Today's News and Commentary

About Covid-19

U.S. Has Far Higher Covid Death Rate Than Other Wealthy Countries: A quick glance at the graphs gives the obvious reason- our vaccination rates are lower.

Many N95, KN95 masks are fake — 8 tips for spotting the difference: A really useful list to keep in mind.

Cheap, quick, smartphone-based COVID testing kit as accurate as PCR: “US researchers have developed an innovative smartphone-based kit that can test saliva samples for the presence of SARS-CoV-2 and influenza viruses. Early studies have found the cheap system is as accurate as current lab-based testing and significantly faster…
This new testing process is based on a different technology known as loop-mediated isothermal amplification (LAMP), which is similar to PCR in that it identifies viral material through a process of amplifying any DNA present.
However, the novelty of LAMP technology is that it can amplify viral material without the complex temperature cycling required by PCR testing. The main problem with LAMP diagnostics has been over-sensitivity. It is so effective at enhancing viral replication that it often results in high volumes of false-positives…
Alongside solving this false-positive problem the researchers designed a novel smartphone-based system that can be produced for less than US$100. The system has been dubbed smaRT-LAMP (smartphone-based real-time loop-mediated isothermal amplification).
Using just a smartphone, LED lights and a hotplate, the researchers claim saliva samples can deliver accurate results in 25 minutes. The cost of each individual test has been estimated at around $7, significantly less than a lab-based PCR test.”

SARS-CoV-2 Infection and Hospitalization Among Adults Aged ≥18 Years…: From the CDC: “As of January 8, 2022, during Omicron predominance, COVID-19 incidence and hospitalization rates in Los Angeles County among unvaccinated persons were 3.6 and 23.0 times, respectively, those of fully vaccinated persons with a booster, and 2.0 and 5.3 times, respectively, those among fully vaccinated persons without a booster. During both Delta and Omicron predominance, incidence and hospitalization rates were highest among unvaccinated persons and lowest among vaccinated persons with a booster.”

Can a plant-based diet help mitigate Covid-19?: The answer is YES!
”Analyzing data from 592,571 participants, Merino et al. showed that a dietary pattern characterized by healthy plant-based foods was associated with a 9% lower risk of Covid-19 infection and a 41% lower risk of severe Covid-19 [3]. The dietary data from 568 Covid-19 cases and 2316 controls from healthcare workers from six countries (France, Germany, Italy, Spain, UK, USA) with substantial exposure to Covid-19 patients have demonstrated that those following a plant-based diet had a 73% lower risk of moderate-to-severe Covid-19 [4].”
If you can get access (through a university library) to this article, it provides a science-based comparison among products: Nutrient Composition of a Selection of Plant-Based Ground Beef Alternative Products Available in the United States.

Republican governors in West Virginia and Virginia ask CMS to get out of vaccine mandate: “The Republican governors of West Virginia and Virginia wrote to the Biden administration asking to get out of its healthcare worker vaccine mandate due to concerns over staffing shortages.”

UnitedHealth has reprocessed more than 1.6M claims for COVID-19 vaccines: “UnitedHealthcare has reprocessed more than 1.6 million claims for COVID-19 vaccines, reimbursing providers for underpayments that stirred controversy late last year.
In a statement to Congress, Sen. Bob Casey, D-Penn., said that 99.8% of the claims were processed by Jan. 14, with the remaining 2,900 claims expected to be finalized by Feb. 1. The average adjustment per claim was $14.55 for a total of $23.9 million, according to the statement (PDF).”

About health insurance

 Humana posts $14M loss in Q4, kick-starts $1B value creation effort: “Humana posted a $14 million loss in the fourth quarter of 2021, according to the insurer's earnings report released Wednesday morning…
Humana said factors impacting its earnings for the quarter include the closure of its acquisition of the remaining shares in Kindred at Home as well as ongoing headwinds related to COVID-19.
Humana brought in $2.9 billion in profit for full-year 2021, down $434 million or 12.9% from its full-year 2020 haul, according to the report. Full-year revenues hit $83.1 billion, up 7.7% from $77.2 billion in 2020.”

DOJ Recovers $5.6B In 2021 For 2nd-Highest FCA Haul: “The U. S. Department of Justice announced Tuesday that it had secured roughly $5. 6 billion in False Claims Act recoveries in 2021, its second-highest FCA haul ever, on the back of billions of dollars in settlements related to the opioid epidemic. The more than $5. 6 billion in FCA judgments and settlements in fiscal year 2021 was up significantly from the $2. 2 billion recovered in 2020, and was the most since the record $6. 2 billion recovered in 2014, according to the DOJ.”

Feds' contract with Pfizer for Paxlovid has some surprises: “The United States is spending about $530 for each 5-day course of Pfizer's COVID-19 pill, Paxlovid. But the contract for the first 10 million doses would allow the government to get a lower price if one of a handful of other wealthy countries gets a better deal on the drug…
The contract [also] includes a buyback clause, meaning that in the event that Paxlovid's emergency use authorization needs to be withdrawn, Pfizer would buy back unexpired treatment courses from the federal government.”

About pharma

 Gilead to fork over $1.25B, pay 3% royalty on blockbuster Biktarvy in GSK patent settlement: “…in a Tuesday settlement, the companies are resolving a legal dispute over lucrative patents related to GSK's HIV drug dolutegravir. 
Under the settlement, Gilead will make a $1.25 billion payment to GlaxoSmithKline's ViiV Healthcare unit in the first quarter of 2022. In addition, the company will pay a 3% royalty on U.S. sales of the big-selling HIV drug Biktarvy until a GSK patent expires in October 2027. The drug generated $7.26 billion last year.”

Humira rings up $20.7B in 2021, but AbbVie still mum on post-biosimilar expectations: “After falling just short of the $20 billion figure in annual sales for three straight years, AbbVie's Humira finally topped the elusive mark—and did it by a comfortable margin—generating $20.7 billion in revenue last year….
The growth came despite biosimilar competition outside the United States and pandemic effects…
In 2023, Humira will have to compete with nine launches of Humira knockoffs, including six at home from formidable makers such as Amgen, Samsung, Boehringer Ingelheim, Mylan, Novartis and Pfizer.”

New Survey Finds Biosimilars Have Wide Acceptance: “To find out how formularies were managing the changes, AmerisourceBergen/Xcenda surveyed 51 of its managed care network advisors to see how biosimilars were being encouraged, used and covered among health plans, integrated delivery networks (IDNs) and pharmacy benefit managers (PBMs).
Of survey participants, 35% cover all of the available biosimilars and 65% said they cover some products. Most respondents said they saw cost savings after putting them on their formularies.”

Martin Shkreli Settles Class-Action Litigation for $28 Million: “The Federal Trade Commission and seven states sued in January 2020, accusing Vyera — formerly Shkreli’s company Turing — of increasing the price of the anti-parasitic Daraprim by more than 4,000 percent from $17.50 to $750 a pill in 2015. Daraprim treats toxoplasmosis, a potentially fatal parasitic disease for HIV patients and other immunocompromised people.
Earlier this month, a federal judge banned Shkreli from the pharmaceutical industry, ordering him to pay about $65 million he made in the anticompetitive scheme for which he was convicted in 2017.”

U.S. drug firm ex-CEO convicted of steering opioids to 'dirty doctors': “Following two days of deliberations, the jury convicted Doud, 78, of conspiring to distribute illegal narcotics and conspiring to defraud the United States.
Doud could face life in prison on the charge of conspiring to distribute controlled substances.
The case, brought by the Manhattan U.S. Attorney's Office, marks the first time prosecutors have criminally charged a drug distributor and company executives with drug trafficking opioids.”

Researchers label early CAR-T therapy patient ‘cured’ after living a decade without cancer: The article tells the great story of this prolonged leukemia cure using CAR-T therapy. Here is the scientific report.

Gilead saw $5.6B in remdesivir sales last year: “Gilead Sciences reported $27.3 billion in year-end revenue for 2021, anchored by sales of its COVID-19 therapeutic remdesivir, known by the brand name Veklury
Gilead reported $1.4 billion in sales for Veklury in the fourth quarter of 2021, a decrease of about 30 percent from the same quarter in 2020. However, full-year revenue for Veklury hit $5.6 billion in 2021, a 98 percent jump from 2020 revenue.”

About the public’s health

 Weekly U.S. Influenza Surveillance Report: From the CDC: “The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate for the entire 2020-2021 season, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.
CDC estimates that so far this season there have been at least 2 million flu illnesses, 20,000 hospitalizations, and 1,200 deaths from flu.”

Long-acting injectable cabotegravir not cost-effective for HIV PrEP: “While the long-acting injectable form of cabotegravir has shown superior effectiveness for HIV pre-exposure prophylaxis (PrEP), a cost-effectiveness analysis found that the drug is too expensive at its current price compared to the daily oral medication available as a generic.”

Evaluation of Adiposity and Cognitive Function in Adults: “The results of this study suggest that generalized and visceral adipose tissue are associated with reduced cognitive scores, after adjustment for cardiovascular risk factors and vascular brain injury.”

About healthcare IT

 VA Needs to Address Data Management Challenges for New System: From the GAO:
”VA’s analyses and GAO’s work indicated that clinicians experienced challenges with the quality of migrated data, including their accessibility, accuracy, and appropriateness. For example, a VA report issued after the initial deployment identified risks to patient safety in the new system related to incomplete data migration. The challenges occurred, in part, because the department did not establish performance measures and goals for migrated data quality.”
Recommendations (with which the VA concurred):
”The Secretary of VA should direct the Deputy Secretary to establish and use performance measures and goals to ensure that the quality of migrated data meets stakeholder needs for accessibility, accuracy, and appropriateness prior to future system deployments. (Recommendation 1)
The Secretary of VA should direct the Deputy Secretary to use a stakeholder register to improve the identification and engagement of all relevant EHRM stakeholders to address their reporting needs. (Recommendation 2)”

Healthcare data breaches hit all-time high in 2021, impacting 45M people: “Cybersecurity breaches hit an all-time high in 2021, exposing a record amount of patients' protected health information (PHI), according to a report from cybersecurity company Critical Insights.
In 2021, 45 million individuals were affected by healthcare attacks, up from 34 million in 2020. That number has tripled in just three years, growing from 14 million in 2018, according to the report, which analyzes breach data reported to the U.S. Department of Health and Human Services (HHS) by healthcare organizations.
The total number of individuals affected increased 32% over 2020, meaning that more records are exposed per breach each year. The total number of breaches only rose 2.4% from 663 in 2020 to 679 in 2021 but still hit historic highs.”

Map of US ransomware attacks (updated daily): Thanks to reader Melinda Harwell from Comparitech.com for sending me this link. It highlights this growing problem. 

About health technology

 Thermo Fisher revenue climbs 22% for 2021, buoyed by product launches and the year’s biggest buyout: “At the end of a year that saw it pour $24 billion into strategic acquisitions and another $2.5 billion into building out the physical footprint and technical capabilities of its manufacturing plants, the medtech giant saw its annual revenue stretch to $39.21 billion, an increase of 22% compared to 2020’s full-year earnings.
The surge in revenue came in large part from new product launches and sales of Thermo Fisher’s existing offerings, including its COVID-19 diagnostics, which brought in $9.23 billion alone throughout the year. The company’s many acquisitions also chipped in, with 3% of the year’s earnings growth linked to its buyouts.”

About healthcare finance

5 Things Moody’s Is Watching In Healthcare This Year:
” 1. Medicaid redeterminations, ACA competition a negative for insurers… Moody’s noted that insurers will aim to transition the 4 million individuals destined to fall off Medicaid rolls to Affordable Care Act coverage. Analysts expect ACA enrollment to remain high in 2022, but noted that profitability of the exchanges will remain lower than pre-pandemic levels thanks to COVID costs and increased competition. The report said conditions linked to the “long COVID” will cost insurers $22 billion this year. 
2. Coverage changes to upset health system finances. Medicaid redeterminations and growth in Medicare will result in lower reimbursement for health systems, which will leave providers more dependent on government funding, the report said. Additionally, the shift to lower-cost sites of care and increased telehealth use will cut revenue. Analysts do not expect emergency department volume to return to pre-pandemic levels…
3. Senior housing to return to pre-pandemic levels by 2023. Moody’s expects occupancy in senior housing facilities to increase up to 6% in 2022 thanks to a drop in number and severity of COVID-19 cases and new treatments. Labor costs will also fall as competition increases among workers who no longer qualify for supplemental unemployment benefits. 
4. No medical device mega-deals, but lots of M&A. Moody’s expects the number of medical device megadeals to fall from 2021, when acquisitions worth more than $5 billion reached a record high of 99, according to PwC…
5. No Surprises Act will constrain physician staffing firms’ cash flow. The federal ban on surprise medical bills will hit ER staffing, air ambulance and anesthesiology and radiology providers’ revenue hard, the report said….”

Today's News and Commentary

About Covid-19

 Pfizer and BioNTech seek emergency-use authorization of the first coronavirus vaccine for children under 5: Pfizer and BioNTech said Tuesday they were seeking emergency-use authorization for the first coronavirus vaccine for children younger than 5 and have begun submitting data on the safety and efficacy of the first two doses of a planned three-dose regimen.
The data has not yet been published or peer-reviewed, but the Food and Drug Administration requested the company to move forward with an application due to the “urgent public health need in this population,” the companies said in a statement, noting that 1.6 million children under the age of 4 have tested positive for the coronavirus.”

Medical boards get pushback as they try to punish doctors for Covid misinformation: “In all, medical boards have sanctioned eight physicians since January 2021 for spreading coronavirus-related misinformation, according to the Federation of State Medical Boards, which has recommended that health officials consider action against medical professionals who dispense false medical claims in public forums. The eight penalized doctors, who’ve been hit with discipline from suspension to revocation of licenses, represent a surprising figure, considering the time it takes for state boards to mete out punishment. The targets of investigations have cited their own scientific expertise in recommending alternative courses of treatment.”

About health insurance

Medicare Advantage receiving bipartisan support in House of Representatives : “More than 340 members of the U.S. House of Representatives… signed a letter late last week to the Centers for Medicare and Medicaid Services, urging the agency to maintain stability with Medicare Advantage, contending that it provides affordable, high-quality health coverage.
In total, 346 representatives signed the letter, topping the previous record of 339; this amounts to 80% of the chamber. It comes as CMS prepares its annual rate-setting process, in which the agency will announce key decisions related to Medicare Advantage beneficiaries' funding for the 2023 plan year.”
What is the real reason for the support?
”The Congressional letter follows polling in Morning Consult that shows 92% of Medicare Advantage beneficiaries consider a candidate's support for the program as important to earn their vote.”

Insurers stretched supplier bonuses, quality investment to avoid discounts, says CMS: “A rule to suppress The way commercial insurance companies spend consumer premium dollars could flip supplier compensation and accelerate acceptance of value-based contracts, experts say.
The Centers for Medicare and Medicaid Services proposed in December that provider bonuses, included as claims arise in insurers’ medical loss ratios, be explicitly linked to standards of quality or clinical improvement. CMS also recommended that only costs directly attributable to quality improvement be considered for insurers’ quality improvement requirements in their MLR…
After an MLR review of a number of health insurance plans, regulators said some insurers should be giving consumers back a larger piece of the pie.Health plans offered bonuses to providers instead of returning excess profits to patients, according to the proposed CMS rule. While some bonuses and incentives should be counted in MLR reports because they motivate and reward high-quality care, offering bonuses to bypass discounts misses the point, the agency said.”

Universal health care bill fails to pass in California: “A bill that would have created the nation’s only government-funded universal health care system died in the California Assembly on Monday as Democrats could not gather enough support to bring it for a vote ahead of a legislative deadline.”

GuideWell closes $900M Triple-S acquisition, brings enrollment to 46 million people: “Florida Blue parent company GuideWell finalized its acquisition of Puerto Rico-based Blue Cross Blue Shield affiliate Triple-S Management Corp., according to a news release shared with Becker's. 
The payer announced its intent to acquire Triple-S for $900 million in August 2021. The move would strengthen the companies' footholds in Florida and Puerto Rico.”

A Medicaid and Children’s Health Insurance Program Primer and Reform Outline: An excellent, current monograph.

About hospitals and healthcare systems

 CMS cuts payments to 764 hospitals over patient complications: “CMS will trim 764 hospitals' Medicare payments in fiscal year 2022 for having the highest rates of patient injuries and infections, according to Advisory Board. 
The Hospital-Acquired Conditions Reduction Program aims to prevent harm to patients by providing a financial incentive for hospitals to prevent hospital-acquired conditions. Under the program, a hospital's total score is based on performance on several quality measures, including rates of infections, blood clots and other complications that occur in hospitals and might have been prevented.”

National Hospital Flash Report: January report from KaufmanHall.
“Takeaways at a Glance:

1. Hospitals are still performing well below 2019 levels without CARES Act funding.
   Hospitals have yet to rebound to pre-pandemic levels of margins and volumes, while risingrevenues have been offset by escalating expenses.

2. Hospitals performed better in 2021 than in 2020.
   In 2021, hospitals rebounded somewhat from the first year of the pandemic—when providers nationwide shuttered elective services for weeks and months on end.

3. Labor expenses continue to drive accelerating overall expenses.
   Labor costs rose above both 2020 and 2019 levels in 2021, contributing significantly to increased overall expenses and dampening hospital margins. The increases occurred as hospitals were hit with intense staffing shortages, reflected in declining FTEs per AOB [Adjusted Occupied Bed].

4. Hospitals began feeling Omicron’s impact in December.
   Hospitals saw rising volumes in December, as patient days and ED visits rose. A flat month for
   OR minutes suggests that many providers and non-COVID patients may have cancelled care due to rising COVID caseloads—a trend that has been seen in previous waves of the pandemic.

About pharma

 Novartis' Sandoz reportedly the target of $25B buyout bid from Carlyle and Blackstone : “As Novartis reviews its generics business, the list of potential Sandoz suitors has grown. The deal could become one of the biggest generic industry acquisitions ever—assuming an offer makes it across the finish line.
Investor groups Blackstone and Carlyle could join forces on a massive $25 billion bid for Sandoz…”

Principles of Premarket Pathways for Combination Products: This latest FDA document addresses approval processes for companies that manufacture combination products. “As set forth in section 503(g) of the FD&C Act and 21 CFR part 3, a combination product is a product comprised of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another). The drugs, devices, and biological products included in combination products are referred to as constituent parts of the combination product.”

Drug distributor to pay $13M to settle kickback allegations: “Pharmaceutical distributor Cardinal Health Inc. has agreed to pay more than $13 million to resolve allegations that it violated federal law by paying kickbacks to some doctors' offices, federal authorities said Monday.
Cardinal Health induced physician practices to buy medications from Cardinal rather than from competitors by paying those practices in advance of any drug purchases, and not in connection with any specific purchases, according to the settlement.”

Native American tribes reach landmark opioid deal with Johnson & Johnson, drug distributors for up to $665 million: “In the largest opioid settlement for Native Americans, the country’s three major drug distributors and Johnson & Johnson will pay up to $665 million to tribal communities…”

About the public’s health

 Blockbuster cancer med Keytruda may help flush out dormant HIV, suggesting a new way to treat long-running epidemic: “ A team at the Fred Hutchinson Cancer Research Center and other collaborators found that the immunotherapy helped dormant HIV exit the immune cells and may also shrink the shrouded pool of HIV that has befuddled drug development to-date.”

Exclusive: U.S. diabetes deaths top 100,000 for second straight year: “More than 100,000 Americans died from diabetes in 2021, marking the second consecutive year for that grim milestone and spurring a call for a federal mobilization similar to the fight against HIV/AIDS…
A report released earlier this month calls for far broader policy changes to stem the diabetes epidemic, such as promoting consumption of healthier foods, ensuring paid maternal leave from the workplace, levying taxes on sugary drinks and expanding access to affordable housing, among other areas.”
Viruses come and go, but unless things change, we will always have at least this many people dying from diabetes.

About healthcare IT

 Nearly 2M medical records breached in January: A breakdown: “In January, 38 organizations reported to HHS that 1,991,781 individuals were affected by data breaches.” Broward Health (Fort Lauderdale, Fla.) accounted for 1,351,431 of the total.

How a decades-old database became a hugely profitable dossier on the health of 270 million Americans: “The family of databases that make up MarketScan now include the records of a stunning 270 million Americans, or 82% of the population.”
This piece is a fascinating look at monetization of patient information.

About healthcare personnel

DaVita loses bid to dismiss DOJ's criminal antitrust charges: A Colorado federal judge on Friday declined to dismiss a criminal antitrust indictment alleging dialysis provider DaVita Inc and its former CEO Kent Thiry conspired with competitors not to hire each other's senior employees, upholding a closely watched prosecution in the labor and employment arena.”
This case is one of many recently in the courts that looks at restrictive covenants and other measures companies use to impede free movement of healthcare personnel.

Today's News and Commentary

About Covid-19

Moderna wins full approval for its Covid-19 vaccine, as Novavax seeks authorization for its version: “The ever-evolving landscape of Covid-19 vaccines shifted again on Monday, with Moderna winning full approval for its jab from the Food and Drug Administration, and Novavax submitting a long-awaited application to the agency for an emergency use authorization for its vaccine.
The approval of Moderna’s vaccine, Spikevax, makes it the country’s second fully licensed vaccine to protect against SARS-CoV-2. It’s also the first product the Cambridge, Mass., biotech has brought through licensure in the United States.”

Nurses made $1.5 million selling fake vaccination cards, prosecutors say: “For years, Julie DeVuono has offered to help people avoid vaccination. In 2017 and 2018, the nurse’s pediatric practice advertised ‘vaccine exemption workshops’ that it said would detail tips for ‘the best chance of acceptance.’
Now DeVuono and an employee are accused of selling fake coronavirus vaccination cards and entering them into a state database. Authorities say the pair from Long Island left behind a ledger recording profits of more than $1.5 million in less than three months.”

Covid Data Tracker Weekly Report: From the CDC: “As of January 26, 2022, the current 7-day moving average of daily new cases (596,860) decreased 19.9% compared with the previous 7-day moving average (744,806). A total of 72,874,041 COVID-19 cases have been reported in the United States as of January 26, 2022.”

The latest Covid variant is 1.5 times more contagious than omicron and already circulating in almost half of U.S. states: “KEY POINTS

• The omicron subvariant, known as BA.2, is 1.5 times more transmissible than the original omicron strain, according to Danish scientists.

• The U.K. Health Security Agency on Friday said BA.2 has a “substantial” growth advantage over the original omicron, known as BA.1.

• Nearly half of U.S. states have confirmed the presence of BA.2 with at least 127 known cases nationwide as of Friday.”

Merck and Ridgeback’s Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Demonstrated Activity Against Omicron Variant in In Vitro Studies: “The in vitro studies were independently conducted by researchers from institutions in six countries including Belgium, Czech Republic, Germany, Poland, the Netherlands and the United States. The studies used established cell-based assays to evaluate the antiviral activity of molnupiravir and other COVID-19 antiviral agents against SARS-CoV-2 variants of concern, including Omicron. Molnupiravir has yet to be studied against Omicron in clinical studies.”

