Today's News and Commentary

About Covid-19

 Moderna seeks FDA authorization for second COVID booster for all adults: “Moderna Inc on late Thursday sought emergency use authorization from U.S. health regulators for a second COVID-19 booster shot, as a surge in cases in some parts of the world fuels fears of another wave of the pandemic.”

 EMA expects data on Omicron-specific vaccine as early as April: “The European Medicines Agency’s (EMA) leading vaccine expert said that data on COVID-19 vaccines tailored for the Omicron variant should be available between April and July this year, potentially paving the way for a decision by the summer.”

Biden administration (finally) elevates healthy buildings as part of national Covid strategy: “The White House announcement on Thursday that it is elevating ‘clean air in buildings’ as a key pillar in the national Covid-19 response is nothing short of a landmark shift in the response.
How so? The country has made enormous gains in its Covid fight along several axes — vaccines and boosters, rapid tests and treatments, and the recent release of N95 masks to the public. But there was one element that was still lacking more than two years into the pandemic: ventilation and filtration. That has now changed.”

About health insurance

 Analysis of Value-Based Payment and Acute Care Use Among Medicare Advantage Beneficiaries: “In this study of MA beneficiaries, advanced value-based payment arrangements (ie, 2-sided risk models) were associated with lower rates of acute care use, especially those events that are potentially avoidable. These findings are consistent with evaluations of value-based payment in traditional Medicare and serve to expand the evidence base around value-based payment models in Medicare Advantage. The lack of significant differences between FFS and upside-only risk models suggests that downside financial risk may play a key role in effective value-based payment arrangements.”
Nothing new here in the general principle- risk-based (downside) contracts result in better performance.
Look at the Table for more details on differences.

These 12 states had uninsured rates higher than 10%, new census data shows: “The U.S. Census Bureau released new American Community Survey health coverage data March 17 that shows which states have the largest uninsured populations as a percentage of their total population. 
The data was collected over a five-year period from 2016-20.
Twelve states had an uninsured rate of higher than 10 percent: Alaska, Arizona, Florida, Georgia, Idaho, Mississippi, Nevada, North Carolina, Oklahoma, South Carolina, Texas and Wyoming.”

Trends in High-Severity Billing of Hospitalized Medicare Beneficiaries Treated by Hospitalists vs Nonhospitalists: “In this cohort study of 4 071 241 Medicare fee-for-service beneficiaries treated in hospitals between 2009 and 2018, hospitalists billed a significantly higher proportion of their initial, subsequent, and discharge encounters of Medicare beneficiaries as high-severity compared with nonhospitalists, even after accounting for patient complexity, and this gap is growing over time…
The growing number of hospitalists that are increasingly caring for Medicare beneficiaries and billing for higher-severity encounters may be an important driver of rising hospital costs nationally.”

About hospitals and healthcare systems

 How the 2 largest nonprofit health systems fared in Q2: For Ascension: “After factoring in nonoperating gains, the health system ended the second quarter of fiscal year 2022 with net income of $949.5 million, down from $2.6 billion a year earlier.”
For CommonSpirit Health: “After factoring in nonoperating income, the health system reported net income of $118 million, down from $1.9 billion in the same period a year earlier.”

Banner Health's operating income slides 59% in 2021: “Banner's operating income was $126.7 million in 2021, a 59.2 percent decrease from 2020 at $310.9 million. Its operating margin was 1 percent for 2021 and 3 percent for 2020.
The system attributed the decrease in operating income to challenges from the COVID-19 pandemic, particularly with the labor market. It used $136 million in provider relief fund dollars to offset external contract labor, mostly in the first half of the year. It took on $800 million in external contract labor costs in 2021…”

Moody's: Shift away from inpatient care will continue to shrink hospital margins: “A drop in inpatient care is expected due to a number of factors including changing reimbursement models, advances in drugs and medical devices and growing investment in outpatient services. This shift, however, will be partially offset by an aging population and demand for higher-acuity care by patients whose care was delayed by the pandemic. 
Even before COVID-19, hospital admission rates were generally flat, according to Moody’s; now, virtual care options and fewer visits to the emergency room have accelerated the shift away from inpatient care. The use of telehealth will likely remain higher than before COVID, particularly among certain specialties…
Outpatient revenue has exceeded inpatient revenue in the past few years, according to Moody's analysis.”

Medical Properties Trust Completes Hospital Partnership With Macquarie Asset Management: “Medical Properties Trust, Inc… announced that it has completed the previously announced transaction with Macquarie Infrastructure Partners V, a private fund managed by Macquarie Asset Management (“MAM”) to form a partnership pursuant to which a MAM controlled subsidiary has acquired a 50% interest in a portfolio of eight Massachusetts-based general acute care hospitals owned by MPT and operated by Steward Health Care System…”

About pharma

 Prevalence of Third-party Tracking on Medical Journal Websites: “This cross-sectional study demonstrated that 99% of medical journals with an impact factor of 2.0 or higher expose visitors to third-party tracking by entities that work with pharmaceutical advertisers. Although similar levels of tracking have been found in health-related websites, tracking on journal websites raises distinctive policy concerns because it may facilitate targeted advertising to clinicians.” 

Top 10 pharma R&D budgets in 2021: “Roche will not be beaten when it comes to pharma R&D. The company has topped our list of top pharma R&D budgets year after year, and 2021 was no different. 
The Swiss pharma landed in the No. 1 slot with a budget of 14.8 billion Swiss francs ($16.1 billion), a 14% increase over 2020. Total revenue for the year was 65.9 billion Swiss francs ($71.4 billion), meaning Roche threw 23% of its haul at R&D. This was a massive spend even by Roche's industry-topping standards.”
See the article for more details about Roche and the other nine companies listed.

About the public’s health

Tobacco Product Use Among Adults — United States, 2020: “In 2020, 19.0% of U.S. adults (47.1 million) used any tobacco product. Cigarettes were the most commonly used tobacco product (12.5%), followed by e-cigarettes (3.7%). From 2019 to 2020, the prevalence of overall tobacco product use, combustible tobacco product use, cigarettes, e-cigarettes, and use of two or more tobacco products decreased.”

 Biden outlines Cancer Moonshot program: 6 things to know: “President Joe Biden outlined initial steps on March 17 for the revival of the Cancer Moonshot program, which aims to reduce cancer deaths by 50 percent over the next 25 years and improve the experience of living with and surviving cancer…
 Six things to know: 

  • The administration is working to create a Cancer Moonshot Scholars program alongside a new early career fellowship program at the National Cancer Institute starting in fiscal year 2023.

  • The FDA is pursuing steps to "significantly reduce" tobacco-related morbidity and mortality.

  • The U.S. Defense Department is expanding a signature clinical research program to all of its hospitals.

  • The Veterans Administration is planning to propose a rule that will consider "presumptive service connection" for several rare respiratory cancers for some veterans.

  • The National Cancer Institute is connecting underrepresented populations to clinical trials and building capacity in cancer research in areas of poverty.

  • The Office of Science and Technology Policy will lead an effort to provide scientific support to assess and address cancer risks from air pollution.”

Medical Misinformation Runs Rampant, and Many Americans Have Trouble Identifying It: Key takeaways:

  • Over 70% of people have been exposed to medical or health-related misinformation.

  • Of those exposed, almost half are not confident in their ability to discriminate between true health information and misinformation.

  • Social media is cited as the most common source of misinformation.”
    Family and friends are also a significant source of misinformation.

About healthcare IT
Healthcare organizations now must report cyberattacks to DHS: “Healthcare organizations will be required to report any cyberattacks to the Department of Homeland Security, under a law signed March 15 by President Joe Biden…
The new law, which is part of a broader government funding package, requires organizations in "critical sectors," or sectors considered vital to the U.S. economy, public health and safety, to inform the government of any ransomware or hacks. These organizations must make the attacks known within 72 hours of discovery and 24 hours of ransom payment. However, which specific companies within each sector are affected by this law is unknown yet.”

Massive digital health system for veterans plagued by patient safety risks, watchdog finds: “More than a year after a disastrous deployment at its first hospital, the $16 billion effort to modernize veterans’ medical records still poses grave safety risks to patients, from medication errors to failures to safeguard patients at high danger of suicide, the Department of Veterans Affairs’ internal watchdog reported Thursday.
Three reports on the project’s rollout in Spokane, Wash., cast doubt on how smoothly it will expand next week, when VA plans to bring its digital health records system to a second Washington hospital in Walla Walla, then accelerate implementation at other hospitals and clinics in the Pacific Northwest and elsewhere by December.”

Today's News and Commentary

About Covid-19
At least 216.8 million people have been fully vaccinated in the U.S. “This includes more than 96.2 million people who have received a booster shot…
About two-thirds of the country is fully vaccinated in over a year of distributing shots. More than a million doses per day were administered nationwide November through January, but rates have since declined, according to the latest data from the Centers for Disease Control and Prevention, including first doses, second doses and boosters.”
The article, published today, has data by state, race and age groups.

A covid surge in Western Europe has U.S. bracing for another wave: “In all, about a dozen nations are seeing spikes in coronavirus infections caused by BA.2, a cousin of the BA.1 form of the virus that tore through the United States over the past three months…
Kristen Nordlund, a spokeswoman for the Centers for Disease Control and Prevention, said in an email Tuesday that ‘although the BA.2 variant has increased in the United States over the past several weeks, it is not the dominant variant, and we are not seeing an increase in the severity of disease.’”

FDA Expediting Pfizer’s/BioNTech’s EUA Request for a Second COVID-19 Booster: “The FDA is asking its vaccines advisory committee to meet next month to make a recommendation on Pfizer’s and BioNTech’s March 15 request to amend its Emergency Use Authorization (EUA) for approval of a fourth shot/second booster of its COVID-19 vaccine Comirnaty for people age 65 and older.”

Four WTO Members Agree to Waive COVID-19 Vaccine Patents: “Four World Trade Organization (WTO) members — the European Union, South Africa, India and the U.S. — agreed this week to waive intellectual property rights for the production of COVID-19 vaccines.
The document outlining their compromise, a year-and-a-half in the making, indicates that the agreement only covers vaccines for now, but could later be extended to therapies and diagnostics for COVID-19.
The four WTO members said they intend to implement the agreement no later than September 2022.”

Alnylam files patent infringement lawsuits against Pfizer, Moderna: “Alnylam said it was seeking damages over the use of lipid nanoparticle (LNP) technology used in the Pfizer/BioNTech and Moderna vaccines to carry and deliver genetic material into the body…
Alnylam's lawsuit against Moderna says it discussed licensing its technology to the company in late 2013 or 2014, and shared confidential information about it with Moderna at the time.
The lawsuit against Pfizer said Alnylam's LNP technology is also ‘essential’ to the effectiveness and safety of Pfizer's vaccine.
Arbutus Biopharma Corp separately sued Moderna in Delaware federal court last month, claiming Moderna's COVID-19 vaccine infringes its patents, which also relate to RNA-delivery technology.”

CDC confirms uptick in Covid virus found in wastewater: “‘It’s too early to know if this current trend will continue,’ according to the head of the agency's wastewater monitoring program.
The federal Centers for Disease Control and Prevention acknowledged the increase after Bloomberg reported that a third of the agency’s wastewater sample sites showed a rise in Covid cases from March 1 to March 10.
That was double what it was from Feb. 1 to Feb. 10, when the highly infectious omicron variant that had roared across the country during the holiday season was starting to wane, the Bloomberg analysis of CDC data found.”

Japan to buy 145 mln Pfizer, Moderna COVID vaccines for 4th shots: Another country is moving ahead with a second booster.

Hospitalizations of young children increased fivefold during omicron surge, but few died, says CDC report: “Young children in the United States were hospitalized at much higher rates this winter as omicron became the dominant variant than they were during the delta surge, according to a new report published by the Centers for Disease Control and Prevention.
At the peak of the omicron wave, infants and other children under 5 were hospitalized at about five times the rate documented during the delta wave, although few deaths were reported, the study said. For infants under six months, hospitalizations were about six times higher during the omicron surge.”

MIT-made COVID-19 vax produced by yeast could address global vaccine inequity: “Fifteen months since the first COVID-19 vaccine was authorized, only 14% of people in low-income countries have received at least one dose compared to almost two-thirds of the global population. 
Researchers at MIT and Beth Israel Deaconess Medical Center may have an inexpensive solution, announcing Wednesday that their yeast-produced COVID-19 jab, in combination with adjuvants, performed comparably to other approved vaccines, including J&J’s one-shot vax…
he researchers focused on producing a shot that could be easily manufactured, electing to develop a subunit vaccine with pieces of the receptor-binding domain portion of the SARS-CoV-2 spike protein. To boost the immunogenicity, the researchers coated a virus-like particle with the protein rather than just using the RBD protein itself. The RBD portion of the spike protein acts as the viral key that fits into the lock on cellular receptors in the body. Both the particle and the protein are produced by yeast, which can be grown in a bioreactor.”

 Dr. Ashish Jha to replace Jeffrey Zients as Biden's COVID czar: “Ashish Jha, MD, dean of Brown University's School of Public Health, was tapped by President Joe Biden to serve as the next White House COVID-19 response coordinator.
Dr. Jha will succeed Jeffrey Zients, who has served in the role over the last 14 months.”

About health insurance

Anthem Blue Cross discontinues payment of consultation services: “Anthem Blue Cross is the latest payor to halt the reimbursement of consultation services. Effective January 1, 2022, Anthem is no longer reimbursing for inpatient and outpatient consultation CPT codes 99241-99245 and 99251-99255 for its for commercial insurance products. Instead, providers will need to bill utilizing the appropriate evaluation and management (E/M) procedure code that describes the office visit, hospital care, nursing facility care, home service or domiciliary/rest home care.
Anthem Blue Cross’ announcement follows similar policies previously implemented by Cigna and UnitedHealthcare disallowing reimbursement for consultation services for their commercial product lines."
Comment: It’s about time. Medicare did away with those codes on 1/1/2006 (and stopped accepting them for billing after 1/1/2010). The HHS OIG wrote at that time: “Medicare allowed approximately $1.1 billion more in 2001 than itmshould have for services that were billed as consultations.”
In my own research, published in 2009, I found: “Overall, the coding error rate was 32.4%. When the requesting physician ordered a consultation, the error rate was 5.5%; however, with lower paid referral requests, the error rate was 78.0%. Changing ambulatory consultation codes to those for new patient visits would save Medicare $534.5 million per year.”

Citi to Cover Worker Abortion Travel as States Limit Access
: “Citigroup Inc. is starting to cover travel costs for employees seeking abortion after several states including Texas implemented or proposed a near-total ban on abortions.
‘In response to changes in reproductive health-care laws in certain states in the U.S., beginning in 2022 we provide travel benefits to facilitate access to adequate resources,’ the bank wrote in a filing for its shareholders meeting set for April 26.”

Medicaid and CHIP Eligibility and Enrollment Policies as of January 2022: Findings from a 50-State Survey: “The 20th annual survey of state Medicaid and Children’s Health Insurance Program (CHIP) officials conducted by KFF and the Georgetown University Center for Children and Families in January 2022 presents a snapshot of actions states are taking to prepare for the lifting of the continuous enrollment requirement, as well as key state Medicaid enrollment and renewal procedures in place during the PHE [Public Health Emergency].”
One disturbing finding: “The majority of states (39) plan to take up to a full year to process redeterminations and return to routine operations…”

About hospitals and healthcare systems

Reputation Report Healthcare Industry ‘22: “The Reputation Data Science team examined 2,778,931 patient ratings and reviews across providers’ websites and social channels to understand how and how often patients reviewed facilities and physicians in 2021.” Here are some highlights:
Facility star ratings are on the rise: facilities achieved an average star rating of 4.4, up 0.05 points over 2020.
Healthcare provider ratings are falling: physicians received an average star rating of 4.7, which was a drop of 0.03 points from 2020.
Consumers pay close attention to star ratings: 72% of consumers told us that they want the provider they choose to be rated 4 out of 5 stars or higher.
Biggest positive sentiment driver: the bedside manner of physicians and nurses constituted the strongest driver of positive sentiment.
Biggest negative sentiment driver: ratings of staff were among the biggest drivers of negative sentiment.
Across all industries, employee feedback is consistently lower than customer feedback.
—Sentiment for healthcare as a whole is lower than other industries.
—Employee sentiment for all industries has trended lower for several years.
—Feedback from nurses has always been more negative and continues to be.
The study also ranks the top 15 systems by reputation. #1 is Community Health Systems with a score of 723.
By way of comparison, #15 is Intermountain with a score of 494.

 Hospital mergers and acquisitions: 7 recent deals by the numbers: This item is FYI, no comment needed.

 RACIAL INCLUSIVITY: The Lown Institute’s rankings of hospitals’ racial inclusivity and exclusivity.

