Today's News and Commentary

Despite some of the really important news today, the lead healthcare story is that tomorrow the Supreme Court will hear California v. Texas, deciding the fate of the ACA.

About the public’s health

PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY: This messenger RNA vaccine is the first of its kind. Here is what Pfizer reported today:

• “Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis

• Analysis evaluated 94 confirmed cases of COVID-19 in trial participants

• Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected

• Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November

• Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints”

The Health 202: Biden is expected to unwind dozens of Trump-era health-care changes: A really good summary of these projected policy changes as well as who may serve in healthcare posts in the new government.

President-elect Joe Biden announces Covid task force: Read the article for the listing and also, see: President-Elect Biden Has A Plan To Combat COVID-19. Here's What's In It for the agenda go the task force.

United States nears 10 million coronavirus cases: Sadly, the headline speaks for itself.

Biden team held COVID-19 talks with Operation Warp Speed drugmakers before election: “In their talks, Biden’s advisers indicated to drug company officials that his administration would not be interested in making changes to Warp Speed that would disrupt work in getting new drugs and vaccines to market, Bloomberg reported, adding his administration will want to assist the companies’ efforts when Biden assumes office.”

FDA authorizes first test that screens for Covid-neutralizing antibodies:

• “The Food and Drug Administration announced on Friday that it has authorized the first serology test that screens for neutralizing antibodies caused by a previous coronavirus infection.

• Neutralizing antibodies prevent viruses from infecting cells, though questions remain about how long antibodies against Covid-19 last and how much protection they provide.

• Patients and health providers should not interpret the positive results of the test to mean that patients are protected against Covid-19, the FDA said.”

An Explanation for Some Covid-19 Deaths May Not Be Holding Up: “Recent studies have created doubts about an agent in cytokine storms, and suggest that treatments for it may not help.”

About pharma

Biogen Alzheimer’s drug in doubt after criticism from expert panel: “The future of Biogen’s potential blockbuster Alzheimer’s treatment was thrown back into doubt on Friday when an unusually combative scientific panel contradicted the positive conclusions of staff at the US drug regulator. 
The panel voted that the company’s main trial data did not provide enough evidence that the drug, aducanumab, really worked.”

Sandoz ships first medicine in collaboration with Civica Rx to supply US hospitals: Sandoz Inc. “announced that it has shipped pantoprazole sodium for injection, 40 mg to Civica Rx to supply the hospitals it serves as part of a multiyear collaboration to help reduce supply shortages, with several other medicines on the way before the end of the year.
Pantoprazole is the first Sandoz medicine to ship to Civica since entering into the agreement in July… Sandoz previously announced it will supply six injectable medicines under the Civica private label to its 1,200 US hospitals.”

The 2020 Fierce Pharma Marketing Awards: See who won and what their ad campaigns looked like.

About health insurance

A battle of Blue Cross plans is brewing: “A tentative $2.7 billion settlement of an antitrust case would free Blue Cross plans to invade each other's markets. Under the deal, the Blue Cross Blue Shield Association agreed to loosen a rule that barred such competition.”

Medicare’s ‘Part B’ outpatient premium to rise by $3.90: “Medicare’s ‘Part B’ monthly premium for outpatient care will go up by $3.90 next year to $148.50, officials announced late Friday afternoon. 
For most retirees, the health care cost increase will claim a significant slice of their Social Security cost-of-living adjustment, or COLA. It works out to nearly 20% of the average retired worker’s COLA of $20 a month next year.”

About healthcare IT

Pear Therapeutics Announces Publication of Real-World Data Demonstrating Impact of reSET-O for Patients with Opioid Use Disorder: “Data from more than 3000 patients prescribed and using reSET-O across the U.S. supports high real-world engagement and a positive association between product use and outcomes of reduced illicit opioid use and retention in treatment.”
reSET-O is an FDA-approved app that is used with buprenorphine.

Digital stethoscope maker Eko nets $65M to develop home telehealth offerings: “The company’s Duo stethoscope captures both heart sounds and electrocardiogram readings, and is connected to an AI program that received an FDA clearance at the top of this year to detect the signs of atrial fibrillation and heart murmurs.”

Today's News and Commentary

About health insurance
Medicaid Expansion and Mortality Among Patients With Breast, Lung, and Colorectal Cancer: “Among patients with newly diagnosed breast, colorectal, and lung cancer, Medicaid expansion was associated with a decreased hazard of mortality in the postexpansion period, which was mediated by earlier stage of diagnosis.”

Nashville school district leader overhauls maternity benefit pricing:Vanderbilt University and Nashville teachers created “MyMaternityHealth — a maternity benefit that bundles all costs associated with pregnancy and delivery into one price for employers. The price is adjusted based on whether the individual pregnancy is low, medium or high-risk. By eliminating out of pocket costs, employees save approximately $2,500 each time they have a baby.”

A New Item on Your Medical Bill: The ‘Covid’ Fee: “The coronavirus pandemic has made the practice of health care more costly as providers must wear protective gear and sanitize equipment more often, even as they face declining revenue. Two groups of providers have been particularly hard hit. Dentists have lost billions since patients began postponing nonurgent dental care this spring. And assisted living facilities, grappling with lower overall demand, have also been forced to admit fewer residents to help stop the spread of infection
To address this financial shortfall, some health providers are turning directly to patients. Surprise ‘Covid’ and ‘PPE’ fees have turned up across the country, in bills examined by The New York Times.”

Trends in Birth Rates After Elimination of Cost Sharing for Contraception by the Patient Protection and Affordable Care Act: “In this cross-sectional study, the elimination of cost sharing for contraception under the ACA was associated with improvements in contraceptive method prescription fills and a decrease in births among commercially insured women. Women with low income had more precipitous decreases than women with higher income, suggesting that enhanced access to contraception may address well-documented income-related disparities in unintended birth rates.”

About the public’s health

More state officials announce restrictions as US tops 100,000 new Covid-19 infections for second day in a row: The headline speaks for itself as the number of national cases continues to grow.

CDC seeks input on proposal to centralize COVID-19 laboratory test reporting:”The Centers for Disease Control and Prevention would like to partner with one or more organizations to enable centralized reporting from COVID-19 testing entities to public health departments, the agency said this week in a request for information.”

World Health Assembly charts course for COVID-19 response and global health priorities: The headline speaks for itself.

Prothrombotic autoantibodies in serum from patients hospitalized with COVID-19: “Patients with COVID-19 are at high risk for thrombotic arterial and venous occlusions. Lung histopathology often reveals fibrin-based occlusions in the small blood vessels of patients who succumb to the disease…
These findings suggest that half of patients hospitalized with COVID-19 become at least transiently positive for aPL [Antiphospholipid] antibodies and that these autoantibodies are potentially pathogenic.”

Distinct antibody responses to SARS-CoV-2 in children and adults across the COVID-19 clinical spectrum: Children and adults develop different antibody patterns if infected with SARS-CoV-2. More specifically, this research suggests “a distinct infection course and immune response in children independent of whether they develop MIS-C [multisystem inflammatory syndrome]…” This finding has “implications for developing age-targeted strategies for testing and protecting the population.”

First COVID-19 Vaccine Doses To Go To Health Workers, Say CDC Advisers: “Health care workers will almost certainly get the first doses of COVID-19 vaccine in the U.S. when one is approved, according to Dr. José Romero, head of the committee that develops evidence-based immunization guidelines for the Centers for Disease Control and Prevention.”

About hospitals and health systems

19 hospitals with strong finances: While this article is FYI, note that six of the nineteen are children’s hospitals.

About pharma

Some financial results from pharma companies:
BMS bumps up full-year profit estimate as Q3 sales surge 75%;
Teva posts wider loss in Q3 after $4.6-billion impairment charge;
Eisai's sales gain, profit slips in second quarter

Controversial Alzheimer’s drug gets boost from FDA staff: “A [Biogen] drug that would be the first new treatment for Alzheimer’s disease in nearly two decades received a vote of confidence Wednesday from Food and Drug Administration clinical reviewers, who said ‘exceptionally persuasive’ data showed the drug slowed cognitive decline caused by the devastating ailment.”

Antirheumatic metallodrug can resurrect 'last resort' antibiotics to kill multi-drug resistant superbugs: “A research team from Hong Kong University discovered “that by repurposing an antirheumatic gold drug, auranofin (AUR), ‘last-resort’ antibiotics can be resensitized for treatment of infections caused by multidrug-resistant superbugs including bloodstream infections, pneumonia and wound infections.
The findings provide insights into development of inorganic pharmaceutics and new therapeutic approach for superbug infections.”
This finding, if reproduced, could have a significant impact on the growing problem of drug resistant infections.

