indicate roughly 1 in 10 people worldwide may have been infected by the coronavirus — more than 20 times the number of confirmed cases — and warned of a difficult period ahead.”

BioNTech, Pfizer start rolling EMA approval filing for COVID-19 vaccine:”BioNTech and Pfizer have started a rolling submission of their COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA). The news comes days after EMA named AstraZeneca's AZD1222 as the first COVID-19 vaccine to start the rolling review process.
The EMA uses rolling reviews to start assessing data on an experimental candidate before all the evidence needed to make a final decision is available, cutting the time it takes to decide whether to approve a prospect once the pivotal clinical trial results are submitted to the agency.”

About pharma

8 drugs Trump has been given for his COVID-19 treatment: A good summary of the science (or lack of it) behind the drugs the President received for his COVID-19 infection.

Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial:“In patients admitted to hospital with COVID-19, lopinavir–ritonavir was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. These findings do not support the use of lopinavir–ritonavir for treatment of patients admitted to hospital with COVID-19.”

Trump’s use of Regeneron’s experimental coronavirus treatment creates ‘very tough situation,’ CEO says: In a related story:

• “The president, who announced Friday that he tested positive for the coronavirus, was given an 8 gram dose of Regeneron’s monoclonal antibody treatment, his doctors said.

• The company said it provided the drug to the president in response to a ‘compassionate use’ request from Trump’s doctors.

• That means that while the president’s doctors were confident enough of the drug’s benefit to administer it to Trump, the treatment remains unavailable to most Americans.”
  
  Compassionate use is usually reserved for patients who have few choices left for their therapies when proven treatments have failed. The medications are in the development or testing phase and show potential promise.
  

About health insurance

Walmart and Clover Health team up to offer Medicare Advantage plans:”Insurer Clover Health has partnered with Walmart to offer a series of Medicare Advantage plans aimed at low-income, Medicare-eligible beneficiaries in Georgia.
This will be the first foray for Walmart into the health plan space, though the retail giant does have a co-branded Medicare Part D plan with Humana. It has also launched a series of health clinics.”

About hospitals and health systems

New Report Finds Rapid Growth of Catholic Health Systems: Among the study’s findings:
“The 10 largest Catholic health systems have grown and strengthened through mergers and acquisitions, and now own or control 394 short-term acute care hospitals, a 50 percent increase since 2001. The reach of these 10 systems extends beyond traditional acute care hospitals, with over 1,100 total inpatient health care facilities, 864 urgent care centers, 385 ambulatory surgery centers and 274 physician groups.”

About healthcare IT

With ‘nutrition labels’ and an anthropologist’s eye, Duke pioneers a new approach to AI in medicine: “If not for an anthropologist and sociologist, the leaders of a prominent health innovation hub at Duke University would never have known that the clinical AI tool they had been using on hospital patients for two years was making life far more difficult for its nurses…
The researchers are part of a larger team at Duke that is pioneering a uniquely inclusive approach to developing and deploying clinical AI tools. Rather than deploying externally developed AI systems — many of which haven’t been tested in the clinic — Duke creates its own tools, starting by drawing from ideas among staff. After a rigorous review process that loops in engineers, health care workers, and university leadership, social scientists assess the tools’ real-world impacts on patients and workers.”

Today's News and Commentary

About pharma

BMS to buy MyoKardia for $13.1 billion, expanding cardiovascular franchise: “Bristol Myers Squibb announced Monday that it agreed to purchase MyoKardia for $225 per share in cash, or approximately $13.1 billion, gaining the latter's experimental heart disease drug mavacamten.”

Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products: “This study found that most comparative efficacy trials supporting the FDA approval of biosimilars appeared to be as rigorous as and often larger, longer, and more costly than pivotal trials for new molecular entities. Further research is needed into whether less costly comparative efficacy trials could provide adequate evidence of biosimilarity and whether animal studies contribute useful scientific evidence.”

Oxford researchers start new trial on the use of anti-TNF to treat Covid-19 in care homes:”Researchers at the University of Oxford are starting a new study to explore the effectiveness of the anti-tumour necrosis factor (anti-TNF) drug adalimumab [Humira] as a treatment for patients with COVID-19 in the community, especially care homes.”

Nitric oxide a possible treatment for COVID-19, study finds:”Researchers at Uppsala University have found that an effective way of treating the coronavirus behind the 2003 SARS epidemic also works on the closely related SARS-CoV-2 virus, the culprit in the ongoing COVID-19 pandemic. The substance concerned is nitric oxide (NO), a compound with antiviral properties that is produced by the body itself. The study is published in the journal Redox Biology.
‘To our knowledge, nitric oxide is the only substance shown so far to have a direct effect on SARS-CoV-2,’ says Åke Lundkvist, a professor at Uppsala University, who led the study.”

For the first time, drug makers and PBMs must jointly face an insulin price fixing lawsuit: “A federal judge ruled that a Texas county can proceed with a lawsuit accusing several drug makers and pharmacy benefit managers of conspiring to fix prices for insulin, the first time these companies will have to collectively defend their role in the rising cost of the life-saving diabetes medicine.”

About the public’s health

CDC says airborne transmission plays a role in coronavirus spread in a long-awaited update after a website error last month:”The long-awaited update to the agency Web page explaining how the virus spreads represents an official acknowledgment of growing evidence that under certain conditions, people farther than six feet apart can become infected by tiny droplets and particles that float in the air for minutes and hours, and that they play a role in the pandemic.
The update follows an embarrassing incident last month when the agency removed a draft that had not gone through proper review and was posted in error.”

Amid COVID-19 pandemic, less than 60% in U.S. plan to get flu vaccine: The latest survey by the National Foundation for Infectious Diseases found that 59% “of people in the United States plan to be vaccinated against the flu this winter…
Although fewer than one-third of respondents said that the COVID-19 pandemic would make them more likely to be vaccinated, nearly half said they were concerned about the potential effects of the new coronavirus on the seasonal bug, the data showed.” The number is good compared to other years but still much lower than it should be.

US panel tackles race, poverty in virus vaccine priorities: “As expected, the panel recommended health care workers and first responders get first priority when vaccine supplies are limited. The shots should be provided free to all, the panel said. And throughout the vaccine campaign, efforts also should focus on disadvantaged areas to remedy racial health disparities, according to the report from the National Academies of Sciences, Engineering and Medicine.”

Only 3 states are reporting declines in new coronavirus cases as the US hits its highest daily rate in 2 months: “As of Saturday night, new cases were down in Texas, Missouri and South Carolina, while 21 states reported a rise in cases and a little more than half held steady compared with the week before.
Friday, there were 54,506 new reported cases, according to Johns Hopkins University, the highest single day case number since 64,601 cases were reported on August 14.”

COVID-19 Antibodies Decline Quickly in Donated Plasma: Study: “Antibodies against COVID-19 in people who've recovered from the disease begin to vanish about three months after they develop symptoms, researchers say.
This suggests that sooner is better for recovered COVID-19 patients to donate antibody-containing blood plasma for convalescent plasma treatment, according to the authors of a small study published Oct. 1 in the journal Blood…
By about 88 days, all 15 donors had decreases in antibodies, and half of detectable antibodies dropped within 21 days after that, the investigators found.”

Effect of Face Masks on Gas Exchange in Healthy Persons and Patients with COPD: One less reason to avoid wearing a mask: “Although we did not measure changes in tidal volume or minute ventilation, this data find that gas exchange is not significantly affected by the use of surgical mask, even in subjects with severe lung impairment.”

