Today's News and Commentary

About Covid-19

WHO Rejects Hydroxychloroquine for Preventing COVID-19: We can FINALLY put this issue to rest.
Along the same lines: U.S. trial of COVID-19 blood plasma halted after no benefit found: “The U.S. National Institutes of Health (NIH) said on Tuesday that it has halted a trial of convalescent blood plasma in the treatment of patients with mild-to-moderate COVID-19 symptoms as it was unlikely to benefit this group.”
And: GSK, Vir hit as COVID-19 drug hopeful halted on possible weak efficacy in key NIH phase 3: “GlaxoSmithKline and partner Vir Biotechnology have seen a key, late-stage test of their experimental COVID-19 drug stopped for new patients amid concerns it may not be working well enough. 
In an update Wednesday morning, the two partners said a study of VIR-7831, a dual-action SARS-CoV-2 monoclonal antibody, would see enrollment stopped as an independent data monitoring board said ‘sensitivity analyses of the available data raised concerns about the magnitude of potential benefit.’”

Merck must do a new trial for faltering $425M COVID-19 drug the U.S. government asked it to buy: “Merck will no longer be able to supply the experimental COVID-19 drug from its $425 million buyout of OncoImmune to the U.S. government, from which it was granted a $356 million contract, as the FDA demanded more data…
This med, now known as MK-7110 (formerly CD24Fc) was initially used in allogeneic hematopoietic stem-cell transplant patients. But the biotech believed it could be used to help certain COVID-19 patients.”

Nanoparticle-delivered COVID-19 vaccine candidate shows promise in preclinical studies: “Other benefits of the protein nanoparticles include minimizing cellular damage and providing stronger immunity at lower doses than traditional protein subunit vaccines against other viruses, like influenza.
The team's vaccine uses the ferritin nanoparticles to deliver tiny, weakened fragments from the region of the SARS-CoV-2 spike protein that selectively binds to the human entry point for the virus (this fragment is called the receptor-binding domain, or RBD). When the SARS-CoV-2 RBD binds with the human protein called ACE2 (angiotensin-converting enzyme 2), the virus can enter host cells and begin to replicate.”

New report says failures at OSHA under Trump could have put more workers at risk during pandemic: “The OIG report bolsters complaints made by workers advocates, labor unions and other liberal groups for much of the pandemic about the way the agency fell short of its mission on workplace safety under Trump and then-Labor Secretary Eugene Scalia during an unprecedented public and occupational health crisis…
The agency received 15 percent more safety complaints between Feb. 1 and Oct. 26, the period studied in the report, than the same time frame in 2019, yet performed 50 percent less inspections, the report noted.”

LONG COVID PATIENTS SAY THEY FEEL BETTER AFTER GETTING VACCINATED: This finding is not research-based, but there are many anecdotal stories. In any case, vaccination is recommended for people previously infected.

514 million Africans risk falling below extreme poverty line in 2021 due to COVID-19: “About nine out of ten extremely poor people in the world currently live in Africa. The ECA warns that COVID19 will push an additional 5 to 29 million below the extreme poverty line. If the impact of the pandemic is not limited by 2021. An additional 59 million people could suffer the same fate, which would bring the total number of extremely poor Africans to 514 million people.”

Texas to lift statewide mask mandate, despite warnings from public health officials: “The governor's executive order, which will take effect on March 10, also lifts capacity restrictions imposed on the state's businesses. Local officials can still impose "mitigation strategies" if hospitalizations in their area surge, but are banned from punishing residents who defy mask guidance and cannot limit business capacity to less than 50%.”

Whole towns are refusing Covid-19 vaccines in Mexico: “Indigenous communities… have a history of mistrust toward the federal government. In the best of cases, community leaders say, they have been ignored. In the worst of cases, they've been subjected to land-grabs, discrimination, abuse and attacks. This time, it seems a lack of information and conspiracy theories that have spread in the region like wildfire are to blame for vaccine hesitancy.”

About health insurance

Buried in Biden's stimulus plan is a 29 percent spending hike in Obamacare subsidies: “The Congressional Budget Office estimated the stimulus provision, which increases subsidies for private plans purchased on HealthCare.gov, would cost $34.2 billion to get 1.7 million more people into the individual marketplaces. Of those, 1.3 million would be previously uninsured, while the rest would be people transitioning to marketplace plans from some other type of health coverage…
Yet the cost is more per person than the government spends to insure people through its major insurance programs, Medicare and Medicaid [emphasis in original]— and illustrates just how expensive it is to rely on the nation’s for-profit insurance industry to get Americans covered.”

Oscar Health raises $1.4bn from stock market listing: “Oscar Health, the health insurance company co-founded by Joshua Kushner, raised more than $1bn in an initial public offering that topped the company’s marketed price range, in a sign of investor confidence despite political uncertainty over the future of US healthcare. The New York-based company priced its shares at $39 each on Tuesday, according to a statement, raising about $1.4bn. Oscar would have a market capitalisation of $7.9bn at that price, based on the total number of shares outstanding.”

CMS Puts $2.3M Toward Navigator Funding for Special Enrollment: “CMS will be offering $2.3 million in additional navigator funding for grantees in light of the special enrollment period, the agency announced by email.”

Optum to acquire 715-physician group in Massachusetts: “UnitedHealth subsidiary Optum signed a definitive agreement to acquire Atrius Health, a 715-physician group based in Newton, Mass…”

Medicare Should Transform MIPS [Merit-Based Incentive Payment System] Not Scrap It: “A … practical solution would be to transform MIPS by aligning it as closely as possible with alternative payment models (APMs)—payment arrangements that more directly link payment to value-based care…
First, Medicare can couple clinicians’ performance in the Quality and Cost domains. Currently, MIPS evaluates quality and cost performance independently…
Second, Medicare could revise financial rewards in MIPS to better reflect APM incentives. Currently, MIPS incentives are structured as upward or downward reimbursement rate adjustments. This approach could unintentionally reward increased spending by paying clinicians higher rates for all services, while failing to expose clinicians to APM incentives, which are not based on reimbursement rates….
Third, Medicare should redesign MIPS to move clinicians through the program in a more explicit, predictable fashion. Currently, MIPS does not require clinicians to progress through specific competencies and milestones over time…”

Two recent JAMA articles provide great discussion points for health insurance policy discussions:
Regulation of Health Care PricesThe Case for Backstop Price Caps in Commercial Health Care Markets and
Trade-offs in Public Health Insurance Design

About pharma

Paying for Prescription Drugs in the New Administration: A good overview of policy issues with respect to pharma costs.

Factors Associated With Prescriptions for Branded Medications in the Medicare Part D Program: “This cross-sectional study of 169 million Medicare part D multisource prescription drug claims in 2017 revealed that branded drugs were dispensed because of prescriber request 16.9% of the time and because of patient request 13.5% of the time. The projected savings for switching the branded drugs requested by prescribers to generics were $997 million for Medicare and $161 million for patients; projected savings for switching patient-requested drugs were $673 million for Medicare and $109 million for patients.”

Prevalence and Persistence of Cost-Related Medication Nonadherence [CRN] Among Medicare Beneficiaries at High Risk of Hospitalization: “In this cohort study of 1655 Medicare beneficiaries, the population-adjusted prevalence of CRN was 53.6%, and 28.4% of those who reported CRN at least once had persistent CRN during the 15-month study period. Younger age, worse self-reported health, and depression were associated with greater likelihood of persistent CRN…
These findings suggest that refined predictive modeling is needed to identify patients at high risk of CRN by including multiple factors associated with CRN, including age, health perception, and depression, and possibly a broad set of other variables that were not significantly associated with CRN in this study but may be with use of a larger sample.”

FDA approves first liquid-filled aspirin capsule: “Aspirin is sold in enteric-coated and immediate-release forms. Enteric coating is designed to ensure the dosage form only fully dissolves upon reaching the small intestine, potentially reducing stomach irritation. However, there is also some evidence that the coating reduces absorption in some people, making the plain, immediate-release formulation a better option in certain situations. 
Now, PLx has provided patients with a third aspirin option. Vazalore, which comes in full-strength and low-dose versions, is a capsule that contains aspirin in a liquid form. The product is based on the PLxGuard drug delivery platform, which is designed to enable the release of the active ingredient to targeted portions of the gastrointestinal tract.”

About healthcare systems

Amazon Care, Intermountain, Ascension launch hospital-at-home healthcare alliance: “The group, dubbed Moving Health Home, will support and update healthcare policy changes to designate the home as a site of clinical service, according to a March 3 news release. 
Amazon Care, launched in 2019 to provide telemedicine and in-person primary care services to its employees, and the other Moving Health Home founders cited tech advancements including telehealth, remote monitoring, digital therapeutics and medical records sharing as contributing factors in making home care equivalent to some services offered in facilities. 
Additional founding members of the coalition include Signify Health, Landmark Health, Dispatch Health, Elara Caring and Home Instead.”

About the public’s health

Beneficial Effect of Consecutive Screening Mammography Examinations on Mortality from Breast Cancer: A Prospective Study: “Women participating in the last two breast cancer screening examinations prior to breast cancer diagnosis had the largest reduction in breast cancer death. Missing either one of the last two examinations conferred a significantly higher risk.”

2021’s Most Overweight and Obese Cities in the U.S.: The geography of this problem is obvious from the list.

Big Tobacco Wins 3rd Delay Of Graphic New Warning Labels: “A Texas federal judge on Tuesday delayed for a third time the effective date of the U. S. Food and Drug Administration's new rule requiring tobacco companies to put graphic warning labels on cigarette packs, kicking the compliance deadline that was initially set for this June to April 14, 2022.”
Perhaps a law would be better in this case than an FDA rule.

Today's News and Commentary

Too Much Choice Is Hurting America: Learning from subprime, health care and electricity: Great article from Paul Krugman in The NY Times. Here is the crux of his argument:
”But the argument that more choice is always good rests on the assumption that people have more or less unlimited capacity to do due diligence on every aspect of their lives — and the real world isn’t like that. People have children to raise, jobs to do, lives to live and limited ability to process information.
And in the real world, too much choice can be a big problem.
The lesson of subprime mortgages, health insurance and now Texas electricity is that sometimes people offered too much choice will make bigger mistakes than they imagined possible. But that’s not all. Too much choice creates space for predators who exploit our all-too-human limitations.”

About Covid-19

Global COVID-19 infections up for first time in seven weeks, WHO says: The headline speaks for itself.

Virus Variant in Brazil Infected Many Who Had Already Recovered From Covid-19: “B.1.1.7, first identified in Britain, has demonstrated the power to spread far and fast. In South Africa, a mutant called B.1.351 can dodge human antibodies, blunting the effectiveness of some vaccines.
Scientists have also had their eye on a third concerning variant that arose in Brazil, called P.1. Research had been slower on P.1 since its discovery in late December, leaving scientists unsure of just how much to worry about it.”
The concern is that this mutation may make it easier for the virus to re-infect those who previously had the disease.

Attacked and Threatened: Health care targeted in conflict and COVID-19: An interactive map showing global sites where healthcare institutions and personnel have been attacked and threatened. (Non- secure site.)

CDC says J&J Covid vaccine is OK for people who have allergic reaction to Pfizer’s or Moderna’s: “A CDC scientist said Monday that people who have an allergic reaction to the first dose of either the Pfizer or Moderna vaccine could get the J&J vaccine instead at least 28 days later.
The CDC currently recommends that people who have a severe allergic reaction to either of the two-shot vaccines not get the second shot.”

Countries urge drug companies to share vaccine know-how: “Across Africa and Southeast Asia, governments and aid groups, as well as the World Health Organization, are calling on pharmaceutical companies to share their patent information more broadly to meet a yawning global shortfall in a pandemic that already has claimed over 2.5 million lives. Pharmaceutical companies that took taxpayer money from the U.S. or Europe to develop inoculations at unprecedented speed say they are negotiating contracts and exclusive licensing deals with producers on a case-by-case basis because they need to protect their intellectual property and ensure safety.
Critics say this piecemeal approach is too slow at a time of urgent need to stop the virus before it mutates into even deadlier forms. WHO called for vaccine manufacturers to share their know-how to ‘dramatically increase the global supply.’”

Biden to announce ‘historic partnership’: Merck will help make Johnson & Johnson coronavirus vaccine, officials say: “President Biden will announce Tuesday that pharmaceutical giant Merck will help make Johnson & Johnson’s single-shot coronavirus vaccine — an unusual pact between fierce competitors that could sharply boost the supply of the newly authorized vaccine, according to senior administration officials.”

Novavax targets May approval for COVID-19 vaccine in the U.S.: “Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the first half of the year.
The success of the vaccine in a 15,000-subject U.K. phase 3 clinical trial gives Novavax a clear path to a positive decision by the Medicines and Healthcare products Regulatory Agency (MHRA). However, the lack of data from another phase 3 trial that only recently completed enrolling 30,000 subjects in the U.S. and Mexico makes the route to a FDA OK less clear.”

7 signs those new N95s at your physician practice might be fake: “According to NIOSH [National Institute for Occupational Safety and Health] here are seven signs of counterfeit respirators that physicians and staffers at medical groups and health systems should look for:

• No markings at all on the filtering facepiece respirator.

• No approval number on filtering facepiece respirator or headband.

• No NIOSH markings.

• NIOSH spelled incorrectly.

• Presence of decorative fabric or other decorative add-ons.

• Claims of approval for children—NIOSH does not approve any type of respiratory protection for children.

• Filtering facepiece respirator has ear loops instead of headbands”

A Covid Vaccine Side Effect, Enlarged Lymph Nodes, Can Be Mistaken for Cancer: “Coronavirus vaccinations can cause enlarged lymph nodes in the armpit or near the collarbone, which may be mistaken for a sign of cancer.
As vaccines are rolled out across the country, doctors are seeing more and more of these swollen nodes in recently immunized people, and medical journals have begun publishing reports aimed at allaying fears and helping patients avoid needless testing for a harmless condition that will go away in a few weeks.”

J&J COVID-19 vaccine shipping to U.S., but new deliveries hinge on regulators: “Johnson & Johnson will ship nearly 4 million doses of its newly authorized single-dose COVID-19 vaccine around the United States this week, but a top executive said on Monday that the next round of deliveries is contingent on regulatory approvals at a new plant.”

The Trump administration quietly spent billions in hospital funds on Operation Warp Speed: “The Trump administration quietly took around $10 billion from a fund meant to help hospitals and health care providers affected by Covid-19 and used the money to bankroll Operation Warp Speed contracts, four former Trump administration officials told STAT.
The Department of Health and Human Services appears to have used a financial maneuver that allowed officials to spend the money without telling Congress, and the agency got permission from its top lawyer to do so. Now, the Biden administration is refusing to say whether the outlay means there will be less money available for hospitals, physicians, nursing homes, and other providers.”

New Orleans archdiocese urges Catholics to avoid new Johnson & Johnson vaccine: “The archdiocese issued the statement on Friday (Feb. 26), stating that while the decision regarding whether to get a vaccine is an individual choice, ‘the latest vaccine from Janssen/Johnson & Johnson is morally compromised as it uses the abortion-derived cell line in development and production of the vaccine as well as the testing.’
Several COVID-19 vaccine manufacturers used cells originally derived from tissue from an aborted fetus in the 1970s, but the Moderna and Pfizer-BioNTech vaccines used the cell lines only to test their vaccines, making the ‘connection to abortion … extremely remote,’ the statement said.”

Updates on Covid-19 test approvals:
Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test: “The at-home COVID-19 nasal polymerase chain reaction (PCR) kit can be sold directly to consumers without a prescription and can be ordered online for $99, the company said.”
Quidel’s At-Home COVID-19 Test Gets FDA EUA: “Patients using the antigen test can collect their own samples at home and do not need to send them off to a laboratory for analysis. The device is authorized for prescription home use with self-collected anterior nasal swabs from patients aged 14 and older or individuals 8 and up whose swabs are collected by an adult.”

Vaccine Significantly Lessened Asymptomatic Infections: “A single dose of the Pfizer/BioNTech vaccine significantly lowers asymptomatic SARS-CoV-2 infections, which means it also reduces the risk of transmission from asymptomatic individuals, a new UK study has shown.
Researchers at Cambridge University analyzed thousands of COVID-19 tests from staff working in a UK hospital in January and found that healthcare workers were four times less likely to become infected with COVID-19 12 days postvaccination with a single shot — and asymptomatic infections dropped by 75 percent.”

About health insurance

Highmark, HealthNow New York complete affiliation: “Highmark has completed its affiliation with HealthNow New York, bringing its membership to more than 6 million and making it the country's fourth-largest Blues plan.
Under the deal, HealthNow will be rebranded as Highmark Blue Cross Blue Shield of Western New York and Highmark Blue Cross Blue Shield of Northeastern New York. The New York insurer will maintain local leadership and offices to continue as a community presence…”

CMS pushes pause on controversial Geographic Direct Contracting model: “The Biden administration is reviewing a controversial payment model that would tie Medicare payments to spending and quality for an entire region.
The Centers for Medicare & Medicaid Services’ (CMS') webpage for the Geographic Direct Contracting model said it is currently under review in an update posted Monday.
The agency did not immediately respond to a request for comment on the reason the model was put under review nor for how long it would happen.”

Biden Administration’s Plan to Rescind States’ Medicaid Work Rules Faces Temporary Hitch: “Just weeks before President Biden took office, the Trump administration urged states in a Jan. 4 letter to sign agreements that would preserve work requirements in the program for nine months before they could be undone by the federal government. 
The letters say the Centers for Medicare and Medicaid Services, the federal agency that oversees the program, must go beyond offering states a hearing to contest changes, as is typically the case, and instead follow a longer, nine-month process for revoking the arrangements. An HHS spokesman said 17 states signed the agreements, including Georgia, Tennessee and Arkansas. 
Republican leaders in the states, having signed those agreements, say work requirements should be binding until September.”

Limiting Private Insurance Reimbursement to Medicare Rates Would Reduce Health Spending by About $350 Billion in 2021: Among findings from this Kaiser family Foundation study:

• Total health care spending for the privately insured population would be an estimated $352 billion lower in 2021 if employers and other insurers reimbursed health care providers at Medicare rates. This represents a 41% decrease from the $859 billion that is projected to be spent in 2021.

• Aggregate employer contributions toward employee premiums would decrease by about $194 billion, assuming employers’ share of premiums stays constant after private rates drop to Medicare levels.

• Employees and their dependents would spend at least $116 billion less for health care, through a combination of lower premiums and out-of-pocket spending. The reduction in federal and individual spending on health care for an estimated 19 million people in the non-group market would total $42 billion.

• Nearly half of the total reduction in spending (45%) would be for outpatient hospital services, due in part to high private rates relative to Medicare rates for outpatient care, compared to most other services. Inpatient services account for 27% of the decrease in spending, and physician office visits account for 14% of the decrease.

• Health care spending for privately insured adults ages 55 to 64 would be an estimated $115 billion lower in 2021 if private insurers used Medicare rates—this is one third of the estimated total reduction in spending. The proportion of the decrease in spending attributable to adults 55 to 64 is roughly equivalent to their share of current spending.”

Hospitals rely on cost shifting to private insurers to make up for lower Medicare and Medicaid payments, free care and underpaid services. Where can they make up this difference? Also, private insurers would need to change from fee-for-service or per diems to DRGs to get comparable inpatient rates.

An Employer-Provider Direct Payment Program Is Associated With Lower Episode Costs: “We examined the impacts on episode cost and patient cost sharing of a program that applies bundled payments for orthopedic and surgical procedures in a commercially insured population. The program we studied negotiates preferred prices for selected providers that cover the procedure and all related care within a thirty-day period after the procedure and waives cost sharing for patients who receive care from these providers. After implementation, episode prices for three selected surgical procedures declined by $4,229, a 10.7 percent relative reduction. Employers captured approximately 85 percent of the savings, or $3,582 per episode (a 9.5 percent relative decrease), and patient cost-sharing payments decreased by $498 per episode (a 27.7 percent relative decrease).”

About pharma

AstraZeneca’s and Amgen’s Tezepelumab Slashes Severe Asthma Attacks: “AstraZeneca’s and Amgen’s biologic drug tezepelumab reduced the rate of asthma attacks by 56 percent among patients with severe and uncontrolled forms of the condition, according to their phase 3 trial results.
Tezepelumab works by blocking the action of thymic stromal lymphopoietin (TSLP), an immune protein in the lining of the lungs that plays a key role in asthma inflammation, as well as helping to alert the body’s immune system that it needs to react to a threat…
Tezepelumab improved lung function in patients, helped control asthma better and cut the risk of hospitalizations or emergency visits by 79 percent, trial data showed.”
Since the mechanism of action is new, this drug could be a real innovation in asthma treatment.