A decision algorithm to promote outpatient antimicrobial stewardship for uncomplicated urinary tract infection: ”Kanjilal et al. applied a machine learning approach calibrated to local hospital electronic health record data to predict the probability of resistance to first- and second-line antibiotic therapies for uncomplicated UTI. The algorithm then recommended the least broad-spectrum antibiotic to which a given isolate was predicted nonresistant. Use of the pipeline reduced both broad-spectrum and ineffective antibiotic prescription for UTI in the patient cohort relative to clinicians, suggesting the clinical potential of the approach.”
The frequency of urinary tract infections has caused an increase in drug resistance. This successful use of an algorithm for treatment decision-making may alleviate that problem and lower cost.

About healthcare IT

FCC’S Connected Care Pilot Program Application Window to Open on November 6: Public Notice Outlines Application Submission Process and Eligible Services: “The Connected Care Pilot Program is open to nonprofit and public eligible health care providers, located anywhere in the country. Specifically, the Pilot Program will use Universal Service Fund monies to help defray the costs of connected care services for eligible health care providers, providing support for 85% of the cost of eligible services and network equipment, which include: (1) patient broadband Internet access services; (2) health care provider broadband data connections; (3) other connected care information services; and (4) certain network equipment. The Pilot Program will not provide funding for end-user devices.”

About supply chains

Vizient to Acquire Intalere, Expanding its Supply Chain Capabilities: Vizient announced “that it has signed an agreement under which it will acquire Intalere from Intermountain Healthcare, enhancing itself as a leader in the health care supply chain. Intermountain Healthcare will now partner with Vizient for supply chain solutions and services, thereby expanding their current relationship with Vizient in clinical and cost analytics.”

AAFP [ American Academy of Family Practice], Other Groups Decry DEA Telemedicine Rule-making Delay: More than “80 health care professional, insurer, behavioral health and telehealth provider groups ― including the AAFP ― recently sent to the Drug Enforcement Administration, calling for the agency to ‘expedite and complete its efforts to implement a telemedicine special registration process enabling providers to safely prescribe controlled substances remotely.’
In the Oct. 26 missive to DEA Acting Administrator Timothy Shea, the organizations urge that the special registration process outlined in a provision of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 be finalized so physicians and other qualified health care professionals can use telemedicine to prescribe certain medications to treat substance use disorders.”

Today's News and Commentary

About the public’s health
Rich Countries Reserve Billions Of Covid-19 Vaccine Doses Even Before There Is One: “Currently there are nearly 200 Covid-19 candidates that are moving forward through the development and clinical trials processes, and over ten candidates are already in Phase-3 large-scale trials, the analysis found. The confirmed purchases from countries cover nearly four billion doses of vaccines, with another five billion doses under negotiation. 
There will not be enough vaccine to cover the world’s population until 2024, according to current models taking into account the manufacturing capacity.”

The US just reported more than 100,000 new Covid-19 infections, the most cases in a single day since pandemic's start: The headline speaks for itself.

More than a million Americans live without indoor plumbing — and most of them live in big cities: “An estimated 471,000 households or 1.1 million individuals lack connection to piped water, according to a recent study.
Researchers also revealed racial disparities in access to water in urban areas across the United States.”

Cigna says health utilization continued to rebound in Q3: “Cigna, which posted a $1.39 billion profit in the third quarter, said that healthcare use remains slightly below average when not taking into account costs for COVID-19. The insurer's performance in the quarter was bolstered by its newly rebranded Evernorth subsidiary.  
Cigna executives said that utilization was 95% below [I think they meant 95% of normal levels]normal levels without factoring COVID-19 costs.”

About pharma

Merck to Acquire VelosBio: “Merck… and VelosBio Inc. today announced that the companies have entered into a definitive agreement pursuant to which Merck, through a subsidiary, will acquire all outstanding shares of VelosBio for $2.75 billion in cash, subject to certain customary adjustments. VelosBio is a privately held clinical-stage biopharmaceutical company committed to developing first-in-class cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1).”

About healthcare markets

Health care still loves a divided Congress: “Health care stocks skyrocketed after Tuesday's election results indicated Republicans likely will maintain control of the Senate, all but assuring continued gridlock in both chambers of Congress…
The winners: Health insurance companies, pharmaceutical companies and medical device firms scored the biggest stock gains.”

About healthcare IT

The 146 telehealth services Medicare is covering during the pandemic: “CMS since March has expanded the number of services Medicare will cover when provided via telehealth to help support access to healthcare during the COVID-19 pandemic.”

About healthcare professionals

Assessment of Changes in Rural and Urban Primary Care Workforce in the United States From 2009 to 2017: “In this study, the density of primary care clinicians increased overall, yet rural-urban disparities in the primary care workforce are increasing in the US.”

About health insurance

UnitedHealth ordered to reprocess 67,000 mental health claims:”UnitedHealth Group must redo 67,000 medical claims for behavioral healthcare that it previously denied, a federal judge ordered Nov. 4. 
The order comes after a March 2019 ruling from Judge Joseph Spero of the U.S. District Court of Northern California. He ruled that a UnitedHealth unit instituted guidelines that denied care to patients needing mental health treatment to cut costs.”

Today's News and Commentary

About the public’s health
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers: “The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2.” This FDA notice contains recommendations for minimizing this problem.

These are the top coronavirus vaccines to watch: This article is a really good summary by The Washington Post. Ten are in Phase III testing.

Pfizer to bypass gov't, use its own network to ship COVID-19 vaccine: “The pharma company will seek to ensure ‘end-to-end visibility and control’ in its distribution of millions of doses of its vaccine, once it's approved for use in the United States, according to Pfizer Vice President for Biopharma Global Supply Chain Tanya Alcorn.
Alcorn said rather than tap healthcare logistics provider McKesson, as recommended by federal regulators, the serious challenges involved in doling out a vaccine requires Pfizer to keep tight control of distribution.”

Special Diets Among Adults: United States, 2015–2018: From the CDC:
”Data from the National Health and Nutrition Examination Survey

• In 2015–2018, 17.1% of U.S. adults aged 20 and over were on a special diet on a given day.

• More women were on a special diet than men, and more adults aged 40–59 and 60 and over were on a special diet than adults aged 20–39.

• More non-Hispanic white adults (17.8%) were on a special diet than non-Hispanic black (14.7%) and non-Hispanic Asian (14.9%) adults.

• The most common type of special diet reported among all adults was a weight loss or low-calorie diet.

• From 2007–2008 through 2017–2018, the percentage of adults on any special diet, weight loss or low-calorie diets, and low carbohydrate diets increased, while the percentage of adults on low-fat or low-cholesterol diets decreased.”

Climate change: US formally withdraws from Paris agreement: “After a three-year delay, the US has become the first nation in the world to formally withdraw from the Paris climate agreement.
President Trump announced the move in June 2017, but UN regulations meant that his decision only takes effect today, the day after the US election.
The US could re-join it in future, should a president choose to do so.”

California dialysis measure fails, mixed results for tobacco taxes in state-level ballot measures: Here are some health-related ballot decisions from yesterday’s state election proposals.

About healthcare IT

2020-2025 Federal Health IT Strategic Plan: This document is a detailed outline of the mission, vision and goals for the Office of the National Coordinator for the next five years.

Pediatrician Electronic Health Record Time Use for Outpatient Encounters: “Pediatric physicians spent an average of 16 minutes per encounter using their EHR. Chart review (31%), documentation (31%), and ordering (13%) functions accounted for most of the time. The distribution of time spent by providers using their EHR is highly variable within subspecialty but is similar across specialties.”

Interview with current Administrator of The Centers for Medicare & Medicaid Services on how the pandemic bolstered digital health use: Among the key points is: “Before the pandemic, 14,000 Medicare beneficiaries used telehealth weekly—but from mid-March to early-July, over 10 million beneficiaries received care via telehealth.”

About health insurance

New York ER docs sue UnitedHealth for alleged underpayments: The story is state-specific but the issue has been in the news around the country.

The feds paid $1.5B to states to cover uninsured COVID-19 costs. These states got the most: “The federal government has paid out $1.5 billion to cover the testing and treatment of uninsured COVID-19 patients, and states with high uninsured rates are getting the most dollars…
The state with the highest COVID-19 reimbursement per person was New Jersey with $586 per case.”

DC Circ. Judge Dubious Of Medicare Overpayment Rule Fight:  “ A D. C. Circuit judge didn't seem swayed Tuesday by UnitedHealthcare Insurance Co. 's push to affirm a lower court order vacating a Medicare Advantage overpayment rule with multibillion-dollar implications for reimbursement as she pressed an attorney for the country's largest seller of private Medicare policies to explain why the rule is unlawful.”

