Today's News and Commentary

About the public’s health

The US has reported its highest one-day Covid-19 death tally: Over 2,800:”More than 2,800 Covid-19 deaths were reported Wednesday in the United States -- the most the country has ever reported in a single day -- as health care officials say their staff and facilities are struggling to support burgeoning numbers of patients.
The number of Covid-19 patients in US hospitals Wednesday -- 100,226, according to the COVID Tracking Project -- also is the highest reported on a given day during the pandemic.”

Vaccination cards will be issued to everyone getting Covid-19 vaccine, health officials say: “The Department of Defense released the first images of a Covid-19 vaccination record card and vaccination kits Wednesday.” See the article for a picture of the card.

The U.S. has spent billions stockpiling ventilators, but many won’t save critically ill COVID-19 patients: “With the COVID-19 pandemic sweeping across its shores earlier this year, the U.S. government in April announced orders for almost $3 billion of ventilators for a national stockpile, meant to save Americans suffering from severe respiratory problems brought on by the disease.
But of the 140,000 machines added since then by the government to the U.S. Strategic National Stockpile, almost half were basic breathing devices that don’t meet what medical specialists say are the minimum requirements for ventilators needed to treat Acute Respiratory Distress Syndrome, the main cause of death among COVID-19 patients, according to a Reuters review of publicly-available device specifications and interviews with doctors and industry executives.”

How Risk of Exposure to the Coronavirus at Work Varies by Race and Ethnicity and How to Protect the Health and Well-Being of Workers and Their Families: This in-depth report from the Urban Institute is worth reading. Among the findings:
”We find that Black, Native American, and Hispanic/Latinx workers are more likely than white workers to have jobs that place them at greater risk of exposure to and transmission of the coronavirus. More than half of all Black, Native American, and Hispanic/Latinx workers have essential or nonessential jobs that must be done in person and close to others, compared with 41 percent of white workers. In addition, Black, Native American, and Hispanic/Latinx workers who must work in person and close to others have lower incomes than white workers in these jobs and are less likely to have health insurance. Finally, Black, Native American, and Hispanic/Latinx households face greater risks of transmission of the virus at home because they are more likely to have a worker who works in person and close to others and to live in households with multiple generations of adults.”

Anthony Fauci slams U.K.'s speedy review of Pfizer, BioNTech COVID shot: “‘If you go quickly and you do it superficially, people are not going to want to get vaccinated,”’NIAID director Anthony Fauci told Fox News. ‘We have the gold standard of a regulatory approach with the FDA.’
The U.K.'s Medicines and Healthcare Products Regulatory Authority (MHRA) did not do it as carefully,’ he added.”

UN commission reclassifies cannabis, no longer considered risky narcotic: “In reviewing a series of World Health Organization (WHO) recommendations on marijuana and its derivatives, the CND [Commission on Narcotic Drugs] zeroed-in on the decision to remove cannabis from Schedule IV of the 1961 Single Convention on Narcotic Drugs — where it was listed alongside deadly, addictive opioids, including heroin. 
The CND’s 53 Member States voted to removed cannabis – where it had been placed for 59 years – from the strictest control schedules, that even discouraged its use for medical purposes.  
With an historic vote of 27 in favour, 25 against, and one abstention, the CND has opened the door to recognizing the medicinal and therapeutic potential of the commonly-used but still largely illegal recreational drug.”

Food insecurity rates high among people with heart disease:”People with atherosclerosis, particularly those who earn a low income and have other socioeconomic disadvantages, are more likely to experience food insecurity than those without the condition, according to new research.
Researchers analyzed several socioeconomic factors from self-reported data for 190,113 U.S. adults. Among the 18,442 (8.2%) adults with atherosclerosis, about 1 in 7 – or 14.6% – reported being food insecure. That was compared with 9.1% among those without atherosclerosis.
The findings also showed food insecurity affects nearly 1 in 2 people with the condition who also are among the most disadvantaged socioeconomic groups.”

The 2020 report of The Lancet Countdown on health and climate change: responding to converging crises: An excellent report about climate change and health.
“The Lancet Countdown is an international collaboration established to provide an independent, global monitoring system dedicated to tracking the emerging health profile of the changing climate.
The 2020 report presents 43 indicators across five sections: climate change impacts, exposures, and vulnerabilities; adaptation, planning, and resilience for health; mitigation actions and health co-benefits; economics and finance; and public and political engagement. This report represents the findings and consensus of the 35 leading academic institutions and UN agencies that make up The Lancet Countdown, and draws on the expertise of climate scientists, geographers, engineers, experts in energy, food, and transport, economists, social, and political scientists, data scientists, public health professionals, and doctors.

About pharma

Regeneron and UPenn Forge Gene Therapy Pact for COVID-19 Antibody Cocktail:”Regeneron has partnered with the University of Pennsylvania (UPenn) to develop a gene therapy nasal delivery system for its COVID-19 antibody cocktail, casirivimab and imdevimab, which received an Emergency Use Authorization from the FDA last month for mild-to-moderately ill coronavirus patients at high risk.”

HHS enlists CVS to pilot administering Eli Lilly's antibody drug to high-risk patients: “The Trump administration has purchased an additional 650,000 doses of Eli Lilly's antibody treatment for COVID-19 and enlisted CVS Health to pilot administering the therapy to patients in long-term care facilities and at home.”

About health insurance

CMS' outpatient payment rule for 2021: 5 things to know: An excellent short summary of the 1312 page final rule.
Here is another short summary of the changes.

About healthcare IT

North Korean Hackers Are Said to Have Targeted Companies Working on Covid-19 Vaccines: ”North Korean hackers have targeted at least six pharmaceutical companies in the U.S., the U.K. and South Korea working on Covid-19 treatments, according to people familiar with the matter, as the regime seeks sensitive information it could sell or weaponize.”

Today's News and Commentary

About the public’s health

Covid-19: Pfizer/BioNTech vaccine judged safe for use in UK from next week: Today’s top story.
”The first doses are already on their way to the UK, with 800,000 due in the coming days, Pfizer said.
Health Secretary Matt Hancock said the NHS will contact people about jabs.
Elderly people in care homes and care home staff have been placed top of the priority list, followed by over-80s and health and care staff.
But because hospitals already have the facilities to store the vaccine at -70C, as required, the very first vaccinations are likely to take place there - for care home staff, NHS staff and patients - so none of the vaccine is wasted.”

Phased Allocation of COVID-19 Vaccines: The CDC recommends that the first recipients of a SARS-CoV-2 vaccine are health care personnel and long term care facility residents. This document gives the rationale for the decision and who is next to receive the vaccine.
As an aside, when you first search for this information, you will find pages of media reporting on this decision. It takes some work to get the original document. Perhaps there is a role for search engines to list original documents at the top and reporting after (instead of by popularity of clicks).

CDC says 2-week coronavirus quarantines can be cut to 10 or 7 days: “The move reflects the agency’s recognition that the two-week quarantine rule is onerous for many people and that most of the public health benefit from quarantining people exposed to the virus can be gained with a more flexible approach.
The CDC acknowledges that this new guidance involves a trade-off. The existing 14-day recommendation reflects the ability of the virus to incubate for a long period before symptoms appear. But lack of compliance — for example, among people who are reluctant to talk to contact tracers because they fear they or their friends or family members could lose a job or two weeks of income — can undermine the public health benefit from that standard.”

First shipments of Pfizer vaccine to be delivered December 15: “The first shipments of Pfizer's coronavirus vaccine will be delivered on December 15, according to an Operation Warp Speed document obtained by CNN on Tuesday.
The document, provided to governors ahead of a call with the Vice President Monday, also estimated the first shipment of Moderna's vaccine will be delivered on December 22.
Those distribution dates are contingent upon a decision by the US Food and Drug Administration to authorize each vaccine for emergency use. Pfizer submitted an application to the FDA on November 20, and Moderna submitted an application on November 30.”
A related article gives a really good timeline over the next year of the approval and rollout processes.

Decline in SARS-CoV-2 Antibodies After Mild Infection Among Frontline Health Care Personnel in a Multistate Hospital Network — 12 States, April–August 2020: “Among 156 frontline health care personnel who had positive SARS-CoV-2 antibody test results in spring 2020, 94% experienced a decline at repeat testing approximately 60 days later, and 28% seroreverted to below the threshold of positivity. Participants with higher initial antibody responses were more likely to have antibodies detected at the follow-up test than were those who had a lower initial antibody response.
What are the implications for public health practice?
SARS-CoV-2 antibodies decline over weeks following acute infection. Negative SARS-CoV-2 serologic results do not exclude previous infection, which has significant impacts on how serologic studies are interpreted.”

Cancer patients may shed viable COVID-19 virus for 2 months: “A New England Journal of Medicine study yesterday of cancer patients with COVID-19 demonstrated viral RNA shedding for up to 78 days and live virus for up to 61 days, suggesting extended infectiousness in patients whose immune system is suppressed.”

COVID-19 Susceptibility in Bronchial Asthma: The results of this research are not what you might think.
”No significant impact of antileukotrienes, inhaled corticosteroids, and long-acting beta-blockers use was revealed on COVID-19 positivity proportions. Multiple logistic regression analysis adjusted for sex, age, smoking, and comorbidity revealed a negative association of asthma with the likelihood of being positive for COVID-19 [emphasis added] (odds ratio, 0.71; 95% CI, 0.58-0.87; P = .001).”

Trump Covid vaccine czar says side effects ‘significantly noticeable’ in 10% to 15% of recipients: “President Trump’s coronavirus vaccine czar said Pfizer’s and Moderna’s Covid-19 vaccines are safe, with only 10% to 15% of volunteers reporting ‘significantly noticeable’ side effects [redness and pain at the injection site as well as fever, chills, muscle aches and headaches].
The side effects can last up to a day and a half, said Dr. Moncef Slaoui, who is leading the Trump administration’s Covid-19 vaccine program Operation Warp Speed.”

Leaked documents reveal China's mishandling of the early stages of Covid-19: A really interesting investigative report from CNN. The problem starts here and then “goes downhill”:
”In a report marked ‘internal document, please keep confidential,’ local health authorities in the province of Hubei, where the virus was first detected, list a total of 5,918 newly detected cases on February 10, more than double the official public number of confirmed cases, breaking down the total into a variety of subcategories. This larger figure was never fully revealed at that time, as China's accounting system seemed, in the tumult of the early weeks of the pandemic, to downplay the severity of the outbreak.”

About pharma

The $38B pie: Pfizer, Moderna COVID-19 vaccines set for lion's share of 2021 sales: “In fact, the top five players are set to divvy up about $38.5 billion in sales, Bernstein analysts figure, with the first-to-market companies reaping more than half of that. Pfizer, which just won U.K. approval Wednesday, is in line for $14.3 billion in COVID-19 vaccine sales next year, followed by $10.9 billion for Moderna, $6.4 billion for AstraZeneca, $3.9 billion for Novavax and $3 billion for Johnson & Johnson, according to the projections.”

About diagnostics

In potential ‘gamechanger,’ blood test may accurately predict Alzheimer’s: “Scientists in Sweden and Britain now believe blood tests can be used to predict Alzheimer’s years before the onset of symptoms.
Writing in the journal Nature Aging, they described how they developed and validated models of individual risk based on the levels of two key proteins in blood samples taken from more than 550 patients with minor cognitive impairments.
The model, based on these two proteins, had an 88 percent success rate in predicting the onset of Alzheimer’s in the same patients over the course of four years.”

About health insurance

Ala. Judge Gives Initial OK To $2.67B BCBS Antitrust Deal: “Citing ‘historic and substantial’ structural reform terms and a massive, $2.67 billion class damage award, a federal judge in Alabama granted preliminary approval late Monday to a settlement of claims that the nation's Blue Cross plans conspired for years to thwart competition nationwide. U. S. District Judge R. David Proctor noted in his memorandum opinion that the agreement in the Northern District of Alabama includes one of the largest class payouts in history, in a case that alleged a long-running health insurance market-control conspiracy affecting tens of millions of insured members.”