Takeda Sells Off Four Diabetes Drugs in $1.25 Billion Deal: “Takeda is divesting itself of the rights to Nesina, Liovel, Inisync, and Zafatek, transferring the assets, marketing rights and eventually marketing authorization associated with the portfolio to Teijin. The four drugs generated about $290 million in sales for Takeda in fiscal year 2019.”

Perrigo Announces Agreement To Sell Generic Rx Business For $1.55 Billion In Total Consideration: “Perrigo Company plc, a leading global provider of Consumer Self-Care Products, announced today that it has reached a definitive agreement to sell its Generic Rx Pharmaceuticals business to Altaris Capital Partners, LLC for total consideration of $1.55 billion, including $1.5 billion in cash, subject to customary adjustments. As part of the consideration, Altaris will also assume more than $50 millionin potential R&D milestone payments and contingent purchase obligations with third-party Rx partners.”

Spending For Orphan Indications Among Top-Selling Orphan Drugs Approved To Treat Common Diseases: “The Orphan Drug Act of 1983 provides benefits to promote the development of treatments for rare diseases that have limited sales potential. Policy makers have questioned whether this purpose is furthered in the case of “partial orphan drugs” approved to treat both rare and common diseases, as many of these drugs are top sellers. In this study we used national commercial claims data to estimate the proportion of spending in the US on fifteen top-selling partial orphan drugs that was assigned to orphan indications in 2018. Of this spending, 21.4 percent was assigned to orphan indications, 70.7 percent to nonorphan indications, and 7.9 percent to neither orphan nor nonorphan indications (for example, off-label use). These findings support growing concerns regarding the costs of granting orphan drug benefits to the sponsors of top-selling partial orphan drugs.”
This article is a great start for discussions centering on re-evaluating the orphan drug subsidies.

About healthcare IT

Principal Deputy Inspector General Grimm on Telehealth: Among the messages in this announcement: “We are aware of concerns raised regarding enforcement actions related to ‘telefraud’ schemes, and it is important to distinguish those schemes from telehealth fraud. In the last few years, OIG has conducted several large investigations of fraud schemes that inappropriately leveraged the reach of telemarketing schemes in combination with unscrupulous doctors conducting sham remote visits to increase the size and scale of the perpetrator's criminal operations. In many cases, the criminals did not bill for the sham telehealth visit. Instead, the perpetrators billed fraudulently for other items or services, like durable medical equipment or genetic tests. We will continue to vigilantly pursue these ‘telefraud’ schemes and monitor the evolution of scams that may relate to telehealth.”

USDA invests $42M in telehealth infrastructure: “In a move to help rural residents gain access to healthcare and educational opportunities, the United States Department of Agriculture is investing $42.3 million in telemedicine and distance learning infrastructure.
Rural areas have greater infection and death rates from COVID-19 because of several factors, including a much higher percentage of underlying conditions, difficulty accessing medical care and lack of health insurance.
The $42.3 million in awards includes $24 million provided through the CARES Act. The investments will benefit five million rural residents in total.”

About hospitals and health systems

Three articles on financial performance:
How CHS, HCA, Tenet and UHS fared in Q4
UPMC annual operating revenue hits $23B: 5 notes
The Challenging Future of the Chicago Safety Net: “The most important safety net hospitals on the city's west and south sides are projected to reach a compounded operaAng loss of $1.76 billion in the coming years.
Based on historical financial trends and our longitudinal modeling, the seven primary safety net hospitals on Chicago’s south side (Advocate Trinity1, Roseland Community, St. Bernard, Holy Cross, Mercy, Jackson Park, and South Shore) are projected to endure a total loss of $1.34 billion by 2024.
The safety net hospital cohort to the city’s west (consisAng of Mount Sinai, LoreZo, St. Anthony, AMITA Health Saint Mary, Elizabeth Medical Center - Saint Mary Campus2, and Norwegian) will bear $421 million in compounded operaAng losses over the same period.”
Start to read about possible solutions to the problem on page 37.

About healthcare personnel

High Nursing Staff Turnover In Nursing Homes Offers Important Quality Information: “Mean and median annual turnover rates for total nursing staff were roughly 128 percent and 94 percent, respectively. Turnover rates were correlated with facility location, for-profit status, chain ownership, Medicaid patient census, and star ratings. Disseminating facilities’ nursing staff turnover rates on Nursing Home Compare could provide important quality information for policy makers, payers, and consumers, and it may incentivize efforts to reduce turnover.”

Today's News and Commentary

About Covid-19

FDA authorizes Johnson & Johnson’s single-shot coronavirus vaccine, adding to the nation’s arsenal against the pandemic:”The new vaccine, which is for adults 18 and older, has clear practical and logistical advantages over the first two vaccines — it does not have to be kept frozen, and there is no need for a second round of appointments. That makes it a boon for rural areas and other hard-to-reach communities, and for distribution to community health centers and physician offices that might not have the freezers needed for the other vaccines, public health officials say.”

US diagnostics company calls for national Covid testing guidelines: ”Thomas Polen, BD’s chief executive, said there had been a lot of talk on how to roll out rapid testing from airports to stadiums but companies were holding back from making large orders of tests until they knew what the rules were. He said the world was at a ‘transition point’ in testing, as the tests for symptomatic patients fall but orders for tests in ‘non-traditional’ settings have yet to ramp up. He said these organisations needed to know how often to test and how they would be expected to report the data.”

Biden Administration Strengthens Requirements that Plans and Issuers Cover COVID-19 Diagnostic Testing Without Cost Sharing and Ensures Providers are Reimbursed for Administering COVID-19 Vaccines to Uninsured: From CMS. The headline speaks for itself.

Exclusive: Hackers Break Into ‘Biochemical Systems’ At Oxford University Lab Studying Covid-19: “Oxford University confirmed on Thursday it had detected and isolated an incident at the Division of Structural Biology (known as ‘Strubi’) after Forbes disclosed that hackers were showing off access to a number of systems. These included machines used to prepare biochemical samples, though the university said it couldn’t comment further on the scale of the breach. It has contacted the National Cyber Security Center (NCSC), a branch of the British intelligence agency GCHQ, which will now investigate the attack.”

Have a case of a COVID variant? No one is going to tell you: “COVID-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by a variant.
Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged but can’t do the kind of investigation and deliver the notifications needed to slow the spread, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.”

Lilly announces additional doses of neutralizing antibody therapy purchased by U.S. government to treat COVID-19: “The U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together, Eli Lilly and Company announced. Bamlanivimab and etesevimab together recently received emergency use authorization for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.”

About healthcare IT

More than 350K health records breached in February: More details here and at the HHS website.

Machine learning method accurately spots premalignant colon polyps: “Using radiomics, the system correctly differentiated between benign and potentially cancerous polyps more than 80% of the time, the data showed.
Radiomics is an analytical process allowing additional information to be gleaned from medical images, providing views of scans that are impossible with the naked eye.”
More precisely, the results have a sensitivity of 82%, and a specificity of 85%. But it would need to be a lot better to avoid unnecessary biopsies.

USQHIN ANNOUNCES THE LAUNCH OF THE NATIONAL ADT HUB NETWORK: “The National ADT Hub Network is USQHIN’s first use case and aims to foster collaboration between vendors, health information exchanges, health systems, government agencies, and health insurers. By working together, participating ‘Gateway Partners’ demonstrate their commitment to addressing individual patient well-being, critical national public health needs, and the greater good.
ADT notifications are sent when a patient is admitted to a facility, transferred within the facility, or discharged from the facility. Notifications are then sent to update physicians and care management teams on a patient’s status, thus improving post-discharge transitions, prompting follow-up, reducing readmissions, improving communication among providers, and supporting patients with multiple or chronic conditions. They can also serve an important role in being able to distribute demographic data and other attributes about patients quickly and efficiently to a patient’s extended care team.”

Bipartisan bills gain support for telehealth reform, SDOH coordination: “The new bipartisan Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act was introduced by  Senators Dan Sullivan, R-Alaska, and Chris Murphy, D-Connecticut.
The LINC to Address Social Needs Act would offer one-time seed funding for states to help establish communication between social service providers and healthcare organizations for referral, capacity management, and outcome tracking between social service providers and healthcare organizations.”

Teladoc's virtual visits reach 3M during Q4 as revenue grows to $383M: “Teladoc's 2020 revenue reached $1.1 billion as virtual care visits continued to soar.
The telehealth giant reported it delivered 10.6 million virtual visits last year, up 156% from 2019. The company's U.S. paid membership hit 51.8 million, up about 41% from 36.7 million users in 2019.
Teladoc, one of the nation's top telehealth providers, reported 3 million total virtual visits during the fourth quarter, up 139% from 1.2 million visits in the fourth quarter of 2019.”

Allscripts reports $414M in Q4 with strong growth in its Veradigm data business: “Allscripts is seeing strong growth in its life sciences data business as the market heats up among large health IT vendors.
That business, along with the steady return of patient volumes among its provider clients, helped the electronic health record (EHR) vendor post $414 million in revenue in the fourth quarter of 2020. Revenue was down 8% from $451 million a year ago.
The Chicago-based company reported full-year 2020 revenue of $1.6 billion, down 8% from $1.8 billion, according to 2020 and fourth-quarter earnings results.”

About hospitals and health systems

FTC drops challenge to Philadelphia health system merger: “The Federal Trade Commission is no longer challenging the merger between Jefferson Health and Einstein Healthcare Network, clearing the way for the two Philadelphia-based health systems to combine.”

Mayo Clinic annual revenue grows to $13.9B: “For the 12-month period ended Dec. 31, the 51-hospital system recorded revenue of $13.9 billion, a 1.5 percent increase from the same period one year prior. Mayo Clinic saw its medical service revenue drop slightly year over year to $11.5 billion, down from $11.6 billion recorded in 2019. 
Mayo Clinic saw its expenses rise year over year to $13.2 billion, a 3.3 percent increase year over year. The health system attributed the expense increase to the unpredictability of the pandemic.”

About the public’s health

FDA clears novel neck collar to help protect student athletes' brains from sports-related injuries: “The FDA has cleared a new type of device worn around the back of the neck by athletes ages 13 and up, to help protect them from brain injuries caused by typically lighter, but repeated, impacts during sports.
The Q-Collar, developed by Q30 Innovations, doesn’t replace helmets or shoulder pads, but simply compresses the veins of the neck to increase the amount of blood around the brain. This helps cushion it within the skull, from hits that may not be enough to cause concussions on their own but can add up over time.”

About health insurance

It's like the Obamacare repeal-and-replace fight all over again: Reconciliation bills may be the only way Senate Democrats can pass health insurance legislation, for example, to modify ACA eligibility. This article is a great explanation of what this process allows and doesn’t allow.

Today's News and Commentary

About Covid-19

BREAKING: FDA Panel Clears J&J COVID-19 Vaccine For Emergency Use: “A U.S. Food and Drug Administration panel approved Johnson & Johnson's request for emergency use authorization of its COVID-19 vaccine Friday, clearing the way for a third vaccine that J&J said is safe and offers strong protection against severe disease, hospitalization and death.
The committee voted to back emergency use unanimously 22 to 0 with no abstentions, the last step before the FDA decides whether to issue an emergency use authorization, or EUA, which is a quicker process than seeking full FDA approval. While the FDA doesn't have to follow the committee's advice, it often does and is expected to approve the EUA soon.”

Biden marks 50 million coronavirus vaccines but warns virus fight not over: “Biden said the vaccine count marked major progress toward reaching and surpassing his administration’s goal of getting 100 million shots in the arms of Americans in his first 100 days in office…
Some public health experts have criticized Biden’s goal of 100 million vaccinations in 100 days as too low.”

New COVID-19 deaths in U.S. rise to highest level in 2 weeks: “The data show an addition of almost 75,000 COVID-19 cases nationwide on Wednesday, a slight increase over the day before but still way down from the peak in the middle of January.”

FDA allows storage, transport of Pfizer vaccine at higher temperatures: “The U.S. Food and Drug Administration on Thursday approved storage and transportation of COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE at standard freezer temperatures for up to two weeks instead of ultra-cold conditions.”

COVID-19 vaccine websites violate disability laws, create inequity for the blind: “Many COVID vaccination registration and information websites at the federal, state and local levels violate disability rights laws, hindering the ability of blind people to sign up for a potentially lifesaving vaccine, a Kaiser Health News investigation has found.”

KFF COVID-19 Vaccine Monitor: February 2021: A great update with charts as recent as 3 days ago.

COVID-19 vaccine vial maker Stevanato preps IPO valuing it at up to $5 billion: sources: “Italy’s Stevanato Group, manufacturer of glass vials for COVID-19 vaccines and other healthcare products, is making plans for an initial public offering this year that could value the company at between $4 billion-$5 billion, three sources with knowledge of the situation told Reuters.”

Lilly scores $210M supply deal for newly authorized coronavirus antibody cocktail: “ Eli Lilly on Friday scored a government supply deal for its newly authorized antibody cocktail, which dramatically reduced deaths and hospitalizations in a late-stage trial. 
Lilly agreed to sell the U.S. government 100,000 doses of the bamlanivimab-etesevimab combination for $210 million. The doses will be delivered before the end of March, and the government has the option to purchase 1.1 million more doses through Nov. 25 depending on demand.”

About pharma

Watch out, Novo Nordisk. Lilly's new dual action diabetes med could pressure Ozempic: analyst: “Novo Nordisk’s Ozempic is already duking it out with Eli Lilly’s Trulicity in the once-weekly diabetes treatment field. But looming competition from the Indianapolis pharma could pose a serious threat, especially at its lowest tested dose, one analyst said.
That’s the tentative conclusion Bernstein analyst Ronny Gal reached after delving into results from three phase 3 clinical trials of Eli Lilly’s investigational drug candidate tirzepatide, a dual GIP/GLP-1 agonist.
Data unveiled from the SURPASS-3 and -5 trials last week showed the drug was able to significantly drive down blood sugar levels as well as body weight at all three dosing levels tested.”

The CRO megamerger is back as Icon snaps up PRA Health for $12B: “Icon is getting out its checkbook in a massive $12 billion buyout of PRA Health.
The deal sees Icon stump up that sum in a cash and stock transaction, and it's around a 30% premium to PRA’s closing price as of Feb. 23. This comes after a tough year for Icon, which, in the spring last year, amid the height of the first pandemic wave, was forced to slash costs due to the COVID-19 disruptions to its business, while around a third of trial sites were hit.”

Orna Therapeutics Launches with over $100M Raised to Develop a New Class of Fully Engineered Circular RNA Therapies: “Orna's engineered circular RNAs have several key advantages, including superior protein expression, simpler and more cost-effective manufacturing, and improved delivery. Unlike other RNA therapies, oRNA does not require the addition of cap or tail structures and does not require the use of modified nucleotides to address innate immune responses. In addition, oRNAs are designed to drive unparalleled protein production while resisting degradation inside the body.”

AbbVie, Eli Lilly lead Big Pharma's 2020 market cap growth as Merck, Gilead lag: The headline speaks for itself. More details in the article.

Moderna expects $18.4bn from Covid vaccine deals this year: “The Boston-based biotech’s coronavirus vaccine revenue forecast is far higher than the $11.2bn analysts had predicted for 2021, as well as the $15bn that Pfizer said it expected when it reported earnings this month. Moderna said this number could rise because it was in discussions with governments about more vaccine orders for 2021 and 2022, as well as Covax, the vaccination programme for the developing world.”

Merck & Co. to buy Pandion for $1.85 billion, gaining autoimmune drug pipeline: ”Merck & Co. announced Thursday a definitive agreement to acquire Pandion Therapeutics for $60 per share in cash, representing an equity value of approximately $1.85 billion. The purchase will hand Merck a clutch of experimental drugs, including lead candidate PT101, that target a range of autoimmune diseases…
PT101 is an engineered IL-2 mutein fused to a protein backbone designed to activate and expand regulatory T-cells (Tregs) as a potential treatment for ulcerative colitis and other autoimmune diseases.”

Small Odds Humira Patents All Invalid 'Worries' 7th Circ: “Do Humira buyers need to prove every single patent in the ‘thicket’ surrounding AbbVie's blockbuster immunosuppressant was invalid to show the drug giant is illegally shielding the biologic from competition? A Seventh Circuit judge seemed to think so Thursday on a divided panel weighing whether to revive the lawsuit. Circuit Judge Frank H. Easterbrook hit the plaintiffs with their toughest questions during oral arguments, pressing Tom Sobol of Hagens Berman Sobol Shapiro LLP to explain how they can accuse AbbVie of protecting the world's best-selling drug with a thicket containing many allegedly ‘overlapping and non-inventive’ patents even though they were granted. . .”
This case has very important implications for drug patent protections. A common strategy is for pharma companies to get as many patents as possible on each of their products so that competitors will need to successfully challenge all of them.

About hospitals and health systems

Brookdale Selling Majority Stake in Home Health Business to HCA Healthcare: ”Brookdale has agreed to sell 80% of the equity in Brookdale Health Services to the Nashville, Tennessee-based HCA Healthcare for a purchase price of $400 million.”

UHS records $944M annual profit, notes cyberattack loss of $67M: “Despite COVID-19 expenses and taking a $67 million hit from a cyberattack last year, King of Prussia, Pa.-based Universal Health Services ended 2020 with a $944 million profit, according to financial documents released Feb. 25. This net income was a growth of 15.8 percent year over year. 
In the 12 months ended Dec. 31, the for-profit hospital operator saw its revenue hit $11.6 billion in 2020, up slightly from $11.4 billion recorded in 2019. It also saw its expenses rise less than 1 percent to $10.2 billion.
After factoring in the expenses, UHS recorded an operating income of $1.4 billion for 2020, up from $1.2 billion recorded in 2019. 
UHS also said the cyberattack experienced from Sept. 27, 2020 into October 2020, negatively affected its financial results. UHS said that it was forced to divert patients to competitor facilities, saw significant increases in labor expenses to restore its networks and saw administrative functions such as coding and billing delayed into December, "which had a negative impact on our operating cash flows during the fourth quarter of 2020."

About healthcare IT

Cigna's Evernorth to acquire telehealth company MDLive: “Cigna will acquire telehealth platform MDLive, the insurer announced Friday morning.
Cigna has been a longtime partner of and investor in MDLive and will fold it into its Evernorth subsidiary, which houses its health services business. The deal is expected to close in the second quarter of 2021, pending regulatory approvals.”

Allscripts Announces Fourth Quarter 2020 Results and Outlook For 2021:

• “Fourth quarter GAAP EPS of $4.82; 71% year-over-year growth in non-GAAP diluted EPS to $0.29

• Closed sales of EPSi and CarePort Health and recognized a combined pre-tax gain of $1.2 billion

• Repurchased $280 million of stock in the quarter and ended the quarter in a net cash position”

Telehealth company sues HHS for allegedly excluding overseas physicians: “RemoteICU wants to compel Medicare to pay for telehealth services provided by overseas physicians amidst an intensivist shortage and the pandemic.
RemoteICU wants to compel Medicare to pay for telehealth services provided by overseas physicians amidst an intensivist shortage and the pandemic.”

About health insurance

Fort Worth Doctor Sentenced to 10 Years in Health Care Fraud Conspiracy: “A Fort Worth osteopath who attempted to incinerate clinic records has been sentenced to 10 years in federal prison for his role in a $10 million healthcare fraud…
Mark Kuper, the 43-year-old owner of the Texas Center for Orthopedic and Spinal Disorders (TCOSD), was indicted in June 2020. The defendant admitted he fraudulently billed insurers for services the clinic never actually rendered, including physical therapy and psychotherapy, and required patients to attend these bogus appointments in order to receive Schedule II controlled substance prescriptions.
He also admitted that he gave his wife access to the secure device and passcode he used to sign controlled substance prescriptions, allowing her to improperly dispense pain medications on her own initiative, without his input.”

Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million: “Priority Healthcare will pay Roche Diagnostics $43.3 million to settle a lawsuit alleging that it fraudulently submitted claims to insurers and pharmacy benefit managers for Roche’s Accu-Chek blood glucose test strips that put Roche on the hook for tens of millions of dollars.
Roche claimed in its 2018 complaint that it had to pay more than $37.5 million in “unwarranted” rebates to insurance companies and PBMs for blood-glucose testing strips that either were different, pricier versions of the test strips patients actually received or were not shipped to patients at all. Roche also contended that Priority Healthcare’s efforts to introduce new pharmacies caused it to pay millions of dollars per year in unwarranted rebates for the tests.”