Centers for Medicare and Medicaid Services announces 51 direct contracting entities:”Direct contracting is the next CMMI model and is based on Next Generation, Medicare Shared Savings and Medicare Advantage plans…
The 51 direct contracting entities serve beneficiaries in 39 states as well as in the District of Columbia and Puerto Rico.”

About pharma
McKesson Indicates Opioid Settlement Could Reach $21 Billion: “McKesson and two other U.S. drug distributors could pay an estimated $21 billion to resolve thousands of state lawsuits over their alleged role in fueling the opioid addiction epidemic, according to McKesson’s latest quarterly report.”

About medical devices

FTC OKs Stryker's $4B Wright Medical Deal, With Divestitures “The Federal Trade Commission is requiring medical device company Stryker Corp. to divest all its ankle replacement and finger joint implant products before going forward with its slated $4 billion acquisition of rival Wright Medical Group NV, the agency said Tuesday, in an effort to quell antitrust concerns stemming from the proposed merger. The FTC said Stryker will have to divest its ankle and finger joint businesses to DJO Global Inc. and give the company transition assistance so it can become an ‘independent, viable, and effective competitor’ in those markets.”

About healthcare professionals

Association Between Industry Payments to Physicians and Device Selection in ICD Implantation: “Patients were more likely to receive ICD or CRT-D [implantable cardioverter-defibrillator or cardiac resynchronization therapy-defibrillator, respectively] from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually.”

Trends in Industry Payments to Physicians in the United States From 2014 to 2018: “Open Payments, a federal transparency program reporting industry-physician financial relationships since 2013, was established out of concern for undue industry influence on health care decision-making and costs…
Annual payment values decreased for physicians receiving lower-value total payments (≤$50 000), potentially due to transparency, organizational restrictions on industry interactions, or decreased direct-to-physician marketing.Physicians receiving higher-value total payments (>$50 000) continued to receive similar or greater amounts, perhaps reflecting evolving industry strategy that concentrates payments, for which greater return on investment is anticipated.”

Today's News and Commentary

About the public’s health

Cases of Covid-19 in children on rise, with highest 1-week spike yet: ”There were 61,000 new cases in children during the last week of October, ‘which is larger than any previous week in the pandemic,’ the AAP [American Academy of Pediatrics] said in a statement. From the onset of the pandemic through October 29, more than 853,000 children have tested positive for Covid-19, the AAP said, including nearly 200,000 new cases during the month of October…
(E)arly research has suggested children may not get fever, cough or shortness of breath as often as adults. Fever and cough was found in 56% and 54% of children in one study, compared to 71% and 80% of adults, according to the CDC. Shortness of breath was found in only 13% of pediatric patients, compared to 43% of adults. Sore throat, headache, muscle pain, fatigue and diarrhea were also less commonly reported in children.”

Top Trump adviser bluntly contradicts president on covid-19 threat, urging all-out response: “‘We are entering the most concerning and most deadly phase of this pandemic … leading to increasing mortality,’ said the Nov. 2 report from Deborah Birx, coordinator of the White House coronavirus task force. ‘This is not about lockdowns — it hasn’t been about lockdowns since March or April. It’s about an aggressive balanced approach that is not being implemented.’
Birx’s internal report, shared with top White House and agency officials, contradicts Trump on numerous points…”

A Health Opportunity Cost Threshold for Cost-Effectiveness Analysis in the United States: “Cost-effectiveness analysis is an important tool for informing treatment coverage and pricing decisions, yet no consensus exists about what threshold for the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life-year (QALY) gained indicates whether treatments are likely to be cost-effective in the United States…
Given available evidence, there is about 14% probability that the threshold exceeds $150 000 per QALY and about 48% probability that it lies below $100 000 per QALY…
Given current evidence, treatments with ICERs above the range $100 000 to $150 000 per QALY are unlikely to be cost-effective in the United States.”

Health agencies resist Trump civil service executive order: “President Donald Trump’s executive order making it easier to fire federal employees is meeting fierce resistance within the Food and Drug Administration, amid fears the White House is planning a purge of senior health officials it views as disloyal.
The order — which Trump issued on Oct. 21 — would strip certain civil service and due process protections from career federal employees who make policy.
FDA officials see it as laying the groundwork for an across-the-board effort to replace longtime career scientists with political allies in a second Trump term.”

HHS Appeals LGBTQ-Friendly Decision in Obamacare Regulation Row: “The Health and Human Services Department is appealing a September federal district court decision barring it from enforcing a rule that would allow certain religious organizations to discriminate against LGBTQ people in connection with health care.
The agency filed its notice of appeal Oct. 31 in a case brought by Whitman-Walker Clinic Inc., health-care providers, and advocates for LGBTQ people. The plaintiffs challenged HHS’s rewrite of a rule implementing the Affordable Care Act’s anti-discrimination provision, Section 1557.”

About health insurance

Georgia’s latest 1332 proposal continues to violate the ACA: This article from USC-Brookings is an excellent analysis of the Georgia ACA waiver reported yesterday.

Geographic Variation In Medicare Per Capita Spending Narrowed From 2007 To 2017: “The difference in Medicare price- and risk-adjusted per capita spending between hospital referral regions (HRRs) in the top decile and those in the bottom decile decreased from $3,388 in 2007 to $2,916 in 2017—a reduction of $472, or 14 percent. The spending convergence occurred almost entirely between 2009 and 2014, during the early years of the Affordable Care Act (ACA). The highest-spending HRRs in 2007 had the lowest annual growth rates from 2007 to 2017, and the lowest-spending HRRs in 2007 had the highest annual growth rates. We also found that a greater supply of postacute care providers, especially hospice providers, significantly predicted lower spending growth across HRRs after the implementation of the ACA.”

California health system pays $31.5M to settle drug overbilling case: “From December 2016 to May 2019, Memorial Health Services submitted claims to Medi-Cal for outpatient prescription drug reimbursements that were higher than the actual cost the system paid for the drugs. The health system disclosed the overcharges to the Office of the Inspector General in October 2019.
…FY 2020 EPS guidance, now anticipating GAAP EPS to be in a range of $24.70 to $24.95and Adjusted EPS in a range of $18.50 to $18.75.
FY 2020 EPS guidance reflects fourth quarter 2020 losses of approximately $2.55 per share on a GAAP basis, approximately $2.40 per share on an Adjusted basis.
As previously noted, Humana anticipates fourth quarter losses to reflect the continued support for its constituents, along with the impact of increasing utilization, and COVID-19 testing and treatment costs
Increases full year expected individual Medicare Advantage membership growth to approximately 375,000 members from the previous range of 330,000 to 360,000 members, representing expected year-over-year growth of approximately 10 percent.”

Today's News and Commentary

Philip R. Lee, MD passed away at age 96. He was a giant in the field of healthcare public policy. Here is a fitting tribute to his career: UCSF Remembers Philip Lee, Former Chancellor and Health Care Reformer Who Served 2 US Presidents

About health insurance
2022 Medicare Advantage and Part D Advance Notice Part II: On Friday, CMS “released Part II of the Calendar Year (CY) 2022 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS released Part I of the CY 2022 Advance Notice on September 14, 2020. CMS will accept comments on both parts of the CY 2022 Advance Notice through Friday, November 30, 2020, before publishing the final Rate Announcement by April 5, 2021.” Medicare Advantage (MA) and Part D payments are expected to increase by 2.82% in 2022.

‘Obamacare’ sign-ups begin as millions more are uninsured: Open enrollment started yesterday and lasts until December 15.

BCBS Insurers Reach $2.67B Antitrust Deal In Alabama: “The nation's Blue Cross Blue Shield insurers tentatively agreed late Friday to a $2.67 billion class settlement fund and sweeping anti-competitive practice reforms to settle a long-running multi-district suit based in Alabama federal court that was filed by dozens of subscriber groups. A memorandum in support of the deal filed by attorneys for subscribers in the Northern District of Alabama described the deal as ‘historic,’ with far-reaching competitive benefits."

HHS grants Georgia a waiver to bypass the ACA: The previously reported application has been approved for the period January 1, 2022 through December 31, 2026. A summary is on page 5 of the document. It is yet unclear, but likely, that a Biden win will overturn this type of waiver.

Medicare Fines Half of Hospitals for Readmitting Too Many Patients:”The penalties are the ninth annual round of the Hospital Readmissions Reduction Program created as part of the Affordable Care Act’s broader effort to improve quality and lower costs. The latest penalties are calculated using each hospital case history between July 2016 and June 2019, so the flood of coronavirus patients that have swamped hospitals this year were not included.”

About the public’s health

Study links Trump rallies to more than 700 Covid deaths: “President Donald Trump's campaign rallies between June and September may have caused some 30,000 coronavirus infections and more than 700 deaths, according to a new study by Stanford University economists.”