About health insurance

UnitedHealthcare planning largest MA geographic expansion in 5 years: “The insurance giant, which currently covers more than 6.5 million people in its MA plans, will expand to 300 additional counties to reach nearly 3.2 million additional members for plan year 2021.”

Cigna expands Medicare Advantage offerings to 67 new counties in 2021: “In 2021, Cigna will expand its MA plans into 67 new counties in five new states, with both HMO and PPO plans available. The new markets will be in Ohio, Virginia, Oklahoma, Utah and New Mexico. Additionally, it is broadening its PPO offerings in more than 150 of its existing communities.” 

About hospitals and health systems

50 Best Teaching Hospitals for America: Yet another list…this one is “based on their performance in three broad categories: patient outcomes (mortality etc.), civic leadership (treating lower-income and minority patients etc.), and value of care (avoiding overtreatment).” The order of institutions and omissions are surprising.

Investors Extracted $400 Million From a Hospital Chain That Sometimes Couldn’t Pay for Medical Supplies or Gas for Ambulances: “In the decade since Leonard Green & Partners, a private equity firm based in Los Angeles, bought control of a hospital company named Prospect Medical Holdings for $205 million, the owners have done handsomely.
Leonard Green extracted $400 million in dividends and fees for itself and investors in its fund — not from profits, but by loading up the company with debt.”

Lafayette General Health Joins Ochsner Health:”The combined system includes $465 million growth plan for Acadiana and an immediate $100 million expansion at Ochsner Lafayette General Medical Center.”

American Renal Associates shares skyrocket 70% premarket on news of take-private bid: “American Renal Associates Holdings Inc. shares…jumped 70% in premarket trade Friday, after the provider of outpatient dialysis services said it has reached an agreement to be acquired by private-equity firm Nautic Partners in a deal with an enterprise value of about $853 million.”

About healthcare IT

VA considers moving to Cerner patient portal, racking up to $300M more in EHR project costs:”The Department of Veterans Affairs is in talks to retire its current EHR patient portal and switch to Cerner's tool, which could cost anywhere from $60 million to $300 million.”

Clinical evaluation and diagnostic yield following evaluation of abnormal pulse detected using Apple Watch: “A clinically actionable cardiovascular diagnosis of interest was established in only 30 (11.4%) patients, including 6 of 41 (15%) patients who received an explicit alert.” In other words, there is a very high false positive reading with these watches.

University of Minnesota develops AI algorithm to analyze chest X-rays for COVID-19: “A team of researchers at the University of Minnesota recently developed and validated an artificial intelligence algorithm that can evaluate chest X-rays to diagnose possible cases of COVID-19. Working together with M Health Fairview and Epic, the algorithm will be available at no cost to other health systems through Epic, the medical records software used by many health care organizations across the country.”

Nvidia to build the UK’s fastest supercomputer for AI drug-hunters at GSK, AstraZeneca and more: “Through a new partnership with GlaxoSmithKline, AstraZeneca and the U.K.’s National Health Service, the chip maker Nvidia plans to build Great Britain’s most powerful supercomputer—and dedicate its use to artificial intelligence research in healthcare.
Dubbed Cambridge-1, the machine is designed to deliver 400 petaflops of performance, or 400 quadrillion floating-point calculations per second.”

HHS Renews $10.2 Million Contract For Controversial COVID-19 Data Tracking Company:”The Department of Health and Human Services decided to award a second $10.2 million, six-month contract to TeleTracking Technologies even though Congressional committees are investigating the process by which the contract was awarded and the HHS Inspector General is looking at how the company is securing the information it is gathering, an NPR Investigation has learned.”

Today's News and Commentary

Obviously today’s top story is the President and First Lady testing positive for SARS-CoV-2. His age and obesity make him at high risk for complications. She is 50 years old and, as far as we know, healthy. See: White House says Trump 'not incapacitated', working from isolation; Pence negative
Undoubtedly he will not be campaigning for at least the next couple weeks and the second presidential debate will be canceled (though not yet announced).

About the public’s health

Companies Ditch Plans for Rapid Coronavirus Spit Tests at Home: “E25Bio and OraSure, two companies pursuing rapid at-home coronavirus tests, have abandoned efforts to use saliva in their products. Their tests, which detect pieces of coronavirus proteins called antigens, will for now rely on shallow nose swabs instead.” But in a related article: OralDNA Labs Wins Emergency Authorization for COVID-19 Oral Rinse Test.

Trump’s ‘early’ travel ‘bans’ weren’t early, weren’t bans and didn’t work: A really good analysis of what we did, when we did it, and whom it affected. Not quite what the President claims.

US traffic deaths fell 2% in 2019; 3rd straight yearly drop: “The agency says deaths fell 2% last year, to 36,096. That’s 739 fewer than the 36,835 fatalities reported to the agency in 2019. 
The decrease came even though vehicle miles traveled increased by nearly 1%, reducing the fatality rate to 1.1 per 100 million miles traveled. That was the lowest since 2014.” However, deaths have been up the past few months despite decreased travel.

About health insurance

Vulnerable Republicans break with Trump on ObamaCare lawsuit: “GOP Sens. Susan Collins (Maine), Joni Ernst (Iowa), Cory Gardner (Colo.) Martha McSally (Ariz.) and Dan Sullivan (Alaska) voted to advance a Democratic-sponsored bill that would block the Justice Department from advocating in court for the invalidation of ObamaCare. The measure was supported by all Senate Democrats and just one other Republican…
Recent polls show Collins, Ernst, Gardner and McSally all trailing their Democratic challengers. Sen. Lisa Murkowski (R-Alaska), who is up for reelection in 2022, also voted for the measure…
The vote itself came about under unusual circumstances.
Usually, Senate Majority Leader Mitch McConnell (R-Ky.) controls the floor schedule, but Senate Minority Leader Charles Schumer (D-N.Y.) caught Republicans by surprise Tuesday when he filed a procedural motion to bring the health care bill up for a vote when no GOP senator was on the floor to object…
the measure received 51 votes, falling short of the 60 votes needed to advance.”

MedPAC supports changes to the development of MA [Medicare Advantage] plan payment benchmarks: “The group was largely in favor of creating a new payment approach that calculates MA payments based on a blend of local and national spending as opposed to the current methodology, which sets benchmarks on a county-by-county basis.
The panel did not decide on how exactly to blend the Medicare benchmarks and has yet to formalize a recommendation to Congress. But the meeting underscored the panel’s desire to make reforms to the MA payment structure. MedPAC data show that MA plan payments are on average 2% higher than traditional Medicare.”

About healthcare professionals

Physician Work Hours and the Gender Pay Gap — Evidence from Primary Care: “Female PCPs generated less visit revenue than male colleagues in the same practices owing to a lower volume of visits, yet spent more time in direct patient care per visit, per day, and per year.”

U.S. HHS announces further $20 billion funding to healthcare providers:”The U.S. Department of Health and Human Services on Thursday announced a fresh round of $20 billion funding for frontline healthcare providers dealing with the COVID-19 pandemic.
The new allocation will take into account financial losses and changes in operating expenses caused by the coronavirus, the agency said, adding that providers that have already received relief fund payments can also apply for more funds.”

About hospitals and health systems

Advocate Aurora, Beaumont cancel merger: “The merger plan faced criticism from some Beaumont physicians, nurses, and donors. In August, the Beaumont board of trustees confirmed it would delay a vote on the planned merger. The trustees decided to postpone the vote after seeing the results of a survey, completed by 1,500 of the system's 5,000 physicians, that revealed a lack of confidence in Beaumont's leadership and concerns about its proposed merger with Advocate Aurora.
In announcing the deal was canceled, Beaumont said it wants to focus on ‘local market priorities.’”