The AHA and FAH urge CMS to deny DHR’s request for an exception to the prohibition on expansion of the facility capacity of a physician-owned hospital: “CMS is not obligated by statute or regulation to grant an expansion request to any facility that satisfies the ‘high Medicaid facility’ exception criteria, and CMS should deny DHR’s [Doctors Hospital at Renaissance,Edinburg, TX] request because the requested expansion is inconsistent with Congress’s intent, does not serve a valid public policy purpose, and would set a bad precedent. 
Further, the current exception request clearly illustrates how the “high Medicaid facility” exception, as amended in the 2021 hospital outpatient prospective payment system (OPPS) final rule published on December 2, 2020, opens the door for requests that may technically meet, but clearly violate the spirit of the general statutory ban on physician-owned hospitals. Accordingly, we also urge CMS to reverse the 2020 amendments to the ‘high Medicaid facility’ exception.” [Emphasis in original]

About pharma

 AstraZeneca throws open doors to new ideas in global postdoc challenge: “AstraZeneca is throwing open its doors to ideas from scientists near the start of their careers. Through its global R&D Postdoctoral Challenge, the Anglo-Swedish drugmaker will equip researchers to pursue novel approaches to treating diseases.
Like other large drug developers, AstraZeneca runs a postdoc program. The challenge opens up a new way for AstraZeneca to engage with postdoc researchers and students in the final year of their M.D. or Ph.D. by enabling them to receive funding to study their own ideas.”

Walgreens Accused of Overcharging Health Plans for Drugs: “Blue Cross and Blue Shield units and other health care plans allege that Walgreen Co.engaged in a fraudulent scheme to overcharge for prescription drugs by submitting claims for payment at inflated prices and made false statements to conceal the scheme.
Walgreens has overcharged the plaintiffs hundreds of millions of dollars, the plaintiffs said in a Tuesday complaint filed in the U.S. District Court for the Northern District of Illinois.
A spokesperson for Walgreens declined to comment.”

Biogen’s Aduhelm Reduces Underlying Pathologies of Alzheimer Disease, New Data Show: “Biogen has announced new data showing that aducanumab-avwa (Aduhelm) injection 100 mg/mL for intravenous use continued to significantly reduce 2 key Alzheimer disease (AD) pathologies in a 128-week extension phase of a phase 3 trial.
The 2 pathologies that were reduced in the long-term extension phase were amyloid beta plaques and plasma p-tau181. The data also showed that in both phase 3 trials, at 78 weeks, individuals with reduced levels of plasma p-tau181 had less clinical decline than those who did not see that reduction.”
And in related news: Medicare premiums could decrease ‘soon,’ after decision on Alzheimer’s drug Aduhelm: “Whether seniors get an unprecedented mid-year discount on Medicare premiums will hinge on a forthcoming decision about how the program will cover a pricey, controversial new Alzheimer’s drug that is expected by mid-April.”

About the public’s health

Sleep experts say Senate has it wrong: Standard time, not daylight saving, should be permanent: “Sleep experts widely agree with the Senate that the country should abandon its twice-yearly seasonal time changes. But they disagree on one key point: which time system should be permanent. Unlike the Senate, many sleep experts believe the country should adopt year-round standard time.
After the Senate voted unanimously and with little discussion Tuesday to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement cautioning that the move overlooks potential health risks associated with that time system. (The legislation, which would take effect next year, must get through the House and be signed by President Biden to become law.)”

 Effect of cocoa flavanol supplementation for prevention of cardiovascular disease events: The COSMOS randomized clinical trial: “Cocoa extract supplementation did not significantly reduce total cardiovascular events among older adults but reduced CVD death by 27%… Additional research is warranted to clarify whether cocoa extract may reduce clinical cardiovascular events.”

US drug overdose deaths reach another record high as deaths from fentanyl surge: “An estimated 105,752 people died of a drug overdose in the 12-month period ending October 2021, according to provisional data published Wednesday by the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics.
About two-thirds of those deaths involved synthetic opioids such as fentanyl, a stronger and faster-acting drug than natural opiates.”

About healthcare IT

 Some highlights from HIMSS 2022:
Samsung rolls out smart healthcare TV, digital health tools for hospitals: “According to Samsung, its the first 4K QLED smart healthcare TV in the industry and transforms in-room displays into all-in-one communication hubs personalized for hospital patients and senior care residents, significantly improving collaboration, patient engagement and workflow efficiency. 
The advanced in-room technology offers clinicians seamless access to display patient EHRs, information and telehealth consultations right in the room.”
The Race Toward Digital Transformation: 2022 Health System Survey: In November of 2021, The Chartis Group surveyed 143 U.S. health system executives about the state of digital transformation. Respondents represented a range of organization types, locations, and revenue sizes.”
Highlights presented at HIMSS 2022:
--”Although health systems overwhelmingly agree that digital transformation is critical, most are stuck in planning stages. [61% of respondents said the main reason for digital transformation is to improve outcomes; 23% said it was to reduce costs]

--The digital health competitive landscape is shifting as disruptors become rivals. 

--These new market entrants, not traditional hospitals and health systems, are setting the pace toward digital transformation. 

--Health systems want to better understand their patient consumers but have not aggregated those insights to meaningfully personalize care. 

--Expanding their scope of insights beyond clinical interactions will give health systems the depth of understanding they need to create differentiated digital experiences. 

--Key to successfully achieving digital transformation will be linking value drivers for the patient (like a seamless consumer experience) with value drivers for the health system.”
Salesforce connects its health tech solutions in new Customer 360 for Health suite: “Salesforce is expanding its consumer data platform offering to healthcare and life sciences companies to support the shift to tech-enabled care delivery…
The new healthcare suite includes care coordination support via Slack, virtual care infrastructure for remote visits and health scoring tools to predict outcomes as well as features to help organizations meet HIPAA compliance requirements.”

FCC awards $30M in telehealth funds to 16 providers: “The Federal Communications Commission on March 16 selected the fourth and final set of  projects for its Connected Care Pilot Program, awarding nearly $30 million to 16 providers.
The program was introduced by the FCC in 2018. It began accepting applications in November 2020 and is set to fund 107 projects aimed at helping providers expand telehealth services.”

Today's News and Commentary

Senate votes unanimously to make daylight saving time permanent: “Clock-switching would end in 2023 under measure that still must pass the House and get Biden’s signature before it can become law.”

About Covid-19

 Pfizer and BioNTech seek authorization of second coronavirus booster shot for people 65 and older: As anticipated yesterday, the filing was submitted.

Senate votes to overturn mask mandate on airplanes, transit: “The Senate on Tuesday voted 57-40 to overturn a federal requirement that passengers on U.S. airplanes and other modes of public transportation wear masks.
The Congressional Review Act measure, introduced by Sen. Rand Paul, R-Ky., is the latest salvo in a fight between congressional Republicans and the Biden administration over public health requirements related to the pandemic, which has killed more than 963,000 Americans to date, according to Centers for Disease Control and Prevention statistics.”
If passed by the house (unlikely), the President vowed to veto the law.

Omicron sub-variant makes up 23.1% of COVID variants in U.S. - CDC: “The BA.2 sub-variant of Omicron was estimated to be 23.1% of the coronavirus variants circulating in the United States as of March 12, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.”

U.S. will run out of key COVID treatments without more funds, White House says: “The White House said on Tuesday that the US government will run out of supplies of monoclonal antibodies as soon as late May and will have to scale back plans to get more unless Congress provides more funding…
The government would also not have enough money to provide additional COVID-19 booster vaccine doses or variant-specific vaccines without a new injection of cash.
The White House has requested $22.5 billion in immediate emergency funding to address the pandemic, but the money was removed from the latest government funding bill recently passed by lawmakers.”

Lab Advisory: HHS Updates COVID-19 Laboratory Reporting Guidance: From the CDC:
Beginning April 4, 2022, COVID-19 testing facilities are no longer required to report NEGATIVE results for tests authorized for use under a CLIA certificate of waiver. This includes rapid and antigen testing performed for screening testing at schools, correctional facilities, employee testing programs, long-term care facilities, and rapid testing performed in pharmacies, medical provider offices, and drive-through and pop-up testing sites. In addition, testing facilities are no longer required to report POSITIVE or NEGATIVE antibody test results.
The updated guidance still requires laboratories to report both POSITIVE AND NEGATIVE results for laboratory-based nucleic acid amplification tests (NAATs) that are performed in a facility that is certified under CLIA to perform moderate- or high-complexity tests.” [Emphases in the original.]

About health insurance

No Medicare Payment Hike Needed for Docs in 2023, MedPAC Says: [Sign up for this free site to read the article]. A really good summary of the recommendations for all Medicare programs and some feedback from the AMA and MGMA. In the case of physicians and other healthcare professionals, the recommendation was: “For calendar year 2023, the Congress should update the 2022 Medicare base payment rate for physician and other health professional services by the amount determined under current law.” The current law specifies no change.
For the complete document go to this site. The summary recommendations start on page 551.

About pharma

 FDA approves transdermal patch to treat Alzheimer’s-related dementia: “Biopharmaceutical company Corium announced that the FDA has approved Adlarity to treat patients with mild, moderate or severe dementia associated with Alzheimer’s disease…
The FDA approved once-weekly use of Adlarity (donepezil, Corium) in 5 mg/day or 10 mg/day formulations. The transdermal patch, which can be placed by a patient or caregiver on a patient's back, thigh or buttocks, delivers a consistent dose of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal side effects associated with oral donepezil.”

Eli Lilly to halt exports of non-essential medicines to Russia: “Eli Lilly will stop exporting non-essential medicines to Russia including Cialis, a treatment for erectile dysfunction, following Vladimir Putin’s invasion of Ukraine. Highlight text The US drugmaker said on Tuesday it would continue to supply treatments for life-threatening diseases such as cancer and diabetes but that it would suspend all investments, promotional activities and new clinical trials in Russia.”

First Generic OK'd for Popular Asthma, COPD Inhaler: “The first generic version of Symbicort -- a metered-dose inhaler that combines the corticosteroid budesonide with the long-acting bronchodilator formoterol -- has been approved for asthma and chronic obstructive pulmonary disease (COPD), the FDA announced on Tuesday
’Today's approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,"‘Sally Choe, PhD, who heads the Office of Generic Drugs at FDA, said in a statement. ‘This reflects the FDA's continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.’”
And in a related article: First Generic to Treat Dry Eye: “The FDA recently approved the first generic formulation of cyclosporine ophthalmic emulsion (Restasis) to increase tear production for patients with a condition commonly known as dry eye.”

Gilead to limit 340B discounts for hepatitis C drugs: “Gilead will stop offering 340B discounts to safety-net hospitals effective May 2 if providers do not submit certain patient claims data, the drugmaker said March 15. ‘We are making this change across our branded hepatitis C products because of the acute impact of duplicate discounts and diversion," Gilead said in its announcement. "The claims level data being requested is similar to the data Gilead receives from other purchasers and payers and is tailored to minimize burdens on covered entities while mitigating duplicate discount and diversion concerns.’”

Drug manufacturers are fighting their holy war on three fronts: A great perspective about how “big pharma” is protecting its turf. Among the facts that should be considered:
”For drug manufacturers, it’s a holy war to defend its US business which generates $363 billion (9% of total 2020 US spending), employs 811,000 and generates per capita spending for prescription drugs that’s 104% higher than the 38-country OECD median. Understandably, they spend big to fend-off unwelcome intrusion in their pricing strategies:
From 1998 to 2021, the Pharmaceuticals/Health Products industry spent $5,066,805,717 on its lobbying activity—more than any other industry and 56% more than #2 insurers, 145% more than hospitals and nursing homes (#8) spending) and 191% more than health professionals (#12).
In 2021, the pharmaceutical industry spent $353,940, 506 on its lobbying activity for 546 companies employing 1746 lobbyists—58% of who previously worked for the government—to garner favor from lawmakers.”

Cancer Drug Approvals That Displaced Existing Standard-of-Care Therapies, 2016-2021: “Between May 1, 2016, and May 31, 2021, there were 207 FDA cancer drug approvals in oncology and malignant hematology. Of these 207 approvals, 28 drugs (14%) were first-line displacing therapies. A total of 32 drugs (15%) were first-line drug alternatives/new drugs. A total of 61 drugs (29%) were add-on therapies. Finally, 86 drugs (42%) were approved as later-line therapies.”

About the public’s health

 2022 Alzheimer’s Disease Facts and Figures: “An estimated 6.5 million Americans age 65 and older are living with Alzheimer’s dementia in 2022.A2,224 Seventy-three percent are age 75 or older…
Of the total U.S. population: About 1 in 9 people (10.7%) age 65 and older has Alzheimer’s dementia.”
While the rate of new cases has declined, the expansion of the older population has increased total number of cases. This monograph is an excellent review.

The Association of Consumption Time for Food With Cardiovascular Disease and All-Cause Mortality Among Diabetic Patients: “Higher intake of potato or starchy vegetable in forenoon, whole grain in the afternoon, and dark vegetable and milk in the evening and lower intake of processed meat in the evening was associated with better long-term survival in people with diabetes.”

Autism Screening Test for Toddlers Wins on Accuracy— Younger diagnosis age means earlier support for kids with autism, researcher says: “n autism diagnosis tool for toddlers proved highly accurate, creating the potential for autism to be diagnosed at a younger age, results from a community-based study suggest.
The Social Attention and Communication Surveillance-Revised (SACS-R) tool had an 83% positive predictive value (95% CI 0.77-0.87) and an estimated 99% negative predictive value (95% CI 0.01-0.02) in over 13,500 toddlers ages 12 to 24 months…”

About healthcare IT

 Global Achievement: Intermountain Healthcare Named World’s First Triple Stage 7 Organization under new HIMSS model: “The Healthcare Information and Management Systems Society (HIMSS) has announced that Intermountain Healthcare has become the first organization in the world to earn Triple Stage 7 designation under new requirements, the highest level of achievement on how health systems are improving care using digital tools…
HIMSS measured Intermountain in three areas to see how they utilized their EMR. To reach a level 7 an organization is scored by how they’re improving patient safety and satisfaction, supporting clinicians and securing data.

  1. Electronic Medical Record Adoption Model (EMRAM) – measures clinical outcomes, patient engagement and clinical use of EMR technology to strengthen organizational performance and health outcomes across patient populations.

  2. Outpatient Electronic Medical Record Adoption Model (O-EMRAM) – assesses maturity of EMR technology in outpatient facilities and its impact on patients served, overall population health and health system operational efficiency with a focus on quality of care, patient safety, and cost reduction.

  3. Adoption Model for Analytics Maturity (AMAM) – measures the analytics capabilities that healthcare organizations have gained from having a strong analytics strategy and competency and advances an organization’s healthcare analytics regardless of the technologies installed.”

Morgan Health invests $5M in physician-led analytics company: “Morgan Health, the healthcare arm of JPMorgan Chase, invested $5 million in a physician-led analytics company.

Morgan Health participated in Embold Health's $23 million series B funding round. The platform measures provider performance through real-time data, connecting patients to top-performing providers and specialists, according to a March 16 press release.  
This is the second investment the company has made in the healthcare field. 
On Aug. 5, Morgan Health also made a $50 million investment into Vera Whole Health, a holistic primary care startup based in Seattle.”

About healthcare personnel

Clinician of the Future-2022: I picked some interesting (to me) highlights from this Elsevier physician survey”

 —”More informed patients: in the survey, 86% of clinicians agreed the rise of patients informed about their health conditions is driving healthcare change 
—51% of clinicians agreed telehealth will negatively impact their ability to demonstrate empathy with patients
—64% of clinicians agreed the impact of health inequalities will be exacerbated by the greater use of digital health
— 43% expect every individual will have their genome sequenced to support illness prevention
—Noncommunicable diseases: 71% of clinicians agreed there will be an increase in comorbidities among younger patients in 10 years
—73% of clinicians globally identified that in 10 years’ time managing public health will be a key priority in their role
—41% of clinicians expect to be seen as less valuable to patients”

About health technology

Illumina Unveils Groundbreaking Comprehensive Genomic Profiling Test for Cancer in Europe: “Illumina, Inc…. announced the launch of TruSight™ Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer.
TSO Comprehensive (EU) assesses biomarkers in 517 cancer-relevant genes across nearly 30 solid tumor types by evaluating both DNA and RNA, and complex genomic signatures, such as microsatellite instability (MSI) and tumor mutational burden (TMB). This comprehensive assessment eliminates the need for running separate, sequential gene tests from multiple biopsy procedures. The fast turnaround time of four to five days for sample-to-clinical report generation, versus weeks in some cases, enables clinicians to make decisions regarding personalized medicine or clinical trial enrollment for their cancer patients.”
The announcement came after the test received a CE-mark.