The Latest: Trump says he may fire disease specialist Fauci: “President Donald Trump is suggesting that he will fire the nation’s top infectious disease expert after Tuesday’s election, as he expresses frustration that the coronavirus remains in the news amid a nationwide spike of COVID-19.”

Transmission of SARS-COV-2 Infections in Households — Tennessee and Wisconsin, April–September 2020: From the CDC: “Findings from a prospective household study with intensive daily observation for ≥7 consecutive days indicates that transmission of SARS-CoV-2 among household members was frequent from either children or adults.
Household transmission of SARS-CoV-2 is common and occurs early after illness onset. Persons should self-isolate immediately at the onset of COVID-like symptoms, at the time of testing as a result of a high risk exposure, or at time of a positive test result, whichever comes first. All household members, including the index case, should wear masks within shared spaces in the household.”

THE SCIENCE OF SUPERSPREADING: The article is a great explanation (with helpful graphics) of how superspreading works.

The Challenges of Contact Tracing as U.S. Battles COVID-19: This study from the Pew Research Center highlights why contact tracing is difficult— about 40% of respondents would be not at all/not too likely to speak with a public health official about the corona virus outbreak if they were contacted by phone, text or in person.

Gloves in demand for hospitals facing shortages due to COVID-19: Premier: “A survey of 905 hospitals that are members of Premier found 40% are having a shortage of nitrile exam gloves.
The survey found that 28% face a N95 mask shortage, and another 10% need more gowns.”

5th Circ. To Rehear Planned Parenthood Texas Abortion Suit: “The Fifth Circuit agreed on Friday to rehear en banc Whole Woman's Health and multiple Planned Parenthood affiliates' suit challenging a 2017 Texas statute that limits physicians performing second-trimester abortions, vacating a divided panel's opinion finding the law violates the 14th Amendment by overburdening women. A majority of the Fifth Circuit judges voted in favor — on the court's own motion — to rehear the case en banc…”

FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order:”As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency. A recent executive order directed the agency, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.”
Here is a list of those items.

About pharma
FTC nod clears way for merger between Pfizer's Upjohn unit, Mylan: In order to overcome antitrust concerns, the FTC said that “it is requiring that the rights and assets related to Upjohn's amlodipine besylate/atorvastatin, phenytoin, prazosin, spironolactone, gatifloxacin and medroxyprogesterone be divested to Prasco. The parties must also divest the rights and assets related to Mylan's eplerenone. In addition, the proposed order also requires prior FTC approval before Pfizer, Mylan or Viatris [the new company’s name] may gain an interest in, or exercise control over, any third party's rights to levothyroxine, sucralfate and varenicline.
The regulator noted that the divested generic drugs will continue to be manufactured by Upjohn and Mylan's current suppliers, reducing the risk of any supply interruptions…”

Novartis changes its position of 340B drugs: The company will still provide discounted drugs to contract pharmacies, but only if those facilities are within 40 miles of the 340B hospital’s location.

About healthcare IT

Teladoc Health Completes Merger with Livongo: The merger was completed within 3 months.

Nearly 700,000 health records breached in October: “In October, 35 organizations reported to HHS a total of 692,490 individuals being affected by data breaches.” Check the article for a summary. Wonder why people do not trust healthcare systems to keep their data private? However…

More than half of Americans would use virtual care, UnitedHealth Group survey finds: “According to UnitedHealth Group's fifth annual UnitedHealthcare Consumer Sentiment Survey, which examines Americans’ opinions about multiple areas of healthcare, a survey-record 56% said it is likely they would use virtual care for medical services.”

Today's News and Commentary

About healthcare professionals

2020 Physician Compensation Report: Overall, huge differences still persist between cognitive and procedural specialties. Lots of details in this study worth considering.

About hospitals and healthcare systems

Universal Health Services, Inc. Reports 2020 Third Quarter Financial Results: “Universal Health Services, Inc. announced today that its reported net income attributable to UHS was $241.3 million, or $2.82 per diluted share, during the third quarter of 2020, as compared to $97.2 million, or $1.10 per diluted share, during the comparable quarter of 2019. Net revenues increased 3.2% to $2.913 billion during the third quarter of 2020 as compared to $2.822 billion during the third quarter of 2019.”

Hospital Bankruptcy Surge Looms as Virus Rages, Stimulus Lapses: Despite the above story: “Even before the Covid-19 pandemic, providers were pushed to their breaking points, especially those in rural areas. At least 30 hospitals entered bankruptcy in 2019, and at least three dozen have done the same so far this year, according to data compiled by Bloomberg.”

Ascension expands pharmacy services: This move continues a trend of hospitals into this sector.
”Ascension Rx—the newly launched model for its nationwide pharmacy—presents specialty treatment packaging and supply, infusion remedy and medicine administration, together with monetary assist coordination. A brand new specialty pharmacy in Austin, Texas is slated to open subsequent spring, which can present prior authorization, treatment administration help for suppliers and affected person consults with scientific pharmacists, amongst different wraparound providers. 
Ascension, which has greater than 140 hospitals throughout 19 states, can be engaged on a centralized nationwide mail order pharmacy service, executives mentioned.”

About the public’s health
Internal Documents Reveal COVID-19 Hospitalization Data The Government Keeps Hidden: “NPR has obtained documents that give a snapshot of data the U.S. Department of Health and Human Services collects and analyzes daily. The documents — reports sent to agency staffers — highlight trends in hospitalizations and pinpoint cities nearing full hospital capacity and facilities under stress. They paint a granular picture of the strain on hospitals across the country that could help local citizens decide when to take extra precautions against COVID-19.
Withholding this information from the public and the research community is a missed opportunity to help prevent outbreaks and even save lives, say public health and data experts who reviewed the documents for NPR.”

Flu vaccine may lower risk for severe COVID-19, study suggests: “People who received the flu vaccine in the year before testing positive for COVID-19 are nearly 2 1/2 times less likely to be hospitalized with a severe form of the disease than those who were not vaccinated, an analysis published Wednesday by the Journal of the American Board of Family Medicine found.
In addition, those vaccinated against the flu within a year of being diagnosed with COVID-19 were more than three times less likely to be admitted to an intensive care unit because of the new coronavirus, according to researchers at the University of Florida.”

Fauci says first U.S. COVID-19 vaccines could ship late December or early January: “Based on current projections from vaccine front-runners Moderna Inc and Pfizer Inc, Americans will likely know ‘sometime in December whether or not we have a safe and effective vaccine,’ Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a live chat on Twitter and Facebook.”

Death Rates Have Dropped for Seriously Ill Covid Patients:”…as the virus continued its rampage over the summer and fall, infecting nearly 8.5 million Americans, survival rates, even of seriously ill patients, appeared to be improving. At one New York hospital system where 30 percent of coronavirus patients died in March, the death rate had dropped to 3 percent by the end of June.
Doctors in England observed a similar trend.”

Vaccine Makers Can Skip U.S. Inspections: “FDA regulations don’t require what’s known as a pre-approval inspection for products seeking emergency use, said Jerry Weir, director of the Division of Viral Products in the FDA’s vaccines office. Weir spoke last week at a meeting of FDA advisers to discuss standards for Covid-19 vaccines…
FDA’s Weir said vaccine developers seeking an emergency authorization will have to submit complete details of their manufacturing process and show they’ve established a quality control unit.”
Some vaccines are being manufactured by newer companies without extensive manufacturing experience, like Moderna. Also, some newer techniques are being used for vaccines, such as RNA-based antigens. The last thing we want is for the public to lose confidence in vaccines from lack of quality oversight. See a related article: Sanofi, SK flu shots halted in Singapore as South Korea post-vaccination deaths climb to 59: “Singapore has temporarily pulled its backing for SK Bioscience’s SKYCellflu Quadrivalent and Sanofi Pasteur’s VaxigripTetra, the Ministry of Health said Sunday. Among the seven brands administered to people who died in South Korea, these two are the only ones also available in Singapore…
As of Monday, at least 59 people, mostly in their 70s and 80s, have died in South Korea following flu vaccination, up from 46 Saturday. That’s among more than 14.7 million people who have been inoculated this season.”

Vaccine bond sale raises $500m to fund immunisation programmes: “The money was raised for Gavi, the UN-backed vaccines alliance, by a financing vehicle, the International Finance Facility for Immunisation. The deal on Thursday attracted more than $1.5bn of orders for the three-year debt, and offered investors a yield of 0.44 per cent.”

Unions Sue OSHA For Rule Protecting Health Care Workers:”A coalition of nurses' and teachers' unions asked the Ninth Circuit on Thursday to make the U.S. Department of Labor move forward with a long-delayed rule to protect health care workers from infectious diseases as U.S. coronavirus cases surge.
The DOL's Occupational Safety and Health Administration bungled its obligation to protect health care workers from workplace hazards by failing to issue a rule after more than a decade of uneven development, the unions said in their petition for a writ of mandamus to the Ninth Circuit.”