 Empowered Diagnostics lands FDA Class I recall tag for 286K unauthorized COVID tests: “The recall was initiated at the end of December and given a Class I rating—the FDA’s most serious—last week. It comprises at least 284,575 CovClear rapid antigen tests and 2,100 ImmunoPass rapid antibody tests that were distributed between Jan. 1 and Nov. 11 of last year.” 

Promising COVID-19 antiviral pill, Paxlovid, in scarce supply, as doctors, patients compete for access: “According to an ABC News analysis of federal data on Paxlovid in more than 3,100 U.S. counties, three-quarters didn't have any of the drug on hand as of Jan. 27, and about three-fifths had no access to a provider offering Paxlovid.”

About health insurance

 Former South Florida Pharmacy Executive Pleads Guilty to $88 Million Health Care Fraud Conspiracy Targeting Military Health Care Programs: “As part of his guilty plea, 58-year-old Matthew Smith admitted his role in fraudulently billing Tricare and CHAMPVA for expensive, medically unnecessary compound drugs from a Broward pharmacy…
Smith—then executive vice-president of the pharmacy—and his co-conspirators paid approximately $40 million in kickbacks to patients, patient recruiters and doctors in exchange for their ordering expensive pain creams, scar creams and vitamins without regard to the beneficiaries’ actual medical needs. The drugs were formulated to maximize profit without legitimate therapeutic value. The reimbursement rates sometimes reached $15,000 for a one-month supply. In addition, the pharmacy did not charge beneficiaries the mandatory copayments, something that the co-conspirators concealed. The fraudulent billings caused a loss to the programs of approximately $88 million.”

Walmart and Health at Scale Launch Customized Provider Recommendations for Plan Participants: Health at Scale today announced a collaboration with Walmart to provide personalized provider recommendations to Walmart associates and their families who work in locations where Health at Scale is offered and are enrolled in the company's health plan. This technology will be incorporated into Walmart's health plan administrator's search engine and virtual care referrals for associates in select geographies, making it easier for plan participants to find providers that match to their unique health needs and care history. Through this initiative, Walmart and Health at Scale will establish a more personalized healthcare experience that focuses on the needs of each individual in the moment and leverages industry-leading machine intelligence to identify providers who have successfully treated patients with similar characteristics and care needs…
Health at Scale's Precision Navigation™ goes beyond non-personalized process-based star ratings, reputation rankings, and volume-based metrics and instead uses industry-leading AI and machine learning to model variations in provider outcomes across thousands of health factors. The service covers 25 different specialties as well as 34 procedures and imaging.”

About hospitals and healthcare systems

 Safety net hospitals say pharma's 340B drug restrictions already endangering future services: “340B Health, an industry group representing these hospitals, said critical access hospitals (CAHs) report losing an average of 39% of the contract pharmacy savings they would have seen from the program, or $220,000 dollars per CAH. Ten percent of those smaller rural hospitals told the group they had lost at least $700,000 due to the drugmakers’ new policies.
Other, larger 340B hospitals such as disproportionate share hospitals, sole community hospitals and rural referral centers reported missing out on 23% of their community pharmacy savings, according to 340B Health’s survey. These facilities’ median reported loss landed at $1 million, with the top 10% tallying losses of $9 million or more.”

HCA to buy back $8B in stock: “The 182-hospital system plans to buy back up to $8 billion in outstanding stock, according to a filing with the Securities and Exchange Commission. The authorization allows the company to buy back the shares through the open market and privately negotiated transactions.”

About pharma

 Drugmakers Raised Prices by 6.6% on Average Early This Year: “In all, about 150 drugmakers raised prices on 866 products in the U.S. through Jan. 20, according to an analysis from Rx Savings Solutions, which sells software to help employers and health plans choose the least-expensive medicines.
Price hikes on drugs rivaled the 7% overall consumer inflation rate, the highest in nearly four decades.”

About the public’s health

 OSHA pursues new safety rule for health-care facilities after previous efforts faltered, expired: “After previous attempts expired or were knocked down in federal court, the Labor Department is now working to create a permanent set of coronavirus safety rules for health-care facilities, trying to establish the only enforceable workplace safety rules two years after the virus began spreading through the United States.
The agency’s effort, which is in an early stage, shows how much the Biden administration has struggled to stand up a set of policies aimed at protecting workers from an easily transmissible virus. Writing and implementing the rules could take months, or even years, because of pushback and court challenges. But White House officials believe the policies are important for safeguarding public health.” 

U.S. EPA moves to advance mercury and air toxics rule: “The U.S. Environmental Protection Agency on Monday revived an Obama administration-era legal finding that regulating hazardous air toxics and mercury from power plants is necessary, a key step before it can strengthen those air regulations.”

Factors Associated With Disparities in Hospital Readmission Rates Among US Adults Dually Eligible [DE] for Medicare and Medicaid: “Question  To what extent are state- and community-level factors associated with within-hospital disparities in hospital readmission for dual-eligible Medicare patients?
Findings  In this cohort study of 2.5 million US adults aged 65 years or older, within-hospital disparities in 30-day readmission for dual-eligible patients persisted after accounting for state- and community-level social and health service availability factors. There was no meaningful change in hospital ranking or between hospital variation in disparity performance when adjustments for community-level factors were included…
Conclusions In this cohort study, within-hospital disparities in 30-day readmission for DE patients were only moderately explained by differences in social risk measured at the community level. This suggests that hospital efforts to advance equity should focus on improving the quality of care transitions at discharge for hospitalized DE patients.”

About healthcare IT

 BCBSA Invests In Digital Health Savings Account Startup: “Digital benefits startup First Dollar raised $14 million led by Blue Cross Blue Shield Association’s venture arm, with participation from Next Coast Ventures and Meridian Street Capital, the company announced on Thursday. 
First Dollar…offers a digital wallet consumers can use to spend tax-advantaged cash like Health Savings Accounts…”
This investment shows the BCBSA’s interest in entering the health savings account business.

Today's News and Commentary

Pioneering cardiologist Jeremiah Stamler dies at 102: “Dr. Jeremiah Stamler, founding chair and professor emeritus of preventive medicine at Northwestern University Feinberg School of Medicine, is credited with teaching the world about the links between diet and cardiovascular health.
Stamler also discovered new ways to treat hypertension and, in the 1970s, helped introduce the concept of cardiovascular ‘risk factors’ like cholesterol, blood pressure, diabetes and smoking… He also helped establish the connection between increased sodium intake and high blood pressure.”
Dr. Stamler was a real giant in the field of epidemiology and prevention. He was a pioneer in discovering risk factors that we now take for granted. He once commented to me about a popular breakfast item: Lox (low salt), yes…but no cream cheese!

About Covid-19

 Association of Child Masking With COVID-19–Related Closures in US Childcare Programs: “In this survey study of 6654 childcare professionals from all 50 states, child masking at baseline (May 22 to June 8, 2020) was associated with a 13% reduction in program closure within the following year, and continued child masking throughout the 1-year study period was associated with a 14% reduction in program closure.
Meaning  These results suggest that masking of children in childcare programs is associated with reduced program closures, supporting current masking recommendation in younger children provided by the Centers for Disease Control and Prevention.”

Yet Another COVID-19 Testing Company That Got Millions From The Feds Being Investigated After Patients Say Their Results Were Flawed: “The list of Chicago-based companies that operate COVID-19 testing sites now under investigation is growing, with a third company under scrutiny after collecting more than $154 million from the federal government amid a sea of consumer complaints.
Northshore Clinical Laboratories, which is not affiliated with NorthShore HealthSystem, worked with third-party pop-ups all over the United States before ending its partnerships with them in late December. It’s also partnered with schools, nursing homes, politicians and other groups on testing and vaccinations. It’s processed at least 5 million tests, according to a federal report.”

Hyperimmune intravenous immunoglobulin does not improve outcomes for adults hospitalized with COVID-19: “A clinical trial has found that the combination of remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, is not more effective than remdesivir alone for treating adults hospitalized with the disease. The trial also found that the safety of this experimental treatment may vary depending on whether a person naturally generates SARS-CoV-2-neutralizing antibodies before receiving it. The results of the multinational Phase 3 trial were published today in the journal The Lancet.”

About health insurance

 Health Coverage Changes From 2020-2021: “KEY POINTS:

• The most recent National Health Interview Survey shows that the uninsured rate for the U.S. population was 8.9 percent for Q3 2021 (July – September 2021), down from 10.3 percent for Q4 2020.

• Individuals with incomes below 200% of the federal poverty level experienced the largest decrease.

• The uninsured rate for children decreased by 2.2 percentage points and for working-age adults (18-64) decreased by 1.5 percentage points.

• Coverage gains were somewhat larger for private coverage than public coverage.

• These data suggest that policies including the American Rescue Plan, the 2021 Marketplace

  Special Enrollment Period, and state Medicaid expansions, in addition to the economic recovery, have helped Americans gain insurance coverage during the COVID-19 public health crisis.”

Physician Compensation Arrangements and Financial Performance Incentives in US Health Systems: “Do health system physician compensation arrangements primarily incentivize volume or value?
Findings  This cross-sectional mixed-methods study of 31 physician organizations affiliated with 22 US health systems found that volume was a component of primary care and specialist compensation for most POs (83.9% and 93.3%, respectively), representing a substantial portion of compensation when included (mean, 68.2% and 73.7%, respectively). While most primary care and specialist compensation arrangements included performance-based incentives, they averaged less than 10% of compensation.”

CMS: $49M In Grants To Boost Medicaid, CHIP Enrollment: “The Centers for Medicare and Medicaid Services opened $49.4 million in grant funding Thursday to advance Medicaid and Children’s Health Insurance Program enrollment and retention among kids, parents and pregnant individuals…
Organizations including state and local governments, tribal organizations, not-for-profits, schools and more can apply to receive up to $1.5 million each over three years to help more children gain health coverage. Applications will be open until March 28.”

Number of ACOs increases modestly to 483 for 2022, which advocates say should be wake-up call: “CMS announced that 66 new ACOs were joining the program this year and that 140 existing ACOs renewed their membership. This brings the total number of ACOs in the MSSP to 483 this year, slightly up from the 477 that were running in 2021.
But the number of beneficiaries who are cared for by an ACO continues to grow.
As of Jan. 1, 2022, more than 11 million Medicare beneficiaries get care from a provider in an MSSP ACO, up by 340,000 (3%) from 2021, CMS' analysis said.”

Oscar Health Delivers Historic Growth, Issues Guidance for 2022 of More Than $6B in Premiums: “For full year 2022, Oscar projects premiums will increase to $6.1 billion - $6.4 billion, a YoY increase of roughly 80% at the midpoint. The Company is also projecting an Adjusted EBITDA loss of ($380) million to ($480) million, which reflects both improving MLR and administrative expense ratios YoY.”

Georgia Bill Aims to Limit Profits of Medicaid Managed-Care Companies: “Georgia lawmakers will consider a bill that could force the state’s Medicaid managed-care insurers to repay millions of dollars if their spending on medical care doesn’t reach a certain threshold…
Tucked inside the legislation is a provision that would require the Medicaid managed-care companies to refund payments to the state if they don’t spend enough on medical care and quality improvements for patients.
Georgia Health News and KHN reported in September that Georgia was one of only a few states that doesn’t mandate a minimum level of medical spending for its Medicaid insurers.
Each year, Georgia pays three insurance companies — CareSource, Peach State Health Plan, and Amerigroup — a total of more than $4 billion to run the federal-state health insurance program for low-income residents and people with disabilities. For 2019 and 2020, the companies’ combined profits averaged $189 million per year, according to insurer filings reported by the National Association of Insurance Commissioners.”

About hospitals and healthcare systems

 12% of US hospitals critically understaffed, 23% anticipate shortages: Numbers by state: “More than 12 percent — or 742 of 6,008 — of hospitals reporting staffing levels in the U.S. are experiencing critical staffing shortages, according to HHS data posted Jan. 27.” 

About pharma

 Samsung shells out $2.3 billion for Biogen stake in biosimilar joint venture: “Samsung Biologics announced Thursday that it has agreed to buyout Biogen's stake in their nearly decade-long biosimilars joint venture Samsung Bioepis for $2.3 billion.” 

About the public’s health

 Doctors, nurses, hospitals warn blood shortage could jeopardize ability to meet patients' needs:
A reminder that this problem persists:
”In an statement issued by the American Hospital Association, the American Nurses Association and the American Medical Association, workers said that the current "severity and duration" of the blood supply shortage could "significantly jeopardize" the ability of health care providers to meet the many urgent needs around the country.
The U.S. currently faces its worst blood shortage in over a decade.”

Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2022: The “Advisory Committee on Immunization Practices recommended 15-valent PCV (PCV15) or 20-valent PCV (PCV20) for PCV–naïve adults who are either aged ≥65 years or aged 19–64 years with certain underlying conditions. When PCV15 is used, it should be followed by a dose of PPSV23, typically ≥1 year later.”

Addressing the unprecedented behavioral-health challenges facing Generation Z: “A series of consumer surveys and interviews conducted by McKinsey indicate stark differences among generations, with Gen Z reporting the least positive life outlook, including lower levels of emotional and social well-being than older generations. One in four Gen Z respondents reported feeling more emotionally distressed (25 percent), almost double the levels reported by millennial and Gen X respondents (13 percent each), and more than triple the levels reported by baby boomer respondents (8 percent).”

About healthcare IT

 Research shows gender, specialty, geography among top factors contributing to “pajama time” work for clinicians: “Conducted in the first half of 2021, the findings from the athenahealth Research and Insights team show that factors including region, gender, organizational structure, and medical specialty are all associated with the amount of time clinicians spend documenting in the EHR.”
Higher charting times were characteristic of larger organizations;  adult-medicine primary care clinicians, followed by neurologists; female practitioners in all specialties; and New England region location. Of note is that patient volume does not correlate well with these hours. The study noted, for example: “Despite data showing that orthopedic surgeons schedule the most patients weekly, they spend the least amount of time in the EHR as compared to other top specialties.”

Today's News and Commentary

Justice Breyer helped the Supreme Court save most of Obamacare: With Justice Breyer’s announcement that he is stepping down from the Supreme Court, this article is a great summary of his contributions to healthcare jurisprudence.

About Covid-19

 Development and Validation of a Treatment Benefit Index to Identify Hospitalized Patients With COVID-19 Who May Benefit From Convalescent Plasma: “This prognostic study of 2287 patients hospitalized with COVID-19 identified a combination of baseline characteristics that predict a gradation of benefit from CCP compared with treatment without CCP. Preexisting health conditions (diabetes, cardiovascular and pulmonary diseases), blood type A or AB, and earlier stage of COVID-19 were associated with a larger treatment benefit.” And in a related article: Association of Convalescent Plasma Treatment With Clinical Status in Patients Hospitalized With COVID-19A Meta-analysis: “This meta-analysis found no association of CCP [COVID-19 convalescent plasma] with better clinical outcomes for the typical patient.”

Federal vaccination mandate begins for healthcare workers in 25 states: “Healthcare workers in 25 states face their first deadline Jan. 27 to comply with the Biden administration's COVID-19 vaccination mandate. 
Per CMS, providers in the District of Columbia, the U.S. territories and 25 states must ensure staff have received at least one shot, have a pending request for an exemption, have been granted a qualifying exemption, or have been identified as having a temporary delay as recommended by the CDC, by Jan. 27. They also must ensure their employees are fully vaccinated by Feb. 28.”

3rd dose of Pfizer kids’ COVID-19 vaccine gets CPT code: Important not only for billing but also tracking number of doses given:
”0073A—Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; third dose”

Another Major COVID Testing Company — Which Got $186 Million From The Feds — Is Under Investigation As Complaints Pile Up: “O’Hare Clinical Lab has been reimbursed more than $186 million from the federal government for testing and treatments since the start of the pandemic. The company is based in Chicago and its suburbs, and it has more than 100 locations across the United States.”

U.S. vaccine donations have now topped 400 million, White House to announce: “The latest donations will begin shipping Thursday through the Covax global vaccine sharing program, with nearly 3.2 million doses of the Pfizer-BioNTech vaccine going to Bangladesh and nearly 4.7 million doses going to Pakistan, according to the official. With the latest shipment, more than 47.4 million doses will have been sent to Pakistan, more than any other country in the U.S. donation program, the official said.”

Some Americans are hesitant about Covid vaccines. But they’re all-in on unproven treatments: “Gov. Ron DeSantis of Florida has refused to say whether he’s received a booster shot. He’s suggested, misleadingly, that Covid-19 vaccines cause infertility. He hired a surgeon general who has questioned the data surrounding vaccines and called those who refuse to be immunized ‘brave.’
But when it comes to experimental Covid therapeutics, DeSantis and his government are all-in — even when outside researchers, the Food and Drug Administration, and the medicines’ own manufacturers say they don’t work…
The Florida controversy underscores a bizarre phenomenon: That while largely baseless vaccine hesitancy has hindered the U.S. pandemic response, Americans are tripping over themselves to take therapeutics that are experimental, expensive, and ineffective — precisely the characteristics that anti-vaccine advocates falsely ascribe to Covid immunizations, which are proven, free, and effective.”

About health insurance

Sign-ups in Affordable Care Act marketplaces reach record 14.5 million: “About 14.5 million Americans have signed up to get health coverage this year through Affordable Care Act insurance marketplaces, eclipsing the previous record enrollment by nearly 2 million…
Five state-run marketplaces plus the District’s are still open for consumers to buy health coverage for 2022. And three states and the District have created special enrollment periods that will allow uninsured residents longer to sign up for ACA coverage.”

HHS TO AUDIT PRF-FUNDED HOSPITALS FOR BALANCED BILLING COMPLIANCE: “Healthcare providers and hospitals that received funding from the Provider Relief Fund (PRF) will be audited for their compliance of the balanced billing requirement (or "surprise billing"), a requirement they must follow to receive the funds.”

About hospitals and healthcare systems

 HCA posts $7B annual profit, plans to add 8 hospitals : “The 182-hospital system reported revenue of $15.1 billion in the fourth quarter of last year, up from $14.3 billion in the same period of 2020. The for-profit hospital operator said same-facility admissions, emergency room visits and outpatient surgeries increased year over year, while inpatient surgeries declined. 
After factoring in expenses and nonoperating items, HCA's net income in the fourth quarter of 2021 totaled $1.8 billion, up from $1.4 billion in the same quarter a year earlier….
HCA has 47 hospitals in Florida and plans to start building three more this year. The company announced in November that it is building a 90-bed hospital in Gainesville, a 100-bed hospital in Fort Myers and a 60-bed hospital near the Villages. The three hospitals will be part of HCA Florida Healthcare. 
The company plans to expand its 45-hospital footprint in Texas by buildingfive more.”

About pharma

Prescription Drugs: Spending, Use, and Prices: The latest update from the CBO (even though data only goes to 2018). Too many findings to summarize, but if you have been keeping track of the sector, no real surprises. The summary statement:
”Nationwide spending on prescription drugs increased from $30 billion in 1980 to $335 billion in 2018. (All estimates of drug spending and prices in this report are expressed in 2018 dollars.) Over that period, real per capita spending on prescription drugs increased more than sevenfold: from $140 to $1,073. That increase in spending was driven by the development and use of many types of drugs that have yielded myriad health benefits. Because of those health benefits, some drugs, such as those that treat cardiovascular conditions, are associated with reductions in spending on services provided by hospitals and physicians. Other types of drugs, such as those that treat multiple sclerosis or cancer, may not offer such compensating savings, but they have improved the lives of those with chronic conditions and have also extended life.”

About the public’s health

 National Diabetes Statistics Report: These latest statistics from the CDC are staggering:

“Diabetes

• Total: 37.3 million people have diabetes (11.3% of the US population)

• Diagnosed: 28.7 million people, including 28.5 million adults

• Undiagnosed: 8.5 million people (23.0% of adults are undiagnosed)

Prediabetes

• Total: 96 million people aged 18 years or older have prediabetes (38.0% of the adult US population)

• 65 years or older: 26.4 million people aged 65 years or older (48.8%) have prediabetes”

About healthcare IT

 Venture capital firm launches $75M telehealth-focused fund: Venture capital firm Swiftarc Ventures launched Swiftarc Telehealth, a $75 million fund that will focus on telehealth and digital health…
The fund is set to work collaboratively with medical experts on its advisory board to focus on obesity, mental and behavioral health, and pediatrics.”

Maker Of $295 Prescription Video Game For Kids With ADHD To Go Public In Palihapitiya-Led SPAC Deal: “The deal, expected to close in mid-2022, values the 10-year old company around $1 billion, and will bring Akili public through a merger with blank check company Social Capital Suvretta Holdings Corp. I. Akili is the second target company identified for a series of four biotechnology-focused SPACs launched in June 2021 by former Facebook executive and “SPAC King” Palihapitiya and Kishen Mehta, a portfolio manager at Suvretta Capital Management. The first, ProKidney, which is developing a cell therapy for chronic kidney disease, was announced last week.”

About healthcare personnel

New report calls for global action plan to address nursing workforce crisis and prevent an avoidable healthcare disaster: “A new report has revealed how the COVID-19 pandemic has made the fragile state of the global nursing workforce much worse, putting the World Health Organization’s (WHO) aim of Universal Health Coverage at serious risk. It suggests up to 13 million more nurses will be required over the next decade, the equivalent of almost half of the world’s current 28 million-strong workforce.”

About health technology

 GSK kicks off trials of pioneering ‘bioelectronic’ disease treatment: “GlaxoSmithKline has treated the first patient with a bioelectronic implant that modifies nerve signals to organs in the body’s core, as part of a joint venture to treat chronic diseases with Google sister company Verily. The UK drugmaker and US life sciences company formed Galvani Bioelectronics in 2016 to create implants that can precisely target nerves to specific organs and can stay inside a patient for the rest of their life. A Scottish patient was the first to receive an implant as part of two early stage trials to treat rheumatoid arthritis in the UK and the US. In keyhole surgery lasting just under an hour, a small device was placed in the torso via the navel. The device is attached to the inside of the body wall, where it can be controlled wirelessly by an app.”

Today's News and Commentary

About Covid-19

Israeli panel recommends fourth Covid vaccine dose for all adults: “Israel’s vaccine advisory panel has recommended a fourth dose of a Covid-19 shot for all adults [over 18], a world first, as the country battles a surge in infections driven by the Omicron coronavirus variant. The move fol”lows research showing fourth doses doubled protection against symptomatic Covid-19 and increased protection against severe illness by three to five times, compared with three doses. Other countries, including the UK, US and Chile, have signed off on fourth doses for immunocompromised people, such as those living with HIV or certain transplant recipients, but have hesitated on launching a widescale second booster campaign.”

