Today's News and Commentary

About Covid-19

 CDC expected to update mask guidance as early as next week: “The Centers for Disease Control and Prevention is expected to loosen its indoor masking guidelines to states soon, according to several people familiar with the matter. The agency’s update could come as early as next week.
Dr. Rochelle Walensky, the director of the CDC, is expected to discuss masking guidance [next] Wednesday at a White House Covid-19 Response Team briefing.”

Texas Republicans sue Biden administration over airline mask mandates: “Attorney General Ken Paxton (R), U.S. Rep. Beth Van Duyne (R-Tex.) and their allies argue that the mandates were unlawfully issued because they weren’t approved by Congress. They also say the CDC didn’t place the mask order up for notice and comment, which Paxton and others say is ordinarily required for such regulations.”

Ex-NIH chief Collins returns as science adviser to Biden weeks into retirement: “That was quick. Francis Collins, M.D., Ph.D., after exiting the top perch at the National Institutes of Health (NIH) in the last weeks of 2021, is back in the upper echelons of U.S. scientific leadership as President Joe Biden's science adviser.
Collins also assumes the role of co-chair of Biden's Council of Advisors on Science and Technology…
Alongside Collins' appointment, Biden promoted Alondra Nelson, Ph.D., to director of the White House Office of Science and Technology Policy, or OSTP. Nelson was previously deputy director for science and society at the OSTP. Nelson was also president of the Social Science Research Council from 2017 to 2021.
Nelson and Collins are filling a vacancy left by Eric Lander, who resigned from his post last week after a White House investigation found evidence that he violated workplace conduct rules by demeaning his staff.” 

About health insurance

 State to merge health insurance markets in bid to help small businesses: A new approach to ACA exchanges: “The state will merge the Affordable Care Act insurance markets for individuals and small groups to create more stable pricing for health coverage, particularly needed among the declining group market used by small businesses.
Maine will be first in the nation to combine the two markets into a subsidized reinsurance program, officials said. The merger was authorized by the Made for Maine Health Coverage Act, signed into law by Gov. Janet Mills in 2020.”

BCBS of Louisiana to face antitrust suit over rates: “The initial lawsuit, which seeks class action status, was brought by Opelousas General Hospital Authority in 2016. In it, the hospital authority alleges Blue Cross and Blue Shield of Louisiana violated antitrust laws by leveraging discounted rate reimbursements created by its BlueCard Program. 
The program allows Blue Cross Blue Shield members to receive care from facilities in other states at a discounted rate, according to the lawsuit. When a patient visits a facility outside of its plan's network but in-network with another Blue Cross Blue Shield affiliate, they pay a rate equivalent to those negotiated with in-network providers in their state's plan.”

UnitedHealth Wants High Court Review Of Medicare Rule: “UnitedHealth Group is asking the U. S. Supreme Court to review a Medicare Advantage overpayment rule that has multibillion-dollar implications for insurer reimbursement and False Claims Act enforcement, calling a D. C. Circuit opinion against it ‘egregiously wrong.’ In its Monday petition to the high court, UnitedHealth said the justices should take up its challenge to an August D. C. Circuit reversal of a lower court decision that vacated the rule. The clawback rule at issue requires Medicare Advantage insurers to return excess payments within 60 days.”

Biden administration to reverse the Trump-era 'public charge' rule that denied green cards to poor immigrants: “The Biden administration is throwing out the Trump administration's "public charge" rule, which denied permanent residency to immigrants who used public assistance programs or were suspected of using them in the future.
Department of Homeland Security Secretary Alejandro Mayorkas on Thursday said in a statement the 2019 rule’was not consistent with our nation's values.’”

About hospitals and healthcare systems

New Data Finds 69% of Americans Would Consider Switching Healthcare Providers for More “Appealing” Services – Same Day Appointments Top the List: “Some Americans might say they are pleased with their current healthcare provider, but a new Tegria survey conducted by The Harris Poll reveals that nearly 7 in 10 Americans (69%) would consider switching to another provider that offers more appealing services. Top drivers that could inspire people to switch include the availability of same-day appointments for non-routine issues (35%), convenient locations where they already go (30%) and self-scheduling (29%). In fact, more than 4 in 5 Americans (81%) believe the ability to schedule healthcare appointments online would make the scheduling process much easier and more than three quarters (79%) want the ability to use technology when managing their healthcare experience.”

 Baylor Scott & White's operating income dips 13% as expenses climb: “Dallas-based Baylor Scott & White saw its operating income fall more than 13 percent in the six months ending Dec. 31, largely driven by an increase in expenses, according to recently released financial results. 
For the first half of fiscal year 2022, Baylor Scott & White recorded an operating income of $644 million, down from the $742 million recorded in the same period one year before. The health system's operating margin was 10.2 percent for the first half of fiscal 2022. In the same period in fiscal 2022 the operating margin was 12.8 percent…
The health system also saw its expenses rise in the first half of fiscal 2022 to $5.7 billion, up 12.6 percent from the same period in fiscal 2021. The health system attributed the expense jump to rising costs for employee wages and supplies.”

About pharma

 Judge sides with AstraZeneca in 340B dispute: “A federal judge ruled Feb. 16 that HHS violated procedural rules by compelling AstraZeneca to resume drug discounts for hospitals participating in the 340B program… In May 2021, HHS notified six drugmakers, including AstraZeneca, that they were in violation of 340B requirements by restricting discounts for hospitals that use contract pharmacies. In the warning letter, HHS said the drugmakers must immediately begin offering their drugs at discounted prices or potentially face civil monetary penalties.”

Generic drug approvals continued to fall in 2021: “The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in recent years.
In calendar year 2020, FDA approved or tentatively approved 948 ANDAs for generic drugs, which was down from 1,014 in 2019. The latest figures are part of the FDA’s Office of Generic Drugs (OGD) 2021 Annual Report.

Statin intolerance is 'over-estimated and over-diagnosed': World’s largest study shows less than 10% suffer side-effects caused by the drug: “As many as one in two patients stop taking statins, reduce the dose or take them irregularly because they believe the cholesterol-lowering drugs cause muscle pain and other side-effects. Now, a new study of over four million patients has shown that the true prevalence of statin intolerance worldwide is between six to ten percent.
The authors of the research, published in the European Heart Journal, say that their findings show that statin intolerance is over-estimated and over-diagnosed, with the result that patients are at greater risk of heart and blood vessel problems, including death, caused by high cholesterol levels.”

Teva takes 'skinny' label dispute with GlaxoSmithKline to the Supreme Court: reports: “The case comes down to ‘skinny’ labeling, a popular type of carve-out in the world of copycat drugmakers. For decades, generic drugmakers have been able to get their copycats approved for one or several–but not necessarily all–approved indications of their brand-name counterparts. If a generic doesn’t cover all the indications of its reference product, then its label is ‘skinny.’
Branded companies, for their part, argue that pharmacists sometimes ignore the skinny labels, leading to infringement when patients take generics for unapproved indications.” 

About the public’s health

 Recommended Adult Immunization Schedule, United States, 2022: FYI

About healthcare IT

 Top 15 specialties for telehealth: “Telehealth adoption rates are highest for specialties that manage chronic illness, according to the "State of Telemedicine" report released Feb. 16 by health IT and telehealth networking platform Doximity.”
At the top is endocrinology.

Today's News and Commentary

About Covid-19

Israel finds fourth Covid jab cuts infection and serious illness: “Initial data in January from the Sheba Medical Center at Tel Hashomer suggested that the fourth dose made little difference in protecting against Omicron, and even though the jabs are now available for many population groups, diminishing numbers of Israelis are opting for the fourth jab.
However, Maccabi Health Services virus task force head Dr. Arnon Shahar said, ‘We see that when the fourth vaccine dose is freshly administered, up to six weeks, it reduces infection by 50% and the risk of serious illness is five times less.’
Israeli Ministry of Health figures show that 7% of those hospitalized in serious and critical condition with Covid had four Covid vaccinations compared with 28% who have had three jabs, with the third vaccination not administered recently, while 45% have not been vaccinated at all.”

Hospitalizations of Children and Adolescents with Laboratory-Confirmed COVID-19 — COVID-NET, 14 States, July 2021–January 2022: “Coinciding with increased circulation of the Omicron variant, COVID-19–associated hospitalization rates among children and adolescents aged 0–17 years increased rapidly in late December 2021, especially among children aged 0–4 years who are not yet eligible for vaccination. Throughout the periods of Delta and Omicron predominance, hospitalization rates remained lower among fully vaccinated adolescents aged 12–17 years than among unvaccinated adolescents.”

Excess Deaths Associated with COVID-19: Per CDC data: “Total predicted number of excess deaths since 2/1/2020 across the United States: 1,045,389”

Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19–Associated Hospitalization in Infants Aged <6 Months — 17 States, July 2021–January 2022: “Effectiveness of maternal completion of a 2-dose primary mRNA COVID-19 vaccination series during pregnancy against COVID-19 hospitalization among infants aged <6 months was 61% (95% CI = 31% to 78%). Effectiveness of completion of the primary COVID-19 vaccine series early and later in pregnancy was 32% (95% CI = –43% to 68%) and 80% (95% CI = 55% to 91%), respectively.”

Covid-19 booster shot uptake is at all-time low in the US, CNN analysis finds: “As of Monday, about 64% of the US population is fully vaccinated against Covid-19 with at least their initial two-dose series, and 28% have received a booster shot. But the pace of booster doses going into arms is the lowest it has been in months -- since the US Centers for Disease Control and Prevention first recommended boosters for seniors and other at-risk adults in September, according to a CNN analysis of CDC data. The agency expanded its recommendation for booster doses in November to include all adults.” 

Biden admin seeks $30 bln more from Congress to fight COVID -sources: “The $30 billion request includes $17.9 billion for vaccines and therapeutics, two sources familiar with it said.”

COVID-19 therapeutics for nonhospitalized patients: Sorting out these therapies is often confusing.
eTable 1 provides a great comparison among these treatments.

About health insurance

 Fraud Section Year in Review-2021- From the Department of Justice. The healthcare report begins on page 15. In short:
”The Department announced criminal charges against 138 defendants, including 42 doctors, nurses, and other licensed medical professionals, charged between August 1 and September 17, 2021, in 31 federal districts for their alleged participation in various health care fraud and illegal opioid distribution schemes that resulted in a combined total of approximately $1.4 billion in alleged losses. The charges targeted approximately $1.1 billion in alleged fraud committed using telemedicine (the use of telecommunications technology to provide health care services remotely), $29 million in COVID-19 health care fraud, $133 million connected to substance abuse treatment facilities, or ‘sober homes,’ and $160 million connected to other health care fraud and illegal opioid distribution schemes across the country.”

About hospitals and healthcare systems

 CommonSpirit Health reports $81M operating loss as COVID surges drove up supply, staffing costs: “CommonSpirit’s net patient and premium revenue for the second quarter increased 9.3% ($710 million) year over year, while same-store adjusted admissions rose 1.5% year over year, outpatient visits rose 5.1% year over year and emergency department visits jumped 16.6% year over year. Total operating revenue for the quarter was $8.88 billion.
 But the health system also saw a 12.3% year-over-year increase in labor expenses per adjusted admission and an 11.6% ($152 million) rise in supply costs.”

About pharma

HOW DO COPAYMENT COUPONS AFFECT BRANDED DRUG PRICES AND QUANTITIES PURCHASED?: “Using data on net-of-rebate prices and quantities from a large Pharmacy Benefits Manager, we find that coupons increase quantity sold by 21-23% for the commercial segment relative to Medicare Advantage in the year after introduction..
For this category of drugs, we estimate that coupons raise negotiated prices by 8% and result in just under $1 billion in increased U.S. spending annually. Combined, the results suggest copayment coupons increase spending on couponed drugs without bioequivalent generics by up to 30 percent.”

Identifying Higher-Volume Antibiotic Outpatient Prescribers Using Publicly Available Medicare Part D Data — United States, 2019: “The highest 10% of antibiotic prescribers prescribed 41% of total antibiotic prescriptions for Medicare Part D beneficiaries in 2019. The antibiotic prescribing rate of these higher-volume prescribers was 60% higher than that of lower-volume prescribers.”

 FDA wallops Indian drugmaker with warning letter blasting API quality, equipment cleanliness and more: “The FDA has dinged Indiana Chem-Port with a laundry list of problems related to controls, cleaning, maintenance, testing and quality assurance in its API [active pharmaceutical ingredient] production operation. The regulator handed down a five-observation warning letter earlier this month after inspecting Indiana Chem-Port’s Gujarat, India, manufacturing facility in August last year.”
The reason this action is important is that India, with China, are the top two sources for our APIs.

Merck & Co. inks drug-development deal with Curve Therapeutics: “Merck & Co. entered into an agreement with Curve Therapeutics potentially worth up to $1.7 billion to develop modulators of up to five therapeutic targets, initially for oncology and neurology indications, the latter company said Wednesday. Along with an undisclosed upfront payment and milestones, Curve is also eligible to receive sales royalties on any approved products resulting from the alliance.
Under the deal, Curve will perform high throughput mammalian cell-based functional screening, hit characterisation, data-mining and analysis, as well as optimisation using its Microcycle technology.”

About the public’s health

 Validation Status of Blood Pressure Measuring Devices Sold Globally: The state of the art for blood pressure monitoring is ambulatory self-measurement, However, validation of devices has not been performed on a wide scale. Disturbingly, this global study found:
”From 2486 upper arm cuff devices, 248 (10.0%) were validated, 327 (13.2%) were equivalent, and there was no evidence of validation for 1816 (73.0%) (Table). From 925 wrist-based devices, 52 (5.6%) were validated, 51 (5.5%) were equivalent, and there was no evidence of validation for 786 (85.0%)…
Lack of validation may undermine optimal medical practice through increased potential for incorrect hypertension diagnosis and inappropriate care. Global and national policy frameworks, including regulations with enforcement, are needed, with the goal that all devices meet minimum requirements for independent validation before premarket clearance. Currently, to determine if a device is validated, consumers should check a validated device list.” See: How to check whether a blood pressure monitor has been properly validated for accuracy

About healthcare IT

 athenahealth Acquired by Hellman & Friedman and Bain Capital: “athenahealth, Inc. (“athenahealth” or “the Company”), a leading provider of cloud-based enterprise software solutions for medical groups and health systems nationwide, today announced that affiliates of Bain Capital and Hellman & Friedman have completed their acquisition of athenahealth from Veritas Capitaland Evergreen Coast Capital for $17 billion.”