About healthcare IT

Digital health company Hims & Hers goes public in blank check deal: “Startup Hims & Hers is going public through a merger with a special purpose acquisition company (SPAC) in a blank check deal.
The three-year old telehealth company will merge with Oaktree Acquisition Corp. in a deal that will value the company at about $1.6 billion…
San Francisco-based Hims launched in November 2017 as a men's wellness brand offering skincare, hair-loss products and erectile dysfunction medication. It has since added a women’s health business, called Hers, focused on birth control, sexual health, and skin and hair care products.
The company now provides access to medical care and treatment for more than a dozen conditions with more than 50 products. It has scaled its business quickly and has facilitated more than 2 million telehealth consultations.”

6 things to know about telehealth medical malpractice concerns: A good, brief summary of this issue.

About pharma

Diabetes patients turn to underground insulin networks as Covid-19 exposes limits of copay caps: The story is about the high cost of insulin causing people to share their prescriptions with others. Apparently the medication is not yet “as cheap as water,” as the President claimed during Tuesday night’s debate.

Drug Pricing Investigation: From the Committee on Oversight and Reform, U.S. House of Representatives (Democrat’s report). Removing the political statements, here are some of the study’s conclusions:

• A recent report found that drug companies have raised the list prices of more than 600 single-source brand name drugs by a median 21.4% between January 2018 and June 2020.

• The Committee’s investigation… reveals new details about the specific tactics drug companies are using to raise prices, maximize profits, and suppress competition among other companies.

• …drug companies are taking full advantage of the federal law that currently prohibits Medicare from negotiating directly with drug companies to lower prices. The drug companies are bringing in tens of billions of dollars in revenues, making astronomical profits, and rewarding their executives with lavish compensation packages—all without any apparent limit on what they can charge.

About medical equipment

Justice Department Opens Ventilator Antitrust Probe Focused on Medtronic: The story shows how complex these transactions can be.
“The probe is centered on a series of events that date to 2012, when Covidien PLC, a device maker that sold ventilators, bought Newport Medical Instruments, a small California-based manufacturer of ventilator systems, for $108 million.
Newport had secured a contract with the federal government in 2010 to develop and supply low-cost ventilators, but the project stalled after Covidien bought Newport, and the two sides eventually agreed to end the contract before any ventilators were delivered.
Nearly three years after Covidien bought Newport, Medtronic bought Covidien in a roughly $50 billion deal, inheriting Newport in the process. Both deals received antitrust clearance from the Federal Trade Commission.”

Today's News and Commentary

About health insurance

Hospitals get more time to repay Medicare loans:”President Donald Trump on Sept. 30 signed a short-term spending bill that funds the government through Dec. 11 and relaxes the repayment terms for Medicare loans hospitals received earlier this year. 
The funding bill, previously passed by the House of Representatives and Senate, extends the date for when CMS will begin recouping Medicare advance payments that were sent to hospitals to help offset financial strain tied to the COVID-19 pandemic. CMS will wait one year after the loan was issued to begin withholding Medicare payments to recoup the funds. The loans were originally due 120 days after they were issued. 
The spending bill also delays Medicaid Disproportionate Share Hospital payment cuts.”

National Health Care Fraud and Opioid Takedown Results in Charges Against 345 Defendants Responsible for More than $6 Billion in Alleged Fraud Losses:Largest Health Care Fraud and Opioid Enforcement Action in Department of Justice History: “These defendants have been charged with submitting more than $6 billion in false and fraudulent claims to federal health care programs and private insurers, including more than $4.5 billion connected to telemedicine, more than $845 million connected to substance abuse treatment facilities, or ‘sober homes,’ and more than $806 million connected to other health care fraud and illegal opioid distribution schemes across the country.”

Marketplace Coverage Enrollment by Metal Tier, 2016-2018: Trends in States Using the Healthcare.gov Enrollment Platform: From an Urban Institute study: “In 2017, on average, a benchmark (second lowest priced) silver premium was 21 percent higher than the lowest-priced bronze plan available to consumers.
In 2018, after federal reimbursement of cost-sharing subsidies ended, the silver plan premiums rose to an average of 38 percent above the lowest-premium bronze plan, sparking an 11-percentage-point drop in the share of marketplace enrollees buying silver plans. Most of that enrollment drop shifted into lower priced bronze plans, coverage that requires substantially higher out-of-pocket costs when using medical care.”

Health Plans Undercutting Obamacare Get Boost From Texas Ruling: “The U.S. judge in Texas who ruled that Obamacare’s individual mandate was unconstitutional has signed off on a kind of low-cost insurance alternative that could pull young, healthy people away from the exchanges and drive up health-care costs for those left behind.
U.S. District Judge Reed O’Connor in Fort Worth overruled the U.S. Labor Department’s objections to novel plans proposed by two would-be providers, including a small Georgia company that proposes to offer health plans to individuals who agree to have their internet activity tracked.”
There is one error in the article: ERISA plans are subject to the essential coverage items of the ACA.

About healthcare IT

HHS urges health care sector to guard against Ryuk ransomware threat: “The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness & Response today released an update on the Ryuk ransomware threat to the health care and public health sector, and urged the sector to take certain actions to reduce the risk of an attack.”

VA EHRM, MHS GENESIS Set to Deploy in October After Delays: FINALLY…”Following delays to both the Department of Veterans Affairs’ (VA) Electronic Health Record Modernization (EHRM) program and MHS GENESIS, the Military Health System’s new EHR system, both are set to go-live in late October…
The agency plans for MHS GENESIS to improve patient experience and safety, enable the application of standardized workflows, integrate healthcare delivery, and increase provider efficiency. It will also provide a single EHR for veterans, service members, and their families….
Constructed by Cerner, MHS GENESIS uses the same software as the EHRM program. This allows secure interoperability between the two healthcare systems.”

More than 5.5M health records breached in September: Not a great month for IT. The list provides details by institution. By far the biggest breach was Inova Health System (Falls Church, Va.), with 1,045,270 individuals affected.

About the public’s health

New poll shows alarming coronavirus vaccine skepticism: “Lack of trust in a potential coronavirus vaccine is becoming a truly major problem, according to a new Stat/Harris Poll survey shared with Axios…
79% of respondents said they would worry about a vaccine's safety if it's approved quickly, and 75% said they worry about politics — rather than science — driving the process.”

HPV Vaccination and the Risk of Invasive Cervical Cancer: From a very large Swedish study: “The cumulative incidence of cervical cancer was 47 cases per 100,000 persons among women who had been vaccinated and 94 cases per 100,000 persons among those who had not been vaccinated.” By far the greatest benefit was in women vaccinated before age 17. 

Moderna CEO says its vaccine won’t be ready for general public until spring: “Stéphane Bancel told the Financial Times during a pharmaceutical and biotechnology conference that the company would not be ready to apply for emergency use authorization [emphasis added] for its potential vaccine from the Food and Drug Administration until Nov. 25 at the earliest…”

Health-care spending attributable to modifiable risk factors in the USA: an economic attribution analysis:From today’s Lancet Public Health:
In 2016, US health-care spending attributable to modifiable risk factors was US$730·4 billion…corresponding to 27·0%… of total health-care spending [emphasis added]. Attributable spending was largely due to five risk factors: high body-mass index ($238·5 billion, 178·2–291·6), high systolic blood pressure ($179·9 billion, 164·5–196·0), high fasting plasma glucose ($171·9 billion, 154·8–191·9), dietary risks ($143·6 billion, 130·3–156·1), and tobacco smoke ($130·0 billion, 116·8–143·5). Spending attributable to risk factor varied by age and sex, with the fraction of attributable spending largest for those aged 65 years and older (45·5%, 44·2–46·8).”