Survey: Majority of U.S. Adults Concerned About Medical Bankruptcy, Debt:”56% of U.S. adults said they were either somewhat or very concerned that a health situation in their household could lead to bankruptcy or debt. 28% of U.S. adults carry medical debt. 32% of U.S. adults have $500 or less in savings for medical bills…
Of those who reported having medical debt, 65% had debts exceeding $1,000.”

BCBS of Illinois to pay hospitals $100M to improve health equity: “The program's first priority is to support hospitals with the highest concentration of BCBSIL members who are at risk of contracting COVID-19. Hospitals that join the equity program must commit to reducing health disparities for BCBSIL patients over the next three years. BCBSIL said it will add to and replace existing bonus structures with the new program, and about $100 million in funding will go to hospitals that participate in the program.”

About healthcare IT

Artificial intelligence model detects asymptomatic Covid-19 infections through cellphone-recorded coughs:”In a paper published recently in the IEEE Journal of Engineering in Medicine and Biology, the team reports on an AI model that distinguishes asymptomatic people from healthy individuals through forced-cough recordings, which people voluntarily submitted through web browsers and devices such as cellphones and laptops.”

Early results from DETECT study suggest fitness trackers and smartwatches can predict COVID-19 infection: “Examining data from the first six weeks of their landmark DETECT study, a team of scientists from the Scripps Research Translational Institute sees encouraging signs that wearable fitness devices can improve public health efforts to control COVID-19.
The DETECT study, launched on March 25, uses a mobile app to collect smartwatch and activity tracker data from consenting participants, and also gathers their self-reported symptoms and diagnostic test results. Any adult living in the United States is eligible to participate in the study by downloading the research app, MyDataHelps.”

CMS Finalizes Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit: Of significance is the permanence of coverage for telehealth. “Home health agencies (HHAs) can utilize telecommunications technologies in providing care to beneficiaries under the Medicare home health benefit, as long as any provision of remote patient monitoring or other services furnished via a telecommunications system or audio-only technology are included on the plan of care. The use of such telecommunications technology or audio-only technology must be tied to the patient-specific needs as identified in the comprehensive assessment. CMS will not require a description of how such technology will help to achieve the goals outlined on the plan of care; rather, documentation in the medical record should explain how such services will help facilitate treatment outcomes.”

Allscripts Announces Third Quarter 2020 Results: “GAAP net income in the third quarter of 2020 totaled $1 million compared with net loss of $6 million in the third quarter of 2019. Non-GAAP net income in the third quarter of 2020 was $33 million compared with $28 million in the third quarter of 2019.
GAAP earnings per share in the third quarter of 2020 was $0.00 compared with loss per share of $0.03 in the third quarter of 2019. Non-GAAP diluted earnings per share in the third quarter of 2020 were $0.20 compared with $0.17 in the third quarter of 2019.” Revenue decreased 9.5% compared to the same period last year.

CERNER REPORTS THIRD QUARTER 2020 RESULTS IN LINE WITH COMPANY EXPECTATIONS: “On a U.S. Generally Accepted Accounting Principles (GAAP) basis, third quarter 2020 net earnings were $357 million and diluted earnings per share were $1.16. Third quarter 2019 GAAP net earnings were $82 million and diluted earnings per share were $0.26.
Adjusted Net Earnings for third quarter 2020 were $222 million, compared to $212 million of Adjusted Net Earnings in the third quarter of 2019. Adjusted Diluted Earnings Per Share were $0.72 in the third quarter of 2020, in line with the Company’s expectations and up 9 percent compared to $0.66 of Adjusted Diluted Earnings Per Share in the year-ago quarter.” Revenue fell 3% from the same period last year.

About pharma
REGN-COV2 INDEPENDENT DATA MONITORING COMMITTEE [IDMC]RECOMMENDS HOLDING ENROLLMENT IN HOSPITALIZED PATIENTS WITH HIGH OXYGEN REQUIREMENTS AND CONTINUING ENROLLMENT IN PATIENTS WITH LOW OR NO OXYGEN REQUIREMENTS: “…based on a potential safety signal and an unfavorable risk/benefit profile at this time, the IDMC recommends further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data on patients already enrolled. The IDMC also recommends continuing enrollment of hospitalized patients requiring either no or low-flow oxygen as the risk/benefit remains acceptable in these cohorts. Finally, the IDMC recommends continuation of the outpatient trial without modification.”

Moderna gearing up for COVID-19 vaccine launch as it takes in $1.1 billion in supply deposits:The headline speaks for itself.

About health care technology

Medtronic to pay over $9M to settle false claims suit:”Medtronic has agreed to pay a total of more than $9 million dollars to settle allegations that it paid kickbacks to a South Dakota neurosurgeon, federal prosecutors announced today.
The Minnesota-based medical devicemaker is accused of violating the False Claims Act and failing to accurately report to CMS payments it made to Dr. Wilson Asfora, allegedly to induce him to use one of its implantable devices. Medtronic also allegedly held more than 100 events over a nine-year period at a restaurant owned by Asfora.”

Today's News and Commentary

About healthcare professionals
Physician survey details depth of pandemic’s financial impact:”The average number of in-person visits to physician offices fell from 97 per week to 57, according to the survey of 3,500 physicians who provided at least 20 hours of patient care a week prior to the pandemic.
Physicians averaged a 32% drop in revenue since February, the AMA survey shows. About one in five doctors saw revenue drop by 50% or more, while nearly one-third saw declines of between 25% and 49%. Only 19% of physicians reported no drop in revenue.”

About healthcare IT

HHS extends interoperability rule deadlines: 10 key compliance dates: This short summary has key compliance dates, starting April 5, 2021 with information blocking provisions.

Medical Device Security Stymied by Legacy Tech, Flawed Segmentation: An interesting article that explains how a large number of medical devices connected to non-secure, legacy programs at hospitals poses a great hacking threat.

FBI warns ransomware assault threatens US healthcare system: “In a joint alert Wednesday, the FBI and two federal agencies warned that they had “credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers.” The alert said malicious groups are targeting the sector with attacks that produce “data theft and disruption of healthcare services.”
The cyberattacks involve ransomware, which scrambles data into gibberish that can only be unlocked with software keys provided once targets pay up. Independent security experts say it has already hobbled at least five U.S. hospitals this week, and could potentially impact hundreds more.”

With pending Livongo deal, Teladoc's virtual care business is booming:”Teladoc continues to see surging demand for its virtual care services even as the use of telehealth across the country has slowly declined from hitting peaks in April.
Teladoc, one of the nation's top telehealth providers, reported 2.8 million total virtual visits during the third quarter, up 206% from 928,000 visits in the third quarter of 2019.
Total telehealth visits in 2020 have jumped 163% from 2.9 million visits during the first nine months of 2019 to 7.6 million visits this year.”

About the public’s health

COVID-19 Trends in Tennessee: Summer turns to Fall: This Vanderbilt study provides yet another reason to wear masks: “Hospitals that predominantly serve patients from areas without masking requirements… continue to see the highest rate of growth in hospitalizations. As the percentage of patients residing in mask-requirement counties increases, the growth curve ‘flattens,’ indicating much lower growth in hospitalizations.”

White House could have traced and contained its covid-19 outbreak. It chose not to.: With regard to the Rose Garden ceremony celebrating the nomination of Amy Coney Barrett: “Officials say the White House called off early efforts to get to the bottom of the outbreak, including sequencing the genomes of virus samples from infected individuals. This genetic analysis could have revealed shared mutations that linked cases in Washington and other affected communities.”

Random effects key to containing epidemics: “…scientists have discovered, using mathematics and computer simulations, why dividing a large population into multiple subpopulations that do not intermix can help contain outbreaks without imposing contact restrictions within those local communities….
The main reason subdividing the population works is because the epidemic is completely extinguished in a significant fraction of the subgroups. This "extinction effect" occurs when infection chains spontaneously terminate.
Another way subdividing works is by desynchronizing the full population. Even if outbreaks occur in the smaller communities, the peaks may come at different times and cannot synchronize and add up to a large number.”

About pharma

REGENERON'S COVID-19 OUTPATIENT TRIAL PROSPECTIVELY DEMONSTRATES THAT REGN-COV2 ANTIBODY COCKTAIL SIGNIFICANTLY REDUCED VIRUS LEVELS AND NEED FOR FURTHER MEDICAL ATTENTION: The company announced that data on “ an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Regeneron has shared these results with the U.S. FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes.”