HHS awards community health centers $55M to expand telehealth access for underserved groups: “The Department of Health and Human Services has awarded community 29 health centers nearly $55 million to reach their underserved populations using telehealth, remote patient monitoring, health information technology platforms and other digital and virtual care tools.
The funds announced Monday will be distributed through the Health Resources and Services Administration (HRSA) and aim to ‘enable health centers to sustain an expanded level of virtual care and identify and implement new digital strategies.’”

Mobile Health App Use Among Older Adults: “Nearly three in ten adults age 50–80 (28%) said they currently use at least one mobile health app, 16% reported that they used them in the past but not currently, and 56% have never used a health app. Adults age 50–64 were more likely than those 65–80 to have ever used a health app (49% vs 38%). Overall, 34% of older adults said they use or have used apps for exercise, 22% for nutrition, 20% for weight loss, and 17% for sleep. Older adults less commonly used apps for recording blood pressure (9%), meditating (8%), and/or mental health/stress management (5%).”

About health technology

 Cleveland Clinic Unveils Top 10 Medical Innovations for 2022: Each year the Cleveland Clinic publishes its “top 10 list”—always worth reading. 

Today's News and Commentary

To readers: For some reason, yesterday’s blog, while sent, was lost.

It is duplicated first below

TODAY'S NEWS AND COMMENTARY

February 14, 2022

About Covid-19

 Federal vaccination mandate begins for healthcare workers in 24 states“Healthcare facilities in 24 states face their first deadline Feb. 14 to comply with the Biden administration's COVID-19 vaccination mandate.”

Almost 1 in 3 older adults develop new conditions after covid-19 infection“Almost a third (32 of every 100) of older adults infected with covid-19 in 2020 developed at least one new condition that required medical attention in the months after initial infection, 11 more than those who did not have covid-19, finds a US study published by The BMJ today.
Conditions involved a range of major organs and systems, including the heart, kidneys, lungs and liver as well as mental health complications.”

CDC recommends people with weakened immune systems get booster doses after three months instead of five“The Centers for Disease Control and Prevention updated its guidance on Friday for some people with weakened immune systems, recommending they get a booster dose of the coronavirus vaccine three months after completing the initial series of the Pfizer-BioNTech or Moderna shots, rather than the current interval of five months.
The guidance also said immunocompromised people who received the one-shot Johnson & Johnson vaccine should get an additional dose. That means two doses, at least 28 days apart, followed by a booster dose of one of the mRNA vaccines.”

About health insurance

UnitedHealth was 2021's most profitable payer. Here's a look at what its competitors earned: A quick look at financial performance for the industry’s top players.

 Medical Director Convicted in $110 Million Addiction Treatment Fraud Scheme“According to court documents and evidence presented at trial, Mark Agresti, M.D., 59, of Palm Beach, unlawfully billed approximately $110 million of urinalysis (UA) drug testing services that were medically unnecessary for patients at a sober living facility, Good Decisions Sober Living (GDSL). GDSL was paid kickbacks for providing patients to addiction treatment facilities in the West Palm Beach area, in violation of Florida state law.”

Association Between High-Deductible Health Plans [HDHPs] and Hernia Acuity “In this cohort study that included 83 281 patients from a large commercial insurance claims database, the study team found that those enrolled in individual HDHP coverage were at 6% higher odds of presenting with an incarcerated or strangulated hernia.
Meaning  Among patients with groin and ventral hernias, enrollment in an HDHP may be associated with delays in surgical care that may result in complex disease presentation.”

About hospitals and healthcare systems

CMS claws back Medicare payments from hospitals that own nursing schoolsFor nearly a decade, the federal government has overpaid hospitals that own nursing schools an estimated $310 million, and now the Centers for Medicare and Medicaid Services want that money back. CMS posted a notice online in late 2020 stating that due to an agency error, nursing schools were overpaid by Medicare from 2008 through 2018 and needed to return that money. For many of the providers, that money will come due this summer unless a congressional effort to forgive the debts is successful.”

 CMS delays hospital star ratings update until July“CMS is postponing its next Overall Hospital Quality Star Ratings update from April to July to fix a calculation error…
The error involved calculations using 2021 hospital data for the OP-10 outpatient imaging efficiency measure.”

Mass General Brigham's operating income falls to $10M in Q1“Although Boston-based Mass General Brigham reported higher revenue in the first quarter of fiscal year 2022, its operating income fell, according to recently released financial documents…”
’We are continuing to address longstanding capacity challenges for our patients, severely exacerbated by deferred care and a staffing crisis during the latest COVID-19 surge,’ Mass General said.”

Catholic Medical Center Agrees To Pay $3.8M For Kickback-Related False Claims“According to the settlement agreement, the United States asserted that CMC, a hospital in Manchester, paid its own cardiologists to cover for, and to be available to provide medical services for, another cardiologist’s patients when she was on vacation or otherwise unavailable. The United States further alleged that CMC provided these call coverage services at no charge. The cardiologist who received the free call coverage referred millions of dollars in medical procedures and services to CMC over the decade in which the free services were provided. Because CMC submitted claims for payment to Medicare, Medicaid, and other federal health care programs for the services referred by the cardiologist, the United States alleged that these claims were the result of unlawful kickbacks.”

Kaiser Permanente Broke Its Own Profit Record In 2021“Kaiser Permanente had its most profitable year yet in 2021, drawing $8.1 billion in net income.
Oakland, California-based Kaiser once again benefited from strong investment returns last year, beefing up its nonoperating income even as its operating income grew slimmer. The integrated health system’s net income grew 27.2% year-over-year, from an already strong $6.4 billion in 2020.”

 About healthcare IT

 WHO: It’s Time to Eliminate Ageism in Artificial Intelligence“As caregivers examine how artificial intelligence (AI) can improve healthcare for seniors, a policy brief by the World Health Organization shows that potential issues can be eliminated by taking various steps, including optimal design and data collection, providing resources, and maintaining good moral codes.
The most common uses of healthcare-focused AI for seniors are remote patient monitoring, which is used as a method of community care, and the production of drugs for aging patients. The report… also stated that optimizing AI capabilities can increase hospital capacity, as beds can be reserved for cases requiring hands-on care.” 

Healthcare clearinghouse to pay $1.12M to settle data breach“nmediata Health Group agreed to pay $1.12 million to resolve allegations it put patients at risk during a 2019 data breach that affected 1.5 million people, Top Class Actions reported.
Inmediata is a Puerto Rico-based healthcare clearinghouse. It ensures providers' medical claims are error-free so payers can accurately process them.”

Doximity brings in record profit in Q3, snaps up Amion to add physician scheduling to its platform“Doximity, a digital platform for medical professionals, brought in $98 million in revenue in the third quarter, a 67% jump from a year ago. The health tech company also boasted a record profit of $56 million during the quarter, up from $17.2 million just one year ago. 
Doximity, which went public in June, operates like a LinkedIn for doctors and provides a digital platform for U.S. medical professionals, including telehealth and scheduling tools. The company has over 1.8 million medical professional members as of March 31, 2021, and claims to have more than 80% of doctors on its network.”

About healthcare personnel

‘A real crisis’: License backlogs in some states are preventing health care workers from seeing patients“In some states, though, licensing delays and their impacts are clear. NBC News spoke to the leaders of nine health care professional organizations in three states who said wait times for licenses are worse than they’ve ever been. Licensing agencies that were already slow and understaffed were put under additional pressure by the pandemic. They’ve dealt with an influx of applicants, had to adapt antiquated paper-based application systems to remote work and built emergency licensing processes nearly overnight. In 2021 and 2022, they’ve lost staff to the Great Resignation.”

 

HERE IS TODAY’S POST

About Covid-19

 Moderna, Pfizer stocks fall as omicron Covid wave subsides in U.S.: “Shares of the major Covid vaccine makers fell on Monday, as the unprecedented wave of omicron infections eased, with new cases rapidly dropping across the country.
Moderna plunged more than 11%, the biggest decline in the S&P 500 Monday. Pfizer tumbled nearly 2% and its partner BioNTech slid more than 9%, while Novavax was off more than 11% and Johnson & Johnson fell over 1%.
White House chief medical advisor Dr. Anthony Fauci told The Financial Times last week that the U.S. is exiting the ‘full-blown pandemic phase of Covid-19.’”

CDC recommends people with weakened immune systems get booster doses after three months instead of five: “The Centers for Disease Control and Prevention updated its guidance on Friday for some people with weakened immune systems, recommending they get a booster dose of the coronavirus vaccine three months after completing the initial series of the Pfizer-BioNTech or Moderna shots, rather than the current interval of five months.
The guidance also said immunocompromised people who received the one-shot Johnson & Johnson vaccine should get an additional dose. That means two doses, at least 28 days apart, followed by a booster dose of one of the mRNA vaccines.”

Almost 1 in 3 older adults develop new conditions after covid-19 infection: “Almost a third (32 of every 100) of older adults infected with covid-19 in 2020 developed at least one new condition that required medical attention in the months after initial infection, 11 more than those who did not have covid-19, finds a US study published by The BMJ today.
Conditions involved a range of major organs and systems, including the heart, kidneys, lungs and liver as well as mental health complications.”

Stroke risk among older adults highest in first 3 days after COVID-19 diagnosis: “Research Highlights:

  • The risk of stroke among older adults diagnosed with COVID-19 was greatest within the first three days of being diagnosed with the virus.

  • The risk of stroke was higher among adults ages 65-74 years old, compared to those 85 and older, and among those without a history of stroke.”

Eagerly awaited COVID lifesavers molnupiravir, Paxlovid now wait for patients: “Supplies of the eagerly awaited oral COVID-19 antiviral prescription medications are slowly arriving at US pharmacies, but despite strong evidence that they can help reduce symptoms and prevent severe illness, federal data and experts suggest that many patients don't know about them or don't want to take them.
Two oral COVID-19 antiviral medications, molnupiravir (Merck) and Paxlovid (nirmatrelvir and ritonavir, Pfizer), have been proven to be safe, effective, and convenient treatments to take at home.”

About health insurance

 Why Millions on Medicaid Are at Risk of Losing Coverage in the Months Ahead: “Before the public health crisis, states regularly reviewed whether people still qualified for the safety-net program, based on their income or perhaps their age or disability status. While those routines have been suspended for the past two years, enrollment climbed to record highs. As of July, 76.7 million people, or nearly 1 in 4 Americans, were enrolled, according to the Centers for Medicare & Medicaid Services.
When the public health emergency ends, state Medicaid officials face a huge job of reevaluating each person’s eligibility and connecting with people whose jobs, income, and housing might have been upended in the pandemic. People could lose their coverage if they earn too much or don’t provide the information their state needs to verify their income or residency.”

Medical Director Convicted in $110 Million Addiction Treatment Fraud Scheme: “According to court documents and evidence presented at trial, Mark Agresti, M.D., 59, of Palm Beach, unlawfully billed approximately $110 million of urinalysis (UA) drug testing services that were medically unnecessary for patients at a sober living facility, Good Decisions Sober Living (GDSL). GDSL was paid kickbacks for providing patients to addiction treatment facilities in the West Palm Beach area, in violation of Florida state law.”

Provider groups scramble to convince lawmakers, CMMI to continue Direct Contracting mode: “The major efforts by several provider groups come in response to concerns from progressive lawmakers in Congress wanting to get rid of the model due to concerns it could fuel privatization of Medicare. Providers say such concerns are unfounded, and the model is needed to shift healthcare from fee-for-service to value.”

About hospitals and healthcare systems

 Evaluation of Unreimbursed Medicaid Costs Among Nonprofit and For-Profit US Hospitals: “In this economic evaluation, nonprofit and for-profit hospitals had similar unreimbursed Medicaid costs as a share of expenses. In half of the 45 states in which both nonprofit and for-profit hospitals operate, nonprofit hospitals had a lower weighted mean unreimbursed Medicaid cost to expense ratio than for-profit hospitals—but only nonprofit hospitals receive a sizeable tax subsidy. Thus, our results suggest that the largest component of community benefit supposedly provided by nonprofit hospitals (ie, unreimbursed Medicaid costs, net of supplemental payments) is poorly aligned with the (effectively automatic) tax subsidy that these institutions receive. Prior research suggested similar results for the provision of charity care by nonprofit vs for-profit hospitals.” 

CMS claws back Medicare payments from hospitals that own nursing schools: “For nearly a decade, the federal government has overpaid hospitals that own nursing schools an estimated $310 million, and now the Centers for Medicare and Medicaid Services want that money back. CMS posted a notice online in late 2020 stating that due to an agency error, nursing schools were overpaid by Medicare from 2008 through 2018 and needed to return that money. For many of the providers, that money will come due this summer unless a congressional effort to forgive the debts is successful.”

Nonprofit Hospital CEO Compensation: How Much Is Enough?: “Within this set of more than 1,000 nonprofit hospitals, we found that hospital executives on average made eight times the wages of workers without advanced degrees in 2018. However, this ratio varied widely. Some hospital CEOs were paid at twice the rate of other workers, while the highest paid received 60 times the hourly pay of general workers.”

About pharma

Robert Califf confirmed to lead FDA for second time: “The US Senate on Tuesday voted 50 to 46 in favour of confirming President Joe Biden nominee Robert Califf as commissioner of the FDA, a position he previously held under the Obama administration. The cardiologist will replace acting Commissioner Janet Woodcock, who stepped into the role from her position as long-time director of the FDA's Center for Drug Evaluation and Research (CDER), when Biden took office in January 2021.”

A Woman Is Cured of H.I.V. Using a Novel Treatment: “The woman, who also had leukemia, received cord blood to treat her cancer. It came from a partially matched donor, instead of the typical practice of finding a bone marrow donor of similar race and ethnicity to the patient’s. She also received blood from a close relative to give her body temporary immune defenses while the transplant took.”

FTC to vote on pharmacy benefit manager competition probe: “The Federal Trade Commission will vote Feb. 17 whether to investigate the anticompetitive impacts of pharmacy benefit managers on independent pharmacies.”