About healthcare quality and safety

How CMS is Improving ACO Data Aggregation, Quality Care Reporting: “…CMS has been transitioning from web-based reporting to more digital methods like electronic clinical quality measures (eCQMs), merit-based incentive payment system quality measures (MIPS CQMs) and digital quality measures (dQMs)…
CMS new six-prong strategy to implement quality measure changes include:

  • Incentive for eCQMs/MIPS CQM reporting

  • Extension of web interface collection for an additional three years to give more time to ACOs to transition to eCQMs/MIPS CQM reporting

  • ACI listening session to provide plans and address concerns with reporting

  • ACO engagement with Office of Burden Reduction and Health Informatics to address transition questions

  • Written guidance documentation with stakeholder input for reporting”

Today's News and Commentary

About Covid-19

 Which Coronavirus Vaccine Will Work in the Youngest Children?: “Moderna…is expected to send federal officials initial data this week on how well its coronavirus vaccine works for the nation’s youngest children.”
The proposed dose for children younger than 6 years would be two shots of one quarter adult strength.

Pfizer and BioNTech to seek authorization of second coronavirus booster shot for people 65 and older: “Pharmaceutical giant Pfizer and its partner, BioNTech, will seek emergency authorization for a second booster shot of their coronavirus vaccine for people 65 and older, an effort to bolster waning immunity that occurs several months after the first booster, according to three people familiar with the situation.
The submission to the Food and Drug Administration, anticipated as soon as Tuesday, is expected to include ‘real world data’ collected in Israel…”

Comparing Human Milk Antibody Response After 4 Different Vaccines for COVID-19: “We demonstrated that SARS-CoV-2–specific IgA in human milk was present more frequently after vaccination with an mRNA-based vaccine [Pfizer/BioNTech and Moderna] compared with a vector-based vaccine [Astra Zeneca and J&J].”
The differences were substantial between the two vaccine types.

About health insurance

Employers Turn to ‘High-Performing’ Physicians for Cost Savings: “Some of the largest companies in Wisconsin are hoping to save money on health care this year by setting up insurance plans that steer employees to primary care physicians who provide high-quality care for less money.
The half-dozen employers in eastern Wisconsin are expected to save more than 15% of $12,000 per employee in annual medical costs—about $10 million this year for the 5,000 employees who enrolled in the plans, Dave Osterndorf, chief actuary of plan administrator Centivo, said.
The companies include Robert W. Baird & Co., Northwestern Mutual, American Roller Co. LLC, and the Guardian Life Insurance Co.”
Not a new idea, but the fact that businesses are actually turning to such measures indicates the market may really be changing to value-based care.

“It’s never been done before”: How NC plans to use Medicaid dollars to improve social determinants of health: “Starting March 15, Hunger and Health — along with more than 90 otherorganizations throughout 33 western and eastern North Carolina counties — will begin scaling up their work and getting reimbursed for parts of it when the state officially rolls out the Healthy Opportunities Pilot: a first-in-the-nation project which hypothesizes that if we use health care dollars to pay for non-medical health-related services, medical costs will fall and people’s overall health will rise….
In North Carolina, the [1115] waiver means that the state can use up to $650 million in Medicaid money to pay for things such as the delivery of healthy food boxes, paying for someone’s first month’s rent or a security deposit, and case management for families experiencing domestic violence.”

California aims to limit health care costs with new office: “… instead of relying on the market or the courts to keep health care prices in check, California Gov. Gavin Newsom wants to order the state’s hospitals, doctors’ offices and insurance companies to keep their costs below a certain level. If they don't, the state could impose a hefty fine.
That's the goal of the proposed Office of Health Care Affordability, part of Newsom's $286.4 billion budget proposal. At least four other states — Massachusetts, Maryland, Rhode Island and Oregon — have similar offices. But none is as comprehensive as the one proposed in California. The big difference: California would be more willing to punish companies that charge too much.”

About hospitals and healthcare systems

VA reveals sweeping plan to shutter aging clinics, hospitals in favor of new facilities, retooled services: “The Biden administration released a sweeping plan Monday to reposition the sprawling veterans’ health-care system to confront demographic changes and shifts in medicine, recommending the closure of hundreds of hospitals and clinics and construction of new ones in areas with greater demand.”
For a very detailed look, see: VA Recommendations to the AIR Commission.
The VA established the Asset and Infrastructure Review (AIR) Commission to study projected needs and facility readiness to meet those needs. The above link details how the recommendations will be implemented in each of the Veterans Integrated Service Networks (VISNs). [For more background about VISNs, see the US Healthcare System book, pages 339-341].

 Investment gains a main driver of health system profits in 2021: The article cites many examples.

6 hospital construction projects worth $1B or more: Hospital expansion continues despite Covid-19 challenges and overall economic conditions.

'World's most ethical companies' list includes 9 health systems: “Ethisphere Institute, a for-profit company that defines and measures corporate ethical standards, has named nine health systems to its 2022 list of ‘world's most ethical companies.’”
It is interesting that three of the nine are in Cleveland.

About pharma

 The Top 15 U.S. Pharmacies of 2021: Market Shares and Revenues at the Biggest Companies: The list includes mail order and specialty pharmacies as well as “bricks and mortar” sites. At the top is CVS, followed by Walgreens.

 Pfizer Updates Company Position in Russia: “Pfizer will maintain humanitarian supply of medicines to Russians and donate all proceeds to providing direct humanitarian support to the people of Ukraine.”

About the public’s health

NIH launches clinical trial of three mRNA HIV vaccines: “The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched a Phase 1 clinical trial evaluating three experimental HIV vaccines based on a messenger RNA (mRNA) platform—a technology used in several approved COVID-19 vaccines. NIAID is sponsoring the study, called HVTN 302, and the NIAID-funded HIV Vaccine Trials Network (HVTN), based at Fred Hutchinson Cancer Research Center in Seattle, is conducting the trial.”

 Novel Malaria Treatment for Children Receives First Approval: “Australian regulators have approved a simple drug combination as an effective cure for a form of malaria in children ages 2 to 16…
The drug is a single dose of tafenoquine (brand name Kozenis), administered along with the traditional chloroquine treatment. The approval was announced on Monday by the nonprofit Medicines for Malaria Venture, which helped develop the drug.
Tafenoquine, made by GlaxoSmithKline, can cure a type of malaria caused by Plasmodium vivax, which is most common in South and Southeast Asia, South America and the Horn of Africa.”

Light exposure during sleep impairs cardiometabolic function: “This laboratory study shows that, in healthy adults, one night of moderate (100 lx) light exposure during sleep increases nighttime heart rate, decreases heart rate variability (higher sympathovagal balance), and increases next-morning insulin resistance when compared to sleep in a dimly lit (<3 lx) environment. Moreover, a positive relationship between higher sympathovagal balance and insulin levels suggests that sympathetic activation may play a role in the observed light-induced changes in insulin sensitivity…
These results demonstrate that a single night of exposure to room light during sleep can impair glucose homeostasis... Attention to avoiding exposure to light at night during sleep may be beneficial for cardiometabolic health.” [Emphasis added]
Also, turn off the TV before falling asleep.

Association of Low- and No-Calorie Sweetened Beverages as a Replacement for Sugar-Sweetened Beverages With Body Weight and Cardiometabolic Risk: A Systematic Review and Meta-analysis: “There are concerns that low- and no-calorie sweetened beverages (LNCSBs) do not have established benefits, with major dietary guidelines recommending the use of water and not LNCSBs to replace sugar-sweetened beverages (SSBs). Whether LNCSB as a substitute can yield similar improvements in cardiometabolic risk factors vs water in their intended substitution for SSBs is unclear…
This systematic review and meta-analysis found that using LNCSBs as an intended substitute for SSBs was associated with small improvements in body weight and cardiometabolic risk factors without evidence of harm and had a similar direction of benefit as water substitution. The evidence supports the use of LNCSBs as an alternative replacement strategy for SSBs over the moderate term in adults with overweight or obesity who are at risk for or have diabetes.”
The results are interesting because some previous studies showed that artificially sweetened beverages increase weight by “tricking” the body into thinking it was ingesting sweets without the associated satiety.

New US Preventive Services Task Force Recommendations on Screening for Eating Disorders: “For the first time, the US Preventive Services Task Force (USPSTF) reviewed eating disorder screening in asymptomatic adolescents and adults and gave it an I statement for insufficient evidence, which was supported by an evidence report and systematic review.The USPSTF only reviewed evidence for adolescents and adults with no signs or symptoms of eating disorders and with a normal or high body mass index (BMI). It is important to note that the insufficient evidence statement is not a recommendation for or against screening, but rather that there is not enough evidence to make a recommendation either way.”
See the Table for a good review of the different types of eating disorders.

About healthcare IT

Check this site for coverage of HIMSS22.

 Epic integrates AI tools for symptom assessment: “Epic added digital health company Ada Health's artificial intelligence tools to its App Orchard online marketplace…
Healthcare providers can now offer patients AI-powered symptom assessments within their Epic MyChart patient portal, which can then be accessed by the care team through the EHR.”

Meditech and Google Health to collaborate on clinical search in Expanse EHR: “Today at HIMSS22, Meditech and Google Health have announced their intent to collaborate on an integrated solution within Meditech's Expanse EHR platform.
The combined technology will enable the use of Google Health's search and summarization capabilities within the Expanse EHR with the aim of helping clinicians provide the best care through quick and easy access to information from multiple sources with a longitudinal view of a patient's health history.”

How Cincinnati Children's uses VR in the OR: A really interesting story about the use of virtual reality in planning pediatric cardiac surgery.

About healthcare personnel

 Primary Care in High-Income Countries: How the United States Compares: From the Commonwealth Fund study comparing 10 high income countries.
”Highlights

  • U.S. adults are the least likely to have a regular physician or place of care, or a longstanding relationship with a primary care provider.

  • Access to home visits or after-hours care is lowest in the U.S.

  • U.S. primary care providers are the most likely to screen for social service needs.

  • Half of U.S. primary care physicians report adequate coordination with specialists and hospitals — around the average for the 11 countries studied.”

About healthcare quality and safety

Patient Safety Excellence Award: Healthgrades just published its 2022 safety report.

Today's News and Commentary

About Covid-19

 Last week, Pfizer’s CEO said the company is investigating use of a 4th dose of its Covid-19 vaccine. Below are two related international stories:
Call to offer more people fourth jab as Covid rises in England: “Scientists say that the UK government should consider extending the plan to give a fourth dose of COVID vaccines to older people because of evidence of waning immunity, The Guardian reported.
Figures show that one in 25 people, or 3.8% of England's population, was infected on March 5, and research by the React-1 study indicated that cases are rising in those aged 55 and over.”
France to launch fourth COVID shot for over-80s, PM says: “French Prime Minister Jean Castex said the country will start offering a fourth COVID-19 vaccine to people over 80 years old who had their previous booster dose more than three months ago, as reported in National Post.”

About health insurance

 Small Practice Participation and Performance in Medicare Accountable Care Organizations: “We conducted a modified difference-in-differences analysis that allowed us to compare large vs small practices before and after the Medicare Shared Savings Program (MSSP) ACO started, between 2010 and 2016. Our sample included Medicare fee-for-service beneficiaries with 12 months of Medicare Part A and Part B (unless death) who were attributed to small (≤ 15 providers) and large (> 15 providers) practices participating in ACOs and non-ACOs. The outcome was patient annual spending based on CMS’ total per capita costs.
Results: Patients attributed to small practices in ACOs had annual Medicare spending decreases of $269 (95% CI, $213-$325; P < .001) more than patients attributed to large practices in ACOs. Small ACO practices reduced spending more than large practices by $165 for physician services (95% CI, $140-$190; P < .001), $113 for hospital/acute care (95% CI, $65-162; P < .001), and $52 for other services (95% CI, $27-$77; P < .001). Small practices in ACOs spent $253 more on average at baseline than small practices in non-ACOs. ACOs with a higher proportion of small practices were more likely to receive shared savings payments.
Conclusions: Small practices in ACOs controlled costs more so than large practices. Small practice participation may generate higher savings for ACOs.”

About pharma

 Ohio Doctor Sentenced for Overprescribing Painkillers, Fraud: “A doctor in Ohio who denied doing any harm to his patients after being convicted of overprescribing painkillers has been sentenced to five years in prison.
A federal judge on Thursday also ordered Dr. William Bauer of Port Clinton to pay $460,000 in restitution. 
Bauer, 85, was convicted last summer on charges of distributing controlled substances at his office in Bellevue and healthcare fraud.
Federal prosecutors said he prescribed dangerous drug combinations and high doses of addictive narcotics that weren’t medically necessary.”

About the public’s health

 Trends in Diet Quality Among Older US Adults From 2001 to 2018: “In this cross-sectional study of 10 837 adults aged 65 years or older in the National Health and Nutrition Examination Survey, the mean primary American Heart Association score had a significant 8% decrease. The proportion of older US adults with poor diet quality significantly increased from 51% to 61%, and the proportion with intermediate diet quality significantly decreased from 49% to 39%; the proportion of older US adults with ideal diet quality remained consistently low.” 

Inverse Association Between Variety of Proteins With Appropriate Quantity From Different Food Sources and New-Onset Hypertension: “The variety score of protein sources was defined as the number of protein sources consumed at the appropriate level, accounting for types and quantity of proteins. New-onset hypertension was defined as systolic blood pressure ≥140 mm Hg and diastolic blood pressure ≥90 mm Hg, or physician-diagnosed hypertension or receiving antihypertensive treatment, during the follow-up. During a median follow-up of 6.1 years, there were U-shaped associations of percentages energy from total, unprocessed or processed red meat-derived, whole grain-derived, and poultry-derived proteins with new-onset hypertension; an reverse J-shaped association of fish-derived protein with new-onset hypertension; L-shaped associations of eggs-derived and legumes-derived proteins with new-onset hypertension; and an reverse L-shaped association of refined grain-derived protein with new-onset hypertension (all P values for nonlinearity <0.001). That is, for each protein, there is a window of consumption (appropriate level) where the risk of hypertension is lower. Moreover, a significantly lower risk of new-onset hypertension was found in those with higher variety score of protein sources (per score increment, hazard ratio, 0.74 [95% CI, 0.72–0.76]). In summary, there was an inverse association between the variety of proteins with appropriate quantity from different food sources and new-onset hypertension.”
In this Chinese study, data was gathered from subject’s recall. Nevertheless, the findings are intriguing.

Millions suffering in deadly pollution ‘sacrifice zones’, warns UN expert: “In a report … presented to the UN human rights council on Thursday, Boyd says pollution contributed to twice as many premature deaths as Covid-19 in the first 18 months of the coronavirus pandemic.
Giving the death toll from pollution in that period is a staggering 9 million, the report adds: ‘One in six deaths in the world involves diseases caused by pollution, three times more than deaths from Aids, malaria and tuberculosis combined and 15 times more than from all wars, murders and other forms of violence.’”

About quality and safety

ECRI: Top 10 Patient Safety Concerns 2022:

1. Staffing shortages
2. COVID-19 effects on healthcare workers’ mental health 3. Bias and racism in addressing patient safety
4. Vaccine coverage gaps and errors
5. Cognitive biases and diagnostic error
6. Nonventilator healthcare-associated pneumonia
7. Human factors in operationalizing telehealth
8. International supply chain disruptions
9. Products subject to emergency use authorization
10. Telemetry monitoring 

 

Today's News and Commentary

About Covid-19

How the pandemic may fundamentally change the health-care system: “Exactly two years ago, the World Health Organization declared the coronavirus a pandemic and much of American life began grinding to a halt.”
The article is a good review of what has changed and may remain.

Deltacron: 6 things to know about the potential coronavirus variant: Some highlights:
”Three COVID-19 infections in southern France were identified with a delta 21J/AY.4-omicron 21K/BA.1 recombinant, or deltamicron, according to a preprint published March 8 in MedRxiv
’We have not seen any change in the epidemiology with this recombinant," WHO COVID-19 technical lead Maria Van Kerkhove, PhD, said of deltacron during a March 9 media briefing. "We haven't seen any change in severity. But there are many studies that are underway.’”

 Justice Department reports more than $8 billion in alleged fraud tied to federal coronavirus aid programs: “In some of the cases, suspects wrongfully obtained federal loans to bolster companies that did not actually exist. In others, large, transnational crime syndicates stole workers’ identities to receive generous unemployment benefits under someone else’s name. And in a series of additional allegations that struck at the very heart of Americans’ pandemic anxieties, federal officials charged a litany of actors who promised tests, which proved faulty, or cures that turned out to be fake — then at times submitted fake Medicare claims to the government for reimbursement.” 

Senate Roll call: To prohibit funding for COVID-19 vaccine mandates: 49 For, 50 against, 1 Abstention. The individual votes are listed.

About health insurance

 Santa Paula Doctor and Lancaster Patient Recruiter Arrested in Hospice Fraud Scheme that Received Over $30 Million from Medicare: “Authorities today arrested a physician and a marketer on federal charges stemming from a scheme that bilked Medicare out of more than $30 million for medically unnecessary hospice services provided to patients who were obtained through illegal kickbacks.”