 OSHA withdraws its workplace vaccine rule.: “The Biden administration is withdrawing its requirement that large employers mandate workers be vaccinated or regularly tested, the Labor Department said on Tuesday.
In pulling the rule, the department recognized what most employers and industry experts said after a Supreme Court ruling this month — that the emergency temporary standard could not be revived after the court blocked it.”

BiologyWorks COVID-19 Test Achieves 99.1 Percent Accuracy in Study: “Los Angeles, Calif.-based startup BiologyWorks said its handheld, reusable molecular-testing device for COVID-19 matched the 99.1 percent accuracy seen in polymerase chain-reaction (PCR) tests in a clinical trial…
The molecular test has multiple possible applications, including identifying infections, such as influenza A/B, hepatitis B, Streptococcus, sexually transmitted diseases, pneumonia and even cancers, the company said.”

Biden administration seeks Medicare coverage of at-home COVID-19 tests: “The administration has received pressure from lawmakers and researchers to expand coverage, and some health insurers have decided to broaden coverage beyond the federal requirements, which were outlined Jan. 10.”

Multiple Early Factors Anticipate Post-Acute COVID-19 Sequelae [PASC]: “We resolved four PASC-anticipating risk factors at the time of initial COVID-19 diagnosis: type 2 diabetes, SARS-CoV-2 RNAemia, Epstein-Barr virus viremia, and specific autoantibodies. In patients with gastrointestinal PASC, SARS-CoV-2-specific and CMV-specific CD8+ T cells exhibited unique dynamics during recovery from COVID-19.”

Hospitals are denying transplants for patients who aren’t vaccinated against Covid, with backing from ethicists: “Perhaps because of the politicization of Covid-19 vaccines more broadly, the reaction to such decisions is sometimes greeted with outrage. But ethicists and transplant physicians stress that organ allocation has to be partially determined by who can survive and thrive with a scarce resource. With so many people waiting for an organ, clinicians try to maximize the chances of a successful transplant. Hospitals don’t want to allocate an organ to people who are putting themselves at higher risk of dying after a transplant — especially since that organ can’t then go to someone else.

About health insurance

Anthem reports $1.1B in profit for Q4, doubling its haul year over year: “The results beat Wall Street, according to analysts from Zacks Investment Research. Anthem did fall short of Street expectations on revenue for the quarter, however, posting $36.6 billion, though that does represent a 14.9% increase from its fourth-quarter 2020 haul of $31.8 billion.
The insurer brought in $6.1 billion in profit for full-year 2021, up from $4.6 billion in 2020. Full-year revenues were $138.6 billion, according to the company's earnings report released Wednesday.”

 Insurers missing the mark on mental health parity, new federal report says: “Mental health parity laws require that insurers cannot impose financial requirements or treatment limitations on mental health care that exceed those on physical care services. The report, issued by the departments of Labor, Health and Human Services (HHS) and Treasury to Congress, found many insurers are failing in this regard…
The Employee Benefits Security Administration has issued 156 letters across 86 investigations, according to the report. The Centers for Medicare & Medicaid Services has also issued 15 letters between May and November 2021 in states where it has authority over mental health parity, namely Texas, Missouri and Wyoming, as well as to nongovernmental plan sponsors.”

About hospitals and healthcare systems

 Curb costs or get fined, state tells Mass General Brigham: “Boston-based Mass General Brigham must develop a performance improvement plan to reduce costs after the state's healthcare watchdog determined that the health system pushed healthcare spending above acceptable levels throughout the last few years…
The Massachusetts Health Policy Commission found that Mass General Brigham had substantially higher than average commercial spending from 2014 to 2019. In total, the health system had $293 million in total spending across those years, which was more than any other provider. The commission said this high level of spending that stems from the system's expensive care has hurt the state's ability to control healthcare costs and meet the state's affordability benchmarks.
Failure to comply comes with a $500,000 fine, according to the commission's website.”

About pharma

New Drug Application (NDA): The FDA has proposed updated rules for its 21 year-old Abbreviated NDA labeling requirements after revisions to the approved labeling of a reference listed drug (RLD) on which a generic drug is based.

Big Insulin Makers Spent Big Money on Lobbying in 2021: “ According to lobbying disclosures, Eli Lilly shelled out $7 million on lobbying in 2021, which represents an almost 30 percent increase over 2020, but was similar to what the company spent in 2019.
Another big maker of insulin, Novo Nordisk, spent $3.2 million, almost a quarter more than in 2020.”

 Trulicity Instagram post draws OPDP’s first untitled letter of 2022: “In an untitled letter dated 19 January 2022, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) cites drugmaker Eli Lilly for a social media post about its type 2 diabetes mellitus drug Trulicity (dulaglutide).
According to the untitled letter, an Instagram post with a video component promoting Trulicity failed to adequately present the drug’s FDA-approved indication and limitations of use. It also failed to include “material information” about the risk of hypoglycemia with concomitant insulin use.
The post contains multiple frames with text stating “Make every moment count,” and ‘Trulicity may help lower A1C*’ but does not prominently display information about the drug’s indication, limitations of use or risk information.”

J&J's drug sales rise 16.5% in Q4, boosted by COVID-19 vaccine: “Johnson & Johnson said that it expects sales of its COVID-19 vaccine Ad26.COV2.S to be between $3 billion and $3.5 billion this year, up from $2.4 billion in 2021, which topped analyst forecasts of $1.5 billion.
The company noted that including sales of the coronavirus vaccine, revenue this year is seen between $98.9 billion and $100.4 billion, representing growth in the range of 5.5% to 7%. Analysts estimate full-year sales of around $97.8 billion. Meanwhile, earnings per share are predicted to be between $10.40 and $10.60.” 

About healthcare personnel

 COVID-Related Stress and Work Intentions in a Sample of US Health Care Workers: “Among 20,665 respondents at 124 institutions (median organizational response rate, 34%), intention to reduce hours was highest among nurses (33.7%; n=776), physicians (31.4%; n=2914), and advanced practice providers (APPs; 28.9%; n=608) while lowest among clerical staff (13.6%; n=242) and administrators (6.8%; n=50; all P<.001). Burnout (odds ratio [OR], 2.15; 95% CI, 1.93 to 2.38), fear of exposure, COVID-19–related anxiety/depression, and workload were independently related to intent to reduce work hours within 12 months (all P<.01)…
 Conclusion: Approximately 1 in 3 physicians, APPs, and nurses surveyed intend to reduce work hours. One in 5 physicians and 2 in 5 nurses intend to leave their practice altogether.”

About health technology

Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Today, the FDA issued this document to encourage patient feedback in the design of medical devices and clinical trials to prove their efficacy. “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.”
The reason for these suggestions is that the  “FDA believes medical device clinical studies prospectively designed with input from diverse patient advisors, including those from racially and ethnically diverse populations, may help to address common challenges faced in these clinical studies and could result in:

• Faster study/research participant recruitment, enrollment, and study completion;

• Greater study/research participant commitment and retention, resulting in decreased loss

  to follow-up;

• Greater study/research participant adherence resulting in fewer protocol

  deviations/violations;

• Greater study/research participation by diverse patient populations;

• Fewer protocol revisions;

• Streamlined data collection resulting in better quality data; and

• More relevant data on outcomes that matter to patients.”

Abbott weathers 2021’s COVID-testing roller coaster ride with $7.7B in annual diagnostic sales: “For the full year, the medtech giant reported total COVID test sales of $7.7 billion. The fourth quarter of 2021 brought in more than its fair share of those earnings, with $2.3 billion, though it fell short of the same three-month period in 2020 when Abbott raked in about $2.4 billion from its coronavirus offerings.
Still, 2021’s earnings massively dwarfed those of 2020, which saw total COVID-related sales of about $3.9 billion between the second and fourth quarters.”

About healthcare finance

Health-Stock Drubbing Gets Uglier in Longest Drop Since 1994: “Amid concerns about rising rates and a broader market rout, the sector has dropped more than 9% so far in January and is also poised for its worst monthly plunge since 2009. That compares with a 24% jump last year.
Investors have been turning away from pandemic stock winners as the market gets more optimistic that Covid-19 will be tamped down to a more manageable virus like the flu. Caught in the economic reopening trade are the scientific tools and service stocks that outperformed last year and of course vaccine makers including Pfizer Inc. and Moderna Inc.”

Today's News and Commentary

About Covid-19

 FDA ends for now use of two monoclonal antibodies, spurring a halt in federal shipments of the covid-19 treatments: “The Food and Drug Administration on Monday took two monoclonal antibody therapies off the list of covid-19 treatments for now, saying the medications should not be used anywhere in the United States because they are ineffective against the dominant omicron variant.
As a result, the Department of Health and Human Services, which distributes covid treatments to states, notified state health officials that it has halted distribution of the antibody medications made by Regeneron Pharmaceuticals and Eli Lilly…” 

Third Dose of Pfizer/BioNTech COVID-19 Shot Neutralizes Omicron, Lab Studies Show: “Peer-reviewed findings from one study by the companies published in the journal Science demonstrated that the blood serum antibodies of individuals given three vaccine doses showed full protection against Omicron while those given two doses only had limited antibody protection.
In addition, pre-print findings from the University of Texas indicated that one month after receiving a booster the participants had a 22-fold increase in neutralizing antibodies against Omicron vs. those who only received two doses.”

Global conditions perfect for more Covid variants to emerge, WHO’s Tedros says: “Conditions are ripe for Covid-19 to mutate into more new variants, and it is dangerous to assume the pandemic is approaching its endgame, the WHO’s top official warned Monday.
Last week, an average 100 cases were reported every three seconds, Tedros Adhanom Ghebreyesus added, and someone lost their life to the virus every 12 seconds.”

US pharmacies get first shipments of free N95s: “The shipments, coming from the Strategic National Stockpile, are part of the federal government's plan to advance access to high-quality masks to combat the omicron-driven COVID-19 surge…
The White House was planning to send 400 million masks to pharmacies and community health centers, with the national program set to be in full gear by early February. 
Masks were set up for distribution as of Jan. 24 at select Hy-Vee and Meijer grocery stores in the Midwest, with shipments set to arrive at grocers in the southeastern region of the country by Jan. 28… There is a limit of three masks per person…”

Pfizer, BioNTech launch trial for potential omicron-busting vaccine: “The new vaccine will be included in a three-cohort study that will also examine different regimens of the companies’ existing COVID-19 shot, Comirnaty, according to a Tuesday press release.”

Cash shortages mean Covax cannot accept new doses, says executive: “The Covax vaccine initiative set up to ensure Covid-19 vaccines reach the world’s poorest people is unable to accept new dose donations because it has nearly exhausted the funds needed to buy crucial accessories including syringes, one of its leaders has warned. Vaccine shortages have plagued many poorer countries and contributed to the uneven rollout of jabs around the world. Public health experts have repeatedly said such disparities could lead to new coronavirus variants emerging in areas where fewer people have been vaccinated. The World Health Organization-backed programme last week said it needed a fresh cash injection of $5.2bn to support its global vaccine rollout this year.”

About pharma

 FDA Issues Latest Update on Drug Shortages: “The FDA has released an updated drug shortages list showing 116 drugs currently in shortage and 48 drugs in limited supply but for which the cause of the shortage has been resolved.
The list includes numerous generic products, such as injectable acetazolamide, used to treat glaucoma, epilepsy and altitude sickness; several amphetamine compounds, prescribed for attention deficit hyperactivity disorder, narcolepsy and obesity; and injectable bupivacaine hydrochloride, a surgical anesthesia.” 

About the public’s health

 Estimated Number of Deaths Prevented Through Increased Physical Activity Among US Adults: “Increasing MVPA [moderate-to-vigorous physical activity] by 10, 20, or 30 minutes per day was associated with a 6.9%, 13.0%, and 16.9% decrease in the number of deaths per year, respectively. Adding 10 minutes per day of physical activity resulted in an estimated 111 174 preventable deaths per year (95% CI, 79 594-142 754), with greater benefits associated with the addition of more physical activity (209 459 preventable deaths [95% CI, 146 299-272 619] for 20 minutes and 272 297 preventable deaths [95% CI, 177 557-367 037] for 30 minutes)…”

The impact of a poverty reduction intervention on infant brain activity: “This study demonstrates the causal impact of a poverty reduction intervention on early childhood brain activity. Data from the Baby’s First Years study, a randomized control trial, show that a predictable, monthly unconditional cash transfer given to low-income families may have a causal impact on infant brain activity. In the context of greater economic resources, children’s experiences changed, and their brain activity adapted to those experiences. The resultant brain activity patterns have been shown to be associated with the development of subsequent cognitive skills.”

Screening for Atrial Fibrillation [AF]- US Preventive Services Task Force Recommendation Statement: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for AF. (I statement)” Also see the excellent editorial: Screening for Atrial Fibrillation—More Data Still Needed

About healthcare IT

Understanding Physicians’ Work via Text Analytics on EHR Inbox Messages: “This study demonstrated that advanced text analytics provide a reliable data-driven methodology to understand the individual physician’s EHR inbox management work with a significantly greater level of detail than previous approaches. This methodology can inform decision makers on appropriate workflow redesign to eliminate unnecessary workload on PCPs and to improve cost and quality of care, as well as staff work satisfaction.”

 Consumer Willingness to Share Personal Digital Information for Health-Related Uses: “In this survey study of 3543 US adults, consumer willingness to share digital data was associated with a range of factors, most importantly the source and type of data. Certain data (eg, financial, social media, public cameras) were viewed as more sensitive than electronic health record data, but underlying views on digital health privacy were strongly associated with consumer views on sharing any digital information…”

State Of Digital Health: Among the highlights of this report: "The US digital health market continues to dominate, reaching a record $37.9B in 2021. US funding hit $10.8B in Q4’21 alone — more than the second-largest global market, Asia, recorded in all of 2021 ($10.7B).
US deal count dropped to 303 in Q4 – the lowest on record for 2021. This comes as smaller financings were overtaken by mega-rounds, which accounted for 63% of total US funding in Q4'21.”

Welcome to Nightingale Open Science: Well worth a look. The site has open source data, for now only on a few topics, that links images and other information to actual patient outcomes…all assisted by AI.

Truveta and LexisNexis Risk Solutions Partner to Advance Health Equity and Health Research Quality: “Truveta… and the Health Care business of LexisNexis Risk Solutions… announced a strategic partnership that will improve the quality of all health research and enable new insights on health equity in our country. For the first time, daily clinical data from over 16% of all clinical care in the U.S. will be linked together across health providers, and then integrated with 40% of all Medicare and Medicaid medical insurance claims, 70% of all commercial medical insurance claims, social determinants of health data on every adult American, and comprehensive mortality data in one data platform for medical research.”

About healthcare personnel

 HHS distributing $2B to healthcare providers: Breakdown by state: “HHS Jan. 25 it is providing more than $2 billion in Provider Relief Fund phase 4 payments, through the Health Resources and Services Administration, to more than 7,600 providers affected by the COVID-19 pandemic.
Coupled with the $9 billion that came in December, a total of $11 billion in phase 4 payments have been given to more than 74,000 providers in all 50 states, Washington, D.C., and five territories.”

Today's News and Commentary

About Covid-19

England’s public health body investigates new offshoot of Omicron: “An offshoot of the Omicron coronavirus variant, known as BA.2, is being investigated by England’s public health body over concerns that it may be even faster spreading than the original version. The UK Health Security Agency said it was designating the Omicron offshoot a ‘variant under investigation’ because of ‘increasing numbers of BA.2 sequences identified both domestically and internationally’. Early analysis suggests the BA.2 sub-variant may have an ‘increased growth rate’ over the earlier form of Omicron, officially designated as BA.1, according to UKHSA, which stressed that there is a ‘low level of certainty early in the emergence of a variant’. Moreover, BA.2 has not been named a ‘variant of concern’ — the highest risk ranking for new strains.”

Omicron Pressure Eases in Some U.S. States, but Infections Remain High: “The seven-day average of total people in U.S. hospitals declined for the second consecutive day, reaching 158,788 on Saturday, according to data from the Department of Health and Human Services. The number of new admissions to hospitals across the U.S. was also down.”
Still, some states remain in crisis (see the article’s map of average daily cases per 100K).

White House launches call line for free COVID-19 test orders: Starting last Friday, Americans who could not order “the COVID-19 tests on the website launched by the White House… can call 1-800-232-0233 to do so… The call line, which serves those speaking English, Spanish and more than 150 additional languages, is open 8 a.m. until midnight EST, seven days a week.
The Biden administration has also set up a text-based line for hearing-impaired callers at 1-888-720-7489.”

FDA expands use of remdesivir to patients with high risk of hospitalization: “The U.S. health regulator on Friday expanded its approval for the use of Gilead Sciences' antiviral drug remdesivir to treat non-hospitalized patients 12 years and older for the treatment of mild-to-moderate COVID-19 disease with high risk of hospitalization.”

Comparison of mRNA-1273 and BNT162b2 Vaccines on Breakthrough SARS-CoV-2 Infections, Hospitalizations, and Death During the Delta-Predominant Period: “Immune responses to mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) vaccines decline by 6 months after vaccination, although antibody titers are higher with mRNA-1273…
 This study found that recipients of mRNA-1273 compared with BNT162b2 had a lower risk of breakthrough SARS-CoV-2 infections and hospitalizations during the Delta period.” 

WHO Recommends Extending Use of Pfizer/BioNTech COVID-19 Jab to 5-11 Year Olds: “The advisory panel recommended a 10-microgram dose, one-third of the full 30-microgram dose for older children and adults, but did not did not make a recommendation about offering booster doses to young children.”

Trends in US Ambulatory Care Patterns During the COVID-19 Pandemic, 2019-2021: “In this retrospective cohort study that included more than 14.5 million patients, there was an overall increase in the return to expected rates of use of 6 ambulatory care services between March 2020 and February 2021. This increase was significantly lower for patients with Medicaid or those with Medicaid-Medicare dual eligibility than for those with commercial, Medicare Advantage, or Medicare fee-for-service.”

Cannabidiol inhibits SARS-CoV-2 replication through induction of the host ER stress and innate immune responses: “Here we report that cannabidiol (CBD) inhibits infection of SARS-CoV-2 in cells and mice. CBD and its metabolite 7-OH-CBD, but not THC or other congeneric cannabinoids tested, potently block SARS-CoV-2 replication in lung epithelial cells. CBD acts after viral entry, inhibiting viral gene expression and reversing many effects of SARS-CoV-2 on host gene transcription…This study highlights CBD as a potential preventative agent for early-stage SARS-CoV-2 infection and merits future clinical trials. We caution against use of non-medical formulations including edibles, inhalants or topicals as a preventative or treatment therapy at the present time.” [Emphasis added]

Los Angeles school district tells students to upgrade from cloth masks: “The Los Angeles Unified School District is prohibiting students from wearing only cloth face masks on campus as the country grapples with a continued surge of COVID-19 infections driven by the omicron variant.
The district announced updated guidance on Friday requiring students to wear "well-fitting, non-cloth masks with a nose wire" both indoors and outdoors. Employees will have to wear surgical grade masks or higher.
Students and employees will be able to get masks from the district if they need them.”

Changes in COVID-19 Vaccine Hesitancy Among Black and White Individuals in the US: “This survey study of 1200 US adults found that COVID-19 vaccine hesitancy decreased more rapidly among Black individuals than among White individuals since December 2020. A key factor associated with this pattern seems to be the fact that Black individuals more rapidly came to believe that vaccines were necessary to protect themselves and their communities.”

 About pharma

New clinical trial organization launches with promise to conduct randomized trials at fraction of the cost: “Protas emerged Monday with Sanofi signed on as a strategic partner, and the company's overall goal is to design smarter trials that leverage new technologies and collaborations. The organization will be led by Prof. Sir Martin Landray, a 20-year veteran of conducting large clinical trials at Oxford University’s Nuffield Department of Population Health.”

 Senators Propose Bill to Balance FDA’s Domestic, Foreign Inspections Requirements: “Sens. Joni Ernst (R-Iowa) and Mike Braun (R-Ind.) have introduced a bill to eliminate the advance notice foreign drugmakers receive before an FDA inspection to level the playing field for domestic companies that don’t typically receive any such prenotification.
The Creating Efficiency in Foreign Inspections Act is meant to do away with the incentive drug manufacturers have to keep their facilities abroad and urge pharma companies to ship their plants back to the U.S. to strengthen the supply chain.”

FDA’s Maintains Stable Performance Across PDUFA and BsUFA Tasks During the Pandemic: “Despite the pandemic, the FDA’s product review performance as it related to the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Amendments (BsUFA) remained relatively stable through fiscal year 2020 to fiscal year 2021, according to the latest data posted on the agency’s ‘dashboard’ — which tracks how well the agency is living up to its review commitments under the user fee programs.”

Capital Rx and Independa Partner to Bring Prescription Savings to the Masses via LG Televisions: “LG TV customers can access the Capital Rx prescription savings card through their Independa services on LG TVs, or via downloading the Independa mobile app, all free, to begin saving up to 90% on prescription costs.
Capital Rx Advantage savings card accepted at 65k pharmacies and major retailers, including Walgreens, Walmart, Costco and more.”

UK’s NICE to launch sweeping changes to drug assessments to be faster, more agile: “It will give patients earlier access to innovative treatments by allowing greater flexibility over decisions about value for money and consideration of a broader evidence base. The new assessment will also provide greater predictability for industry, greater transparency for patients and enable swift decision making for NICE’s independent committees, NICE said in a statement.
One key addition will be a weighting the severity of diseases, intended to provide more equitable access to treatments. Currently, a similar approach is taken — insomuch as a higher price threshold is offered — only for medicines used at the end of life.
NICE will also take greater account of real-world evidence and consider uncertain benefits for treatments for rare diseases and children’s medicines, for example, where evidence can be harder to gather. NICE said it wants to ensure valuable innovations in these areas are made available while managing potential risks to patients. Its decisions apply to England and Wales and are often adopted in Northern Ireland.”
Comment: NICE is often used a s benchmark for “enlightened,” evidence-based decisions on use of drugs and healthcare technology.

About the public’s health

 Exclusive-U.S. opposes plans to strengthen World Health Organization: “The United States, the World Health Organization's top donor, is resisting proposals to make the agency more independent…
The proposal, made by the WHO's working group on sustainable financing, would increase each member state's standing annual contribution…
The plan is part of a wider reform process galvanised by the COVID-19 pandemic, which has highlighted the limitations of the WHO's power to intervene early in a crisis.
But the U.S. government is opposing the reform because it has concerns about the WHO's ability to confront future threats, including from China, U.S. officials told Reuters.
It is pushing instead for the creation of a separate fund, directly controlled by donors, that would finance prevention and control of health emergencies.”

About healthcare IT

 IBM Watson Health data sale to include imaging and public health software: More information about the previously reported sale.