The top 10 M&A targets in biotech for 2022: FYI

 GSK becomes 13th drugmaker to restrict 340B discounts to safety net hospitals: “GlaxoSmithKline will limit 340B drug discounts for safety net hospitals' contract pharmacies, the drugmaker said in a Feb. 14 letter to hospitals. 
Effective April 1, GSK will provide 340B discounts only to locations registered as a 340B covered entity or child site location affiliated with that covered entity.”

Wearables play an increasingly pivotal role in clinical trials: “Wearable device sales are increasing worldwide. The global wearable devices market is expected to reach $62.82 billion by 2025. With wearables, patients, physicians and clinical trialists can collect data without the need for frequent office or health centre visits. FirstWord interviewed four experts in wearable technology and drug development about the use of wearables in clinical trials.
According to ClinicalTrials.gov, there have been approximately 1400 trials conducted using wearable devices. Through wearables, clinical trial researchers have captured and analysed information on various biometric data points such as heart rate, respiratory rate, blood oxygen saturation, body temperature, sleep pattern, glucose monitoring, haptics, ultraviolet tracking, pressure sensors, sweat analysis and electro-stimulation. This information can be used alone or combined with other information like patient-reported outcomes, hospitalisation rates and physical activity.
The experts said wearables are beneficial for clinical trials because they reduce the burden of data collection – automatically collating data and sending it back to pharma companies or clinical research organisations for analysis – and generate reliable, accurate information. In addition, wearables provide objective, high-frequency data from patients daily, rather than subjective data gathered from patient surveys or site visits.”

"Amazing" Nanoparticles from Maize: A Potent and Economical Anti-Cancer Therapeutic: Fascinating new nano technology: “Researchers from Tokyo University of Science have recently developed novel corn-derived bionanoparticles for targeting cancer cells directly, via an immune mechanism. The results are encouraging, and the technique has demonstrated efficacy in treating tumor-bearing laboratory mice. Moreover, no serious adverse effects have been reported in mice so far.”

About the public’s health

Why Health Affairs can't promote its latest issue: Health Affairs' entire February issue is devoted to the topic of racism and health, but Google and Twitter are blocking its paid media ads to promote the content, flagging racism as ‘sensitive content…’
The two platforms' automated systems flagged the term "racism" as sensitive content and withheld approval for the paid ads, effectively placing them in digital limbo.”

Endo Opioid Saga 'Like A John Grisham Movie,' Judge Says: “A Tennessee judge who found Endo Pharmaceuticals liable by default for opioid abuse in the state told Law360 on Monday that his extraordinary ruling stemmed from "the worst case of document hiding" he has ever encountered, likening the situation to the plot of a Hollywood legal thriller. In a Monday afternoon interview, Circuit Court Judge Jonathan Lee Young outlined the basis for his default judgment in favor of various Tennessee counties, which have alleged in a sweeping lawsuit that Endo "knowingly participates in the illegal drug market for opioids" through its past sales and marketing of prescription narcotics.”

About healthcare IT

 US warns organizations to brace for potential Russian cyberattacks: “The Cybersecurity and Infrastructure Security Agency issued a recommendation that all U.S. organizations should increase cybersecurity to shield up against potential threats from Russia.
The CISA warning, posted Feb. 14, came after the State Department advisory that urged Americans to leave Ukraine because of increased threats by the Russian military.”

South Shore Hospital breach leaves 116,000 patients' data vulnerable: “Chicago-based South Shore Hospital notified current and former patients about a cybersecurity incident that left 115,670 patients' protected information vulnerable…
The investigation found the attacker gained access to files that contained patients' and employees' first and last names, addresses, dates of birth, Social Security numbers, financial information, health insurance information, medical information, diagnoses, health insurance policy numbers, and Medicare and Medicaid information.”

Doximity brings in record profit in Q3, snaps up Amion to add physician scheduling to its platform: “Doximity, a digital platform for medical professionals, brought in $98 million in revenue in the third quarter, a 67% jump from a year ago. The health tech company also boasted a record profit of $56 million during the quarter, up from $17.2 million just one year ago. 
Doximity, which went public in June, operates like a LinkedIn for doctors and provides a digital platform for U.S. medical professionals, including telehealth and scheduling tools. The company has over 1.8 million medical professional members as of March 31, 2021, and claims to have more than 80% of doctors on its network.”

About healthcare personnel

 As state medical boards try to stamp out COVID misinformation, some in GOP push back: “Although doctors have leeway to decide which treatments to provide, the medical boards that oversee them have broad authority over licensing and discipline for misconduct. Often, doctors are investigated for violating guidelines on prescribing high-powered drugs. But physicians are sometimes punished for other types of ‘unprofessional conduct.’”
The article explains the situation in Tennessee as an example. 

Today's News and Commentary

About Covid-19

Pfizer, BioNTech delay FDA request to expand COVID-19 jab in young children: “Pfizer and BioNTech said Friday they are delaying their request for the FDA to authorise their COVID-19 vaccine Comirnaty for children under 5, as they await more data on the effectiveness of a third dose. An FDA advisory panel set to discuss the filing on February 15 has also been postponed. ‘The extension allows the FDA time to receive updated data on the two- and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion,’ the companies said.”

Booster effectiveness wanes after 4 months, but showed sturdy protection against hospitalization, CDC study shows: “Booster shots of the Pfizer-BioNTech and Moderna vaccines lose substantial effectiveness after about four months — but still provided significant protection in keeping people out of the hospital during the omicron surge, according to a study published Friday by the Centers for Disease Control and Prevention.
Researchers found the booster shots remained highly effective against moderate and severe covid-19 for about two months after a third dose. But their effectiveness declined substantially after four months, suggesting the need for additional boosters, the study said.”

 Association of Primary Care Physicians Per Capita With COVID-19 Vaccination Rates Among US Counties: “In this cross-sectional study, we found that the number of PCPs per 100 000 population was independently associated with higher COVID-19 vaccination rates in the US. Our findings suggest that PCPs play a critical role in ensuring vaccine acceptance, especially in resource-limited and vaccine-hesitant regions, potentially through counseling and building local community trust and partnerships before they had access to vaccines.”

What are taxpayers spending for those ‘free’ COVID tests? The government won’t say: “How much is the government paying for each test? And what were the terms of the agreements? The government won’t yet say, even though, by law, this information should be available.”

Placental Tissue Destruction and Insufficiency from COVID-19 Causes Stillbirth and Neonatal Death from Hypoxic-Ischemic Injury: A Study of 68 Cases with SARS-CoV-2 Placentitis from 12 Countries: “The pathology abnormalities composing SARS-CoV-2 placentitis cause widespread and severe placental destruction resulting in placental malperfusion and insufficiency. In these cases, intrauterine and perinatal death likely results directly from placental insufficiency and fetal hypoxic-ischemic injury. There was no evidence that SARS-CoV-2 involvement of the fetus had a role in causing these deaths.”
In a related article:  Association of BNT162b2 COVID-19 Vaccination [Pfizer-BioNTech]During Pregnancy With Neonatal and Early Infant Outcomes: “Maternal BNT162b2 vaccination in pregnancy was not associated with detrimental outcomes to the offspring.”

NYC set to fire nearly 3,000 unvaccinated employees: “The city requires its workforce of 370,000 — teachers, police, firefighters, office staff and others — to get at least one dose of the coronavirus vaccine by Friday. Nearly 95 percent have received at least one dose…”

New Report Finds 82% of Patients Still Experience Medication Delays, Despite Healthcare Industry Advancements:New data…[from] CoverMyMeds found 82% of patients experienced medication delays in the last year due to COVID-19 restrictions, insurance processes, communication challenges and prescription cost. Of patients who experienced medication delays, 85% had to make financial sacrifices to afford their prescriptions…
In addition to medication delays, many patients also postponed medical visits in the past year. According to the 2022 Medication Access Report, 84% of patients delayed or skipped in-person healthcare visits, mostly due to COVID-19 fears or a scarcity of appointments, contributing to an estimated 500 million missed diagnostic visits and more than 15 million fewer new prescriptions.”

How much 7 drugmakers are earning from COVID-19 treatments: FYI
And in a related article: Lilly back in COVID-19 antibody game with $720 million deal with U.S. for omicron-busting hopeful: “The U.S. has agreed to a $720 million deal for bebtelovimab, the company announced on Thursday. Lilly has submitted its request for an emergency use authorization, and contingent upon an FDA nod, the company will supply 600,000 courses of the treatment for high-risk patients with mild-to-moderate COVID-19.”

About health insurance

 2021 AMA prior authorization (PA) physician survey: Among other findings, this AMA member survey found the following:
—”24% of physicians report that PA has led to a patient’s hospitalization.
—18% of physicians report that PA has led to a life-threatening event or required intervention to prevent permanent impairment or damage.
—8% of physicians report that PA has led to a patient’s disability/permanent bodily damage, congenital anomaly/birth defect or death.”
Undoubtedly, insurers will push back on the necessity of PA for cost and quality reasons.

Even insured Americans lack funds for out-of-pocket medical costs, new Aflac Care Index shows Nationwide survey reveals the financial implications of medical bills not covered by insurance and identifies the 11 most at-risk states: “According to the Aflac Care Index, 24% of respondents report having no money in their savings accounts and 48% say they have $1,000 or less. Further exacerbating the situation is that 33% of insured Americans cannot go more than one week without a paycheck, while 71% cannot endure a month without pay, leading many (25%) to have to borrow money in the event of a medical emergency, almost a quarter (22%) saying they would need to find an additional job, and 6% would have to file bankruptcy. At the same time, approximately three-quarters of insured respondents underestimate their financial exposure to common medical challenges, such as heart disease (79%) and breast cancer (73%).”

Association Between Hospice Enrollment and Total Health Care Costs for Insurers and Families, 2002-2018: “In this cohort study, hospice use by community-dwelling Medicare beneficiaries was associated with significantly lower total health care costs across all payers in the last 3 days to last 3 months of life. We found no evidence of cost shifting from Medicare to families and families had significantly lower out-of-pocket health care costs in the last 3 days to last month of life when patients enrolled with hospice.”

Signify Health Buying Caravan Health for $250 Million: “The transaction also includes contingent additional payments of up to $50 million based on the future performance of Caravan, which will join Signify Health in supporting a wide spectrum of advanced payment models.
With the acquisition, Signify adds Caravan's more than 200 health systems and 100 Federally Qualified Health Centers with more than 10,000 primary care providers that collectively manage over 500,000 patients.
The combination supports Signify Health's diversification strategy to offer a comprehensive platform and solution set supporting and integrating episodes and total cost of care risk arrangements across Medicare programs.”

Molina Healthcare revenue up 43% to $27.8B: 6 things to know: “The payer reported $659 million in net income, down 2 percent over 2020's year-end income. The medical care ratio for 2021 was 88.3 percent, up 1.7 percentage points from 2020's. Molina Healthcare set a $29.5 billion revenue outlook for 2022, representing an increase of 6 percent.”

South Florida Medical Clinic Owner Sentenced to 10 Years in Prison for Orchestrating $42 Million Health Care Fraud Conspiracy: “Yesterday, a federal district judge in Miami sentenced Bradley Jason Kantor, 49, of Key Largo, Florida, to 10 years in federal prison for submitting approximately $42 million in fraudulent health care claims to United Healthcare.
From April 2013 to March 2017, Kantor owned and operated Mobile Diagnostic Imaging, Inc. (“MDI”), a medical clinic in Davie, Florida that purported to provide antigen therapy and other allergen immunotherapy services, such as allergy testing and allergy shots, to commercial insurance beneficiaries.  Kantor offered and paid kickbacks to co-conspirators to induce them to refer beneficiaries to MDI, so that MDI could bill commercial insurers for services that it never provided.”

Ten Indicted for Healthcare Kickbacks: “Ten people, including two medical doctors, have been indicted in a $300 million healthcare fraud, announced U.S. Attorney for the Northern District of Texas Chad E. Meacham…
According to the indictment, the founders of several lab companies, including Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs LLC, allegedly paid kickbacks to induce medical professionals to order medically unnecessary lab tests, which they then billed to Medicare and other federal healthcare programs.
The medical professionals -- including internal medicine specialist Eduardo Canova, family medicine practitioner Jose Maldonado, and nurse practitioner Keith Wichinski – allegedly accepted the bribes and ordered millions of dollars’ worth of tests.
Meanwhile, Unified, Spectrum, and Reliable disguised the kickbacks as legitimate business transactions, including as medical advisor agreement payments, salary offsets, lease payments, and marketing commissions.”


About hospitals and healthcare systems

 Prospect to sell Crozer to ChristianaCare: “Newark, Del.-based ChristianaCare plans to acquire Springfield, Pa.-based Crozer Health from Los Angeles-based Prospect Medical Holdings after signing a letter of intent.
Through the deal, ChristianaCare would also take over Crozer's related businesses, real estate assets, Crozer Health Medical Group, associated assets, ambulatory centers, medical office buildings, physician clinics and ancillary outpatient services, according to a Feb. 11 news release…
Crozer, which has about 4,000 employees, will return to a nonprofit organization once the deal is finalized.”

About pharma

Pharma R&D Pipeline and New Product Launches Reach Record Levels in 2021 According to New IQVIA Institute for Human Data Science Report: Highlights of the study:

  • “Clinical trial activity saw sustained growth through the pandemic with 5,500 new planned clinical trial starts in 2021, a 14% increase over 2020

  • The total number of products in active development exceeded 6,000, up 68% from 2016

  • A record 84 novel active substances were initially launched globally in 2021, double the number of five years ago

  • The composite R&D success rate across all therapy areas declined to 5% in 2021, due to the more challenging clinical development programs being deployed

  • Emerging biopharma companies are responsible for a record 65% of the molecules in the R&D pipeline — up from less than 50% in 2016”

 FDA panel gives thumbs down to Lilly, Innovent's China-developed cancer drug: A “follow-on” to yesterday’s article about FDA’s caution approach to Chinese studies:
”An FDA advisory panel voted 14 to 1 on Thursday that Eli Lilly and Innovent Biologics should conduct more trials of their anti-PD-1 antibody sintilimab in order to win US approval. The vote comes days after FDA staff scientists concluded that a Chinese study used to support the drug's administration in first-line non-small-cell lung cancer (NSCLC) had several shortcomings and its results were not applicable to US patients.”