UnitedHealth Group Updates Business Outlook Ahead of Investor Conference: “Under the updated outlook, UnitedHealth Group revenues for 2020 are expected to approximate $257 billion, with net earnings to approach $15.90 per share and adjusted net earnings to approach $16.75 per share. Adjusted net earnings exclude from net earnings only the after-tax non-cash amortization expense pertaining to acquisition-related intangible assets.
UnitedHealth Group will also introduce its initial 2021 outlook, which includes revenues of $277 billion to $280 billion, net earnings of $16.90 to $17.40 per share, and adjusted net earnings of $17.75 to $18.25 per share. These figures include approximately $1.80 per share in potential net unfavorable impact to accommodate continuing COVID-19 effects, such as: treatment and testing costs; the residual impact of people deferring care in 2020; and unemployment and other economic-driven factors. Cash flows from operations are expected to range from $20 billion to $21 billion in 2021.”

Today's News and Commentary

About the public’s health

Operation Warp Speed Chief: 100 percent of Americans will be able to get vaccine by June: “‘We will have over 300 million doses available to the American public, well before [June],’ stated retired Lt. Gen. Paul Ostrowski, Director of Supply, Production & Distribution for Operation Warp Speed.”

SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis: “No study detected live virus beyond day 9 of illness, despite persistently high viral loads, which were inferred from cycle threshold values. SARS-CoV-2 viral load in the upper respiratory tract appeared to peak in the first week of illness, whereas that of SARS-CoV peaked at days 10–14 and that of MERS-CoV peaked at days 7–10.
Interpretation:
Although SARS-CoV-2 RNA shedding in respiratory and stool samples can be prolonged, duration of viable virus is relatively short-lived….
[The] highest risk of transmission occurs very early in the disease course (a few days before and within the first 5 days after symptom onset)…”

Dr. Scott Atlas resigns from Trump administration: He did not give a reason and the White House did not comment.

Serologic testing of U.S. blood donations to identify SARS-CoV-2-reactive antibodies: December 2019-January 2020: “To determine if SARS-CoV-2 reactive antibodies were present in sera prior to the first identified case in the U.S. on January 19, 2020, residual archived samples from 7,389 routine blood donations collected by the American Red Cross from December 13, 2019 to January 17, 2020, from donors resident in nine states (California, Connecticut, Iowa, Massachusetts, Michigan, Oregon, Rhode Island, Washington, and Wisconsin) were tested at CDC for anti-SARS-CoV-2 antibodies…
[The] findings suggest that SARS-CoV-2 may have been introduced into the United States prior to January 19, 2020 [emphasis added].
So…did it originate in Wuhan?

OSHA Let Employers Decide Whether to Report Health Care Worker Deaths. Many Didn’t: “Workplace safety regulators have taken a lenient stance toward employers during the pandemic, giving them broad discretion to decide internally whether to report worker deaths. As a result, scores of deaths were not reported to occupational safety officials from the earliest days of the pandemic through late October.” This piece is a fascinating (and troubling) expose from Kaiser Health News (KHN).

States Fear Shortfall of Supplies for Vaccine Rollout, U.S. Watchdog Says: ”Thirty-eight states told the Government Accountability Office that they were concerned about having enough supplies to distribute and administer vaccines, according to the report Monday by the nonpartisan agency. Between a third and half of states had shortages of some testing supplies in October, including rapid point-of-care tests, the GAO found.”

About pharma

London A.I. Lab Claims Breakthrough That Could Accelerate Drug Discovery: “DeepMind, a lab owned by the same parent company as Google, said on Monday that its system, called AlphaFold, had solved what is known as “the protein folding problem.” Given the string of amino acids that make up a protein, the system can rapidly and reliably predict its three-dimensional shape.
This long-sought breakthrough could accelerate the ability to understand diseases, develop new medicines and unlock mysteries of the human body.”

CarepathRx and UPMC Announce Landmark Partnership to Bring Comprehensive Pharmacy Care Solutions to More Patients: “CarepathRx will acquire the management services organization responsible for the operational and strategic management of {UPMC subsidiary] Chartwell while UPMC becomes a strategic investor in CarepathRx.” The acquisition price is reported to be $400 million.

Crestor to be divested to Grünenthal in Europe: “AstraZeneca has agreed to sell the rights to Crestor (rosuvastatin) and associated medicines in over 30 countries in Europe, except the UK and Spain, to Grünenthal GmbH (Grünenthal)…
AstraZeneca will continue to manufacture and supply Crestor to Grünenthal during a transition period. AstraZeneca will also continue selling the medicine in other countries, including those in North America, in Japan, China and other emerging markets…
The divestment is anticipated to close in the first quarter of 2021, subject to customary closing conditions and regulatory clearances, upon which Grünenthal will make an upfront, non-contingent payment to AstraZeneca of $320m and may also make future milestone payments of up to $30m.”
This sale will become important if the medication is included in reference pricing for US drugs.

About healthcare providers

Thousands of Doctors’ Offices Buckle Under Financial Stress of COVID: This article is a good update about how COVID-19 has financially affected medical practice.

About hospitals

National Hospital Flash Report (November 2020): This Kaufman Hall report goes through the end of October and details the aggregate financial performance of 900 hospitals. For example, “eight months into the pandemic, the Kaufman Hall median operating Margin Index* remained below 2019 performance at 2.4% YTD through October with CARES Act funding, and -1.6% without CARES. The Kaufman Hall Operating EBITDA Margin Index was 7.3% YTD with the federal aid and 3.8% without CARES.”

About healthcare IT

Google Cloud teams up with Deloitte, KPMG to launch healthcare interoperability program for providers and payers: “On Monday, the tech giant's cloud division announced a Healthcare Interoperability Readiness Program designed to help healthcare organizations understand the current status of their data and where it resides, map out a path to standardization and integration and make use of data in a secure, reliable, compliant manner.
Google Cloud worked with industry consultants and partners like Bain & Company, Boston Consulting Group, Deloitte, HCL Technologies, KPMG, MavenWave, Pluto7, SADA and 8K Miles to develop the program with tailored services, technologies and strategies, according to Aashima Gupta, global director, healthcare strategy and solutions at Google Cloud and Amit Zavery, vice president, business application platform at Google Cloud, in a blog post published Monday.”

Today's News and Commentary

About the public’s health

Cocoa Increases Mental Agility And Cognitive Ability, Finds Study: Start off the week with some good news.
”Researchers at the University of Birmingham have found in a new study that increased consumption of flavanols can increase your mental agility.The study revealed that people given a cocoa drink containing high levels of flavanols were able to complete certain cognitive tasks more efficiently than when drinking a non-flavanol enriched-drink. Flavanols, a sub-group of plant flavonoids, are present in cocoa, grapes, apples, tea, berries and other foods. They give fruits and vegetables their bright colors and are known to have a beneficial effect on cardiovascular health, but their effects on brain health are not well understood.”

New ‘Green’ Mediterranean Diet May Be Even Healthier for You: “Researchers say a new ‘green’ Mediterranean diet is healthier for you than even the traditional Mediterranean diet.
The green version replaces the minimal amount of red meat allowed in the traditional Mediterranean diet with plant-based protein.
Experts say plant proteins have additional health benefits that include anti-inflammatory characteristics.”

'A natural disaster ... in all 50 states' is unfolding just as travelers disperse nationwide after Thanksgiving: Now back to reality…an update on COVID-19 statistics.

Moderna to file for FDA emergency use authorization for COVID-19 vaccine: “Moderna announced that it plans to file with the FDA Monday for an emergency use authorization for its coronavirus vaccine, which the company said has an efficacy rate of 94.1%.”

Biden’s other health crisis: A resurgent drug epidemic: “Biden, who has stocked his team with addiction experts with extensive backgrounds in public health, will emphasize new funding for substance abuse treatment and prevention, while calling to eliminate jail time for drug use. It’s a departure from his tough-on-crime approach as a senator — and from President Donald Trump’s frequent focus on a law enforcement response to the drug crisis, which experts said undercut necessary public health measures.”

Estimated incidence of COVID-19 illness and hospitalization — United States, February–September, 2020: This research indicates the number of reported COVID-19 cases may have underestimated the true incidence.
”We estimated that through the end of September, 1 of every 2.5 (95% Uncertainty Interval (UI): 2.0–3.1) hospitalized infections and 1 of every 7.1 (95% UI: 5.8–9.0) non-hospitalized illnesses may have been nationally reported. Applying these multipliers to reported SARS-CoV-2 cases along with data on the prevalence of asymptomatic infection from published systematic reviews, we estimate that 2.4 million hospitalizations, 44.8 million symptomatic illnesses, and 52.9 million total infections may have occurred in the U.S. population from February 27–September 30, 2020.”

Democrat Schumer says $30 bln in federal funds needed to distribute COVID vaccine: The headline speaks for itself.

Biden adds new members to COVID-19 task force: “The new members are Jane Hopkins, RNMH; Jill Jim, PhD; and David Michaels, PhD.
Ms. Hopkins, who immigrated to the U.S. from Sierra Leone, worked for more than two decades as a bedside nurse, most recently in the Seattle area, and is executive vice president of SEIU Healthcare 1199NW. 
Dr. Jim is a Navajo Nation member and executive director of Window Rock, Ariz.-based Navajo Nation Department of Health. 
Dr. Michaels, a former Occupational Safety and Health Administration administrator, is an epidemiologist and professor at the George Washington University School of Public Health in Washington, D.C.”

The task force is wonderfully diverse with respect to race and gender, but lacks logistics and social marketing expertise.

United Begins Flying Pfizer’s Covid-19 Vaccine: Speaking of logistics… “United Airlines Holdings Inc. on Friday began operating charter flights to position doses of Pfizer Inc.’s Covid-19 vaccine for quick distribution if the shots are approved by regulators, according to people familiar with the matter.
The initial flights are one link in a global supply chain being assembled to tackle the logistical challenge of distributing Covid-19 vaccines. Pfizer has been laying the groundwork to move quickly if it gets approval from the Food and Drug Administration and other regulators world-wide.”

About health insurance

CMS proposed rule reduces user fee in ACA exchanges: “In the proposed annual Notice of Benefit and Payment Parameters for the 2022 Proposed Rule released late Wednesday afternoon, CMS is proposing to reduce the user fee for federally facilitated exchange issuers from 3% to 2.25% of premium for the 2022 benefit year. This will add to the 0.5% reduction in the user fee rate included in the 2020 payment notice, for a total reduction of 1.25% over the past four years. 
CMS proposes to reduce the user fee for issuers offering plans through state-based exchanges that use the federal platform to 1.75% of premium…
CMS is continuing to allow states to implement Section 1332 waivers to waive certain ACA statutory requirements. This proposal allows states to decentralized enrollment through insurers and web brokers rather than using HealthCare.gov.”

CMS announces new flexibilities for care outside of a hospital setting amid COVID-19 surge: “The Centers for Medicare and Medicaid Services has approved waivers for six health systems to provide acute care at home.
The hospitals include  Brigham and Women's Hospital in Massachusetts; Huntsman Cancer Institute in Utah; Massachusetts General Hospital in Massachusetts; Mount Sinai Health System in New York City; Presbyterian Healthcare Services of New Mexico; and UnityPoint Health of Iowa.“

About pharma

Canada blocks bulk exports of some prescription drugs in response to Trump import plan: It was inevitable… “‘Certain drugs intended for the Canadian market are prohibited from being distributed for consumption outside of Canada if that sale would cause or worsen a drug shortage,’ Health Minister Patty Hajdu said in a statement.
‘Companies will now also be required to provide information to assess existing or potential shortages, when requested, and within 24 hours if there is a serious or imminent health risk,’ the statement said.”