Telehealth heavy hitters join new advocacy group: “The American Telemedicine Association has partnered with telehealth organizations to form an advocacy group. 
The organization, ATA Action, will work to advocate for telehealth policy and expand policy gains made during the COVID-19 pandemic… The trade organization supports action at the state and federal levels to ensure individuals have access to telemedicine, including appropriate coverage and payment policies.”

Global digital health funding skyrockets to $57.2B with record cash for mental health, telehealth: “Digital health investment around the world hit an all-time high of $57.2 billion in funding in 2021, fueled by the growing need to provide digital solutions and delivery models to patients during the pandemic.
The record-breaking funding marks a 79% jump from the $32 billion raised globally in 2020, according to a year-end report by market intelligence firm CB Insights.
That record amount was raised in 2,930 deals, compared to 2,518 deals in 2020.”

Woman charged $847 'facility fee' for telehealth visit: “Brittany Tesso, a mother in Colorado, was recently charged $847.35 for a "facility fee" for her 3-year-old son's telehealth visit at Aurora-based Children's Hospital Colorado, KDVR reported Jan. 23.
She also received a bill of $676.86, which she paid. Her son's visit was to see if he needed speech therapy.
‘I was like, “Facility fee? I didn't go to your facility. I was at home and as far as I could tell some of the doctors were at home too.” And [a hospital representative] said, “Well, we charge the same whether you come to the facility or it's a telehealth appointment,”’ Ms. Tesso told KDVR.’”

About healthcare personnel

 Rich Countries Lure Health Workers From Low-Income Nations to Fight Shortages: Not a new problem, but it has been exacerbated by global labor shortages due to the Covid pandemic. The article provides some good examples of this practice.

Health-Care Strike Risk Runs High as Hundreds of Labor Deals End: “Hundreds of union contracts will expire in 2022 at health-care facilities from Boston to Sacramento, setting up fights over staff-to-patient ratios, pay, and other safety concerns as beleaguered workers continue to battle the Covid-19 pandemic.
The cluster of expiring labor agreements will force health-care management to reckon with the physical and mental toll the pandemic has had on workers during the worst staffing shortage in memory.
At least 207,000 health-care workers are covered by the more than 400 labor agreements set to expire this year, according to an analysis of federal disclosures and contract settlement data compiled by Bloomberg Law. That figure is a conservative estimate that will only grow throughout the year as more companies report information on expiring contracts to the federal government.”

Today's News and Commentary

About Covid-19

Booster shots in U.S. have strongly protected against severe disease from omicron variant, CDC studies show: “One of the new CDC reports analyzed data from hundreds of thousands of emergency room visits, urgent care visits and hospitalizations between August 2021 and Jan. 5, 2022. It showed that a third dose of either the Pfizer-BioNTech or Moderna shots reduces the chance of hospitalization by 90 percent compared to unvaccinated people, and reduces the chance of a trip to the emergency room by 82 percent. The data covered a period that includes three weeks when omicron was the predominant variant.”

 More than 2 dozen drugmakers to make Merck’s COVID-19 pill: “A U.N.-backed organization announced Thursday that it has signed agreements with more than two dozen generic drug makers to produce versions of Merck’s COVID-19 pill to supply 105 developing countries.
The Medicines Patent Pool said the deals would allow drug companies to make both the raw ingredients for molnupiravir and the finished product itself.”

How Are Private Insurers Covering At-Home Rapid COVID Tests?: An excellent up-to-date review of major insurers’ policies.

Center For COVID Control Closed For ‘Foreseeable Future’ In Illinois Amid Federal, State Investigations: “The Center for COVID Control, an embattled chain of testing pop-ups, won’t reopen in Illinois amid an investigation from state authorities, the Illinois Attorney General’s Office announced Thursday night.
The company closed all its testing sites Jan. 14 as it faces federal and state investigations. It was set to reopen some locations Friday — but its leaders have agreed to stay closed in Illinois for the “foreseeable future” after the Illinois Attorney General’s Office contacted them, according to a news release from that agency.
The company… has said it has 300 locations around the United States. It has been paid more than $124 million for testing from the federal government since the start of the pandemic and has processed more than 400,000 tests.”

Burned Out Health-Care Workers Get $103 Million Boost From HHS: “A $103 million investment from the Biden administration will support health-care workers facing burnout as they enter their third pandemic year.”

Association of Major Depressive Symptoms With Endorsement of COVID-19 Vaccine Misinformation Among US Adults: “In this survey study including 15 464 US adults, people with moderate or greater major depressive symptoms on an initial survey were more likely to endorse at least 1 of 4 false statements about COVID-19 vaccines on a subsequent survey, and those who endorsed these statements were half as likely to be vaccinated.
These findings suggest another potential benefit of public health efforts to address depressive symptoms, namely reducing susceptibility to misinformation.”

Decoy vesicles protect against COVID-19 from coronavirus variants in early tests: “Evolving variants of the SARS-CoV-2 coronavirus are threatening the efficacy of existing COVID-19 vaccines and therapeutics. Now, a group of scientists from Northwestern University and the University of Texas MD Anderson Cancer Center showed that some naturally occurring tiny vesicles isolated from COVID-19 patients could fight off an infection from various subtypes of coronaviruses.
The team identified tiny cell-released lipid particles that expressed a protein called ACE2 from COVID-19 patients’ blood. These circulating extracellular vesicles that express ACE2 (evACE2) blocked infections from different coronavirus variants in lab dishes. Delivered via the nose, the nanoparticles also protected mice from COVID-19. The results were published in Nature Communications. 
The researchers believe evACE2 could be developed as a biological product for prevention and treatment of COVID-19 caused by current and future SARS-CoV-2 variants and potentially other coronaviruses as well. 

About health insurance

Florida Providers, Insurers Won't Use Federal Surprise Billing Resolution Process: “Healthcare providers and insurers in Florida will use the state's own dispute resolution process for out-of-network bills instead of the controversial methodology in the federal No Surprises Act. About 30 states, including Florida, already had their own laws governing balance billing when the new federal balance billing ban was passed. The Centers for Medicare & Medicaid Services is now determining whether those state laws can supersede the No Surprises Act when it comes to issues like payment dispute resolution. This week, the agency disclosed its finding that Florida's methodology will determine payment resolution in most situations. That's on top of about a dozen other states found to have so-called ‘specified state laws,’ meaning their own laws will supersede at least some aspects of the federal balance billing law.”

CVS Health and Uber Health partner on free medical transportation to reduce barriers to care: “Those rides, coordinated by Uber’s healthcare arm, will be available to high-risk populations in Atlanta; Columbus, Ohio; and Hartford, Connecticut, leveraging ride-sharing technology to reduce barriers to care.”

 Seven Texas Doctors and a Hospital CEO Agree to Pay over $1.1 Million to Settle Kickback Allegations: “The settlements announced today resolves allegations that seven Texas doctors received thousands of dollars in illegal remuneration from eight management service organizations (MSOs) in exchange for ordering laboratory tests from Rockdale Hospital d/b/a Little River Healthcare (Little River), True Health Diagnostics LLC (True Health), and Boston Heart Diagnostics Corporation (Boston Heart). Little River allegedly funded the illegal remuneration to the doctors, in the form of volume-based commissions paid to independent contractor recruiters, who used MSOs to pay numerous doctors for their referrals.  The MSO payments to the doctors were allegedly disguised as investment returns but in fact were based on, and offered in exchange for, the doctors’ referrals.”

The Prices That Commercial Health Insurers and Medicare Pay for Hospitals’ and Physicians’ Services: “CBO examined potential explanations for why the prices paid by commercial insurers are higher and more variable than those paid by Medicare FFS. CBO’s analysis and literature review suggest the following conclusions: 

—Greater market power among providers consistently leads to prices for commercial insurers that are higher than Medicare FFS’s prices and that vary more widely, both among and within areas. Hospitals and physicians’ groups may have market power because they have a dominant share of the market in an area or because an insurer sees them as essential to its network of providers. 

—Some of the variation in the prices that commercial insurers pay for hospitals’ and physicians’ services is explained by differences in the prices of inputs needed to deliver those services. 

—Higher hospital quality is associated with higher prices paid by commercial insurers, although whether there is a causal link between quality and prices, and the direction of any such link, is not clear. 

—The share of providers’ patients who are covered by Medicare and Medicaid is not related to higher prices paid by commercial insurers. That finding suggests that providers do not raise the prices they negotiate with commercial insurers to offset lower prices paid by government programs (a concept known as cost shifting).”
Comment: One must closely read the monograph to clarify these over-simplistic conclusions. Particularly, the variation in payments for both hospital and professional services vary widely among the states (less so for Medicare than FFS). Also, the last statement about cost shifting must be tempered by the fact that some providers with high Medicare/Medicaid populations may not have the ability to cost shift, e.g., inner city and disproportionate share hospitals. The monograph, however, is a great document for policy discussions about health care pricing and provider market power.

About hospitals and healthcare systems

 Tufts Medical Center will close its pediatric hospital after more than a century of treating sick kids: “After more than a century of treating sick children, Tufts Medical Center will close its 41-bed pediatric hospital in July and use those beds to treat more adult patients.
Tufts will refer children who need hospitalization to Boston Children’s Hospital, its longtime competitor and the dominant pediatric hospital in the state.”

The top-rated hospitals for patient experience, state-by-state: “Using the Hospital Consumer Assessment of Healthcare Providers and Systems scores from CMS, Becker's has compiled a list of the best hospitals for patient experience in each state. Hospitals either received five or four patient summary star ratings.” 

About the public’s health

 THE IMPACT OF ALCOHOL CONSUMPTION ON CARDIOVASCULAR HEALTH: MYTHS AND MEASURES : “In the Global Action Plan for Prevention and Control of NCDs, the World Health Organization (WHO) calls for a 10% relative reduction in the per capita use of alcohol between 2013-2030. Based on recent evidence, it has been concluded that there is ‘no safe level of alcohol consumption.’”

Update on abortion laws and court decisions: Excellent review of these issues in the Health 202 column in today’s Washington Post.

FDA urges doctors to prioritize blood draws as collection tube supplies dwindle: “The FDA is recommending that healthcare providers only perform blood draws considered medically necessary, after interruptions in the nationwide supply chain and the COVID-19 pandemic have caused broad shortages of blood specimen collection tubes.”

About healthcare IT

 Francisco Partners to Acquire IBM’s Healthcare Data and Analytics Assets: “IBM and Francisco Partners, a leading global investment firm that specializes in partnering with technology businesses, today announced that the companies have signed a definitive agreement under which Francisco Partners will acquire healthcare data and analytics assets from IBM that are currently part of the Watson Health business. The assets acquired by Francisco Partners include extensive and diverse data sets and products, including Health Insights, MarketScan, Clinical Development, Social Program Management, Micromedex, and imaging software offerings.
The transaction is expected to close in the second quarter of this year and is subject to customary regulatory clearances. Financial terms of the transaction were not disclosed.”
The story is from IBM’s new site. The announcement did not give any reason for the sale.

Half of internet-connected devices in hospitals are vulnerable to hacks, report finds: “Over half of internet-connected devices used in hospitals have a vulnerability that could put patient safety, confidential data, or the usability of a device at risk, according to a new report from the healthcare cybersecurity company Cynerio…
The most common type of internet-connected device in hospitals was an infusion pump. These devices can remotely connect to electronic medical records, pull the correct dosage of a medication or other fluid, and dispense it to the patient. Infusion pumps were also the devices most likely to have vulnerabilities that could be exploited by hackers, the report found — 73 percent had a vulnerability. Experts worry that hacks into devices like these, which are directly connected to patients, could be used to hurt or threaten to hurt people directly. Someone could theoretically access those systems and change the dosage of a medication, for example.”

Does virtual care save money? Cigna study says yes, up to $141 per visit: “The analysis estimates that depending on the type of virtual care, virtual visits can save members as little as $93 per visit versus low-acuity care and as much as $141 per visit versus using an urgent care facility. Patients also save on average $120 per visit on specialist care by using virtual visits…
[It] also decreased the need for lab visits, resulting in $118 in savings per episode of care for urgent care episodes.”

About health technology

Kidneys From a Genetically Altered Pig Are Implanted in a Brain-Dead Patient: “Surgeons at the University of Alabama at Birmingham reported on Thursday that they had for the first time successfully transplanted kidneys from a genetically modified pig into the abdomen of a 57-year-old brain-dead man.” 

Today's News and Commentary

About Covid-19

Fauci says FDA could authorize Pfizer’s Covid vaccine for kids under 5 in the next month: “Fauci said younger children will likely need three doses, because two shots did not induce an adequate immune response in 2 to 4 year olds in Pfizer’s clinical trials.”

 Senior citizens are fuming that Medicare won't pay for Covid-19 tests at retailers: “Asked why Medicare is not paying for the home tests, the Centers for Medicare and Medicaid Services said that Medicare pays for Covid-19 tests performed by a laboratory at no cost when the test is ordered by a physician or other health care provider. The agency noted that enrollees can also visit free testing sites or order free home tests through the federal program at covidtests.gov.” 

Why the US is seeing more COVID-19 hospitalizations than other high-income countries: “The U.S. has reported more COVID-19 hospitalizations than other high-income countries during the omicron surge, according to Our World in Data…
What could explain the higher hospitalization rates in the U.S.? According to the same data, vaccination rates are lower in the U.S. than the other countries included in the analysis. The U.S. is reporting the lowest proportion of its population fully vaccinated — 62.5 percent compared to more than 70 percent for all others — and also the lowest rate of booster shots given.”

How many health care workers are vaccinated? It’s anyone’s guess: “As of the end of December, about three in four hospital workers — 77.6 percent — were fully vaccinated, the Centers for Disease Control and Prevention said, but those figures, which include non-medical staff such as custodial and cafeteria workers, come from only about 40 percent of the nation’s hospitals. About four out of five nursing home staffers are fully vaccinated, according to the CDC.
Nursing homes have been required to submit weekly data since last May and roughly 90 percent do so, according to an agency spokesperson.
Hospitals, however, won’t have to submit data until May 15 under a federal rule released by CMS in August.”

Persistent T cell response to omicron after infection and vaccination: “The omicron variant can partly evade the antibody response provided by vaccination or infection with previous variants of SARS-CoV-2. However, T cells still recognise omicron, scientists at Karolinska Institutet in Sweden report in a study published in the journal Nature Medicine.”
The best T cell response was in those who were vaccinated- even better than in those who had the disease.

Some good news about the short term effects of Covid-19 infection:

Rapid vigilance and episodic memory decrements in COVID-19 survivors: “Reassuringly, COVID-19 survivors performed well in most abilities tested, including working memory, executive function, planning and mental rotation. However, they displayed significantly worse episodic memory (up to 6 months post-infection) and greater decline in vigilance with time on task (for up to 9 months). Overall, the results show that specific chronic cognitive changes following COVID-19 are evident on objective testing even amongst those who do not report a greater symptom burden. Importantly, in the sample tested here, these were not significantly different from normal after 6–9 months, demonstrating evidence of recovery over time.”

Longitudinal Assessment of Cardiac Outcomes of Multisystem Inflammatory Syndrome in Children Associated With COVID‐19 Infections: “Our short‐term study suggests that functional recovery and coronary outcomes are good in multisystem inflammatory syndrome in children. Use of sensitive deformation parameters provides further reassurance that there is no persistent subclinical dysfunction after 3 months.”

6 states where delta is lingering: “The omicron variant accounts for 99 percent of new COVID-19 cases nationwide, but some states are still seeing delta variant proportions as high as 43 percent, according to the Walgreens COVID-19 Index, an interactive tracking tool the company launched Jan. 19…
Based on data analyzed Jan. 18, the six states with the highest delta case prevalence are:

• Maine — 43.5 percent

• Kansas — 36.5 percent

• Iowa — 29.2 percent

• New Mexico — 25.2 percent

• Oklahoma — 24.2 percent

• Indiana — 23.6 percent

• Utah — 23.5 percent”

About health insurance

 Trends in Small-Group Market Insurance Coverage: Some findings from this Urban Institute study:

• “Health insurance enrollment among small-firm employees remained relatively stable from 2013 to 2019, hovering between 8.9 and 9.6 million enrollees.

• The rate at which small firms offer health insurance coverage decreased by just 2.6 percentage points from 2013 to 2020. For comparison, it declined by 10.6 percentage points from 2002 to 2012. Steady offer rates likely reflect consistent demand for employer-sponsored coverage from small-firm employees and greater stability in health insurance costs resulting from ACA reforms…

• Annual premium growth in the employer-sponsored insurance (ESI) market was similar across all firm sizes; premiums for single coverage grew by an average of 3.2 percent per year in the small-group market and by 3.7 percent in both the medium- and large-group markets. Nongroup premiums were significantly more unstable during this period, which may have affected small employers’ decisions to maintain coverage.

• The share of establishments offering a self-insured plan grew from 13.2 percent in 2013 to 16.0 percent in 2020.”

122 organizations stand against California single-payer coverage proposal: “In a letter to the state's Assembly Appropriations Committee, the organizations claim the pair of proposals would "create a new and exorbitantly expensive government bureaucracy" controlled by the government and kill jobs. 
The organizations claim the proposals would unsustainably raise taxes on individuals and businesses and dramatically expand the state's budget and ultimately only cover the 6 percent of Californians without coverage — a group comprised largely of undocumented immigrants and one that is soon to be covered under Gov. Gavin Newsom's budget proposal.”

Humana's CenterWell Senior Primary Care to expand to 12 state markets: “Humana subsidiary CenterWell Senior Primary Care, the largest senior-oriented primary care provider in the nation, is expanding its reach to 12 states. 
Between 2022 and early 2023, CenterWell will create an additional 26 care centers and enter Arizona, Kentucky and Tennessee for the first time, according to the Jan. 20 news release.”

About hospitals and healthcare systems

Community Health Systems, Inc. Announces Offering of $1,535.0 Million of Senior Secured Notes Due 2030: “The Issuer intends to use the net proceeds of the Notes Offering to redeem all of its outstanding 6.625% Senior Secured Notes due 2025 (the “2025 Notes”) and to pay related fees and expenses.”

About pharma

 New Tool Assesses Evolutionary Risks of Antibiotics: “Giving one drug to a patient often causes bacteria to evolve resistance against it. Fortunately, some of these resistant mutants become more susceptible to a second drug, which allows doctors to successfully treat the infection. However, doctors can’t always be sure when and if evolution will take this fortunate course. Even worse, resistance against the initial drug can backfire and cause an increase in resistance against the second drug, leaving the doctors without any further treatment options.
University of California San Diego scientists have now developed a way that can help doctors calculate the odds of the fortuitous outcomes for different drug pairs and thereby boost the odds of a successful treatment. As described in the journal eLife, graduate student Sarah Ardell and Assistant Professor Sergey Kryazhimskiy developed a mathematical model that can calculate the risk of resistance evolution for various drug pairs.”
In a related article: Antibiotic resistance kills over 1m people a year, says study: Put into perspective, that number is more than annual deaths attributable to AIDS or malaria. This excellent article is from the Financial Times.

Mark Cuban Cost Plus Drug Company's Online Pharmacy Launches with Lowest Prices on 100 Lifesaving Prescriptions: “Mark Cuban Cost Plus Drug Company (MCCPDC) today officially launched its online pharmacy [www.costplusdrugs.com]…
Because the company refuses to pay spread prices to third-party PBMs in order to be allowed to process insurance claims, the online pharmacy will be a cash pay venture. However, its model means patients can immediately purchase a broad array of medications at prices often less than what most insurance plans' deductible and copay requirements would total.”
The announcement has some lower-cost examples.

BMS Becomes 12th Big Drugmaker to Reject 340B Drug Discount Program: “In exchange for participation in Medicare and Medicaid, the 340B program requires drugmakers to offer discounts to hospitals and clinics that treat significant numbers of low-income patients. But over the past year, drugmakers have stopped participating, defending their withdrawal from the program by saying that duplicate orders and faulty rebates in the system, among other factors, justified their actions.”

The characteristics of patents impacting availability of biosimilars: An excellent research paper in Nature Biotechnology. Unfortunately it is subscription-only. The US biosimilar approval process is slowed by factors having little to do with the patent on the actual chemical entity. The article argues for a more streamlined approval approach.
“As of June 2020, only 24 of 177 (14%) approved biologics had approved biosimilars or biosimilars in development. Of the remaining 153, 125 were patent-protected and 28 were off-patent. As of 1 December 2021, the FDA had approved 31 biosimilars for 11 originator products, of which 21 had been marketed for use. By contrast, the European Medicines Agency (EMA) had approved 75 biosimilars under its abbreviated pathway, which was created 6 years earlier than the BPCIA [Biologics Price Competition and Innovation Act (BPCIA), which was part of the 2010 ACA]…
Among patents asserted in US biosimilar litigation, only 6% covered the active ingredient in the biologic drug, while the vast majority covered uses or peripheral features of the drug, such as its manufacturing processes or delivery devices. The median time of patent filing was more than a decade after approval of the originator biologic, and one-fifth of the patents had no equivalents — either patents or patent applications — in the European Union, Canada or Japan.
These findings provide insight into the role of the US patent system in biosimilar competition.”

About the public’s health

 National Trends of Mental Health Care Among US Adults Who Attempted Suicide in the Past 12 Months: “In this cross-sectional analysis of 484 732 National Survey of Drug Use and Health respondents, the rate of suicide attempts among US adults has increased within the past decade. However, past-year receipt of mental health services did not increase significantly among those who made suicide attempts.
These findings suggest a need to expand service accessibility and/or acceptability, as well as public and population-wide prevention efforts.”
Comment: While telemedicine has increase accessibility for behavioral health services, more professionals are needed to handle case loads. Also, those who require services must be aware they need care and know how to access it.

About healthcare IT

 Quantitating and assessing interoperability between electronic health records: “Electronic health records (EHRs) contain a large quantity of machine-readable data. However, institutions choose different EHR vendors, and the same product may be implemented differently at different sites. Our goal was to quantify the interoperability of real-world EHR implementations with respect to clinically relevant structured data…
 We defined and demonstrated a quantitative measure of interoperability between site EHR systems and within/between implemented vendor systems. Two sites that share the same vendor are, on average, more interoperable. However, even for implementation of the same EHR product, interoperability is not guaranteed. Our results can inform institutional EHR selection, analysis, and optimization for interoperability.”

Negative Patient Descriptors: Documenting Racial Bias In The Electronic Health Record: “We analyzed a sample of 40,113 history and physical notes (January 2019–October 2020) from 18,459 patients for sentences containing a negative descriptor (for example, resistant or noncompliant) of the patient or the patient’s behavior….Compared with White patients, Black patients had 2.54 times the odds of having at least one negative descriptor in the history and physical notes. Our findings raise concerns about stigmatizing language in the EHR and its potential to exacerbate racial and ethnic health care disparities.”