Oscar Health, Bright Health, Clover Health post losses exceeding half a billion dollars in 2021: “Despite seeing revenue gains and significant membership growth, three of the largest health insurtech providers — companies that blend technological innovations with traditional insurance — posted losses exceeding $570 million in 2021.”
Details about each are in the article.

About hospitals and healthcare systems

 Sutter Health Defeats $411M Antitrust Class Action At Trial : “A California federal jury cleared Sutter Health in a $411 million certified class action claiming the hospital giant used restrictive contracts with insurance companies to illegally boost prices and overcharge millions of premium-paying employers and individuals in Northern California, finding Friday that the hospital giant hadn't violated antitrust laws.” 

About the public’s health

Tobacco Product Use and Associated Factors Among Middle and High School Students — National Youth Tobacco Survey, United States, 2021: Still a big problem: “In 2021, approximately one in 10 U.S. middle and high school students (9.3%) had used a tobacco product during the preceding 30 days. By school level, this represented more than one in eight high school students (13.4%) and approximately one in 25 middle school students (4.0%). E-cigarettes were the most commonly used tobacco product in 2021. Tobacco product use was higher among certain subpopulations, such as those identifying as LGB or transgender, or those reporting psychological distress. Importantly, approximately two thirds of students who currently used tobacco products were seriously thinking about quitting. However, factors that might continue to promote tobacco product use among U.S. youths, such as the availability of flavors, access to tobacco products, exposure to tobacco product marketing, and misperceptions about harm from tobacco product use, remained prevalent in 2021.”

Interim Estimates of 2021–22 Seasonal Influenza Vaccine Effectiveness — United States, February 2022: “Based on data from 3,636 children, adolescents, and adults with acute respiratory infection during October 4, 2021–February 12, 2022, seasonal influenza vaccination did not reduce the risk for outpatient respiratory illness caused by influenza A(H3N2) viruses that have predominated so far this season.”
While disappointing, it puts into perspective how effective the COVID-19 vaccines have been.
 
Texas Supreme Court rules against abortion providers challenge to fetal heartbeat law: “The Texas Supreme Court has delivered another blow to abortion providers who are challenging the state’s abortion restrictions, rejecting a lawsuit that objected to the state licensing board enforcing the law.
At issue was whether licensing boards can penalize abortion providers who violate the law that prohibits abortions after a heartbeat is heard, which is usually around six to eight weeks of pregnancy.”

Trends in Cost Attributable to Kidney Transplantation Evaluation and Waiting List Management in the United States, 2012-2017: “In this economic evaluation of cost reports from all certified transplant hospitals in the United States, kidney transplantation–related Organ Acquisition Cost Center (OACC) payments from Medicare amounted to $1.32 billion in 2017 (3.7% of total Medicare End-Stage Renal Disease Program expenditure), and OACC cost per transplantation increased from $81 000 in 2012 to $100 000 in 2017. Transplantation waiting list size and comorbidities were associated with an increase in OACC cost per transplant.
Meaning  These findings suggest that pre–kidney transplantation cost is increasing rapidly and these increases may be accelerated by efforts to expand waiting list access.”

About healthcare IT

 Critical Access Hospitals Not Included in Congressional Telemedicine Expansion: “The $1.5 trillion package will extend Medicare telemedicine coverage for five months after the end of the public health emergency for several types of providers, but not for critical access hospitals that primarily serve rural areas.
It’s not yet clear why CAH hasn’t been included, but supporters say they’re going to fight to have the issue resolved…
Federal medical centers, rural health clinics, physical and occupational therapists, hospices and other Medicare providers have been included in the telemedicine expansion.” 

About healthcare personnel

 Nurses are waiting months for licenses as hospital staffing shortages spread: From an NPR investigation:
—Almost 1 in 10 nurses who were issued new licenses last year waited six months or longer, according to an analysis of licensing records from 32 states. More than a third of these 226,000 registered nurses and licensed practical nurses waited at least three months.
—-Some states with lots of nurses are particularly slow: California, Pennsylvania, Texas, Ohio and others stretched average processing times for certain types of licenses to almost four months.
—-Wait times in some states underestimate the problem. NPR's investigation found that states often start the clock on processing times only after an application is marked complete. But nurses NPR spoke with described scenarios where they spent weeks or longer arguing that their applications were in fact complete. Many state boards don't count that lost time when measuring how long it takes to process an application.
—-Several large states have refused to join an interstate agreement that allows nurses to use licenses across state lines — sort of like a driver's license lets you drive across borders. One reason is that nursing boards make most of their money, sometimes tens of millions of dollars, from licensing fees.”

AMA analysis shows 3-year surge in medical liability premium increases: “For the third consecutive year there has been an exceptional surge in the percentage of medical liability premiums with year-to-year increases, according to an analysis issued today by the American Medical Association (AMA). The prevalence of increases in medical liability premiums between 2019 and 2021 has not been observed in about two decades.
The AMA analysis reported that the share of medical liability premiums with year-to-year increases was somewhat stable between 2010 and 2018. The recent period of upward volatility began in 2019 when the proportion of premiums that increased was about 27%, almost double the rate from 2018. In 2020 and again in 2021, roughly 30% of premiums increased….
The size of the largest premium increase in these states ranged from 35.3% in Illinois to 10% in Idaho and Washington.”

Today's News and Commentary

About Covid-19

 Mask mandate extended for airline flights and on public transportation until April 18: “Travelers will have to continue to wear masks until April 18 when flying commercially and in other transportation settings, including on buses, ferries and subways, officials announced Wednesday.”

House Passes $1.5 Trillion Spending Bill as Democrats Drop Covid Aid: “The House on Wednesday passed a sprawling $1.5 trillion federal spending bill that includes a huge infusion of aid for war-torn Ukraine and money to keep the government funded through September, after jettisoning a package to fund President Biden’s new Covid-19 response effort.”
And in a related story: Pelosi says separate coronavirus relief bill will be put on the floor 'hopefully today'

Pfizer launches trial to test Covid pill in children: “Pfizer announced Wednesday that it has started a clinical trial testing its Covid-19 antiviral pill in children as young as 6.
The drugmaker said it aims to enroll approximately 140 participants in the trial, which will look at whether the drug, called Paxlovid, can safely treat Covid in children who are at risk of becoming severely ill.
Paxlovid has already been authorized for people ages 12 and older.”

Architect of Sweden’s no-lockdown Covid strategy resigns: “Anders Tegnell, one of the most high-profile and divisive figures of the Covid-19 pandemic, is stepping down from his role as Sweden’s state epidemiologist and taking a job with the World Health Organization…
The 65-year-old will leave his position at Sweden’s public health authority on Tuesday to take up a role as senior expert at WHO, looking to co-ordinate the global health body’s vaccination efforts with those of the UN’s Children’s Fund and the Gavi vaccine alliance.”
HMMMMM….

About health insurance

Anthem, Inc. Announces Intent for Corporate Rebranding: “Anthem, Inc. today announced its intent to change its name to better reflect the company’s business and its bold purpose of improving the health of humanity. Anthem intends to become Elevance Health, Inc., subject to shareholder approval. The new name underscores the company’s commitment to elevating whole health and advancing health beyond healthcare.” 

16 Defendants, Including 12 Physicians, Sentenced to Prison for Distributing 6.6 Million Opioid Pills and Submitting $250 Million in False Billings: “Sixteen Michigan and Ohio-area defendants, including 12 physicians, have been sentenced to prison for a $250 million health care fraud scheme that included the exploitation of patients suffering from addiction and the illegal distribution of over 6.6 million doses of medically unnecessary opioids. Five physicians were convicted in two separate trials, while 18 other defendants pleaded guilty. Seven defendants await sentencing.”

About hospitals and healthcare systems

 The Crisis in Rural Health Care: “More than 130 rural hospitals have closed over the past decade, and nearly 900 additional rural hospitals — over 40% of all rural hospitals in the country — are at risk of closing in the near future. Over 500 hospitals are at immediate risk of closure because they have experienced large financial losses over multiple years. Over 300 additional hospitals are at high risk of closing due to low financial reserves or high dependence on local taxes or state grants.” 

About pharma

Which Companies Aren’t Exiting Russia? Big Pharma: “…drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.”

10 Prescription Drugs That Cost Medicare the Most: From AARP based on 2020 data. #1 is Eliquis, with $9.9 billion spent and used by 2,641,941 beneficiaries.

 Judge favors boosting Sackler payment in Purdue Pharma deal: “A judge said Wednesday that he would approve a plan that locks members of the Sackler family who own OxyContin maker Purdue Pharma into pumping at least another $1.2 billion into a nationwide lawsuit settlement that, if ultimately confirmed, would transform the company into a public trust.” 

About the public’s health

 Trust, the less-discussed social determinant of health: “ How much trust a patient places in the healthcare system is a significant determinant of good health behavior, according to a report released March 10 by marketing consultancy firm Edelman….
Here are four takeaways:

  1. Fifty-five percent of respondents said medical science is becoming politicized or being used to support political agendas, a concern that makes patients have less trust in the healthcare system.

  2. Patients with lower trust levels are less likely to receive preventive care.

  3. Seventy-two percent of respondents with high levels of trust are likely to accept changing recommendations from healthcare officials, whereas 51 percent of respondents with low trust are likely to accept the same recommendations.

  4. Eighty-two percent of respondents with high trust are fully vaccinated against COVID-19, whereas 61 percent of respondents with low trust are fully vaccinated.”

About healthcare IT

 HHS, health organizations roll out single sign-in for medical records: “The launch later this month will set up a test environment for integrating the technology, said Ryan Howells, principal at Leavitt Partners and program manager at the CARIN Alliance, which is spearheading the efforts. CARIN will issue a public report on how it worked by the end of the year. The Centers for Medicare and Medicaid Services and the federal health IT office will serve as ‘observers,’ Howells said Tuesday at the ViVE health tech conference.
The effort has a range of 20 health care organizations, including health care systems like Kaiser Permanente and Providence, health plans like CVS Health and Cambia, and credential service providers like ID.me.”
Will this action be the first step in a unique patient identifier?

 Epic launches software geared toward independent physicians: “Epic released a new shared environment software service that will give small and independent physician groups access to Epic electronic health records…
Garden Plot is intended to be an avenue for independent medical groups to work with the company when the Community Connect program, which systems can use to extend their Epic instances to nearby medical groups, isn't an option.   
The new model will include integrated products from Availity, Biscom, Change Healthcare, Healthwise, Intelligent Medical Objects, Iron Bridge, Lyniate, OSG Billing Services, Solarity, Sphere, Surescripts and Wolters Kluwer, as well as access to Epic's software suite.” 

About health technology

 World’s first pig heart transplant patient dies 2 months later: “David Bennett died on Tuesday at the age of 57 after his health deteriorated over a number of days, said the University of Maryland Medical Centre, which carried out the pioneering operation. Highlight text The hospital said it as not immediately obvious whether Bennett’s immune system had rejected the pig’s heart, which was supplied by Revivicor, part of the US-based United Therapeutics biotech group. The Maryland doctors and scientists will conduct a thorough postmortem examination to established the cause of death.”

Today's News and Commentary

About Covid-19

 Americans can now order four more free at-home Covid-19 tests: “Americans can now order a second set of free at-home Covid-19 rapid antigen tests from the federal government. 
Covidtests.gov, the website to sign up for the free tests, launched in January, when people could order a maximum of four tests per household. Households that took part in that first round can now order an additional four.
Households that missed the first round of test giveaways can order up to eight tests through the website or by calling 1-800-232-0233.”

WHO says COVID boosters needed, reversing previous call: “An expert group convened by the World Health Organization said Tuesday it “strongly supports urgent and broad access” to booster doses of COVID-19 vaccine amid the global spread of omicron, capping a reversal of the U.N. agency’s repeated insistence last year that boosters weren't necessary for healthy people and contributed to vaccine inequity.”

Pfizer to Submit Data to FDA on Fourth Covid Shot Soon, CEO Says:”Pfizer CEO Albert Bourla said the company will soon submit data to US regulators on a fourth dose of its COVID-19 vaccine Comirnaty…
Meanwhile, findings from a study of a three-dose regimen of the company's vaccine for children under the age of 5 are also expected next month, he added.”

COVID-19 Focused Inspection Initiative in Healthcare: From OSHA: “This memorandum provides instructions and guidance to Federal OSHA Area Offices for a highly focused, short-term inspection initiative directed at hospitals and skilled nursing care facilities that treat or handle COVID-19 patients…
The intent of this initiative is to magnify OSHA’s presence in high-hazard healthcare facilities over a three-month period (March 9, 2022 to June 9, 2022), to encourage employers in these industry sectors to take the necessary steps to protect their workers against the hazards of COVID-19...
Criteria for Conducting Focused Healthcare Inspections…

  1. Follow-up inspection of any prior inspection where a COVID-19-related citation or hazard alert letter (HAL) was issued;

  2. Follow-up or monitoring inspections for randomly selected closed COVID-19 unprogrammed activity (UPA), to include COVID-19 complaints and Rapid Response Investigations (RRIs); or

  3. Monitoring inspections for randomly selected, remote-only COVID-19 inspections where COVID-19-related citations were previously issued.”

About pharma

 FDA Offers Grants for Biosimilar Research: “The FDA’s Center for Drug Evaluation and Research announced plans to fund up to five biosimilar research efforts and has committed $5 million toward the projects in fiscal 2022.
The funding will target projects for innovations in biosimilar and interchangeable products, as part of the FDA’s commitments under the Biosimilar User Fee Amendments (BsUFA).”

About the public’s health

Global community comes together in support of 100 Days Mission and pledges over $1.5 billion for CEPI’s pandemic-busting plan: “The global community [yesterday] came together to commit to the 100 Days Mission – the ambition to have safe and effective vaccines within 100 days of an epidemic or pandemic threat being identified – and pledged $1.535 billion to the Coalition for Epidemic Preparedness Innovations (CEPI) to help kick start the organization’s ambitious plan to tackle epidemics and pandemics, potentially saving millions of lives and trillions of dollars in lost economic output.”

 The Loophole That’s Fueling a Return to Teenage Vaping: “The Food and Drug Administration’s crackdown on flavored e-cigarettes in 2020 was meant to be a comprehensive, aggressive strategy to curtail the epidemic of teenage vaping.
But two years later, sales of disposable, flavored e-cigarettes have soared. Some companies have moved just beyond the reach of the F.D.A. by swapping out one key ingredient. They have circumvented federal oversight of tobacco plant-derived nicotine by using an unregulated synthetic version…
Lawmakers on Tuesday proposed language that they want inserted in the Congressional omnibus budget bill that would give the F.D.A. authority to regulate synthetic nicotine, although it is unclear if the issue will be included in the final bill.”

About healthcare IT

 Considering the Patient Perspective When Prescribing Medical Wearables: “KEY FINDINGS

  • 1 in 5 patients says their wearable device is hard to use.

  • The majority of patients who are manually inputting data (87%) have recorded inaccurate data on their wearable devices.

  • Of these, 85% said the error occurred because the user interface was hard to understand.

  • Despite challenges, patients still see the benefits of wearables: 49% of patients cited the biggest benefit of their wearable as a better understanding of their own health.”

Congress set to add 151 days of telehealth coverage: “Congress is set to grant a five-month extension to telehealth flexibilities, created during the pandemic, as part of the 2022 omnibus spending bill made public March 9.
The $1.5 trillion omnibus legislation, which would set spending levels for defense and nondefense spending for fiscal 2022, would also extend the telehealth federal public health emergency, which is set to expire in April, until Sept. 14.”

Today's News and Commentary

The 10 most innovative health companies of 2022: From Fast Company. At the top is Walgreens (which is #33on the global list of innovative companies).

About Covid-19

Global Covid Deaths Top 6 Million as Omicron Wave Leaves Scars: “More than 6 million people worldwide have died from Covid-19 two years after the novel pathogen started spreading globally, despite the distribution of vaccines that slashed fatality rates across the globe.
The latest 1 million recorded deaths came more slowly than the previous intervals. It took about 125 days to go from 5 million deaths to 6 million, compared to 117 days to hit the 5-million mark and less than 90 days each to reach the 3- and 4-million ones. The pace has returned to what was seen during the first year of the pandemic, when the virus was still taking hold.”

 SARS-CoV-2 is associated with changes in brain structure in UK Biobank: “The availability of pre-infection imaging data reduces the likelihood of pre-existing risk factors being misinterpreted as disease effects. We identified significant longitudinal effects when comparing the two groups, including: (i) greater reduction in grey matter thickness and tissue-contrast in the orbitofrontal cortex and parahippocampal gyrus, (ii) greater changes in markers of tissue damage in regions functionally-connected to the primary olfactory cortex, and (iii) greater reduction in global brain size. The infected participants also showed on average larger cognitive decline between the two timepoints. Importantly, these imaging and cognitive longitudinal effects were still seen after excluding the 15 cases who had been hospitalised.”
One reason not to rely on natural infection for protection. 