The Colchicine Debacle Revisited: This article is a great case study of what happens when “unapproved” drugs that have been used for decades get FDA approval and attendant market exclusivity. The result is, for example, that “Medicaid spending for colchicine increased almost 3000%, from $1.1 million in 2008 to $32.2 million in 2017…
[T]he manufacturer increased the price of colchicine from what had previously been only a few cents to $5 a tablet…”

About healthcare IT

Universal Patient Identifier and Interoperability for Detection of Serious Drug Interactions: Retrospective Study: “Among a population of 49.7 million patients, 242,646 serious drug-drug interaction alerts occurred in 3 years. Of these, 2388 (1.0%) crossed insurance and were discovered because the pharmacy benefit manager used a unique patient identifier. We estimate that up to 10% of serious drug-drug alerts in the United States go undetected by pharmacy benefit managers because of unexchanged information or pharmacy benefit managers that do not use a unique patient identifier. These information gaps may contribute, annually, to up to 6000 patients in the United States receiving a contraindicated medication.”
Is the solution a pharmacy issue or should we (finally) assign unique patient identifiers, like other countries do?

California medical center server issue exposed patient data for 4.5 years: “FMC determined that the misconfiguration existed from around Dec. 16, 2015, to July 31, 2020. The medical center said it cannot rule out unauthorized access to patient records that were present on the server during the time period. Patient data contained on the server includes names, medical images, dates of birth, identification numbers and ordering providers.” While data compromises are, unfortunately, commonplace, this one was unusually long.

About hospitals and health systems

Cleveland Clinic's net income triples in Q3: “The 18-hospital system's revenue climbed to $2.72 billion in the third quarter of this year, up from $2.65 billion in the same period of 2019, according to recently released unaudited financial documents. The increase in revenue was driven by $77 million in grants received through the Coronavirus Aid, Relief and Economic Security Act and employee retention credits. 
The system's net patient service revenue decreased $4.5 million in the third quarter of 2020 compared to the same period of 2019. Inpatient admissions declined 5.3 percent year over year in the third quarter of this year and were down 7.4 percent in the first nine months of 2020.”
These trends have been typical, especially declining patient revenue and admissions as well as reliance on the federal relief funds.

Today's News and Commentary

About the public’s health

CDC may shorten COVID-19 quarantine period guidelines: The shortened time was not specified.

These are the top coronavirus vaccines to watch: This article updates the number of SARS-CoV-2 vaccines in the pipeline and what stage they are at.

Initial Batch Of COVID-19 Vaccines Will Go To States Based On Population, Not Risk: “Instead of waiting for the advisory committee's recommendations, [Operation Warp Speed]… allocated the first 6.4 million doses to states, based on overall population. ‘I finally made the decision, late Friday night,’ said Gen. Gustave Perna, head of logistics for Operation Warp Speed, at the briefing Tuesday. ‘So states could prioritize based on [their] amount,’ meaning how many doses of vaccine each state will receive.”

Evidence Builds That an Early Mutation Made the Pandemic Harder to Stop: “…one mutation near the beginning of the pandemic did make a difference, multiple new findings suggest, helping the virus spread more easily from person to person and making the pandemic harder to stop.
The mutation, known as 614G, was first spotted in eastern China in January and then spread quickly throughout Europe and New York City. Within months, the variant took over much of the world, displacing other variants.” More recently, however: No evidence for increased transmissibility from recurrent mutations in SARS-CoV-2: “At this stage we find no evidence for significantly more transmissible lineages of SARS-CoV-2 due to recurrent mutations.”

Symptoms associated with a positive result for a swab for SARS-CoV-2 infection among children in Alberta: “About two-thirds of the children who tested positive for SARS-CoV-2 infection reported symptoms. The symptoms most strongly associated with a positive SARS-CoV-2 swab result were anosmia/ageusia, nausea/vomiting, headache and fever.”

Zeteo Biomedical Partners With Iowa State University on Nasal COVID-19 Vaccine: “The Austin, Tex., company will contribute its ZEOx2 nasal delivery technology, including devices that support powder and reconstituted powder-to-liquid vaccine formulations that can be administered by either healthcare providers or patients. The company said the nasal delivery devices are commercially scalable to deliver millions of vaccine doses per day.”

With more data on its COVID-19 vaccine, Russian institute offers new evidence of success: “Joining the flood of press releases announcing positive results from COVID-19 vaccine trials, developers of Russia’s Sputnik V vaccine today reported 91.4% efficacy from a second interim analysis of more than 18,000 people, bolstering a claim the team made on 11 November with scant evidence.” While this country will not be using this vaccine, it is important that it really works; many countries will be using this vaccine.

6.4 million COVID-19 vaccine doses expected to be shipped to states by mid-December: ”An estimated 6.4 million doses of Pfizer’s vaccine will be distributed to states and territories by mid-December, assuming it receives Food and Drug Administration (FDA) authorization by that point, Operation Warp Speed officials told reporters Tuesday. 
State officials were notified Friday how many doses they should expect to receive in the initial distribution, and they will make their own decisions about who will be prioritized for the first doses.”

U.S. infectious disease group backs Gilead's remdesivir for COVID-19 treatment: “The Infectious Diseases Society of America (IDSA) in updated guidelines said its experts back the drug for use in severe COVID-19 patients based on a clinical trial showing it reduced hospital stays. The WHO study that led to its recommendation against the drug suggested it had no benefit in saving lives or reducing the need for mechanical breathing assistance.”

Parents' Age Key to Whether Kids Get Vaccinated Against COVID, Study Finds: “Younger parents are much less likely than older ones to plan to vaccinate their children and themselves against COVID-19.”

Oxford Covid vaccine 'bottlenecks' mean UK's full order will not be ready until end of next year: “According to the news source, AstraZeneca is facing an uphill battle, having already fallen behind schedule. During the first wave, the company targeted 30 million doses ready for use in the UK by September, but now expects only four million by the end of the year.
In total, the firm says it will have produced 20 million doses by the end of 2020, but these shots will not yet have been poured into vials, which takes time…”

Aetna pilot harnesses CVS pharmacists to address Medicaid members' social needs: “Through the HealthTag initiative, CVS Health pharmacists and pharmacy employees are empowered to offer more personalized information when Aetna Medicaid members come to pick up prescriptions, providing the members with health information beyond how to take their medications appropriately.
Inside the prescription bag, members are provided additional details on how to access community services to address social concerns like food, housing or transportation. The network of these organizations is backed by Unite Us, a social care coordination program.”

About health insurance

CMS Issues Final Rule to Amend the U.S. Department of Health and Human Services’ Risk Adjustment Data Validation [RADV] Program: “For 2019 benefit year HHS-RADV and beyond, CMS is finalizing the following three modifications to the error rate calculation:

  • CMS will modify the way that it groups medical conditions in HHS-RADV within the same hierarchical condition category (HCC) coefficient estimation groups in risk adjustment to determine failure rates for those HCCs. This modification seeks to better account for the difficulty in categorizing certain conditions and to, therefore, refine how the error rate calculation measures risk differences within and between condition groupings.

  • CMS will make changes that would reduce the magnitude of risk score adjustments for issuers close to the threshold used to determine whether an issuer is an outlier. Currently, issuers whose failure rates are not significantly different from issuers just inside the threshold may see significant changes to their risk scores and transfers, creating a “payment cliff” for issuers just outside the threshold. Adjusting the magnitude of risk score adjustments intends to mitigate this effect.

  • CMS will modify the error rate calculation in cases where certain outlier issuers have a negative failure rate. A low failure rate is not always due to more accurate data submission. A low failure rate can also be due to not identifying conditions that should have been reported in risk adjustment. The final rule refines the error rate calculation to mitigate the impact of adjustments that result from error rates driven by these newly found conditions.”

Connecticut Comptroller Lembo Launches "Network Of Distinction" To Deliver Highest-Quality Care And Save On Costs: “The Office of the State Comptroller is partnering with Signify Health to improve health outcomes for certain common procedures and save on costs through a new ‘Network of Distinction’ program. The doctors, hospitals and provider groups in the network will provide improved patient outcomes at a competitive fixed price for care from evaluation to recovery.
This innovative ‘episode of care’ delivery and payment model establishes a new industry standard by aligning clinical and financial incentives for the state employee health plan and the Connecticut Partnership Plan, totaling more than 220,000 members. Under the initial agreement, 180 health care provider groups have committed to meet a set of quality care standards at the lowest possible cost. New groups will continue to be added throughout the year.”

About healthcare financing

JD Health to raise up to $4bn in Hong Kong IPO: “JD Health, the healthcare unit of Chinese ecommerce group JD.com, will raise up to $4bn in Hong Kong next month, in what is likely to be one of the world’s biggest initial public offerings this year. The company, which sells pharmaceuticals and health services online, said an initial sale of 382m shares could bring in as much as $3.5bn, according to a term sheet seen by the Financial Times. That would value JD Health at up to $28.5bn.”

Today's News and Commentary

About pharma

AstraZeneca probes 'mistake' behind 90% COVID-19 vaccine efficacy: As previously reported, the vaccine dose that was 90% efficacious was a half dose followed by a full dose. That regimen was mistakenly given to some volunteers but proved better than two full doses.

Moderna to charge $25-$37 for COVID-19 vaccine, says CEO: ”Moderna will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered, Chief Executive Stephane Bancel told German weekly Welt am Sonntag (WamS).
‘Our vaccine therefore costs about the same as a flu shot, which is between $10 and $50,’ he was quoted as saying.
On Monday, an EU official involved in the talks said the European Commission wanted to reach a deal with Moderna for the supply of millions of doses of its vaccine candidate for a price below $25 per dose.”

Purdue Pharma Pleads Guilty to Felonies Over OxyContin Sales:”Purdue Pharma LP pleaded guilty Tuesday to three federal felonies related to the marketing and distribution of its powerful opioid painkiller OxyContin, ending the bankrupt company’s exposure to U.S. government action but leaving other liabilities to state and local governments looming.”

3 pharmacy industry groups sue to stop new US drug import rule: “Three pharma industry groups are suing HHS and the FDA to block a rule that would allow the importation of certain prescription drugs from Canada.
The groups filing the suit are Pharmaceutical Research and Manufacturers of America, Partnership for Safe Medicines and the Council for Affordable Health Coverage.”

Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person: “ Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person (post-exposure prophylaxis).” It is only approved for those age 12 and older. Many sites list the cost at $150, but say couponing will bring the out of pocket expense down.
About health insurance

Employers start sending workers shopping for health coverage: This article is a reminder about a subject previously reported:
”Instead of offering one or more options, some companies are turning health insurance shopping over to employees.
A federal rule change last year stoked this new approach. It allows employers to reimburse workers for coverage they bought without paying a tax penalty. 
The concept sends employees to individual insurance markets where they can find more choices for coverage. It also protects employers from huge annual cost spikes. But it’s a big change for workers who are used to having their employer give them benefit choices every year.
This new approach — known as an Individual Coverage Health Reimbursement Arrangement or ICHRA — started with coverage plans for this year. More workers will likely see them offered this fall during their company’s annual sign-up window for 2021 coverage.”

Texas and Louisiana can cut Medicaid funding for Planned Parenthood, federal appeals court rules: “The ruling was handed down by the 5th U.S. Circuit Court of Appeals in New Orleans. While it expressly reversed decisions in Texas and Louisiana, it also affects Mississippi, which is under 5th Circuit jurisdiction. The issue is likely to go next to the U.S. Supreme Court.
Opponents of legal abortion have long sought to deny federal Medicaid funding for Planned Parenthood clinics.”