Today's News and Commentary

About Covid-19

US faces wave of omicron deaths in coming weeks, models say: “The fast-moving omicron variant may cause less severe disease on average, but COVID-19 deaths in the U.S. are climbing and modelers forecast 50,000 to 300,000 more Americans could die by the time the wave subsides in mid-March.
The seven-day rolling average for daily new COVID-19 deaths in the U.S. has been trending upward since mid-November, reaching nearly 1,700 on Jan. 17 — still below the peak of 3,300 in January 2021. COVID-19 deaths among nursing home residents started rising slightly two weeks ago, although still at a rate 10 times less than last year before most residents were vaccinated.”
And in a related story: At least 20 percent of Americans have been infected with COVID-19, data show

Walgreens rolls out new COVID-19 data tracker to trace the spread of omicron, emerging variants: “Data captured in the Walgreens COVID-19 Indexcan track the spread of the omicron variant within 24 to 48 hours, more quickly than other methods, according to the companies. In addition to a national view, data can be reviewed by state.
The Walgreens COVID-19 Index is generated through the combination of Walgreens nationally representative PCR testing services with the associated PCR and next-generation sequencing (NGS) laboratory test results generated by Aegis Sciences.”

 Americans can now order free COVID-19 test kits; N95s to be shipped to pharmacies: “The federal government on Jan. 18 launched its website for Americans to request free rapid COVID-19 test kits be shipped to their homes. 
‘Every home in the U.S. is eligible to order four free at-home COVID-19 tests," the website — covidtests.gov — says. "The tests are completely free. Orders will usually ship in seven to 12 days. Order your tests now so you have them when you need them.’
There is a limit of one order per residential address. Each order includes four individual rapid test kits, and orders will start shipping later this month, the website says.”
Masks will be available in pharmacies starting next week with full program operation by early February.
Comment: If you live in an apartment/condo, make sure to include your unit # when ordering tests. Some people have been blocked because the site records registrants by address.

Pfizer's oral COVID-19 treatment shows efficacy against Omicron: “Findings from the Phase II/III EPIC-HR trial showed that Paxlovid reduced the risk of hospitalisations or death by 89% compared to placebo, when taken within three days of symptom onset, and by 88% when taken within five days. 
Two of the studies in question were conducted by Pfizer.
Commentary: Good news. But try to get this medication, likely to be in short supply.

Frequency of Adverse Events [AE] in the Placebo Arms of COVID-19 Vaccine Trials: Systemic “AEs were experienced by 35% of placebo recipients after the first dose and 32% after the second. Significantly more AEs were reported in the vaccine groups, but AEs in placebo arms (‘nocebo responses’) accounted for 76% of systemic AEs after the first COVID-19 vaccine dose and 52% after the second dose…
This study found that the rate of nocebo responses in placebo arms of COVID-19 vaccine trials was substantial; this finding should be considered in public vaccination programs.”

About health insurance

Obamacare enrollment hits record high after Biden makes post-Trump tweaks to health insurance program: “The official final enrollment number has yet to be tallied. But federal health officials noted that even before the deadline, a whopping 14.2 million people nationally had signed up for coverage…
The big surge came amid boosted financial assistance for enrollments, a wider window for sign-ups, the continuing health effects of the Covid-19 pandemic, which has claimed the lives of more than 850,000 Americans, and the touting of the health-care reform law by the president.”

 UnitedHealth Group reports $4.1B in profit for Q4, $17.3B for full-year 2021: “UnitedHealth Group earned $4.1 billion in profit for the fourth quarter of 2021, bringing its total profit for the year to $17.3 billion, according to the company's earnings report released Wednesday morning.
The results beat Wall Street expectations…
Total revenue for 2021 was $287.6 billion, according to the report.
For comparison, UnitedHealth Group reported $2.2 billion in profit and $65.5 billion in revenue for the fourth quarter of 2020.
For the full year 2020, the company reported $15.4 billion in profit and $257.1 billion in revenue, according to the report.”

About hospitals and healthcare systems

 Hospitals forced to delay patient discharges as nursing homes and rehab centers face major staff shortages: “With nursing homes, skilled nursing facilities (SNFs) and other downstream care settings in a bind, acute care hospitals are having a harder time discharging patients and clearing beds for new arrivals.
The result is not only a capacity issue for facilities facing an influx of COVID-19 cases but unnecessarily longer stays that redouble the demand for costly staff and supplies.”

About pharma

 US Insurer Spending on Ivermectin Prescriptions for COVID-19: “Findings suggest that insurers heavily subsidized the costs of ivermectin prescriptions for COVID-19, even though economic theory holds that insurers should not cover ineffective care. Wasteful insurer spending on these prescriptions, estimated at $2.5 million in the week of August 13, 2021, would extrapolate to $129.7 million annually.”
Comment: Prescriptions have much information associated with them. The one key factor not included is the reason the medication was ordered, i.e., the diagnosis. With all the data included in EMRs, the transition to including this item should not be difficult. It is important to track this information to accurately assess prescriptions ordered for non-FDA approved uses as well as conditions for which insurance coverage is not in force.

Endo to Settle With State of Florida for $65 Million for Role in Opioid Epidemic: “Endo International has agreed to pay up to $65 million to resolve claims by the state of Florida and local governments who claim that the company helped fuel the U.S. opioid epidemic which led to hundreds of thousands of overdose deaths over two decades.
The deal follows Endo’s $63 million settlement in December with Texas over the drugmaker’s role in the opioid crisis.”

Did BMS set up a subsidiary to avoid paying $1.4B in U.S. taxes? The Senate finance chairman is on the case: “In a letter to BMS CEO Giovanni Caforio, Sen. Ron Wyden wrote that he wants to learn more about how the company reduced its tax rate from about 25% in 2010 and 2011 to -6.9% in 2012. The Senator cites reporting from the New York Times to write that BMS used "offshore subsidiaries to allegedly avoid paying as much as $1.4 billion in U.S. taxes" with the help of advisors at PwC and White & Case. Last April, The New York Times reported that the IRS found BMS' tax setup in violation of anti-abuse provisions and was seeking up to $1.38 billion.”

Altos Labs launches with the goal to transform medicine through cellular rejuvenation programming: “Altos Labs™ (Altos™) launched today as a new biotechnology company dedicated to unraveling the deep biology of cellular rejuvenation programming. Altos' mission is to restore cell health and resilience to reverse disease, injury, and the disabilities that can occur throughout life.”
The company will initially be based in the San Francisco Bay Area, San Diego, and in Cambridge, UK, with significant collaborations in Japan. It starts with $3B fully committed from Hal Barron and other biotech veterans.

About the public’s health

 Assessment of US Preventive Services Task Force Guideline–Concordant Cervical Cancer Screening Rates and Reasons for Underscreening by Age, Race and Ethnicity, Sexual Orientation, Rurality, and Insurance, 2005 to 2019: “In this cross-sectional study of 20 557 women (weighted, 113 million women) eligible for cervical cancer screening in the US, the proportion of women without up-to-date screening significantly increased from 14.4% in 2005 to 23.0% in 2019 among all sociodemographic groups, with disparities found across different sociodemographic groups and lack of knowledge reported as the biggest barrier to receiving screening...
This study found that guideline-concordant cervical cancer screening rates decreased between 2005 and 2019; campaigns addressing patient knowledge and practitioner communication may help to improve cervical cancer screening rates, and cultural adaptation of interventions is needed to reduce existing disparities.”

About healthcare IT

As TEFCA goes live, HHS hits major interoperability milestone: “Five years in the making, the nation's top health IT agency released Tuesday the Trusted Exchange Framework and Common Agreement, a critical step in establishing a nationwide data-sharing network.
The long-awaited interoperability framework (PDF), called TEFCA, was mandated by the 21st Century Cures Act back in 2016 and was designed to improve data sharing between health information networks.
The Office of the National Coordinator for Health, within HHS, released the first draft of the TEFCA back in January 2018. The framework provides the policies, procedures and technical standards necessary to exchange patient records and health information between providers, state and regional health information exchanges and federal agencies."

What types of mental health apps actually work? A sweeping new analysis finds the data is sparse: “The meta-review, published on Tuesday in PLOS Digital Health, examined 14 meta-analyses that focused specifically on randomized control trials for mental health interventions, including treatments for depression, anxiety, and smoking cessation. In total, the review included 145 trials that enrolled nearly 50,000 patients. The review found universal shortcomings in study design, leading the researchers to write that they ‘failed to find convincing evidence in support of any mobile phone-based intervention on any outcome.’”

 Microsoft, Cleveland Clinic and Providence join coalition to innovate AI in healthcare: “The Artificial Intelligence Industry Innovation Coalition (AI3C) unites nine other big names alongside Microsoft: the Brookings Institution, Cleveland Clinic, Duke Health, Intermountain Healthcare, Novant Health, Plug and Play, Providence, the University of California, San Diego and the University of Virginia.
Senior executives from each organization on the AI3C board will help co-create new AI tools and follow AI use in the industry, aiming to address the business and socioeconomic barriers that block widespread adoption of the technologies.”

About health technology

 Top 10 Health Technology Hazards for 2022: Annual ECRI report. Top 4:

1. Cybersecurity Attacks Can Disrupt Healthcare Delivery, Impacting Patient Safety

2.Supply Chain Shortfalls Pose Risks to Patient Care

3.Damaged Infusion Pumps Can Cause Medication Errors

4.Inadequate Emergency Stockpiles Could Disrupt Patient Care during a Public Health Emergency
Comment: The list changes every year. Notice 2. and 4. are particularly Covid-related problems.

FDA Reclassifies Apple’s ECG App into Lower-Risk Class II, Special Controls: “Apple’s electrocardiograph (ECG) software for over-the-counter use, available as an app, has received a risk downgrade from the FDA to class II (special controls) as opposed to the highest-risk class III category.”

Today's News and Commentary

About Covid-19

Renewal of De​​termination That A Public Health Em​ergency Exists: Xavier Becerra, Secretary of Health and Human Services, renewed the COVID emergency for an additional 90 days (started January 14).

Fourth vaccine dose boosts antibodies, researchers say, but likely not enough to prevent Omicron breakthrough infections: “Early data out of Israel suggests that a fourth dose of either the Pfizer/BioNTech or Moderna coronavirus vaccine can bring an increase in antibodies -- more than what's been seen after a third dose -- but it still might not be enough to protect against breakthrough infections caused by the Omicron variant.
’These are very preliminary results. This is before any publication, but we're giving it out since we understand the urgency of the public to get any information possible about the fourth dose,’ Dr. Gili Regev-Yochay, director of the Infection Prevention and Control Unit at Sheba Medical Center, told reporters during a virtual news conference Monday about the data.”

WHO says no evidence healthy children, adolescents need COVID-19 boosters: “There is no evidence at present that healthy children and adolescents need booster doses of COVID-19 vaccine, the World Health Organization's chief scientist Soumya Swaminathan said on Tuesday.”

Types of Masks and Respirators: An update from the CDC:

• Clarified that people can choose respirators such as N95s and KN95s, including removing concerns related to supply shortages for N95s

• Clarified that ‘surgical N95s’ are a specific type of respirator that should be reserved for healthcare settings

• Clarified that some types of masks and respirators provide more protection to the wearer than others” Specifically, cloth masks should only be used when surgical or N95/K95 masks are not available.

The effect of COVID certificates on vaccine uptake, public health, and the economy: Lessons from the European practice of COVID certificates. The abstract is worth quoting at length:

“We estimate that the announcement of COVID certificates during summer 2021 led to increased vaccine uptake in France of 13.0%… of the total population up to the end of the year, in Germany 6.2%…, and in Italy 9.7%…. Further, this averted an additional 3,979… deaths in France, 1,133… in Germany, and 1,331…in Italy; and prevented gross domestic product (GDP) losses of €6.0… billion in France, €1.4… billion in Germany, and €2.1 …billion in Italy. Notably, the application of COVID certificates substantially reduced the pressure on intensive care units (ICUs) and, in France, prevented occupancy levels being exceeded where prior lockdowns were instated. Varying government communication efforts and restrictions associated with COVID certificates may explain country differences, such as the smaller effect in Germany. Overall, our findings are more sizeable than predicted. This analysis may help inform decisions about when and how to employ COVID certificates to increase vaccine uptake and thus avoid stringent interventions, such as closures, curfews, and lockdowns, with major social and economic consequences.”

24 states must ensure healthcare workers are fully vaccinated by March 15, CMS says: “CMS issued updated guidance Jan. 14 for enforcement of the agency's healthcare worker COVID-19 vaccination mandate, including that covered providers must ensure their employees are fully vaccinated by March 15.”
These 24 states are the ones that challenged the CMS conditions of participation to combat COVID spread.
”CMS said the Supreme Court decision does not affect compliance timelines for providers in the District of Columbia, the U.S. territories and the other 25 states that did not challenge the mandate, which must have their employees fully vaccinated by Feb. 28.”

Association of Race and Neighborhood Disadvantage with Patient Engagement in a Home-Based COVID-19 Remote Monitoring Program: “In a COVID-19 remote patient monitoring program, Black enrollees preferentially selected, and had higher retention in, telephone- over app-based monitoring. As a result, overall retention was similar between races. Remote monitoring programs with multiple modes may reduce barriers to participation.”

U.S. CDC warns against travel to 22 destinations over COVID-19: “In total, the CDC now lists just over 100 countries and territories at "Level 4." The CDC also raised another 20 countries to Level 3: High," including Uganda, Kuwait, Jamaica, Costa Rica and Cuba.”

About health insurance

 MedPAC: Majority of Medicare beneficiaries to be on MA by 2023, but coding issues remain rampant: “MedPAC found 46% of beneficiaries in Parts A and B were enrolled in MA plans, and that figure is expected to stretch past 50% in 2023…
The panel also found that for this year, 99% of Medicare beneficiaries have access to at least one plan, and 98% of them can choose a plan with a Part D benefit.
But MedPAC found that the explosion of growth has not also led to more savings for traditional Medicare.
The panel discovered that this year spending in MA will be 4% higher than fee-for-service Medicare after considering coding practices such as upcoding, which leads to higher quality bonuses for plans…
In 2020, MedPAC found MA risk scores were 9.5% higher than fee-for-service beneficiaries that had a similar health status.”
One factor that must be taken into consideration is that MA plans have a financial incentive to code correctly while traditional Medicare payments are not diagnosis-dependent.

Some insurance brokers enroll people in ACA plans without consent: “Some insurance brokers are enrolling people into Affordable Care Act health plans without their consent, perhaps for the commissions, a move that could put consumers in danger of owing back the subsidies connected with the coverage. The damage could be hundreds or even thousands of dollars.
A consumer's first hint that something is wrong is a big one: a letter from the IRS or a delay in their tax refund.
Although the practice does not appear widespread, it has prompted the Department of Health and Human Services to seek changes to some oversight rules affecting brokers. They would start in 2023.” 

About pharma

 The top 10 biopharma M&A deals in 2021: “Biopharma merger and acquisition (M&A) activity was subdued in 2021, and it would have approached a record low for recent years but for a flurry of deals in the last quarter.  
The top 10 biopharma M&A deals last year reached a combined value of just under $53 billion, well down from the $97 billion tally in 2020 and a fraction of the $207 billion spent on the 10 largest transactions in 2019.”
See the articles for details of the firms involved.  

Teva settles shareholder lawsuit over generic drug pricing for $420 mln: “Teva Pharmaceutical Industries Ltd has agreed to pay $420 million to settle shareholder litigation alleging the company hid an anti-competitive scheme to fix the price of generic drugs.”

Gilead says counterfeiting network sold $250 mln worth of its HIV drugs: “Gilead Sciences Inc said on Tuesday that tampered and counterfeit versions of its HIV treatments worth $250 million were sold to pharmacies over two years by a network of drug distributors and suppliers.”

About the public’s health

 Texas’s six-week abortion ban remains in effect after federal appeals court ruling: “The nation’s most restrictive abortion law remains in effect in Texas after a federal appeals court on Monday rejected a request from abortion providers to immediately return their legal challenge to a trial court judge who had previously blocked the measure.
In a 2-to-1 decision, the U.S. Court of Appeals for the 5th Circuit temporarily transferred the case to the Texas Supreme Court, a step requested by state officials that could leave the dispute in limbo for months.” 

About healthcare IT

 Oscar Health reveals data breach caused by printing error: “The insurer said Friday that it discovered the breach on or around Nov. 23 and believes the incident occurred between Oct. 28  and Nov. 16. The company found that mailers, which contained personal information, were misrouted to other Oscar members.
The mailers included information such as members' names, Oscar ID numbers, claims numbers, provider information, dates of service, procedure names and plan names or affiliations. This information may have been viewed by another Oscar member who received the mailer, according to the notice.”
The article does not say how many members were affected. 

U.S. Department of Veterans Affairs Partners with Google Cloud to Improve Veteran Access to Benefits and Services: “Through a $13 million, multi-year contract, the VA will deploy Apigee, Google Cloud’s application programming interface (API) management platform. The implementation is part of the continued evolution of the VA’s Lighthouse API program, providing developers with seamless and secure access to VA APIs in the development of new tools and services. For example, with Apigee, developers can use the VA’s Benefits API to create applications that help Veterans submit and track electronic benefits claims and add supplemental documentation. Developers can also easily access the VA’s Health APIs to build new online tools that help Veterans manage their health and access their medical records.”

About health technology

The top 10 medtech M&A deals of 2021: “Looking to make up for lost time and hopefully prepare companies for a new life in a post-COVID landscape, dealmaking kept that pace through the first half of 2021 and then some. Logging about $31.5 billion in transactions over the first six months of the year alone, the medtech sector overtook the $28.8 billion M&A total it saw for all of 2020, according to figures from Evaluate Medtech.”
See the article (or link) for details of the firms involved.

 Special Report:
Trust in a New Era of Health: A very interesting report from Salesforce.com. Results are broken down by segment and also age groups. Well worth a least a skim.

Today's News and Commentary

About Covid-19

Biden deploys military medical teams to 6 more 'hard-hit' states, doubles order for free at-home COVID tests: “President Joe Biden announced today the deployment of additional military medical teams to hospitals in six “hard-hit” states alongside plans to procure and ship 500 million more rapid COVID-19 tests for home use.
…President Biden said that more than 800 military and other federal emergency personnel have been deployed across 24 states, tribes and territories to support healthcare providers’ COVID-19 response. Further, more than 14,000 National Guard members have been activated in 49 states…"

COVID-19 Therapeutics for Nonhospitalized Patients: A great and short subject review in today’s JAMA Network.

COVID-19 Testing Chain Opened Pop-Ups Across The US. Now, It’s Temporarily Closing Amid Federal Investigation And Mounting Complaints: “The Center for COVID Control, a locally [Chicago] based chain of testing sites, is under national scrutiny and has been cited at the highest level by a federal agency as reports come in from across the country of chaos at testing sites and confusion over results.
Amid the heightened scrutiny, the center announced Thursday it will close for a week starting Friday…
Again and again, people going to Center for COVID Control sites have reported getting negatives there — only to get a positive elsewhere. Others have never gotten results, or gotten them so late the test was effectively useless. Some people who didn’t even test at the sites were still sent results.”

Florida won't be Biden's 'biomedical police,' DeSantis' office says after Supreme Court ruling: “Florida won’t be enforcing the Biden Administration’s mandatory vaccination policy for health care workers upheld by the U.S. Supreme Court, a spokeswoman for the governor’s office said Thursday.”
The enforcement would be federal if hospitals do not comply with this provision, which is now part of Medicare and Medicaid conditions of participation in those programs.

About health insurance

MedPAC votes on 2023 payment recommendations: “The Medicare Payment Advisory Commission today recommended that Congress provide a current law update for the hospital inpatient and outpatient prospective payment systems in fiscal year 2023, currently estimated at 2.5% for inpatient and 2.0% for outpatient.
In other action, MedPAC recommended that:

• Congress reduce 2023 payment rates for skilled nursing facilities, home health agencies and inpatient rehabilitation facilities by 5%;

• Congress update 2023 payment rates for long-term care hospitals by the amount specified in current law;

• Congress update 2023 Medicare payment rates for physician and other health professional services by the amount specified in current law, and the Department of Health and Human Services require clinicians to use a claims modifier to identify audio-only telehealth services;

• Congress eliminate the 2023 update to the Medicare conversion factor for ambulatory surgical centers, and the Department of Health and Human Services require ASCs to report cost data; and

• Congress eliminate the 2023 update to Medicare base payment rates for hospice providers, and the Department of Health and Human Services require hospices to report telehealth services on Medicare claims.”

U.S. Attorney Announces The Arrest Of 13 Individuals For $100 Million Healthcare Fraud, Money Laundering, And Bribery Scheme: “U.S. Attorney Damian Williams said: “The thirteen defendants charged in today’s indictments are alleged to have collectively perpetrated one of the largest no-fault insurance frauds in history. In carrying out their massive scheme, among other methods, they allegedly bribed 911 operators, hospital employees, and others for confidential motor vehicle accident victim information. With this information, they then endangered victims by subjecting them to unnecessary and often painful medical procedures, in order to fraudulently overbill insurance companies. Schemes exploiting no-fault insurance laws – which ironically exist to make insurance more affordable – also result in higher costs, and unfairly burden all consumers in the auto insurance market.”

Boca Lab Owner Admits To $6.9M Medical Testing Scheme: “The owner of a Boca Raton toxicology lab pled guilty in Florida federal court Thursday to billing Medicare for $6. 9 million worth of improperly bundled COVID-19 and genetic testing orders obtained through bribery. Christopher Licata, 45, copped to one count of conspiracy to commit health care fraud and agreed to pay a combined $4. 3 million in forfeiture and restitution. The Delray Beach resident had been scheduled to stand trial next week on the government's April indictment. Licata admitted that between 2018 and 2021, he paid bribes to "patient brokers" Juan Nava Ruiz and Eric Frank, who in turn recruited Medicare beneficiaries. . . “

As omicron surges, HealthCare.gov sign-up deadline arrives: “Health and Human Services Secretary Xavier Becerra said Thursday that about 14.1 million people have enrolled or renewed coverage as of Jan. 8. That’s a gain of roughly 2 million covered through HealthCare.gov and state-run insurance marketplaces. Two GOP-led states — Florida and Texas — are seeing particularly strong sign-ups.”

Justices debate state’s right to take tort recoveries from Medicaid beneficiaries: “Monday’s argument in Gallardo v. Marstiller displayed a bench surprisingly divided over a relatively simple question of statutory interpretation. The topic is what to do when a state Medicaid program pays for injuries that a beneficiary suffers, if the beneficiary later recovers a settlement from a third party that caused the injury. All agree that the state can take the portion of the settlement that addresses past medical expenses. The problem, if the settlement for past medical expenses is not enough to repay the expenses already paid by Medicaid, is whether the state also can take the part of the settlement that reflects future medical expenses.”

HRSA Expands Preventive Care Coverage Under ACA for Women, Children: “The ACA and current HRSA guidelines require certain group health plans to offer coverage for preventive health services with no out-of-pocket costs. The administration has updated these guidelines to include coverage for double electric breast pumps with no co-pay or deductible. The new guidelines also include universal suicide risk screening for adolescents.”