 About pharma

US congressional probe alleges Celgene, Teva schemed to drive up cost of key drugs: “The US House Committee on Oversight and Reform released two reports Wednesday outlining various tactics used by Celgene and Teva to drive up prices for their respective drugs Revlimid (lenalidomide) and Copaxone (glatiramer acetate).
… the congressional committee noted that as Medicare is prohibited from negotiating directly with pharmaceutical companies to lower drug costs, Celgene and Teva "targeted the US market for price increases, while maintaining or cutting prices for the rest of the world." For Teva in particular, the panel noted that the net price of Copaxone 40 mg/ml in 2015 was $126 per day in the US, versus $33 in Germany, $26 in Spain, $25 in the UK, and $18 in Russia.”

Remdesivir may not cure coronavirus, but it’s on track to make billions for Gilead: Nice summary odf the issues surrounding this drug. The “news” is: “The government is poised to end its control of distribution of the drug after Sept. 30, a spokeswoman for the Department of Health and Human Services said last week, pushing it into normal drug distribution channels.” AmerisourceBergen will be the sole distributer until the end of the year.

NIAID Stops COVID-19 Trial Enrollment Over Adverse Events: “The National Institute of Allergy and Infectious Diseases has stopped enrolling severely ill COVID-19 patients in a phase 3 trial of Merck’s Rebif (interferon beta-1a) with Gilead Sciences’ remdesivir because of serious adverse events.”

Today's News and Commentary

About pharma

Early data show Regeneron's antibody cocktail cuts viral load, eases COVID-19 symptoms:”Regeneron Pharmaceuticals said Tuesday that adding REGN-COV2 to standard-of-care reduced viral load as well as the time to symptom alleviation in non-hospitalised patients with COVID-19. The company noted that first data from an ongoing adaptive Phase I/II/III trial of its investigational dual antibody cocktail also showed "positive trends" in reducing medical visits. Regeneron indicated that it plans "rapidly" to discuss these results with regulatory authorities.”

7 former FDA commissioners: The Trump administration is undermining the credibility of the FDA:The headline speaks for itself. Read the article for details.

UnitedHealth has acquired DivvyDose, a competitor to Amazon’s PillPack:”UnitedHealth Group… has acquired DivvyDose, a start-up that helps patients with chronic illness get their medicines delivered in pre-sorted packages, according to a person familiar with the deal.
The deal price was just over $300 million, the person said…
Many of the largest retailers and health plans are snapping up start-ups in the online pharmacy space, which aim to make it easier for patients to take their medicines. Amazon acquired PillPack, a competitor to DivvyDose in 2018, and Walmart recently scooped up medication management technology from CareZone.”

6 recent drug, device recalls: Read not just the specifics but for the types of problems.

About health insurance

As insurers move this week to stop waiving telehealth copays, patients may have to pay more for virtual care: “Starting Oct. 1, several private health insurers will no longer fully pay for virtual visits under certain circumstances…” UnitedHealthcare is particularly singled out for this policy change.

Insurers offered new benefits in response to COVID-19. Where do they stand 6 months later?: In addition to the telemedicine benefits mentioned above are early medication renewals and diagnostic COVID-19 testing.

Reasons for Being Uninsured Among Adults Aged 18–64 in the United States, 2019: From the CDC- The problem of the uninsured was already an important issue before COVID-19. Here is a summary of the CDC’s findings:

• “In 2019, 14.5% of adults aged 18–64 were uninsured in the United States.

• Among uninsured adults aged 18–64, the most common reason for being currently uninsured was that coverage was not affordable.

• The percentage of uninsured adults who were uninsured because coverage was not affordable increased with age, from 66.8% among those aged 18–29 to 80.9% among those aged 50–64.

• Hispanic adults (30.4%) were more likely than non-Hispanic white adults (22.3%) to indicate that they were uninsured due to ineligibility.

• Men (26.8%) were more likely than women (14.6%) to indicate that they were uninsured because coverage was not needed or wanted.”

About the public’s health

The first presidential debate: 7 healthcare takeaways: This article is a nice, brief summary of the healthcare points in last night’s debate. See, also: Fact-checking the first Trump-Biden presidential debate.

Is Your State Doing Enough Coronavirus Testing?: An update from the NY Times tracking- 33 states are below target for testing.

HHS ad blitz sputters as celebrities back away: “The health department’s $300 million-plus, taxpayer-funded vehicle to boost confidence in President Donald Trump’s response to the pandemic is sputtering. Celebrities are refusing to participate, and staff are arraying against it. Some complain of the unstated aim of helping Trump’s re-election. Others point to an ill-prepared video team and a 22-year-old political appointee who has repeatedly asserted control despite having no public health expertise, according to six people with close knowledge of the campaign and documents related to its operations.”

CDC director overruled on cruise ship ban:”Robert Redfield, the director of the Centers for Disease Control and Prevention, was overruled when he pushed to extend a ‘no-sail order’ on passenger cruises into next year, according to two sources with direct knowledge of the conversation today in the White House Situation Room…
Vice President Mike Pence, who chaired today's meeting, told Redfield that they would be proceeding with a different plan, according to two task force members.”

About healthcare IT

HHS Announces Funding for Health Information Exchanges to Support Public Health Agencies – STAR HIE Program Funds Five Organizations to Improve Interoperability of Health Data:”The HHS Office of the National Coordinator for Health Information Technology (ONC) is administering $2.5 million in funding from the Coronavirus Aid, Relief, and Economic Security Acts (CARES Act) signed by President Trump on March 27, 2020. The funding will support local health information exchanges (HIEs) under the Strengthening the Technical Advancement and Readiness of Public Health Agencies via Health Information Exchange (STAR HIE) Program.
Each of the five recipients will work to improve HIE services so that public health agencies can better access, share, and use health information during public health emergencies. These efforts will also support communities that are disproportionately impacted by COVID-19.”
Read the announcement for more details about the five recipients.

Anthem to pay $39M to state AGs to settle landmark 2015 data breach:”The insurance giant has reached a settlement with a group of State Attorney Generals [sic] over the historic 2015 hack into its computer network.
Anthem will pay a $39.5 million settlement in connection with the state AGs' investigation.”

Trump administration may push back info blocking rule again due to COVID-19 pandemic: “The Trump administration is planning to delay the compliance deadlines for healthcare information blocking and interoperability regulations for a second time due to the COVID-19 pandemic.
The Department of Health and Human Services (HHS) sent the Office of Management and Budget (OMB) an interim final rule on September 17 that revises the timelines.”

Today's News and Commentary

About pharma

Trump’s drug card plan sows confusion – even within administration:”President Donald Trump’s surprise pledge to send $200 drug discount cards to older Americans has left even his top deputies and health officials scrambling to explain how it would all work — assuming it’s even legal…
Skeptics seized on the way the administration may rely on projected savings from a new drug pricing initiative still under development to justify the more than $6 billion expense as a sign the plan is built on flimsy promises.”