Insurer Participation on the ACA Marketplaces, 2014-2021: “For the third straight year, several insurers are entering the market or expanding their service area in 2021. This year, we find that 30 insurers are entering the individual market across 20 states (Table 1) and an additional 61 insurers are expanding their service area within states they already operated. There will be an average of 5.0 insurers per state in 2021, up from a low of 3.5 in 2018 but still below the peak of 6.0 in 2015. The number of insurers per state ranges from one company operating in Delaware to thirteen operating in Wisconsin.” The article has some helpful graphics that explain the trends.

Cigna CEO, Board Sued for ‘Black Ops’ Effort to Kill Anthem Deal: “A Massachusetts-based pension fund alleges that Cigna CEO David Cordani sought to “poison” the deal after failing to secure the top post in the merged company. He hired lawyers and public relations specialists to help in a ‘Trojan Horse’ campaign, the fund claims. The deal, which would have created the largest U.S. health insurer, collapsed in 2017.”

About the public’s health

There was a 28% increase in child Covid-19 cases over the last two weeks, American Academy of Pediatrics says: “There were more than 144,000 new cases of Covid-19 reported among children last week, the American Academy of Pediatrics (AAP) said Monday.
Over the last two weeks, there has been a 28% increase in child Covid-19 cases and children now account for more than 11% of all confirmed coronavirus cases in the US, according to the AAP.
About 144,145 new cases among children 17 and under were reported from November 12 to 19, AAP said.”

Assessment of 135 794 Pediatric Patients Tested for Severe Acute Respiratory Syndrome Coronavirus 2 Across the United States: “Among the 5374 patients with positive test results, 359 (7%) were hospitalized for respiratory, hypotensive, or COVID-19–specific illness. Of these, 99 (28%) required intensive care unit services, and 33 (9%) required mechanical ventilation. The case fatality rate was 0.2% (8 of 5374).”
”This study suggests that for most pediatric patients, the risk of SARS-CoV-2 infection appears low, but higher concern may be warranted for patients with medically complex conditions or those of minority race/ethnicity.”

A $10 Covid-19 Test? Walmart Heirs Back Startup Developing At-Home Tests: “The billionaire Walton family that controls Walmart Inc. is among a group of investors backing a startup aiming to design at-home Covid-19 tests to sell for as little as $10 at the retail giant’s stores and elsewhere.
NowDiagnostics Inc., based 20 miles south of Walmart’s corporate headquarters, has filed requests for emergency authorization from the U.S. Food and Drug Administration for a Covid-19 antibody blood test, according to the Springdale, Ark., company.
It is also developing two at-home Covid-19 tests that would use a patient’s saliva and deliver results in minutes, said Chief Executive Kevin Clark.”

About healthcare quality

Variations in processes for guideline adaptation: a qualitative study of World Health Organization staff experiences in implementing guidelines: “The contrasting models of guideline adaptation encountered in the interviews show the differing processes employed by WHO staff in different regions in the world. One is a Copy or Customise model of adaptation through consultation with local health authorities and stakeholders. This model takes parts of WHO guidelines and applies them as is or in modified form in-county, while taking into account the local epidemiology, system capacity and existing policies. The other model is based on capacity building where WHO regional offices help build and support national guideline development and adaptation programs so national guidelines can be developed based on WHO or other evidence-based guidelines using thorough framework for evidence evaluation to inform the strength of recommendations in the local setting. The actual processes of guideline adaptation revealed by our interviews existed along a spectrum between these 2 models.”

About health policy

Association of State Certificate of Need Regulation With Procedural Volume, Market Share, and Outcomes Among Medicare Beneficiaries: “Among Medicare beneficiaries who underwent a range of surgical procedures from 2016 through 2018, there were no significant differences in markers of hospital volume or quality between states without vs with certificate of need laws. Policy makers should consider reevaluating whether the current approach to certificate of need regulation is achieving the intended objectives and whether those objectives should be updated.” See also the accompanying editorial: Revisiting States’ Experience With Certificate of Need.
This research is in a long line of other studies that show how ineffective CON regulations are.

Today's News and Commentary

About public policy

Court: Tennessee can enforce Down syndrome abortion ban:”A federal appeals court ruled Friday that Tennessee can begin outlawing abortions because of a prenatal diagnosis of Down syndrome, as well as prohibit the procedure if it’s based on the race or gender of the fetus.”

Modernizing and Clarifying the Physician Self-Referral Regulations: In a strictly fe-for-service environment, these self-referral laws are important to avoid financial conflicts of interest. But with increasing value arrangements where risks and rewards are shared among providers, these restrictions need to be loosened to provide proper incentives.
“This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.” Here is a shortened CMS Fact Sheet of the changes,

About hospitals and health systems

Ascension's net income hits $1B in Q1: Hospitals and systems will start to report Q1 results when some elective services opened up. Now that we are into a pandemic relapse, we may see Q2 results look like they did during the first wave of COVID-19.

About pharma

Amazon’s drugs unlikely to prove fatal to pharmacies, say experts: “CVS, Walgreens, Cigna and United — will begin Monday’s trading a combined $40bn lighter” after Amazon announced its expanded pharmacy service last Tuesday. But many experts predict that it will not have a big impact on retail pharmacies and PBMs because of existing contracts and patient relationships. Also, physicians must want to break established patterns and be able to easily prescribe on the Amazon platform. The one segment that makes sense for Amazon to take over is the low, fixed-price 90 day prescription that some pharmacies now offer for common generics. The “free” delivery feature ia also attractive, helping customers stay clear of crowded facilities.

AstraZeneca, Oxford Covid-19 Vaccine Up to 90% Effective in Late-Stage Trials: The vaccine requires two doses and does not have to be kept at the same low temperatures as the Pfizer-BioNTech product. Also, the most efficacious dose was a smaller first one followed by a full dose a month later.

Hey, pharma: When it comes to influencers, forget lifestyle gurus and stick to patient advocates, study says: “Its recent network survey found that only 14% percent of the WeGo users surveyed mostly or completely trust lifestyle influencers, while 51% completely or mostly trust patient influencers. When it comes to branded pharma products, the survey was even more positive for patient influencers: 85% said they would be very or somewhat receptive to an ad from a patient influencer promoting a drug-related to the patient’s condition.”

Frequently Asked Questions Regarding the Department of Health and Human Services’ Announcement on the Unapproved Drugs Initiative: In addition to the executive orders to end drug price rebates and implement foreign country index drug pricing (see Friday’s post), in Friday’s presidential message is an announcement ending the Unapproved Drug Initiative.
Briefly, some drugs were grandfathered into allowed use or came to market without FDA approval. In the former category were very old drugs (like colchicine for gout); the newer ones did not have equivalents practitioners wanted to treat specific conditions. Since 2006, when the Unapproved Drugs Initiative started, some formulations of these unapproved drugs were pulled from the market because of harmful effects. The result was that pharma companies patented and/or obtained monopolies on those pulled drugs by submitting them for approval. From a quality standpoint, it might seem like process was a good idea; however, the approved drugs often raised the prices dramatically- even for the very old generics. For example, a Vizient analysis published today showed that ending the Unapproved Drugs Initiative could save between $7.52 Billion and $26.59 Billion. This case is a perfect example of cost-quality tradeoff. But the fundamental problem is lack of drug price oversight.

About healthcare IT

FDA clears Baxter’s virtually connected, in-home peritoneal dialysis system: “Baxter has received clearance from the FDA for the latest version of its automated peritoneal dialysis system designed for home use, combining it with a digital platform that aims to help patients with kidney disease manage their care remotely.
The Homechoice Claria system was cleared for both adults and children. Its interface is available in 38 languages and features step-by-step, voice-activated instructions through an accompanying app to help guide the user through therapy.”

About the public’s health

Poor Performance of Masks Secured Using Ear Loops: “When comparing a surgical mask with head ties vs a procedure mask with ear loops, there was a large difference in fitted filtration efficiencies (FFEs) (71.5% v 38.1%, respectively).Even more worrying, there was also a similar trend of poor FFE performance for N95 respirators designed with ear loops vs those with head straps…”

About health insurance

CMMI announces participants of Primary Care First Model: “The Primary Care First Model will begin in January 2021 with 916 primary-care practices participating along with 37 payers. The model, first announced in April 2019, is part of the agency's ongoing effort to expand value-based payment options in Medicare toreduce healthcare spending.”
“Primary Care First is oriented around comprehensive primary care functions: (1) access and continuity; (2) care management; (3) comprehensiveness and coordination; (4) patient and caregiver engagement; and (5) planned care and population health...
Eligible practitioners (that each practice applicant must identify by NPI in its application) are those in internal medicine, general medicine, geriatric medicine, family medicine, and/or hospice and palliative medicine.” For more information, check the CMMI summary.

Today's News and Commentary

About the public’s health

Pfizer and BioNTech will seek regulatory clearance of their coronavirus vaccine: Filing is expected today with vaccine availability in mid to late December.

SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis:”Mean duration of SARS-CoV-2 RNA shedding was 17·0 days… in upper respiratory tract, 14·6 days… in lower respiratory tract, 17·2 days… in stool, and 16·6 days… in serum samples. Maximum shedding duration was 83 days in the upper respiratory tract, 59 days in the lower respiratory tract, 126 days in stools, and 60 days in serum. Pooled mean SARS-CoV-2 shedding duration was positively associated with age... No study detected live virus beyond day 9 of illness, despite persistently high viral loads [emphasis added], which were inferred from cycle threshold values. SARS-CoV-2 viral load in the upper respiratory tract appeared to peak in the first week of illness, whereas that of SARS-CoV peaked at days 10–14 and that of MERS-CoV peaked at days 7–10.”

Nearly half of patients say they'd feel safest getting COVID-19 vaccine at doctor's office: survey: “When asked in the second annual ‘State of Patient Access and Engagement’ 2020 survey where consumers would feel safest receiving the COVID-19 vaccine, nearly half chose the doctor's office. The survey, conducted OnePoll and commissioned by DocASAP, a patient access platform, polled 1,000 U.S. adults who had visited a doctor in the last 12 months. It also found one in three respondents said they'd feel safest getting a vaccine at a hospital and 29% said they'd feel safest at a pharmacy.”

Tobacco Product Use Among Adults — United States, 2019: From the CDC: ”In 2019, approximately 20.8% of U.S. adults (50.6 million) currently used any tobacco product. Cigarettes were the most commonly used tobacco product among adults, and e-cigarettes were the most commonly used noncigarette tobacco product (4.5%). The highest prevalence of e-cigarette use was among smokers aged 18–24 years (9.3%), with over half (56.0%) of these young adults reporting that they had never smoked cigarettes…
18.6% reported using two or more tobacco products.”

The evidence doesn't support closing schools to stop the coronavirus: A good overview of this contentious issue. “The nation's top infectious disease expert, Anthony S. Fauci, said last night he too was a proponent of keeping schools open if at all feasible. ‘One of the things we need to do...is try to keep the kids in school,’ Fauci, director of the National Institute for Allergy and Infectious Diseases, told CNN yesterday. ‘My feeling is the default condition is to keep the schools open if you possibly can.’”

Primary Care & COVID-19: Week 22 Survey: Among the results from this survey:
“Patients’ overall health continues to suffer due to the pandemic. Over 85% of respondents report that the mental health of their patients has decreased during the pandemic, with 31% seeing a rise in patients suffering with addiction. Over a third (37%) say their patients with chronic conditions are in “noticeably worse health resulting from the pandemic.” This is due, in part, to visits that are not happening: 56% of surveyed clinicians have seen an increase in negative health burdens due to delayed or inaccessible care.”

AMA urges multifaceted approach to address social determinants of health: “At the Special Meeting of the American Medical Association (AMA) House of Delegates, physicians adopted policies…to address social determinants of health as part of health insurance coverage. The disproportionate impacts of the COVID-19 pandemic have highlighted the need to address nonmedical, yet critical, health needs and the underlying determinants of health — economic stability, neighborhoods, transportation, education and life opportunities, access to food, quality and safe housing, community/social support, and access to health care.”