About hospitals and healthcare systems

Factors Associated With Overuse of Health Care Within US Health Systems: “In this cross-sectional analysis, we identified occurrences of 17 low-value services in 3745 hospitals and affiliated outpatient sites. Hospitals were linked to 676 health systems in the US using the Agency for Healthcare Research and Quality (AHRQ) Compendium of Health Systems. The participants were 100% of Medicare beneficiaries with claims from 2016 to 2018.”
”In this cross-sectional study of 676 US health care systems, those that were overusing health care had more beds, had fewer primary care physicians, had more physician practice groups, were more likely to be investor owned, and were less likely to include a major teaching hospital.”

2021 M&A in Review: A New Phase in Healthcare Partnerships: Trends in the data for 2021 include the following:

• The trend throughout 2021 was a smaller number of transactions being offset with a higher percentage of large transactions. Eight of the announced transactions in 2021 were ‘mega mergers’ (transactions in which the seller or smaller partner by revenue had more than $1 billion in annual revenue). This year had the largest percentage of announced ‘mega merger’ transactions in the last six years at 16.3%, almost double the percentage (8.9%) in 2020.

• Organizations with high credit quality were the smaller partner in a significant percentage of 2021 announced transactions, in line with 2020 levels and historical peaks. In more than one out of every 10 transactions, the smaller partner had a credit rating of A- or higher in 2021.

• As previously mentioned, the number of transactions in 2021 was down; however, the average size of smaller partner by annual revenue increased significantly to $619 million, up from $388 million in 2020. Since 2011, average smaller partner size by annual revenue has increased at a compound annual growth rate (CAGR) of approximately 8.0%.

• Activity by not-for-profit health systems as both acquirer and seller increased as a percentage of total transactions in 2021. Combined, transactions involving a not-for-profit partner represented 87% of announced transactions, compared with 81% in 2020.”

About pharma

Martin Shkreli is ordered to pay $64 million and is banned from the pharma industry for life: ““Pharma bro” Martin Shkreli was ordered to pay $64.6 million in profits and was banned for life from the pharmaceutical industry for an infamous episode several years ago in which his company purchased an old, lifesaving medicine and then boosted the price by 4,000% overnight.”

Association of Hormonal Contraceptive Use With Adverse Health Outcomes: Recent public health proposals to move oral contraceptives to OTC status could benefit from this study:
”In this umbrella review of 58 meta-analyses of randomized clinical trials and cohort studies describing 156 associations between hormonal contraceptive use and adverse health outcomes among women, no associations with adverse outcomes, including cardiovascular and cancer risk, were supported by high-quality evidence. However, the association between the use of a levonorgestrel-releasing intrauterine system and reductions in endometrial polyps associated with tamoxifen use was graded as having high-quality evidence.”

FDA Warning: Buprenorphine to Treat Opioid Use Disorder Can Cause Dental Problems: The problems include tooth decay; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.

About the public’s health

Eliminating the FDA’s blood donation ban on men who have sex with men would help ease the U.S. shortage: A good discussion of the headline’s proposal in the face of the Red Cross’ statement of sever blood shortage. “Studies report no risk to the blood supply in other countries that do not ban donations from this group of men….
UCLA researchers say lifting the ban would mean as many as 350,000 new donors and could treat more than a million people.”

About healthcare IT

Talkspace faces securities fraud class-action suit as consumer revenue declines: “The digital health company, which connects patients with licensed therapists or psychiatrists for video or text conversations, has been accused of misleading investors before it went public last year by misrepresenting its financials and growth.
Namely, the class-action suit filed Jan. 7 alleges Talkspace failed to disclose critical growth headwinds, including increased advertising and customer acquisition costs and worsening growth and gross margin trends, and overvalued its accounts receivable from certain health plan clients.”

About healthcare personnel

Military Brass, Judges Among Professions at New Image Lows: “For the 20th straight year, nurses lead Gallup's annual ranking of professions for having high honesty and ethics, eclipsing medical doctors in second place by 14 points -- 81% vs. 67%. Grade-school teachers (64%), pharmacists (63%) and military officers (61%) round out the top five most revered professions in this year's list, with more than six in 10 Americans viewing each as highly ethical.”

About health technology

A good summary of this week’s virtual JPM Conference from FirstWord Pharma:

Spotlight On: The JP Morgan Healthcare Conference – Our key takeaways Part I

Spotlight On: The JP Morgan Healthcare Conference – Our key takeaways Part II

Today's News and Commentary

Consumer Price Index Summary: At 2.5%, medical care had the lowest growth among CPI items for 2021 (unadjusted).

About Covid-19

Supreme Court blocks Biden's Covid requirements for businesses, upholds health care workers mandate: As predicted:
”The Supreme Court on Thursday blocked the Biden administration's rule requiring larger businesses to ensure that workers receive the Covid vaccine or wear masks and get tested on a weekly basis. [Justices Stephen Breyer, Sonia Sotomayor and Elena Kagan dissented].But the court said a separate mandate requiring vaccinations for an estimated 20 million health care workers can be enforced [Justices Clarence Thomas, Samuel Alito, Neil Gorsuch and Amy Coney Barrett dissented].”
See this link for a FAQ from MGMA on the health facility final rule requirements.

BioNTech and AI start-up develop tool to predict high-risk coronavirus variants: “The artificial intelligence-based program, developed by BioNTech, the German biotech group behind the leading Covid-19 vaccine, and north African AI start-up InstaDeep, identified more than 90 per cent of variants of concern, including the highly transmissible Omicron strain, on average two months before their designation by the World Health Organization. The results from the study show that the program can evaluate the risks of new variants from their spike proteins within minutes, and monitor them as they evolve ‘nearly in real time’, according to the two companies. Ugur Sahin, chief executive of BioNTech, said the tool would be made freely available.”
The potential of this tool for preemptive development of vaccines cannot be overstated.

U.S. COVID deaths rising but likely due to Delta, not Omicron, says CDC chief: “COVID-19 hospitalizations in the United States have increased by about 33% and deaths are up by about 40% from a week earlier, the head of the U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday…
The recent increase in COVID deaths is likely a lagging effect of the Delta variant, which was surging before Omicron took hold in the United States in December, Walensky said.”

Kids’ low COVID-19 vaccination rates called a ‘gut punch’: ”Distrust, misinformation and delays because of the holidays and bad weather have combined to produce what authorities say are alarmingly low COVID-19 vaccination rates in U.S. children ages 5 to 11.
As of Tuesday, just over 17% were fully vaccinated, more than two months after shots became available to the age group. While Vermont is at 48%, California is just shy of 19% and Mississippi is at only 5%.
Vaccinations among the elementary school set surged after the shots were introduced in the fall, but the numbers have crept up slowly since then, and omicron’s explosive spread appears to have had little effect.”

Qiagen Gains CE Mark for COVID-19 Test That Measures T-Cell Response: “The assay detects CD4+ and CD8+ T-cell responses, which allows a more comprehensive assessment of immunity generated by COVID-19 vaccines, especially in vulnerable individuals.
T-cell response to the virus declines more slowly than antibody responses and may indicate how severe the course of COVID-19 will be in infected patients.”

Quebec plans to impose a ‘health contribution’ tax on the unvaccinated: “Premier François Legault announced the new ‘contribution’ for the unvaccinated on Tuesday, as the province reported 62 new deaths, bringing the total number of people killed by Covid-19 in the province to 12,028 – the most in Canada.
‘A health contribution will be charged to all adults that don’t want to get vaccinated. We are there now,’ he said. ‘Those who refuse to get the shot bring a financial burden to hospital staff and Quebecers. The 10% of the population can’t burden the 90%.’”

About health insurance

Morgan Health, Kaiser Permanente partner on health equity: “Beginning this month, JPMorgan Chase's some 8,000 California employees will be able to access care through Kaiser Permanente, and the partnership will put a focus on health disparities.
The two plan to jointly collect and report health equity metrics for those patients, Morgan Health executives said at the annual J.P. Morgan Healthcare Conference this week. JPMorgan and Kaiser Permanente plan to roll out performance guarantees tied to health equity on certain quality measures for JPMorgan employees beginning in 2023.”
One needs to ask how Morgan Health is different from a self-insured employer contracting with an existing provider network/ third party administrator.

Clover Health's MA enrollment spikes 25% from 2021: “Clover Health saw its Medicare Advantage enrollment increase 25% in 2022 over the previous year, the insurer said this week.
The startup insurer said that it began January 2022 ahead of its full-year guidance of 82,000 members. The overall industry growth in MA averages 10% year-over-year, according to data from the Kaiser Family Foundation.
Clover offers plans in 209 counties across nine states.”

About pharma

Judge Won't Lift Ch. 11 Injunction For J&J Talc Claims: “A New Jersey bankruptcy judge denied on Tuesday a request to allow a talc claim against Johnson & Johnson to go to trial, saying it would unavoidably disrupt the Chapter 11 case of the company's bankrupt talc spinoff.”

Pfizer to Announce a Record $80 Billion in Revenue Amid Layoffs in Sales Force: “Pfizer is expected to announce record revenue of more than $80 billion for 2021 on robust sales of the COVID-19 vaccine it developed with BioNTech and its oral COVID-19 treatment, Paxlovid, both of which are being sold directly to governments.
This is almost double Pfizer’s total revenue in 2020 of $41.9 billion.”

Drugs to Watch 2022: “This year’s Drugs to WatchTM report identifies seven late-stage experimental treatments that Clarivate analysts forecast to reach blockbuster status within five years, i.e., if approved,
are expected to earn $1 billion in annual revenue. These treatments span a remarkably diverse set of therapeutic areas, from conditions like Alzheimer’s disease (AD) and type 2 diabetes mellitus (T2DM), which afflict tens of millions of patients worldwide, to very rare diseases, such as transthyretin amyloidosis (ATTR), which afflict thousands.”

About the public’s health

Progress on Lung Cancer Drives Overall Decline in U.S. Cancer Deaths: Sharp drops in lung cancer deaths fueled greater declines in overall U.S. cancer deaths from decreases of about 1% a year in the late 1990s to 1.5% a year during the 2000s and 2% a year from 2015 through 2019…”

Secondhand nicotine vaping at home and respiratory symptoms in young adults: “Secondhand nicotine vape exposure was associated with increased risk of bronchitic symptoms and shortness of breath among young adults.”

The real cost of smoking by state: Smoking costs the US more than $300B annually. This list divides the costs by state. At the top is DC, with a total lifetime cost (with the highest contribution from lost income) of >$3.3 million.

About healthcare IT

Headspace Health grabs startup Sayana to build out AI-based mental health tools: “Six months after the $3 billion merger with Ginger, Headspace Health acquired Sayana, an AI-driven mental health and wellness company.
Sayana will expand Headspace Health’s ability to provide personalized self-care content to its 100 million users, executives said.
Headspace Health did not disclose the financial terms of the deal.”

Guidelines and quality criteria for artificial intelligence-based prediction models in healthcare: a scoping review: “This scoping review aimed to identify actionable guidance for those closely involved in AI-based prediction model (AIPM) development, evaluation and implementation including software engineers, data scientists, and healthcare professionals and to identify potential gaps in this guidance…
Topics were extracted from the identified literature and summarized across the six phases at the core of this review: (1) data preparation, (2) AIPM development, (3) AIPM validation, (4) software development, (5) AIPM impact assessment, and (6) AIPM implementation into daily healthcare practice.”

Healthcare finance

HCA, Eli Lilly, Atrium Health back $55M venture fund to invest in Black-founded and -led health startups: “Some heavy hitters in the healthcare and pharma industries—HCA Healthcare, Eli Lilly and the American Hospital Association (AHA)—are backing a new venture fund to invest exclusively in Black-founded and -led healthcare startups.
Nashville, Tennessee-based Jumpstart Health Investors (JHI) raised $55 million for its new Jumpstart Nova venture fund, oversubscribing the initial $30 million goal. The fund will invest exclusively in Black founder-led healthcare companies across health IT, digital health, tech-enabled services, diagnostic devices, biotech, medical device manufacturing and consumer health and wellness, according to a press release.”

Today's News and Commentary

About Covid-19

Estimating COVID-19 Infections, Hospitalizations, and Deaths Following the US Vaccination Campaigns During the Pandemic: “Compared with the no vaccination scenario, the actual vaccination campaign saved an estimated 240 797… lives and prevented an estimated 1 133 617…hospitalizations from December 12, 2020, to June 30, 2021. The number of cases averted during the same period was projected to exceed 14 million.”

U.S. secures 600,000 more doses of GSK-Vir's COVID-19 therapy: Highlights:
—”U.S. deal builds on $1 bln order from November
—About 1.7 mln doses of sotrovimab secured globally
—GSK-Vir bolstering supply, 2 mln doses expected globally in H1”

Assessment of Functional Mobility After COVID-19 in Adults Aged 50 Years or Older in the Canadian Longitudinal Study on Aging: Some good news: “These findings suggest that individuals with mild and moderate COVID-19 who were predominantly not hospitalized experienced deficits in functional mobility compared with those without COVID-19.”

WHO says omicron may infect half of Europe within two months, if current coronavirus trends hold: The headline is the story.

About the public’s health

Red Cross Declares First-ever Blood Crisis amid Omicron Surge: “The American Red Cross is facing a national blood crisis – its worst blood shortage in over a decade, posing a concerning risk to patient care. Amid this crisis, doctors have been forced to make difficult decisions about who receives blood transfusions and who will need to wait until more products become available. Blood and platelet donations are critically needed to help prevent further delays in vital medical treatments.”

Consumption of Olive Oil and Risk of Total and Cause-Specific Mortality Among U.S. Adults: “In substitution analyses, replacing 10 g/d of margarine, butter, mayonnaise, and dairy fat with the equivalent amount of olive oil was associated with 8%-34% lower risk of total and cause-specific mortality. No significant associations were observed when olive oil was compared with other vegetable oils combined.”

About health insurance

State Trends in Employer Premiums and Deductibles, 2010–2020: Highlights from from The Commonwealth Fund study:

• “Premium contributions and deductibles in employer health plans accounted for 11.6 percent of median household income in 2020, up from 9.1 percent a decade earlier.[Emphasis added]

• In 37 states, premium contributions and deductibles amounted to 10 percent or more of median income in 2020, up from 10 states in 2010.

• Middle-income workers in Mississippi and New Mexico faced the highest potential costs relative to income, 19 percent and 18 percent, respectively.

• The total cost of premiums plus potential spending on deductibles ranged from a low of $6,528 in Hawaii to a high of more than $9,000 in Florida, Kansas, Missouri, South Dakota, and Texas.”

CVS Health boosts 2021 guidance on back of stronger than expected retail performance in Q4: “CVS Health boosted its 2021 guidance Tuesday ahead of its fourth-quarter earnings in early February, with executives citing better-than-expected performance in its retail segment.
In a filing with the Securities and Exchange Commission, the healthcare giant raised its full-year earnings projections to between $8.33 and $8.38 per share from a previous estimate of $8. The company also affirmed its 2022 guidance range of between $8.10 and $8.30 per share.”

Labor Department demands insurers stop flouting ACA's birth control rules: “The Biden administration is reminding insurers they must fully cover contraceptive coverage after complaints of some payers denying claims for certain products.
The Department of Labor released an updated frequently asked questions document on Monday that outlined requirements for insurers to cover at-home COVID-19 tests. Tucked into the document is a stern reminder of insurers’ requirements under the Affordable Care Act.”

UnitedHealthcare settles class-action underpayment suit for $10M: “The U.S. District Court for the Eastern District of New York approved a $10 million final settlement for a class-action lawsuit targeting UnitedHealthcare and its tiered reimbursement policy.
The lawsuit, filed in 2017, claims that UnitedHealthcare's policy reduced payments for out-of-network mental healthcare providers — including psychologists, counselors and social workers — by between 25 percent and 35 percent…”

6 payers recognized for stakeholder commitment, 3 rank in top 100: “Six payers were recognized by nonprofit JUST Capital for their commitment to stakeholder responsibility, with three ranking among the top 100 U.S. companies.
In tandem with CNBC, the nonprofit released its "2022 Rankings of America’s Most JUST Companies" on Jan. 10, which orders companies based on their success across five stakeholder metrics — investing in its employees, supporting communities, prioritizing good governance, customer service, and environmental impact.”
Anthem is highest among payers at #16 among all companies.

About pharma

Pfizer locks in 2 partners to solidify status as mRNA powerhouse: “In the first deal… Pfizer has secured access to Acuitas Therapeutics’ lipid nanoparticle delivery system for use in mRNA vaccines and therapeutics. The nonexclusive development and option agreement covers up to 10 targets that could someday become vaccines or therapeutic programs. Financial terms of the agreement were not disclosed.
Lipid nanoparticles are critical to protecting mRNA—which provides a set of instructions for cells to, for example, fight a virus—until it arrives at the target in the body. This technology was used in both authorized mRNA COVID-19 vaccines, with Acuitas’ proprietary delivery system specifically tapped for the Pfizer-BioNTech shot.
In the second deal, Pfizer will offer milestone payments “in excess” of $100 million to Codex DNA for access to the biotech’s novel enzymatic DNA synthesis technology. This will similarly be used to develop new mRNA vaccines and therapeutics. The financial terms, which were not spelled out, include an upfront payment and the milestones, which Codex said “could be earned in the near term.”
Codex has developed a system called short oligo ligation assembly (SOLA) EDS technology, which provides a scalable, efficient and cost-effective approach to research. SOLA EDS can construct synthetic DNA, RNA and proteins, which can be used to develop new mRNA-based medicines and vaccines.”

Sanofi makes $75M preclinical bet to join Roche, Novartis and more in congested Parkinson's field: “Add Sanofi to the list of companies aiming to treat Parkinson’s disease by targeting alpha-synuclein. The Big Pharma has claimed a spot toward the back of the pack by paying $75 million upfront for the global rights to a preclinical bispecific that targets the protein.
Sanofi is picking up the rights to the drug, which is currently called ABL301, from South Korea’s ABL Bio in return for the upfront fee and the promise of up to $985 million in milestones. ABL landed the deal after generating preclinical evidence that ABL301 crosses the blood-brain barrier (BBB) more efficiently than a monoclonal antibody and reduces brain aggregated alpha-synuclein.”

PIPELINE INSIGHTS REPORT DRUGS TO WATCH: This Optum report looks at three upcoming drugs to watch in 2022.

About healthcare IT

ONC adds guidelines for e-prescribing, public health reporting: “The Office of the National Coordinator for Health Information Technology updated its Interoperability Standards Advisory to include specifications for e-prescribing and public health reporting.
In a Jan. 11 blog post, the ONC said it has added the National Council for Prescription Drug Programs' Real-Time Prescriptions Benefit Standard Version 12. This addition will help communication efforts between pharmacy benefit payers and prescriber systems.”

Digital Health Startup Transcarent Just Raised $200 Million To Grow Its Concierge Medical Business: “Its customers, which are large-scale employers that self-insure for health coverage, are provided with a concierge medicine-like experience through its digital app, which enables users to connect with a doctor either through text or video call 24 hours a day. For more serious issues, the company will arrange a second opinion and then determine the best doctor and/or hospital to treat the patient. What’s more, those employees who use the service never have to pay premiums, co-pays or other bills.”

About healthcare personnel

Glassdoor: Best places to work in healthcare for 2022: “Glassdoor released its list of "Best Places to Work" in 2022, and four hospitals and health systems made the list. 
Several healthcare, pharmaceutical and medical device companies also were named to the list of 100 companies.”

About healthcare systems

DaVita, Fresenius Accused of Putting Minority Patients at Risk: “Kidney dialysis centers in California are being accused of discriminating against Latino and Asian American patients by subjecting them to unsafe and potentially lethal treatments at disproportionately higher rates in a complaint filed Tuesday with the U.S. Department of Health and Human Services’ Office for Civil Rights.
The Service Employees International Union-United Healthcare Workers West, the National Health Law Program and five dialysis patients say Latino and Asian American patients at centers run by DaVita Inc. and Fresenius Medical Care North America Inc. are being disproportionately exposed to hemodialysis treatments at dangerously higher speeds than white patients….
Latino and Asian American patients are being exposed to these treatments at high speeds at a rate approximately 50% greater than white patients, the complaint alleges.”

Today's News and Commentary

About Covid-19

Insurers must cover at-home COVID-19 tests starting Jan. 15 under new CMS directive: “Insurers must cover at least eight at-home COVID-19 tests per covered individual starting on Saturday, per a new directive from the Biden Administration.
The frequently-asked questions document released by the Centers for Medicare & Medicaid Services (CMS) is an effort to improve access to at-home tests, which have been in short supply in recent weeks amid a surge of the virus fueled by the omicron variant.”

Assessing changes to N95 respirator filtration efficiency, qualitative and quantitative fit, and seal check with repeated vaporized hydrogen peroxide (VHP) decontamination: “Highlights:

•N95 respirators were decontaminated with vaporous hydrogen peroxide 25 times.

•No alterations to respiratory integrity or filtration efficiency seen by 25 cycles.

•Vaporous hydrogen peroxide does not appear to impact fit or filtration efficiency using this defined process.

Merck Delivered 900,000 Antiviral Courses to U.S. Last Month: “Merck & Co. delivered 900,000 courses of its Covid-19 antiviral pill to the U.S. in December and is set to provide 3 million courses ordered by the government by the end of January, Chief Executive Officer Rob Davis said.
Despite the supply-chain issues that have plagued companies around the world, Davis said Merck was able to make 10 million courses of the drug, molnupiravir, as expected last year. They just need to be labeled and shipped, he said.”

Biden coronavirus vaccine-or-test mandate goes into effect: “Key components of the Biden administration’s COVID-19 vaccine or test mandate for more than 80 million workers went into effect Monday amid an ongoing Supreme Court battle that could ultimately doom the rule.   
The months-long legal battle over the requirement, which was previously blocked by a federal court before being reinstated, has created confusion among employers about how to move forward. While Supreme Court justices expressed skepticism about the rule on Friday, they did not block its implementation by Monday’s deadline.  
As of Monday, businesses with 100 or more employees were required to have a database of their workers’ vaccination status, post their company vaccine policy, provide paid leave to workers getting the vaccine and require unvaccinated employees to wear a mask at work.  
The Occupational Safety and Health Administration (OSHA), the agency tasked with enforcing the rule, has said it won’t issue penalties for noncompliance until Feb. 9.”

Usability of COVID-19 Antigen Home Test Kits: “Because of the urgency in providing useful information to consumers as quickly as possible, ECRI selected the seven test kits based on retail availability.” 
Good review.