Whole genome sequencing reveals host factors underlying critical Covid-19: “…we find evidence implicating multiple genes, including reduced expression of a membrane flippase (ATP11A), and increased mucin expression (MUC1), in critical disease….
Our results are broadly consistent with a multi-component model of Covid-19 pathophysiology, in which at least two distinct mechanisms can predispose to life-threatening disease: failure to control viral replication, or an enhanced tendency towards pulmonary inflammation and intravascular coagulation.”

Florida’s top health official says healthy children should not get coronavirus vaccine: “Florida’s governor and chief health official announced a new state policy Monday that will recommend against giving a coronavirus vaccine to healthy children, regardless of their age — a policy that flies in the face of recommendations by every medical group in the nation.”

World’s First Inhaled Covid-19 Vaccine Enters Final Stage Clinical Trials: “Yicai Global said the world's first inhalation-based COVID-19 vaccine is now in Phase III trials, according to a report in Beijing Daily, citing the chief scientist of Chinese vaccine maker CanSino Biologics.
The Convidecia nasal spray vaccine, which is needle-free and does not need to be stored in special bottles or at ultra-low temperatures, has started partial Phase III tests, Zhu Tao said.
It completed first and second stage clinical trials last year and is applying for emergency use in China.
The inhalation-based vaccine uses the same formula as CanSino's recombinant coronavirus jab and is atomized by a special device for nebulized inhalation, which is less painful than traditional intramuscular injections and more conducive to mass distribution.”

Moderna vows never to enforce Covid jab patents in policy U-turn: “Moderna has pledged never to enforce its Covid-19 vaccine patents in low- and middle-income nations following searing criticism by campaigners that its opposition to waiving intellectual property rights threatens Africa’s access to life-saving jabs. The US drug company announced the U-turn on patent enforcement on Tuesday along with up to $1bn funding for new initiatives aimed at better preparing the world for future pandemics and major public health risks.”

About health insurance

Hundreds of organizations reject CMS' direct contracting model rebrand: “More than 250 organizations sent a March 8 letter to HHS Secretary Xavier Becerra condemning its rebranding of the Global and Professional Direct Contracting model.
The new model was announced by CMS Feb. 24 and is now called the Accountable Care Organization Realizing Equity, Access and Community Health model, or ACO REACH.
The letter — signed by organizations representing seniors, people with disabilities, consumers and health professionals — calls for an end to the new model and a rejection of the privatization of traditional Medicare.”

Court Rejects Hospitals Over Medicare Pay for Training Residents: “‘A change in Medicare reimbursement policy under the Affordable Care Act for teaching hospitals’ costs of training residents didn’t apply to costs incurred before the ACA became law, the U.S. Circuit Court of Appeals for the 10th Circuit ruled Monday.’ This ‘lawsuit filed by three teaching hospitals challenged the Department of Health and Human Services’ denial of reimbursement for their shared costs of training residents at community clinics and other off-site locations from 2001 to 2006.’”

Long Island Medical Doctor Pleads Guilty to Medicare Billing Fraud Scheme: “‘With today’s guilty plea, Dr. Barnard admits to committing a multi-million dollar fraud on the Medicare program by billing for procedures he did not perform,’ stated United States Attorney Peace.   ‘By claiming to render services to disabled and other vulnerable patients, Dr. Barnard not only pocketed taxpayer funds that were intended to help beneficiaries in need, he also betrayed his oath for profit.  We will continue to work closely with our law enforcement partners to protect the integrity of taxpayer-funded health care programs.’”

 Tobacco Surcharges Associated With Reduced ACA Marketplace Enrollment: “The Affordable Care Act (ACA) allows insurers to charge tobacco users who have nongroup coverage up to 50 percent more than nonusers of tobacco. In this study we used 2014–19 administrative data on enrollees in the federally facilitated ACA Marketplace, HealthCare.gov, to examine the relationships among surcharge rates, total Marketplace enrollment, and enrollment by tobacco users. We found that the tobacco surcharge rate averaged approximately 14 percent and that it was associated with lower total enrollment as well as a reduced share of total enrollees who reported any tobacco use. Our analysis also found that tobacco surcharges have a significantly larger effect on tobacco users’ share of enrollment in rural areas than in urban areas, which may in turn contribute to urban-rural health disparities. Given that tobacco surcharges may decrease Marketplace enrollment overall and shift the composition of enrollment away from tobacco users, our findings suggest that reducing tobacco surcharges may increase total Marketplace enrollment.”
What the results imply is that smokers would rather continue smoking than quit and have more affordable health insurance. Regarding the recommendation, can companies afford to lower rates when smokers cost so much more than non-smokers? Should the government subsidize smokers’ rates, thereby encouraging that behavior? Perhaps a plan that could work would encourage enrollment by refunding excess premiums for those who take part in smoking cessation programs and quit.

Marketplace Health Insurance Ratings: Most Potential Enrollees Have Access To Plans Of Medium Or High Quality: “In most participating counties (1,390 of 2,265, or 61.4 percent), the highest-rated ACA Marketplace insurer had a three-star rating. Fewer than one-third of counties (703, or 31.0 percent) had access to four- or five-star-rated insurers. Fewer than 10 percent (172, or 7.6 percent) had access to only one- or two-star-rated insurers. In plan-based analyses, each one-point increase in star rating was associated with a $28 increase in the average monthly plan premium…We found no systematic racial or ethnic disparities in access to plans from high-rated insurers.”
And in a related article: 9 of the highest performing Medicare, Medicaid plans in 2020-21

About hospitals and healthcare systems

 Health system financial results for Q4: FYI: Revenue, Net Income and Operating Income for 8 systems.

 Hospital Service Offerings Still Differ Substantially By Ownership Type: “After hospital and market characteristics are adjusted for, nonprofit hospitals offer relatively unprofitable services more than for-profit hospitals and less than government hospitals. Profitable services typically exhibit the opposite pattern. For-profit hospitals are also more likely to adopt or discontinue services consistent with changes in service profitability than are nonprofits, which in turn are more likely to do so than government hospitals. These results are similar to those we found before passage of the Affordable Care Act, when many more patients were uninsured. Policy makers and researchers tend to focus on whether nonprofit hospitals provide sufficient free care to justify tax benefits, thereby overlooking the significance of ownership for service provision, which likely has critical health and spending consequences.”

About pharma

 Women see more adverse events with chemotherapy and newer cancer treatments, study finds: “Overall, women were 34% more likely than men to experience severe adverse effects in response to their cancer treatments, a figure that increased to 49% for women receiving immunotherapies, according to a recent study in the Journal of Clinical Oncology (JCO). The study was based on 30 years of data from the SWOG Cancer Research Network, a global cancer research community that designs and conducts publicly funded clinical trials.
Part of the problem, experts say, is that sex differences are not taken into account in the development of cancer treatments.”

How pharma economics hold back antibiotic development: The article is a really good explanation of the problem stated in the headline. For example, since antibiotics are administered for short courses (days to weeks) and need to be reasonably priced, profitability is not as high as for other pharmaceuticals.

Association of Glucagon-Like Peptide-1 Receptor Agonist vs Dipeptidyl Peptidase-4 Inhibitor Use With Mortality Among Patients With Type 2 Diabetes and Advanced Chronic Kidney Disease: “This cohort study comprising 27 279 participants with type 2 diabetes and advanced-stage chronic kidney disease or end-stage kidney disease revealed that the use of GLP-1 receptor agonists was associated with lower all-cause mortality and lower sepsis- and infection-related mortality than was use of DPP-4 inhibitors.”
This study could change the frequency of medications used to treat diabetes.

Moderna aims to move mRNA vaccines against 15 infectious diseases into clinic by 2025: “Moderna announced that it plans to advance mRNA vaccines targeting 15 infectious diseases, including HIV, malaria and tuberculosis, into clinical studies by 2025. The company added that it will also make its mRNA technology available to researchers working on new vaccines for emerging and neglected infectious diseases through a programme called mRNA Access.”

Teva launches first Revlimid generic in US: “Teva on Monday introduced its generic version of Bristol Myers Squibb's Revlimid (lenalidomide) in the US, making it the first generic of the cancer treatment available in the country. The drug is indicated for patients with multiple myeloma in combination with the dexamethasone, and is also approved for certain myelodysplastic syndromes, as well as mantle cell lymphoma following specific prior treatment.”

Mallinckrodt Agrees to Pay $260 Million to Settle Lawsuits Alleging Underpayments of Medicaid Drug Rebates and Payment of Illegal Kickbacks: “Pharmaceutical company Mallinckrodt ARD LLC (formerly known as Mallinckrodt ARD Inc. and previously Questcor Pharmaceuticals Inc. (Questcor)) (collectively Mallinckrodt), has agreed to pay $260 million to resolve allegations that Mallinckrodt violated the False Claims Act by knowingly: 1. underpaying Medicaid rebates due for its drug H.P. Acthar Gel (Acthar); and 2. using a foundation as a conduit to pay illegal co-pay subsidies in violation of the Anti-Kickback Statute for Acthar. In 2019 and 2020, respectively, the government filed separate complaints detailing these allegations. The settlement, which is based on Mallinckrodt’s financial condition, required final approval of the U.S. Bankruptcy Court for the District of Delaware, which approved the settlement on March 2.”

About healthcare IT

 Senate passes bill to mandate reporting of cyberattacks: “The Senate on Tuesday passed a package of cybersecurity bills that would require operators of critical infrastructure [including hospitals] as well as federal civilian agencies to report cyberattacks on their networks to the Cybersecurity and Infrastructure Security Agency…
The House has yet to pass a similar bill after some lawmakers unsuccessfully attempted to attach a cyber-themed measure to last year’s defense policy bill.”

Google Announces Intent to Acquire Mandiant: “Google LLC today announced that it has signed a definitive agreement to acquire Mandiant, Inc., a leader in dynamic cyber defense and response, for $23.00 per share, in an all-cash transaction valued at approximately $5.4 billion, inclusive of Mandiant’s net cash. Upon the close of the acquisition, Mandiant will join Google Cloud.”

About healthcare personnel

 Physician Practices With Robust Capabilities Spend Less On Medicare Beneficiaries Than More Limited Practices: “Using data from the 2017 National Survey of Healthcare Organizations and Systems linked to 2017 Medicare fee-for-service claims data from attributed beneficiaries, we examined the association of practice-level capabilities with process measures of quality, utilization, and spending…
physician practice locations with “robust” capabilities had lower total spending compared to locations with “mixed” or “limited” capabilities. Quality and utilization, however, did not differ by practice-level capabilities. Physician practice locations with robust capabilities spend less on Medicare fee-for-service beneficiaries but deliver quality of care that is comparable to the quality delivered in locations with low or mixed capabilities. Reforms beyond those targeting practice capabilities, including multipayer alignment and payment reform, may be needed to support larger performance advantages for practices with robust capabilities.” 

About health technology

 AltPep’s Alzheimer’s Disease Blood Test Designated a Breakthrough Device: “The FDA has designated Seattle, Wash.-based AltPep’s SOBA-AD diagnostic for Alzheimer’s disease (AD) a Breakthrough Device.
Existing FDA-cleared diagnostic tests for AD look for amyloid-beta plaques and neurofibrillary tangles in the brains of patients, while the SOBA-AD blood test in plasma aims to detect the early molecular triggers of the disease before plaque formation.”

Today's News and Commentary

2022 Patient Consumer Survey: From JLL. Some highlights:
—”Overall, 83% of patients are traveling less than 30 minutes to access care, though this is down from 89% in 2020. Those who traveled 45 minutes or more were more often seeking acute care, either in a surgery center or hospital, or seeking behavioral health services. Patients prioritize locational convenience over facility quality, which has remained true since 2020….
—Of those who had an in-person doctor’s appointment, had taken a visit to the hospital or had another non-dental medical service since July 1, 70% found location convenience either very or extremely important when selecting a healthcare provider. Location convenience is most important to millennials and respondents in urban communities….
—The overall sentiment surrounding choosing a healthcare provider that’s closer or newly built did not change from the 2020 survey—83% would prefer to be closer to care, even if the facility is old; 17% would drive further for a newly built facility….
—Even if an appointment is available sooner via telehealth, baby boomers are much less likely to schedule a telehealth appointment than other generations, especially when compared to millennials, who were the most likely. Millennials prefer convenience and efficiency, while baby boomers prefer more personalized care and perhaps have strong ties to their medical providers given increased need for care among this age group…
—70% of behavioral health/psychiatry clinic respondents would take an earlier available telehealth appointment, while only 38% of doctor’s office (with physician other than primary care) respondents would…
—A majority of Gen Z respondents find their experiences very positive but, compared to the other generations, have the most average to below average experiences…
—A majority of respondents who had an in-person doctor’s appointment, had taken a visit to the hospital or had another non-dental medical service since July 1 did not check reviews of hospitals or healthcare facilities before their visit.”

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW: “As of March 2, 2022, the current 7-day moving average of daily new cases (53,017) decreased 28.5% compared with the previous 7-day moving average (74,143). A total of 78,977,146 COVID-19 cases have been reported in the United States as of March 2, 2022.” 

About pharma

 GoodRx to acquire pharmacy services platform for $150M: GoodRx has entered a definitive agreement to acquire VitaCare Prescription Services, a digital pharmacy services platform…
The platform is designed to help patients understand their coverage and find savings opportunities for brand medications.”

Biogen Begins Layoffs Amid Disappointing Aduhelm Sales: “Biogen has begun laying off large numbers of its workforce as the company scrambles to save $500 million amid lackluster sales of its controversial Alzheimer’s drug Aduhelm (aducanumab).
The company has not specified how many people it will ultimately let go, but the number could reportedly be as high as 10 percent of its workforce. In its latest annual Securities and Exchange Commission filing, Biogen said it had 9,610 worldwide employees with 5,645 employees in the U.S. and 3,965 abroad.”

About the public’s health

 First-ever malaria vaccine recommendation now published in a position paper and in the WHO guidelines for malaria: “WHO recommends the RTS,S/AS01 malaria vaccine be used for the prevention of P. falciparummalaria in children living in regions with moderate to high transmission as defined by WHO.
The malaria vaccine recommendation was recently added to WHO's consolidated malaria guidelines on the MAGICapp platform. The guidelines bring together the Organization's most up-to-date recommendations for malaria in one user-friendly online platform.”

Hospital stops therapies after gender-confirming care order: “The nation’s largest pediatric hospital has announced it has stopped gender-affirming therapies after Texas Gov. Greg Abbott ordered the state’s child welfare agency to investigate reports of gender-confirming care for kids as abuse.
Texas Children’s Hospital, located in Houston, announced that its decision to stop such hormone-related prescription therapies was made after it reviewed Abbott’s order, which came when Republican Attorney General Ken Paxton last month released a nonbinding legal opinion that labeled certain gender-confirming treatments as ‘child abuse.’”

Exercise Helps You Sleep, But Which Workout Is Best?: “For study participants who had been unable to regularly get at least seven hours of sleep, weight training added an average 40 minutes of shuteye, said lead researcher Angelique Brellenthin, an assistant professor of kinesiology at Iowa State University.
By comparison, aerobic exercise increased sleep time by 23 minutes for another group with similar sleep problems, Brellenthin said.”

About healthcare IT

CVS files to trademark its pharmacy and health clinics in the metaverse: “CVS Health is looking to be the first pharmacy in the metaverse. 
The drugstore and health services company filed for a trademark to sell virtual goods, NFTs and provide health care services, joining major retailers like Walmart and Nike.
In its filing with U.S. Patent Trade Office, CVS is looking to trademark its logo and to provide an online store, as well as downloadable virtual goods, including ‘prescription drugs, health, wellness, beauty and personal care products.’”

Allscripts expands online application store: “Allscripts relaunched its online application store to showcase more certified apps and devices available to its clients.
The rebranded platform will allow for all active developers, who have an app or device that has been built and certified through the Allscripts Developer Program, to feature their apps via the new Allscripts App Expo.”

Three cybersecurity companies to offer free protection to U.S. hospitals and utilities amid concerns of hacking attacks: “… endpoint protection company CrowdStrike, two-factor authentication provider Ping Identity, and Cloudflare, which is best known for guarding websites from automated denial-of-service attacks that would otherwise knock them offline, are offering their services free to the organizations most often thought at risk.
In an announcement Monday, the three said they would give away four months of their services to U.S. hospitals, which have been frequent targets of Russian-speaking ransomware gangs, and to electricity and water utilities, which are vital to everyday life.”

About healthcare personnel

 2021 NSI National Health Care Retention & RN Staffing Report: “From a nursing perspective, the labor market continues to tighten with 39.8% of hospitals projecting to increase their RN staff. This is down 19.2% from last year. In 2020, the turnover rate for staff RNs increased by 2.8% and currently stands at 18.7%. Registered Nurses working in burn care, surgical services and women’s health recorded the lowest turnover rate, while nurses working in step down, behavior health and emergency services experienced the highest.
The cost of turnover can have a profound impact on diminishing hospital margins and needs to be managed. According to the survey, the average cost of turnover for a bedside RN is $40,038 and ranges from $28,400 to $51,700 resulting in the average hospital losing between $3.6m – $6.5m/yr. Each percent change in RN turnover will cost/save the average hospital an additional $270,800/yr.”
Other impressive statistics from the report: “Last year, hospital turnover increased by 1.7% and currently stands at 19.5%. Since 2016, the average hospital turned over 90.8% of its workforce.” 