About healthcare IT

The Sequoia Project Publish Person Matching Case Study with 99.5% Accuracy: The Sequoia Project, a non-profit and trusted advocate for nationwide health information exchange, patient identity management experts collaborated with the Blue Cross Blue Shield Association to apply A Framework for Cross-Organizational Patient Identity Management for the payer community and develop person matching strategies. Today, The Sequoia Project published Person Matching for Greater Interoperability: A Case Study for Payers which demonstrates high matching accuracy rates, and provides actionable insights for improving person identity matching across the payer community, a critical component of successful health information exchange and interoperability.”
Comment: Identity confusion is a not uncommon error in healthcare. While great strides are being made to flawlessly identify patients, the standards do not come close to even acceptable manufacturing errors. At an error rate of 0.5%, assuming everyone in the US is subject to misidentification, the affected number would be about 16.4 million. The fundamental problem is we still do not have a universal patient identifier, a feature which was removed from the original HIPAA legislation.

About health insurance

CMS says 800K more have signed up for coverage on HealthCare.gov in 2nd week: “More than 800,000 additional people signed up for coverage on HealthCare.gov in the second week of open enrollment, according to new data from the Trump administration.
The Centers for Medicare & Medicaid Services (CMS) said Thursday that 803,741 enrolled in plans through HealthCare.gov between Nov. 8-14. Through two weeks, 1.6 million have enrolled in coverage.
That includes 170,284 new customers and 633,457 people renewing coverage in week two, CMS said.”

About pharma

Trump Administration Finalizes Proposal to Lower Drug Costs by Targeting Backdoor Rebates and Encouraging Direct Discounts to Patients: This final rule affects rebates from drug companies to Medicare Part D and PBMs. (See the article for an explanation for why the rule was put in place.) HHS allowed these rebates because there was a “safe-harbor” protection. This final rule eliminates the protection. Medicaid Managed Care Organizations will still have a “safe-harbor” protection on rebates.

Trump Administration Announces Prescription Drug Payment Model to Put American Patients First: From the HHS Fact sheet: “The Centers for Medicare & Medicaid Services (CMS) is announcing a new payment model, the Most Favored Nation (MFN) Model (or the ‘MFN Model’), and issuing a corresponding Interim Final Rule with Comment Period (IFC). The MFN Model will lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals (hereinafter called ‘drugs’) than the lowest price that drug manufacturers receive in other similar countries. The MFN Model will also pay providers a flat add-on amount for each dose of an MFN drug, instead of a percentage of each drug’s cost, removing the tie between drug cost and the add-on amount. Beneficiaries will pay lower coinsurance for these high-cost Part B drugs and will not pay coinsurance on the add-on payment. The MFN Model will require participation of Medicare providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs, with certain exceptions, and begin nationally January 1, 2021…
The MFN Model will test paying Part B drugs at comparable amounts to the lowest adjusted price paid by any country in the Organisation for Economic Co-operation and Development (OECD) that has a Gross Domestic Product (GDP) per capita that is at least 60 percent of the U.S. GDP per capita…
The mandatory MFN Model will operate for seven years, from January 1, 2021 to December 31, 2027.”
Comments: Go to this website to see the large number of countries that will be in the 60% bracket (start on the right and go to the left until you get to Estonia). Also, note this announcement is an Interim Final Rule open for comment.

Surprise Federal Drug Rule Directs Insurers to Reveal What They Pay for Prescription Drugs: “Health insurance companies will have to give their customers estimated out-of-pocket costs for prescription drugs and disclose to the public the negotiated prices they pay for drugs, under an unexpected new Trump administration rule.
The administration said those requirements, part of a broader rule issued Oct. 29 forcing health plans to disclose costs and payments for most health care services, will promote competition and empower consumers to make better medical decisions.
The new rule does not, however, apply to Medicare or Medicaid.
The drug price provisions, which would not begin until 2022, were a surprise because they were not included in the original proposed rule issued in 2019.”

A living WHO guideline on drugs for covid-19: These updates from the WHO are ongoing and published by BMJ. The update includes remdesivir (not recommended, weak evidence) and corticosteroids (recommended only for severe or critically ill patients). The evidence for these recommendations is included in tabs below the introductory graphic. In a related article: Eli Lilly arthritis drug gets FDA nod for emergency use with remdesivir to treat COVID-19:”The U.S. Food and Drug Administration on Thursday approved the emergency use of Eli Lilly and Co’s arthritis drug, baricitinib, in combination with Gilead Sciences Inc’s remdesivir, to treat COVID-19 patients. Baricitinib, sold under the brand name of Olumiant, is an FDA-approved oral medication to treat moderately-to-severely active rheumatoid arthritis.”

Are patients more adherent to newer drugs?: “This study has investigated the relationship between drug quality that we captured by a drug’s vintage as measure of productivity of treatment and medication adherence in the US working population. We demonstrate that patients tend to be more adherent to newer drugs. The medicine possession ratio increases by 2.5 percentage points when the mean vintage of a drug increases by ten years. This effect may appear small, but our estimates indicate that a 10-year increase in drug vintage has the same effect on medication adherence as a 0.35 USD reduction in copayment per day of therapy. Also, our estimates of vintage reflect averaged effects across all drugs of the same vintage, some of which may be more effective in terms of effectiveness than others.”
Comment: This article is likely to be used by the pharma industry to support its case for innovation expenses; but the results should be cautiously interpreted. After reading the article I could not find an answer to a concern I had about the methodology: Patients whose drugs do not work for their illness or who develop side effects will stop them and be classified as non-compliant. For these patients, newer drugs are likely to be used and, if they work, will appear as a higher level of compliance than the discontinued ones. The research is couched in economic theory with little medical input.

Today's News and Commentary

About the public’s health

Covid-19 has killed 250,000 people in the US. That's 10 times the deaths from car crashes in a year: The headline speaks for itself. In a related article: 3 million Americans currently contagious with coronavirus: analysis.

Oxford Covid vaccine could build immunity in older people – study: “The ChAdOx1 nCov-2019 vaccine has been shown to trigger a robust immune response in healthy adults aged 56-69 and over 70…
According to the researchers, the trial demonstrated similar immune responses across all three age groups – 18-55, 56-69, and 70 and over.” The results are from a Phase 2 study.

More people are getting COVID-19 twice, suggesting immunity wanes quickly in some: This report contrasts with the one posted yesterday that immunity can last years. Obviously there is a range of immune responses.

Mysteries of COVID Smell Loss Finally Yield Some Answers: An understandable explanation of this symptom from Scientific American. The short version: “Disruption of the olfactory epithelium could explain the loss of smell. Yet it remains unclear whether the damage is done by the virus itself or invading immune cells…”

A covid-fighting tool is buried in your phone. Turn it on.: “About 100 million Americans now have the ability to get pop-up notifications from local health authorities when they’ve personally spent time near someone who later tested positive for the coronavirus.
But exposure notifications only work if you and the people around you turn them on. Yes, you!
There’s early evidence this anonymous smartphone technology works — but so far isn’t helping very many Americans…”

The Coronavirus Is Airborne Indoors. Why Are We Still Scrubbing Surfaces?: ”Hand washing with soap and water for 20 seconds — or sanitizer in the absence of soap — is still encouraged to stop the virus’s spread. But scrubbing surfaces does little to mitigate the virus threat indoors, experts say…”

INSIGHT - COVID toll turns spotlight on Europe's taboo of data by race:”Many European countries avoid breaking down data along racial or ethnic lines out of concern over privacy or discrimination, but COVID-19's outsized impact on Black and Asian people has exposed flaws in the approach, some scientists and activists said.
They want more comprehensive data collection across the continent to improve understanding about how and why COVID-19 affects different communities, and thereby help countries tailor testing and care to better protect them.”

Azar expects 40M COVID-19 vaccine doses ready to distribute by end of December: “Department of Health and Human Services Secretary Alex Azar expects 40 million doses of Pfizer and Moderna’s COVID-19 vaccines will be ready for distribution by the end of December as providers must gear up now to allocate the doses.
Azar gave an update on vaccine distribution as part of Operation Warp Speed on Wednesday.”

About healthcare IT

2020 HIMSS Cybersecurity Survey: A great source of information from a survey of 168 cybersecurity experts. Some of the findings:

• “Most organizations are experiencing significant security incidents. Significant security incidents are the norm.

• Phishing is the most common type of significant security incident. Phishing is the number one type of significant security incident; most phishing is either general phishing or spear-phishing occurring via e-mail.

• Top threat actors include online scam artists and cybercriminals. Online scam artists (e.g., phishers) and cybercriminals are targeting many healthcare organizations.

• Financial information is king. Threat actors typically seek the following: (i) financial information, (ii) employee information, and (iii) patient information.

Initial hook is by phishing. Phishing e-mail is the typical initial point of compromise.

• Workforce members are the first line of defense. Internal security teams and internal personnel, including non-IT professionals, typically report significant security incidents to the organization.

• Disruption is the Primary Impact. Disruption of information technology (“IT”) operations and business operations are typical outcomes of cyber-attacks. Disruption of clinical care or damage or destruction of clinical care systems and devices also occurs.”

Virtual Healthcare Use Among Medicare Advantage Members Before and During the COVID-19 Pandemic: An insightful analysis of virtual healthcare use in the senior market.
“Mental health conditions and/or substance use disorders were the largest group of primary diagnoses treated virtually, with growth in virtual services of more than 5,000 percent in 2020 compared to 2019.
Older members (ages 75+) used a smaller share of virtual services in March-May 2020 than would be expected based on their 2019 in-person utilization, but still used substantially more virtual services in 2020 than in 2019.”

Bayer initiates new G4A Digital Health Partnerships Program: “Bayer will support five new startup companies as part of the company’s G4A Digital Health Partnerships Program. Focus will be on fostering the development of a digital health ecosystem, while driving forward integrated healthcare solutions in the fields of cardiometabolic and renal diseases, oncology, and women’s health. The participating digital healthcare companies were selected by Bayer from over 400 applications from over 65 countries based upon current and future strategic fit, development stage and assessment.”
Read the article for more in formation about the five companies.

About health insurance

Review of Contract Year 2021 Medicare Advantage supplemental healthcare benefit offerings: This report was prepared by Milliman and assessed the growth of MA supplemental benefits for contract years 2019-2021. The following categories all increased in frequency: Adult Day Health Services, Home-Based Palliative Care, In-Home Support Services, Support for Caregivers of Enrollees, and Therapeutic Massage.”

Appeals court sides with hospitals in latest challenge of DSH payment calculations: “A federal appeals court upheld a ruling that would allow hospitals to calculate their disproportionate share hospital (DSH) payments using Medicaid patients as well as patients eligible for treatment under experimental Medicaid ‘demonstration projects’ approved by the Department of Health and Human Services (HHS).
The opinion, issued Friday, upheld the decision of a lower court that sided with 10 Florida hospitals seeking to include days of care funded by Florida’s Low Income Pool, an approved Medicaid demonstration project. Through the pool, the state and federal governments jointly reimbursed hospitals for care provided to uninsured and underinsured patients.”

About pharma

Judge Strikes Opioid Claims Against Prescribers: “The Ohio federal judge overseeing the multidistrict litigation over the opioid crisis on Wednesday struck pharmacies' claims that third-party healthcare workers were liable for writing opioid prescriptions, saying they're using previously rejected arguments.”

Today's News and Commentary

About the public’s health

PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS: This announcement is for the Phase 3 conclusion and includes the previous efficacy (94.5%) data. It will still be another month or so before the vaccine hits the market. A related article, The Health 202: Coronavirus vaccines are one thing Trump got right, has a really good graphic explanation of the mRNA vaccine process as well as how Pfizer will keep specimens cold for shipment.