Researchers restore function in a gene that can suppress liver cancer and enhance immunotherapy: “A team of researchers from Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH) has reprogrammed the tumor microenvironment of liver cancer by using mRNA nanoparticles. This technology, similar to the one used in COVID-19 vaccines, restored the function of the p53 master regulator gene, a tumor suppressor mutated in not just liver but also other types of cancer. When used in combination with immune checkpoint blockade (ICB), the p53 mRNA nanoparticle approach not only induced suppression of tumor growth but also significantly increased antitumor immune responses in hepatocellular carcinoma (HCC) laboratory models.”

About the public’s health

 CMS expanding coverage for low-dose CT lung cancer screening: “CMS’ final decision will expand eligibility for Medicare beneficiaries to receive such lifesaving screenings by dropping the starting age from 55 down to 50 years old. The agency will also reduce the tobacco smoking history threshold from at least 30 packs per year down to at least 20, according to an announcement.”

The 10 States With the Longest Life Expectancy: At the top is Hawaii. “Nine of the 10 states with the lowest life expectancy in 2019 were located in the South.”  For a full report, see this CDC website.

CDC proposes softer guidance on opioid prescriptions: The current, 6 year old, recommendations have fixed dose limits. The proposed changes call for more individualized doses- the minimum needed to control pain.
And in a related article: Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court: “Doctors have wide latitude to prescribe drugs, including potentially dangerous ones, but even they face limits. The question is, what threshold do physicians have to cross — and what sort of intent do they need to have — for their prescribing to be considered a crime?
It’s an issue headed to the Supreme Court next month, in a case concerning two physicians who were convicted of unlawfully dispensing opioid painkillers.”

Evaluation of Statewide Restrictions on Flavored e-Cigarette Sales in the US From 2014 to 2020: “Were statewide restrictions on flavored e-cigarette sales in Massachusetts, New York, Rhode Island, and Washington associated with a reduction in total e-cigarette unit sales from 2014 to 2020?
Findings  In this cross-sectional study, a difference-in-differences analysis of e-cigarette retail data showed that statewide restrictions on non–tobacco-flavored e-cigarette sales were associated with reductions of 25.01% to 31.26% in total e-cigarette unit sales compared with total sales in states without restrictions. The reductions were attributable mostly to decreases in non–tobacco-flavored e-cigarette sales.”

Uterine Cancer Mortality Now Neck and Neck With Ovarian Cancer: “Uterine cancer has pulled even with ovarian cancer as a leading cause of gynecologic cancer mortality, accompanied by an ‘alarming’ racial disparity, a large epidemiologic study showed.
Annual uterine cancer mortality declined from 4.3 to 4.0 per 100,000 women from 1990 to 1997, then increased to 5.1/100,000 in 2019, representing a 1.7% annual increase. In contrast, ovarian cancer mortality decreased from 9.3/100,000 in 1990 to 6.0/100,000 in 2019 (-2.7%/year from 2010-2019).”

About healthcare IT

 UnitedHealth rolls out new virtual options for dental care: “UnitedHealthcare Dental is launching multiple digital resources aimed at making it more convenient for members to manage their oral health, the insurer announced this week.
UHC will enhance its 24/7 virtual dental benefit to provide two free virtual visits with a dentist per year, an upgrade that will be made available to fully insured employer plans. During these visits, members can seek advice telephonically or via video about acute oral health needs, as well as find guidance on where to access care in-person if needed.”

Outpatient telehealth use soared early in the COVID-19 pandemic but has since receded: “Prior to the onset of the pandemic in the United States, telehealth use was a negligible share (rounding to 0%) of outpatient visits. Many enrollees have had increased access to telehealth services over the last two years. During this period, telehealth use soared from less than 1% of outpatient visits before the pandemic to 13% of outpatient visits in the first 6 months of the COVID-19 pandemic. This rate declined to 11% during the next 6-month period, and then to 8% a year into the pandemic (March-August, 2021).”

About healthcare personnel

 Medicine’s Worst-Paying Specialty Is Luring Billions From Wall Street : “U.S. companies focused on primary care raised about $16 billion from investors in 2021, according to unpublished research by Harvard scholars. That’s more than four times the amount invested in 2020 and up from just $15 million reported in 2010, they said.”
The entire article is well-worth reading for an explanation of how primary care is essential for delivery of risk-based, value-driven care models.

If 1 in 5 healthcare workers have quit, where have they gone?: “When looking at the national numbers, based on Bureau of Labor Statistics data, the overall healthcare workforce is only down 2.7 percent from February 2020…
That number is mostly in nursing homes, she added. When looking at just hospitals, the workforce is down 1.8 percent from February 2020. 
This means many people who quit their jobs are being hired in other healthcare jobs. Or as some leave, others are being hired…”

Today's News and Commentary

Luc Montagnier, Nobel-winning virologist who co-discovered HIV, dies at 89: “The lab of Dr. Montagnier… discovered HIV, the drug-resistant virus that was later found to cause AIDS…Dr. Montagnier and his team fought for recognition from the scientific community, which ignored and sometimes scorned their early research.
Ultimately, the work done by Dr. Montagnier and his colleagues — including Françoise Barré-Sinoussi who detected telltale viral activity in the original sample — paved the way for an HIV blood test, spurred the development of AIDS drugs and therapies, and earned the two Pasteur scientists a share of the Nobel Prize in physiology or medicine in 2008.”

About Covid-19

COVID cases surpass 400 million as Omicron grips world: “It took over a month for COVID cases to reach 400 million from 300 million, compared to five months for the cases to reach 300 million from 200 million, according to a Reuters tally. The pandemic has killed over 6 million people worldwide.”

 Covid-19 hospitalizations drop below 100,000 in the US, but heavy burden persists : “For the first time in more than a month, there are fewer than 100,000 hospital beds in use for patients with Covid-19 nationwide, according to data from the US Department of Health and Human Services.
That's a 38% drop from a few weeks ago, when Covid-19 hospitalizations reached a peak of more than 160,000 beds in use at one time.”

U.S. appeals court will not block order barring Biden federal staff vaccine mandate: “A U.S. appeals court panel on Wednesday declined to block a lower court ruling that President Joe Biden could not require federal employees to be vaccinated against the coronavirus.
By a 2-1 vote, the 5th Circuit Court of Appeals declined to stay the lower-court injunction. Judge Stephen A. Higginson dissented noting a dozen district courts rejected requests to block the vaccine rule while a single district judge issued an injunction.”

HHS awards another $66.5M for community-based vaccination programs: “The Department of Health and Human Services has released another $66.5 million toward community-based vaccination outreach programs across 38 states and the District of Columbia...
These awards are the fourth wave of American Rescue Plan funding and is intended to develop and support a community-based workforce able to reach those living in vulnerable and medically underserved communities.
Although initially announced as a $250 million investment, the latest round of awards bring the administration’s total to nearly $390 million.”

Researchers confirm newly developed inhaled vaccine delivers broad protection against SARS-CoV-2, variants of concern: “Scientists at McMaster University who have developed an inhaled form of COVID vaccine have confirmed it can provide broad, long-lasting protection against the original strain of SARS-CoV-2 and variants of concern…
Because inhaled vaccines target the lungs and upper airways where respiratory viruses first enter the body, they are far more effective at inducing a protective immune response, the researchers report.
The reported preclinical study, which was conducted on animal models, has provided the critical proof of concept to enable a Phase 1 clinical trial that is currently under way to evaluate inhaled aerosol vaccines in healthy adults who had already received two doses of a COVID mRNA vaccine.”

Hospital-acquired COVID-19 infections were rare through fall 2021: “Hospital-developed COVID-19 cases represent about 1.8% of COVID-19 hospitalizations and were potentially on the decline by the tail end of the pandemic’s delta wave, according to a patient data analysis conducted by electronic health record vendor Epic…
These hospital-developed COVID-19 infections—defined as hospitalized patients who tested negative on the day of or day after admission but then tested positive six or more days later—reached its peak on the week of Dec. 6, 2020, with 172 such cases.”

Oklahoma won't discipline physicians prescribing unproven COVID-19 treatments: “Physicians in Oklahoma are not prohibited from prescribing unapproved treatments such as ivermectin and hydroxychloroquine for the off-label purpose of treating COVID-19 patients, the state attorney general's office said Feb. 8. 
The office of Oklahoma Attorney General John O'Connor said it ‘finds no legal basis for a state medical licensure board to discipline a licensed physician’ for using their judgment and prescribing FDA-approved drugs for the off-label — when a drug approved for a specific disease or condition is prescribed for something else — purpose of treating COVID-19.”

Conflicting reports raise questions about whether any monoclonals work against Omicron’s sister variant: “A pair of conflicting reports released this week raised questions about whether the Covid-19 monoclonal antibody sotrovimab — the one such treatment that has continued to work against the Omicron variant — maintains its power against a sister form of the virus, BA.2.”
Read the article for more details.

About health insurance

 Provider groups push court to press pause on controversial surprise billing rule: “The American Medical Association, American Hospital Association and several other provider groups wrote in a legal filing Tuesday that a federal judge needs to quickly issue a stay of the final rule that governs the arbitration process for handling out-of-network charges. The groups pushed back over the arguments that the administration delivered last month.”

Former NFL Player Sentenced to Prison for Nationwide Health Care Fraud Scheme: “According to court documents, Robert McCune, 42, of Riverdale, Georgia, defrauded the Gene Upshaw NFL Player Health Reimbursement Account Plan (the Plan). The Plan was established pursuant to the NFL’s 2006 collective bargaining agreement. It provided former players, their spouses and their dependents, up to a maximum of $350,000 per player tax-free reimbursement of out-of-pocket medical care expenses that were not covered by insurance.
Court documents show that McCune submitted false and fraudulent claims to the Plan on his own behalf and on behalf of dozens of other former NFL players. Between June 5, 2017, and April 12, 2018, he submitted 68 claims for 51 other players. The claims typically sought reimbursement of $40,000 or more for expensive medical equipment such as hyperbaric oxygen chambers, ultrasound machines and electromagnetic therapy devices. None of the medical equipment described in the claims was ever purchased or received. In total, McCune and his co-conspirators submitted approximately $2.9 million in fraudulent claims to the Plan.”

'Big 6' payers ranked by 2021 revenue: “Here are the top 6 payers based on year-end revenue:

1. UnitedHealthcare: $223 billion

2. Cigna: $174.1 billion

3. Anthem: $137 billion* 

4. Centene: $126 billion

5. Humana: $83.1 billion

6. Aetna: $82.2 billion”

About hospitals and healthcare systems

 Semi-Annual Hospital Price Transparency Compliance Report: “Of the 1,000 total hospitals reviewed, we found:
—Only 14.3% were complying with the transparency rule.
—Only 37.9% of the hospitals posted a sufficient amount of negotiated rates, but over half werenot compliant in other criteria of the rule, such as rates by each insurer and named plan.
—Only 0.5% of hospitals owned by the three largest hospital systems in the country – HCAHealthcare, CommonSpirit Health, and Ascension – were in compliance.”

Three New Best Practices in the 2022-2023 Targeted Medication Safety Best Practices for Hospitals:
“New Best Practice 17: Safeguard against errors with oxytocin use…
New Best Practice 18: Maximize the use of barcode verification prior to medication and vaccine administration by expanding use beyond inpatient care areas…
New Best Practice 19: Layer numerous strategies throughout the medication-use process to improve safety with high-alert medications.”
Read the website for more details about these three new items.

Yale New Haven Health to acquire 2 Connecticut health systems: “Yale New Haven (Conn.) Health System agreed Feb. 10 to acquire two Connecticut health systems from Los Angeles-based Prospect Medical Holdings. 
The deal includes the Connecticut systems' related businesses, real estate assets, physician clinic operations and outpatient services, according to a news release from Yale New Haven Health.”

Ascension, Labcorp partnership brings expanded testing to hospital labs: “According to a Feb. 9 news release shared with Becker's, Labcorp will manage Ascension's hospital-based labs in 10 states: Alabama, Florida, Kansas, Maryland, Michigan, New York, Oklahoma, Tennessee, Texas and Wisconsin…
 Labcorp and Ascension anticipate the transactions will close in the first half of 2022.”

About pharma

 Biotechs face cash crunch after stock market ‘bloodbath’ : “Biotech groups, most of them lossmaking, raised a record $32.7bn in initial public offerings over the past two years, according to data from Refinitiv. But 83 per cent of recently listed US biotech and pharma stocks are now trading below their IPO price. Biotech groups that listed in 2021 are trading on average 37 per cent below their IPO price, compared with a 22 per cent fall for all newly US-listed companies. Many such companies raised money through IPOs with the expectation that they would be able to tap investors for fresh funds in subsequent share sales as their drugs progressed through the research and development cycle.”

EMA launches new centre to gather real-world health data for drug regulation: “The European Medicines Agency on Wednesday announced the set-up of a coordination centre that will be key to its efforts to incorporate real-world evidence (RWE) into the regulation of medicines in Europe. It is working with Erasmus University Medical Center Rotterdam to establish the centre, which will form part of the broader Data Analysis and Real World Interrogation Network (DARWIN EU) project, to supply RWE requested by the EMA itself and EU member states' regulators.
DARWIN EU will connect Europe's drug regulatory network to the so-called European Health Data Space (EHDS), an initiative intended to improve the exchange and access to different types of health data. The objective is to assemble a network of real-world health data sources that will provide ‘valid and trustworthy’ RWE from across Europe on things like diseases, patient populations, and the uses and performance of medicines.”

Were Prescription Drug Prices the Fastest-Growing Commodity or Service in 2021?: “Key takeaways:  —Prescription medication prices are no longer the fastest-growing commodity or service. In 2021, the cost of car rentals, tobacco, beef, and moving expenses all outpaced the cost of prescription drugs.
—However, prescription drug costs have still increased 2.5% since the start of the pandemic. 
—Prescription drug prices have also historically grown faster than the rate of inflation. Since 2014, drug prices have increased 35%, while the cost of all items and services has increased 19%.” 