HHS head defends CDC director: 'She doesn't have a degree in marketing': “[HHS Secretary] Becerra defended the leader, saying, ‘Dr. Rochelle Walensky is an infectious disease expert. She has a medical license and she also has a degree in public health. She doesn't have a degree in marketing.’ He then said, ‘Who do I want running CDC? Someone who knows infectious diseases, someone who understands this stuff. And so, while we may have issues with some of the marketing that's been done, I guarantee you, Dr. Walensky is someone we need at CDC.’”
Where is the communications director???

Novartis and Molecular Partners report positive topline data from Phase 2 study for ensovibep (MP0420), a DARPin antiviral therapeutic for COVID-19: Highlights from this first-in-class product:
—”Topline results from the randomized EMPATHY Part A study in acute COVID-19 ambulatory patients comparing single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo, met the primary endpoint of viral load reduction over eight days

—The secondary endpoint of hospitalization and/or ER visits related to COVID-19, or death showed an overall 78% reduction in risk of events across ensovibep arms compared to placebo

—A total of 407 patients were recruited in the Phase 2 study and ensovibep was safe and well-tolerated at all doses (75mg, 225mg and 600mg) – with 75mg the planned dose for further development

—Ensovibep continues to maintain potent in vitro pan-variant activity against all variants of concern identified so far, including Omicron

—Ensovibep is a multi-specific DARPin (Designed Ankyrin Repeat Protein), specifically designed to block the receptor binding domains of SARS-CoV-2 spike protein through highly potent and cooperative binding, making it challenging for escape mutants”

A market-based solution to the anti-vaxxer problem: From The Financial Times: “As the world grapples with the fast-spreading Omicron variant and its potentially devastating consequences, a major policy dilemma revolves around how governments might nudge the unvaccinated or partially vaccinated to join the ranks of those who are fully protected. Policies proposed range from fines (in Greece), and Covid passes to access public venues (in France and Switzerland), to nationwide mandatory vaccination (in Austria). Vaccination mandates in particular rankle liberals and libertarians alike and raise challenging ethical questions, while arguably entrenching the position of the unvaccinated…
One way to nudge the unvaccinated to get a jab is to require that those who remain unvaccinated by choice pay for the cost of their own medical care, in case of Covid-induced hospitalisation — a policy that Singapore introduced last year. Some will argue that such a requirement would hit the less well-off or ethnic minorities, who are disproportionally unvaccinated, while giving a free pass to wealthier individuals. To counter that, I would propose a charge philosophically similar to that applied to speeding fines: as a percentage of (in this case annual) income.”

About pharma

Medicare proposes covering expensive drug for early-stage Alzheimer’s, but with restrictions that will sharply limit use: “Medicare officials announced Tuesday they would cover a controversial Alzheimer’s drug — but only with restrictions that will sharply limit who receives the drug.
The Centers for Medicare and Medicaid Services proposed a national policy that would cover Aduhelm and similar drugs in development only for people enrolled in qualifying clinical trials.
The proposal is open to public comment for 30 days. The agency has said it plans to issue a final decision in April.”

114 drugs currently in shortage, per FDA: “Nationwide, more than 100 drugs are in short supply, including antibiotics, diuretics, opioids and heart failure medications, FDA data shows.
As of Jan. 11, 114 drugs were in shortage, according to the FDA's database of current and resolved drug shortages, which is updated daily. The current tally is a continuation of shortage levels seen last year. In November 2021, the FDA reported 112 drug shortages.”

Judge Allows Sacklers to Appeal Ruling on $4.5 Billion Opioid Settlement: “A federal judge is allowing the Sackler family and their company Purdue Pharma to appeal a ruling that overturned a $4.5 billion settlement resolving thousands of complaints alleging they helped fuel the opioid epidemic.”

Researchers find hormone in fat tissue that could help insulin-resistant patients with diabetes: “Insulin has been the primary way of treating diabetes and other high blood sugar conditions for nearly a century. Now, researchers say a molecule made in fat tissue could pave the way for new diabetes therapies and spark new metabolism research. 
The discovery is FGF1, a hormone that regulates blood glucose by inhibiting the breakdown of fat, a metabolic process known as lipolysis. Insulin and FGF1 both inhibit lipolysis, but the hormones operate differently, which could lead to safe and successful lowering of blood glucose in people who are resistant to insulin, researchers at Salk Institute reported in Cell Metabolism this month.
The researchers found that the two diverge in similarity when it comes to signaling pathways. Insulin tamps down on fat breakdown through PDE3B, whereas FGF1 uses the pathway known as PDE4…
The PDE4 pathway can lead to new drug discovery and basic research focused around high blood glucose and resistance to insulin…”

About health insurance

Humana execs try to soothe skittish investors as new MA enrollment projections disappoint: “The insurer issued a filing with the Securities and Exchange Commission on Thursday that decreased its outlook for MA enrollment from between 325,000 and 375,000 new members to between 150,000 and 200,000 new members. 
Humana added 130,000 members during the annual enrollment period for MA last fall. It said in the filing that it saw higher than expected terminations during the enrollment window and expects an elevated number of terminations through 2022.”

Centene execs tout strong MA enrollment period—though work remains on star scores: “The merger between Centene and WellCare Health Plans created the country's largest sponsor of government insurance, with a massive reach in the Affordable Care Act's exchanges, Medicare and Medicaid.
The company has also invested heavily in rebranding its disparate MA plans to align them across the portfolio and has brought on new ambassadors for outreach to seniors. Even prior to the merger, Centene was working on its digital distribution channels to improve the experience…
[T]he company is working on improving its star ratings. More than half of its members selected a four-star or higher plan for 2022.”

HHS: Nearly 14M people enroll on ACA's exchanges ahead of Jan. 15 deadline: “More than 13.8 million consumers have signed up for 2022 healthcare coverage on HealthCare.gov and state-run marketplaces, according to the latest federal figures.
The Department of Health and Human Services (HHS) delivered the latest sign-up numbers ahead of the Jan. 15 open enrollment deadline. The agency touted enhanced subsidies that are set to expire after this year as a key driver of the growth.”

In an unprecedented move, HHS asks officials to consider lowering this year’s Medicare premiums: “The nation’s top health official Monday directed Medicare to consider lowering the premium for the part of the program that covers visits to the doctor and other care outside hospitals. It marked the first time the vast federal health insurance system for older Americans and those with disabilities has rethought the monthly amount patients pay after a change has gone into effect.
Health and Human Services Secretary Xavier Becerra gave the instructions to the Centers for Medicare and Medicare Services (CMS), the agency that oversees the program, saying a review of the Part B premium is needed because of a price drop in a controversial Alzheimer’s drug that Medicare does not yet pay for but might begin covering soon.”

Gavin Newsom proposes health care access for all in plan to cover undocumented Californians: “Gov. Gavin Newsom is proposing to extend Medi-Cal coverage to all low-income, undocumented adults, a historic expansion that would make California the first state in the nation to provide universal health care access for all residents regardless of legal status. The plan is included in Newsom’s $286 billion state budget proposal, which is flush with a projected $45.7 billion surplus. Coverage would begin on Jan. 1, 2024 and would cost the state an ongoing $2.7 billion annually. The program’s launch in the 2023-24 fiscal year is expected to cost $819.3 million.”
In a related article: Single-Payer Healthcare Makes a California Comeback: This article is an editorial opinion by The Wall Street Journal. Well worth getting access to read, as it breaks down the costs of the proposal. With many high tech companies leaving the state, this measure may accelerate business flight.

About healthcare IT

HHS issues warning for healthcare ransomware threats: “The Department of Health and Human Services' Health Sector Cybersecurity Coordinator Center warned the healthcare sector about a cybercrime group targeting the industry.
In a Jan. 6 alert, the department detailed that financially-motivated cybercrime group Mespinoza is increasing its capabilities to target more frequently.
The group has developed its own ransomware variant, known as PYSA, that can encrypt victims' files.”

Loyola email breach exposes nearly 17,000 patients' info: Loyola University Medical Center in Chicago, a part of Trinity Health, recently notified patients of an October data breach that exposed patients' protected health information…
The exposed information included patients' full names, addresses, phone numbers, dates of birth, email addresses, medical record numbers, conditions, medications, test results, medical facilities, types of service and some health plan information.”

About hospitals and health systems

Staffing expenses led to an extra $440M in operating costs in 2021 for AdventHealth: “Major disruptions in the healthcare labor market cost hospital system AdventHealth an additional $440 million in operating costs last year.”

About healthcare personnel

Best Health Care Jobs: From US News. #1 is nurse practitioner.

About the public’s health

Prevalence and Predictors of Young-Onset Colorectal Neoplasia [CRC]: Insights from a Nationally Representative Colonoscopy Registry: “Increasing age, male sex, white race, family history of CRC, and examinations for bleeding or screening were all associated with higher odds of advanced premalignant lesions (APLs) and CRC. Among patients aged 45-49, 32% had any neoplasia, 7.5% had APLs, and 0.58% had CRC. Rates were almost as high in those aged 40-44. Family history of CRC portended neoplasia rates 5 years earlier. Rates of APLs were higher in Asians and American Indian/Alaskan Natives, but lower among Blacks and Hispanics, compared to white counterparts. The prevalence of any neoplasia and APL gradually increased between 2014-2020, in all age groups.
These data provide support for lowering the screening age to 45 for all average risk individuals.[Emphasis added] Early messaging to patients and providers in the years leading up to age 45 is warranted, especially in those with a family history of CRC.”

About healthcare technology

Medtronic to Acquire Affera: “Medtronic… announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held medical technology company. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for the treatment of patients with cardiac arrhythmias (irregular heartbeats) such as atrial fibrillation (AF). Medtronic, through its minority investment portfolio, has been a strategic investor in Affera and currently holds a 3% ownership stake in the company…”
The price of the acquisition, expected to close in 2023, is $925 million.

Today's News and Commentary

About Covid-19

Coronavirus in the U.S.: Latest Map and Case Count: Latest data from The NY Times. Among the findings:
”With the Omicron variant spreading rapidly, the country is averaging more than 500,000 new cases a day, far more than at any previous point in the pandemic. Omicron appears to cause less severe illness than prior forms of the virus, but has contributed to upticks in hospitalizations…
Hospitalizations have increased more than 50 percent over the last two weeks, a steep incline but so far a much lower rate of increase than cases. More than 100,000 coronavirus patients are hospitalized nationwide. Deaths, which are a lagging indicator of virus activity, have not yet increased.”

FDA shortens timing of Moderna booster to 5 months: “U.S. regulators on Friday shortened the time that people who received Moderna’s COVID-19 vaccine have to wait for a booster — to five months rather than six.
The two-dose Moderna vaccine is open to Americans 18 and older. The Food and Drug Administration’s decision Friday means Moderna recipients are eligible for a booster after at least five months have passed since their last shot. The Centers for Disease Control and Prevention agreed.
That’s in line with new recommendations for recipients of the Pfizer vaccine. Initial Pfizer vaccinations are open to anyone 5 or older. But only Pfizer recipients 12 and older are eligible for boosters, and earlier this week U.S. health authorities said they can get one five months after their last shot.”

U.S. sends states monoclonal antibodies that may not work against omicron: “David Kessler, the chief scientific officer for the administration’s covid response, said the government has been responding to requests from state and local health officials in making all three monoclonal antibodies available. But the administration has made clear that the two that don’t work against the omicron variant should be used ‘only if the delta variant represents a significant proportion of infections in the region and then only with the explicit understanding that these treatments would be ineffective if the patients are infected with the omicron variant.’”

Vaccinated Women Pass COVID-19 Antibodies to Breastfeeding Babies: “Women vaccinated against COVID-19 transfer SARS-CoV-2 antibodies to their breastfed infants, potentially giving their babies passive immunity against the coronavirus, according to University of Massachusetts Amherst research.
The study, published in the journal Obstetrics & Gynecology, measured the immune response to the COVID-19 mRNA vaccine in both breast milk and the stools of breastfed infants.”

A guide to COVID tests: When to test, what kind to use and what your results mean: A good review from NPR.

Association of a Third Dose of BNT162b2 Vaccine With Incidence of SARS-CoV-2 Infection Among Health Care Workers in Israel: “In this cohort study of 1928 health care workers in Israel who were previously vaccinated with a 2-dose series of BNT162b2 [Pfizer/BioN Tech], administration of a booster dose compared with not receiving one was significantly associated with lower risk of SARS-CoV-2 infection during a median of 39 days of follow-up (adjusted hazard ratio, 0.07).”

Pfizer CEO says omicron vaccine will be ready in March: “Pfizer CEO Albert Bourla said an omicron vaccine will be ready in March, and the company is already manufacturing doses.
Bourla said the goal is to produce a vaccine that is much better at preventing infection from omicron.”

About healthcare IT

Teladoc projects $2.03B in 2021 revenue, up from previous guidance, after stock plummeted last year: “Teladoc expects its full-year 2021 revenue to hit $2.03 billion, up from previous guidance of $2.015 billion to $2.025 billion, nearly doubling its 2020 revenue.
The telehealth provider estimates it delivered more than 14.7 million virtual visits in 2021, up from 10.6 million visits in 2020. The company also anticipates between $260 million and $265 million in full-year adjusted EBITDA.
For 2022, Teladoc is projecting full-year revenue of around $2.6 billion.
Despite the company’s strong financial performance, Teladoc’s shares plummeted 54% in 2021, compared to the S&P 500’s strong gain of approximately 27%. The telehealth giant isn’t yet profitable…”

R1 RCM to Acquire Cloudmed, Creating the Strategic Revenue Partner for Healthcare Providers: “R1 RCM Inc. (“R1”), a leading provider of technology-driven solutions that transform the patient experience and financial performance of healthcare providers, today announced that it has entered into a definitive agreement to acquire Cloudmed, a leader in Revenue Intelligence™ solutions for healthcare providers, in an all-stock transaction. The transaction values Cloudmed at approximately $4.1 billion, including $857 million of net debt, based on R1’s closing stock price on January 7, 2022.”

ONC releases data standard for patient addresses: 4 things to know: “The Office of the National Coordinator for Health Information Technology on Jan. 7 issued Version 1.0 of Project US@, its healthcare specification for representing patient addresses to improve patient matching.”

Microsoft warns of continued Log4j exploitation attempts: “Microsoft urges companies to remain vigilant and use scanning systems to detect unusual activity as Log4j's continued exploitation attempts occur.
Microsoft warned organizations in a Jan. 3 blog post that the attempts against Log4j, a highly-utilized open-source code, are extremely threatening and could pose security risks to the healthcare sector.“

About hospitals and health systems

19% of US hospitals critically understaffed, 21% anticipate shortages: An update of a previous post: “Just over 19 percent — or 1,168 of 6,089 — of all hospitals in the U.S. are experiencing critical staffing shortages, according to HHS data posted Jan. 9.
A critical staffing shortage is based on a facility's needs and internal policies for staffing ratios, according to HHS. Hospitals using temporary staff to meet staffing ratios are not counted among those experiencing a shortage.
Meanwhile, more than 21 percent — or 1,287 of 6,089 — of all hospitals in the U.S. are anticipating shortages in the next week.”

About health insurance

New Hampshire reaches $21.1 million settlement with Centene: “New Hampshire has reached a $21.1 million settlement with a Missouri company over the inaccurate reporting of pharmacy benefit services cost, the attorney general's office said Friday…
In recent months, the company has settled with several other states following a two-year investigation into whether the firm had overcharged Medicaid for prescriptions. Kansas in December reached a $27.6 million settlement and Mississippi and Ohio in June settled lawsuits against Centene for a total of nearly $144 million.”

About the public’s health

Association of Cigarette Sales With Comprehensive Menthol Flavor Ban in Massachusetts: “The comprehensive flavor ban in Massachusetts was associated with a statistically significant decrease in state-level menthol and all cigarette sales…
Nonflavored cigarette sales in Massachusetts vs the comparison states increased after the ban, suggesting the potential substitution of nonflavored cigarettes for menthol cigarettes.”

U.S. emissions surged in 2021, putting the nation further off track from its climate targets: “A 17 percent surge in coal-fired electricity helped drive an overall increase of 6.2 percent in greenhouse gas emissions compared with the previous year, according to an analysis published Monday by the Rhodium Group. While emissions remained below pre-pandemic levels, it marked the first annual increase in reliance on the nation’s dirtiest fossil fuel since 2014, the independent research firm said.”

10 Percent of U.S. Adults Meet Vegetable Intake Recommendations: “Only 12.3 and 10.0 percent of U.S. adults met the fruit and vegetable intake recommendations, respectively, in 2019, according to research published in the Jan. 7 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report…
The researchers found that 12.3 and 10.0 percent of adults met fruit and vegetable recommendations, respectively, ranging from 8.4 to 16.1 percent in West Virginia and Connecticut and from 5.6 to 16.0 percent in Kentucky and Vermont, respectively.”

About pharma

Pfizer pays Beam $300 million upfront as part of base editing deal: “Pfizer entered into a four-year research deal with Beam Therapeutics potentially worth over $1.3 billion focused on in vivo base editing programmes for three targets for rare genetic diseases of the liver, muscle and central nervous system, the companies announced Monday…
The three programmes will leverage Beam's in vivo delivery technologies, which use mRNA and lipid nanoparticles (LNP) to deliver base editors to target organs. Under the agreed terms, Beam will conduct all research activities through development candidate selection. Pfizer will then be able to option exclusive, worldwide licenses to each of them, at which point it will take on all development activities.”

23andMe Initiates Phase 1 Clinical Trial for First Wholly-Owned Immuno-oncology Antibody for Patients with Solid Tumors: The headline is the story.
And in a related story: 23andMe snags 3rd FDA nod for cancer risk test, this time for prostate cancer

New York Plans to Install ‘Vending Machines’ With Anti-Overdose Drugs: “New York City health officials have announced a plan to install 10 “public health vending machines” that would dispense sterile syringes, an anti-overdose medication and other “harm reduction” supplies to help neighborhoods that have been hit hard by drug overdoses.”

JPM22, Day 1: The annual JP Morgan Healthcare Conference is being held virtually. “Fierce Pharma will be covering the day's biggest news at it happens. Check back here for updates, and catch Fierce Biotech's coverage here.” Among the announcements: New Johnson & Johnson CEO Duato points out 5 pipeline meds that can generate $5B+: “Among the healthcare giant's pipeline, Duato highlighted five programs that could generate $5 billion or more in peak sales. Those are the Legend Biotech-partnered CAR-T medicine Carvykti, the potential “pipeline in a product” drug nipocalimab, Rybrevant in lung cancer, a potential first-in-class oral Factor XIa inhibitor milvexian and a potential bladder cancer platform called Taris.”

About healthcare technology

In a First, Man Receives a Heart From a Genetically Altered Pig: “A 57-year-old man with life-threatening heart disease has received a heart from a genetically modified pig, a groundbreaking procedure that offers hope to hundreds of thousands of patients with failing organs.
It is the first successful transplant of a pig’s heart into a human being. The eight-hour operation took place in Baltimore on Friday, and the patient, David Bennett Sr. of Maryland, was doing well on Monday, according to surgeons at the University of Maryland Medical Center.”

Fierce Healthcare's Fierce 15 of 2022: “Virtual care, home health and health equity remain key trending topics within healthcare. Our list touches on those in a number of ways, including platforms to address the social determinants of health, ways to treat behavioral health needs digitally, and offer better care in the home.” The article has links to each of the 15 winners.

Today's News and Commentary

About Covid-19

Supreme Court hears challenges to Biden’s vaccine rules for workers: The Court heard two cases today. The first concerned whether OSHA has regulatory authority to impose COVID regulations in the workplace. Given the questioning, it seems likely the Court will reject this authority.
The second case centered on CMS’s ability to require COVID precautions as a condition of participation in federal health programs (Medicare and Medicaid). The argument was that the federal government has the right (and responsibility) to assure safety of beneficiaries for whom it is paying. The justices seems to be inclined to accept CMS’s right to require precautions; however, the basis for such a decision may narrowly focus on the standing of the states that brought the suit (as occurred with the last decision to uphold the ACA).
Throughout the proceedings, the conservative justices raised questions about why COVID was different from past infectious diseases (like the flu) that made the above measures necessary. No one brought up the healthcare state of emergency that the HHS Secretary has renewed during the pandemic.

WHO: Record weekly jump in COVID-19 cases but fewer deaths: “The World Health Organization said Thursday that a record 9.5 million COVID-19 cases were tallied over the last week as the omicron variant of the coronavirus swept the planet, a 71% increase from the previous 7-day period… However, the number of weekly recorded deaths declined.”

False-Positive Results in Rapid Antigen Tests for SARS-CoV-2: “There were 903 408 rapid antigen tests conducted over 537 workplaces, with 1322 positive results (0.15%), of which 1103 had PCR information. Approximately two-thirds of screens were trackable with a lot number. The number of false-positive results was 462 (0.05% of screens and 42% of positive test results with PCR information). Of these, 278 false-positive results (60%) occurred in 2 workplaces 675 km apart run by different companies between September 25 and October 8, 2021. All of the false-positive test results from these 2 workplaces were drawn from a single batch of Abbott’s Panbio COVID-19 Ag Rapid Test Device.”

COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting: A few highlights:
—”Hospitals are responsible for reporting the information to the Federal government. Facilities should report at the individual hospital level, even if hospitals share a Centers for Medicare & Medicaid Services (CMS) Certification Number (CCN).
We recognize that some health care systems choose to report for all facilities in their network from a central corporate location.We also recognize that many states currently collect this information from the hospitals. Therefore, hospitals may be relieved from reporting directly to the Federal government if they receive a written release from the state indicating that the state is certified and will collect the data from the hospitals and take over the hospital’s Federal reporting responsibilities…
—Hospitals, with the exception of psychiatric and rehabilitation hospitals are required to report seven days a week but, where possible and pending further direction from their state or jurisdiction, are encouraged to report weekend data on the following Monday with the data backdated to the appropriate date. Psychiatric hospitals and rehabilitation hospitals report once weekly on Wednesday.”
—The document provides the several accepted methods for reporting the data.

FDA must hit the gas on FOIA request tied to Pfizer's COVID-19 vaccine, judge orders: “Rather than 75 years, it will now take about eight months for the FDA to make public the information it used to license Pfizer and BioNTech’s COVID-19 vaccine—provided the regulator can keep up with the new schedule.
U.S. district judge Mark Pittman on Thursday ordered the FDA to produce all remaining data on the vaccine at a rate of 55,000 pages per month, much faster than the 500-page-per month quota the FDA proposed in November.”

West Virginia seeks permission to offer 4th vaccine dose: “West Virginia is seeking permission from the federal government to offer a fourth COVID-19 vaccine dose to at-risk people, making it the first state to do so. West Virginia Gov. Jim Justice sent a letter to the Biden administration requesting the FDA and CDC authorize the state to offer a second booster to people 50 and older and essential workers at least three months after receiving their first booster, according to Jan. 6 news release.“

Responding to Omicron: Aggressively Increasing Booster Vaccinations Now Could Prevent Many Hospitalizations and Deaths: From the Commonwealth Fund:
”According to the model, at the current pace of booster vaccination, during the next four months COVID-19 will cause an additional 210,000 deaths, nearly 1.7 million hospitalizations, and almost 110 million additional infections. Immediately doubling the December pace of boosters to 1.5 million per day could prevent approximately 41,000 deaths and more than 400,000 hospitalizations by the end of April and avert more than 14 million infections. Tripling the daily rate to 2.3 million per day could prevent more than 63,000 deaths and nearly 600,000 hospitalizations, while preventing more than 21 million infections.”