Eli Lilly still confident in benefits of Covid antibody treatment despite end to hospital study: “Eli Lilly’s coronavirus antibody treatment can still be beneficial to Covid-19 patients, despite the recent end to a government-run study, CEO Dave Ricks told CNBC.
Ricks said the antibody treatment appears to be more effective in people who are earlier in their diagnoses. The stopped study looked at hospitalized patients.
’It’s disappointing, of course. We would have liked to have shown a benefit in the hospital,’ he said.”

COVID-19 fighter remdesivir racks up $873M as Gilead plays defense on unflattering WHO data:”Gilead Sciences started charging for remdesivir in July. Given its status then as the only drug authorized for COVID-19 in the U.S., industry watchers immediately forecast multibillion-dollar sales for this year.
But new clinical data have now put the Big Biotech in defense mode—and prompted analysts to dial down their expectations.
In the third quarter, Gilead sold $873 million of remdesivir, handily topping Wall Street’s previous estimate of $772 million. The drug was fully approved by the FDA last week, under the brand name Veklury, to treat hospitalized COVID-19 patients…
Veklury’s efficacy—as well as the FDA’s decision to approve it—recently came under serious question after a large study by the World Health Organization (WHO) found it offered ‘little or no effect’ in hospitalized COVID-19 patients, in terms of recovery time, requirement for ventilators and death rate.”

About health insurance

Molina Healthcare beats the Street with $185M in Q3 profit:Molina Healthcare earned $185 million in profit for the third quarter, beating Wall Street expectations.
That's up from the third quarter of 2019, when the insurer brought in $175 million in profit…
Molina attributes the jump in revenue to notably higher premium revenues both in the third quarter and across the first nine months of 2020. Premium revenues were up by 16.8% compared to the prior-year quarter and are 11.3% higher than the first three quarters of 2019.”

HHS to dole out $333M in incentive payments to nursing homes that improved COVID-19 care: “The Department of Health and Human Services (HHS) will start distributing about $333 million in performance payments to over 10,000 nursing homes that reduced COVID-19 infections and deaths over a two-month period.
The agency said the announcement illustrates how tying relief payments to outcome-based payments can yield positive results for improving quality.”

Blue Cross of California Partnership Plan Fined $1.2M for Failing to Authorize Medically Necessary Services: “The California Department of Managed Health Care (DMHC) has taken enforcement action including $1,205,000 in fines against Blue Cross of California Partnership Plan, Inc. (Blue Cross) for its failure to timely implement two Independent Medical Review (IMR) determinations to authorize coverage for medically necessary services. The Medi-Cal managed care plan confirmed receiving the Department's notifications of the IMR decisions but failed to timely authorize the enrollees' services.”

Final rule for disclosure of insurance company cost information (from the Departments of the Treasury (IRS), Labor and HHS: “The final rules set forth requirements for group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information upon request to a participant, beneficiary, or enrollee (or his or her authorized representative), including an estimate of the individual’s cost-sharing liability for covered items or services furnished by a particular provider. Under the final rules, plans and issuers are required to make this information available on an internet website and, if requested, in paper form, thereby allowing a participant, beneficiary, or enrollee (or his or her authorized representative) to obtain an estimate and understanding of the individual’s out-of-pocket expenses and effectively shop for items and services. The final rules also require plans and issuers to disclose in-network provider negotiated rates, historical out-of-network allowed amounts, and drug pricing information through three machine-readable files posted on an internet website, thereby allowing the public to have access to health coverage information that can be used to understand health care pricing and potentially dampen the rise in health care spending. The Department of Health and Human Services (HHS) also finalizes amendments to its medical loss ratio (MLR) program rules to allow issuers offering group or individual health insurance coverage to receive credit in their MLR calculations for savings they share with enrollees that result from the enrollees shopping for, and receiving care from, lower-cost, higher-value providers.” Unlike hospitals, which have to disclose 300 stoppable services starting the January 1, insurers will be required to provide a list of 500 shoppable services via the online tool for plan years that begin on or after Jan. 1, 2023. Cost information for additional services will be required on or after Jan. 1, 2024.

About hospitals and health systems

CHS shares jump 30%: “Shares of Franklin, Tenn.-based Community Health Systems soared 30 percent Oct. 28 after the for-profit hospital chain said its longtime CEO would step down and it released better-than-expected financial results for the third quarter.”

Today's News and Commentary

About the public’s health

Western States Join California’s Scientific Safety Review Workgroup to Ensure Safety of COVID-19 Vaccine: “Washington, Oregon and Nevada have joined California’s COVID-19 Scientific Safety Review Workgroup, which will independently review the safety and efficacy of any vaccine approved by the FDA for distribution.”

Coronavirus antibodies decline after infection, study finds, raising questions about herd immunity: “Researchers from Imperial College London screened 365,000 people in England over three rounds of testing between June 20 and Sept. 28.
Analysis of finger-prick tests carried out at home found that rather than people building immunity over time, the number of people with antibodies that can fight Covid-19 declined roughly 26%.”

U.S. Preventive Services Task Force Issues Draft Recommendation on Screening for Colorectal Cancer:”For the first time, the Task Force is recommending that screening start at age 45. This is a B recommendation. The Task Force continues to strongly recommend screening people who are 50 to 75 years old. This is an A recommendation.” (Emphases in original.)

COVID-19 Mitigation Behaviors by Age Group — United States, April–June 2020:”Self-reported engagement in mitigation behaviors (mask wearing, handwashing, physical distancing, crowd and restaurant avoidance, and cancellation of social activities) differed significantly by adult age group. During April–June 2020, the prevalence of these behaviors was lowest among adults aged 18–29 years and highest among those aged >60 years. Whereas mask wearing increased over time, other reported mitigation behaviors decreased or remained unchanged.”

About health insurance

Anthem Reports Third Quarter Results, Reaffirms Commitment to Stakeholders During COVID-19 Pandemic: Anthem sustained an operating loss decline of 86.8% for the 3rd quarter compared to the previous year’s period. For the 9 months so far, both revenue and profit are up about 17.5%.

New CMS Proposals Streamline Medicare Coverage, Payment, and Coding for Innovative New Technologies and Provide Beneficiaries with Diabetes Access to More Therapy Choices: “The proposed rule would expand the interpretation regarding when external infusion pumps are appropriate for use in the home and can be covered as DME under Medicare Part B, increasing access to drug infusion therapy services in the home. The proposed rule also drastically reduces administrative burdens – such as complicated government coverage, payment and coding processes – that block innovators from getting their products to Medicare beneficiaries in a timely manner…
If finalized, today’s proposed rule will also expand Medicare coverage and payment for continuous glucose monitors (CGMs)…”

2019 Quality Payment Program (QPP) Performance Results: From CMS: “We’re pleased to share that the maximum MIPS payment adjustment for exceptional performance during the 2019 reporting year will be the highest since the program began. Clinicians with a final score equal to or above 75.00 points will receive a positive payment adjustment in 2021 of up to 1.79%…
Some other clinicians, however, may see lower than expected positive payment adjustments. This is because the Quality Payment Program is required by law to be budget neutral, and more clinicians who may have faced maximum negative adjustments qualified for reporting exceptions under the MIPS Extreme and Uncontrollable Circumstances policy. As a result, there is a smaller pool of dollars from negative payment adjustments that can be redistributed and used for the positive payment adjustments.”

Anthem to pay $594M share in pending Blues plan antitrust settlement: “Anthem is paying a substantial portion of Blues plans' tentative antitrust settlement, which is estimated to be nearly $3 billion, executives said on a call with investors on Wednesday morning.
Anthem has penciled in $594 million for its contribution to the $2.7 billion settlement. The Blue Cross and Blue Shield Association reportedly agreed to the settlement in a lengthy class action suit late last month…
In the suit, filed in 2012, Blues plans were accused of conspiring to split up geographic regions to avoid competing against one another directly. That lack of competition drove up costs, the plaintiffs allege.”

About healthcare IT

Aetna Pays $1,000,000 to Settle Three HIPAA Breaches: Read the OCR announcement for further details. The events occurred in 2017.

Healthcare technology

Exact Sciences snaps up liquid biopsy company Thrive in $2.15B deal:”Exact Sciences is adding early cancer detection to its pipeline through its buyout of Thrive Earlier Detection for  up to $2.15 billion in cash and stock. The deal comes just three months after Thrive raised $257 million in venture dollars to push its liquid biopsy test into a registrational trial.”