About the public’s health

 Single accountable figure to lead new health and care ‘place boards’ : As our country looks for better organizational models to deliver healthcare, this British proposal calls for a single local head to coordinate both health and social welfare services.
”A white paper, published this afternoon, endorses a model featuring an integrated health and social care board at a 'place' level - more localised than integrated care systems (ICSs). It is at this place board level that budgets would be pooled or aligned, and the single accountable leader would operate.
The white paper, Health and Social Care Integration: joining up care for people, places and populations, says all places with an ICS will be expected to adopt the government’s ‘place-board’ governance model or an equivalent which achieves the same aims, by spring 2023.”

About healthcare IT

 CY2022 Telehealth Update Medicare Physician Fee Schedule: From CMS, a short explanation of telehealth billing; it goes into effect April 1, 2022. 

5 Healthcare Trends for 2022: Some highlights:
72% of U.S. adults read online patient ratings and reviews when considering the decision of a healthcare facility or physician. 

50% of U.S. adults read 10+ reviews, and 23% read 20 or more when selecting care. 

55% of Millennials have selected one physician or location over another based on online reviews. 

72% of healthcare consumers want the provider they choose to be rated 4 out of 5 stars or higher. 

65% of respondents say it’s important for providers to respond to reviews. 

Google is also the #1 review site used by healthcare consumers. 

Brand loyalty is declining everywhere…Among Millennials, the largest population segment in the United States, only 19% say they would choose a physician based on their connection to a brand.”

Today's News and Commentary

About Covid-19

 Updated Pediatric COVID-19 Vaccination Operational Planning Guide — Information for the COVID-19 Vaccine for Children 6 Months–4 Years Old: From the CDC: “This operational planning guide includes details about the anticipated Pfizer-BioNTech product and may be updated as other manufacturers submit applications for FDA review…
 There are approximately 18 million children ages 6 months through 4 years in the United States. The U.S. government has procured enough vaccine to support vaccination of this population, pending FDA EUA and CDC recommendation. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on February 15, 2022. ACIP is anticipated to meet within several days of VRBPAC; the meeting will be posted here once scheduled: https://www.cdc.gov/vaccines/acip/index.html.

U.S. CDC stands by K-12 school masking guidance as states relax rules –Walensky: “With COVID-19 cases still high nationwide, "now is not the moment" to drop mask mandates in schools and other public places, U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky told Reuters on Tuesday.”

J.&J. Pauses Production of Its Covid Vaccine Despite Persistent Need: “A crucial Johnson & Johnson plant has stopped making its Covid vaccine, though the company says it has millions of doses in inventory…
[T]he American company… late last year quietly shut down the only plant making usable batches of the vaccine, according to people familiar with the decision.
The facility, in the Dutch city of Leiden, has instead been making an experimental but potentially more profitable vaccine to protect against an unrelated virus.
The halt is temporary — the Leiden plant is expected to start churning out the Covid vaccine again after a pause of a few months — and it is not clear whether it has had an impact on vaccine supplies yet, thanks to stockpiles.”

The CDC’s do-not-travel list now encompasses more than half the world’s destinations: “The Centers for Disease Control and Prevention has moved seven more countries to its highest-risk category for travel — a list that has grown to include 134 destinations, with many added since the World Health Organization declared omicron a “variant of concern” on Nov. 26.
The CDC on Monday gave the Democratic Republic of Congo, Oman, Libya, Japan, Israel, Cuba and Armenia a “Level 4″ warning, which means it is recommending that Americans avoid traveling there, even if vaccinated.”

HHS is running out of money to pay doctors to treat uninsured COVID-19 patients: “Federal program which reimburses healthcare workers who care for uninsured COVID-19 patients, is expected to run out of money by spring or summer.
The Provider Assistance Fund has paid more than $17 billion to treatment, testing and vaccination providers for the uninsured throughout the pandemic. The Department of Health and Human Services program has become a lifeline for health care providers, especially in states like Texas and Florida, where the percentage of people without health insurance is high.”
Relief funds are not just paying doctors. In a related story: Travel Nurses Make Twice as Much as They Did Pre-Covid-19: “Hospitals and lawmakers are pressing the Biden administration to review federal pandemic-relief programs that they say have distorted pay rates for travel nurses.”

About health insurance

 Anthem rolling out virtual primary care to plans in 11 states: “The expansion will roll out the offering to fully insured plans and select large group administrative services clients in Colorado, Connecticut, Georgia, Indiana, Kentucky, Missouri, Nevada, New York, Ohio, Virginia and Wisconsin, the company said. Eligible members can access a virtual care team that will conduct an initial health check-in and then craft a personalized care plan.
The insurer is expecting a significant number of its administrative services clients to adopt the platform over the course of this year.”

Obamacare Insurers Use Tech, Tenacity to Keep Customers on Board: “Every year, roughly 10% of marketplace plan members have their coverage terminated for nonpayment or other reasons. To maintain the new bumper crop of enrollees, some insurers will use artificial intelligence, advanced analytics, and machine learning to identify members most likely to let their policies lapse. Eventually, all carriers will target their at-risk enrollees with phone calls, emails, texts, and letters.”

Highmark Makes a $245M Impact in the Fight Against Healthcare Fraud, Waste and Abuse in 2021: “Highmark's Financial Investigations and Provider Review (FIPR) department generated more than $245 million in savings related to fraud, waste and abuse in 2021, and has made a cumulative financial impact of nearly $1 billion in such activity since 2017…
FIPR's 2021 savings included approximately $184 million in activity related to billing/coding errors, fraud, waste and abuse in Pennsylvania, $25 million in West Virginia, and $23 million in Delaware.”

Bay City Vascular Surgeon Pleads Guilty in Connection with Defrauding Medicare, Medicaid, And Blue Cross Blue Shield Of $19.5 Million: “According to the plea agreement, [Dr. Vasso] Godiali began knowingly defrauding the three medical insurers in approximately 2009 and did so by causing the submission of false billing to all three insurers. As evidenced in the plea agreement, Godiali’s false and fraudulent billing includes admissions related to claims for the placement of stents in dialysis patients and for the treatment of arterial blood clots. Godiali admitted that he billed for the placement of multiple stents in the same vessel, and prepared medical records purporting to document the medical necessity justifying that billing. In fact, Godiali did not place those stents, and he admitted to billing the insurers for services never rendered while preparing materially inaccurate medical records to justify the fraudulent billing.”

Health Connector offering health insurance sign up on Mass income tax form: Interesting idea: “The Massachusetts Health Connector’s new Simple Sign-up program will let uninsured residents check a box on their state tax forms and start the process of getting health insurance. This will allow the Department of Revenue (DOR) to forward the tax filer’s information to the Health Connector, which will then create and send information to the tax filer to help them obtain the best health plan.”

About hospitals and healthcare systems

 Health Care Paradox: Medicare Penalizes Dozens of Hospitals It Also Gives Five Stars: “The federal government has penalized 764 hospitals — including more than three dozen it simultaneously rates as among the best in the country — for having the highest numbers of patient infections and potentially avoidable complications….
This year’s list of penalized hospitals includes Cedars-Sinai Medical Center in Los Angeles; Northwestern Memorial Hospital in Chicago; a Cleveland Clinic hospital in Avon, Ohio; a Mayo Clinic hospital in Red Wing, Minnesota; and a Mayo hospital in Phoenix. Paradoxically, all those hospitals have five stars, the best rating, on Medicare’s Care Compare website.”

100 top critical access hospitals, by state: FYI: “The Chartis Center for Rural Health recently released its annual list of the top 100 critical access hospitals in the U.S.”

About pharma

 Amgen reports revenue bump in Q4, but Enbrel slides: “The company said revenues in the last three months of 2021 were driven by an increased contribution from the collaboration it has to help make Eli Lilly's COVID-19 antibody treatment. It did not say how much it received from the arrangement in the period, but Amgen recorded $575 million listed under ‘other revenue’ in its quarterly report.
Meanwhile, product sales were down 1% during the period because while unit volumes grew, Amgen said this gain was ‘more than offset by lower net selling price and lower inventory levels,’ which notably affected Enbrel. Still, the company did see double-digit volume growth on some key products such as Prolia, Mvasi, Repatha and Evenity.”

GSK's Q4 results boosted by sales of COVID-19 treatment: “GlaxoSmithKline noted that fourth-quarter sales of prescription drugs were mainly driven by new and specialty products. Sales of Xevudy, a monoclonal antibody for the treatment of COVID-19, reached £828 million ($1.1 billion), topping estimates of £774 million ($1 billion), contributing approximately 20 percentage points to pharmaceuticals growth.”

FDA wary of drugs developed in China: “The FDA is concerned about the quality of studies evaluating cancer drugs and other new medicines developed in China, The Wall Street Journal reported Feb. 9…
Drug industry analysts said the FDA's reservations may mean Chinese biotech companies and their Western partners will need to lead additional U.S.-based tests for their proposed drugs.”

Regular Acetaminophen Use and Blood Pressure in People With Hypertension: The PATH-BP Trial: “Regular daily intake of 4 g acetaminophen increases systolic BP in individuals with hypertension by ≈5 mm Hg when compared with placebo; this increases cardiovascular risk and calls into question the safety of regular acetaminophen use in this situation.”
If confirmed, this finding could indicate a major problem in treating these patients, since NSAID drugs have the same effect.

About the public’s health

 Appeals court rules in Biden’s favor on abortion referrals: “Federally funded family planning clinics can continue to make abortion referrals for now, a federal court ruled Tuesday, in a setback for a dozen Republican attorneys general who have sued to restore a Trump-era ban on the practice.
The 6th U.S. Circuit Court of Appeals in Cincinnati denied a request by the 12 states to pause rules for the federal government’s family planning program while their case is heard. The states were eager to stop implementation before the next round of federal grants starts rolling out in March.”

Prevalence and Income-Related Disparities in Thirdhand Smoke Exposure to Children: “Nicotine was detected on the hands of 189 of 193 children (97.9%) reportedly exposed…and on the hands of 296 of 311 children (95.2%) reportedly protected from exposure to tobacco products…. In multivariable linear regression models, child age, family income, parent tobacco use, home smoking rules, and the number of tobacco users with whom a child had contact were significantly associated with hand nicotine…. Children aged 2 to 4 years, from low-income homes, whose parents used any tobacco products, with multiple contacts with tobacco users, and without complete smoking bans had the highest hand nicotine levels…. Children from lower-income families benefited significantly more from tobacco protections compared with children from higher-income homes…”
What is surprising is the unexpectedly high rate of nicotine detection in houses reported as non-smoking.

About healthcare IT

 Guidelines for US Hospitals and Clinicians on Assessment of Electronic Health Record Safety Using SAFER Guides: “On August 13, 2021, the Centers for Medicare & Medicaid Services (CMS) released a final rule requiring eligible hospitals to attest annually that they performed a safety assessment of their electronic health record (EHR) system using SAFER (Safety Assurance Factors for EHR Resilience) Guides.1 This milestone affects virtually all US hospitals, but there is no specific guidance on how hospitals should perform a self-assessment of these recommended practices. To address this gap, pragmatic guidelines were developed to provide a streamlined, stepwise approach for conducting a systematic EHR safety assessment that optimizes organizational resources, minimizes process inefficiencies, and maximizes EHR vendor involvement.”
The essence of the recommendations is in the online supplement to the article:
1  Identify the SAFER assessment team…

2  Determine which recommendations require EHR vendor action or attestation…

3  Meet synchronously and asynchronously…

4  Document and communicate implementation status…

5  Prioritize and address unmet SAFER recommendations…”

Health insurers may be using biased machine learning models. Here’s how to fix them: “In an analysis published in Health Affairs, researchers from Independence Blue Cross, the Massachusetts Institute of Technology and the University of California Berkeley identified several areas where bias can arise in machine learning tools used by health insurers and outlined recommendations for tackling those issues.”

Indicators of Compromise Associated with LockBit 2.0 Ransomware and Additional Mitigations: “A warning from HHS’s cybersecurity program: “LockBit 2.0 operates as an affiliate-based Ransomware-as-a-Service (RaaS) and employs a wide variety of tactics, techniques, and procedures, creating significant challenges for defense and mitigation. The indicators of compromise (IOCs) and malware characteristics outlined in this Report were derived from field analysis and are current as of February 2022.”

Amazon expanding healthcare service to 20 more cities, lands Silicon Labs, Whole Foods Market as customers: “The online retailer has inked deals to provide healthcare services to Silicon Labs, TrueBlue and Whole Foods Market, the company announced Tuesday. These companies join Precor, a Washington-based fitness equipment company that was acquired by Peloton, and Hilton as clients Amazon has publicly disclosed.”  

Today's News and Commentary

Biden’s top science adviser bullied and demeaned subordinates, according to White House investigation: “President Joe Biden’s top science adviser, Eric Lander, bullied and demeaned his subordinates and violated the White House’s workplace policy, an internal White House investigation recently concluded, according to interviews and an audio recording obtained by POLITICO”
The investigation led to Lander’s resignation last night..

Press Ganey Announces Plans to Acquire Forsta -- a Leader in the 2021 Gartner® Magic Quadrant™ for Voice of the Customer -- to Accelerate Innovation in the Global Healthcare Experience Industry: Press Ganey, a renowned leader in patient, member, employee and consumer experience across the healthcare ecosystem, today announced its plans to acquire Forsta, an industry-leading global provider of customer experience and market research technology. Forsta is named a Leader in the 2021 Gartner® Magic Quadrant™ for Voice of the Customer. The transaction is expected to close in the first or second calendar quarter of 2022, and is subject to regulatory approvals and other customary closing conditions.”

About Covid-19

Biden officials trying to recalculate U.S. Covid-19 hospitalizations: “A task force comprised of scientists and data specialists at the Department of Health and Human Services and the Centers for Disease Control and Prevention are working with hospitals nationwide to improve Covid-19 reporting. The group is asking hospitals to report numbers of patients who go to the facility because they have Covid-19 and separate those from individuals who go in for other reasons and test positive after being admitted…”

 Pharmacies feel stiffed on COVID pill payments: “Some pharmacies are getting paid as little as $1 to dispense the COVID antiviral pills made by Pfizer and Merck.” Dispensing fees from commercial insurers are all “lower than the federal government's dispensing fee for uninsured patients, which is $12.”
Why it matters: Most pharmacies want to offer the drugs, especially the one from Pfizer that drastically cuts the odds of hospitalization and death. But low payments could hurt Americans' ability to access the pills in some areas if pharmacies decide they can't afford to stock them.”