About healthcare professionals

Traumatized and tired, nurses are quitting due to the pandemic: While the headline speaks for itself, the article provides insights via interviews with nurses on the front lines.

About the public’s health

Stopping Menthol, Saving Lives: “For more than 60 years and continuing today, the tobacco industry has targeted Black communities, especially children, with marketing for menthol cigarettes and other tobacco products like flavored cigars.
The industry’s predatory marketing has had a devastating impact on Black health and lives. Tobacco use is the number one cause of preventable death among Black Americans and menthol cigarettes are a major reason why. Black Americans die at higher rates than other groups from tobacco-related diseases such as cancer, heart disease and stroke. To make matters worse, Black Americans are now being disproportionately impacted by COVID-19 and the CDC has found that current and former cigarette smokers are at greater risk for severe illness from COVID-19.”

Today's News and Commentary

About Covid-19

CDC Launches Web Tool To Help Americans Find COVID-19 Vaccines: The “Centers for Disease Control and Prevention, in partnership with Boston Children's Hospital and Castlight Health, is launching a new tool that allows Americans to search for COVID-19 vaccine providers with stock of vaccine where they live.The tool, which builds on the existing VaccineFinder.org platform, will capture inventory data from vaccine providers around the country.”

Biden administration to distribute more than 25 million masks: “The Biden administration will deliver more than 25 million masks to community health centers, food pantries and soup kitchens this spring as part of its battle against the coronavirus pandemic, the White House said on Wednesday.”

Clinical Reference Laboratory Makes First At-Home COVID-19 Saliva Test Available Through Walgreens Find Care®: “Clinical Reference Laboratory (CRL), one of the largest privately held clinical testing laboratories in the U.S., and Walgreens today announced that the FDA-authorized CRL Rapid Response COVID-19 Saliva Test is now available through Walgreens Find Care®, a digital health platform available on the Walgreens app and Walgreens.com. Sold under CRL’s HealthConfirm® brand, the COVID-19 Saliva Test is non-invasive and highly accurate, offering consumers the convenience of self-collecting the test right in their homes without supervision.”

Real-Time Conformational Dynamics of SARS-CoV-2 Spikes on Virus Particles: “The SARS-CoV-2 spike protein has been observed to adopt different structural states. Lu et al. directly visualize the conformational dynamics of spike protein on the surface of virus particles and describe how the conformational landscape changes upon activation by the host receptor or antagonism by antibodies.”
Such knowledge can be used to make more effective vaccines.

White House to ship 3 million to 4 million doses of Johnson & Johnson vaccine to states: “The Biden administration is planning to send states, pharmacies and community health centers 3 million to 4 million doses of Johnson & Johnson's coronavirus vaccine as early as next week, a White House official said Wednesday.”

Researchers find worrying new coronavirus variant in New York City: “Two separate teams of researchers said this week they have found a worrying new coronavirus variant in New York City and elsewhere in the Northeast that carries mutations that help it evade the body's natural immune response -- as well as the effects of monoclonal antibody treatments.
Genomics researchers have named the variant B.1.526. It appears in people affected in diverse neighborhoods of New York City, they said, and is ‘scattered in the Northeast.’
One of the mutations in this variant is the same concerning change found in the variant first seen in South Africa and known as B.1.351. It appears to evade, somewhat, the body's response to vaccines, as well. And it's becoming more common.”

Finland finds new COVID-19 variant that may not show up in PCR test: “The variant, Fin-796H, showed similar mutations from variants discovered in the UK and South Africa but also its own characteristics. 
Taru Meri, researcher of Helsinki-based Vita Laboratories, said the variant was found in a patient last week so it is unclear how easily the virus can spread or if it's resistant to available vaccines.
Meri said it is unlikely the variant emerged in Finland as the country has a low infection rate of the COVID-19. 
The researchers of Vita Laboratories also said it is worth noting that the new variant could escape detection in a PCR test (Polymerase Chain Reaction test), which identifies specific genetic sequences in the virus. 
A researcher said ‘the newly-discovered variant differs from expectations in that it does not genetically resemble any other known variant.’”

New research shows California coronavirus variant is more transmissible: “A coronavirus variant detected in California this winter rapidly became dominant in the state over five months and now makes up more than half of the infections in 44 counties, according to new research from scientists who believe this version of the virus should be declared a ‘variant of concern warranting urgent follow-up investigation.’”

HHS will stop distributing COVID-19 antibody drugs, says they're no longer in short supply: The headline speaks for itself.

Three-shot combo? Pfizer, BioNTech roll COVID-19 booster trial as real world data back first vaccine: “…the companies are in talks with the FDA and EMA about studying a new booster specifically designed to tackle new variants. They're hoping to validate ‘future modified mRNA vaccines with a regulatory pathway similar to what is currently in place for flu vaccines,’ according to a press release.
BioNTech CEO Ugur Sahin said the partners are ‘evaluating a second booster in the current regimen as well as preparing for a potential rapid adaption of the vaccine to address new variants which might escape the current version of our mRNA-based vaccine.’”

'It's Up To You': “The Ad Council is launching a national campaign to promote taking available coronavirus vaccines and a website with answers about their safety.” You should watch this short video and think about its possible effectiveness.

About healthcare IT

Email hack exposes 45,000 patients' data at Covenant HealthCare: “Covenant HealthCare has confirmed that an unauthorized individual gained access to two employees' email accounts, potentially exposing about 45,000 patients' information.
The accounts were accessed May 4, 2020, and contained patients' personal information like names, addresses, Social Security numbers, and medical diagnosis and clinical information. 
An FBI investigation found that hackers repeatedly combined vulnerable user IDs with different passwords until a combination worked, allowing them to access the two email accounts…”

Teladoc loses $394M in Q4: 6 things to know: The company provided a partial explanation: “Net loss for the fourth quarter and full year 2020 also includes $54.7 million of stock-based compensation related to Livongo stock awards that continue to vest after the merger. Net loss also includes an income tax benefit of $85.5 million for the fourth quarter 2020 and $90.9 million for the full year 2020.”

20 medical apps most downloaded by iPhone users: Epic’s MyChart tops the list.

Eli Lilly to connect its upcoming digital insulin pen with Welldoc’s diabetes app: “Eli Lilly & Co. has signed a deal to link Welldoc’s digital health platform with its upcoming connected insulin devices and therapies.
The two will collaborate on a new version of Welldoc’s long-running BlueStar diabetes management app, to include dosing data for several insulins produced by Lilly, ahead of the Big Pharma’s future launch of its connected insulin pen.
The BlueStar app has been cleared by the FDA for adults with Type 1 or Type 2 diabetes, offering insulin titration support, a bolus calculator and personalized health coaching. It is designed to integrate with a range of blood sugar readers and continuous glucose monitoring systems.”

About pharma

Merck inks $1.9B Pandion takeover to square up against Amgen, Lilly and Roche: ”Merck has struck a $1.9 billion deal to buy Pandion. The takeover will give Merck control of a pipeline of immune modulators led by a rival to IL-2 drugs in development at Amgen, Eli Lilly and Roche. 
Pandion went public last year, pulling in $135 million to fund the development of a pipeline led by an engineered IL-2 mutein fused to a protein backbone. The clinical-phase drug, PT101, is designed to selectively activate and expand regulatory T cells (Tregs) and, in doing so, treat autoimmune diseases including ulcerative colitis.”

Merck rolls first Gardasil TV commercial that pushes HPV vaccines for adults: “After years of encouraging parents to vaccinate their kids against HPV, Merck & Co. is launching its first Gardasil campaign aimed at adults.
The TV commercial features a man getting ready to run in a 5K race raising money for cancer…
It's part of a DTC campaign aimed at adults ages 27-45, which includes placements on broadcast, cable, syndication and streaming platform as well as YouTube. Print ads and promotional placement in doctors' offices and pharmacies are also in the mix.”

Head of McKinsey Is Voted Out as Firm Faces Reckoning on Opioid Crisis: “Partners at McKinsey & Company voted out the consulting firm’s top executive, Kevin Sneader, this week as it continues to face blowback over its role in fueling the opioid crisis.
The decision to deny Mr. Sneader a second three-year term as global managing partner came in a vote by more than 600 senior partners, according to a company executive.”

About health insurance

Cost Could Still Be A Deterrent In ACA Special Enrollment Period: “Although 4.0 million uninsured Americans qualify for free bronze level plans during the special enrollment period, deductible costs could continue to be a deterrent.”

Becerra commits to private-sector Medicare but indicates it is too generous: “Xavier Becerra, President Biden’s nominee to lead the Department of Health and Human Services, pledged Wednesday to support Medicare Advantage, the increasingly popular private form of the federal insurance system for older Americans — but indicated he had qualms about more generous benefits it offers.
Testifying at a confirmation hearing before the Senate Finance Committee, Becerra said he ‘will make sure that there is a level playing field’ between traditional Medicare and the private-sector version.”
He apparently does not understand the MA plans. They need to bid to get a government contract and the extra benefits they provide are often free to members. Traditionally they have made money reducing discretionary hospital stays- the most costly (and wasteful) part of healthcare expenses.

2 Californians sentenced for national ACA fraud scheme: “The father, Jeffrey White, was sentenced to three years in prison, and his son Nicholas White was sentenced to 13 months in prison for the scheme, which is believed to be the first to involve fraudulent enrollment in ACA plans on a national scale.
To defraud healthcare programs operating in the ACA marketplaces across the nation, the Whites would enroll individuals in ACA plans in states where the people didn't live, according to court documents and statements made in court. To enroll individuals in the plans, the Whites created fake residential leases and phone numbers for the individuals, according to the Justice Department.
They also paid insurance premiums for the individuals and paid to have them transported to California, where they were placed in residential substance abuse treatment programs, the department said. These programs then billed the ACA plans for thousands of dollars and paid the Whites thousands of dollars in kickbacks for each referral, according to the Justice Department.
The Whites admitted that the scheme defrauded more than $27 million from ACA plans across 12 states.”

Trend Toward More Expensive Inpatient Hospital Stays in Medicare Emerged Before COVID-19 and Warrants Further Scrutiny: From the HHS OIG: “Hospitals are increasingly billing for inpatient stays at the highest severity level, which is the most expensive one. The number of stays at the highest severity level increased almost 20 percent from FY 2014 through FY 2019, ultimately accounting for nearly half of all Medicare spending on inpatient hospital stays. The number of stays billed at each of the other severity levels decreased. At the same time, the average length of stay decreased for stays at the highest severity level, while the average length of all stays remained largely the same. 
Stays at the highest severity level are vulnerable to inappropriate billing practices, such as upcoding-the practice of billing at a level that is higher than warranted. Specifically, nearly a third of these stays lasted a particularly short amount of time and over half of the stays billed at the highest severity level had only one diagnosis qualifying them for payment at that level. Further, hospitals varied significantly in their billing of these stays, with some billing much differently than most…
Accordingly, we recommend that CMS conduct targeted reviews of MS-DRGs and stays that are vulnerable to upcoding, as well as the hospitals that frequently bill them. CMS did not concur but acknowledged that there is more work to be done to determine conclusively which changes in billing are attributable to upcoding.”

About hospitals and health systems

COVID-19 in 2021: The Potential Effect on Hospital Revenues: This Kauffman Hall report finds that hospital losses this year could range from $55-$122B.

Today's News and Commentary

From 340B to price transparency: Here are 3 takeaways from Becerra's confirmation hearing: Good summary of yesterday’s hearings.

About Covid-19

FDA review confirms safety and efficacy of single-shot Johnson & Johnson coronavirus vaccine, especially against severe cases: “A Food and Drug Administration review released Wednesday of the single-shot coronavirus vaccine made by pharmaceutical giant Johnson & Johnson found it was safe and effective and completely prevented hospitalizations and deaths in a large clinical trial.
The review sets the stage for a third coronavirus vaccine to be authorized as soon as this weekend…” In a related article: Johnson & Johnson ready to ship nearly 4 million doses of COVID-19 vaccine in U.S.: “Richard Nettles, Vice President of Medical Affairs at J&J unit Janssen Pharmaceutical, said the company expects to deliver 20 million doses of the vacine by the end of March.”

AstraZeneca expects U.S. COVID-19 vaccine authorization in April: “AstraZeneca Plc expects its COVID-19 vaccine could receive U.S. Emergency Use Authorization at the beginning of April and could immediately deliver 30 million doses of the shot there, a top executive said at a hearing in the U.S. House of Representatives on Tuesday.”

When Could the United States Reach Herd Immunity? It’s Complicated.: Lots of “ifs” in answering the question. The article does a great job explaining different scenarios. If we continue at our current pace with vaccination and controlling infection, my guess is November.

U.S. Federal Regulators Expected To Allow Pfizer-BioNTech Vaccine To Be Stored At Standard Freezer Temperatures: The headline speaks for itself.

Moderna sends COVID-19 booster shot for NIH testing as it hikes production targets past 2B doses: “Moderna on Wednesday said it's now on track to produce 700 million vaccine doses this year, and it's still aiming for 1 billion at the high end. Last year, the company had said 500 million would be its minimum output this year, and it ratcheted up that minimum to 600 million in January.
And for 2022, the biotech is planning for 1.4 billion doses—or perhaps even 2 billion, depending on the dose required for booster shots targeting new variants. The company has shipped a booster candidate to the National Institutes of Health for testing, according to Wednesday's statement; it's targeted specifically at the South Africa variant now worrying public health experts.”

About healthcare IT

Cleveland Clinic, Amwell joint venture launches virtual 2nd opinions service: “The Cleveland Clinic and telehealth company American Well are offering virtual medical second opinions as part of their telehealth joint venture.
The Clinic by Cleveland Clinic aligns the hospital's clinical expertise with innovative digital health technologies to provide easier access to leading medical expertise—ultimately driving better decisions, improved patient outcomes and lower costs, the organization said.
Monday, The Clinic launched its new website and brand identity.”

2 More Telehealth Bills Return to Congress For Another Try: “Two popular telehealth bills that failed to make it through last year’s Legislature are being reintroduced this week on Capitol Hill, adding to a growing number of connected health bills aimed at continuing the momentum for telehealth beyond the coronavirus pandemic.
On Monday, Senators Rob Portman (R-OH) and Sheldon Whitehouse (D-RI) re-submitted the Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act, which would make permanent certain emergency actions passed during the coronavirus pandemic to boost telehealth access for substance use disorder (SUD) treatment.”

Microsoft updates Cloud for Healthcare with new virtual care, patient monitoring features: “The tech giant announced its Cloud for Healthcare service back in October that brings together existing services such as Microsoft Teams, Azure IoT and chatbots to help healthcare organizations manage operations.
The first update will be available in April and includes services for care plan management and will support eight additional languages.”

About the public’s health

Fructose reprogrammes glutamine-dependent oxidative metabolism to support LPS-induced inflammation: In other words, the fructose that is common in fast foods has a pro-inflammatory effect on our immune systems.

About pharma

UCB taps Microsoft to accelerate drug discovery, clinical trials: “UCB and Microsoft have entered into a multiyear strategic collaboration. The deal will see Microsoft use its capabilities in computational services, cloud computing and artificial intelligence to support drug discovery and development at UCB…
Belgium’s UCB is also looking to identify other areas of its operation that could benefit from AI and additional computing power. UCB is yet to name areas it is exploring, saying only that the work will span ‘every part of the drug discovery and delivery value chain”’and is intended to accelerate the development of life-changing treatments in immunology and neurology.”

Retail Health Clinic Engagement Rising; May Be Key to Supercharging COVID-19 Vaccine Rollout:

• “Nearly half (48%) of retail pharmacy customers used at least one health and wellness service in 2020, up significantly from 2019 (43%)

• One in five (20%) customers spoke to a pharmacist during their visit, up from 16% in both 2018 and 2019

• When customers use two or more health and wellness services, overall customer satisfaction and brand advocacy increases, and average customer spending doubles”

About health insurance

Impact of Policy Options for Reducing Hospital Prices Paid by Private Health Plans: From RAND: “In this report, we focus on policies that address prices paid to hospitals by private health plans. We analyze the impact of three policy options—regulating hospital prices, improving price transparency, and increasing competition among hospitals—on hospital spending by employer-sponsored and individual market plans and their enrollees. For each policy option… we explore key considerations and estimate the potential impact on hospital prices and spending using data from the CMS Hospital Cost Report Information System.” A summary is on this page. You can click the pdf for the full report.

Carrum Health First to Launch Bundled Cancer Care for Employers in Collaboration with Memorial Sloan Kettering: A bit of hype…and it is not the first cancer care bundle.
”Carrum Health, the first digital health company connecting employers and employees to Centers of Excellence (COEs) through a technology-powered platform… announced that it is extending its COE model into oncology with the industry's first-ever cancer care bundle. Working in collaboration with Memorial Sloan Kettering Cancer Center (MSK), Carrum Health will offer comprehensive bundles that cover in-person treatment at MSK for eligible patients with breast and thyroid cancers, as well as remote diagnosis, treatment planning, and care guidance for all forms of cancer. For breast and thyroid cancers, the bundle includes complete medical treatment for up to two years….”

Expanding Premium Tax Credits to Middle-Income Families Would Reduce the Number of People Uninsured and Increase Marketplace Enrollment: “In this brief, we analyze a policy that would expand Marketplace premium tax credits by raising the eligibility cutoff from 400 to 600 percent of the federal poverty level (FPL). The policy would lessen the financial burden of high premiums for such families and increase Marketplace enrollment for this group. A potential drawback, however, is that some employers might stop offering employer-sponsored insurance to their workers. However, we find such concerns unwarranted. Research shows most employers responded the Affordable Care Act (ACA) by increasing the rate at which they offer insurance to their employees. Incorporating that evidence, our analysis finds extending the eligibility cutoff for Marketplace premium tax credits to 600 percent of FPL would decrease the number of people uninsured by more than 116,000, and 48,000 people with non-ACA-compliant coverage would enroll in Marketplace plans. Together, these effects would move 164,000 people into plans providing minimum essential coverage.”

Survey: Healthcare Costs Loom Large Among Women Medicare Recipients:
“Key findings:

• Almost two-thirds of women (66%) are concerned about their ability to pay for future healthcare compared to just over half (51%) of men.

• 18% of women report trouble paying for prescription drugs within the last year, compared to just 11% of men.

• Six in 10 (60%) women said Democrats would better protect Medicare, compared to roughly four in 10 (43%) men.”

Today's News and Commentary

About Covid-19

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants: Yesterday, the “U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.”
One major update is guidance for vaccine modifications to combat variants. Akin to influenza vaccine policy, such Covid-19 vaccine modifications will not have to conduct the same extensive testing as new products.

At least 44.5 million people have received one or both doses of the vaccine in the U.S.: “This includes more than 19.9 million people who have been fully vaccinated. 82.1 million doses have been distributed.”

‘Held to ransom’: Pfizer demands governments gamble with state assets to secure vaccine deal: “Pfizer has been accused of ‘bullying’ Latin American governments in Covid vaccine negotiations and has asked some countries to put up sovereign assets, such as embassy buildings and military bases, as a guarantee against the cost of any future legal cases…
In the case of one country, demands made by the pharmaceutical giant led to a three-month delay in a vaccine deal being agreed. For Argentina and Brazil, no national deals were agreed at all.”
While the alleged demands are excessive, it does raise the issue of liability for an essential global product.
This concern is addressed in this related article: No-fault compensation programme for COVID-19 vaccines is a world first: “The World Health Organization (WHO) and Chubb Limited (NYSE: CB), through ESIS Inc., a Chubb company, signed an agreement on behalf of the COVAX Facility on 17 February 2021 for the administration of a no-fault compensation programme for the 92 low- and middle-income countries and economies eligible for support via the Gavi COVAX Advance Market Commitment (AMC) of the COVAX Facility.”

Pharmacists say 'pooling' Covid vaccines could save thousands of doses: “Inova pharmacists did an experiment, taking 100 vials that had residual vaccine. Eighty of them had significant amounts left over. The pharmacists found that with the vaccine left in the 80 vials, they could make 40 additional full doses. That meant that on a typical vaccination day, when the hospital will typically give more than 4,000 shots, it could give an additional 400 vaccination shots with the same supply.
Even though pooling is common [with other injectables], the FDA says pharmacists and other clinicians cannot pool leftover Covid-19 vaccine because neither Moderna's nor Pfizer's products contain preservatives, which help stop microbial growth in case the vaccine is contaminated with bacteria or other germs.”