About pharma

Eli Lilly nabs $375M deal to supply COVID-19 antibody to U.S. government despite trial failure: “Eli Lilly may have deep-sixed trials of its COVID-19 antibody treatment in hospitalized patients for lack of efficacy, but that’s not stopping the U.S. government from placing a huge bet on the drug’s success in other settings.
The government struck a $375 million deal with the company for 300,000 vials of the antibody treatment, bamlanivimab (LY-CoV555), provided it wins an emergency use authorization from the FDA…”

Today's News and Commentary

About the public’s health

Pharmacies See Record Flu Shot Demand in First Season With Covid: For example:“CVS Health Corp. has already surpassed the 9 million flu shots it gave during the entire previous season and expects to double that number by the end of this cycle, a spokesman said. Walgreens Boots Alliance has administered 60% more doses in its U.S. stores than at this point last year, said Rina Shah, group vice president of pharmacy operations.”

Medicare and Medicaid to cover early Covid vaccine: “The Trump administration this week will announce a plan to cover the out-of-pocket costs of Covid-19 vaccines for millions of Americans who receive Medicare or Medicaid, said four people with knowledge of the pending announcement.
Under the planned rule, Medicare and Medicaid will now cover vaccines that receive emergency use authorization from the Food and Drug Administration, the people said, which is a change from current policy.” 

Sugary Drinks, Artificially-Sweetened Beverages, and Cardiovascular Disease in the NutriNet-Santé Cohort: Consumption of both sugary drinks and artificially sweetened beverages are associated with increases in the incidence of cardiovascular disease.

Illinois study tracks evolution of SARS-CoV-2 virus mutations:”A group of graduate students in a spring-semester Bioinformatics and Systems Biology class at Illinois tracked the mutation rate in the virus’s proteome – the collection of proteins encoded by genetic material – through time, starting with the first SARS-CoV-2 genome published in January and ending more than 15,300 genomes later in May.
The team found some regions still actively spinning off new mutations, indicating continuing adaptation to the host environment. But the mutation rate in other regions showed signs of slowing, coalescing around single versions of key proteins.” The slower mutating areas appear to code for successful adaptations to spreading.

America’s pandemic: This piece is a Washington Post documentary about how recent past Presidents have handled actual or threatened public health crises.

About pharma

Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial: “The ACTIV-3 clinical trial is being run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and is the only study evaluating the efficacy of bamlanivimab in hospitalized COVID-19 patients. Based on an updated dataset from the trial reviewed on October 26, no additional COVID-19 patients in this hospitalized setting will receive bamlanivimab. This recommendation was based on trial data suggesting that bamlanivimab is unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease. In this updated dataset, differences in safety outcomes between the groups were not significant.”

Bayer Acquires Asklepios BioPharmaceutical to Broaden Innovation Base in Cell and Gene Therapy:”Bayer AG… announced the acquisition of Asklepios BioPharmaceutical, Inc. (AskBio), a US-headquartered biopharmaceutical company specialized in the research, development and manufacturing of gene therapies across different therapeutic areas. AskBio’s development portfolio includes investigational pre-clinical and clinical stage candidates for the treatment of neuromuscular, central nervous system, cardiovascular and metabolic diseases.”
The purchase price is $2 billion upfront and up to $2 billion in success-based milestone payments.

Florida fails to attract bidders for Canada prescription drug importation program:”Florida’s plan to import cheaper prescription drugs from Canada — designed by Gov. Ron DeSantis and endorsed by President Donald Trump — has tasted its first bitter pill.
No private firms bid on Florida’s $30 million contract to set up and operate a drug importation program. Bids were due at the end of September.
The setback is likely to delay by at least several months Florida’s effort to become the first state to import drugs.”

About health insurance

Health Literacy Key to Better Health Outcomes: A really good piece about how improved healthcare literacy can improve health status and save money. For example, prevent about 1 Million hospital visits and save $25 billion per year.

Today's News and Commentary

About pharma

Business Groups Rally Behind J&J's $465M Opioid Appeal: “The U. S. Chamber of Commerce, a defense bar organization called the Product Liability Advisory Council and other lobbying groups have urged the Oklahoma Supreme Court to overturn a nearly half-billion-dollar judgment against Johnson & Johnson in the nation's first and only opioid-crisis trial. The Product Liability Advisory Council in a Thursday brief said product liability law is more than adequate to protect consumers, not public nuisance law. If the verdict is not overturned, then product liability law's aims to protect consumers and encourage economic activity will be thwarted and the floodgates would open for more novel public nuisance claims…”

Shorter course of antibiotics OK for children with pneumonia who are improving: “Among children with community-associated pneumonia who have improved by day 5, study findings showed that additional days of antibiotic therapy did not confer additional benefits…”

About the public’s health

More than 83,000 new coronavirus cases recorded in US for second-straight day:”About 35 states reported more new cases in the last week than the previous week, Johns Hopkins noted. New Jersey and Michigan both reported records for single-day cases, with 1,994 cases and 3,338, respectively. 
And Illinois reported its highest single-day total since the pandemic began, with 6,161 new cases.”

Drug-resistant superbug thriving in hospitals hit hard by COVID-19: As if we didn’t have enough to worry about, Candida auris spread continues in hospitals and may increase among those with COVID-19.

Vaccine hopes rise as Oxford jab prompts immune response among old as well as young adults: “One of the world’s leading COVID-19 experimental vaccines produces an immune response in both young and old adults, raising hopes of a path out of the gloom and economic destruction wrought by the novel coronavirus.
The vaccine, developed by the University of Oxford, also triggers lower adverse responses among the elderly, British drug maker AstraZeneca Plc, which is helping manufacture the vaccine, said on Monday.”

Covid-19 vaccine trials from AstraZeneca, Johnson & Johnson to restart: The headline speaks for itself.

Aspirin Use is Associated with Decreased Mechanical Ventilation, ICU Admission, and In-Hospital Mortality in Hospitalized Patients with COVID-19: The message is in the headline. The dose of aspirin was only 81mg. The authors caution: “However, a sufficiently powered randomized controlled trial is needed to assess whether a causal relationship exists between aspirin use and reduced lung injury and mortality in COVID-19 patients.”

About hospitals and health systems

Texas COPA law may pave the way for more hospital M&A: Remember Certificate of Need regulations? It’s “opposite” are relatively new Certificate of Public Advantage (COPA) laws, which allows states to override FTC concerns for mergers. The link has an excellent podcast discussion of these laws with a focus on a Texas hospital merger case.

Sanford Health plans to merge with Intermountain Healthcare: “The combined organization would employ more than 89,000 people, and operate 70 hospitals and 435 clinics across seven states. It would also provide senior care and other services in 366 locations in 24 states, and insure 1.1 million people. 
The organization would be headquartered in Salt Lake City, Utah — which is Intermountain's current headquarters — while keeping corporate offices in Sioux Falls, South Dakota where Sanford is headquartered.”

HCA Healthcare Reports Third Quarter 2020 Results: “Consistent with the Company’s preview of third quarter 2020 results, revenues in the third quarter of 2020 increased to $13.311 billion, compared to $12.694 billion in the third quarter of 2019. Net income attributable to HCA Healthcare, Inc. totaled $668 million, or $1.95 per diluted share, compared to $612 million, or $1.76 per diluted share, in the third quarter of 2019.”

Kaiser Permanente to build medical center in Maryland: “Kaiser Permanente Aspen Hill Medical Center will house an ambulatory surgery center as well as space for primary care, obstetrics, urology, pain management and ophthalmology. It will also have a pharmacy, imaging and laboratory services.
The first phase of the project will include building a 130,000-square-foot facility and 542 parking spaces. In the second phase, a 50,000-square-foot addition will be added and a parking garage with 304 spaces will be built.”
The facility is expected to open in 2022.

About health insurance

CMS delays radiation oncology payment model following fierce opposition from physician community: “The Centers for Medicare and Medicaid Services has decided to delay the start of its mandatory radiation oncology bundled payment model following fierce opposition from the physician community. 
CMS had planned to launch the effort on Jan. 1; however, the go-live date will now move to July 1, 2021…”

UnitedHealth Ships Flu Kits to Medicare Recipients: “UnitedHealthcare… plans to provide at-risk patients with 200,000 kits that include Tamiflu, the prescription antiviral treatment; a digital thermometer; and a coronavirus P.C.R. diagnostic test. People can take the test at home and then mail it in for laboratory analysis, helping patients and doctors determine the cause of their symptoms, which is particularly important because the coronavirus and flu have similar symptoms but differ in treatment.”

Trump Administration Health Reimbursement Arrangements Put ACA Subsidies at Risk: The monograph explains what individual coverage health reimbursement arrangements (ICHRAs) are and how they can put employees’ premium tax credits at risk when they buy an ACA compliant plan. It also describes how such arrangements can distort insurance markets by separating employees who are healthier from those with chronic conditions.