CMS Issues Over-the-Counter Coronavirus Testing Guidance: “CMS released guidance around the over-the-counter coronavirus testing requirement, providing greater clarity regarding what kinds of direct-to-consumer access mechanisms fall under compliance and answering questions related to testing shortages and fraud.
The guidance explained that the requirement to provide adequate access to over-the-counter coronavirus tests entails establishing an in-person method of receiving the tests and a direct-to-consumer shipping option.”

Durability of Anti-Spike Antibodies in Infants After Maternal COVID-19 Vaccination or Natural Infection: “This study found that the majority of infants born to COVID-vaccinated mothers had persistent anti-S antibodies at 6 months, compared with infants born to mothers with SARS-CoV-2 infection.” Another piece of evidence that Covid-19 vaccination can afford better protection than natural infection.”

CDC to recommend faster Covid-19 boosters for certain immunocompromised people: “The CDC has been recommending that immunocompromised people who got an mRNA vaccine get an additional booster, a fourth shot, at least five months after their third shot. It's going to revise these guidelines to encourage a booster at three months instead. This applies to people 18 and older who got the Moderna vaccine and people 12 and older who got the Pfizer/BioNTech vaccine.”

Governors in 4 states plan for end to school mask mandates: “The governors of four states announced plans Monday to lift statewide mask requirements in schools by the end of February or March, citing the rapid easing of COVID-19′s omicron surge.
The decisions in Connecticut, Delaware, New Jersey and Oregon were announced as state and local governments grapple with which virus restrictions to jettison and which ones to keep in place. The changes also come amid a growing sense that the virus is never going to go away and Americans need to find a way to coexist with it.”

About health insurance

 Centene hits $126B in 2021 revenue, up 13%: 10 things to know: Some highlights: “Centene hit the top end of its 2021 revenue outlook, landing at $126 billion largely thanks to Medicare and Medicaid growth….
The revenue growth was attributed to both Medicare and Medicaid membership growth, as well as acquiring Pantherx and Circle Health….
Revenue growth contributed to a reported $598 million in fourth quarter profits and $3 billion in year-end profit.”

About hospitals and healthcare systems

Healthgrades Announces 2022 America's Best Hospitals™: Check the website for state-by-state listings in different categories.

 States Move to Protect Hospital Patients from Heavy Medical Debt: “More states are imposing new limits on hospital billing practices, making fresh attempts to help patients avoid heavy medical debts. 
At least 10 states, including Connecticut, Maryland, New Mexico and Maine, enacted laws last year with a range of provisions affecting healthcare providers and collection agencies, including requirements for hospitals to provide financial assistance to people with low incomes or limit aggressive debt-collection practices. Other states, including Washington and Vermont, are currently considering bills to add or bolster consumer medical-billing protections.”

 Tenet sees annual profit more than double, plans to retire $700M of debt: “Dallas-based Tenet Healthcare ended 2021 with a net income from continuing operations of $915 million, more than doubling the $399 million recorded the same period one year before. 
The for-profit hospital operator said its results for the year ending Dec. 31, 2021, included a pre-tax gain of $406 million associated with the divestiture of five Miami-area hospitals, as well as stimulus funds totaling $205 million. In 2020, Tenet recorded grant income of $899 million.”

About pharma

 FDA Resumes Domestic Inspections: “The FDA resumed normal domestic inspections of device facilities yesterday, citing the declining rates of COVID-19 cases across the country.
The FDA had announced on Dec. 29 that it was temporarily suspending many of its domestic and foreign inspections due to fast-spreading SARS-CoV-2 Omicron variant. The agency said it will continue to use a variety of tools to conduct both domestic and foreign mission-critical inspections, including remote assessments.”

CVS teams with Medable to expand access to clinical trials: “CVS Health is teaming up with Medable to access and engage around clinical trials at select MinuteClinics, the healthcare giant announced Monday.
CVS Health Clinical Trial Services, a new arm at the company launched last May, will harness Medable's software platform to deliver clinical trials with a focus on accessibility and retention to enhance the effectiveness of research, according to the announcement.”

PBMs ranked by market share: CVS Caremark is No. 1: “Three companies dominate the pharmacy benefit manager market, accounting for 79 percent of all prescription claims in 2020, according to data from Health Industries Research Companies, an independent, non-partisan market research firm.”

About the public’s health

Commission on Combating Synthetic Opioid Trafficking: A fascinating bipartisan report sponsored by a number of governmental agencies. The Commission notes that illegal use has moved from prescription opioids, to heroin, to synthetics, especially fentanyl. The latter is easier and cheaper to produce than the other opioids.
To put the problem in perspective: “Higher potency allows cartels [mostly Mexican] to reduce volume and increase profits. The Commission estimated that only 3 to 5 metric tons of pure fentanyl is needed to satisfy the entire annual U.S. consumption of illegally supplied opioids—a fraction of the estimated 47 metric tons of heroin and 145 metric tons of cocaine that were consumed in the United States in 2016.” If you download the pdf, see Fig. S1 on page XV for a summary of recommendations.
In a related article: Texas Strikes $225M Deal With Teva Over Opioid Crisis

Inactivated and live-attenuated seasonal influenza vaccines boost broadly neutralizing antibodies in children: “Repeated seasonal vaccination results in significant boosting of a durable bNAb [broadly neutralizing antibodies] response. Boosting of serological bNAb titers is comparable within inactivated and live attenuated (LAIV) vaccinees and declines with age.”

Effectiveness of e-cigarettes as aids for smoking cessation: evidence from the PATH Study cohort, 2017–2019: “Sales increases in high nicotine e- cigarettes in 2017 did not translate to more smokers using these e-cigarettes to quit smoking. On average, using e-cigarettes for cessation in 2017 did not improve successful quitting or prevent relapse.”

Treatment of Tobacco Smoking: A Review: “Approximately 34 million people in the US smoke cigarettes and could potentially gain up to a decade of life expectancy by stopping smoking. First-line therapy should include both pharmacotherapy and behavioral support, with varenicline or combination NRT as preferred initial interventions.”

About healthcare IT

 How NFTs could transform health information exchange: “Personal (sometimes called “protected”) health information (PHI) is highly valued (1) and will become centrally important as big data and machine learning move to the forefront of health care and translational research. The current health information exchange (HIE) market is dominated by commercial and (to a lesser extent) not-for-profit entities and typically excludes patients. This can serve to undermine trust and create incentives for sharing data (2). Patients have limited agency in deciding which of their data is shared, with whom, and under what conditions. Within this context, new forms of digital ownership can inspire a digital marketplace for patient-controlled health data. We argue that nonfungible tokens (NFTs) or NFT-like frameworks can help incentivize a more democratized, transparent, and efficient system for HIE in which patients participate in decisions about how and with whom their PHI is shared.” 

Amazon Care rolls out telehealth services nationwide: “Amazon Care’s virtual health services are now available nationwide, and its in-person services will be rolled out in more than 20 new cities in 2022, Amazon said Feb. 8 in a post on its website.” 

About health technology

Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis:  “Here, we hypothesized that an arrangement of electrodes targeting the ensemble of dorsal roots involved in leg and trunk movements would result in superior efficacy, restoring more diverse motor activities after the most severe SCI. To test this hypothesis, we established a computational framework that informed the optimal arrangement of electrodes on a new paddle lead and guided its neurosurgical positioning. We also developed software supporting the rapid configuration of activity-specific stimulation programs that reproduced the natural activation of motor neurons underlying each activity. We tested these neurotechnologies in three individuals with complete sensorimotor paralysis as part of an ongoing clinical trial (www.clinicaltrials.gov identifier NCT02936453). Within a single day, activity-specific stimulation programs enabled these three individuals to stand, walk, cycle, swim and control trunk movements. Neurorehabilitation mediated sufficient improvement to restore these activities in community settings, opening a realistic path to support everyday mobility with EES in people with SCI.”
This technique is an extremely important innovation.

 

Today's News and Commentary

About Covid-19

CDC backs Moderna COVID-19 shots after full US approval: “The Centers for Disease Control and Prevention on Friday continued its endorsement of Moderna’s COVID-19 vaccine for adults, now that U.S. regulators have given the shots their full approval.
The decision has little practical effect. Tens of millions of Americans have already gotten Moderna shots, following its emergency authorization by the Food and Drug Administration more than a year ago. 
Earlier…, the FDA gave the product full licensure, following the kind of rigorous, time-consuming review given to other vaccines.”

 Walgreens, CVS lift rapid test purchase limits: Increased stocking of tests has eliminated limits in most locations.

 U.S. considers lengthening gap between first 2 COVID shots to 8 weeks: “U.S. health officials on Friday said they are considering lengthening the recommended interval between the first two doses of the most widely used COVID-19 vaccines to eight weeks to lower the risk of heart inflammation and improve their effectiveness.”

High Rates of Rapid Antigen Test Positivity After 5 days of Isolation for COVID-19: PREPRINT, NOT YET PEER REVIEWED.
”These results indicate that a substantial proportion [~40%] of individuals with COVID-19 are likely still contagious after day 5 of illness regardless of symptom status. Early liberation from isolation should be undertaken only with the understanding that inclusion of individuals on day 6-10 of illness in community or work settings may increase the risk of COVID-19 spread to others which, in turn, may undermine the intended benefits to staffing by resulting in more sick workers.”

16 states renew fight against CMS' vaccine rule: No, this article is not a few months old. It is from today.
”Sixteen state attorneys general asked a federal judge Feb. 4 to block the federal vaccine mandate for healthcare workers…  
Fourteen of the attorneys general are from the 24 states that were affected by the Jan. 13 Supreme Court decision that upheld CMS' vaccination mandate for eligible staff at healthcare facilities participating in the Medicare and Medicaid programs.”
As before, the issue claimed by the plaintiffs is that the requirements reduce the availability of already critical staff shortages. These shortages have become worse with omicron-variant infections.

About health insurance

 Association of Health Insurance Literacy With Enrollment in Traditional Medicare, Medicare Advantage, and Plan Characteristics Within Medicare Advantage: “In this cross-sectional study of 6627 Medicare beneficiaries, higher health insurance literacy—particularly, annual review and comparison of coverage choices—was associated with higher Medicare Advantage enrollment and choice of low-cost or high-rated Medicare Advantage plans. However, health insurance literacy was low among Medicare beneficiaries with low socioeconomic status.
Meaning  These findings suggest that policy makers should develop programs to make health insurance information accessible and understandable and to encourage annual review and comparison of coverage options, especially for vulnerable populations.”

Medical Crowdfunding and Disparities in Health Care Access in the United States, 2016‒2020: “Campaigns raised more than $2 billion from 21.7 million donations between 2016 and 2020. Returns were highly unequal, and success was low, especially in 2020: only 12% of campaigns met their goals, and 16% received no donations at all. Campaigns in 2020 raised substantially less money in areas with more medical debt, higher uninsurance rates, and lower incomes.
Conclusions. Despite its popularity and portrayals as an ad-hoc safety net, medical crowdfunding is misaligned with key indicators of health financing needs in the United States. It is best positioned to help in populations that need it the least.”

About pharma

 Top 10 most anticipated drug launches of 2022: FYI

FDA announces proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers: “FDA is announcing the availability of the proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providersas required by the Drug Supply Chain Security Act (DSCSA). The proposed rule, when finalized, would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain.
Requirements for wholesale drug distributors currently vary significantly across state lines creating a patchwork system. In passing DSCSA, Congress believed a uniform national standard would address this issue.”

The hits keep coming: Biogen's Aduhelm marketing, approval under fire in new FTC and SEC probes: “The Federal Trade Commission (FTC) and the Securities and Exchange Commission (SEC) have launched two separate investigations into Biogen and its troubled Alzheimer’s med, the company revealed in an annual securities filing Thursday.
The FTC has made a civil investigative demand—a type of administrative subpoena—in pursuit of documents related to Aduhelm’s marketing and approval, plus healthcare sites, the company said.
The SEC, meanwhile, has launched a separate inquiry that also seeks marketing and approval information on the beleaguered anti-amyloid antibody.”

In a victory for medical journals, Pacira loses a libel lawsuit over ‘faulty scientific research’ allegations: “A federal judge has dismissed an unusual libel lawsuit brought by Pacira BioSciences that claimed a medical journal, its editor, and the authors of several papers published articles that were based on “faulty scientific research” that portrayed its only medicine as ineffective.
Pacira alleged the papers, which were published early last year in the journal Anesthesiology, reflected a ‘bias’ against its Exparel painkiller and ‘disparaged’ the drug, as we noted at the time.”

Sanofi drops Pasteur, Genzyme names as it simplifies brand: “Sanofi on Thursday unveiled a new corporate brand and said that it will no longer use the Genzyme and Pasteur names as it moves forward with one shared identity. The overhaul follows a similar move made in 2011, when the company dropped Aventis from its name in an effort to simplify its brand.”

About the public’s health

 Weekly U.S. Influenza Surveillance Report: Some key points”

  • “The majority of influenza viruses detected are A(H3N2). Most of the H3N2 viruses identified so far this season are genetically closely related to the vaccine virus. Some viruses show antigenic differences that developed as H3N2 viruses have continued to evolve.

  • The percentage of outpatient visits due to respiratory illness decreased nationally again this week and is now below baseline. Influenza is contributing to levels of respiratory illness, but other respiratory viruses are also circulating. The relative contribution of influenza varies by location.

  • The number of hospital admissions reported to HHS Protect declined slightly again this week.

  • 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.”

Global urban temporal trends in fine particulate matter (PM2·5) and attributable health burdens: estimates from global datasets: “Although regional averages of urban PM2·5 concentrations decreased between the years 2000 and 2019, we found considerable heterogeneity in trends of PM2·5 concentrations between urban areas. Approximately 86% (2·5 billion inhabitants) of urban inhabitants lived in urban areas that exceeded WHO's 2005 guideline annual average PM2·5 (10 μg/m3), resulting in an excess of 1·8 million (95% CI 1·34 million–2·3 million) deaths in 2019. [Emphasis addded]Regional averages of PM2·5-attributable deaths increased in all regions except for Europe and the Americas, driven by changes in population numbers, age structures, and disease rates. In some cities, PM2·5-attributable mortality increased despite decreases in PM2·5 concentrations, resulting from shifting age distributions and rates of non-communicable disease.”