Insurers, Employers Urge Price Caps on ‘Free’ Home Covid Tests: “Federal health officials are expected to release guidance this month outlining how private health plans must reimburse their beneficiaries for the cost of at-home Covid tests. The policy is key to the administration’s effort to tamp down the spread of the virus, now occurring at historic levels…
The concern for consumer advocates is that some retailers or even diagnostic companies will raise the cost of the tests once they know insurers are footing the bill.
‘If insurers have to reimburse for at-home tests from anywhere at any price, they will be at the mercy of price gouging by unscrupulous sellers,’ Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, said. ‘If insurers are left holding the bag, consumers will be shielded in part from price gouging, but they still face risks.’”

Risk Factors for Severe COVID-19 Outcomes Among Persons Aged ≥18 Years Who Completed a Primary COVID-19 Vaccination Series — 465 Health Care Facilities, United States, December 2020–October 2021:
From the CDC:
”Among 1,228,664 persons who completed primary vaccination during December 2020–October 2021, severe COVID-19–associated outcomes (0.015%) or death (0.0033%) were rare. Risk factors for severe outcomes included age ≥65 years, immunosuppressed, and six other underlying conditions. All persons with severe outcomes had at least one risk factor; 78% of persons who died had at least four.”

About hospitals and health systems

Hospitals lose 5,100 jobs in December: “Hospitals lost jobs in December for the second straight month, according to the latest jobs report from the U.S. Bureau of Labor Statistics.
Hospitals lost 5,100 jobs in December, compared with 3,900 lost in November. Hospitals gained 1,100 jobs in October and lost 8,100 jobs in September.”
And in a related article: More than 19% of US hospitals are critically understaffed: Numbers by state: “Just over 19 percent — or 1,167 of 6,051 — of all hospitals in the U.S. are experiencing critical staffing shortages, according to HHS data posted Jan. 6.
A critical staffing shortage is based on a facility's needs and internal policies for staffing ratios, according to HHS. Hospitals using temporary staff to meet staffing ratios are not counted among those experiencing a shortage.”
Rates range from 53% in Vermont to 0% in DC.

About pharma

States Oppose Purdue's 2nd Circ. Appeal Try In Ch. 11 Case: “Numerous states filed briefs Thursday in New York federal court opposing the request by bankrupt drugmaker Purdue Pharma to appeal the unraveling of its Chapter 11 plan to the Second Circuit, arguing that the appeal would further delay resolution of the case.”

Walgreens Posts Higher Sales and Profit From Covid-19 Demand: “Walgreens Boots Alliance Inc. rode the latest Covid-19 surge to its highest retail sales increase in 20 years, but Americans’ scramble for vaccines and tests has overwhelmed workers and dented growth in prescriptions…
Covid-19-related demand took a toll on other parts of the business, Walgreens said. Prescription sales, not including vaccines, grew 1.8%, as staffing shortages prompted some stores to close early and prevented pharmacists from calling patients to ensure they are keeping up on their medications.”

Merck leans into AI with $610M in biobucks for Absci drug discovery pact: “Merck is taking a deep dive into complex proteins with the help of artificial-intelligence-powered drug discovery company Absci. The two companies have signed a research collaboration for up to three targets in a deal worth up to $610 million in upfront fees and milestone payments. 
Merck will use Absci’s Integrated Drug Creation platform, which uses AI and synthetic biology to find new drug targets and match them up with potential medicines. The company also generates cell lines to manufacture the therapeutic candidates, all in one process.”

Merck KGaA to acquire Exelead for $780 million: “Merck KGaA said Thursday that it is acquiring biopharmaceutical contract development and manufacturing organisation (CDMO) Exelead for about $780 million in cash. The German drugmaker noted that Exelead specialises in complex injectable formulations, including lipid nanoparticle (LNP)-based drug delivery that is a key component in mRNA therapeutics.”
Note: Merck KGaA is a different company from Merck mentioned above.

About health insurance

CY 2023 Medicare Advantage and Part D Proposed Rule (CMS-4192-P): “This proposed rule would revise the MA and Part D regulations related to marketing and communications, the criteria used to review applications for new or expanded MA and Part D plans, quality ratings for MA and Part D plans, provider network adequacy requirements, medical loss ratio reporting, special requirements during disasters or public emergencies, and the use of pharmacy price concessions to reduce beneficiary out of pocket costs for prescription drugs under Part D. This proposed rule would also revise regulations for D-SNPs, and in some cases other special needs plans, related to enrollee advisory committees, health risk assessments, and ways to improve integration of Medicare and Medicaid. Many proposals are based on lessons learned from the Medicare-Medicaid Financial Alignment Initiative.”
A few highlights:
—”CMS is proposing a policy that would require Part D plans to apply all price concessions they receive from network pharmacies to the point of sale, so that the beneficiary can also share in the savings. Specifically, CMS is proposing to redefine the negotiated price as the baseline, or lowest possible, payment to a pharmacy, effective January 1, 2023. This policy would reduce beneficiary out-of-pocket costs and improve price transparency and market competition in the Part D program…
—Current regulations have special requirements for MA plans during disasters or emergencies, including requirements for plans to cover services provided by non-contracted providers and to waive gatekeeper referral requirements. The proposal would require a MA plan to comply with the special requirements when there is a declaration of disaster or emergency (including a public health emergency) and disruption in access to health care…
CMS is proposing to require thatplan applicants demonstrate they have a sufficient network of contracted providers to care for beneficiaries before CMS will approve an application for a new or expanded MA plan.
—Our proposal would require MA organizations and Part D sponsors to report the underlying cost and revenue information needed to calculate and verify the MLR [Medial Loss Ratio] percentage and remittance amount, if any. In addition, we propose to require that MA organizations report the amounts they spend on various types of supplemental benefits not available under original Medicare (e.g., dental, vision, hearing, transportation).”

Use of Preventive Care Services and Hospitalization Among Medicare Beneficiaries in Accountable Care Organizations That Exited the Shared Savings Program: “How is the exit of an accountable care organization (ACO) from the Medicare Shared Savings Program (SSP) associated with clinical quality delivered to beneficiaries, and does the association change over time after exit?…
In this cohort study of more than 1.7 million Medicare beneficiaries, SSP exit was associated with considerably lower rates of preventive service use, though not associated with rates of hospital utilization. These associations differed depending on how far removed an ACO was from SSP participation, where the reductions in clinical quality were most prominent in the first 2 years after exit…
Observations of declines in clinical quality after ACO exit from the SSP are important given recent changes to the SSP that could accelerate program exit.”

Today's News and Commentary

About Covid-19

White House: No plans to change definition of 'fully vaccinated': “‘Individuals are considered fully vaccinated against COVID-19 if they've received their primary series, that definition is not changing,’ Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said at a press briefing.
She said that the CDC is instead using the term ‘up to date’ to encourage people to get boosters.”

Pfizer to supply U.S. with 10 mln more courses of COVID-19 pills: “The Biden administration doubled its order for Pfizer Inc's oral COVID-19 antiviral treatment, the company and the White House said on Tuesday, providing the government a total of 20 million courses as it fights a record surge in COVID-19 cases.”

Unions go to court to get OSHA to release permanent COVID-19 protection standard: “The AFL- CIO, National Nurses United and other major unions filed a petition Wednesday in the U.S. Court of Appeals to force the Occupational Safety and Health Administration (OSHA) to make a permanent COVID-19 protection standard in place of the temporary measure installed last June.
Unions say a permanent standard that details minimum standards for equipment and staffing numbers is vital as the omicron variant has helped fuel surges of COVID-19 across the country.”

Omicron Causes Delay of FDA Inspections, as Well as Planning of In-Person Foreign Inspections: “The FDA has announced that due to the fast-spreading Omicron variant of COVID-19, it will postpone the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022, as well as postponing nonmission-critical work.”

About the public’s health

Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life Years for 29 Cancer Groups From 2010 to 2019: “In this systematic analysis, there were 23.6 million new global cancer cases in 2019 (17.2 million when excluding those with nonmelanoma skin cancer), 10.0 million cancer deaths, and an estimated 250 million disability-adjusted life years estimated to be due to cancer; since 2010, these represent increases of 26.3%, 20.9%, and 16.0%, respectively. Absolute cancer burden increased in all SDI [Sociodemographic Index] quintiles since 2010, but the largest percentage increases occurred in the low and low-middle SDI quintiles…
The study results suggest that increased cancer prevention and control efforts are needed to equitably address the evolving and increasing burden of cancer across the SDI spectrum.”
See Figure 2 for “Cancer Group Rankings by Disability-Adjusted Life Years (DALYs) in 2019 and Percentage Change From 2010 to 2019.”

Trajectories of Prescription Drug Misuse Among US Adults From Ages 18 to 50 Years: “US adults born from 1965 to 1996 had high exposure to controlled medications, yet little is known about how this exposure has affected them over time. Prescription drug misuse (PDM) has increased among adults in the past 2 decades, with related increases in emergency department visits, overdoses, and deaths…
This cohort study included 11 cohorts of adolescents who were followed up longitudinally from age 18 years (study start, 1976-1986) to age 50 years (2008-2018) in the Monitoring the Future (MTF) study, which included a national multistage random sample of US 12th grade students.”
”In this cohort study of 26 575 individuals followed up from ages 18 to 50 years, nearly half of respondents reported prescription drug misuse. All prescription drug misuse trajectories had significantly increased odds of developing substance use disorder symptoms in adulthood, especially later peak trajectories, and baseline characteristics associated with prescription drug misuse trajectories included belonging to more recent cohorts, binge drinking, cigarette smoking, and using marijuana.”
One criticism is that 79.3% of study participants were white.

2022’s Best and Worst Cities for Active Life Style: At the top are San Francisco and Chicago. At the bottom are Winston-Salem (99) and North Las Vegas (100).

Pharmacists can give flu shots in states where they're not licensed, HHS says: “HHS is permitting pharmacists and qualified pharmacy interns to administer flu vaccines in states where they are not licensed or certified, effective Jan. 7. 
HHS released an amendment to the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, allowing licensed pharmacists and pharmacy interns in good standing to prescribe, dispense and administer flu shots in any state. Pharmacists may also order vaccines in states where they're not licensed.”

About healthcare IT

Study rates every state’s telehealth laws for patient access and ease of providing services: The study looks at eight dimensions that facilitate telehealth care. For example: “Only three states — Arizona, Florida, and Indiana — allow all providers to easily practice telehealth across state lines. Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

Hackers hit Broward Health network, potentially exposing data on 1.3M patients, staff: “The southeast Florida health system, which operates more than 30 healthcare locations in Broward County, disclosed it was hit with a cyberattack on Oct. 15, 2021, when an intruder gained unauthorized access to the hospital's network and patient data through a third-party medical provider, according to a statement posted to the health system's website Saturday…
Broward Health said it waited months to notify victims and make the breach public because the DOJ told them to hold off on sending out breach notification letters to preserve an ongoing law enforcement investigation…”

Ciox Health data breach affects ​​AdventHealth, Northwestern and 30 more providers: “Health information management company Ciox Health has notified 32 providers of an email security incident affecting their patients' protected health information.
The company said an unauthorized person accessed a Ciox employee's email account between June 24, 2021, and July 2, 2021, and they may have downloaded emails and attachments in the account.”
The article lists clients affected by the breach.

Stryker ponies up $3B to buy Vocera and amp up its digital communications: “The care coordination provider found new value during the COVID-19 pandemic, when clinicians and surgeons needed to find new ways to connect with their patients remotely and also to streamline their efforts to help meet the high demand for real-time, personal interactions.
Stryker said it plans to wield Vocera’s portfolio—which includes smartphone apps and workflow analytics software as well as its own hand-held communications hardware for hospital staff—to link up the medtech’s various data-generating medical devices.”

About pharma

Amgen chooses Generate in $1.9B biobucks deal to churn out up to 10 multispecific drugs: “The pair announced the deal Thursday morning, which includes $50 million upfront for the initial five program, with an option to collaborate on five more. Amgen will pay up to $370 million in milestones and also royalties for each resulting program from the pact, with a total potential transaction value of $1.9 billion in biobucks for Generate. Specific indications or disease areas were not disclosed in the announcement.”

Pfizer and BioNTech team up to develop mRNA-based shingles vaccine: “Pfizer and BioNTech have chosen to target shingles, for which GSK had a vaccine approved in 2017. GSK’s Shingrix is more than 90 per cent effective but the UK drugmaker has struggled to increase production to meet demand. Pfizer and BioNTech hope that a shot based on mRNA technology will be easier to scale up than Shingrix, which is a protein-based vaccine with an adjuvant.”

About health insurance

Complaints about medical billing: As previously reported, federal Surprise Medical Bill provisions became effective January 1. This CMS website allows patients to submit a complaint about such a bill.

North Carolina Physician Indicted for Adulterating Medical Devices for Reuse on Patients, Fabricating Records, and Other Charges: “A federal grand jury returned an indictment today charging a Raleigh woman with Adulteration of Medical Devices, Paying Illegal Remunerations, Making and Using Materially False Healthcare Documents, Mail Fraud, and Conspiracy.
According to the Superseding Indictment, between 2014 and 2018, Anita Louise Jackson, 58, billed Medicare more than $46 million for allegedly rendering more than 1,200 incidents of “balloon sinuplasty” services to more than 700 patients. Her practice, Greater Carolina Ear, Nose, and Throat (GCENT), received more than $5.4 Million for the services. During portions of this same time period, Jackson was the top-paid provider of balloon sinuplasty services in the United States, despite the location of her practice outside of a major metropolitan area. Jackson profited substantially from these billings to the Medicare program.”

About healthcare personnel

Governor Hochul Announces Direct Payments to Healthcare Workers as Part of $10 Billion Healthcare Plan: “Governor Kathy Hochul today announced a $10 billion multi-year investment in healthcare, the largest in State history, to rebuild and grow the healthcare workforce and strengthen the healthcare system as part of the 2022 State of the State. The plan will invest $10 billion in New York State’s healthcare sector, including more than $4 billion to support wages and bonuses for healthcare workers, and will invest in the healthcare workforce development pipeline to meet the current and increasing demand for medical professionals.”

Today's News and Commentary

About Covid-19

CDC Backs Boosters for High-Risk Kids Aged 5-11, Shorter Time Between Shots: “The U.S. Centers for Disease Control and Prevention on Tuesday backed the emergency use approval of Pfizer's booster shot for high-risk kids between the ages of 5 and 11, along with shortening the time period between a second dose and a booster shot from six months to five months.
Both approvals came from the U.S. Food and Drug Administration on Monday…”

CDC recommend Pfizer-BioNTech booster for 12-to-17-year-olds: “The Centers for Disease Control and Prevention recommended Wednesday that children 12- to 17-years-old should get a Pfizer-BioNTech coronavirus vaccine booster, expanding protection to adolescents and teens as surging infections threaten to disrupt schools and workplaces across the country.”

A variant found in France is not a concern, the W.H.O. says.: “The World Health Organization says that it is monitoring a coronavirus variant detected in a small number of patients in France, but that, for now, there is little reason to worry about its spread.
The B.1.640.2 variant was first identified in October and uploaded to Gisaid, a database for disease variants, on Nov. 4. Only about 20 samples have been sequenced so far, experts said this week, and only one since early December.
Abdi Mahmud, a Covid incident manager with the W.H.O., told reporters in Geneva on Tuesday that the variant had been on the agency’s radar since November, but added that it did not appear to have spread widely over the past two months.”

Omicron estimated to be 95.4% of coronavirus variants in U.S. - CDC: “The Omicron variant was estimated to be 95.4% of the coronavirus strains circulating in the United States as of Jan. 1, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.”

Biden’s coronavirus testing push will need to face the ghost of websites past: “The swift spread of the omicron variant has laid bare the dearth of coronavirus tests nationwide, prompting President Biden last month to announce plans to make 500 million rapid tests available in part through a new federal website where citizens can sign up to receive them.
If history is any indication, though, the portal’s launch could face some of the same technological stumbling blocks that have plagued similar projects in the past.”

Israeli study reports fivefold jump in antibodies with 4th Pfizer vaccine shot: “A fourth shot of the Pfizer-BioNTech coronavirus vaccine generated a fivefold boost in antibodies a week after the jab, according to preliminary results of a study made public by the Israeli government Tuesday…
‘The fourth shot acted just like the first and second shots,’ said Sheba spokesperson Steve Walz. ‘A few people had low fevers, a few had sore arms but nothing more than that.’”

Existing vaccines effective against severe Omicron, study suggests: “Cellular immunity elicited by the BioNTech/Pfizer and Johnson & Johnson Covid-19 vaccines is effective against the Omicron coronavirus variant, according to a study, suggesting vaccines will protect against severe disease even if the antibody responses against the strain are not as strong or durable. The findings, contained in a new Harvard medical school study, add to evidence that the current vaccines hold up against severe Covid outcomes, and could help health authorities to decide whether to switch to Omicron-targeted jabs.”

COVID-19 Oral Vaccine and Antibody Booster: B. subtilis Spores, Biotechnology Breakthrough by DreamTec: “In its recently published peer-reviewed paper in an international medical journal Vaccines, which demonstratesBacillus subtilis (B. subtilis) spores, expressing a SARS-CoV-2 spike protein receptor binding domain (sRBD) on their surface can then produce neutralizing antibodies. DreamTec conducted a pilot study for a new COVID-19 oral vaccine which is able to elicit an immune response in both mice and human volunteers without adverse effects…”

Dr. Reddy’s to Price Generic Pill of Merck’s COVID-19 Antiviral at 50 Cents: “Generics giant Dr. Reddy’s Laboratories has reportedly priced its generic version of Merck’s COVID-19 oral antiviral, molnupiravir, at approximately 50 cents a pill.
Shortly before the new year, Dr. Reddy’s won Emergency Use Authorization from the Drugs Controller General of India allowing the company to produce its generic, which will be sold under the brand name Molflu in India. The drug will reportedly be made available to Indian pharmacies starting next week.”

COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly: From the Office of HHS OIG: “Medicare Part B spent $1.5 billion on COVID-19 tests in 2020, while at the same time, spending on non-COVID-19 tests declined by $1.2 billion. The result was a net spending increase of 4 percent, but the decrease in utilization of non-COVID-19 tests raises questions about the potential impacts on beneficiary health.”

U.S. reports over 1 million new daily Covid cases as omicron surges: “The U.S. has reported a record single-day number of daily Covid cases, with more than 1 million new infections.
A total of 1,082,549 new coronavirus cases were reported Monday, according to data compiled by Johns Hopkins University, as the highly infectious omicron variant continues to spread throughout the country and beyond.
The U.S. also has the highest seven-day average of daily new cases in any country tracked by Johns Hopkins.”

Walmart, Kroger Raise Prices of Covid-19 Test Kits: “Walmart Inc. and Kroger Co. are raising their prices for BinaxNOW at-home rapid tests, after the expiration of a deal with the White House to sell the test kits at cost for $14…
The deal with the White House expired in December, and Walmart said this week that it is raising the kits’ price to $19.98 a box. Kroger now sells them for $23.99. The BinaxNOW tests aren’t currently available on Amazon.”

Walmart to offer COVID-19 antiviral prescriptions: “Walmart said Pfizer’s Paxlovid and Merck’s Molnupiravir, both oral medicines, will be available at some Walmart and Sam’s Club pharmacies this week as supplies allow….
Since Paxlovid and Molnupiravir are prescribed to people with COVID-19, the drugs will be available at Walmart and Sam’s Club only via curbside pickup or drive-through pharmacy windows, according to Walmart.”

About health insurance

Centene closes $2.2B acquisition of Magellan Health: “Centene has completed its $2.2 billion acquisition of managed care organization Magellan Health, moving the insurer further into the behavioral health space, the company said Tuesday.
Centene and Magellan cleared all regulatory hurdles, both at the state and federal level, a condition of closing the deal. Magellan will operate independently under the Centene umbrella and will continue to be led by CEO Ken Fasola…
Magellan will add 5.5 million members and boost Centene's established presence in specialty healthcare and pharmacy management.”

About pharma

Delaware Judge Denies Sarepta Protection Under Hatch-Waxman “Safe Harbor”: On January 4, 2022, Judge Andrews from the United States District Court for the District of Delaware denied Sarepta Therapeutics, Inc.’s (“Sarepta”) Rule 12(b)(6) motion to dismiss a complaint for infringement of U.S. Patent No. 10,526,617 filed by Regenxbio, Inc. (‘Regenx’) and the University of Pennsylvania (‘UPenn’).
The ‘617 patent claims a ‘cultured host cell containing a recombinant nucleic acid molecule encoding the capsid protein.’  Regenx and UPenn alleged that Sarepta manufactured and used cells covered by the ‘617 patent in order to make certain gene therapy products including Sarepta’s ‘SRP-9001…
In denying Sarepta’s motion, Judge Andrews agreed with Regenx and relied on Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008), a case which found that the Safe Harbor did not apply to use of a patented optical spray analyzer that was used in connection with regulatory submissions for aerosol drug delivery systems but was itself not subject to regulatory approval. Citing several district court rulings following Proveris, Judge Andrews held that “a patented product that is not subject to FDA premarket approval is not a ‘patented invention’ under §271(e)(1)” and is therefore not covered by the Safe Harbor.”
The text of the decision quotes from the Hatch-Waxman Act:
“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

DC Circ. Revives Terror-Funding Case Against AstraZeneca: “The D. C. Circuit on Tuesday revived a lawsuit accusing AstraZeneca, Pfizer and several other pharmaceutical companies of helping to finance terror acts — through lucrative medical goods contracts with Iraq's health ministry — that have injured or killed hundreds of U. S. service members and civilians in the country between 2005 and 2011. A three-judge panel overturned and remanded a D. C. federal court's July 2020 dismissal order, which found that service members and other victims of the Hezbollah-linked militia group Jaysh al-Mahdi failed to state claims for either direct or secondary "aiding-and-abetting" liability under the Anti-Terrorism Act, or ATA.”

About hospitals and health systems

Hospitals Still Not Fully Complying With Federal Price-Disclosure Rules: “No hospitals have been penalized as of late December, according to the Centers for Medicare and Medicaid Services, which is responsible for enforcing the rules. The maximum penalty this year for violators is $109,500 per hospital, and the penalty increases to as much as $2 million in January.
The agency has issued approximately 335 warnings for violations and is giving hospitals information and technical help to increase compliance as of early December, a CMS spokeswoman said. Regulators also requested that 98 hospitals submit plans for how and when they would comply.”