Today's News and Commentary

HHS further delays rule that could void thousands of regulations: “HHS will further delay the start date on a rule that would require the department to eliminate existing regulations after 10 years unless the department reviewed them and could justify keeping the regulation in place, according to an March 3 Federal Register notice.
The Securing Updated and Necessary Statutory Evaluations Timely, or SUNSET rule, was finalized by HHS a day before President Joe Biden's inauguration. The policy was slated to take effect in March 2021, but HHS postponed the final rule until March of this year.
Now, the rule will be delayed by another six months to Sept. 22, pending judicial review, HHS said.”

About Covid-19

 More than 90% of U.S. population in areas where masks not needed -CDC: "The U.S. Centers for Disease Control and Prevention (CDC) on Thursday said some 93% of the U.S. population live in locations where COVID-19 levels are low enough that people do not need to wear masks indoors…
When it announced the revised guidelines, the CDC said about 70% of U.S. counties and 72% of the U.S. population were in communities where indoor face coverings are no longer recommended. The CDC plans to update its county ratings weekly.
The agency said on Thursday that 85.4% of counties now rank as low or medium risk and 92.9% of the population lives in those counties.”

Health care workers don unnecessary protective gear. The CDC and WHO need to update their PPE guidance: “Having taken care of hundreds of Covid-19 patients, we would have no concern about entering a patient’s room without an isolation gown, because this infection is transmitted through the air via droplets and aerosols, not by touching a contaminated surface. Although hand washing is always an important part of infection prevention efforts, contamination of one’s clothes, hair and shoes have never been shown to be a problem.
It makes no sense for health care workers to gown up to go into the rooms of Covid-19 patients they often have fleeting contact with.
The CDC also needs to dial back on its messaging that cleaning surfaces and using hand sanitizer will decrease the risk of Covid transmission, when there is no evidence to support either.”
The authors stress that the needless PPE use also adds to a problem of medical waste.

About health insurance

 CMS URGES STATES TO TAKE IT SLOWIn a Thursday letter, Center for Medicaid and CHIP Services Director Daniel Tsai cautioned states not to rush through the process of determining whether Medicaid enrollees are still eligible for their health coverage when the pandemic ends. Many state officials and Medicaid advocates have long worried about what will happen when the redetermination process resumes…
Some highlights:
A new timeline: Federal health officials had planned to give states 12 months to complete their work. Now, they’re being given 14 months — 12 months to start the renewals and an extra two months to wrap up.
A request for data: States would be required to submit data monthly over 14-months to demonstrate their progress toward completing the redetermination process.
A word of caution: Federal health officials warn states that, if they don’t stick to CMS’ timeline and try to rush through the redetermination process, they might face corrective action.”

Seeking to Shift Costs to Medicare, More Employers Move Retirees to Advantage Plans: “Over the past decade, an increasing number of employers have taken a similar deal, using the government’s Medicare Advantage program as an alternative to their existing retiree health plan and traditional Medicare coverage. Employers and insurers negotiate behind closed doors to design a private Medicare Advantage plan available only to retirees from that employer. Then, just as it does for private individuals choosing a Medicare Advantage plan, the federal government pays the insurer a set amount for each person in the plan.
Experts say this arrangement often saves the employer money because the federal payment reduces the employer’s share of the cost of coverage…
The number of beneficiaries in employer-sponsored Medicare Advantage plans has soared from about 1.6 million in 2008 to more than 5 million last year, according to CMS…”

About hospitals and healthcare systems

 Court Tosses Medicare Reimbursement Boost for Low-Wage Hospitals: “Congressionally required adjustments in Medicare reimbursements designed to account for regional differences in labor costs cannot be further adjusted to give an extra boost to low-wage hospitals, a federal district judge ruled.
The lawsuit was filed by a group of hospitals challenging a 2019 regulation issued to address wages disparities among hospitals. The hospitals claimed they would receive reduced reimbursements as a result of the regulation.”

About pharma

 Robotic pill can orally deliver large doses of biologic drugs: Biologics cannot be given orally because they are digested before the active ingredients are absorbed. “Now, NIBIB [National Institute of Biomedical Imaging and Bioengineering]-funded researchers are developing a robotic pill that, after swallowing, can deliver biologic drugs into the stomach, which could potentially revolutionize the way that certain conditions are treated…
Once the pill has been swallowed and makes its way into the stomach, it uses its weighted bottom to orient itself properly, so that its injection mechanism is flush against the stomach wall. After a few minutes, a carbohydrate pellet at the top of the pill dissolves, activating a spring and enabling a needle to inject the biologic drug into the stomach tissue. Then, a second, newly exposed pellet dissolves, freeing the spring and retracting the needle back inside the pill, allowing for safe passage of the device through the gastrointestinal tract…
In their study, reported in Nature Biotechnology, the authors loaded their robotic pills with one of four biologic drugs—insulin; a glucagon-like peptide 1 (GLP-1) analog (also used for the management of diabetes); adalimumab (brand name Humira®, an immunosuppressive drug used for a variety of conditions, including arthritis and Crohn's disease); or epinephrine (for the emergency treatment of allergic reactions or asthma attacks).”

About the public’s health

 Study finds drinking wine with meals was associated with lower risk of type 2 diabetes:
Research Highlights:

  • A study including nearly 312,000 current drinkers suggests consuming moderate amounts of alcohol (no more than 14 grams per day for women and 28 grams per day for men), especially wine, with meals was associated with a lower risk of developing type 2 diabetes.

  • Lower type 2 diabetes risk occurred only when people drank alcohol with meals, not when alcohol was consumed alone.

  • Only moderate amounts of alcohol had a positive impact on the development of type 2 diabetes – up to one glass of wine daily for women and up to two glasses daily for men.

  • The American Heart Association recommends that adults who do not drink alcohol should not start. Among adults who drink alcohol regularly, they should talk with their doctors about the benefits and risks of consuming alcohol in moderation. Experts caution these results are not a reason for nondrinkers to start consuming alcohol.”

The Association Between E-Cigarette Use and Prediabetes: Results From the Behavioral Risk Factor Surveillance System, 2016–2018: “We defined sole E-cigarette users as current E-cigarette users who are never combustible-cigarette users, and dual users were defined as both current E-cigarette and combustible-cigarette users…
In this representative sample of U.S. adults, E-cigarette use was associated with greater odds of prediabetes. The results were consistent in sole E-cigarette users.”

About healthcare IT

 Microsoft closes on $16 billion acquisition of Nuance : “The deal, which was announced last year, helps Microsoft Corp. get more entrenched into hospitals and the health care industry through Nuance’s widely used medical dictation and transcription tools. The acquisition is Microsoft’s second-largest after its $26 billion purchase of career networking service LinkedIn in 2016.”

Health information exchanges boost physician referrals 46%: study: “A study from the New York-based University at Buffalo School of Management analyzed datasets from 22,000 Medicare beneficiaries in Western New York from 2009 to 2012 to examine the impact of health information exchanges on patient referral. 
Researchers found that physicians who joined an exchange experienced a 44 percent to 46 percent increase in the rate of referrals to and from other members.” 

Today's News and Commentary

About Covid-19

 Call for Stories and Research on Health Misinformation: “U.S. Surgeon General Dr. Vivek Murthy is calling for research, data, and personal experiences related to health misinformation, in an effort to deepen our collective understanding of its sources and impact.”

Effectiveness of Ad26.COV2.S [J&J] Vaccine vs BNT162b2 [Pfizer/BioNTech] Vaccine for COVID-19 Hospitalizations: “This study found that the Ad26.COV2.S vaccine is less effective against COVID-19–related hospitalization than the BNT162b2 vaccine. These results strengthen the evidence supporting a second dose in people who received the Ad26.COV2.S vaccine by an mRNA vaccine as recommended in both France and the US.”

In Symbolic Vote, Senate Rejects Vaccine Mandate for Health Workers: “In a vote forced by Republicans, the measure passed 49 to 44 along party lines, after six Democratic absences left the majority party short of the votes needed to defeat it. The measure is all but certain to die in the Democratic-controlled House; even if it cleared that chamber, the White House said on Wednesday that Mr. Biden would veto it.”

Hundreds of COVID trials could provide a deluge of new drugs: A great summary of what has been approved and what is in the pipeline.

 Prioritizing Case Investigation and Contact Tracing for COVID-19: Some highlights of a new policy this week from the CDC:

—”Universal case investigation and contact tracing are not recommended for COVID-19.
—Health department jurisdictions should prioritize specific settings and groups at increased risk.
—Case investigation and contact tracing are separate processes with distinct benefits and goals; decisions to initiate either should be made separately.
—Investigations should focus on COVID-19 cases and close contacts with onsets and exposures in the previous 5 days for those settings and groups at increased risk.”

U.S. to share some coronavirus technologies with World Health Organization: “Under the plan, some technologies now being developed by the National Institutes of Health will be licensed to the WHO’s COVID-19 Technology Access Pool, senior NIH official Anthony S. Fauci told reporters. The technologies will also be sub-licensed to the United Nations-backed Medicines Patent Pool.
Fauci declined to detail which technologies would be made available for licensing by other countries, saying the plan’s details were ‘still being ironed out.’”

About health insurance

Suburban Chicago Businessman Admits Swindling Hospital in Connection With Attempted Purchases of Personal Protective Equipment: “Haggerty and two business partners in March 2020 formed a company called At Diagnostics Inc. to sell personal protective equipment. The company reached an agreement with a hospital in Iowa to sell 500,000 N95 respirator masks for $2.495 million. Haggerty created an invoice to reflect the agreement and to instruct the hospital on where to wire the payment. Based on the invoice, the hospital on March 31, 2020, wired the money to a bank account that Haggerty falsely claimed was an At Diagnostics account but which was actually the account of a different business solely controlled by Haggerty.
 Haggerty admitted in a plea agreement that he spent part of the money for his own personal benefit, including purchasing two Maserati automobiles and a Land Rover sport-utility vehicle, paying nearly $189,000 to credit card companies, withdrawing more than $147,000 in cash, and paying $20,000 to a personal friend. Haggerty further admitted that At Diagnostics never delivered the masks, and when questioned about it by the hospital he falsely claimed that the bank had no record of the hospital’s payment being received.”

Memorandum Regarding Continuing Surprise Billing Protections for Consumers: From the US Department of Labor Department of Labor:
”On February 23, 2022, the United States District Court for the Eastern District of Texas, in the case of Texas Medical Ass'n, et al. v. United States Department of Health and Human Services, et al., Case No. 6:21-cv-425 (E.D. Tex.), invalidated portions of an interim final rule, Requirements Related to Surprise Billing; Part II, 86 Fed. Reg. 55,980 (Oct. 7, 2021) (the "Rule"), issued by the Departments of Health and Human Services, Labor, and the Treasury (the "Departments") governing aspects of the federal independent dispute resolution (IDR) process under the No Surprises Act.
This court's order did not affect any of the Departments' other rulemaking under the No Surprises Act. Thus, consumers continue to be protected from surprise bills for out-of-network emergency services, out-of-network air ambulance services, and certain out-of-network services received at in-network facilities. The patient-provider dispute resolution process for uninsured and self-pay consumers to dispute bills that exceed a provider's or facility's good faith estimate by $400 or more also remains available and unchanged by the court's order. To learn more about these protections, visit www.cms.gov/nosurprises.”

Bright Health Group Reports Fourth Quarter and Full Year 2021 Results: “Bright Health Group, Inc., a diversified healthcare services company building a technology-enabled, fully-aligned, national Integrated System of Care personalized for consumers, reported [yesterday] financial results for its fourth quarter and full year ended December 31, 2021.” As usual for these type of reports, the article leads with a rosy forecast from the CEO: "Bright Health Group achieved substantial growth in 2021, delivering $4 billion in Revenue, and reaching a significant scale milestone of serving over 1 million health plan lives for the start of 2022.”
However, the Medical Expense and Operating Cost Ratios are at their historic highest, with adjusted EBITDA loss of $1,080.9 million and GAAP Net Loss of $1,178.4 million.

About hospitals and healthcare systems

DO HIGHER-PRICED HOSPITALS DELIVER HIGHER-QUALITY CARE?: “Being admitted to a hospital with two standard deviations higher prices raises spending by 52% and lowers mortality by 1 percentage point (35%). However, the relationship between higher prices and lower mortality is only present at hospitals in less concentrated markets. Receiving care from an expensive hospital in a concentrated market increases spending but has no detectable effect on mortality.”

 CMS wallops nursing homes with planned staffing requirements and increased penalties: “The Centers for Medicare & Medicaid Services will establish minimum staffing requirements as part of a broad plan to “crack down on unsafe nursing homes,” the White House announced on Monday. 
The agency said it plans to conduct a new study to determine the level and type of staffing needed to ensure safe and quality care and will issue proposed rules within one year.”

About pharma

 Civica to manufacture, distribute insulin at discounted price: “Civica, a nonprofit generic pharmaceutical company, plans to manufacture and distribute three insulins to make them available to people with diabetes at significantly lower prices than those currently on the market. 
The company will produce glargine, lispro and aspart, the generic versions of Lantus, Humalog and Novolog, respectively, and plans to recommend consumer prices be capped at $30 per vial and $55 for a box of five pen cartridges, according to a March 3 news release.
Civica will co-develop the drugs with GeneSys Biologics, complete clinical trials and file FDA approval applications. The company expects glargine, the first insulin it plans to produce, will be available in early 2024, pending FDA approval.”

Sacklers agree to $6 billion Purdue bankruptcy settlement over opioid crisis: “The Sackler family members who own Purdue Pharma have agreed to pay up to $6 billion to settle a hotly contested bankruptcy plan, which will allow state governments and tens of thousands of people to be compensated for the company’s role in the opioid crisis.”

Pain Clinic Owners Convicted of Unlawfully Distributing Opioids and Multimillion-Dollar Health Care Fraud: “Mark Murphy, 65, and his wife, Jennifer Murphy, 65, both of Lewisburg, owned and operated North Alabama Pain Services (NAPS), which closed its Decatur and Madison offices in early 2017. Over the approximately five-year period leading up to the clinic closing its Alabama locations, Murphy and his wife, who was the office manager, caused over $50 million in fraudulent or unnecessary medical services to be charged to Medicare, TRICARE, Blue Cross Blue Shield of Alabama and others.”

About the public’s health

 Suicide Mortality in the United States, 2000–2020: “After increasing from 2000 through 2018, the age-adjusted suicide rate declined from 2018 (14.2 per 100,000) to 2020 (13.5).
Suicide rates for females in all age groups over age 25 showed recent declines, while rates for those aged 10–14 and 15–24 have generally increased.”
Firearms was the leading method.

About healthcare IT

 Allscripts to sell net assets of hospital business segment for $700M: “Allscripts is selling the net assets of its business segment for hospitals and large physician practices to N. Harris Computer Corp., a subsidiary of Constellation Software…
The business segment includes the following Allscripts products: Sunrise, Paragon, Allscripts TouchWorks, Allscripts Opal, STAR, HealthQuest and dbMotion, according to a March 2 news release.” 

About health technology

Fitbit recalls 1 million Ionic watches after burn injuries: “Google-owned Fitbit has recalled 1 million of its Ionic smartwatches after dozens of users reported burn injuries after the battery overheated.”

Today's News and Commentary

Biden's State of the Union: 7 healthcare takeaways: An excellent summary of the headline’s topic.
Also, read: AHIP Comments on President Biden’s State of the Union Health Care Priorities

About Covid-19

Omicron subvariant doubling every week in US: “The subvariant accounted for an estimated 8.3 percent of COVID-19 cases in the week ending Feb. 26…
The U.S. has confirmed 2,796 COVID-19 cases involving BA.2 as of Feb. 28, according to outbreak.info, a platform that tracks data on coronavirus variants and is supported by the CDC and other national research groups.
The subvariant has been found in every U.S. state and 86 countries worldwide.”

White House rolls out next COVID-19 plan: 8 details: “The debut of the 96-page plan coincides with falling COVID-19 cases in the U.S., which President Joe Biden mentioned during his State of the Union address to Congress on March 1.”

Declines in COVID concerns and mask mandate support: “Twenty-four percent are extremely or very worried about themselves or a family member being infected with COVID-19. This is down from 36% who felt the same in the past couple of months, when the omicron variant caused a spike in cases. Vaccinated adults are about twice as likely as unvaccinated Americans to be concerned about infection (28% vs. 13%)…
Half of Americans approve of mask mandates compared with 28% who oppose. Yet, support for this measure is down from 55% who supported the mask mandates in August 2021 and 75% in December 2020.
Americans vaccinated against COVID-19 are more likely to support mask mandates than the unvaccinated.  Even when controlling for vaccine status, Democrats are also more likely than Republicans and independents to say they support the policy.”