J&J Seeks WHO Emergency Use Listing for COVID-19 Vaccine: “Johnson & Johnson (J&J) has filed with the World Health Organization (WHO) for an Emergency Use Listing (EUL) for its COVID-19 vaccine — a listing that would clear the way for the vaccine to be distributed through the WHO’s COVAX vaccine-sharing program.
J&J reached an agreement in December with Gavi, the Vaccine Alliance, a co-leader of COVAX, to provide up to 500 million vaccine doses through 2022.”

UK real-world data show COVID-19 vaccine linked to lower infection, hospitalisation rates: “Data from new analyses were released Monday shedding light on the short-term impacts of COVID-19 vaccinations in the UK. One analysis from Public Health England's (PHE) SIREN study appears to corroborate early evidence that Pfizer and BioNTech's vaccine BNT162b2 offers high levels of protection against infection and symptomatic disease from the first dose, while another conducted by Public Health Scotland (PHS) indicates that COVID-19 vaccinations have lowered the risk of serious disease by cutting hospital admittance rates. Neither is peer-reviewed and both were released as preprints by The Lancet…
Results, which focused on Pfizer's vaccine, demonstrated that BNT162b2 was 72% effective at reducing the risk of symptomatic and asymptomatic infection 21 days after the first dose, rising to 86% seven days after the second in the antibody-negative cohort. Overall, hospitalisation and death from COVID-19 declined by over 75% in those who received a dose of the vaccine.”

OCR lifts HIPAA fines for use of COVID-19 vaccine scheduling tools: “Healthcare organizations won't be penalized for potential Health Insurance Portability and Accountability Act (HIPAA) violations related to the good faith use of online or web-based scheduling applications for COVID-19 vaccine appointments.
The Office for Civil Rights (OCR) at the U.S Department of Health and Human Services announced (PDF) this week that it won't enforce fines against providers when using apps and other digital tools that don't fully comply with HIPAA.”

Pfizer eyes higher prices for COVID-19 vaccine after the pandemic wanes: exec, analyst: “A top Pfizer exec said the drugmaker aims to charge more after the ‘pandemic pricing environment,’ and an influential analyst says the company could be eying prices 3 to 4 times higher.”

About health insurance

Biden administration asks U.S. Supreme Court to dump Medicaid work case: “President Joe Biden’s administration on Monday asked the U.S. Supreme Court to cancel an upcoming oral argument on a policy introduced under his predecessor Donald Trump backing work requirements for people who receive healthcare under the Medicaid program for the poor.
Acting Solicitor General Elizabeth Prelogar said the Biden administration has started the process of reversing the previous policy and asked the justices to dump the scheduled March 29 arguments concerning pilot programs adopted by the states of Arkansas and New Hampshire.”

Affordable Coverage Coalition Principles for Extending Coverage and Protecting Patients: This statement by a number of major healthcare organizations calls for principles to implement universal healthcare coverage. The initiative is based on ACA expansion. For example: “Ensure everyone with an income up to 138 percent of the federal poverty level has comprehensive coverage. To provide incentives for states that have not yet expanded Medicaid to act, Congress should again fund a three-year, 100 percent federal match for Medicaid expansion.”

Health Care Reform: One (Percent) Step At A Time: This article from Health Affairs (open access) reviews 16 strategies for saving health costs- each having an impact of <1%. They add up to 8.87% savings. For a country with about 3.7 trillion in healthcare spending, that’s about $337 billion less cost. The authors are part of the 1% Steps for Health Care Reform Project.

Oscar Health, Inc. Announces Launch of Initial Public Offering: “Oscar Health, Inc. (“Oscar”)… announced the launch of its initial public offering of 31,000,000 shares of its Class A common stock. The offering consists of 30,350,920 shares of Class A common stock offered by Oscar and 649,080 shares of Class A common stock to be sold by certain of Oscar’s existing stockholders.”
The offering could raise more than $1 Billion.

About pharma

High Court Knocks Out PBM Group's 8th Circ. Preemption Win: “The U. S. Supreme Court struck down a win Monday for a trade group that brought an ERISA case challenging North Dakota's oversight of the pharmacy benefit manager industry, sending the suit back to the Eighth Circuit for another look in light of the justices' recent Rutledge ruling. The justices granted the Pharmaceutical Care Management Association's petition for them to take up the case, then vacated the group's Eighth Circuit victory in a deregulation fight invoking the Employee Retirement Income Security Act.”
For background on the case, see: Eighth Circuit: State’s PBM Law Preempted by ERISA, Unenforceable.

Charles River Buys Cognate BioServices for $875 Million: “Charles River Laboratories is acquiring Cognate BioServices, a Baltimore, Md.-based cell and gene therapy contract development and manufacturing firm for $875 million.
The Cognate BioServices acquisition will provide biopharmaceutical clients ‘an integrated solution to help accelerate their cell and gene therapy programs from discovery and nonclinical development through commercialization,’ said Charles River CEO James Foster.”

Johnson & Johnson tots up a potential $4B talc bill as tens of thousands of lawsuits pile up: “Johnson & Johnson has been battling for years against lawsuits claiming its talc powders cause cancer, but now investors are getting a sense of what the litigation could cost the drug giant. And it's about twice as much as J&J had figured on last year.
In an annual filing with the SEC, J&J said its multibillion-dollar 2020 litigation expense is “primarily associated with talc related reserves and certain settlements” worth $3.9 billion. The company faces 25,000 lawsuits alleging the household products cause cancer, and it's still in the process of appealing a massive verdict out of Missouri.”

Today's News and Commentary

About Covid-19

Prospective mapping of viral mutations that escape antibodies used to treat COVID-19: “Here we map how all mutations to the receptor binding domain (RBD) of SARS-CoV-2 affect binding by the antibodies in the REGN-COV2 cocktail and the antibody LY-CoV016. These complete maps uncover a single amino acid mutation that fully escapes the REGN-COV2 cocktail, which consists of two antibodies, REGN10933 and REGN10987, targeting distinct structural epitopes. The maps also identify viral mutations that are selected in a persistently infected patient treated with REGN-COV2 and during in vitro viral escape selections. Finally, the maps reveal that mutations escaping the individual antibodies are already present in circulating SARS-CoV-2 strains.[Emphasis added]”

U.S. nears 500,000 COVID-19 deaths as Biden plans commemoration: “While the number of COVID-19 cases fell for the fifth straight week and officials scrambled to inoculate the population, the nation was poised to reach 500,000 deaths from the highly infectious respiratory disease.”

Finnish Nasal Vaccine Meant to Stop Coronavirus 'Completely' to Start Human Tests This Summer: “If successful, the news source said the nasal vaccine would be a major improvement over vaccines currently in use, and potentially eliminate the risk of the virus mutating in vaccinated individuals.
Additional advantages of the single-dose Finnish vaccine are that it can be stored at refrigerator temperature and is inexpensive to produce, the news source added.
However, with the nasal approach, doctors have less control over how large a dose the patient actually receives, compared to an injection.”

World Bank pushing for standard vaccine contracts, more disclosure from makers: “The World Bank is looking to standardise COVID-19 vaccine contracts that countries are signing with drugmakers, as reported in National Post.
In addition, the World Bank is pushing manufacturers to be more open about where vaccine doses are headed.
The bank’s International Finance Corp has $4 billion to invest in expanding existing production plants or building new ones, but World Bank president David Malpass said it needs more data on where current production is headed.”

After Pfizer deal, Sanofi offers a hand to Johnson & Johnson for COVID-19 vaccine production: “The deal follows a separate agreement for Sanofi to turn out 100 million doses of the Pfizer-BioNTech vaccine for Europe this year. 
When J&J's one-dose-and-done vaccine scores an authorization, Sanofi will give the company access to its plant in Marcy l’Etoile, France. Workers there will formulate the J&J vaccine and fill vials, and the site will turn out around 12 million doses per month, Sanofi said.”

About pharma

Hide-and-Seek Can Lead to Higher Drug Prices: An interesting European study about the effects of drug rebates on cost. Since we face the same issues it is worth a read.

Approval and Coverage of Cancer Drugs in England, Canada, and the US: Another fascinating international comparison driven by factors such as differences in surrogate endpoints and cost-benefit calculations.

The 10 most-anticipated drug launches of 2021: At the top of the list: “No other pending drug approval faces more skepticism on one hand, and more cheerleading on the other, than Biogen’s anti-amyloid beta antibody aducanumab for Alzheimer’s disease.”

Most, least expensive US cities for prescription drugs: No surprise that NYC is most expensive. Denver tops the least expensive list.

About the public’s health

Justices To Review 'Gag Rule' On Abortion Referrals: “The U. S. Supreme Court on Monday agreed to examine a Trump administration ‘gag rule’ that would prohibit physicians from referring patients to abortion providers, taking up a controversial case that has divided lower courts. The justices will review a U. S. Department of Health and Human Services regulation — upheld by the Ninth Circuit but blocked nationwide by the Fourth Circuit — that would bar doctors who receive federal funds for family planning services from helping patients access abortion services.”

About healthcare professionals

‘I Am Worth It’: Why Thousands of Doctors in America Can’t Get a Job: “Medical schools are producing more graduates, but residency programs haven’t kept up, leaving thousands of young doctors ‘chronically unmatched’ and deep in debt.”

About healthcare IT

Breaches Cost US Healthcare Organizations $13bn in 2020: “Last year saw a double-digit surge in the volume of healthcare data breach incidents in the US, with over 26 million people affected… incidents increased by over 55% on 2019 figures to reach 599 breaches in the sector, impacting over 26.4 million people.
The vast majority (67%) were down to ‘hacking and IT incidents’ stemming from external attackers. This category also accounted for larger breaches than the others, amounting to over 91% of compromised records.”

Do Medical Scribes Help Primary Care Providers Respond More Quickly to Out-of-Visit Tasks?: “Our study suggests that scribes are not associated with improved time to completion of inbox messages for PCPs. While scribes seem to have many benefits, our study suggests they may not improve time to completion of out-of-visit tasks. Reducing the time to completion for these tasks likely requires other interventions targeted to achieve those outcomes.”

Today's News and Commentary

Walmart is slowing its ambitious push into healthcare, employees and leaked documents reveal: The company is not now sure of the direction or pace of its actions in healthcare.

About Covid-19

White House announces $4 billion in funding for Covax, the global vaccine effort that Trump spurned: “At a Group of Seven meeting of leaders of the world’s largest economies Friday, President Biden will announce an initial $2 billion in funding for Gavi, the Vaccine Alliance, to be used by the Covax Facility, senior administration officials said in a briefing.
The United States will release an additional $2 billion over two years once other donors have made good on their pledges and will use this week’s G-7 summit to rally other countries to do more.”

Why grandparents can’t find vaccines: Scarcity of niche biotech ingredients: “Acuitas Therapeutics, a tiny biotechnology firm in Vancouver, B.C., has just 30 employees and leases its labs from the University of British Columbia. The company doesn’t even have a sign on its building. Until last year, it outsourced production of only small volumes of lipid nanoparticles, fat droplets used to deliver RNA into cells, for research and a single approved treatment for a rare disease.
But now, one of Acuitas’s discoveries has become a precious commodity. A proprietary molecule called an ionizable cationic lipid is a crucial piece of the mRNA vaccine made by Pfizer and its German partner BioNTech, and it is in urgent demand for production of billions of vaccine doses worldwide.”

Pfizer wants to store vaccine at higher temperatures, making distribution easier: “The companies have submitted new temperature data to the FDA to support an update to the current label that would allow vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks.
The current label requires the vaccine to be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.”

US will not send vaccines to developing countries until supply improves: “The US will not donate any coronavirus vaccine doses to developing countries until there is a plentiful supply of jabs in the US, Biden administration officials said on Thursday in a firm rejection of a proposal made by Emmanuel Macron, president of France.”

EU Unveils Vaccine Incubator to Combat COVID-19 Variants: “A new initiative under the EU’s Health Emergency Response Authority (HERA), the HERA Incubator will adopt the same approach as is used for the annual flu vaccine, the European Commission said.
The incubator will bring together researchers, biotech companies, manufacturers, regulators and public authorities to ‘monitor variants, exchange data and cooperate on adapting vaccines,’ the commission said.”

AI-based voiceprint screener for COVID-19 nets European approval: “Using artificial intelligence software to analyze a multitude of voice recordings, Vocalis has secured a CE mark for the use of its digital COVID-19 screening programs in Europe.
Run off a smartphone, the user records themselves counting up from 50 to 70 while the program analyzes the quality of their voice and searches it for signs associated with the disease. Though not a diagnostic itself, Vocalis believes it could be a useful tool to screen large populations of people and point those at the highest risk of infection toward the clinic.”

Novavax, coronavirus shot data in hand, strikes an eye-popping supply deal with global vaccine consortium: “Novavax on Thursday unveiled a memorandum of understanding with Gavi, the Vaccine Alliance, to provide 1.1 billion doses of its coronavirus vaccine candidate to COVAX, a global effort to ensure equitable vaccine distribution. The Serum Institute of India will help produce doses under a prior deal between that company and Gavi.
The deal will support work by Gavi, the Coalition for Epidemic Preparedness Innovations and the World Health Organization to distribute doses in every country worldwide.”

About healthcare IT

A retrospective look at the predictions and recommendations from the 2009 AMIA policy meeting: did we see EHR-related clinician burnout coming?: “At the 2020 annual meeting of the American College of Medical Informatics (ACMI), ACMI fellows participated in a modified Delphi process to assess the accuracy of the 2009 predictions and the response to the recommendations. Among the findings, the fellows concluded that the degree of clinician burnout and its contributing factors, such as increased documentation requirements, were significantly underestimated. Conversely, problems related to identify theft and fraud were overestimated. Only 3 of the 15 recommendations were adjudged more than half-addressed.”

IBM Explores Sale of IBM Watson Health: “IBM is studying alternatives for the unit that could include a sale to a private-equity firm or industry player or a merger with a blank-check company, the people said. The unit, which employs artificial intelligence to help hospitals, insurers and drugmakers manage their data, has roughly $1 billion in annual revenue and isn’t currently profitable, the people said.
Its brands include Merge Healthcare, which analyzes mammograms and MRIs; Phytel, which assists with patient communications; and Truven Health Analytics, which analyzes complex healthcare data.”

About the public’s health

U.S. will pay WHO more than $200 million in membership fees withheld by Trump: The headline speaks for itself.

Five chronic conditions cost employers over $2.5 billion over two years: “Companies spent $2.5 billion to treat employees' asthma, diabetes, hypertension, mental health and substance abuse and back disorders over the course of two years, according to a new study. UnitedHealthcare reviewed all claims issued by the Health Action Council's 57 nationwide employer members—which are responsible for coverage of 281,000 individuals—to find that more than 60% of workers struggle with at least one of these chronic conditions, making them the top cost drivers in employer healthcare.”
See, also: Health and Economic Costs of Chronic Diseases from the CDC. That site adds: “Nothing kills more Americans than heart disease and stroke. More than 868,000 Americans die of heart disease or stroke every year—that’s one-third of all deaths. These diseases take an economic toll, as well, costing our health care system $214 billion per year and causing $138 billion in lost productivity on the job.” Note the magnitude differences.

South Carolina passes abortion ban, Planned Parenthood sues: “As one of the most restrictive abortion bans, the so-called ‘fetal heartbeat’ law bans abortion after a fetal heartbeat is detected, often at six weeks and before a woman realizes she is pregnant.”

About pharma

Federal judge dismisses hospital groups' lawsuit against HHS over 340B drug feud: “ A federal judge has dismissed a lawsuit filed by several hospital groups seeking to get the Department of Health and Human Services (HHS) to clamp down on drugmakers restricting access to products.
Federal Judge Yvonne Gonzalez Rogers issued a ruling Wednesday that hospitals had to use a new dispute resolution process to settle the feud with the drugmakers, which the hospitals cannot sue individually under federal law for 340B violations.”

Trump Drug Rebate Policy Delayed Until 2023 After Court Ruling: See the HHS announcement for more details.

AbbVie, Eli Lilly lead Big Pharma’s 2020 market cap growth as Merck, Gilead lag: “Among the top 10 companies with the largest market cap as of the end of 2020, AbbVie enjoyed the biggest year-over-year growth—a whopping 44.4% to $189.2 billion, according to numbers compiled by GlobalData. The Illinois pharma doesn’t have any prominent COVID products.
In contrast, COVID-19 vaccine makers Pfizer and AstraZeneca both failed to beat their pre-COVID market valuation. It’s worth noting that Gilead Sciences, which sells the only fully FDA-approved COVID drug, Veklury, also saw its market cap drop—by 11.2% in its case—though it’s not a member of the top 10 class.”

Pharma's reputation rehab: A whopping two-thirds of Americans now offer a thumbs-up, Harris Poll finds: “Almost two-thirds of Americans now give the pharma industry a thumbs up. It’s a stunning reversal from just one year ago when only about one-third (32%) rated the industry positively, according to The Harris Poll surveys.
In its most recent February poll, 62% rated the pharma industry as a 5, 6 or 7 on a 7-point scale, with 1 equating to ‘very bad’ and 7 to ‘very good.’That’s an increase of 30 percentage points since January 2020, before the pandemic hit U.S. shores.”

About hospitals and health systems

CommonSpirit's net income triples to $1.9B in Q2: “CommonSpirit, a 140-hospital system based in Chicago, saw revenues rise in the second quarter of fiscal year 2021 and ended the period with a net gain, which was fueled by strong investment income growth. 
CommonSpirit, formed in 2019 through the merger of San Francisco-based Dignity Health and Englewood, Colo.-based Catholic Health Initiatives, reported revenues of $8.3 billion in the second quarter of fiscal 2021, up from $7.5 billion a year earlier.”
It will be interesting to see if other systems report positive results based on increases in the market value of their investments.

Medicare Cuts Payment to 774 Hospitals Over Patient Complications: “The federal government has penalized 774 hospitals for having the highest rates of patient infections or other potentially avoidable medical complications. Those hospitals, which include some of the nation’s marquee medical centers, will lose 1% of their Medicare payments over 12 months.
The penalties, based on patients who stayed in the hospitals anytime between mid-2017 and 2019, before the pandemic, are not related to covid-19.”

Today's News and Commentary

AMA removes public displays of founder over past racism, discrimination: “The American Medical Association removed some recognitions of its founder, Nathan Davis, MD, whose actions explicitly excluded women and Black physicians from representation in the association. 
The association removed a bust and display of Dr. Davis in its Chicago headquarters and placed them in its archives to use as educational material. The association also removed his name from an annual award it gives to individuals for outstanding government service.”

About Covid-19

C.D.C. Announces $200 Million ‘Down Payment’ to Track Virus Variants: “As lawmakers push for billions of dollars to fund the nation’s efforts to track coronavirus variants, the Biden administration announced on Wednesday a new effort to ramp up this work, pledging nearly $200 million to better identify the emerging threats.” In a related article: Biden administration will spend $1.6B to expand COVID-19 testing, sequencing.

Businesses, public health organizations form alliance to strengthen COVID-19 response: “The Ad Council, Business Roundtable, the CDC Foundation, the de Beaumont Foundation and the Robert Wood Johnson Foundation have jointly formed the Health Action Alliance, which will assist a participating network of businesses in improving their workers' health, providing COVID-19 prevention and vaccination information and strengthening their public health capabilities.
Another focus, the organizations said, is on improving health equity and assisting underserved and disproportionately impacted communities.
Initial participants in the program include big names such as Amazon, CVS Health, Facebook, JPMorgan Chase, Comcast, Walgreens and Walmart. The alliance is backed by impact firm Meteorite…”

On social media, vaccine misinformation mixes with extreme faith: “The rapid spread of this material has triggered debate and concern among U.S. Christian leaders and experts who believe the religious movement against vaccines is growing, even as many leaders such as Pope Francis and Southern Baptist Convention policy leader Russell Moore are urging people to get shots.”

U.K. gets approval to infect healthy volunteers in world’s first coronavirus ‘challenge trial’: ”Britain will become the first country to deliberately infect healthy volunteers with the coronavirus, now that the country's ethics body has approved a ‘human challenge trial.’
The effort, funded by the British government, aims to accelerate scientific understanding of vaccines and treatments.
The first stage will begin within the month and see up to 90 adults, age 18 to 30, exposed to the coronavirus “in a safe and controlled environment” to gauge the smallest amount of virus needed to cause infection, the government said in a statement Wednesday.”