Immunity to the Coronavirus May Last Years, New Data Hint:”The research, published online, has not been peer-reviewed nor published in a scientific journal. But it is the most comprehensive and long-ranging study of immune memory to the coronavirus to date.”

Hospitals Can’t Go On Like This: “Now new data released by the Department of Health and Human Services quantify the crisis in America’s hospitals in closer detail. At The Atlantic’s request, HHS provided data on the number of hospitals experiencing staffing shortages. From November 4 to November 11, 958 hospitals—19 percent of American hospitals—faced a staffing shortage. This week, 1,109 hospitals reported that they expect to face a staffing shortage. That’s 22 percent of all American hospitals.
In eight states, the situation is even more dire. More than 35 percent of hospitals in Arkansas, Missouri, North Dakota, New Mexico, Oklahoma, South Carolina, Virginia, and Wisconsin are anticipating a staffing shortage this week.”

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home: “The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only. 
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.”

Imputed State-Level Prevalence of Achieving Goals To Prevent Complications of Diabetes in Adults with Self-Reported Diabetes — United States, 2017–2018: “Effective management of hemoglobin A1C, blood pressure, cholesterol, and avoiding smoking (ABCS) is important in preventing complications from diabetes…
During 2017‒2018, the proportion of U.S. adults with self-reported diabetes who met ABCS goals was suboptimal. Only 26.4% met all the ABCS goals, 75.4% met the A1C goal, 70.4% met the blood pressure goal, 55.8% met the cholesterol goal, and 86.0% were current nonsmokers.”

First ever vaccine listed under WHO emergency use: WHO “listed the nOPV2 vaccine (Bio Farma, Indonesia) for emergency use to address the rising cases of a vaccine-derived polio strain in a number of African and East Mediterranean countries. Countries in WHO’s Western Pacific and South-East Asia regions are also affected by these outbreaks. The emergency use listing, or EUL, is the first of its kind for a vaccine and paves the way for potential listing of COVID-19 vaccines.”

Britain to ban new petrol cars by 2030 on road to net zero emissions: “Britain will ban the sale of new petrol and diesel cars and vans from 2030, five years earlier than previously planned, as part of what Prime Minister Boris Johnson is casting as a ‘green revolution’ to cut emissions to net zero by 2050.”

FDA to make emergency use authorization data public for COVID-19 vaccines: “The U.S. Food and Drug Administration said on Tuesday it would make public reviews of all data and information regarding the emergency use authorization (EUA) granted to COVID-19 drugs and vaccines.”

Ranking the effectiveness of worldwide COVID-19 government interventions: A comprehensive evaluation of non-pharmacological interventions around the world.

About pharma

House Passes Bill Targeting Orphan Drug Exclusivity: “The U. S. House of Representatives on Tuesday passed a bill that would require drugmakers to prove they don't expect to recoup research and development costs through sales of a new drug if they want market  exclusivity under a shield for drugs that treat rare diseases.”

 Purdue Pharma Gets Court Approval For $8B Deal With Feds: “A New York bankruptcy Judge on Tuesday approved Purdue Pharma's $8 billion settlement of federal felony charges stemming from its OxyContin sales and   said Purdue's former owning family can pay $225 million in fines without violating court orders.” 

 China pharma shares fall as western rivals lead in vaccine trials: “Successful trials of western pharmaceutical groups’ coronavirus vaccines have sliced more than $13bn off the market capitalisation of Chinese rivals, hitting Beijing’s ambitions to lead the global fight against the pandemic. An index tracking shares of 14 vaccine producers listed in Shanghai and Shenzhen has dropped 11 per cent since Pfizer first announced its positive phase-three trial results earlier this month, and is down about a third from its peak in August.”

About health insurance

CMS: Estimated improper Medicare payments down $15B since 2016: “CMS said the improper payment rate in Medicare fee-for-service declined to 6.27% in the 2020 federal fiscal year that ended in September. The rate is down from 7.25% in fiscal 2019 and 2020 is the fourth consecutive year that the rate is below 10%.
The decline in 2020 was primarily due to improvements in two areas. The first is home health, where CMS clarified documentation requirements and educated providers, resulting in a $5.9 billion decline in estimated improper payments from fiscal 2016 through 2020.
Another area that saw reductions was skilled nursing facilities, which saw a $1 billion decline in estimated improper payments in the last year.”

US Oncology Network Achieves Record Patient Enrollment for Oncology Care Model Program: “A total of 100,000 patients are now enrolled Centers for Medicare & Medicaid Innovation’s (CMMI) Oncology Care Model (OCM), as a result of the efforts of The US Oncology Network (The Network). Participation of The Network in OCM has saved Medicare a collective $122 million in the first 6 performance periods (PP).”

Healthcare exec pleads guilty to part in $1.2B Medicare fraud scheme: “Mr. Davydov was one of 24 defendants charged in April 2019 for his alleged participation in the overarching $1.2 billion healthcare fraud scheme. According to federal prosecutors, the complex scam began with telemarketers calling Medicare beneficiaries and getting them to accept free or low-cost durable medical equipment braces, regardless of medical necessity. The call centers would allegedly transfer Medicare beneficiaries to telemedicine companies for consultations with physicians, who allegedly prescribed the orthopedic braces to patients whom they had never met. The call centers would sell the prescriptions to DME companies, which shipped the braces to beneficiaries, billed Medicare and paid kickbacks to physicians, according to prosecutors. 
Mr. Davydov received and completed the physicians' orders and billed Medicare and private insurers for the braces. He concealed his ownership of the medical equipment companies by falsely reporting to Medicare that various straw owners owned the companies, according to the Justice Department.”

Today's News and Commentary

About the public’s health

WHO sees limited COVID-19 vaccine doses in early 2021: “The World Health Organization’s chief scientist said on Monday she expected there to be ‘very limited’ COVID-19 vaccine doses available in the first half of 2021.”

Use of adenovirus type-5 vectored vaccines: a cautionary tale: Different techniques are being investigated for effective SARS-CoV-2 vaccines. One of theses methods uses a viral delivery system. This article cautions that this type of virus has been used before in attempting to develop an HIV vaccine.
”Over a decade ago, we completed the Step and Phambili phase 2b studies that evaluated an Ad5 vectored HIV-1 vaccine administered in three immunisations for efficacy against HIV-1 acquisition. Both international studies found an increased risk [emphasis added] of HIV-1 acquisition among vaccinated men.”

A cervical cancer-free future: First-ever global commitment to eliminate a cancer: “WHO‘s Global Strategy to Accelerate the Elimination of Cervical Cancer, launched today, outlines three key steps: vaccination, screening and treatment. Successful implementation of all three could reduce more than 40% of new cases of the disease and 5 million related deaths by 2050.
Today’s development represents a historic milestone because it marks the first time that 194 countries commit to eliminating cancer - following adoption of a resolution at this year’s World Health Assembly.”
The article has the metrics that will be used in evaluating the success of this program.

Pfizer to start pilot delivery program for its COVID-19 vaccine in four U.S. states: “Pfizer Inc has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements.
Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).”

Effect of School-Based Body Mass Index Reporting in California Public Schools: It is important to know what works as well as what does not. “Body mass index reports alone do not improve children’s weight status and may decrease weight satisfaction. To improve student health, schools should consider investing resources in evidence-based interventions.”

 About healthcare quality

Fortune and IBM Watson Health Recognize Top-Performing U.S. Cardiovascular Hospitals: “Extrapolating the results of this year's study, if all Medicare inpatients received the same level of care as those treated in the award-winning facilities more than 7,000 additional lives and over $1.6 billion could be saved annually, and more than 5,000 additional bypass and angioplasty patients could be complication-free.” Where is the Cleveland Clinic?

Cesarean Delivery and Gender of Delivering Physicians: ”Female physicians are less likely to perform cesarean delivery and less likely to prefer it. This was observed across different health systems and populations.”

About pharma

Amazon launches digital pharmacy: “The e-commerce giant on Tuesday unveiled Amazon Pharmacy, a section of its retail website and mobile application that lets people order medication. Shoppers can pay using their health insurance. Prime members who don’t use their insurance are eligible for discounts on generic and brand-name drugs on Amazon’s site or at about 50,000 participating pharmacies…
Walgreens Boots stock was down 8.8 percent this morning.”

Special Fraud Alert: Speaker Programs: This announcement is from HHS’ Inspector General. The framing as a fraud alert is novel.
”This Special Fraud Alert highlights the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies. For purposes of this Special Fraud Alert, speaker programs are generally defined as company-sponsored events at which a physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.” 

Trump officials preparing to move forward with major step to lower Medicare drug prices:”The Trump administration is preparing to move forward with a major proposal to lower drug prices and rulemaking could come as soon as this week, according to people familiar with the effort.
The move, fiercely opposed by the pharmaceutical industry, would implement President Trumps’ ‘most favored nation’ proposal and lower certain Medicare drug prices to match prices in other wealthy countries.”

Evaluation of Time to Benefit of Statins for the Primary Prevention of Cardiovascular Events in Adults Aged 50 to 75 Years: “These findings suggest that statin medications for the primary prevention of cardiovascular events may reduce cardiac events for some adults aged 50 to 75 years with a life expectancy of at least 2.5 years; no data suggest a mortality benefit.”

A network medicine approach to investigation and population-based validation of disease manifestations and drug repurposing for COVID-19:”We identified that melatonin usage (odds ratio [OR] = 0.72, 95% CI 0.56–0.91) is significantly associated with a 28% reduced likelihood of a positive laboratory test result for SARS-CoV-2 confirmed by reverse transcription–polymerase chain reaction assay…
Importantly, melatonin usage (OR = 0.48, 95% CI 0.31–0.75) is associated with a 52% reduced likelihood of a positive laboratory test result for SARS-CoV-2 in African Americans after adjusting for age, sex, race, smoking history, and various disease comorbidities using PS [propensity score] matching.”
The results are interesting, but so is the technique used to extract the information.

About healthcare IT

Telemedicine and Office-Based Care for Behavioral and Psychiatric Conditions During the COVID-19 Pandemic in the United States: A good summary of the data about this process.

Trends in Outpatient Care Delivery and Telemedicine During the COVID-19 Pandemic in the US: This article is more general than the one above. “In this national study of a commercially insured population, growth in telemedicine use offset roughly two-thirds of the decline in in-person visit volume during the COVID-19 pandemic. Although there was geographic variation in the magnitude of changes, every state experienced a drop in total visits, illustrating the broad scope of deferred care during the first months of COVID-19.”

Newest clinical assessment tool allows AllianceRx Walgreens Prime cancer patients to manage care online: “Cancer patients who self-administer their therapy can now better manage their care online, thanks to the latest digital clinical assessment available only through AllianceRx Walgreens Prime. The newly-released self-serve tool simplifies patients’ online experiences when refilling their prescriptions. Earlier this year, AllianceRx Walgreens Prime announced the release of clinical assessments available for patients with chronic inflammatory disease, multiple sclerosis, cystic fibrosis, idiopathic pulmonary fibrosis, organ transplants, lipid and blood disorders. The addition of oncology to the clinical assessments means 85% of AllianceRx Walgreens Prime patients are eligible to use the online clinical assessment tool.”

About health insurance

Medicare Advantage Provider to Pay $6.3 Million to Settle False Claims Act Allegations:”Kaiser Foundation Health Plan of Washington, formerly known as Group Health Cooperative (GHC), agreed to pay $6,375,000 to resolve allegations that it submitted invalid diagnoses to Medicare for Medicare Advantage beneficiaries and received inflated payments from Medicare as a result…”

About hospitals and health systems

Premier, 34 systems partner with global medical manufacturer to create domestic gown maker: “Premier and 34 health systems including AdventHealth and Henry Ford Health System partnered with global medical manufacturer DeRoyal to create a new joint venture dedicated to the production of isolation gowns.” Recall hospitals are also getting into the generic pharma business to lower costs and meet shortage needs.