Workers of color and LGBTQ employees face healthcare inequity regardless of income: “Management consulting firm McKinsey and Company’s report on healthcare inequity in the workplace found that 69% of employees of color and 66% of LGBTQ employees who earn up to $100,000 a year experienced two or more unmet basic needs, such as personal safety, social support and food security. Meanwhile, only 49% of white employees felt similarly. Workers with one or more unmet basic needs were around 2.4 times more likely to have not received needed physical healthcare while focusing on immediate concerns like housing and safety.”

New highly virulent and damaging HIV variant discovered in the Netherlands: “Individuals infected with the new “VB variant” (for virulent subtype B) showed significant differences before antiretroviral treatment compared with individuals infected with other HIV variants:

• Individuals with the VB variant had a viral load (the level of the virus in the blood) between 3.5 and 5.5 times higher.
• In addition, the rate of CD4 cell decline (the hallmark of immune system damage by HIV) occurred twice as fast in individuals with the VB variant, placing them at risk of developing AIDS much more rapidly.
• Individuals with the VB variant also showed an increased risk of transmitting the virus to others.

Reassuringly, after starting treatment, individuals with the VB variant had similar immune system recovery and survival to individuals with other HIV variants. However, the researchers stress that because the VB variant causes a more rapid decline in immune system strength, this makes it critical that individuals are diagnosed early and start treatment as soon as possible.”

About healthcare IT

 Investment firm will take SOC Telemed private in deal valued at $300M: “Healthcare investment firm Patient Square Capital plans to take SOC Telemed private in a deal that values the company at roughly $304.2 million…
Founded in 2004, SOC provides acute telemedicine services to nearly 1,000 facilities, including more than 700 hospitals across 47 states and services 19 of the 25 largest health systems.”

About health technology

Scientists Reveal "Rosetta Stone" of Immune Cell Function: CRISPR genome editing has served as a powerful tool for deleting or altering DNA sequences and studying the resulting effect. A recent variation, known as CRISPRa, allows researchers to forcibly activate genes—rather than edit them—in human cells. Now, researchers at Gladstone Institutes and UC San Francisco (UCSF) have adapted the CRISPRa system to human immune cells…
The scientists activated each gene in the genome in different cells, enabling them to test almost 20,000 genes in parallel. This allowed them to quickly learn the rules about which genes provide the most powerful levers to reprogram cell functions in ways that could eventually lead to more powerful immunotherapies.”

 Abbott delivers first implant of its dual-chamber leadless pacemaker in a clinical study: “Abbott has taken a major step in the development of its dual-chamber leadless pacemaker technology, with the company’s first patient receiving two miniaturized, implanted devices within different areas of the heart that synchronize themselves wirelessly to help control the muscle beat by beat.
Traditional pacemaker systems have included a separate power generator placed under the skin near the collarbone, which then connects to the heart with a series of wires. But a new generation of leadless pacemakers, at about one-tenth the size, can be planted inside the heart itself and anchored directly to the muscle wall in a less invasive procedure.”

Zimmer Biomet plots $1B revenue for spine, dental spinoff ZimVie, sets launch date: “When the separation is complete, the standalone public company—dubbed ZimVie after its progenitor and the French word for “life”—will begin trading on the Nasdaq as ‘ZIMV.’ Zimmer Biomet will retain a stake of just under 20% of ZimVie’s outstanding shares of common stock, though the elder company said it would ultimately divest those shares in an unspecified ‘tax-efficient manner.’
The remaining 80% of ZimVie’s outstanding stock will go to current Zimmer shareholders, distributed as one ZimVie share for every 10 Zimmer shares they own.” 

Today's News and Commentary

About Covid-19

COVID-19 Vaccination Demographics in the United States, National: CDC’s comprehensive, current database of vaccination demographics.

Prevalence and Durability of SARS-CoV-2 Antibodies Among Unvaccinated US Adults by History of COVID-19: “In this cross-sectional study of unvaccinated US adults, antibodies were detected in 99% of individuals who reported a positive COVID-19 test result, in 55% who believed they had COVID-19 but were never tested, and in 11% who believed they had never had COVID-19 infection. Anti-RBD levels were observed after a positive COVID-19 test result up to 20 months, extending previous 6-month durability data.”

Vaccine refusal tied to 4,934 healthcare job cuts in January: U.S.-based companies announced 19,064 job cuts in January, and 5,757 workers lost their jobs because they refused to get vaccinated against COVID-19, according to a report from Challenger, Gray & Christmas, an executive outplacement and coaching firm. 
Of the job cuts for vaccine refusal in January, 4,934 were from healthcare providers, according to the report. The healthcare industry had the most job cuts in January, with 5,053.” 

 San Francisco allowing extra booster shot for Johnson & Johnson recipients: “In a break with federal guidance, San Francisco health officials are allowing adult residents who received the Johnson & Johnson coronavirus vaccine to get a second booster shot.”

About health insurance

Kaiser Permanente's special California Medicaid contract raises concerns: “California awarded Kaiser Permanente an exclusive Medicaid contract that would allow it to hand-pick enrollees as it grows in the state, according to Kaiser Health News. 
However, the contract, which was negotiated via a secret meeting between the payer and the state, raises concerns among Kaiser Permanente's competitors that the patients left for them will be riskier and potentially more costly…
In a statement, Kaiser Permanente said the plan was struck to uniquely help the payer — which also operates as a provider — to grow beyond its capacity.”

About hospitals and healthcare systems

 Hospital CEOs' No. 1 concern is staffing for 1st time in 17 years: “Hospital CEOs ranked personnel shortages as their No. 1 concern in 2021. Financial challenges, which consistently held the top spot since 2004, were listed the second-most pressing concern in the American College of Healthcare Executives' annual survey.”

This is why hospitals need more time to pay off Medicare loans: “The current payback terms, which Congress eased in 2020, start at 25% one year after the initial payment for 11 months. After that, the payback increases to 50% for six months. If everything is not paid off in these 29 months, the agency will set an interest rate of 4%.
In a  letter sent to President Joe Biden and Congressional leaders on Jan. 19, hospitals and health care systems have made a number of requests, including for loan repayment deferrals. The letter acknowledges that many providers have already paid the money in full.” The letter is short and worth reading.

About pharma

Estimation of Potential Savings Associated With Switching Medication Formulation: “In this study, we found that switching medication formulations can reduce expenditure on the drugs we analyzed by more than 40%.”

 Mallinckrodt wins approval of restructuring plan, opioid deal: “Pharmaceutical company Mallinckrodt PLC on Thursday won court approval of its reorganization plan, which includes a $1.7 billion settlement of opioid-related litigation, bringing its 16-month bankruptcy close to an end.
U.S. Bankruptcy Judge John Dorsey in Wilmington, Delaware signed off on the plan in a 103-page written decision. In addition to settling thousands of lawsuits accusing it of deceptively marketing its opioids, the plan allows Mallinckrodt to reduce $5.3 billion in debt by $1.3 billion and hands control of the reorganized company to creditors.” 

  About healthcare personnel

 Biden administration announces $19 million for new residency positions: “The Biden administration on Thursday made $19 million in grants available to train primary care residents in rural and under-served communities, part of an effort to address physician shortages. The funding will support an additional 120 residency slots at community-based ambulatory patient care centers. "This funding provides our primary care workforce with opportunities to train in areas where they can make a profound impact, and is one of the many steps we're taking to address long-standing health disparities," Health and Human Services Secretary Xavier Becerra said.” 

About diagnostics

 Labcorp launches online platform for ordering at-home tests, scheduling in-person appointments: “With Labcorp OnDemand, consumers can choose from a wide range of tests and multitest packages, all available without a physician’s referral. Depending on the type, the diagnostics can either be ordered for at-home sample collection or the buyer will be prompted to schedule an appointment at one of Labcorp’s patient service centers, 2,000 of which are located in Walgreens stores and standalone labs across the U.S.
Regardless of how the sample is collected, after it’s been processed by Labcorp, the results are automatically available on the OnDemand platform’s online portal. The resulting report not only explains each test’s results and highlights potential areas of concern but can also be shared with healthcare providers.”
This process is a marked departure from the requirement for a physician’s order for most tests. The question of insurance payment for such self-ordered tests was not discussed in the article. 

About Covid-19

Covid sufferers become infectious quicker than first thought, study shows: “The UK government-funded ‘human challenge’ trial found that levels of the Sars-Cov-2 virus in the nose and throat peaked after five days, though participants remained infectious for an average of nine days and a maximum of 12 days after exposure. The researchers said their results support guidance that people should quarantine for 10 days after they first feel Covid symptoms or have a positive test result. The study took place in a special unit at the Royal Free Hospital in London. Eighteen of the 34 volunteers aged 18 to 29 became infected after receiving a low dose of the original Sars-Cov-2 strain via droplets in the nose.”
Another important finding of the study was: “No quantitative correlation was noted between VL [viral load] and symptoms, with high VLs even in asymptomatic infection…”

KFF COVID-19 Vaccine Monitor: January 2022 Parents And Kids Update: “Key Findings

  • In the midst of the latest surge of the omicron COVID-19 variant, the share of parents who say their child has gotten at least one shot of a COVID-19 vaccine increased between November and January. Six in ten parents of 12-17 year-olds now say their child has received at least one shot (61%, up from 49% in November), as do one-third of parents of 5-11 year-olds (33%, up from 16% in November). Three in ten parents of children under 5 say they’ll get their child vaccinated right away once a vaccine is approved for their age group, up somewhat from one in five in July.

  • One in five (21%) parents of vaccinated teens say their child has already received a COVID-19 booster, and around two-thirds (65%) say they will “definitely” or “probably get” one. Just one in seven parents of vaccinated 12-17 year-olds say their teen “probably” or “definitely won’t” get the booster (14%).

  • Half of parents report being worried about their child becoming seriously sick from the coronavirus, including substantially higher shares among parents who are Black or Hispanic and those with lower incomes.

  • Four in ten parents of school-age children report some type of disruption to their child’s in-person learning in the first month of the year, including needing to quarantine, schools shutting down in-person classes, or parents choosing to keep children home due to safety concerns. Most (63%) say their child’s school did not provide access to COVID-19 testing before returning to classes in January.”

Army to begin discharging soldiers who refuse coronavirus vaccination: “The U.S. Army announced Wednesday that soldiers who refuse coronavirus vaccinations will be immediately discharged.
The Army order, which applies to regular soldiers, active-duty reservists and cadets, comes in response to the Pentagon’s August order mandating vaccination for all U.S. troops… The Army’s deadline was in December.”

AMA announces CPT update for pediatric COVID-19 vaccine candidate: “For quick reference, the article has the new product and administration codes assigned to the Pfizer-BioNTech COVID-19 vaccine for children in the age range of 6 months to 5 years is:

Biden-Harris Administration Will Cover Free Over-the-Counter COVID-19 Tests Through Medicare: “As part of the Biden-Harris Administration’s ongoing efforts to expand Americans’ access to free testing, people in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through eligible pharmacies and other participating entities. This policy will apply to COVID-19 over-the-counter tests approved or authorized by the U.S. Food and Drug Administration (FDA).”

BD doubles COVID sales forecast for 2022 even as steep testing dropoff leads to revenue loss: “In BD’s case, even though the medtech giant spent the last year introducing new devices and diagnostics and making acquisitions to break into new businesses, it still reported a drop in revenue for the first quarter of its 2022 fiscal year, attributed almost solely to a sharp dip in COVID-related earnings.
BD raked in just under $5 billion for the three-month period ending Dec. 31. That marks a 6% decline compared to the first fiscal quarter of the previous year, when it took in $5.3 billion.
Subtracting the impact of COVID-only diagnostic testing from those totals, however, tells a completely different story. Without those test sales, BD earned $4.8 billion for the quarter, which represents an increase of 8.1% over the previous year’s $4.5 billion COVID-less haul.”

 At Nursing Homes, Long Waits for Results Render COVID Tests 'Useless': “The double whammy of slower turnaround times for lab-based PCR tests and a shortage of rapid antigen tests has strained facilities where quickly identifying infections is crucial for keeping a highly vulnerable population safe.
A KHN [Kaiser Health News]analysis of data from the Centers for Medicare & Medicaid Services finds that 25% of nursing homes that sent tests to a lab waited an average of three or more days for results as of Jan. 16. In early December, that number was 12%.”

Unvaccinated to Pay More Out-of-Pocket Under New Covid Policies: “People who choose not to get vaccinated can’t be denied health insurance, but they could be forced to pay more for their coverage. 
The Affordable Care Act prohibits private health insurers from denying someone coverage or charging higher premiums because of a pre-existing condition or their health status, which would include whether or not they’re vaccinated. 
Short-term health plans are an exception. Those plans could turn down applicants who refuse the Covid-19 vaccine because they aren’t subject to ACA regulations.
The ACA allows employer wellness programs to charge unvaccinated workers a surcharge as long as it doesn’t discriminate against people with disabilities.”

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH [CDRH] PROGRAMMATIC ACCOMPLISHMENTS EMERGENCY USE AUTHORIZATIONS: A review of its activities during the pandemic, which involve not only test reviews but also PPE approvals. In summary: “CDRH authorized 15 times more Emergency Use Authorization (EUA) requests than during all previous public health emergencies combined.” Translates to 2039 medical devices authorized (EUA and full market authorizations).