BioNTech/Pfizer vaccine is less potent against South African variant: “The BioNTech/Pfizer Covid-19 vaccine appears to be significantly less effective against the virus variant that emerged in South Africa, according to a study published on Wednesday. The vaccine still works against the strain known as 501Y.V2, but the shot produced only a third of the antibodies that it did for the original virus in a lab study using an engineered virus. The partners said there was ‘no clinical evidence’ that people vaccinated with their Covid-19 shot lacked protection against the variant. It is hard to draw firm conclusions from lab experiments on how the vaccines will work on the variants in humans.”
In a related article, SARS-CoV-2 Variants of Concern in the United States—Challenges and Opportunities, authors also express concern about reduced immune response to new variants. 
It should be noted that many of the studies are lab-based and focus only on antibody responses, not cellular immune responses.

About the public’s health

CDC: U.S. life expectancy fell by a year during first half of 2020 due to COVID-19: “ Life expectancy in the United States declined by a year during the first half of 2020, due in large part to the impact of the COVID-19 pandemic, according to data released Thursday by the U.S. Centers for Disease Control and Prevention.
From January through June of last year, life expectancy at birth for the total population of the United States was 77.8 years, down from 78.8 years in 2019.”

USPSTF Advises Screening for Gestational Diabetes Mellitus: “The U.S. Preventive Services Task Force (USPSTF) recommends gestational diabetes mellitus (GDM) screening at or after 24 weeks of pregnancy in asymptomatic individuals. This recommendation forms the basis of a draft recommendation statement published online Feb. 16.”

About health insurance

Biden picks another Obama veteran to oversee Medicare, Medicaid: “President Biden has selected Chiquita Brooks-LaSure to lead the Centers for Medicare and Medicaid Services, filling a major role in his health-care leadership team, according to four people who spoke on the condition of anonymity because they were not authorized to discuss the decision.
Brooks-LaSure served in the Obama administration as a senior CMS official who helped implement the Affordable Care Act’s coverage expansion and insurance-market reforms. She also worked on Capitol Hill as a Democratic staff member for the House Ways and Means Committee, building ties with then-Rep. Xavier Becerra, Biden’s choice to lead the Health and Human Services department and who sat on the committee at the time.”

Trends in Low-Value Health Service Use and Spending in the US Medicare Fee-for-Service Program, 2014-2018: “This study found that among individuals with fee-for-service Medicare receiving any of 32 measured services, low-value care use and spending decreased marginally from 2014 to 2018, despite a national education campaign to address low-value care and increased attention on reducing health care waste.” 
Reimbursement changes “from volume to value” have not yet been implemented. Until they are, we cannot expect to see these changes.

Biden admin appears to withdraw final rule aimed at streamlining prior authorization: “The Biden administration appears to have withdrawn a rule finalized last minute by the Trump administration that aims to streamline prior authorization, a major source of provider administrative burden… that press release no longer appears on CMS’ website, and the rule does not appear in the Federal Register.
CMS did not say why the rule appeared to be withdrawn.”

Biden wants a 'public option' health plan. Two Senate moderates say they have just the bill: Called Medicare-X, it would not lower the age of eligibility to 60 as had been previously discussed, but it proposes to: 

• “Allow Medicare to pay 50 percent more to rural hospitals and providers, up from a 25 percent allowance.

• Require marketplace plans to fully cover primary care services with no cost-sharing for patients.

• Fix the so-called “family glitch” in the Affordable Care Act, which bases a family's eligibility for marketplace subsidies on whether an employee's offer of workplace coverage was affordable for the individual but not necessarily affordable for the whole family.”

In a related article: Democrats' plan to expand ACA insurance would cost about $53B, CBO estimates.

Appeals court strikes down oncology group's lawsuit aimed at rolling back Medicare sequestration cuts: “A federal appeals court has struck down the Community Oncology Alliance’s lawsuit [filed in 2018] to get rid of a 2% cut to Medicare Part B payments installed via sequestration.” 
Unfortunately since it was decided on jurisdictional grounds, the decision did not clarify this issue.

How Aetna, Anthem, Humana, Cigna and UnitedHealth performed in Q4: A good summary of the results. Keep in mind that CVS and UnitedHealth have incomes from non-health insurance sources (pharmacy and Optum-related services, respectively). 

About hospitals and health systems

Association of Inclusion of Medicare Advantage Patients in Hospitals’ Risk-Standardized Readmission Rates, Performance, and Penalty Status: “In this cohort study, the inclusion of data from MA patients changed the penalty status of a substantial fraction of US hospitals for at least 1 of 3 reported conditions [acute myocardial infarction (AMI), congestive heart failure (CHF), or pneumonia]. This suggests that policy makers should consider including all hospital patients, regardless of insurance status, when assessing hospital quality measures.”

CHS sheds 18 hospitals, swings to $511M profit: Bigger is not always better (or more profitable). “Franklin, Tenn.-based Community Health Systems, which operates 85 hospitals in 16 states, saw revenues decline in 2020 but ended the period in the black…
Looking at full-year 2020 results, the company posted net income of $511 million on revenues of $11.8 billion, compared to a net loss of $675 million on revenues of $13.2 billion in 2019.” 

10 hospitals planning upgrades, expansions: FYI. Still amazed at the continued expansions. 

Today's News and Commentary

About Covid-19

Why Do COVID-19 Death Rates Differ Wildly from Place to Place?: “…a country’s level of pre-COVID income inequality was by far the best predictor of the COVID death rate. The same finding emerged when the researchers studied variations in COVID death rates across U.S. states: higher death rates tend to occur is U.S. states with higher pre-COVID income inequality…”
The “death rate among low-income Americans would have been a staggering 30 percent lower if this group had the same COVID case-fatality rate as high-income people. The researchers surmise that lower-income people presumably came into the pandemic with more preexisting health conditions that made them much more predisposed to succumb to the virus than those with more money.”

Trump’s vaccine tsar launches European biotech roll-up: “Moncef Slaoui, the former GlaxoSmithKline research boss who became the Trump administration’s vaccine tsar, is returning to the private sector at a new venture that is rolling up smaller biotech companies in an attempt to take on Big Pharma…
Slaoui is also a partner at Medixci, which will roll its stakes in the merged companies into a shareholding in Centessa. The new umbrella company includes drug development programmes ranging from cancer to blood pressure. It has four products in clinical trials, including a drug for kidney disease in a phase 3 study and a cancer drug in phase 2/3.”

White House says it will send 13.5 million vaccine doses a week to U.S. states: “The White House said on Tuesday it is increasing the supply of coronavirus vaccines sent each week to states to 13.5 million doses, and is also doubling the amount shipped to pharmacies to 2 million doses this week.”

Thousands of the world’s most trusted brands—including Pepsi, Starbucks, Comcast, Verizon, Marriott, and even the CDC—have funded COVID-19 misinformation, including Chinese and Russian propaganda websites: The headline speaks for itself. How can companies screen their outlets to avoid these problems?

Saliva Test May Predict Severity of COVID-19: “‘We discovered that the saliva viral load is a much better correlate of disease outcome than the nasopharyngeal viral load,’ says Akiko Iwasaki, PhD, lead author of the study, and an immunologist at Yale School of Medicine…
’The saliva viral load correlates not only with the disease severity, but also with the immune response to COVID-19, and older age, [male] sex, and co-morbidities that have been found to put people at higher risk—essentially every parameter that we've examined,’ Iwasaki says.”

North Korea accused of hacking Pfizer for Covid-19 vaccine data: “North Korea attempted to steal Covid-19 vaccine technology from US pharmaceutical company Pfizer, according to South Korean intelligence officials. 
It is currently unclear as to what, if any, data was stolen.”

Moderna Provides U.S. COVID-19 Vaccine Supply Update: “Moderna expects to deliver 100 million doses to the U.S. Government by end of March 2021.
Moderna expects to deliver 100 million additional doses by end of May 2021 followed by another 100 million additional doses by end of July 2021.”

Fauci more cautious on COVID-19 vaccine rollout, pushing ‘open season’ to late May or June: “‘We were expecting a greater number of doses from Johnson & Johnson, and it looks like, even though it’s a good vaccine, that we’re not going to have a substantial amount of doses until we get into April and May,’ he said…”

FDA could reject AstraZeneca’s COVID vaccine on efficacy and manufacturing shortfalls:analyst: “It was bad enough when a study released last week concluded that AstraZeneca’s COVID-19 vaccine was largely ineffective against the aggressive B.1.351 variant that recently emerged in South Africa. Now, analysts are wondering whether inconsistent manufacturing of the vaccine for the clinical trials may have muddied the results—concerns that could give the FDA pause when considering the vaccine for emergency use.
That was the conclusion of a note SVB Leerink analysts sent to clients Wednesday, in which they laid out both the bear and bull cases for FDA authorization of AstraZeneca’s COVID vaccine. The bottom line? The bear case is worrisome, they said.”

Key things to know about Biden's agenda to battle Covid-19: A good summary of this issue, including last night’s CNN town hall meeting.

About healthcare IT

Humana to pilot new tech-enabled chronic care management platform: “Humana is launching a pilot for a new, tech-enabled chronic care management platform.
Humana Care Support will harness enhanced data analytics to create an integrated, personalized experience for members, the company said in an announcement provided first to Fierce Healthcare.
The program will also offer members with chronic illnesses access to a multidisciplinary care team to address their individual needs. The team includes a nurse, a pharmacist, a social worker and a behavioral health expert, Humana said.
The model is designed to integrate the social determinants of health and value-based care into its personalized approach, according to the announcement.”

FDA Selects First Head of Medical Device Cybersecurity:”The FDA’s Center for Devices and Radiological Health has appointed Kevin Fu as acting director of its newly created medical device cybersecurity division.
A prominent medical device security researcher at the University of Michigan, Fu has trained hundreds of engineers at medical device companies in cybersecurity engineering.”

About pharma

AbbVie, Novo Nordisk lead pharma TV advertisers into big-spending January: “Pharma marketers are continuing their TV ad push into 2021. January pharma TV spending picked up where December ended—matching branded ad spending among the top 10 almost dollar for dollar.
The highest spenders racked up $216 million for the month after a robust $217 million December, according to data from real-time TV ad tracker iSpot.tv.”
How does all that spending really translate into sales?

McKinsey's Opioid Woes Far From Over Despite $600M Deals: “Plaintiffs lawyers who spearheaded opioid litigation against pharmaceutical companies are opening a new front against McKinsey & Co. on behalf of local governments, indicating that the consulting giant's settlements worth $600 million with nearly every state won't end its legal troubles. One sign of the emerging onslaught played out during a Tuesday court hearing over New York Attorney General Letitia James' requested approval of a $32 million settlement for the Empire State. The tentative settlement is among more than 50 deals with states and territories that McKinsey announced earlier this month…”

Bristol Myers, Sanofi To Appeal $834M Hawaii Order On Plavix: The headline speaks for itself. See previous blog for the story.

An mRNA vaccine delivered in hydrogel shows promise as a durable cancer immunotherapy: “…scientists at China’s National Center for Nanoscience and Technology (NCNST) have designed a hydrogel to deliver an mRNA vaccine with an immune-stimulating adjuvant. When injected into mice with melanoma, the vaccine stayed active for at least 30 days, inhibiting tumor growth and preventing metastasis, according to results published in the American Chemical Society journal Nano Letters.
The results showed that the hydrogel delivery system holds potential for helping mRNA vaccines achieve long-lasting anti-tumor effects as cancer immunotherapy, the researchers said.”

As Drug Prices Keep Rising, State Lawmakers Propose Tough New Bills to Curb Them: A good summary of some state efforts to lower pharma costs.

About the public’s health

Recommended Childhood and Adolescent Immunization Schedule: United States, 2021: Open access statement from the American Academy of Pediatrics.

A comparative analysis of premature heart disease- and cancer-related mortality in women in the USA, 1999–2018: “The mortality gap between cancer and heart disease is decreasing among women <65 years. Intensive cardiovascular health interventions are required focusing on vulnerable young demographic subgroups and underserved regional areas to meet the American Heart Association’s Impact Goal and Million Hearts Initiative.”

Today's News and Commentary

Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic: “America's top infectious disease official Dr. Anthony Fauci received a prestigious $1 million Israeli prize Monday, along with six other researchers who shared two additional $1 million prizes for their contributions to health and medicine.
The Dan David Prize, affiliated with Tel Aviv University, said it honored Fauci for his career in public health and ‘speaking truth to power’ during the politicized COVID-19 crisis.”

About COVID-19

AstraZeneca's COVID-19 vaccine to be trialed in young people for first time: “AstraZeneca's COVID-19 vaccine development partner has announced that it will launch the first study to evaluate safety and immune responses of the AZD1222 candidate in children and adolescents aged six to 17 years. According to the University of Oxford, the new study would build on previous trials of the vaccine that have shown it produces ‘strong immune system responses and has high efficacy in all adults’…
The Phase II trial will recruit 300 paediatric volunteers, with up to 240 receiving AZD1222, while the remainder will be administered a control meningitis vaccine.”

Covid vaccine: Elderly show fewer post-vaccine symptoms than young: Study: “Elderly people in India have reacted with fewer symptoms after receiving the COVID-19 vaccine, compared to people in the age group from 20 to 40, reported The Economic Times…
The news source said women are also more likely than men to develop symptoms.”

Israeli study finds 94% drop in symptomatic COVID-19 cases with Pfizer vaccine: “Israel's Clalit health maintenance organization says it has seen a 94% decrease in symptomatic COVID-19 infections among 600,000 people who received two doses of Pfizer's vaccine, as reported in the Financial Post…
The Clalit healthcare provider, which covers more than half of all Israelis, also said the same group was also 92% less likely to develop severe COVID-19.”

Effect of High-Dose Zinc and Ascorbic Acid Supplementation vs Usual Care on Symptom Length and Reduction Among Ambulatory Patients With SARS-CoV-2 Infection: They don’t work.

Hospitals face severe shortages as pandemic grinds forward: “Hospitals around the country say their supplies of crucial medical supplies including personal protective equipment (PPE) are lower than ever as demand for different items has soared to an all-time high.
Data detailing usage rates of PPE and other supplies analyzed by Premier, a company that consults for health care systems, revealed that usage of supplies for COVID-19 testing and treatment has reached the highest rate seen since the pandemic began last year."

Novavax to complete US vaccine trial enrolment in record time:”Novavax, one of the unexpected success stories of the Covid-19 vaccine race, is about to finish enrolling its US trial in record time, bringing it another step closer to fulfilling orders to inoculate 50m Americans.
The 30-year-old biotech — which has never before successfully brought a drug to market — has almost enrolled the 30,000 participants in its US trial, which began in late December, according to its chief executive, Stanley Erck.”

U.S. Enrolls in WHO’s ACT Accelerator Program for Pandemic Relief: “The U.S. has joined the World Health Organization (WHO)’s Access to COVID-19 Tools (ACT) Accelerator program, a global effort to speed development and production of coronavirus vaccines, treatments and tests, and to help lower-income nations obtain them.
The WHO claims that the program is still in need of at least $26 billion to achieve its goals of delivering COVID-19 drugs and diagnostics to low- and middle-income countries.”

Covid-Linked Syndrome in Children Is Growing and Cases Are More Severe: “Doctors across the country have been seeing a striking increase in the number of young people with the condition Braden had, which is called Multisystem Inflammatory Syndrome in Children or MIS-C. Even more worrisome, they say, is that more patients are now very sick than during the first wave of cases, which alarmed doctors and parents around the world last spring…
The reasons are unclear. The surge follows the overall spike of Covid cases in the United States after the winter holiday season, and more cases may simply increase chances for severe disease to emerge. So far, there’s no evidence that recent coronavirus variants are responsible, and experts say it is too early to speculate about any impact of variants on the syndrome.”

Keeping schools open without masks or quarantines doubled Swedish teachers’ COVID-19 risk: “A careful analysis of health data from Sweden suggests keeping schools open with only minimal precautions in the spring roughly doubled teachers’ risk of being diagnosed with the pandemic coronavirus. Their partners faced a 29% higher risk of becoming infected than partners of teachers who shifted to teaching online. Parents of children in school were 17% more likely to be diagnosed with COVID-19 than those whose children were in remote learning.”

WHO lists two additional COVID-19 vaccines for emergency use and COVAX roll-out: “WHO listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.”

Seven coronavirus variants potentially similar to UK type have been detected in US: study: “Seven variants of the COVID-19 virus have been detected in the U.S., and all or some of them may contain mutations similar to the qualities exhibited by a strain of extra-contagious COVID-19 spreading in the United Kingdom, a new study found.
The study, published Sunday on MedRxiv.org, found seven previously undiscovered variants of COVID-19 in U.S. patients, all of which are thought to have originated domestically…”

About pharma

2021 Medication Access Report: “CoverMyMeds conducted surveys of patients, providers and pharmacists over a two-month period during September and October 2020. We surveyed 1,000 patients, 400 providers and 328 pharmacists to achieve a 95 percent confidence interval and achieved a ±5 percent margin of error…
Over 40 percent of all patients said to stretch out their prescription, they skipped or reduced doses, potentially putting their health and adherence at risk.8 The proportion was even higher for uninsured patients, at 58 percent, and those on Affordable Care Act (ACA) plans, at 60 percent.”
Forty-three percent of patients said they checked a pharmacy comparison app to find cheaper medications prices, up from 28 percent the previous year.
Read the study for more details.

The top 10 biotech IPOs of 2020: FYI, with details on each.

Plavix partners Sanofi, Bristol Myers vow to appeal Hawaii's $834M marketing verdict: “Sanofi and Bristol Myers Squibb have spent years battling Plavix litigation—including state-level claims that the drugmakers didn’t adequately warn about the blood thinner's risks to certain patients.
Now, a judge in Hawaii has ordered each company to pay the state $417 million for failing to fully disclose its risks in non-white patients.”

Gilead lets local HIV community groups take the lead with $3 million grant: Gilead “is pledging $3.2 million over two years to the Human Rights Campaign, the largest lesbian, gay, bisexual, transgender and queer (LGBTQ+) civil rights organization in the U.S. The money will be distributed through the campaign's educational arm to support communities disproportionately affected by HIV, particularly communities of color.”

About healthcare IT

Mobile Health Apps Systematically Expose PII and PHI Through APIs, New Findings from Knight Ink and Approov Show: A recently released study showed that “fully 100 percent of the 30 popular mHealth apps analyzed by Alissa Knight, partner at Knight Ink, are vulnerable to API attacks that can allow unauthorized access to full patient records including protected health information (PHI) and personally identifiable information (PII).” usage of the APIs put at least 23 million people at risk.

Third party breach exposed data on 35-million, Florida insurer says: “Hackers attacked Florida Healthy Kids Corp.'s web hosting vendor and inappropriately accessed and tampered with the addresses of some of the 3.5 million people affected.”

About health insurance

New enrollment window opens for health insurance shoppers: “A sign-up window opened Monday for government insurance markets and runs through May 15 in most states. It’s available for people who don’t have coverage through work, and it is expected to make finding a plan less of a hassle for those who lost a job.”

CVS' Lynch: Aetna planning to re-enter ACA exchanges in 2022: The insurer had pulled out of such markets in 2018 after sustaining losses. These markets are more stable now and easier for plans to analyze.

About hospitals and health systems

Association of Medicaid Expansion With Quality in Safety-Net Hospitals: “This difference-in-differences cohort study found that despite reductions in uncompensated care and improvements in operating margins, there appears to be little evidence of quality improvement among SNHs in states that expanded Medicaid compared with those in states that did not.” The question of what they do need to improve results is not clear- is it more money, expertise, or a combination?

About the public’s health

Recommended Adult Immunization Schedule, United States, 2021: Click on the chart to enlarge it.

About diagnostics

Guardant Health launches surveillance blood test for detecting colorectal cancer recurrence: “Guardant Health has launched a simple blood test to monitor patients after undergoing surgery for colorectal cancer to spot any early signs that tumor cells remain or to catch the disease before it returns.
The Guardant Reveal test, expected to turn around results in one week, is the company’s first liquid biopsy to help manage the treatment of early-stage cancer, and the company plans to make it available for other cancer types in the future.”