Today's News and Commentary

About the public’s health

Moderna's COVID-19 Vaccine Shines In Clinical Trial: Today’s top story. Like Pfizer-BioNTech’s vaccine, this one is also based on messenger RNA. The vaccine is reported to be about 95% effective after 2 doses. It does not require as stringent freezing as does the one from Pfizer-BioNTech.

Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration: How fast are “usual” vaccines developed? “Since 2010, most novel vaccines approved by the FDA required about 8 years [emphases added] of clinical development and were based on evidence from a median of 7 clinical trials, including at least 2 pivotal efficacy trials that were randomized, masked, and used a comparator group. These pivotal efficacy trials enrolled a median of 5000 patients, who were followed up for serious adverse events for at least 6 months.”

Unexpected detection of SARS-CoV-2 antibodies in the prepandemic period in Italy: “This study shows an unexpected very early circulation of SARS-CoV-2 among asymptomatic individuals in Italy several months before the first patient was identified, and clarifies the onset and spread of the coronavirus disease 2019 (COVID-19) pandemic. Finding SARS-CoV-2 antibodies in asymptomatic people before the COVID-19 outbreak in Italy may reshape the history of pandemic.”

Premature Years of Life Lost [PYLL] Due to Cancer in the United States in 2017: Just so we don’t lose track of other major illnesses during the pandemic, this article puts cancer deaths in perspective:
”PYLL was defined as the sum of the total years of life lost prior to age 75 years…The largest number of PYLL in 2017 was due to deaths from cancers of the lung/bronchus (891,313; 20.8%), colon/rectum (409,538; 9.6%), and breast (400,643; 9.4%). Cancers with the highest PYLLs generally also caused the largest number of deaths and had the highest mortality rates, with the exception of prostate cancer (5.1% of deaths, 2.0% of PYLL). In contrast, PYLLs per death were greatest for deaths due to cancers of testis (mean = 34.0 years), bones/joints (26.4), and other endocrine sites including thymus (25.2).” In sum, in 2017 there were more than 4 million PYLL.

J&J tops list of healthcare supply chains amid COVID vaccine effort—and Pfizer wins kudos, too: “J&J topped Gartner's top 25 list of healthcare supply chains for the second year in a row, just as the drugmaker gears up to distribute up to 1 billion doses of its investigational COVID-19 vaccine, Ad26.COV2.S, in 2021…Further down Gartner's list were fellow drugmakers Novo Nordisk (No. 11), Pfizer (No. 15), Roche (No. 21) and Biogen (No. 25). The list also highly ranked distributor McKesson (No.4), the U.S. government's partner in rolling out a range of COVID-19 vaccines to American patients.”

The Hot New Covid Tech Is Wearable and Constantly Tracks You: The article provides examples of all the entities using, or planning to use, wearable tracking devices that could pick up early signs of COVID-19.

About health insurance

Evaluation Of Medicare Alternative Payment Models: What The Data Show : This article is an excellent update evaluating the success of these different models. For example:
”The evidence indicates that ACOs continue to realize value-based care’s goal of providing better care at lower costs. Data from MedPAC, researchers at Harvard University, and the analytic firm Dobson DaVanzo and Associates show that ACOs are lowering Medicare spending annually by 1 percent to 2 percent. Knowing Medicare Parts A and B cost $636 billion in 2018, a 2 percent reduction in spending would save nearly $200 billion when compounded over a decade, assuming Medicare spending would grow at 4.5 percent per year without ACOs.
Importantly, based on the authors’ analysis of Centers for Medicare and Medicaid Services Public Use Files, ACOs also hit an average quality score of more than 94 percent in 2019, the latest year for which Medicare data are available.”

 Insurers' strong financial performance continues in Q3 as they brace for a potentially rocky Q4: “Major national health insurers continued to largely turn a significant profit in the third quarter, though numbers didn't quite reach the sky-high figures reported in the first half of the year.
And some warned that the fourth quarter could be ugly, with pent-up utilization and costs related to COVID-19 coming to a head.”
See the article for a good summary of the performances of the major companies.

About pharma

Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial: “We assessed the efficacy and safety of inhaled nebulised interferon beta-1a (SNG001) for the treatment of patients admitted to hospital with COVID-19…Patients who received SNG001 had greater odds of improvement and recovered more rapidly from SARS-CoV-2 infection than patients who received placebo, providing a strong rationale for further trials.”
As with many other drugs in this situation, more research needs to confirm its effectiveness.

Recommendations for five new drugs lead decisions from CHMP's November meeting: This article provides a good summary of what is happening in the pharma industry viewed through drug actions in the EU: “At its November meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended five drugs for approval, including one following a re-examination, as well as six line extensions. Meanwhile, the committee issued one negative opinion following a re-examination, with three companies also withdrawing marketing applications.”

11 drugs PBMs are adding back to their formularies after dropping last year: The headline speaks for itself; the article lists these medicines and the PBMs that re-added them.

About healthcare professionals

Authority of VA Professionals To Practice Health Care: This statement from the Federal Register is a really important departure from state-specific licensure laws. The immediate impact will be on telemedicine.
“The Department of Veterans Affairs (VA) is issuing this interim final rule to confirm that its health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. Specifically, this rulemaking confirms VA's current practice of allowing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other State requirement, thereby enhancing beneficiaries' access to critical VA health care services. This rulemaking also confirms VA's authority to establish national standards of practice for health care professionals which will standardize a health care professional's practice in all VA medical facilities.”

About healthcare quality

A Call for Action: Insights From a Decade of Malpractice Claim: A really good summary of trends by specialty and cause. For example, the top two allegations are surgery/procedure-related (29.2%) and diagnosis-related (27.3%). Together they account for 59% of payments.

Today's News and Commentary

About healthcare IT

Amwell® Announces Results for Third Quarter 2020: The telehealth company announced 3Q results. Compared to the same period last year:

  • “Total active providers of approximately 62,000 at the end of the third quarter increased 930% compared to a year ago

  • Total visits of 1,414,000 in the third quarter increased 450% compared to a year ago

  • Revenue of $62.6 million in the third quarter increased 80% compared to a year ago…

  • Net loss was $(64.6) million, compared to $(24.1) million”

About the public’s health

The US has added half a million new coronavirus cases since Monday: “The US has added more than half a million new Covid-19 cases since hitting 10 million on Monday, according to data from Johns Hopkins University. 
At this rate, the number should pass 11 million in the next four days, making for the fastest addition of another million yet, John Hopkins data show.”

Trump Administration Partners with Chain and Independent Community Pharmacies to Increase Access to Future COVID-19 Vaccines: “To maximize access to COVID-19 vaccines for all Americans, the U.S. Department of Health and Human Services (HHS)… announced the U.S. government’s partnerships with large chain pharmacies and networks that represent independent pharmacies and regional chains. Through the partnership with pharmacy chains, this program covers approximately 60 percent of pharmacies throughout the 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.”

Survey: Americans Likely to Attend Large Holiday Gatherings Despite COVID-19: “A new national survey by The Ohio State University Wexner Medical Center finds that although a majority of Americans plan to take precautions at holiday gatherings, such as social distancing and asking those with COVID symptoms not to attend, many will also put themselves at risk. Nearly two in five report they will likely attend a gathering with more than 10 people and a third will not ask guests to wear masks.”
And in a related story: At dinner parties and game nights, casual American life is fueling the coronavirus surge as daily cases exceed 150,000.

Progress Toward Regional Measles Elimination — Worldwide, 2000–2019: Not everything can be blamed on COVID-19.
“During 2000–2016, annual reported measles incidence decreased globally; however, measles incidence increased in all regions during 2017–2019. Since 2000, estimated measles deaths decreased 62% and measles vaccination has prevented an estimated 25.5 million deaths worldwide. No WHO region has achieved and maintained measles elimination.”
In the US: “From January 1 to December 31, 2019, 1,282* individual cases of measles were confirmed in 31 states. This is the greatest number of cases reported in the U.S. since 1992. The majority of cases were among people who were not vaccinated against measles.”
Laxness in attention to currency of vaccinations as well as availability (in developing countries) are contributing factors. Of course, in developed countries, the anti-vaxers are part of the problem.

COVID-19 fatality rate down 30% since April, study finds: “In the United States, COVID-19 now kills about 0.6% of people infected with the virus, compared with around 0.9% early in the pandemic…”
The “statistics reflect that doctors have figured out better ways to care for patients, including the use of blood thinners and oxygen support. Effective treatments, such as the generic steroid dexamethasone, have also been identified.”

CureVac Says Its COVID-19 Vaccine Can Be Stored Under Normal Refrigeration: “German drugmaker Curevac says its COVID-19 vaccine candidate, CVnCoV, can remain stable for at least three months at 41 degrees Fahrenheit (5 degrees Celsius), making it easier to distribute than some competitors’ vaccines.
This storage temperature would present fewer distribution challenges than the Pfizer/BioNTech vaccine that must be kept at an ultra-cold -94 degrees Fahrenheit (-70 degrees Celsius).”
However, this vaccine will not be one of the first ones on the market.

About health insurance

CMS: More than 800K signed up for ACA plans on HealthCare.gov on first week of open enrollment:”The Centers for Medicare & Medicaid Services, which reported the numbers late Thursday, said that there were 173,344 new consumers and 645,021 who renewed their coverage for 2021.”

Medical groups implore Congress to extend moratorium on sequester cuts as COVID-19 ramps up: “A collection of provider and payer groups are imploring Congress to continue a moratorium on Medicare payment cuts instituted under the sequester.
The letter sent Friday by more than 20 groups to congressional leaders is concerned that the moratorium installed under the CARES Act expires on Jan. 1. The groups want the moratorium to extend through the COVID-19 public health emergency, which has been renewed by the federal government several times.
The groups said that the moratorium needs to be extended as healthcare facilities are under massive financial stress with new surges of COVID-19.”

Mechanicsburg Physician To Pay $850,000 To Resolve Potential Liability Under The False Claims Act: “The United States Attorney’s Office for the Middle District of Pennsylvania announced today that Nava K. Nawaz, M.D. of Mechanicsburg, PA has agreed to pay the United States $850,000 to resolve allegations that she submitted fraudulent travel claims to the Medicare program.  As part of the settlement, Dr. Nawaz has also agreed not to seek or be an owner or operator of a laboratory for the next 18-months. According to U.S. Attorney David J. Freed, Dr. Nawaz used her laboratory company Perll Diagnostics, Inc. to defraud Medicare by submitting over 23,000 false and inflated travel reimbursement claims for specimen collection and testing between 2014 and 2017.  In doing so, the government contends that Dr. Nawaz misrepresented the distances traveled by Perll’s lab technicians and wrongly obtained taxpayer dollars for travel that never occurred.”
Notice how cases like this one almost always involve Medicare or Medicaid, as opposed to private insurance.

About pharma

Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: “In this preliminary study, adult outpatients with symptomatic COVID-19 treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days; however, determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.”

Today's News and Commentary

About the public’s health

STAT-Harris Poll: Most Americans won’t get a Covid-19 vaccine unless it cuts risk by half:The latest poll on this issue: “Six in 10 Americans said they are somewhat or very likely to get a Covid-19 vaccine if doing so would lower the risk of becoming infected by about half, according to a new survey from STAT and The Harris Poll. The poll also found that more Americans say they are likely to get a vaccine, practice social distancing, and wear a mask if they or someone they know has contracted Covid-19.”

Association of Racial/Ethnic and Gender Concordance Between Patients and Physicians With Patient Experience Ratings:”In this study, higher Press Ganey survey scores were associated with racial/ethnic concordance between patients and their physicians; thus, efforts to improve the patient experience among racially/ethnically discordant patient-physician dyads may be necessary to improve health care delivery.”

These are the top coronavirus vaccines to watch: This article is the latest in periodic updates from The Washington Post.