FDA doubles dosage of Covid-19 monoclonal antibody, raising concerns about access and supply: “‘Based on the most recent information and data available, Evusheld may be less active against certain Omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose,’ the FDA said in a news release.”

 Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5–17 Years — VISION Network, 10 States, April 2021–January 2022: “Two doses protect against COVID-19–associated emergency department and urgent care encounters among children and adolescents. However, vaccine effectiveness (VE) was lower during Omicron predominance and decreased with time since vaccination; a booster dose restored VE to 81% among adolescents aged 16–17 years. Overall, 2-dose VE against COVID-19–associated hospitalization was 73%–94%.” 

Hospital Worker Vaccination Rate Data Withheld Until October: “The Centers for Medicare & Medicaid Services has three months-worth of data on vaccination rates that it started requiring hospitals to submit Oct. 1, 2021. ‘CMS will not be updating this measure with quarterly refreshes until the agency has a full year of data in October 2022,’ a CMS spokesperson said in an email.
The agency said it takes time to collect the data, analyze it, and get it ready for public viewing. Advocates say the data, even if incomplete, could help patients make informed decisions about the risks associated with visiting a hospital.”


About health insurance

Variation in Estimated Surgical Procedure Times Across Patient Characteristics and Surgeon Specialty: This article and the accompanying editorial highlight the inaccuracy of using a time component to set RVUs for surgery.
”How do procedure times estimated using Medicare claims compare with the times used in the valuation process for determining Medicare payments for procedures?

Findings  In this cross-sectional study that analyzed 4.9 million procedures, the mean estimated procedure time was 27% lower than the time currently used in the valuation process. There was substantial variation across specialties in the difference between estimated and valuation procedure times.”
When 1 Plus 1 Equals 3—The Art, Not Science, of RVU Valuations: One highlight:
”…each work measure—operative time, length of stay, etc—is multiplied by an intensity factor to allow higher or lower rates of compensation per unit time. Intensity is the true black box of the RVU update process. These modifiers vary more than 40-fold from 1 procedure to the next with no relationship between intensity and any traditional measure of surgical complexity.7 There is little justification that any procedure should pay a physician more than 40 times more, per minute, than another.”

 Better Medicare Alliance: 99.9% of Medicare Advantage plans offering supplemental benefits: “A new study found that 99.9% of Medicare Advantage plans are offering supplemental benefits in 2022, with vision and hearing benefits the most widely offered…
The Centers for Medicare & Medicaid Services (CMS) expanded the number of benefits MA plans could offer to enrollees in 2018 and 2019.
The benefit most widely offered by MA plans was vision coverage, an option included in 97% of plans. This was shortly followed by hearing (94%), fitness (94%) and dental care at 91%.”

Feds Report $88B In Medical Debt On Credit Reports: “Medical debt is far and away the most common type of liability on credit reports. On Tuesday, Consumer Financial Protection Bureau officials questioned whether it belongs there at all. As of last year, 58% of all third-party debt collections were for medical debt, the agency determined in a new report. About 20% of U.S. households owe medical debt, which appears on 43 million credit reports, the CFPB found.”

About hospitals and healthcare systems

 Cleveland Clinic's operating income more than triples in 2021: “Cleveland Clinic posted an operating income of $746.3 million in 2021, more than triple the $232.4 million recorded in 2020, according to its recently released financial results.
The 19-hospital system also reported a 66.7 percent increase in net income for the 12 months ended Dec. 31, 2021, from $1.3 billion in 2020 to $2.2 billion in 2021.”

About pharma

Harvard, MIT Win Patent Dispute Over Gene-Editing Technology: “A federal patent board says the valuable rights to develop and market gene editing, the transfer of genetic technology between living organisms with the potential to cure diseases, belong not to UC Berkeley but to a research institute affiliated with Harvard and the Massachusetts Institute of Technology.
A researcher with the Broad Institute published a study in 2012 describing how the so-called CRISPR technology could be used to alter genes in humans, other animals and plants. The U.S. Patent and Trademark Office granted a patent to Broad in 2014, but it was challenged by the University of California, which contended the work was not original. Six months before Broad's study, a team of scientists led by UC Berkeley biochemist Jennifer Doudna had issued the first report on the use of CRISPR to alter DNA.
On Monday, however, the U.S. Patent Trial and Appeal Board said Broad's research had been original and its patent was valid. Although the Berkeley study was the first to uncover technology that could transform genetic material, the board said, it involved DNA in bacteria and had no direct application to genes in plants and animals, whose cells are classified as ‘eukaryotes.’”

Boots sale thrown off course by fewer buyers and market turmoil: “ Plans for a multi-billion-pound sale of UK chemist Boots have run into a series of difficulties after a potential buyer walked away and bidders raised concerns about financing a deal with markets in turmoil because of Russia’s invasion of Ukraine. Highlight text A consortium of Bain Capital and CVC Capital, previously seen as a leading candidate to buy the business from US parent Walgreens Boots Alliance, did not make a bid ahead of a deadline last week, two people with knowledge of the matter said.”

Nevada joins a little-known, ambitious state consortium dedicated to better drug prices: “After months of talks, the state of Nevada has joined a consortium formed by Oregon and Washington to pool purchasing power and get better prices on prescription drugs, the latest bid by a state government to try to blunt the rising cost of medicines.
The Northwest Prescription Drug Consortium, which began in 2006, claims to facilitate the purchase of more than $800 million in prescription drugs each year and saved at least 1 million people in Oregon and Washington nearly $100 million over the last six years.”

DIGITAL CONSUMER TRENDS IN PHARMA 2022: From Press Ganey. Some highlights:
”Nearly 1 in 2 [of surveyed persons] says finding the right doctor is a barrier to treatment
Almost 50% research prescriptions, medications, and medical devices on brand websites
~90% want physician directories available on life sciences and pharmaceutical sites
83% are more likely to use (or recommend) a brand website that has a doctor directory
Most consumers would prefer a digital appointment scheduling option”

 Federal Judge Rejects Eli Lilly’s Request That Whistleblower Suit Be Tossed Out : “This week, a federal judge in Chicago rejected Lilly’s attempt to dismiss the lawsuit, saying that the plaintiff, lawyer and pharmacist Ronald Streck, have presented evidence to the court suggesting that Lilly made false statements to the Centers for Medicare and Medicaid Services (CMS) regarding the amounts it charged distributors for its medicines between 2005 and 2016.”

About the public’s health

 Class-action lawsuits hit Abbott over contaminated baby formulas: “Several class-action lawsuits have been filed against Abbott Laboratories, claiming the company’s baby powder formulas—notably its Similac line— are making infants sick with bacterial infections, some so severe that several babies have been hospitalized and two have died…
 Salmonella newport and another type of bacteria called cronobacter sakazakii have been linked to baby powder formulas manufactured at Abbott’s Sturgis, Mich., plant.”

About healthcare IT

 Telemedicine destinations boost demand for medical office space: “More than 30% of telemedicine visits resulted in a physical office visit, according to a new survey by JLL…Notably, the survey did not indicate whether it was a new or returning patient, or what type of treatment the patients were looking for, the researchers say….
Despite this, the number of calls to specialists has increased the demand for medical offices, said Jay Johnson, managing director of JLL Healthcare. 
’Demand for medical office buildings is growing and supply has not kept pace. Rents for medical office buildings have peaked in the U.S. in the past couple of years,’ he said, adding that demand for medical office space rentals has been strong. before the pandemic. ‘The pandemic has not dampened this trend and has potentially reinforced it.’”

Allscripts Veradigm Ink Collaborates with the Social Security Administration: “Under the agreement, the agency will be able to request medical records electronically through the Veradigm network when processing disability claims. The health care providers in the company’s network will then receive electronic requests for medical records from the SSA with patient authorization, which can then be automatically released.”

About health technology

Magnets in newer portable electronic devices can interfere with implanted defibrillators: “Magnet technology is increasingly being used in portable electronic devices, such as the Apple AirPods Pro charging case, the Apple Pencil 2nd Generation and the Microsoft Surface Pen. However, if the devices are carried in pockets near the chest, and the individual has an implanted cardiac device (ICD), the magnets may interfere with the ICD’s ability to help regulate the heart, according to new research published today in Circulation: Arrhythmia and Electrophysiology, a peer-reviewed journal of the American Heart Association.”

 

 

Today's News and Commentary

About Covid-19

140 million Americans have had coronavirus, according to blood tests analyzed by CDC: “The estimates, compiled by the Centers for Disease Control and Prevention, show that about 43 percent of the country has been infected by the virus. The study shows that the majority of children have also been infected.”

 Most Americans say the coronavirus is not yet under control and support restrictions to try to manage it, Post-ABC poll finds: “The 34 percent overall who say they regard the pandemic as largely controlled is among the highest proportion since surveys began tracking such attitudes early in the pandemic. Yet nearly 6 in 10 U.S. adults think it is more important to control the virus, with some restrictions in daily life, while 4 in 10 prefer no restrictions.”
As expected (see the graphs), results are different between Democrats and Republicans. 

About health insurance

 Cigna stock buyback kicks off goal to generate $12B in value: “Cigna is looking to create $12 billion in value throughout 2022, starting with a plan to buy back $6 billion in stocks. 
The move was approved at Cigna's February board meeting, which brought the payer's total share repurchase authority to $10 billion. The company has already repurchased $1.2 billion in shares, with the intent to tap $7 billion this year on stock buybacks. 
The company highlighted that $5.4 billion of its deployable capital for the effort stems from its sale of international life, accident and supplemental benefits companies.”

Humana rolls out Kindred at Home's new brand, signals 'full integration': “Humana is rolling out Kindred at Home as CenterWell Home Health, an arm under its payer-agnostic brand, CenterWell.
Humana announced the creation of CenterWell in early 2021, a rebranded segment that houses all of its healthcare service offerings. Other subsidiaries have been rebranded to fit under this umbrella, with Kindred at Home being the latest move. 
The rollout as CenterWell Home Health signals Kindred's "full integration" into Humana, the payer announced March 1.”

Memorial Hermann, Blue Cross Blue Shield terminate contract, forcing estimated 100K patients out of network: “The state’s biggest insurer and the region’s biggest health system were unable to resolve their differences on the status of independent physicians affiliated with Memorial Hermann. Blue Cross Blue Shield wanted the doctors to contract directly with the insurer rather than through Memorial Hermann, which now negotiates rates for nearly 3,000 independent doctors in its system.” 

About pharma

Pharmaceutical Spending Up 77% Over 10 Years, Yet Out-of-Pocket Prescription Drug Costs Have Fallen in Same Period: Key findings

  • Spending on pharmaceutical products — prescription and nonprescription drugs — in the U.S. has skyrocketed since 2010. In 2020, pharmaceutical spending topped $570 billion — a 77% increase from $322 billion in 2010…

  • Despite these increases, out-of-pocket prescription drug costs are down compared to 2010 — even with some big jumps in the middle of the decade. Costs (including copays and coinsurance) dropped from $48 billion in 2010 to $47 billion in 2020, even with a spike to $52 billion in 2015.

  • Nationally, prescriptions cost $4,571 a year per household…

  • Only 5% of prescriptions are paid for entirely out of pocket across the U.S., but it varies widely by state. A staggering 12% of prescriptions in North Dakota are completely paid out of pocket, versus 3% or less in each New England state — Vermont, Massachusetts, Connecticut, Rhode Island, New Hampshire and Maine.”

FDA Clears Blood Cancer Treatment: “U.S. drug regulators ap- proved a new customized, cell- based treatment for blood cancer from Johnson & John- son that is the first such ther- apy in the U.S. to be developed initially in China.
The Food and Drug Administration on Monday cleared the therapy, named Carvykti, for the treatment of multiple myeloma in adult patients whose disease has worsened despite prior treatments with other drugs.
The approval suggests a possible path forward for Western drugmakers seeking to bring China-developed drugs to the U.S. amid con- cerns about the quality of the drugs’ development: conduct- ing separate, confirmatory studies in Americans.”

 Endo, Arnold & Porter Opioid Discovery Called 'Truly Awful': “Endo Pharmaceuticals and Arnold & Porter used a ‘coordinated strategy’ to hide key materials in opioid litigation, and the drugmaker deployed ‘disinformation’ and ‘intimidation’ after being severely punished for its discovery misconduct, a Tennessee judge wrote Monday. In a pair of rulings, Circuit Court Judge Jonathan Lee Young explained why he found Endo liable by default for discovery shortcomings in an opioid crisis case and rejected the company's argument that he has appeared biased and should disqualify himself from the matter.”

Viatris Agrees to Settle EpiPen Antitrust Litigation for $264M: “Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay generic competition to its EpiPen allergy treatment…”
And in a possibly related story: Viatris Selling Its Biosimilars Business to Bangalore-Based Biocon for Up to $3.3B

HSA Singapore the First National Regulatory Authority Awarded the Highest Recognition for an Advanced Medicines Regulatory System by the World Health Organization: “The Health Sciences Authority (HSA) is the first National Regulatory Authority (NRA) and Singapore is the first World Health Organization (WHO) member state to achieve Maturity Level (ML) 4 for its advanced medicines regulatory system. This achievement came after a rigorous and comprehensive assessment by a team of 15 international assessors and 4 WHO officials using the WHO’s Global Benchmarking Tool
ML4 is the highest level of attainment for a regulatory system classification system conferred to an NRA that has met the highest quality standards stipulated by WHO for regulatory excellence. 

About the public’s health

 US births continue to decline but 'may be returning to pre-pandemic levels,' preliminary CDC data suggests: “US births dropped 2% in the first half of 2021 compared with the year prior, according to the new National Center for Health Statistics report, released Tuesday by the US Centers for Disease Control and Prevention. The same decline in births was observed for the first half of 2020, and births fell 5% in the second half of 2020…
NCHS researchers found that during the first half of 2021, compared with the same period in 2020, the nation's number of births declined 9% in January and 2% in February but then rose non-significantly by less than 1% in March and 1% in April, declined again by 1% in May and rose again by 3% in June.”

Senate Republicans, Manchin block bill to protect the right to abortion: “The Senate on Monday blocked consideration of a bill to protect the right to abortion nationwide, an election-year measure pushed by Democrats as the Supreme Court decides the fate of the landmark decision guaranteeing access to abortion.
Republicans and Sen. Joe Manchin III (D-W.Va.) voted against moving ahead on the legislation. The Senate fell 14 votes short of the 60 necessary to begin debate on a vote of 46-to-48.”

About healthcare IT

 Nearly 1M health records breached in February: “In February, 26 organizations reported to HHS that 941,680 individuals were affected by data breaches.” 

Information Blocking Claims: By the Numbers: “Total number of possible claims of information blocking complaints: 274” 176 were from patients; the next largest number, 42, was from attorneys.

Cigna plans to invest $450M in venture arm for digital health, analytics: “The company is eyeing targeted bolt-on or tuck-in acquisitions along with investments in earlier-stage companies through Cigna Ventures. The company's board authorized an additional $450 million to invest in its venture capital arm with a focus on contributing to early-stage companies in the areas of insights and analytics, digital health and experience and care delivery and enablement, according to an announcement.”

About healthcare personnel

 Health Care Expenditures Attributable to Primary Care Physician Overall and Burnout-Related Turnover: A Cross-sectional Analysis: “Turnover of PCPs results in approximately $979 million in excess health care expenditures for public and private payers annually, with $260 million attributable to PCP burnout-related turnover.”  

About healthcare finance

 Healthcare Trust of America, Healthcare Realty to combine in medical REIT deal: “The combined real estate investment trust will have 727 properties in its portfolio and a pro-forma total enterprise value of $17.6 billion as of Thursday's close.”

Today's News and Commentary

About Covid-19

Pfizer Shot Is Far Less Effective in 5- to 11-Year-Olds Than in Older Kids, New Data Show: “The vaccine’s effectiveness against hospitalization declined to 73 percent from 85 percent in the older children. In the younger children, effectiveness dropped to 48 percent from 100 percent. But because few children were hospitalized, these estimates have wide margins of error.
The numbers for protection from infection are more reliable. Vaccine effectiveness against infection in the older children decreased to 51 percent from 66 percent. But in the younger children, it dropped sharply to just 12 percent from 68 percent.”

Nearly half of Biden’s 500M free COVID tests still unclaimed: “Nearly half of the 500 million free COVID-19 tests the Biden administration recently made available to the public still have not been claimed as virus cases plummet and people feel less urgency to test.
Wild demand swings have been a subplot in the pandemic, from vaccines to hand sanitizer, along with tests. On the first day of the White House test giveaway in January, COVIDtests.gov received over 45 million orders. Now officials say fewer than 100,000 orders a day are coming in for the packages of four free rapid tests per household, delivered by the U.S. Postal Service.”