Today's News and Commentary

About COVID-19

Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): preliminary results of a randomised, controlled, open-label, platform trial (Preprint, not yet peer reviewed): “Patients allocated to tocilizumab were more likely to be discharged from hospital alive within 28 days (54% vs. 47%; rate ratio 1.23; 95% CI 1.12-1.34; p<0.0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (33% vs. 38%; risk ratio 0.85; 95% CI 0.78-0.93; p=0.0005). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes regardless of the level of respiratory support received and in addition to the use of systemic corticosteroids.”

Early initiation of prophylactic anticoagulation for prevention of coronavirus disease 2019 mortality in patients admitted to hospital in the United States: cohort study: “Early initiation of prophylactic anticoagulation compared with no anticoagulation among patients admitted to hospital with covid-19 was associated with a decreased risk of 30 day mortality and no increased risk of serious bleeding events. These findings provide strong real world evidence to support guidelines recommending the use of prophylactic anticoagulation as initial treatment for patients with covid-19 on hospital admission.”

Next coronavirus vaccines may be sprays, pills or printed on demand: The headline speaks for itself.

As Millions Get Shots, F.D.A. Struggles to Get Safety Monitoring System Running: ”More than 34 million Americans have received Covid vaccines, but the much-touted system the government designed to monitor any dangerous reactions won’t be capable of analyzing safety data for weeks or months, according to numerous federal health officials.
For now, federal regulators are counting on a patchwork of existing programs that they acknowledge are inadequate because of small sample size, missing critical data or other problems.”

CDC gives road map for safely reopening schools: Masking and hand washing are musts.
”When infection rates in the community are higher, the agency recommends shifting to a combination of in-person and remote learning to minimize the number of people in school buildings at any given time. Fully remote learning is recommended only in certain cases when virus rates are very high.
And while the CDC reiterated that states should prioritize teachers for vaccination, the agency said it is not a prerequisite for reopening.”

About health insurance

Voya finds employees still don’t understand their benefits: “35% of employed individuals do not fully understand any of the employee benefits they’ve selected, according to a new survey by Voya Financial. Millennials in particular have a hard time navigating their benefits, with 54% saying they don't understand their offerings.” 66% say they want employers to help them understand the benefits.

How Much Does a C-Section Cost? At One Hospital, Anywhere From $6,241 to $60,584: The availability of hospital charge data has given the media the opportunity to get “actual” numbers on the spread of these figures. In a related article: How Hospitals Are Faring in Meeting Price Transparency Requirements: The hospitals charge data must be in both consumer-friendly and machine-readable formats. 40% of hospitals are not compliant with the former and 52% are not compliant with the latter. “Overall, most providers were compliant with at least one of the file types, though approximately 30% of providers were not compliant for either. Hospitals that are not compliant have expressed they either have significant resource constraints (COVID-19 or otherwise), a lack of understanding of the ruling, and/or are waiting to see what their competitors are doing.”

The Health Cost of Cost Sharing: The cost-quality tradeoff due to cost sharing has been debated for decades. Cost sharing reduces utilization; but it can cause reductions in necessary as well as unnecessary care. The research from the NBER sheds more light on this issue. You should read the entire abstract below:
”We use the design of Medicare’s prescription drug benefit program to demonstrate three facts about the health consequences of cost-sharing. First, we show that an as-if-random increase of 33.6% in out-of-pocket price (11.0 percentage points (p.p.) change in coinsurance, or $10.40 per drug) causes a 22.6% drop in total drug consumption ($61.20), and a 32.7% increase in monthly mortality (0.048 p.p.). Second, we trace this mortality effect to cutbacks in life-saving medicines like statins and antihypertensives, for which clinical trials show large mortality benefits. We find no indication that these reductions in demand affect only ‘low-value’ drugs; on the contrary, those at the highest risk of heart attack and stroke, who would benefit the most from statins and antihypertensives, cut back more on these drugs than lower risk patients. Similar patterns exist for other drug–disease pairs, and irrespective of socioeconomic circumstance. Finally, we document that when faced with complex, high-dimensional choice problems, patients respond in simple, perverse ways. Specifically, price increases cause 18.0% more patients (2.8 p.p.) to fill no drugs, regardless of how many drugs they had been on previously, or their health risks. This decision mechanically results in larger absolute reductions in utilization for those on many drugs. We conclude that cost-sharing schemes should be evaluated based on their overall impact on welfare, which can be very different from the price elasticity of demand.”

Edited Transcript of MOH.N [Molina Health] earnings conference call or presentation 11-Feb-21: Despite increased revenue and membership growth, such factors as COVID-19 and acquisition expenses led to a $100M dip in year over year profits.

Biden moving to withdraw Trump-approved Medicaid work rules: “The Biden administration on Friday will notify states it plans to revoke Medicaid work requirements, starting the process of dismantling one of the Trump administration's signature health policies.” However, a related article, HHS Faces Hurdles Revising Medicare Interpretive Rules, points out that some of Biden’s changes require a 90 day comment period before they can take effect.

About pharma

Bristol Myers Squibb pens $1.3B biobucks pact with Molecular Templates, axes Celgene CAR-T asset: ”Bristol Myers Squibb is putting down up to $1.3 billion on a next-gen engineered toxin body (ETB) cancer platform from Molecular Templates as it cuts an unwanted cell therapy from its Celgene buyout.”
The deal is “worth just $70 million upfront with the rest in milestones…
ETBs represent a new class of targeted therapeutics that act through differentiated mechanisms of action, including the ability to force receptor internalization, deliver therapeutic payloads and directly kill targeted cells through the enzymatic inactivation of ribosomes.”

Gilead's $5B Galapagos black hole widens as pair tosses out phase 3 asset after flop: “Gilead has sunk billions into Galapagos over the past few years, but this is quickly turning into one of the most disastrous biotech deals in recent history [as]… an independent body checked out its phase 3 data for the experimental autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF).
The outcome was not good. Following a regular review of unblinded data, an independent monitoring board “concluded that ziritaxestat’s benefit-risk profile no longer supported continuing these studies.”

Bristol Myers Squibb's CAR-T liso-cel wins long-delayed FDA nod: “After regulatory delays and manufacturing issues caused Bristol Myers Squibb investors to miss out on Celgene contingent value rights, the closely watched CAR-T drug liso-cel has scored an FDA nod. 
Friday, the agency endorsed the drug, to be called Breyanzi, to treat patients with certain types of large B-cell lymphoma who haven’t responded to two other systemic treatments or who have relapsed after receiving those treatments.”

US Pays Pfizer, Moderna $3.7B For 200M More Vaccine Doses: “The Biden administration on Thursday ordered a total of 200 million additional doses of the COVID-19 vaccines from Pfizer Inc. and Moderna Inc., purchases that mean all Americans could be vaccinated by the end of the summer, according to President Joe Biden.
The federal government shelled out about $2 billion to Pfizer and its German partner BioNTech, and $1.65 billion to Moderna for the additional doses, according to a joint statement from the U.S. Department of Health and Human Services and the U.S. Department of Defense.”

Regeneron's Evkeeza, carrying big price tag, wins FDA approval in ultra-rare cholesterol disease: “Regeneron has been battling against rival Amgen with their mass-market PCSK9 cholesterol drugs, and now the company is underway with a new launch to match its rival in the ultra-rare disease homozygous familial hypercholesterolemia (HoFH).
Regeneron’s Evkeeza scored approval on Thursday as an add-on to other lipid-lowering therapies in patients 12 and older with HoFH, which affects approximately 1,300 patients in the U.S. The company has a "dedicated and experienced team in place" to support the rollout, a spokesman said. The drug is given once per month through an intravenous infusion…
The new drug is dosed by weight and will carry a list price of about $450,000 per year on average, Regeneron said.”
Hospitals Ask Supreme Court to Take Up 340B, Site-Neutral Payments: “The American Hospital Association (AHA), joined by member hospitals and other national organizations, have filed petitions asking the Supreme Court to reverse two appeals court decisions impacting hospital payments.
The first case involves a lawsuit brought on by the AHA and other organizations challenging the nearly 30 percent cut to Medicare outpatient prospective payment system drug payments for hospitals participating in the federal 340B Drug Pricing Program.
A district court had sided with the hospital groups, ruling that the payment reduction was unlawful. However, an appeals court overturned the decision in July 2020, finding HHS to be within its statutory boundaries with the rate reductions.
The second case hospitals are asking the Supreme Court to consider again involves reductions to Medicare outpatient prospective system payments. This time, AHA and others are challenging a 2019 site-neutral payment policy that reduced rates for clinic visits delivered at off-campus provider-based departments.”

About healthcare IT

Signify Health raises $564M in its IPO driven by investor interest in home care, value-based models: “Signify Health launched in December 2017 as the result of a merger between CenseoHealth and Advance Health. The company provides a value-based care platform that uses advanced analytics and other technology to shift health services toward the home.”

This startup is using telehealth to provide eating disorder therapy, and it just got backing from Optum: “A startup providing online eating disorder therapy has raised $13 million as investors ramp up funding for virtual care providers that target specific behavioral health conditions. 
San Diego-based Equip virtually delivers evidence-based eating disorder treatment to families at home and has raised $17 million to date. The series A round was led by Optum Ventures with participation from new investor .406 Ventures and existing investor F-Prime Capital, which led the company’s prior seed round.”

Today's News and Commentary

About COVID-19

Single dose of Pfizer vaccine shows signs of success in UK: “Public Health England found that a single dose reduced symptomatic infection by 65 per cent in younger adults and 64 per cent in the over-80s, while two jabs conferred 79 and 84 per cent protection respectively.”

WHO recommends use of Oxford/AstraZeneca vaccine for all adults: “The WHO’s Strategic Advisory Group of Experts on Immunization (Sage) said the vaccine could be used by all people over the age of 18 in all countries, including places such as South Africa where the circulation of new variants had raised some concerns over its efficacy.”

Infographic: COVID-19 patients with high-risk conditions 3x more likely to need the ICU: This Blue Cross Blue Shield Association analysis of 90,900 COVID-19 cases across 4.5 million Americans found the average cost per admission for high-risk COVID-19 patients (26%) was 30 percent higher than for patients without underlying chronic conditions (74%). Of the 95% of the total who did not require hospitalization, the average cost of treatment was between $500 and $1,000. But for the 5% who were hospitalized treatment costs were 45 times higher than in an outpatient setting.

Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States: This updated CDC guidance includes the following change:
”…vaccinated persons with an exposure to someone with suspected or confirmed COVID-19 are not required to quarantine if they meet all of the following criteria:

• Are fully vaccinated (i.e., ≥2 weeks following receipt of the second dose in a 2-dose series, or ≥2 weeks following receipt of one dose of a single-dose vaccine)

• Are within 3 months following receipt of the last dose in the series

• Have remained asymptomatic since the current COVID-19 exposure

Persons who do not meet all 3 of the above criteria should continue to follow current quarantine guidance after exposure to someone with suspected or confirmed COVID-19.”

Biden to announce his administration has secured 200 million additional vaccine doses promised last month: “President Biden is expected to announce Thursday afternoon that his administration has secured deals for another 200 million doses of coronavirus vaccine as promised last month, according to three people familiar with the matter who were not authorized to discuss it.” 100M each from Pfizer and Moderna.

FDA Says COVID-19 Treatment Remdesivir Shouldn’t Be Compounded: “Gilead Sciences’ FDA-approved antiviral treatment for COVID-19, Veklury (remdesivir), should not be compounded, the FDA has warned.
The agency said it has recently learned that ‘various entities’ are offering to sell the active pharmaceutical ingredient in remdesivir to compounders and that the products could be ‘substandard or counterfeit.’”

Can’t Find an N95 Mask? This Company Has 30 Million That It Can’t Sell.: “A year into the pandemic, the disposable, virus-filtering N95 mask remains a coveted piece of protective gear. Continuing shortages have forced doctors and nurses to reuse their N95s, and ordinary Americans have scoured the internet — mostly in vain — to get them.
But Luis Arguello Jr. has plenty of N95s for sale — 30 million of them, in fact, which his family-run business, DemeTech, manufactured in its factories in Miami. He simply can’t find buyers…
In one of the more confounding disconnects between the laws of supply and demand, many of the nearly two dozen small American companies that recently jumped into the business of making N95s are facing the abyss — unable to crack the market, despite vows from both former President Donald Trump and President Biden to ‘Buy American’ and buoy domestic production of essential medical gear.”

About healthcare IT

Cerner's net earnings up $250M in 2020: 4 things to know: “Cerner reported $780.1 million in net earnings in 2020, a 47 percent increase from $529.5 million in 2019…
For the full year, Cerner posted $5.5 billion in revenue, down 3 percent from $5.6 billion in 2019.”

20 medical apps most downloaded by iPhone users: FYI

14 health systems team up on 'ethical innovation' with launch of provider-led data platform:
“Fourteen health systems, including Trinity Health, Northwell Health and Tenet Health, are partnering to create a comprehensive, de-identified data platform that will glean more robust insights on medical conditions such as rare diseases and COVID-19.
The new platform, dubbed Truveta, will serve as a universal database of patient population information pooled from the participating health systems, according to a Feb. 11 announcement.
The de-identified clinical data will span across all diagnoses, geographies and demographics to provide physicians and researchers with stronger analyses of medical conditions, treatment therapies and prognoses.”

About pharma

AstraZeneca drops breast, prostate cancer programs in Q4 pipeline cull: “AstraZeneca has dropped two oncology programs from its clinical-phase pipeline. The Big Pharma has stopped work on AZD9496 in breast cancer and imaradenant in prostate cancer on safety or efficacy grounds.”

About health insurance

Humana Begins Coverage of Hospice Services as Part of Medicare Demonstration: “As part of a four-year demonstration created by the U.S. Centers for Medicare & Medicaid Services (CMS), Humana’s program is intended to help the company and CMS learn whether hospice services provided within the Part A benefits package of Medicare results in additional innovation, enables a more seamless care continuum and improves quality and timely access to palliative and hospice care. Humana started offering the new benefit on select plans on January 1, 2021, in order to ease care transitions and ensure hospice-eligible patients who need it can receive the full benefits of hospice care.”
Hospice has been a stand-alone program, so this initiative’s innovation is integrating hospice into Medicare A and Medicare Advantage plans.

Medicare FFS Utilization Decreased During the COVID-19 Pandemic: “Avalere found healthcare utilization decreased in the first 3 months of the pandemic (March, April, and May of 2020) compared to these same months in 2019. This decrease was largest in April when there was a 51% reduction in outpatient claims and a 42% reduction in professional claims in 2020 compared to 2019. valere also examined healthcare utilization changes between the first half of 2019 and 2020 by race and found that utilization among the White Medicare population decreased more than among the Black or Hispanic populations. However, the largest utilization decreases were observed among the Asian beneficiaries, who account for 2% of the overall Medicare FFS population (White Medicare beneficiaries constitute 81%; Black Medicare beneficiaries, 9%; and Hispanic Medicare beneficiaries, 2%…).”

About hospitals and health systems

Crises Collide:The COVID-19 Pandemic and the Stability of the Rural Health Safety Net: The Chartis Center for Rural Health found that: “Today the stability of the rural health safety net is even more tenuous. Rural hospital closures now stand at 135,1 and our research indicates that another 453 are vulnerable…
For the average rural hospital, 77 percent of total revenue is associated with outpatient services. As the pandemic has progressed, many rural providers have suspended or limited outpatient procedures, further compounding financial instability. In addition, our analysis has shown that the average rural hospital has 33 days cash on hand.to closure.”

Today's News and Commentary

About COVID-19

Seasonal human coronavirus antibodies are boosted upon SARS-CoV-2 infection but not associated with protection: “Our studies indicate that most individuals possessed hCoV [human coronavirus]-reactive antibodies before the COVID-19 pandemic. We determined that ∼20% of these individuals possessed non-neutralizing antibodies that cross-reacted with SARS-CoV-2 spike and nucleocapsid proteins. These antibodies were not associated with protection against SARS-CoV-2 infections or hospitalizations, but they were boosted upon SARS-CoV-2 infection.”

U.S. to start sending COVID-19 vaccines directly to community health centers: “The government will send doses to 250 centers nationwide selected based on their proximity to vulnerable groups, such as homeless people and those with limited proficiency in English, they said. Typically, vaccine doses would go to state governments for distribution to health centers.
Eventually the effort will expand to more than 1,300 community health centers.”

Verily links with Janssen for at-home COVID-19 immune system study: “Verily is teaming up with Johnson & Johnson’s Janssen division to observe the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their own homes. 
The study will be launched through Verily’s Project Baseline testing program and aims to collect biological information and real-world data in the weeks immediately after a person tests positive for COVID-19.”
Verily is “Google’s life-science-focused sibling company…”

About hospitals and health systems

Tenet Healthcare posts $414M profit in 4th quarter: “Tenet Healthcare beat Wall Street expectations Tuesday as it posted a profit of $414 million, or $3.86 per share, in the final quarter of a year of historic challenges.
The fourth-quarter earnings are a jump from a loss of $3 million, or three cents per share, in the same quarter of 2019. The Dallas-based health system reported revenue was up 2.2% at $4.9 billion for the quarter from fourth-quarter revenue in 2019.”

Kaiser Permanente income narrowed to $2.2B last year amid COVID-19 squeeze: “Kaiser Permanente generated $2.2 billion in operating income last year as the hospital system weathered financial challenges from the pandemic.
Kaiser announced late Friday that it generated $88.7 billion in total operating revenue in 2020, up about 5% compared with $84.5 billion the year before. The system’s operating income dropped to $2.2 billion, down about 19% from the income of $2.7 billion generated in 2019.
The system touted membership gains in its health plan and its ‘integrated model’ in handling the financial fallout from COVID-19 that forced patient volumes to plummet.”
An example of payer-provider integration that shields such a system from losses when “volumes plummet.”

Negligent Credentialing Suit in Iowa Could Affect Hospitals Everywhere: This case is perhaps the most-talked-about action in healthcare because of far-reaching implications. “Should the Iowa Supreme Court recognize that there is a tort claim for negligent credentialing, it could spell increased accountability and liability for hospitals.” Read the article for more details.

Hospitals’ Covid-19 heroics have them poised for power in the new Washington: “The hospital business is booming on Capitol Hill like never before. Lawmakers showered the industry with more than $275 billion last year, and handed hospitals wins even on seemingly unrelated issues. And Democrats’ agenda will almost certainly be better for their bottom lines.
The Covid-19 pandemic has transformed the industry’s image in Washington, where large health care systems have long been vilified as corporate profit mongers instead of community caregivers. Now, more than two dozen lobbyists and consultants told STAT that they are keenly aware of just how much power the industry has accrued — and are prepared to seize the moment.”

7 hospital construction projects costing $500M or more: FYI

About healthcare IT

50-State Survey of Telehealth Commercial Insurance Laws: A really good summary as of January, 2021 by law firm Foley & Lardner.

Nuance Announces Acquisition of Saykara: “ Nuance Communications, Inc…. announced the acquisition of Saykara, Inc., a like-minded startup focused on developing a mobile AI assistant to automate clinical documentation for physicians. The acquisition underscores Nuance's ongoing expansion of market and technical leadership in conversational artificial intelligence (AI) and ambient clinical intelligence (ACI) solutions that reduce clinician burnout, enhance patient experiences, and improve overall health system financial integrity.”

Stolen Chatham county data posted online after cyber incident, includes personnel files, other sensitive documents: Cyber criminals are serious about the consequences of not cooperating with them. “Sensitive data files stolen following Chatham County’s Oct. 28 governmental 'cyber incident’ have been posted online by the criminal enterprise responsible, the News + Record has learned.
The files include such things as personnel records of some county employees, medical evaluations of children who are the subjects of neglect cases, eviction notices and documents related to ongoing investigations within the Chatham County Sheriff’s office.”

Physiological Data from a Wearable Device Identifies SARS-CoV-2 Infection and Symptoms and Predicts COVID-19 Diagnosis: Observational Study: “Longitudinally collected HRV [heart rate variability] metrics from a commonly worn commercial wearable device (Apple Watch) can identify the diagnosis of COVID-19 and COVID-19 related symptoms. Prior to the diagnosis of COVID-19 by nasal PCR, significant changes in HRV were observed demonstrating its predictive ability to identify COVID-19 infection.”

Deep-learning-assisted analysis of echocardiographic videos improves predictions of all-cause mortality: Published research from Geisinger Clinic: “Here we show that a convolutional neural network trained on raw pixel data in 812,278 echocardiographic videos from 34,362 individuals provides superior predictions of one-year all-cause mortality. The model’s predictions outperformed the widely used pooled cohort equations, the Seattle Heart Failure score (measured in an independent dataset of 2,404 patients with heart failure who underwent 3,384 echocardiograms), and a machine learning model involving 58 human-derived variables from echocardiograms and 100 clinical variables derived from electronic health records. We also show that cardiologists assisted by the model substantially improved the sensitivity of their predictions of one-year all-cause mortality by 13% while maintaining prediction specificity. Large unstructured datasets may enable deep learning to improve a wide range of clinical prediction models.”