About health insurance

Medicare beneficiaries can get monoclonal antibody COVID-19 treatments at no cost: “Medicare beneficiaries won't have to pay out-of-pocket for monoclonal antibody treatments of COVID-19 for the duration of the public health emergency, the Centers of Medicare and Medicaid announced…”

Biden Plan to Lower Medicare Eligibility Age to 60 Faces Hostility From Hospitals: The article is a good summary of this proposal and potential problems with and barriers to its enactment.

CVS Health invests nearly $9 million for new Orlando affordable housing: “CVS Health, the corporation that emerged from a drug-store chain, is investing $8.7 million to help build affordable housing in Orlando, officials announced Tuesday.
The project — Fairlawn Village — is a $24 million, 116-unit affordable housing complex that is part of the city of Orlando’s master plan for the Mercy Drive corridor, an area once dominated by blight.”
Hospitals have set up most of these housing programs…this spin is a bit unusual.

Virginia physician convicted on 52 charges related to billing fraud scheme:”A federal jury convicted Javaid Perwaiz, MD, on Nov. 9 of 52 counts related to his scheme to perform unnecessary hysterectomies and other surgeries on women and bill insurers for the procedures, according to the Department of Justice
According to court records, Dr. Perwaiz billed government and commercial insurers for millions of dollars of surgeries that were not medically necessary for his patients between 2010 and 2019. In many cases, Dr. Perwaiz allegedly told patients they needed the surgeries to avoid cancer to get them to agree to the procedures. 
Evidence presented at trial also showed that Dr. Perwaiz falsified records for his obstetric patients so he could induce their labor early to ensure he would be able to conduct and be reimbursed for the deliveries, according to the Justice Department.”
It is very disturbing that he was found out by insurance fraud and not with quality review by peers.

About healthcare providers

Direct primary care provider acquires 230 clinics, changes name: “Paladina changed its name to Everside after completing the acquisition of Charlotte, N.C.-based Healthstat's 230 clinics. Everside now operates 350 health clinics in 32 states and has partnerships with several health systems, including Chicago-based CommonSpirit Health and St. Louis-based SSM Health.”

Today's News and Commentary

The Supreme Court heavily weighed the issues of severability and standing when it heard oral arguments in the ACA case yesterday. The consensus seems to be that the entire law (with or without the mandate) will be upheld by at least a 5-4 vote. Here is what the NY Times , Washington Post and Bloomberg Law say.

About the public’s health

Agency Review Teams: Here are the review teams that will direct the transition for the Biden-Harris transition.

Scientific Brief: Community Use of Cloth Masks to Control the Spread of SARS-CoV-2: From the CDC: “Experimental and epidemiological data support community masking to reduce the spread of SARS-CoV-2. The prevention benefit of masking is derived from the combination of source control and personal protection for the mask wearer.” [Emphasis added]

Preexisting and de novo humoral immunity to SARS-CoV-2 in humans:”Using diverse assays for antibodies recognizing SARS-CoV-2 proteins, we detect preexisting humoral immunity. SARS-CoV-2 spike glycoprotein (S)-reactive antibodies were detectable by a flow cytometry-based method in SARS-CoV-2-uninfected individuals and were particularly prevalent in children and adolescents.”
This finding may explain why children usually do not get as severe COVID-19 illness as do adults.

Amid cold chain blues, Pfizer looks to powder vaccine formula in 2021: report: “Pfizer on Monday revealed stellar early results from its phase 3 COVID-19 vaccine trial, but the news was quickly met with concerns about access as the vaccine comes with hefty cold chain requirements. Pfizer, for its part, already has its sights set on a next-generation formula that could help resolve those storage concerns, the drugmaker's top scientist said.”

Tested by a pandemic, pharma supply chain showed resilience: The headline speaks for itself and gives examples.

Almost 1 in 5 Parents Are 'Vaccine Hesitant,' Study Finds: “Nearly one in five American parents described themselves as ‘hesitant about childhood shots’ in 2019, a new U.S. government study finds.
That was fewer than the one in four who expressed hesitancy about vaccines in 2018.
The new research found real consequences from vaccine hesitancy. Rates of flu vaccination were 26 percentage points lower in children of "vaccine-hesitant" parents in both years studied.”

Several state leaders are urging residents to stay home as Covid-19 hospitalizations hit a record level: The headline speaks for itself.

Suburban Chicago Businessman Charged With Swindling Hospitals in Connection With Attempted Purchase of $2.6 Million in PPE: The orders were never filled, though the money was received. And a related story: More than Half of Disposable Gowns ECRI Tested Fail to Meet Necessary Protection Standards
About healthcare IT

Updates on 10 hospital malware attacks: Just a reminder that this problem is still very much with us.

The US Government Will Pay Doctors to Use These AI Algorithms: “The US Centers for Medicare & Medicaid Services (CMS) recently said it would pay for use of two AI systems: one that can diagnose a complication of diabetes that causes blindness, and another that alerts a specialist when a brain scan suggests a patient has suffered a stroke. The decisions are notable for more than just Medicare and Medicaid patients—they could help drive much wider use of AI in health care.
Both products are already cleared by the Food and Drug Administration and are in use by some providers. But new devices and treatments generally aren’t widely used until the US government authorizes payments for Medicare and Medicaid patients. Private insurers often take their cues on whether to cover a new invention from CMS, although they usually pay higher rates.”

Effect of an Electronic Health Record “Nudge” on Opioid Prescribing and Electronic Health Record Keystrokes in Ambulatory Care: “Autocompleting prescription forms with guideline-recommended values was associated with a large increase in guideline concordance in an organization where baseline concordance was low, but not in an organization where it was already high. The redesign markedly reduced the number of keystrokes needed to place orders, with important implications for EHR-related stress.” This method could be applied to other prescriptions, like antibiotics.

Association of Display of Patient Photographs in the Electronic Health Record With Wrong-Patient Order Entry Errors: “The results of this study suggest that capturing patient photographs and displaying them in the electronic health record may be a simple and cost-effective strategy for reducing wrong-patient errors.”

About pharma

Health officials to begin distribution of Eli Lilly antibody drug this week: “The federal government will begin distributing Eli Lilly's coronavirus antibody treatment this week, but supplies will be limited and getting the drug into infected patients will be a challenge, officials said.
The drug itself is administered through an IV infusion that takes more than an hour and requires another hour of observation afterward, officials said.”

About health insurance

Court sides with UnitedHealth in mental health denial case: “UnitedHealthcare didn't violate federal or state parity laws in denying coverage for out-of-state mental health services sought by one of its members, an appellate court said in a Nov. 9 opinion.
The opinion comes as UnitedHealthcare faces growing scrutiny of its mental health coverage denials. 
On Nov. 4, a federal judge ordered UnitedHealth Group to redo 67,000 medical claims for behavioral healthcare that it previously denied. The order followed a March 2019 ruling that found UnitedHealth instituted guidelines that denied care to patients needing mental health treatment to cut costs.”

Harvard Pilgrim Health Care and Doctor On Demand Launch SimplyVirtual: “Harvard Pilgrim Health Care today announced the launch of SimplyVirtualSM, a new, innovative model for health care that gives members access to virtual visits with primary care providers (PCPs) and care team support through its existing partner, Doctor On Demand. The new plan will be available to large employers (51+ subscribers) in Connecticut, with a January 1, 2021 effective date. SimplyVirtualSM is the first virtual primary care plan being offered by a health insurance company in Connecticut.”

ACA Offers Protection as the COVID-19 Pandemic Erodes Employer Health Insurance Coverage: The study was done by the RWJF:

  • “The share of adults with employer-sponsored insurance fell from 64.9 percent in late March/early April to 63.4 percent in mid-to-late September, which is equivalent to about 3.1 million adults.

  • The drop in employer coverage did not correspond with a statistically significant increase in the uninsurance rate, which was 11.5 percent in March/April and 11.9 percent in September.   

  • The losses in employer coverage were mostly offset by increases in Medicaid/CHIP and nongroup coverage.”

About healthcare providers

Rite Aid unveils its 'stores of the future' in bid to become healthcare destination: “Rite Aid has officially unveiled its new concept stores as it overhauls its brand to keep up with competitors like CVS Health and Walgreens.
The pharmacy chain opened the third store built around its ‘Stores of the Future’ model in Moscow, Pennsylvania, with plans to open further stores in other markets over the next several months.
The redesigned stores, which are part of the company's broader RxEvolution brand overhaul, bring pharmacists out from behind the counter to enable them to communicate more directly with customers, and includes an overhauled assortment of products aimed at ‘clean, healthy living,’ Rite Aid said.”

Oak Street Health opens 13 health centers in Q3 as revenue jumps 57%: “The company has yet to be profitable and reported that its losses deepened during the quarter to $59 million, compared to a loss of $33 million in the third quarter of 2019. Net share per share came to a loss of 15 cents.
Oak Street now operates 67 centers serving around 90,000 patients with about 66% of those patients are under capitation agreements.”

Today's News and Commentary

As mentioned yesterday, arguments start today in the Supreme Court over the future of the ACA.

About the public’s health

SARS-CoV-2 survives for 9 hours on human skin: “ARS-CoV-2 can survive on human skin for about 9 hours — significantly longer than influenza A virus — underscoring the importance of hand hygiene, researchers said.
Recent studies have looked at how long SARS-CoV-2 can survive on surfaces, with one analysis demonstrating that the virus was still viable for up to 28 days on glass, polymer currency, stainless steel, vinyl and paper currency.”

HHS Released More Coronavirus Vaccine Contracts As Election Results Unfolded: The concern is lack of full transparency and consumer protections, including prices.

About health insurance

2019 MLR [Medical Loss Ratio] Rebates by State: Based on MLR reports filed through October 16, 2020, CMS issued national totals and per state amounts. The total is $2.458B with an average across all markets of $219 per person. Large rebates were expected because of the huge number of delayed elective procedures during the COVID-19 pandemic.

Screening for High Blood Pressure in Children and AdolescentsUS Preventive Services Task Force Recommendation Statement: “The USPSTF concludes that the evidence to support screening for high blood pressure in children and adolescents is insufficient and that the balance of benefits and harms cannot be determined.”

About pharma

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19: “Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) [to Eli Lilly & Co.] for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.”

Trial results reveal that long-acting injectable cabotegravir [CAB LA] PrEP is highly effective in preventing HIV acquisition in women: The WHO published a study showing that “CAB LA is significantly more effective in preventing HIV acquisition than oral PrEP in an intention-to-treat analysis from this trial.” The problem now is distribution and guaranteeing that it can be administered monthly.

Accelerating Regulatory Product Development and Approval for Drugs and Biologics in the US: This monograph is very timely as many products are being approved through this process to combat the COVID-19 pandemic.

About hospitals and health systems

Medical tourism craters during coronavirus pandemic, hospitals lose billions: The headline speaks for itself.

About healthcare IT

Cigna Ventures, Humana, and Optum Ventures Among Investor Set Re-Upping in Buoy Health Series C Financing: Buoy Health, the AI-powered healthcare navigation platform, today announced the completion of a $37.5 million Series C funding round. Cigna Ventures and Humana led the funding round and were joined by Optum Ventures, WR Hambrecht + Co, and Trustbridge Partners. To date, Buoy has raised $66.5 million…
Buoy will use the proceeds to further buildout its IP with respect to artificial intelligence and other technologies…”
Check the Buoy website for details about how it works. What is newsworthy is the payer investment.

FDA clears Apple Watch sleep app that intervenes to stop nightmares caused by PTSD: “The FDA has cleared an app for the Apple Watch to help people suffering from nightmares or post-traumatic stress disorder (PTSD) get a better night’s sleep.
Dubbed Nightware, the prescription app monitors the wearer’s heart rate and movement while they sleep—and, if they’re having a nightmare, gently prods them out of the dream without aiming to wake them up completely, using the smartwatch’s vibrations.”

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.”