Calif. To Manufacture Its Own Generic Drugs Under New Law: “California Gov. Gavin Newsom on Monday signed legislation allowing the Golden State to manufacture its own generic prescription drugs, which is aimed at lowering the cost of prescription drugs…”

Once-weekly insulin had similar effects to daily insulin in type 2 diabetes, industry-funded trial finds: “Once-weekly treatment with insulin icodec, an investigational treatment not yet approved by the FDA, had glucose-lowering efficacy and a safety profile similar to those of once-daily insulin glargine U100 in patients with type 2 diabetes, an industry-funded study found.”

Pfizer to Supply $22 Million in Drugs to Covid Stockpile:”Pfizer Inc. will supply almost $22.2 million in drugs to the national medical stockpile to treat patients with Covid-19 and prepare for future emergencies.
The Strategic National Stockpile is purchasing the pharmaceuticals as part of a plan to restructure and resupply, known as SNS 2.0, so that there are enough in the case of future Covid-19 flare-ups.”

About healthcare IT

Efficacy of Smartphone Applications for Smoking CessationA Randomized Clinical Trial: “In this 2-group stratified, double-blind, individually randomized clinical trial of 2415 adult smokers with a 12-month follow-up and high retention, participants assigned to the smartphone application based on ACT [acceptance and commitment therapy] 1.49 times higher odds of quitting smoking compared with the participants assigned to the smartphone application based on US clinical practice guidelines.”

Health Insurer Pays $6.85 Million to Settle Data Breach Affecting Over 10.4 Million People: “Premera Blue Cross (PBC) has agreed to pay $6.85 million to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over 10.4 million people. This resolution represents the second-largest payment to resolve a HIPAA investigation in OCR history.”

Major hospital system hit with cyberattack, potentially largest in U.S. history: “Computer systems for Universal Health Services, which has more than 400 locations, primarily in the U.S., began to fail over the weekend, and some hospitals have had to resort to filing patient information with pen and paper, according to multiple people familiar with the situation.”

Drug Reimbursement Regulation in 6 Peer Countries: Drug regulation varies across countries; before we decide to import or benchmark prices, we need to understand those processes. This article is a good overview of how 6 countries handle this issue. Also, see the editorial: Sophisticated Purchasing of Pharmaceuticals- Learning From Other Countries.

About the public’s health

Feds to ship millions of tests in bid to reopen K-12 schools: “The tests will go out to states based on their population and can be used as governors see fit, but the Trump administration is encouraging states to place a priority on schools. White House officials said at a Rose Garden event that 6.5 million tests will go out this week and that a total of 100 million tests will be distributed to governors over the next several weeks.”

1 in 3 parents won't get flu shots for their child during Covid-19, study finds:”One-third of American parents have no plans to get their children vaccinated for the flu this year, according to the National Poll on Children's Health released Monday, despite the very real possibility their child could also catch the deadly Covid-19.
In addition, two-thirds of parents don't believe getting a flu shot for their child is more important this year, despite advice to the contrary from major government organizations and pediatricians.”

Pfizer urged to hold off on coronavirus vaccine until late November: “Pfizer CEO Albert Bourla and his vaccine partner BioNTech have said the companies expect phase 3 data by the end of October—and that an FDA application could soon follow. But more than 60 researchers and bioethicists urged the partners to wait for more safety data before submitting their shot for a green light…”

United Airlines teams up with Color to make COVID-19 tests available to passengers: “United Airlines is working with health technology and genomics company Color to roll out the first COVID-19 testing program for air travelers.
The airline will offer COVID-19 tests—either rapid tests at the airport or mail-in at home tests prior to travel—to passengers flying from San Francisco International Airport to Hawaiian airports beginning Oct. 15.”

Heavy consumption of sugar-sweetened beverages[SSBs] significantly declines in US: “Overall, the percentage children and adults who drank about 3.5 12-ounce cans of regular soda each day dropped in the United States during a recent 13-year period, researchers reported.”
The reason given for this decrease among all age groups is “likely due to the enforcement of beverage taxes and ordinances that require restaurants to offer only healthy beverages to children instead of SSBs with their meals.”

New U.S. COVID-19 cases rise in 27 states for two straight weeks:”The number of new COVID-19 cases in the United States has risen for two weeks in a row in 27 out of 50 states, with North Carolina and New Mexico both reporting increases above 50% last week, according to a Reuters analysis.
The United States recorded 316,000 new cases in the week ended Sept. 27, up 10% from the previous seven days and the highest in six weeks, according to the analysis of state and county data.”

Coronavirus: New global test will give results 'in minutes': “A test that can diagnose Covid-19 in minutes will dramatically expand the capacity to detect cases in low- and middle-income countries, the World Health Organization (WHO) has said.
The $5 (£3.80) test could transform tracking of Covid-19 in less wealthy countries, which have shortages of healthcare workers and laboratories.
A deal with manufacturers will provide 120 million tests over six months.”

About health insurance

12 Leading Medicare Advantage Payers by 2020 CMS Star Ratings: “Leading into 2020, twelve payers rose above the rest with their Medicare Advantage-prescription drug plans.
These plans earned five stars from CMS for delivering high quality service to their members according to 45 quality measures…
The data showed that Medicare Advantage plans continued to grow more competitive going into 2020, with the average star rating hovering around 4.16. This rise in competition may have been aided by the October 2019 executive order giving plans more flexibility with benefits and changes to payment models.
The year boasted 20 five-star Medicare Advantage-prescription drug plans, a slight decrease from 2018.”

Molina Healthcare to Acquire Affinity Health Plan:”Molina Healthcare, Inc. announced today that it has entered into a definitive agreement to acquire substantially all of the assets of Affinity Health Plan. The purchase price for the transaction is approximately $380 million, net of expected tax benefits and inclusive of an amount representing Molina’s target allocation of required regulatory capital. Molina intends to fund the purchase with cash on hand.”

Short-term plans spent little on medical claims in 2019: “Health insurers selling the plans reported an average medical loss ratio of 61.6%, meaning they spent roughly 62 cents of every dollar they collected in premiums on members' medical claims.”

About healthcare quality

AMA and others ask CMS not to finalize proposed ACO quality changes: “Citing the ongoing COVID-19 public health emergency, 10 leading healthcare organizations are urging CMS not to move forward with changes to how accountable care organizations and other alternative payment models are assessed on quality in the Medicare Shared Savings Program and the merit-based incentive payment system.
The proposed changes are in the 2021 proposed physician fee schedule.
CMS proposes to abruptly end the use of the Web Interface reporting mechanism, a tool that has been used since the MSSP's inception, the group said. 
The proposed rule would also remove the pay-for-reporting year currently provided to ACOs beginning an initial MSSP contract, as well as individual measures that are newly introduced to the measure set.”

About diagnostics
FDA Allows Use of CapsoVision’s Capsule Endoscope at Home: “The FDA has said it will allow CapsoVision’s CapsoCam Plus, a small bowel capsule endoscope, to be used at home during the pandemic.
The agency said it will exercise “enforcement discretion,” meaning that it won’t enforce its normal requirements for the devices because it has determined that the risk to patients is low.”

About hospitals and health systems

Common Spirit plans $2 billion bond issue amid rush to borrow: The headline speaks for itself.

Today's News and Commentary

About the public’s health

FDA greenlights its first coronavirus antibody blood test for the point of care: “The FDA has authorized its first COVID-19 antibody test designed to be used on-site at the point of care—such as within doctors' offices, urgent care centers and emergency rooms—as opposed to having samples shipped and tested within a central laboratory.
The fingerstick blood test, which operates using only a lined strip similar to a pregnancy test, is designed to provide results for two types of coronavirus antibodies within 15 minutes.”