About healthcare IT

First VA medical center (finally) goes live on Cerner EHR as part of $16B project: “The Department of Veterans Affairs' achieved a major milestone Saturday in its decades-long, multi-billion-dollar effort to upgrade its aging health IT systems.
Mann-Grandstaff VA Medical Center in Spokane, Washington went live with a new Cerner EHR system this weekend, the first site as part of VA's massive medical records project.
It marks progress in the latest effort to upgrade the VA's system, a $16 billion technology project that's been plagued by delays, leadership turnover, and infrastructure problems since it kicked off in 2018.”

Today's News and Commentary

About pharma

FDA approves first COVID-19 drug: antiviral remdesivir:  “The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.
It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month.”
Recall that the WHO does not endorse its efficacy.

4 AbbVie brands land on pharma's top TV spenders list for September: ”The top 10 brands spent $182 million, the highest monthly total since January, according to data from real-time TV ad tracker iSpot.tv. AbbVie’s Humira led the way as usual, but with an even bigger budget of $57.7 million, an increase of 45% over what the Illinois drugmaker spent on the product in August.”

About the public’s health

Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial): “Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.”

U.S. signs international declaration challenging right to abortion and upholding ‘role of the family’: “The United States joined Brazil, Egypt, Hungary, Indonesia and Uganda on Thursday to co-sponsor a nonbinding international antiabortion declaration, in a rebuke of United Nations human rights bodies that have sought to protect abortion access.
Secretary of State Mike Pompeo and Health and Human Services Secretary Alex Azar participated in the virtual signing ceremony.”

Mich. Law Gives Employers Immunity From COVID-19 Suits: “Michigan Gov. Gretchen Whitmer on Thursday signed bills that allow workers to stay home if they have COVID-19 symptoms and grant immunity to employers from lawsuits filed by workers or customers who contract the coronavirus so long as they are following federal, state and local safety laws.” This immunity is something the Republicans wanted to include in COVID-19 financial relief packages; the Democrats refused. Interesting that a Democratic governor approved of this measure. Perhaps other states will follow suit.

Wikipedia and W.H.O. Join to Combat Covid Misinformation: “As part of efforts to stop the spread of false information about the coronavirus pandemic, Wikipedia and the World Health Organization announced a collaboration on Thursday: The health agency will grant the online encyclopedia free use of its published information, graphics and videos.”

About health insurance

Trump says he hopes Supreme Court strikes down ObamaCare: In a “60 minutes” interview, Trump said he hopes the Supreme court will strike down the ACA. He was very vague about a plan to replace it. He reiterated those statements in last night’s debate.

About healthcare IT

Correlations Between COVID-19 Cases and Google Trends Data in the United States: A State-by-State Analysis: “This study documents the feasibility of syndromic surveillance of internet search terms to monitor new infectious diseases such as coronavirus disease 2019. This information could enable better preparation and planning of health care systems.” 

About diagnostics

Quest Diagnostics ups guidance, notches major sales growth and gives back CARES Act cash: “The New Jersey-based testing company has seen sales hit $2.78 billion for the third quarter, up more than 42% on the year-ago period, with sales up 11% to $6.43 billion for the nine-month period. 
What’s driving this growth? COVID-19 testing. The company has now performed more than 22 million molecular and serology tests to date, what it says is ‘more than any other provider.’” 

Today's News and Commentary

About health insurance

MA Enrollees Can Access COVID-19 Supplemental Benefits in 2021: “New analysis from Avalere finds that… MA plans will continue to increase their supplemental benefit offerings in 2021. More plans will offer primarily health-related benefits, such as meals and transportation. In addition, 1 in 3 MA plans will start offering new types of supplemental benefits specifically related to the pandemic, such as no cost-sharing for COVID-19 testing and care packages.”
Read the report for more details.

Harvard Pilgrim Health Care partners with Foodsmart to offer comprehensive nutrition support to its members “Harvard Pilgrim Health Care has partnered with Foodsmart by Zipongo, a telenutrition and digital foodcare solution based in San Francisco, CA.Foodsmart is a digital nutrition platform that offers online food ordering, immunity-boosting recipes, meal planning for the whole family, and more. The Foodsmart NutriQuiz helps monitor progress against health goals, and facilitates personalization of meal plans and grocery lists based on eating habits, food preferences, allergies, and nutrition needs.” This article explains a recent example of insurers addressing non-medical needs of members.

Cohere Health Announces Partnership with Humana to Modernize Prior Authorization and Improve Physician and Member Experience:”Humana will employ the CohereNext Platform to streamline prior authorizations in musculoskeletal treatment in Alabama, Georgia, Indiana, Kentucky, Michigan, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and West Virginia. The platform will initially serve approximately 2 million members and more than 3,500 physician practices.”
How will this system for one “organ system” enhance coordination of patient care, particularly if other entities are managing other disease categories?

About the public’s health

CDC expands definition of who is a ‘close contact’ of an individual with covid-19:”The updated guidance, which health departments rely on to conduct contact tracing, now defines a close contact as someone who was within six feet of an infected individual for a total of 15 minutes or more over a 24-hour period, according to a CDC statement Wednesday.”

California Will Independently Verify COVID-19 Vaccine: The headline speaks for itself. Illinois will also independently verify vaccines.

About pharma

Community health centers sue HHS to install method to handle 340B violations after drugmaker feud: “An association representing community health centers is suing the Department of Health and Human Services (HHS), seeking help in combating drug manufacturers that are refusing to give their products to 340B contract pharmacies…
The centers want HHS to install a dispute resolution process to give 340B entities a pathway to remedy program violations.
The lawsuit comes after several drug companies announced they won’t provide 340B-discounted products to contract pharmacies, third-party entities that are hired by a 340B entity to dispense the drugs.”

Remdesivir’s hefty price tag ignores NIH investment in its creation: “Research from the Center for Integration of Science and Industry… determined that between gathering knowledge behind remdesivir’s chemical structure and molecular target, the NIH invested as much as $6.5 billion between 2000 and 2019. This is referred to as ‘basic research’ that might never have resulted in a drug. Instead, the work was performed to learn about the inner workings of cells and organisms and how these systems function as a whole.” This article raises the question of whether governmental investment should be recouped either directly or through lower prices pharma companies charge. The article points out that march-in rights that were “established by Congress under the Bayh-Dole Act, allow the federal government to retain patent rights for inventions developed with government funding, but have never been used. March-in-rights… would allow other distributors to help manufacture remdesivir, increasing the supply and lowering its cost.”

Today's News and Commentary

About the public’s health

State of Global Air 2020: Among the most shocking findings was that nearly “500,000 newborns died in 2019 as a result of air pollution exposure.”

Do Masks On Plane Flights Really Cut Your Risk Of Catching COVID-19?: You should read the entire article if you are contemplating flying, but the “bottom line” is that: “All together, these data suggest masks are working — and working well.”

Long-term effects of PM2·5 [fine particulate matter] on neurological disorders in the American Medicare population: a longitudinal cohort study: “We provide evidence that exposure to annual mean PM2·5 in the USA is significantly associated with an increased hazard of first hospital admission with Parkinson's disease and Alzheimer's disease and related dementias. For the ageing American population, improving air quality to reduce PM2·5 concentrations to less than current national standards could yield substantial health benefits by reducing the burden of neurological disorders.”

Microplastics Are Seeping Out of Baby's Bottle, Study Shows: “High levels of microplastic particles are released from baby bottles during formula preparation, researchers discovered during lab testing.
Infants are likely exposed to an average daily dose of nearly 1.6 million microplastic particles through baby formula they drink from heated plastic bottles, researchers estimated in the Oct. 19 issue of Nature.
It's not clear whether these particles represent either an immediate or long-term health risk to growing babies, however.”

OraSure’s At-Home Saliva Sample Collection System Authorized for Emergency Use: “The EUA allows the device to be used in healthcare settings or by patients at home to collect and ship saliva samples for approved COVID-19 test kits. The collection system was previously cleared in the EU.”

About pharma

Purdue Pharma Pleads Guilty to Criminal Charges for Opioid Sales: “The Justice Department announced an $8 billion settlement with the company. Members of the Sackler family will pay $225 million in civil penalties but criminal investigations continue.” 

About health insurance

CMS to allow Nebraska to install voluntary Medicaid wellness and work requirements: “The Trump administration has approved a waiver to let Nebraska offer extra benefits to new Medicaid beneficiaries that in turn meet work and wellness requirements.
The waiver, approved Tuesday by the Centers for Medicare & Medicaid Services (CMS), comes as the agency’s efforts to install work requirements in several states have been struck down by federal courts.
Nebraska’s waiver applies to people who are eligible for Medicaid under the Affordable Care Act’s expansion, which the state recently implemented after a successful ballot initiative. Pregnant women, elderly adults, children and disabled adults are not eligible to participate in the program.”

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.