About health insurance
 QUALITY PAYMENT PROGRAM [QPP] PARTICIPATION IN 2020: RESULTS AT-A-GLANCE: Good graphical presentation of latest results from the QPP. Some highlights:
For 2020:

--”89.11% were engaged in QPP in 2020 

--Fewer clinicians participated in MIPS APMs than in 2019  (2020 – 398,719; 2019 – 416,201) 

--25.72% received reweighting of one or more MIPS performance categories 

Snapshot of 2022 Payment Adjustments for MIPS Eligible Clinicians: 

--81% will receive an additional adjustment for exceptional performance 
933,547 Total clinicians who will receive a MIPS payment adjustment (positive, neutral, or negative) 

--10% will receive a positive payment adjustment 

7% will receive a neutral adjustment (no increase of decrease) 

2% will receive a negative payment adjustment

 Cigna beats the Street with $1.1B in profit for Q4: “Cigna brought in $1.1 billion in earnings for the fourth quarter, down from a $4.1 billion haul in the same period in 2020.
Revenues for the quarter were $45.7 billion, up from $41.7 billion in the prior-year quarter, the company said in its earnings report released Thursday. Both figures exceeded Wall Street's expectations, according to Zacks Investment Research.
For full-year 2021, Cigna earned $5.4 billion in profit and $174.1 billion in revenue. By comparison, the insurer raked in $8.5 billion in profit for 2020 and $160.4 billion in revenue.”

CMS Releases 2023 Medicare Advantage and Part D Advance Notice: “CMS is requesting input on a potential change to the MA and Part D Star Ratings that would take into account how well each plan advances health equity. CMS is also requesting comment on including a quality measure in MA and Part D Star Ratings that would specifically assess how often plans are screening for common health-related social needs, such as food insecurity, housing insecurity, and transportation problems.”

Next big health crisis: 15M people could lose Medicaid when pandemic ends: “States expect the current federal public health emergency to expire this year, triggering a requirement that they must comb through their Medicaid rolls to see who is no longer eligible. Those audits, which have been suspended for the past two years, could lead to as many as 15 million people losing their health insurance, including 6 million children, according to an analysis from the Urban Institute.”

Medicare Advantage Plans Can Increase Income by Almost 8%: “Centers for Medicare and Medicaid Services on Wednesday proposed a 7.98% increase in Medicare Advantage payments in 2023 as they anticipate future changes to their risk adjustment model.
In a proposed fee policy for 2023, the agency solicited feedback on whether the risk adjustment model and MA star ratings could account for the impact of the social determinants of health and health equity.
Under the proposed changes, revenue for Medicare Advantage organizations could increase by nearly 8% next year compared to 2022. The proposed increase is nearly double the 4.08% salary increase planned for 2022.
This projection includes a 3.5% increase in the MA risk score trend, which is a median increase in risk scores. Risk estimates take into account a participant’s expected costs and tend to be higher when participants are sicker. The forecast also takes into account an effective growth rate of 4.75%.”

Georgia nurse practitioner convicted of health care fraud in complex telemedicine fraud scheme: “As described in court documents and testimony, Beaufils, as a nurse practitioner, facilitated orders for more than 3,000 orthotic braces that generated more than $3 million in fraudulent or excessive charges to Medicare. Co-conspirators captured the identities of senior citizens, identified through a telemarketing scheme, and bundled that information as ‘leads.’
Beaufils then signed her name to fake medical records, in which she falsely claimed she provided examinations of those patients, and then created orders for orthotic braces for patients she never met or spoke with – including a knee brace for an amputee, and a back brace for a recently deceased patient – and other durable medical equipment, in exchange for money. Beaufils’s fraudulent orders were then sold to companies that would generate reimbursement from Medicare.”

About hospitals and healthcare systems

Bottom-tier hospitals got better at infection control, but still hit with 1% Medicare pay cuts: “Hospitals with the worst rates patient infections have, on average, improved since 2018. Despite moving the needle on healthcare-associated infections, however, there will always be losers under the CMS Hospital-Acquired Condition Reduction Program. The bottom 25%—749 hospitals—are subject to 1% Medicare payment cuts in fiscal 2022. The Affordable Care Act established the penalty program as a way to put a spotlight on persistent patient safety problems. But the hospital industry questions whether the system is is fair, especially because healthcare-associated infections were declining prior to the COVID-19 pandemic.”

 Union accuses HCA of widespread Medicare fraud in 45-page report: “Service Employees International Union is taking aim at Nashville, Tenn.-based HCA Healthcare, accusing the hospital operator of maximizing profits at the expense of patient care and obtaining more than $1 billion in fraudulent payments from Medicare…
The Medicare fraud allegations stem from SEIU's analysis of the average emergency department admission rate among HCA hospitals. The union found that HCA hospitals' admission rates exceeded the national average by more than 5 percent from 2014 to 2019. In some states, like Texas and California, the average HCA ED admission rate is 10 percent higher than the state average, the report found.”

 Association of Emergency Department Pediatric Readiness With Mortality to 1 Year Among Injured Children Treated at Trauma Centers: “In this cohort study of 88 071 injured children from 8 states cared for in 146 EDs of trauma centers in 15 states, receiving initial care in an ED in the highest quartile of readiness was associated with 30% lower hazard of death to 1 year. The findings were consistent after removing children who died early…
Results of this study indicate high ED readiness is independently associated with long-term survival among injured children.”

Drug prices for hospitals to increase 3% in 2022, with remdesivir topping adalimumab in total spend: “Drug prices for hospitals are expected to increase by 3.09% in the coming year with newfound COVID-19 treatment remdesivir (Veklury) edging out longtime leader adalimumab (Humira) as hospitals’ top drug by total spend, according to a recent market outlook report from Vizient…
Remdesivir alone comprised 3.42%, more than $1 billion, of total Vizient member spend, according to the group’s report. It also led the way for anti-infective drugs, comprising 4% of total spend within the class and outstripping the second product, rifaximin (Xifaxan), by a factor of 10.”

About pharma

Pharma Marketing in the Era of COVID: This monograph is not about Covid, but about how the pandemic changed pharma marketing. Several trends are noteworthy.
First, obviously, is an accelerated trend to digital communication media.
Second "is personalising content for customers. While at least 77 percent of pharma marketers believe that personalisation of content is a high priority, only 25 percent have access to the right technology to do so.” Third, as “almost all in-person meetings were cancelled in 2020, and many took a hybrid approach through 2021, the importance of digital opinion leaders (DOLs) has grown. As physicians increasingly turn to social media for knowledge translation and education, DOLs – keen scientific minds with social media savvy – have become an important marketing tool. DOLs tend to be different to traditional key opinion leaders (KOLs). Academic KOLs receive their status based on their experience, seniority and roles within an institution. A DOL’s stature is based on their online influence, which is not necessarily related to their years of experience or position.10 However, some KOLs have been making the transition to DOL.”

Characteristics of Clinical Trials Evaluating Biosimilars in the Treatment of Cancer: “This meta-analysis and systematic review of 31 cancer biosimilar studies of 3 reference products involving 12 310 patients found that, compared with pivotal trials of reference drugs, studies of 3 cancer drugs with biosimilars available at the time of the analysis were, on average, larger, more often a randomized clinical trial, and more often double blinded. Meta-analyses showed biosimilars to be as effective as their reference products in all disease settings…
This study suggests that studies of biosimilars for treating cancer have design elements of rigorous trials and show equivalent effectiveness to their reference products.”
See, also, the accompanying editorial: Cancer Biosimilars—A Regulatory Success So Far, but Value Still to Be Determined

 Astellas maintains full-year outlook, despite drop in Q3 profit: “Astellas maintained its full fiscal-year forecast of sales totalling JPY 1.3 trillion ($11.4 billion) on profit of JPY 174 billion ($1.5 billion).” 

Takeda boosts full-year outlook: “Takeda now expects mid-single-digit revenue growth in fiscal year 2021 to JPY 3.5 trillion ($30.5 billion), up from a prior estimate of JPY 3.4 trillion ($29.6 billion). Meanwhile, profit is now seen at JPY 242.5 billion ($2.1 billion), lifted from an earlier forecast of JPY 184.3 billion ($1.6 billion).”

AbbVie's blockbuster eye drug Restasis under threat as FDA approves Viatris' copycat: “The FDA has approved Viatris' generic to AbbVie's chronic dry eye treatment Restasis, which generated $1.23 billion in U.S. sales last year. Patents on the drug began expiring in 2014, Viatris' Mylan Pharmaceuticals has noted, but generics haven't been able to pass through the FDA's gate until today despite years of regulatory efforts.”

Biogen's Aduhelm call to action backfires as CMS receives many more comments in favor of restrictive coverage: analyst: “During a January Q&A call with investors, Biogen chief Michel Vounatsos pressed Aduhelm supporters to fight the Centers for Medicare & Medicaid Services’ (CMS') restrictive coverage proposal on the beleaguered Alzheimer’s drug. Turns out, however, most people think CMS made the right call—at least according to one group of analysts.
The public supports CMS’ decision, which would limit Medicare coverage for antibeta-amyloid drugs like Aduhelm to patients enrolled in approved clinical studies, according to a BofA Securities analysis of more than 1,000 comments received by CMS.
There were thrice as many comments in support of CMS’ National Coverage Determination (NCD) and questioning Aduhelm’s efficacy as there were comments asking for a proposal tweak, BofA’s Geoff Meacham wrote in a note to clients Tuesday.
But are all those comments legit? More than 500 letters posted in support of CMS’ restrictive coverage were generated through a campaign run by non-profit media outlet More Perfect Union, a Biogen spokesperson said over email.”

J&J's Janssen inks $1B biobucks pact for Mersana's ADC tech in 3 targets: “After expanding its antibody-drug conjugate (ADC) deal with Synaffix last November to the tune of $1 billion, Mersana Therapeutics is back with another major deal. This time, Johnson & Johnson's Janssen unit is doling out $40 million upfront and more than $1 billion in biobucks for ADCs spanning three targets. 
The pair will work together to research target candidates during preclinical development. J&J's biotech unit will provide proprietary antibodies, and Mersana will contribute its Dolasynthen platform to help find the new ADC product candidates.”

Amgen enters hot protein degradation field with $500M biobucks deal with Plexium: “Amgen is breaking into the protein degradation space in a $500 million biobucks deal with Plexium just weeks after lining up for RNA degraders in a tie-up with Arrakis. 
The California neighbors entered a multi-year research collaboration and licensing agreement for new protein degradation therapies initially focused on two programs in cancer and other serious diseases. Amgen will dish out the milestones in exchange for a commercial license to the two programs.”

About the public’s health

 Appeals court restores Tennessee Down syndrome abortion ban: “A federal appeals court on Wednesday once again reinstated a Tennessee ban on abortions because of a prenatal diagnosis of Down syndrome, or because of the race or gender of the fetus.
The ban is part of a sweeping anti-abortion measure that has faced multiple legal challenges since it was enacted in 2020 by Republican Gov. Bill Lee. Notably, the law banned abortion as early as six weeks — a time frame when most women don’t know they’re pregnant — but that portion has remained blocked from going into effect.”

Responding to the opioid crisis in North America and beyond: recommendations of the Stanford–Lancet Commission: For those interested in an overview, read the introductory comments in the seven Domains the Commission identifies.

Development of an Open Database of Genes Included in Hereditary Cancer Genetic Testing Panels Available From Major Sources in the US: “Hereditary cancer syndromes occur when germline variants increase an individual’s risk of developing cancer. Genetic testing can identify these variants, enabling clinicians to intervene through increased screening or prophylactic surgery.”
However, databases for these genes are not synched. Among other findings, the study found: “A total of 706 genes were included in at least 1 laboratory’s panel. Only 13 genes were included by all 17 companies. Only 110 genes appeared in at least 1 clinical guideline for hereditary cancer or had a ClinGen gene-disease relationship assessment.” Hence, the need for an open database.

About healthcare IT

Deploying digital health tools within large, complex health systems: key considerations for adoption and implementation:  “In this piece, we put forth nine dimensions along which clinically validated digital health tools should be examined by health systems prior to adoption, and propose strategies for selecting digital health tools and planning for implementation in this setting. By evaluating prospective tools along these dimensions, health systems can evaluate which existing digital health solutions are worthy of adoption, ensure they have sufficient resources for deployment and long-term use, and devise a strategic plan for implementation.”
This article is well worth reading. It is a thoughtful, management tool that fulfills the purpose of the headline.

 National Survey Trends in Telehealth Use in 2021: Disparities in Utilization and Audio vs. Video Services:

  • “Overall during the study period, we found that one in four respondents (23.1%) reported use of telehealth services in the previous four weeks.

  • Telehealth use rates were similar (21.1-26.8%) among most demographic subgroups but were much lower among those who were uninsured (9.4%) and young adults ages 18 to 24 (17.6%).

  • The highest rates of telehealth visits were among those with Medicaid (29.3%) and Medicare (27.4%), Black individuals (26.8%), and those earning less than $25,000 (26.7%).

  • There were significant disparities among subgroups in terms of audio versus video telehealth use. Among telehealth users, the highest share of visits that utilized video services occurred among young adults ages 18 to 24 (72.5%), those earning at least $100,000 (68.8%), those with private insurance (65.9%),andWhiteindividuals(61.9%). Videotelehealthrateswerelowestamongthosewithouta high school diploma (38.1%), adults ages 65 and older (43.5%), and Latino (50.7%), Asian (51.3%) and Black individuals (53.6%).

  • Policy efforts to ensure equitable access to telehealth, in particular video-enabled telehealth, are needed to ensure that disparitiesthat emerged during the pandemic do not become permanent.”
    Comment: An additional problem not mentioned in the summary is need for expansion and affordability of broadband access. See: As internet access limits telehealth’s reach, insurers are starting to cover the bill Nearly a quarter of adults in the U.S. don’t have broadband at home, network speeds are insufficient for video calls in much of rural America, and 15% struggle to pay for internet.”

Top 5 telehealth diagnoses in November 2021: “Across the U.S., mental health conditions were the No. 1 telehealth diagnosis in November 2021, according to new data from Fair Health.
Telehealth claim lines remained steady from October 2021 to November 2021, rising from 4.1 percent of all medical claim lines to 4.4 percent….
1.Mental health conditions: 62.2 percent
2.Acute respiratory disease and infections: 4.5 percent
3.Developmental disorders: 1.9 percent
4.Joint/soft tissue diseases and issues: 1.8 percent
5.COVID-19: 1.4 percent”

About healthcare personnel

 Strained US hospitals seek foreign nurses amid visa windfall: “There’s an unusually high number of green cards available this year for foreign professionals, including nurses, who want to move to the United States — twice as many as just a few years ago. That’s because U.S. consulates shut down during the coronavirus pandemic weren’t issuing visas to relatives of American citizens, and, by law, these unused slots now get transferred to eligible workers.”  

 

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.”