Young adults account for more COVID-19 cases than any other age group, CDC says: “While older Americans were the ones disproportionately affected early in the pandemic, young adults aged 20 to 29 now account for 20 percent of all cases. 
The findings suggest that young people are not as immune to the virus as some previously thought, and that young adults are contributing to the community spread of the virus, including to people at high risk for more severe illness.”

NOWHERE TO GO: MATERNITY CARE DESERTS ACROSS THE U.S. 2020 REPORT: From the March of Dimes: “Today, 7 million women of childbearing age live in counties without access or with limited accessto maternity care. These women are giving birth to more than 500,000 babies a year and this is putting them at risk of serious health complications.”

U.S. records over 7 million COVID-19 cases as Midwest outbreak surges:”The number of novel coronavirus cases in the United States topped 7 million - more than 20% of the world’s total - as Midwest states reported spikes in COVID-19 infections in September, according to a Reuters tally.”

CDC will distribute $200 million for COVID-19 vaccine preparations: “The money will be sent through CDC's existing immunization cooperative agreement and will help support 64 jurisdictions as they plan and implement COVID-19 vaccination services, HHS said.
The amount each jurisdiction receives is determined based on the size of the population there.”

Trump says White House may overrule FDA plans for stricter COVID-19 vaccine standards:”US President Donald Trump indicated that the White House could block plans by the FDA to release tougher standards for granting emergency-use authorisation (EUA) of eventual COVID-19 vaccines, claiming that such a move by the agency appears politically motivated.”

Black women with breast cancer experience delayed, longer treatment than whites: “Our study found that Black women experienced delays in both treatment initiation and duration more often than white women. Even among women with low socioeconomic status, we still saw fewer delays among white women, underscoring the disparate experience of Black women, who appear to experience unique barriers…”

Trends in Cardiovascular Disease Prevalence by Income Level in the United States: “This study found substantial and increasing disparities in CVD prevalence between the richest and poorest participants in the NHANES from 1999 to 2016, with lower CVD rate reported among the highest-resources group. Additional research into the dynamics of income inequality and health outcomes as well as policy and public health efforts to mitigate this inequality are needed.”

About pharma

Trump approves final plan to import drugs from Canada ‘for a fraction of the price’: “The final plan clears the way for Florida and other states to implement a program bringing medications across the border despite the strong objections of drugmakers and the Canadian government.
Florida, the biggest swing state in the presidential election, is one of six states to pass laws seeking federal approval to import drugs. Trump’s announcement came the same day counties in Florida began sending out vote-by-mail ballots.”

FDA updates benzodiazepine boxed warning: ”The new information, to be added to an updated boxed warning and to prescribing information for all benzodiazepine medicines, will provide a uniform method of describing the risks of misuse or abuse, as well as risks of addiction and the potential for withdrawal symptoms ‘consistently across all the medicines in the class,’ according to FDA.”

About health insurance

Trump signs U.S. healthcare executive orders that may have little impact: The President signed two executive orders, neither of which has the force of law. The first “guarantees” insurance companies cannot discriminate on the basis of pre-existing conditions. The ACA, which the administration is trying to repeal, does legally guarantee that right. The other order says Congress should work to solve the problem of surprise bills, something on which it has already been working.

Trump Administration Announces Historically Low Medicare Advantage Premiums and New Payment Model to Make Insulin Affordable Again for Seniors: “The Medicare Advantage average monthly plan premium is expected to decrease 11 percent to $21.00 (estimated) in 2021 from an average of $23.63 in 2020. Since 2017, the average monthly Medicare Advantage premium has decreased by an estimated 34.2 percent. This is the lowest that the average monthly premium for a Medicare Advantage plan has been since 2007.”

Catastrophic Health Expenditures Across Insurance Types and Incomes Before and After the Patient Protection and Affordable Care Act: “ACA implementation was associated with 2 million fewer US adults with catastrophic expenditures each year. Financial protection improved for the lowest income quartile, which was one of the ACA’s principal aims. However, improvements were not observed in higher income quartiles or among the privately insured, who represent an increasing share of those experiencing catastrophic expenditures. Among individuals in the poorest quartile, the privately insured are the most vulnerable, with one-third experiencing catastrophic spending annually. These findings help to explain why so many US residents, including those with insurance, continue to worry about their ability to afford needed care.”
2020 Scorecard on State Health System Performance: The Commonwealth Fund’s three major conclusions:

”Insurance coverage gains associated with the Affordable Care Act (ACA) have stalled, and affordability and out-of-pocket costs are worsening.

Increased prices for health care services are a major driver of overall spending growth, and this has led to higher costs for consumers in commercial plans.

Premature deaths from treatable conditions and deaths from suicide, alcohol, and drug overdose continue to impact life expectancy.”

The top state was, again, Hawaii. Read the report for more details.

About healthcare quality
As hospitals look to prevent infections, a chorus of researchers make a case for copper surfaces: “As hospitals across the country hunt for ways to reduce the spread of pathogens to patients, a growing chorus of researchers is arguing that a simple swap might help: replace stainless steel surfaces with copper.”

About hospitals and health systems

100 of the largest hospitals and health systems in America | 2020: A list FYI.

16 hospitals planning upgrades, expansions: Amazing that institutions are still building.

Today's News and Commentary

About health insurance

Blue Health Insurers Reach Tentative Antitrust Settlement for $2.7 Billion: “The Blue Cross Blue Shield insurance group has negotiated a tentative settlement in a sweeping antitrust suit filed on behalf of customers, according to people with knowledge of the matter, in a deal that would require a payout of around $2.7 billion and curtail practices that allegedly limited competition among its three dozen member-companies.
The settlement isn’t final, according to these people. The Blue Cross Blue Shield Association has signed off on the agreement, but it hasn’t been approved by the boards of all 36 Blue Cross Blue Shield insurers.” 

About pharma

Gilead To Pay $97M To Resolve Copay Kickback Claims: Gilead used a foundation to pay patient copays, a plan HHS has banned.

Novartis sells bonds tied to expanding access to medicines in poor countries: “In a first-of-its-kind move by a large drug maker, Novartis (NVS) raised approximately $2.1 billion last week by selling bonds that are tied directly to its progress in making medicines accessible in certain low- and middle-income countries.
Specifically, the stated goal is to expand the number of patients who receive its brand-name medicines by at least 200% by 2025, as well as programs that market medicines to combat leprosy, malaria, Chagas, and sickle cell disease by at least 50% over the same period.”

CVS accused of patient steering: The National Community Pharmacists Association "conducted a survey of 412 community pharmacies between Sept. 8 and Sept. 11 and found that 79 percent of community pharmacies said patient steering happened with one or more of their patients in the past six months, and almost 78 percent said some of their patients then moved their prescriptions to CVS. 
Patient steering happens when an insurance company moves a patient's prescriptions to a different pharmacy without their knowledge or consent.” CVS denies the claim.

Pfizer partner BioNTech sees no role for its vaccine in UK challenge trial: The trial in the UK involves challenging volunteers with live Sars-CoV-2 to see if the vaccine works.

Letter to Eli Lilly and Company from the HHS General Council criticizing the drugmaker’s decision to restrict its participation under the 340b program.