About pharma

Fresenius To Pay $50M For Impeding FDA Investigation: “Indian drug manufacturer Fresenius Kabi Oncology Ltd. will plead guilty and pay $50 million to end claims that it destroyed and hid records related to the production of cancer drugs before a 2013 investigation by the U. S. Food and Drug Administration, the U. S. Department of Justice announced Tuesday. The DOJ charged FKOL in Nevada federal court with violating the Federal Food, Drug and Cosmetic Act for failing to turn over certain documents requested by the FDA, prosecutors said in a release.”

PacBio nets $900M from SoftBank to support its long-read sequencing goals: “Just over a year after Illumina’s $1.2 billion bid for its fellow sequencer manufacturer fell apart under federal scrutiny, Pacific Biosciences has secured a new benefactor with a $900 million commitment from SoftBank.
The Japanese conglomerate has signed up to purchase convertible senior notes due in 2028 at $43.50 apiece, or a 30% premium above PacBio’s 30-day closing average, through its SB Management subsidiary.”

About healthcare professionals

Apollo To Make An Up To $470M Investment In Health Care Biz: “Apollo Global Management said Tuesday it will make an up to $470 million investment in emergency medicine and hospitalist services business US Acute Care Solutions as the physician-owned group buys out the minority stake of a separate private equity firm. Apollo's preferred equity stake in the Canton, Ohio-based business facilitates a full recapitalization of the company, as well as an exit of Welsh Carson Anderson & Stowe, the asset manager said. As a result of the deal, USACS will be 90% owned by its physicians and continue to be controlled by its doctors..”

About health insurance

Biden Administration Backs ACA at Top Court, Flipping Trump’s Stance: “President Joe Biden’s administration told the U.S. Supreme Court the Affordable Care Act is constitutional, filing an unusual letter that flips the government’s position three months after the justices heard arguments on the law.
The Trump administration had argued against the health-care law, also known as Obamacare, when the justices heard the case Nov. 10.
Opponents are trying to invalidate the entire law by pointing to a Republican-backed 2017 tax change that eliminated a penalty for not having insurance. The penalty was central to the 2012 Supreme Court decision that upheld the so-called individual mandate to have insurance as a legitimate use of Congress’ constitutional taxing power.”

Amid Pandemic, 53% of California Employers Prefer Health Plans with High-quality Providers Over Low-cost Plans; 86% Will Pay More for Top-quality Networks: “When researchers asked California health benefit managers to rank priorities, the study found that:

·       Fifty-three percent (53%) of businesses preferred offering health plans that featured high-quality care providers

·       Less than half of employers (42%) prioritized low-cost plans with smaller provider networks

·       Eighty-six percent (86%) of employers would pay more for plans with the best-rated health care providers

The survey’s results reflect other impacts of the pandemic, as well. For example:

·       Seventy-one percent (71%) of health benefit decision-makers surveyed reported their employees having to switch doctors because of the pandemic; of this group, 93% said they expect employees to pick health plans with in-network doctors close to them.

·       Forty-two percent (42%) of employers preferred health plans with telehealth and virtual-care options; these allow employees to engage providers and use resources while practicing social distancing.”

Today's News and Commentary

About the public’s health

As alcohol abuse rises amid pandemic, hospitals see a wave of deadly liver disease: “Although national figures are not available, admissions for alcoholic liver disease at Keck Hospital of USC were up 30% in 2020 compared with 2019, said Dr. Brian Lee, a transplant hepatologist who treats the condition in alcoholics. 
Specialists at hospitals affiliated with the University of Michigan, Northwestern University, Harvard University and Mount Sinai Health System in New York City said rates of admissions for alcoholic liver disease have leapt by up to 50% since March.”

Anthropogenic climate change is worsening North American pollen seasons: ”Our results indicate that human-caused climate change has already worsened North American pollen seasons, and climate-driven pollen trends are likely to further exacerbate respiratory health impacts in coming decades.”

Incorporating Baseline Breast Density When Screening Women at Average Risk for Breast Cancer: “Baseline screening at age 40 years followed by annual screening at age 40 to 75 years for women with dense breasts and biennial screening at age 50 to 75 years for women without dense breasts was effective and cost-effective, yielding an incremental cost-effectiveness ratio of $36 200 per QALY versus the biennial strategy at age 50 to 75 years.”
An accompanying editorial provides an important critique. Among the comments:

“Several aspects of Shih and colleagues' results are surprising and inconsistent with prior studies… Generally, annual screening results in a higher ratio of harms to benefits because few added deaths are averted—compared with biennial screening—whereas the added cost of annual screening is large. The screening strategy proposed by Shih and colleagues would do annual screening on 60% of women, which raises questions about how it could be cost-effective.
Breast density is an important risk factor to include in risk-based screening strategies because it is both a strong and prevalent risk factor accounting for a large proportion of breast cancers. However, we argue that breast density should be combined with age and other risk factors when developing risk-based screening strategies that optimize benefits and minimize harms. We believe that until a more robust risk-based strategy is identified, the frontier curves presented in Shih and colleagues' analyses support screening biennially from ages 50 to 74 years.”

Segregation, Poverty Tied to Worse Outcomes for Black Lung Cancer Patients: “For years, U.S. studies have documented racial disparities in lung cancer. Black Americans are less likely to receive surgery for early-stage lung cancer -- the standard of care -- and they typically die sooner.
The reasons, however, are not fully clear.
Researchers said the new study implicates residential segregation -- a manifestation of structural racism -- in the disparities.
It found that Black lung cancer patients living in the most segregated U.S. counties were 49% more likely to be diagnosed at an advanced stage, compared to those living in the least segregated counties.
And among those with early-stage lung cancer, Black patients in highly segregated areas were 47% less likely to receive surgery.”

About COVID-19

WHO team: Coronavirus unlikely to have leaked from China lab: “The coronavirus most likely first appeared in humans after jumping from an animal, a team of international and Chinese scientists looking for the origins of COVID-19 said Tuesday, saying an alternate theory that the virus leaked from a Chinese lab was unlikely. 
A closely watched visit by World Health Organization experts to Wuhan — the Chinese city where the first coronavirus cases were discovered — did not dramatically change the current understanding of the early days of the pandemic, said Peter Ben Embarek, the leader of the WHO mission.”

U.S. COVID-19 cases and hospitalizations log biggest weekly drops since pandemic started: “The United States reported a 25% drop in new cases of COVID-19 to about 825,000 last week, the biggest fall since the pandemic started, although health officials said they were worried new variants of the virus could slow or reverse this progress.
New cases of the virus have now fallen for four weeks in a row to the lowest level since early November, according to a Reuters analysis of state and county reports. The steepest drop was in California, where cases in the week ended Feb. 7 fell 48%. Only Oregon, Puerto Rico, Arkansas and Vermont saw cases rise.“

Most Americans say they will continue preventive measures after COVID-19 pandemic ends: “[Iahn Gonsenhauser, MD, chief quality and patient safety officer at The Ohio State University Wexner Medical Center] and colleagues surveyed more than 2,000 adults. Results showed that after the pandemic ends:

• 72% plan to continue to wear masks in public;

• 80% intend to still avoid crowds; and

• 90% plan to frequently wash their hands and use sanitizer.”

The Big Number: During pandemic, heart surgeries plummeted by 53 percent: “The number comes from an analysis of national data through the end of 2020 and included information on 717,103 heart surgery patients and more than 20 million covid-19 patients. The finding was presented at a January meeting of the Society of Thoracic Surgeons.
The analysis found that adult cardiac surgery volume fell by more than half nationwide, to roughly 12,000 surgeries a month on average. The decline included 65 percent fewer elective surgeries and 40 percent fewer nonelective surgeries, with all types of heart operations experiencing a decline, including coronary artery bypass grafting, aortic or mitral valve replacement, a combination or something else.”
Understandable why elective surgeries were postponed, but a drop of 40% for non-elective procedures?

NHS Covid app prevented 600,000 infections, claim researchers: “The NHS contact-tracing app has prevented the transmission of hundreds of thousands of Covid-19 cases in England and Wales, researchers have estimated, in one of the world’s first studies of efficacy of the smartphone-based system developed in conjunction with Apple and Google. Researchers at the Alan Turing Institute and Oxford university have estimated that every 1 per cent increase in app users can reduce coronavirus cases by as much as 2.3 per cent. The app has sent 1.7m notifications to its more than 21m users telling people to isolate so far. Of those, the Turing/Oxford researchers estimate that about 600,000 cases were averted by the end of December.”

Pfizer Withdraws Emergency Use Application of COVID-19 Vaccine in India: “Pfizer has withdrawn its application for emergency use approval of its COVID-19 vaccine in India after the country’s drug regulator requested a domestic trial.
India’s vaccine regulatory authority called for a study on safety and immune responses in its population, while Pfizer sought to have the trial requirements waived based on its currently available global phase 3 data.”
This story is a small item but raises large questions. Usually it is the US that requires domestic studies when a drug or device is approved elsewhere in the world. I suspect this turnabout has more to do with India protecting its domestic vaccine industry (the world largest) than the quality of the Pfizer vaccine.

Coronavirus Vaccine Tracker: Excellent update on the history and status of coronovirus vaccines, as well as how they work. In The New York Times, but appears to have open access. See, also: Coronavirus Variants and Mutations.

About hospitals and health systems

7 hospitals buying land for expansions: Many hospitals went ahead with scheduled building plans this past year, but buying land now for expansion is a real committment.

Rochester's Destination Medical Center forges ahead, despite COVID-19: “Steps away from the Mayo Clinic in Rochester, the steel framework of a new $45 million structure bearing big ambitions has taken shape in recent months — rising in determined fashion despite the spread of the deadly COVID-19 virus.
Once completed, Discovery Square 2 is expected to welcome innovative health care firms just like its glassy sister structure known as One Discovery Square, the cornerstone of the $5.6 billion Destination Medical Center (DMC) project.
Now in its sixth year, DMC is a public-private economic development effort unlike any other in Minnesota history. With the world-renowned Mayo Clinic leading the charge — along with the city, Olmsted County and the state — the ambitious project is intent on dramatically retooling Minnesota's third-largest city into a ‘premier destination for health and wellness.’”

About health insurance

Centene Corporation Reports 2020 Results:

—“Total revenues of $28.3 billion for the fourth quarter of 2020, representing 50% growth compared to the fourth quarter of 2019, and $111.1 billion for the full year 2020, representing 49% growth year-over-year…
—Diluted loss per share for the fourth quarter of 2020 of $(0.02), compared to diluted EPS of $0.49 for the fourth quarter of 2019. Diluted EPS for the full year 2020 of $3.12, compared to $3.14 for the full year 2019.
—Adjusted diluted EPS for the fourth quarter of 2020 of $0.46, compared to $0.73 for the fourth quarter of 2019. Adjusted diluted EPS for the full year 2020 of $5.00, compared to $4.42 for the full year 2019.”
In a related story: Centene launching organizational restructuring effort, will cull 3K employees, [and eliminate] 1.5K open jobs

Oscar Health, Inc. Announces Filing of Registration Statement for Proposed Initial Public Offering: “The number of shares of Class A common stock to be offered and the price range for the proposed offering have not yet been determined. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.”

About health IT

Effect of Wearing a Novel Electronic Wearable Device on Hand Hygiene[HH] Compliance Among Health Care Workers: “The use of this device did not change HH compliance, but increased the duration of hand rubbing and volume of ABHR [alcohol-based hand rubbing] used by HCWs [healthcare workers].”

About healthcare quality

America's Best Hospitals2021 America's 250 Best Hospitals: Healthgrade’s annual ratings. Note the conspicuous absence of academic medical centers in the top lists.

Who is Responsible for Discharge Education of Patients? A Multi-Institutional Survey of Internal Medicine Residents: “Of the 613 resident responses (63% response rate), 35% reported they were unsure which member of the multidisciplinary team is primarily responsible for discharge education. Residents who believed it was either the intern’s or the resident’s primary responsibility had 4.28 (95% CI, 2.51–7.30) and 3.01 (95% CI, 1.66–5.71) times the odds, respectively, of reporting doing discharge communication practices frequently compared to those who were not sure who was primarily responsible. To improve multidisciplinary discharge communication, residents called for the following among team members: (1) clarifying roles and responsibilities for communication with patients, (2) setting expectations for communication among multidisciplinary team members, and (3) redefining culture around discharges.”

2020 CAQH [Council for Affordable Quality Healthcare] INDEX®- Closing the Gap: The Industry Continues to Improve, But Opportunities for Automation Remain: “Data from the 2020 CAQH Index found that, of the $372 billion spent on administrative complexity in the United States healthcare system, $39 billion, or 10 percent, is spent conducting administrative transactions tracked by the CAQH Index . Of the $39 billion, the industry can save $16 .3 billion, or 42 percent of existing annual spend, by transitioning to fully electronic transactions . While the industry has already avoided $122 billion annually by automating administrative transactions, meaningful opportunities for additional savings remain for both the medical and dental industries.”

About healthcare spending

Breaking the cost curve—Deloitte predicts health spending as a percentage of GDP will decelerate over the next 20 years: Consultants at Deloitte think healthcare spending, as a percent of GDP, will slow over the next 20 years and cost less than current government projections. Reasons include “a well-being dividend—the return on investment for tools, systems, or protocols that help consumers to take an active role in their health and well-being…”
They also predict that: “three major changes will likely impact incumbent health care stakeholders, driving more revenue. These include:

• The end of the general hospital as we know it

• The slowdown of mass-produced biopharma

• A seismic shift in the way health care is financed”

Today's News and Commentary

About COVID-19

Andy Slavitt wants to see most vaccines get administered within a week of shipping: An informative Washington Post interview about what we can expect in the near future from the Biden administration with respect to COVID-19.

Oxford/AstraZeneca jab fails to prevent mild and moderate Covid from S African strain, study shows: “In both the human trials and tests on the blood of those vaccinated, the jab showed significantly reduced efficacy against the 501Y.V2 viral variant, which is dominant in South Africa, according to the randomised, double-blind study seen by the Financial Times.
’A two-dose regimen of [the vaccine] did not show protection against mild-moderate Covid-19 due to [the South African variant]’, the study says, adding that efficacy against severe Covid-19, hospitalisations and deaths was not yet determined.”

New COVID-19 deaths in U.S. top 5,000 to set new single-day record: “According to the data, there were almost 5,100 coronavirus-related deaths on Thursday -- by far the most of any day since the pandemic began a year ago. The previous one-day record was about 4,500 deaths.”

Where Did Covid Come From? Investigator Foreshadows Fresh Clues: “Scientists probing the origins of the coronavirus are wrapping up a lengthy investigation in China and have found ‘important clues’ about a Wuhan seafood market’s role in the outbreak.
Peter Daszak, a New York-based zoologist assisting the World Health Organization-sponsored mission, said he anticipates the main findings will be released before his planned Feb. 10 departure. Speaking from the central city of Wuhan, where Covid-19 mushroomed in December 2019, Daszak said the 14-member group worked with experts in China and visited key hot spots and research centers to uncover ‘some real clues about what happened.’”

Biden health team hatches new vaccine strategy as variant threat builds: “The Food and Drug Administration is preparing to release new standards for Covid-19 vaccine booster shots, tests and drugs in the coming weeks — all aimed at preparing the country to beat back fast-spreading virus variants that are less susceptible to existing shots.
The agency confirmed Thursday that it plans to release draft guidance. It could come in two to three weeks, according to four people familiar with the discussion. In the meantime, federal and state officials are scrambling to track how widely the coronavirus variants first found in South Africa, Brazil and the United Kingdom are spreading in the United States.”

NHS plans for annual coronavirus vaccinations: “Nadhim Zahawi, the vaccines minister, told the BBC’s Andrew Marr Show that the government was expecting annual inoculations to take place every autumn in much the same way as flu prevention, adding: ‘Where you look at what variant of virus is spreading around the world, you rapidly produce a variant of vaccine, and then begin to vaccinate and protect the nation.’”

Biden to use Defense Production Act to increase supply of Covid-19 vaccines and tests: ”The Biden administration announced new initiatives Friday to speed up Covid-19 vaccinations and increase the availability of tests and protective gear — even as top health officials pleaded with Americans to double down on basic public health measures like wearing masks.
The White House will use the Defense Production Act to make at least 61 million at-home or point-of-care coronavirus tests available by summer. And the Defense Department will deploy more than 1,000 active military personnel to support state vaccination sites, beginning in California on Feb. 15.”

Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase: “Pfizer expects to nearly cut in half the amount of time it takes to produce a batch of COVID-19 vaccine from 110 days to an average of 60 as it makes the process more efficient and production is built out, the company told USA TODAY.”

Amazon Alexa can now tell you the nearest spot to get a Covid-19 test — here’s how to use it: “It works on phones and through the Amazon Echo smart speaker… it’s best on a phone or on an Echo with a screen since it shows you a list of the nearby locations and how far each place is. Here’s what you do.

• Open the Alexa app on your phone.

• Touch the “Tap to talk to Alexa” button at the top.

• Say: “Where can I get tested for Covid-19?”

Alexa will return a list of nearby places using data pulled from GISCorps and other sources, such as Yelp…If you tap a location, you’ll see a phone number you can call to confirm that there are appointments available, if one is needed.”

About pharma

Drug used to treat arthritis may cause serious heart problems, cancer, FDA warns: “The FDA said Xeljanz, also known as tofacitinib, can increase a patient’s risk of developing serious heart-related problems and cancer, specifically in those being treated for rheumatoid arthritis.
The FDA said Thursday preliminary results from a safety clinical trial of Xeljanz, which compared it to a similar type of medication, revealed the potential risks.
The safety clinical trial was requested by the FDA, which also investigated other potential health risks including blood clots in the lungs and death, though the final results are not yet available.
In 2019, the FDA warned that interim trial results found there was an increased risk of blood clots and death in patients prescribed the higher 10 mg twice daily dosage.”

OIG: Part D opioid prescriptions dipped during onset of COVID-19 pandemic: “The report [from the Department of Health and Human Services’ Office of Inspector General (OIG)] looked at opioid prescriptions from January through August of 2020. It found that for most months, about 1.1 million Medicare Part D beneficiaries are getting a short-term opioid prescription, which is roughly the same rate as in 2019.
But there was a significant decline in the spring of 2020. In April, the number fell to 727,505 beneficiaries, a major one-third decline.”

Jazz Pharmaceuticals to Buy GW Pharmaceuticals for $7.2 Billion: “Jazz Pharmaceuticals is set to acquire GW Pharmaceuticals, a UK drugmaker known for its cannabidiol (CBD) products Epidiolex (cannabidiol) and Sativex (nabiximols), for a whopping $7.2 billion.
Sativex, a cannabis extract administered orally as a spray, received UK approval in 2010 for treatment of multiple sclerosis symptoms. The product is currently going through phase 3 trials to support FDA approval for treating spasticity associated with multiple sclerosis and spinal cord injury.”

COVAX Releases Distribution Plan for COVID-19 Vaccines: “The COVAX vaccine program aims to distribute almost 340 million vaccine doses during the first half of the year, according to its latest distribution plan.
COVAX — which is administered by GAVI, the Vaccine Alliance, with backing from the World Health Organization — aims to inoculate 3.3. percent of the populations of 145 participating nations during the first half of this year, including essential healthcare workers and groups deemed to be most vulnerable.”

20 most expensive prescription drugs in 2021: FYI

Novel immunotherapy approach to treat cat allergy: “Researchers from the Department of Infection and Immunity of the Luxembourg Institute of Health (LIH) brought forward the potential of high doses of a specific adjuvant molecule, namely CpG oligonucleotide, in successfully modulating the immune system's allergic response to the main cat allergen Fel d 1, thereby inducing a tolerance-promoting reaction and reverting the main hallmarks of cat allergy. The researchers analysed the molecular mechanisms underlying this tolerance and proposed a pre-clinical allergen-specific immunotherapy approach to improve the treatment and control of this common type of allergy. The full study results were published recently in the journal Allergy, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI).”