About hospitals and health systems

The National Patient and Procedure Volume Tracker™: Among the findings:
”Inpatient volume has not fully recovered with inpatient procedures and surgeries still down significantly

• Volumes now approaching 2019 levels, but lost volumes have not recovered

• The “new normal” may be 90-95% of previous levels

• Inpatient procedures and surgeries continue to trail 2019 levels, down 18.6% cumulatively, having a negative financial impact

• Medical, not surgical service lines, have come back strongest as patients have focused on chronic, preventative, and screening care

Outpatient volume has recovered for some, but not for all

• Volumes fell significantly, but have now recovered, down 56% at the start, but down only 1.5% for the past 30 days

• Recovery is not evenly distributed, as some areas have come back strongly, while other care areas still lag

• Volume rebound demonstrates ongoing recovery outside the inpatient setting, including new channels such as telehealth”

Trump Administration Plans Crackdown On Hospitals Failing To Report COVID-19 Data: “The federal government is preparing to crack down aggressively on hospitals for not reporting complete COVID-19 data daily into a federal data system, according to internal documents obtained by NPR.
The draft guidance, expected to be sent to hospitals this week, also adds new reporting requirements, asking hospitals to provide daily information on influenza cases, along with COVID-19. It's the latest twist in what hospitals describe as a maddening flurry of changing requirements as they deal with the strain of caring for patients during a pandemic.”

About healthcare IT

BestBuy Health, Amazon Alexa team up on new telehealth-enabled flip phone for seniors: “BestBuy Health… launched a new flip phone equipped with Amazon Alexa voice assistance and telehealth capabilities that help connect older adults to healthcare services.
The phone, dubbed Lively Flip, has Amazon Alexa capabilities so individuals can use their voice to make calls and send text messages. The device is also designed with an urgent call button, which if pressed, automatically connects the caller to a clinical urgent care team via GreatCall, a medical alert system and device provider that offers 24/7 access to urgent response agents.”

Today's News and Commentary

About the public’s health

Coronavirus Vaccine Tracker: From the NY Times…A great article on the vaccine development and what companies are at what stages in their clinical trials.

Democrats seek investigation into Pentagon’s coronavirus fund following Washington Post article: “Congressional Democrats sharply criticized a Defense Department decision to repurpose a $1 billion coronavirus fund into an economic stimulus for defense contractors, a change the lawmakers say violated congressional intent…
The funds, set aside under the Cares Act economic stimulus package passed in March, were given to the Pentagon to ‘prevent, prepare for, and respond to coronavirus.’ But the Defense Department decided to divert most of that funding toward long-standing defense concerns such as drone technology, body armor and dress uniforms. The decision was made in consultation with the White House Office of Management and Budget, as well as other federal agencies, according to a defense official who spoke on the condition of anonymity to discuss sensitive internal deliberations.”

FDA poised to announce tougher standards for a covid-19 vaccine that make it unlikely one will be cleared by Election Day: The headline speaks for itself.

U.S. News and Aetna Foundation release 2020 Healthiest Communities rankings:At the top is Los Alamos County, New Mexico. Check the article to get the compete list.

Massive genetic study shows coronavirus mutating and potentially evolving amid rapid U.S. spread:”Scientists in Houston on Wednesday released a study of more than 5,000 genetic sequences of the coronavirus, which reveals the virus’s continual accumulation of mutations, one of which may have made it more contagious.
That mutation is associated with a higher viral load among patients upon initial diagnosis, the researchers found.
The new report, however, did not find that these mutations have made the virus deadlier or changed clinical outcomes. All viruses accumulate genetic mutations, and most are insignificant, scientists say.”

Vitamin D Deficiency in Adults: Screening: In draft statement the “USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults.”

Trump Administration Dips Into Protective Gear, CDC Funds to Fund Vaccine Push:”The Trump administration has shifted billions of dollars previously allocated to public-health programs into its Operation Warp Speed vaccine push, reflecting the U.S. government’s increasing focus on a medical solution to ease the Covid-19 pandemic…
One of the biggest transfers came in August, with $6 billion pulled from $16.7 billion that had been allocated to the U.S. Strategic National Stockpile, which buys, holds and distributes crucial medical supplies in times of national crisis.  The money had originally been meant to replenish stocks of medical protective gear, ventilators, and Covid-19 testing supplies, all of which have experienced shortages at points during the pandemic.”

Most KN95 masks fall short of U.S. standards for effectiveness, ECRI finds: “Up to 70% of KN95 masks manufactured in China do not meet U.S. standards for effectiveness, an analysis by ECRI found. 
ECRI, a patient safety organization, said it found 60% to 70% of imported KN95 masks do not filter 95% of aerosol particulates despite the standard the KN95 mask name suggests. ECRI tested nearly 200 masks from 15 different manufacturer models purchased by some of the largest health systems in the U.S.”

About health insurance

Repeal of the McCarran-Ferguson Act would undermine states’ authority and harm millions of Americans: This article is AHIP’s response to the House passage of a bill to remove anti-trust immunity for the insurance industry.

Trump administration reimposes 'public charge' rule following court victory: “Under the the rule, any immigrant who receives at least one designated public benefit — including Medicaid, food stamps, welfare or public housing vouchers — for more than 12 months within any three-year period will be considered a “public charge” and will be more likely to be denied a green card.
The rule would make it easier for immigration officials to deny entry or legal status to people likely to rely on government assistance.”

OIG: Coding errors led to $14M in overpayments to Medicare Advantage plans: “Incorrect diagnosis codes from providers led to a $14 million windfall for some Medicare Advantage plans, a federal watchdog found.
The Department of Health and Human Services’ Office of Inspector General audited diagnosis codes for strokes as part of an investigation into codes that are at a high risk of being miscoded. The result was that the Centers for Medicare & Medicaid Services made an estimated $14.4 million in inaccurate payments in 2015 and 2016.”

ASCs projected to save Medicare more than $73B in next decade: analysis: “Ambulatory surgery centers reduced Medicare costs by nearly $29 billion between 2011 and 2018 by providing services in a lower-cost setting than hospital outpatient departments, according to a new analysis. 
The report also estimates ASC's saved Medicare $4.2 billion in 2018, the latest data available.”

About healthcare IT

FDA Launches the Digital Health Center of Excellence: “The U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.”

Economic impact of clinical decision support [CDS] interventions based on electronic health records: “Twenty-seven studies are investigated in this review. Of those, twenty-two studies indicate a reduction of healthcare expenditure after implementing an EHR based CDS system, especially towards prevalent application areas, such as unnecessary laboratory testing, duplicate order entry, efficient transfusion practice, or reduction of antibiotic prescriptions. On the contrary, order facilitators and undiscovered malfunctions revealed to be threats and could lead to new cost drivers in healthcare.”

Microsoft makes big play for healthcare cloud business in competition with Google, Amazon: “Microsoft's new cloud service designed specifically for healthcare will be generally available October 30…The Microsoft Cloud for Healthcare service bring together existing services such as Teams, Azure IoT and chatbots to help healthcare organizations manage operations.
Microsoft, Google and Amazon Web Services (AWS) are all pushing deeper into healthcare in a battle to provide cloud computing and data storage technology to hospitals.”

Epic EHR 1st to integrate with Microsoft Teams for telehealth: The headline speaks for itself.

Hospitals and health systems
Ascension records $1B annual loss: “After factoring in nonoperating items, including losses from investments of $410.2 million, Ascension reported a net loss of $1.04 billion in fiscal 2020. A year earlier, the health system reported investment gains of $1.1 billion and net income of $1.23 billion. 
The health system said its charity care costs climbed 9.8 percent year over year to $665 million. The increase was primarily attributable to more patients qualifying for financial assistance, Ascension said.” 

About pharma

GoodRx raises $1.1B in IPO as it sell shares above target: “The GoodRx IPO began trading Wednesday at $46 per share, 39% above its $33 per share offering price. GoodRx stock rose above $49 per share in early afternoon action, Investors.com reported. That boosted the consumer healthcare technology firm's market cap to about $12.7 billion.”

About healthcare quality
Updated Core Measures Focus on Improving Patient Care, Reducing Burden, and Eliminating Redundancies:”Today, the Core Quality Measures Collaborative (CQMC) released four updated core measure sets covering specific clinical areas as part of its mission to provide useful quality metrics as the nation’s health care system moves from one that pays based on volume of services to one that pays for value…
The four updated core measure sets released today cover:

• Gastroenterology

• HIV and Hepatitis C

• Obstetrics and Gynecology

• Pediatrics”

Today's News and Commentary

About health insurance

House votes to restore the application of antitrust laws to insurance business: If passed into law, this measure would be the biggest change to health insurance law since the ACA and possibly of equal importance.
“The US House of Representatives voted Monday in favor of legislation that would amend the 1945 McCarran-Ferguson Act and restore the ability of the federal government to charge health insurers under antitrust laws.
This bill, HR 1418, is part of the Competitive Health Insurance Reform Act of 2019, which was cosponsored by dozens of Democrats and Republicans in a bipartisan push to bring insurers under federal antitrust protections. It was first introduced in February 2019.
The Act states that restoring the application of ‘antitrust laws to the business of health insurance … protect[s] competition and consumers.’ The McCarran-Ferguson Act allows for antitrust exemptions to insurance businesses and gives states the power to regulate such insurance, which took insurance companies out of the protections of antitrust acts like the Sherman Act and the Clayton Act.”

About healthcare finance

Health-care stocks fall on uncertainty over Supreme Court and Obamacare: “Shares of Medicaid insurers Centene and Molina Health fell roughly 8.5%. The ACA has helped fuel the growth Medicaid in states that have expanded coverage to low-income and poor adults.
Hospital operator stocks also fell, with Tenet Healthcare sinking 13%, Universal Health Services down 8.6% and Community Health Systems off 6%. Investors worry that the repeal of the ACA could result in higher uncompensated care for the facilities, if millions were to lose health coverage.”

About the public’s health

Live updates: U.S. surpasses 200,000 coronavirus deaths: The headline, sadly, speaks for itself.

In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.: “In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.
Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power “is reserved to the Secretary.” The bulletin was sent to heads of operating and staff divisions within H.H.S.”

CDC reverses itself and says guidelines it posted on coronavirus airborne transmission were wrong: “On Monday morning, the Centers for Disease Control and Prevention edited its Web page describing how the novel coronavirus spreads, removing recently added language saying it was “possible” that it spreads via airborne transmission. It was the third major revision to CDC information or guidelines published since May.
The agency had posted information Friday stating the virus can transmit over a distance beyond six feet, suggesting that indoor ventilation is key to protecting against a virus…
The CDC shifted its guidelines Friday, but the change was not widely noticed until a CNN report Sunday. Where the agency previously warned that the virus mostly spreads through large drops encountered at close range, on Friday, it had said ‘small particles, such as those in aerosols,’ were a common vector.”

COVID-19; Federal Efforts Could Be Strengthened by Timely and Concerted Actions: An extensive analysis and recommendations from the GAO. Among the recommendations:

• “HHS, in coordination with FEMA, should immediately document roles and responsibilities for supply chain management functions transitioning to HHS, including continued support from other federal partners, to ensure sufficient resources exist to sustain and make the necessary progress in stabilizing the supply chain.

• HHS, in coordination with FEMA, should further develop and communicate to stakeholders plans outlining specific actions the federal government will take to help mitigate supply chain shortages for the remainder of the pandemic.

• HHS and FEMA—working with relevant stakeholders—should devise interim solutions, such as systems and guidance and dissemination of best practices, to help states enhance their ability to track the status of supply requests and plan for supply needs for the remainder of the COVID-19 pandemic response.”
  Later in the monograph, the GAO makes 16 specific recommendations including: “As CDC implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should involve key stakeholders to help ensure the complete and consistent collection of demographic data.”

Analysis of the 30-Pack-Year Smoking Threshold in African Americans From an Underserved Lung Cancer Screening Program: “Race was not associated with lung cancer diagnosis, but African Americans were the only race to have lung cancer if pack-years were <30. The incidence of cancer in African Americans was similar in those who reported ≥30 or <30 pack-years (2.2% vs. 2.7%; odds ratio, 1.21; 95% confidence interval, 0.39-3.75; P = .740), and the 30-pack-year threshold was not associated with lung cancer diagnosis.” The criteria for screening may need to be lowered in tis population if the results are confirmed.

Trends in Recurrent Coronary Heart Disease [CHD] Following Myocardial Infarction Among US Women and Men Between 2008 and 2017: “ Rates of recurrent MI [heart attack], recurrent CHD events, heart failure hospitalization, and mortality in the first year after an MI declined considerably between 2008 and 2017 in both men and women, with proportionally greater reductions for women than men. However, rates remain very high and rates of recurrent MI, recurrent CHD events and death continue to be higher among men than women.”

Medicare Wouldn’t Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization: The vaccine may be free but not the cost of administration.

About healthcare professionals

U.S. Medical School Applications Soar in Covid-19 Era: “Through the end of August, the number of applicants rose nearly 17% from a year earlier, marking an interest not seen in more than a decade, according to the Association of American Medical Colleges, which administers the main medical-school entry exam. Compared with past years, this year’s numbers are unprecedented, said Patrick Fritz, a senior director with AAMC.”

About hospitals and health systems

Moody's: Hospital financial outlook worse as COVID-19 relief funds start to dwindle: “For-profit hospitals are expected to see a financial decline over the next 12 to 18 months as federal relief funds that shored up revenue losses due to COVID-19 start to wane, a recent analysis from Moody’s said.
The analysis, released Monday, finds that cost management is going to be challenging for hospital systems as more surgical procedures are expected to migrate away from the hospital and people lose higher-paying commercial plans and go to lower-paying government programs such as Medicaid.”

About pharma

Roche Buys Up Inflammatory Disease Biotech for $447 Million: “Roche has announced that it will acquire the biotech Inflazome for $447 million as it expands its presence into drugs for the treatment of inflammatory diseases.”

About healthcare IT

Sam’s Club Teams Up with 98point6 to Offer Exclusive Subscription Plan Options with the 98point6 Mobile App: “Through the collaboration with 98point6, Sam’s Club members with either a Club or a Plus membership can purchase a quarterly subscription at a lower members-only introductory fee of just $20 for the first 3 months per participant, compared to 98point6’s regular sign-up fee of $30 per participant. The subscription includes visits for just $1, with unlimited use, and access to U.S. board-certified doctors 24 hours a day and seven days a week. After the first three months, members will pay $33.50 every three months per participant.”

Sharecare tapped by Amazon to deliver trusted health and well-being information through Alexa:”Sharecare, the digital health company that helps people manage all their health in one place through its comprehensive and data-driven virtual heath platform, today announced it is integrating its library of more than 80,000 questions and answers on various health and well-being topics into the Alexa voice service….”
For example:

• “Alexa, when should I get screened for colon cancer?”

• “Alexa, how long does it take your body to digest food?”

• “Alexa, when is the peak of flu season?”

• “Alexa, how long are you supposed to wash your hands?”

• “Alexa, why are my feet cold?”

• “Alexa, why do people smoke?”