About health insurance

MA Enrollment in Plans With Extra Benefits for Chronically Ill Tripled in 2021: “New analysis of 2021 benefits and enrollment from Avalere finds that 787 MA [Medicare Advantage] plans offered by 44 parent organizations are providing special supplemental benefits for the chronically ill (SSBCI) in 2021. Those plans represent 16% of all analyzed MA plans. A majority (86%) of the total Medicare beneficiary population live in counties where at least 1 MA plan that offers at least 1 type of SSBCI is available. Overall, in 2021, 15% of enrollees in non-employer MA plans are enrolled in plans offering SSBCI, as compared to 6% in 2020.”

Fla. Biz Owner Pleads Out Of $400M Health Fraud Case: “A Florida businesswoman settled out of criminal and civil charges stemming from what prosecutors say was a health care scheme involving the submission of $400 million worth of false medical equipment claims to Medicare and other federal health care programs, the U. S. Department of Justice said. Kelly Wolfe copped to conspiracy to commit health care fraud and filing a false tax return in 2017, charges that carry an up to 13-year prison sentence, in a plea deal…”

New UnitedHealthcare policies change coverage for lab tests, specialty drugs. Hospitals want CMS to review them: “The American Hospital Association urged CMS to review new policy changes from UnitedHealthcare for diagnostic and specialty pharmacy services that the insurer says are needed to lower medical costs.
In a Feb. 4 letter to acting CMS Administrator Elizabeth Richter, the AHA argued two new UnitedHealthcare policies ‘create significant barriers to access to necessary diagnostic and specialty pharmacy services for tens of millions of health plan enrollees.’
One policy is UnitedHealthcare's designated diagnostic provider program. Beginning July 1, diagnostic tests completed at a facility that isn't a "designated diagnostic provider" won't be covered for UnitedHealthcare's commercial health plan members. Labs that are designated diagnostic providers will be reimbursed at a fixed rate. 
Under the policy, coverage will be denied for patients who receive testing at a non-designated laboratory even if the provider is considered "in-network." UnitedHealthcare is providing members a one-time exemption if they use a non-designated lab, but otherwise, members will need to pay out of pocket for testing that is completed at a non-designated lab. The requirement doesn't include inpatient or emergency room tests.”

Today's News and Commentary

About COVID-19

Britain explores mixed COVID vaccine shots as variants threaten: “British researchers are to explore mixing doses of the Pfizer and AstraZeneca COVID-19 vaccines in a world first trial aimed at finding new ways to swiftly reduce coronavirus infections as new mutated variants emerge.”

U.S. FDA gearing up for rapid review of potential COVID-19 booster shots: “The U.S. Food and Drug Administration is planning a rapid review process for quick turnaround of new COVID-19 booster shots if variants of the coronavirus emerge against which the vaccines do not provide protection, the agency’s top official said on Thursday.
Dr. Janet Woodcock, acting commissioner of the FDA, said that if new variants of the coronavirus emerge that require booster shots or changes to vaccines, the agency will not require the type of large trials that were required for emergency use authorization or approval.”

About healthcare systems

Catholic health giants join 'equity pledge,' commit to fighting systemic racism: “Catholic health systems around the U.S.—including giants like CommonSpirit​​​​​​​ and Ascension—committed to address systemic racism by taking concrete steps to reduce health disparities, it was announced Thursday.
More than 20 health system members of the Catholic Health Association (CHA) joined the Confronting Racism by Achieving Health Equity commitment so far, officials said.”

About diagnostics

23andMe going public at $3.5B via merger with Branson's blank check company: “23andMe is merging with VG Acquisition Corp., a special purpose acquisition company founded by billionaire Richard Branson, to go public.
The deal values the consumer genetic testing company at $3.5 billion, including debt.
The deal is expected to close in the second calendar quarter of 2021.”

Roche's COVID-19 diagnostics boosted 2020 sales despite other testing losses: “Roche’s diagnostics division saw its sales grow 14% over the full year of 2020—totaling over 13.8 billion Swiss francs, or about $15.3 billion—with demand for COVID-19 testing more than outweighing its losses due to clinic lockdowns and deferred health screenings.
The company launched 15 different tests for COVID-19 over the past year, including both rapid, point-of-care solutions and high-throughput, centralized laboratory diagnostics across each type of test, including antigen-, antibody- and molecular-based methods. Other tests worked to gauge the potential severity of a person’s immune response to the virus.”

About healthcare IT

Letter to the Editor: New phones, old problem? Interference with cardiovascular implantable electronic devices by phones containing magnets: “In a patient with a Medtronic Inc. Cobalt Cardiac Resynchronisation Therapy-Defibrillator (CRT-D) device (Minneapolis, MN, USA), therapies were suspended when the iPhone 12 was brought within close proximity of the generator, which was a consistent observation throughout the testing procedure. These findings raise possible safety concerns around MagSafe technology and cardiovascular implantable electronic devices (CIED). It is unknown whether this interference is a consistent observation across device types and manufacturers of CIED, or whether this is unique to the iPhone 12.”
Watch for further media stories about this finding.

Google expands into health tracking using smartphone cameras to monitor heart, respiratory rates: “Google Health, the tech giant’s health and wellness division, has added new features to its Google Fit app that enables users to take their pulse just by using their smart phone's camera…
The new features will be available in the Google Fit app for Pixel phones in the next month, with plans to expand to more Android devices, the company said…”
Read the article to understand how the technology works.

About pharma

Pfizer, Johnson & Johnson balk at shareholders' push for COVID-19 vaccine pricing info: “Two major players in the pandemic fight, Pfizer and Johnson & Johnson, are urging the Securities and Exchange Commission (SEC) to forestall shareholder resolutions that would require them to disclose how they set prices on their COVID-19 vaccines.
Several not-for-profit groups are pushing the two companies—along with fellow pharmas Eli Lilly, Gilead, Merck & Co. and Regeneron—for information on their drug and vaccine pricing decisions, citing the federal money all have received, either for supplies, R&D or manufacturing scale-up. Or all three.”

Coronavirus latest: Gilead’s Covid drug [Remdesivir] delivers $2bn boost to quarterly revenue – as it happened: The headline speaks for itself.

BioNTech fund pays €600m dividend on back of vaccine success: “One of the early backers of Germany’s BioNTech will pay a dividend of €600m to its own investors after selling most of its stake in the developer of the Covid-19 vaccine for a 4,500 per cent net return. Munich-based venture capital fund MIG is making the payout after initially investing just over €13m in BioNTech, the start-up founded by Ugur Sahin and Ozlem Tureci in 2008.”

Bristol Myers Secures COVID-19 Antibody Through Rockefeller University Pact: “The antibody is a combination of two drugs that together block the SARS-CoV-2 spike protein to neutralize the virus, and preclinical data indicate it could be an effective treatment against the virus’ multiple variants…
Financial details of the agreement were not disclosed but Rockefeller will receive royalty payments on any future sales.”

Walmart Loses Bid To Short-Circuit Feds' Opioid Suit: “A Texas federal judge on Thursday axed Walmart Inc. 's lawsuit seeking a declaration that its prescription opioid sales are lawful, ruling that the retail giant hadn't identified a Justice Department action that has adversely affected it and therefore can't preemptively sue the government.”
Walmart’s move was to preempt federal lawsuits for its role in the opioid crisis.

About health insurance

Cigna execs say COVID-19 costs outstripped savings from lower utilization at end of 2020: “Chief Financial Officer Brian Evanko told investors on the company's earnings call Thursday that the ratio between COVID costs and decreases in care utilization evolved over the course of the year. In the second quarter, for instance, savings from care deferrals significantly offset costs related to the pandemic.
In Q3, by contrast, COVID costs were largely on par with savings related to lower utilization, Evanko said. By the end of the fourth quarter, however, costs related to COVID-19 were higher than money saved in care deferrals, he said.”

About the public’s health

Vaccines Saved 37 Million Lives, Mostly Children, Over Past Two Decades: “Vaccinations are also projected to prevent a total of 69 million deaths between 2000 and 2030, researchers say.
Their modeling study also shows that vaccination against the 10 diseases -- including measles, rotavirus, HPV and hepatitis B -- means that people born in 2019 will have a 72% lower risk of death from those diseases over their lifetime.”

High levels of toxic heavy metals found in some baby food: U.S. report: “The [House Oversight subcommittee] panel examined products made by Nurture Inc, Hain Celestial Group Inc, Beech-Nut Nutrition and Gerber, a unit of Nestle, it said, adding that it was ‘greatly concerned’ that Walmart Inc, Campbell Soup Co and Sprout Organic Foods refused to cooperate with the investigation. The U.S. baby food market was worth an estimated $8 billion in 2020, according to Euromonitor.
The report said internal company standards ‘permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.’
The report urged U.S. regulators to set maximum levels of toxic heavy metals permitted in baby foods and require manufacturers to test finished products for heavy metals, not just ingredients, while baby food companies said they were working to reducing levels of metals that occur naturally in food products.”

28 Black medical pioneers to know: In honor of Black History Month, this list is a great historical read, in addition to celebrating individual accomplishments.

Today's News and Commentary

Several articles of general interest by key thought leaders:

Addressing Consolidation in Health Care Markets

Vital Directions For Health And Health Care: Priorities For 2021

Health Costs And Financing: Challenges And Strategies For A New Administration: The article focuses on affordability, access and equity. Quality per se is not discussed, except a small section on value-based compensation.

About COVID-19

Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine: “Pharmaceutical giant Johnson & Johnson submitted its single-shot coronavirus vaccine to U.S. regulators Thursday afternoon for emergency use authorization after the vaccine was shown to be robustly effective against illness in a global trial — and especially at preventing severe disease and death.”

Burned by Low Reimbursements, Some Doctors Stop Testing for Covid: “Across the country, some doctors are seeing reimbursement rates so low that they do not cover the cost of the test supplies, jeopardizing access to a tool experts see as crucial to stopping the virus’s spread.”

Swiss medical regulator rejects Oxford/AstraZeneca Covid vaccine: “Switzerland’s medical regulator has said it cannot authorise use of the Oxford/AstraZeneca Covid-19 vaccine based on the available trial data…”

Data privacy startup Skyflow jumps into digital health passport market to help public spaces reopen: “Data privacy startup Skyflow is entering the health care space to provide a way for people to go back to public spaces amid the COVID-19 pandemic with a digital passport.
The company launched Skyflow for Healthcare, which consists of digital passports for COVID-19 and vaccination. Airlines, theme parks and government agencies can use the digital diagnostics and vaccination solution to verify if a person is safe from COVID-19 and ready to enter a public space.”

About pharma

McKinsey Settles for $573 Million Over Role in Opioid Crisis: “McKinsey & Company, the consultant to blue-chip corporations and governments around the world, has agreed to pay $573 million to settle investigations into its role in helping ‘turbocharge’ opioid sales, a rare instance of it being held publicly accountable for its work with clients.
The firm has reached the agreement with attorneys general in 47 states, the District of Columbia and five territories, according to a court filing in Massachusetts on Thursday. The settlement comes after lawsuits unearthed a trove of documents showing how McKinsey worked to drive sales of Purdue Pharma’s OxyContin painkiller amid an opioid crisis in the United States that has contributed to the deaths of more than 450,000 people over the past two decades.”

Roche hit by worst-case biosim assault—to the tune of $5.6B—as COVID-19 hurts new king Ocrevus: “Biosimilars to the three cancer megablockbusters in the U.S., EU and Japan put a CHF 5.05 billion ($5.62 billion) dent in Roche’s top line in 2020, the company said Thursday. The worldwide loss was about CHF 5.7 billion.”

Ken Frazier to retire as Merck CEO after 10-year run, handing the baton to CFO Robert Davis: “The only Black CEO of a Big Pharma company—and one who's spoken out about racial injustice and pandemic promises—is now retiring.
Ken Frazier, who has been Merck & Co.’s chief executive since 2011, will retire June 30, the New Jersey pharma said Thursday. He will continue to serve as executive chairman for a transition period that’s yet to be determined.
Robert Davis, currently Merck’s chief financial officer, will take the reins.”

About health insurance

A number of healthcare organizations issued a joint letter to Congress asking for an extension on the Medicare sequestration moratorium.

UnitedHealth Group CEO Wichmann to retire, Optum chief Witty named successor: “Wichmann has served as CEO of UnitedHealth since 2017 after first joining the company in 1998; he also was previously its chief financial officer.
Witty will take the title immediately and will join the company's board.”
Recall that before joining United, Witty headed up GSK pharmaceuticals fro a number of years.

About hospitals and health systems

Proposed Community Benefit Minimum Spending Floor Notification: Many states have a community benefits standard for purposes of hospital tax-free status. This announcement from the Oregon Health Authority sets a specific dollar minimum for five Legacy System’s hospitals: $252,951,639 for fiscal year 2022. This announcement is a call for comments before implementation.

Today's News and Commentary

About COVID-19

Age groups that sustain resurging COVID-19 epidemics in the United States: “We estimate that as of October 2020, individuals aged 20-49 are the only age groups sustaining resurgent SARS-CoV-2 transmission with reproduction numbers well above one, and that at least 65 of 100 COVID-19 infections originate from individuals aged 20-49 in the US. Targeting interventions – including transmission-blocking vaccines – to adults aged 20-49 is an important consideration in halting resurgent epidemics and preventing COVID-19-attributable deaths.”

White House plans to send millions of vaccine doses to retail pharmacies: “The White House next week will start shipping coronavirus vaccines directly to retail pharmacies alongside ongoing deliveries to states, increasing weekly supplies of shots nationwide to 11.5 million, a top aide said on Tuesday.
U.S. President Joe Biden’s COVID-19 response coordinator, Jeff Zients, said the program will launch on Feb. 11 and will make 1 million doses available to 6,500 stores. As supply grows, the program could expand to as many as 40,000 stores, he said.”

Amazon spreads vaccine misinformation, iSchool researchers find: “Amazon's search algorithm gives preferential treatment to books that promote false claims about vaccines, according to research by UW Information School Ph.D. student Prerna Juneja and Assistant Professor Tanu Mitra.
Meanwhile, books that debunk health misinformation appear lower in Amazon's search results, where they are less likely to be seen, the researchers wrote in a paper that was recently accepted to CHI, the top annual conference on human-computer interaction.”

City of Chicago turns to Zocdoc to help get COVID-19 vaccines into arms: “The city of Chicago is teaming up with Zocdoc to help get COVID-19 vaccines into the arms of its 2.7 million residents.
The online medical appointment booking company will aggregate real-time appointment availability from select Chicago point-of-dispensing sites as well as from local care organizations such as Amita Health and Rush University Medical Center to serve as Chicago's central site for eligible residents to find and book vaccinations, officials from Zocdoc said.
Chicago is the first city to implement Zocdoc's vaccine scheduler tool, a new service care organizations or public health agencies can use, free of charge, to support streamlined vaccine scheduling.”

Oxford coronavirus vaccine shows sustained protection of 76% during the 3-month interval until the second dose: This vaccine is unique in that the booster provides better coverage if delivered three months after the first dose, rather than the 3 weeks with the Moderna and Pfizer vaccines. This finding highlights the need to assess each vaccine separately.

GSK and CureVac to develop vaccines to tackle Covid variants: “The UK’s GlaxoSmithKline and Germany’s CureVac will work together on a new generation of Covid-19 vaccines to tackle emerging variants of the virus that have shown some resistance to existing ones. The two companies have agreed a €150m deal to develop jointly a product using mRNA technology that would work on multiple variants of the Sars-Cov-2 virus and could be ready for use in 2022, subject to approval. GSK will also help manufacture up to 100m doses of CureVac’s mRNA vaccine candidate at its plant in Belgium. The CureVac vaccine, the only mRNA shot that is stable at conventional fridge temperatures, is in the final phases of testing.”

About health insurance

More Americans Choosing Medicare Advantage Plans Amid Pandemic: “Based on preliminary open enrollment data collected from October 15 to December 7, 2020, 36% of the 67.7 million Medicare beneficiaries in the United States are enrolled in a Medicare Advantage (MA) plan this year, marking a 9% year-over-year increase…
While 29% chose the plan for its prescription drug coverage, and 16% for its affordability, 9% of MA enrolled Americans chose it for its supplemental benefits. 
Of those 9%, more than one-third (35%) cited COVID-19 supplemental benefits specifically and 27% referenced its telehealth benefits.”

When will Biden ask the Supreme Court to uphold Obamacare?: “The challenge for Biden's Justice Department is not only telling the justices it manifestly opposes the position taken by the Trump administration in the case, but how to pull off the task. Changing its position on the Affordable Care Act wouldn't end the lawsuit, which was brought by Texas and other Republican-led states, but could inform how the justices look at the case.”

Annual Out-Of-Pocket Spending Clusters Within Short Time Intervals: Implications For Health Care Affordability: The study, based on 2017, data “found that although most commercially insured people had several health care encounters throughout the year, their out-of-pocket spending was mostly concentrated within short time intervals. Nearly one-third of people with above-the-median total annual health care spending (plan plus out-of-pocket spending) incurred half of their annual out-of-pocket spending in just one day.” The purpose of insurance is to protect against catastrophic loss. Perhaps in addition to annual out-of-pocket limits there ought to be a month maximum, or totals spread over months.

Humana Reports Fourth Quarter 2020 Financial Results; Provides Full Year 2021 Financial Guidance: Highlights:
—”Reports 4Q20 loss per common share of $2.07 on a GAAP basis, $2.30 on an Adjusted basis; reports full year (FY) 2020 earnings per diluted common share (EPS) of $25.31 on a GAAP basis, $18.75 on an Adjusted basis (in-line with the company's initial FY 2020 Adjusted EPS guidance as communicated throughout the year)
—Announces FY 2021 EPS guidance in a range of $20.82 to $21.32on a GAAP basis, $21.25 to $21.75 on Adjusted basis; while acknowledging the heightened uncertainty surrounding the ongoing pandemic
—Reaffirms FY 2021 expected individual Medicare Advantage membership growth range of approximately 425,000 to 475,000 members, representing expected year-over-year growth of approximately 11 to 12 percent”

Anthem's pharmacy revenues ballooned in 2020: “While Anthem's fourth-quarter financial results may have disappointed investors, the insurer's in-house pharmacy benefit manager — IngenioRx — saw significant growth in the final quarter of 2020, according to recent financial filings. 
In the fourth quarter of 2020, IngenioRx recorded revenues of $5.9 billion, up 81.4 percent year over year. Its operating gain for the fourth quarter of 2020 was $363 million, higher than Anthem's combined operating gain for its commercial/specialty and government insurance businesses. For the year ended Dec. 31, 2020, IngenioRx brought in $21.9 billion in revenue, up 305.6 percent from $5.4 billion in 2019.”

About healthcare IT

HIMSS21 still a 'go' for Vegas in August with 400 exhibitors signed up, organizers say: The news is that the planned conference will be in person, not virtual.

FDA names its first medical device cybersecurity director: “The FDA has appointed its first medical device cybersecurity chief to help guide the agency’s regulatory strategies as more devices become interconnected—and potentially more vulnerable to digital attacks and breaches.
Kevin Fu, an associate professor and research fellow at the University of Michigan, was named to the post. He will serve a one-year term as an expert-in-residence at the agency’s Center for Devices and Radiological Health (CDRH) as well as at its nascent Digital Health Center of Excellence, which launched last fall.”

AT&T And U.S. Department of Veterans Affairs Will Pilot Healthcare Innovations With AT&T 5G And Multi-Access Edge Computing: From the AT&T press release of this first-of-kind program:
“AT&T has delivered AT&T 5G capabilities across the entirety of the U.S. Department of Veterans Affairs (VA) Puget Sound Health Care System in Seattle in a public-private partnership with the VA. VA expects to pilot a variety of healthcare use cases with our 5G and multi-access edge computing (MEC ) technologies to explore how they can improve healthcare delivery to the approximately 9 million Veterans who use VA healthcare services each year.
Multi-access edge computing is essentially a computer and cellular network architecture that brings real-time, high-bandwidth, low-latency access to latency dependent mobile applications... Among the healthcare-focused use cases that could be piloted are:

• Mobile-to-mobile connectivity across/between medical devices, allowing the tracking of people and assets within the facility.

• Improved medical procedures and training through the use of emerging technologies such as augmented reality (AR) and virtual reality (VR).

• Remote and virtual pain management using AR and VR.

• Remote and/or near real-time surgical assistance via the ability to layer multiple surgical techniques using AR.”

 Epic named top overall software suite: 6 insights from 2021 'Best in KLAS' rankings: Not a promotion for Epic. Look at the list in this article and notice a variety of “bests” for different uses.