 Japanese study examines efficacy and side effects of mixed vaccines: “The average antibody level for people with triple Pfizer increased 54.1-fold and for those who received Moderna as their third dose, the average antibody level increased 67.9-fold.”
It remains to be seen whether this difference  is clinically significant.

Children with, without asthma maintain oxygen levels while masked during exercise: “Oxygen saturation did not significantly decrease among children who participated in low- or moderate-intensity exercise while masked, according to data presented at American Academy of Allergy, Asthma & Immunology Annual Meeting.
Also, researchers found no significant differences in peripheral oxygen saturation (SpO2) or dyspnea among those with and without asthma.”
So much for those who complain that masking children is bad for their physical health.

Health Canada Approves Plant-Based COVID-19 Vaccine: “Health Canada has approved Medicago’s Covifenz COVID-19 two-dose vaccine, the first authorized vaccine that uses plant-based proteins.
The vaccine, which is authorized for people aged 18 to 64 years old, was found to be 71 percent effective against symptomatic infection and 100 percent effective against severe disease in clinical trials. Each 3.75-mg dose is meant to be administered 21 days apart.”

Evusheld May Have Less Efficacy Against Omicron Subvariants: “AstraZeneca’s COVID-19 antibody Evusheld (tixagevimab/cilgavimab) may have limited efficacy against the Omicron subvariants, BA.1 and BA.1.1, the FDA said.
The agency also amended the therapy’s Emergency Use Authorization (EUA) to double the initial dosage to 300 mg of tixagevimab and 300 mg of cilgavimab, given the concerns over diminished efficacy.”

Moderna faces new lawsuit over lucrative coronavirus vaccine: “Arbutus and Genevant said in their lawsuit that Moderna infringed on their patent for so-called lipid nanoparticle technology, which they say was key in the development of Moderna’s mRNA vaccine and took scientists from Arbutus and Genevant ‘years of painstaking work to develop and refine.’ The suit had been expected after Moderna lost a U.S. Court of Appeals ruling last year in the protracted patent battle.”

Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians:

“Practice Point 1: Consider Remdesivir for 5 Days to Treat Hospitalized Patients With COVID-19 Who Do Not Require Invasive Ventilation or ECMO

Practice Point 2: Consider Extending the Use of Remdesivir to 10 Days to Treat Hospitalized Patients With COVID-19 Who Develop the Need for Invasive Ventilation or ECMO Within a 5-Day Course

Practice Point 3: Avoid Initiating Remdesivir to Treat Hospitalized Patients With COVID-19 Who Are Already on Invasive Ventilation or ECMO”

About health insurance

 UnitedHealthcare axes paper prior authorization, decision letters: UnitedHealth Group is beginning to act on its November promise to shore up its sustainability efforts by halting its mailing paper of prior authorization and clinical decisions to providers, according to a Feb. 25 post on the California Medical Association website. 
The first move — a nationwide shift to digital clinical decision letters — is effective March 4 for most UnitedHealthcare Medicare Advantage and commercial plan members. Instead of receiving a mail appeal decision, providers can view the decisions digitally immediately after they are made. 
According to the announcement, more UnitedHealthcare communications will make the shift to digital during 2022. The payer will issue warnings for each document moving to virtual distribution 90 days in advance.”

Lawyers say the California malpractice ruling will have minimal impact on insurance rates.: “Legal experts say the new ruling, which upholds California’s medical malpractice limit, will not materially impact providers’ insurance rates. 
On Thursday, the California Supreme Court upheld a lower court decision to cut $4.25 million in malpractice compensation for pain and suffering to the state’s $250,000 non-economic damages limit.”
Read the article for the particulars of the case. Many states have set or tried to set limits for non-economic damages for malpractice.

About hospitals and healthcare systems

 February 2022 National Hospital Flash Report: From KaufmanHall.
Margins
The sudden volume shifts and persistent expense increases pushed margins down in January. Not including federal CARES aid, the median change in Operating Margin dropped 71.3% from December to January. Year-over-year (YOY), the median change in Operating Margin was down 23.7% versus January 2021 and 73.3% compared to before the pandemic in January 2020, not including CARES.
The median change in Operating EBITDA Margin declined 52% month-over- month, 14.9% versus January 2021, and 52.7% versus January 2020. With CARES, the median change in Operating Margin declined 80.7% month-over-month and 23.8% YOY. The median change in Operating EBITDA Margin (with CARES) decreased 59.4% month-over-month and 19.6% YOY.

Volumes
The Omicron surge drove a drop in outpatient care as many providers and patients delayed nonurgent procedures in efforts to mitigate spread of the virus and ease traffic to hospitals experiencing an influx of COVID-19 cases. Operating Room Minutes were down 15.7% from December to January and 20.4% compared to before the pandemic in January 2020.
Hospitals saw an increase in more severe patients requiring longer hospital stays. Patient Days rose 1.7% month-over-month and 2.1% YOY. The Average Length of Stay (LOS) jumped 8.6% from December to January, and was up 4.9% compared to January 2021 and 17.2% versus January 2020.”

Mayo Clinic operating income jumps to $1.2B: Still, there are some “winners.”
“Rochester, Minn.-based Mayo Clinic's revenue totaled $15.7 billion last year, up from $13.8 billion in 2020. Net medical service revenue was up 7.7 percent year over year…
Mayo Clinic's operating expenses climbed 11.1 percent year over year to $14.5 billion in 2021. The health system saw expenses increase across several categories, including salaries and benefits. 
Mayo Clinic ended 2021 with an operating income of $1.2 billion, up from $728 million a year earlier.”

About pharma

  FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making: “ FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making…
These guidances are part of FDA’s PFDD efforts in accordance with the 21st Century Cures Act and The Food and Drug Administration Reauthorization Act of 2017 Title I.”

About the public’s health

 New Report Recommends Changes to U.S. Organ Transplant System to Improve Fairness and Equity, Reduce Nonuse of Donated Organs, and Improve the System’s Overall Performance: Realizing the Promise of Equity in the Organ Transplantation System [ Note: Free pdf download] makes near- and long-term recommendations to create a fairer and more equitable, transparent, cost-effective, and efficient system for deceased donor organs. In addition to organ donors and patients, the key components of the transplantation system include donor hospitals, where the deceased donor is admitted; organ procurement organizations (OPOs), which procure organs after declaration of death; transplant centers, where the recipient is taken to surgery and gets the organ transplant; and the U.S. Department of Health and Human Services (HHS), which oversees the system’s performance. The report recommends actions that HHS should take to improve coordination across the different parts of the system, and ensure they have common goals and unified policies and processes.”

Children Living in Households That Experienced Food Insecurity: United States, 2019–2020: “In 2020, 10.8% of children aged 0–17 years lived in households that experienced food insecurity during the past 30 days.
The percentage of children who lived in food-insecure households was higher for non-Hispanic Black (18.8%) than Hispanic (15.7%) children, and higher for both non-Hispanic Black and Hispanic children than for non-Hispanic White children (6.5%).”

About healthcare IT

 STAT and MIT rooted out the weaknesses in health care algorithms. Here’s how we did it: “In July 2021, STAT and the Massachusetts Institute of Technology set out to answer a simple question with big implications for the use of AI in medicine: How do popular algorithms used to warn of bad outcomes for patients hold up over time?
The months-long experiment, born of a novel partnership in journalism and science, yielded an illuminating result: the algorithms deteriorated over several years, delivering faulty advice about which patients were at the highest risk of deadly complications and prolonged hospital stays.”

Digital Reshaping the Health-Care Ecosystem: From Bloomberg Intelligence: “Health-care delivery via telehealth will continue to accelerate after the industry's sea change in value with the pandemic. We believe the channel could reach $20 billion in revenue and represent 15% of outpatient visits by 2027 as barriers to adoption fall and new offerings such as virtual primary care take root. Incumbents like Teladoc and large managed-care companies will drive the next leg of growth….
At a minimum, we foresee the market expanding by 25% annually which essentially triples revenues to almost $17 billion in 2027.”

Teladoc set to launch on Amazon's Alexa: “Teladoc Health customers in the U.S. will be able to connect with a Teladoc care provider 24/7 from Echo devices for general medical needs. To get connected, patients can say “Alexa, I want to talk to a doctor” to their device. Echo will then connect with a Teladoc doctor for a virtual visit related to nonemergency needs, such as experiencing symptoms of a cold, flu or allergies, according to a Feb. 28 press release
The cost per visit will vary, ranging from $0 per visit with insurance or $75 without insurance.”

About healthcare personnel

 Association of Physician Management Companies and Private Equity Investment With Commercial Health Care Prices Paid to Anesthesia Practitioners:  “What is the association between outpatient facilities that contract with physician management companies (PMCs) and prices paid to anesthesia practitioners?
Findings  This cohort study of 2 255 933 privately insured patients who received anesthesia services in hospital outpatient departments and ambulatory surgery centers from 2012 to 2017 found that allowed amounts and unit prices increased by 16.5% and 18.7%, respectively, when facilities contracted with a PMC relative to non-PMC facilities. Larger increases were found if the PMC received private equity investment.”
PMCs consolidate practices, so they have better negotiating leverage. But the profit motive is still an important component of the higher negotiated fees.
The accompanying editorial is a good overview of PMCs: Physician Management Companies—Should We Care?

 

Today's News and Commentary

About Covid-19

CDC changes approach to covid: Most Americans can go without masks: “The Centers for Disease Control and Prevention eased mask recommendations for the vast majority of the country Friday under a new framework to monitor coronavirus that immediately affects about 70 percent of Americans — a process that state and local officials had already begun amid demands for a return to normalcy…
Under the new approach, many parts of the country that were previously considered to have high or substantial levels of the virus are now reclassified as having low to medium levels of covid-19 disease. CDC recommends mask-wearing for indoor public settings, including schools, only in communities with high levels of disease.”

How many people died believing vaccine misinformation?: “In a just-published nationwide survey of 18,782 people across all 50 states and the District of Columbia, the Covid States Project asked about four vaccine misinformation claims, asking respondents whether they were “true” or “false” or if a respondent was “not sure.” Five percent said they thought that vaccines contained microchips; 7 percent said vaccines used aborted fetal cells; 8 percent said the vaccines could alter human DNA; and 10 percent were concerned that vaccines could cause infertility. Forty-six percent were uncertain about the veracity of at least one of the four false statements…
Misinformation about vaccines has a direct correlation with whether people get immunized. The survey showed that among those who did not believe any of the false statements, 80 percent said they were already vaccinated. In the group that thought multiple false statements were true, 60 percent were hesitant to get the shot.”

 Moderna projects $19 billion in Spikevax sales this year: “During its earnings call on Thursday, Moderna said it generated $17.7 billion from its coronavirus vaccine Spikevax in 2021, through sales of 807 million doses worldwide. For this year, the company says it has signed $19 billion worth of orders for its vaccine, up from $18.5 billion announced in January. However, options for 2022 orders were revised downward to $3 billion, roughly $500 million less than what it had previously projected, amid fading pandemic concerns.”

EMA recommends authorisation of booster doses of Comirnaty from 12 years of age: “EMA's human medicines committee (CHMP) has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where appropriate to adolescents from 12 years of age. Comirnaty is already authorised in the EU as a 2-dose primary course in adolescents1 (as well as adults and children from 5 years of age) and a booster dose is currently authorised from 18 years of age.
The CHMP opinion follows an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young recipients in Israel.”

Florida governor issues new COVID-19 guidance to 'buck CDC': “Florida Gov. Ron DeSantis and Florida Surgeon General Joseph Ladapo, MD, updated the state's COVID-19 guidance Feb. 24, which shortens isolation periods, advises against masks in community settings and grants healthcare practitioners flexibility to treat patients with emerging and off-label drugs for the virus.”

About health insurance

 Medicare Advantage plans gain record hold on the market in 2021, study says: “Medicare Advantage corporations added 2.3 million enrollees in 2021, with 1.3 million of these people switching from conventional, fee-for-service Medicare, in accordance with a report launched on Thursday by The Chartis Group. At least half of the eligible inhabitants in 11 states are actually enrolled in Medicare Advantage plans, up from three states final yr, the report stated…
Forty-five % of all beneficiaries—or 28 million people—are actually enrolled in Medicare Advantage plans.”

CMS overhauls Direct Contracting model to include new requirements on governance, health equity in 2023: “The Centers for Medicare and Medicaid Services announced Thursday that the professional and global Direct Contracting model will transition in 2023 to the Accountable Care Organization Realizing Equity, Access and Community Health (REACH) Model. In addition, the geographic Direct Contracting model on pause since March 2021 will be eliminated immediately.”
The changes are summarized here: CMS gives ACO model a makeover: 7 things to know: “The ACO REACH model has three main principles. The first is to improve health equity and bring the benefits of accountable care to underserved areas. CMS will do this through better support care delivery and will require model participants to create a health equity plan to be implemented in underserved communities.
The second principle is to promote provider leadership and governance, which will make sure doctors and healthcare providers play a vital role in accountable care, according to CMS. At least 75 percent of each ACO is to be controlled by participating providers and their designated representatives; the Global and Professional Direct Contracting model only required 25 percent. It also requires at least two beneficiary advocates on the governing board, with one being a Medicare beneficiary and one a consumer advocate.
The third principle is to protect beneficiaries and the model through more participant vetting, monitoring and transparency. More information on applicants' ownership, leadership and governing board will be required. There will be more up-ront screening of applicants, monitoring of participants and more transparency while the model is implemented. There will also be stricter protections against incorrect coding and risk score growth.”
The CMS Fact Sheet is here: Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model

Trends in Disenrollment and Reenrollment Within US Commercial Health Insurance Plans, 2006-2018: “In this longitudinal cohort study of 3 018 633 individuals, approximately 1 in 5 members disenrolled from a commercial insurer each year; however, among departing enrollees, approximately 1 in 3 returned to the insurer within 5 years.
Meaning  The findings of this study suggest that insurers can benefit from investing in members’ long-term health outcomes despite substantial short-term turnover rates.”

Other states keep watchful eye on snags in Washington’s pioneering public-option plan: “Washington state, in its second year of offering the nation’s first public-option health insurance plan, has learned an important lesson: If you want hospitals to participate, you’re probably going to have to force them.
The Washington public option is more of a public-private partnership: The plan was designed by the state but is offered by private insurance companies. Anyone buying their own policy on the state’s health insurance marketplace can sign up for a public-option plan and, depending on their income, may receive significant subsidies from the federal government to lower its cost. But two years in, the plans are available in only 25 of the state’s 39 counties, enrollment numbers have been underwhelming, and state leaders blame hospitals.”

UnitedHealth Unit Pays $5.8M To End Mass. Drug Price Probe: “A UnitedHealth Group subsidiary will pay $5.8 million to settle allegations that it overcharged Massachusetts employees for prescriptions under the state's workers' compensation program, the state's attorney general said Thursday.”

Physician pays over half million to settle allegations concerning ultrasound billing: “A 41-year-old primary care doctor has paid $504,588.40 to resolve allegations that he billed for excessive ultrasounds, announced U.S. Attorney Jennifer B. Lowery. 
Dr. Jose Escandon operates in Mission [Texas]. From Aug. 1, 2014, to Oct. 31, 2018, Escandon violated the False Claims Act by causing the submission of claims to Medicare for ultrasounds that were medically unnecessary or unreasonable. 
This investigation arose out of a proactive review of claims data showing Escandon was a significant statistical outlier for ultrasound claims.”

About hospitals and healthcare systems

Organ transplants reached their peak in 2021. Here are the busiest hospitals and common donor types: “During the start of the COVID-19 pandemic, organ transplants plummeted by half. Though there was an increase in deceased donors in 2020 from the year before, there were fewer living donors, possibly explained by the postponement of elective surgeries.
In 2021, however, the rate recovered and the U.S. reached a record number of transplants, at more than 41,300, though a significant waitlist for organs remains and may grow; experts expect there may grow a significant demand for kidney transplants in the years to come due to COVID…
California currently has the biggest waitlist for organs, with more than 20,500 candidates listed, of whom most (45%) are Hispanic. Texas has the second-biggest waitlist, with nearly 10,000 candidates, most of whom (43%) are also Hispanic. New York follows with the third-biggest waitlist, with more than 8,400 on the list, most of whom are white (34%) and Black (33%).”

About pharma

Judge Backs J&J Talc Bankruptcy, Keeping Cancer Lawsuits Frozen: “A bankruptcy judge allowed Johnson & Johnson to use chapter 11 to drive a settlement of litigation linking its baby powder to cancer, backing a controversial tactic that has helped profitable companies freeze roughly a quarter of a million injury lawsuits.
Judge Michael Kaplan of the U.S. Bankruptcy Court in Trenton, N.J., ruled Friday against personal-injury lawyers who asked to throw out the chapter 11 filing of a J&J subsidiary created last year to move into bankruptcy about 38,000 pending lawsuits over allegedly dangerous talc-based products.”

Johnson & Johnson, three pharma wholesalers finalize $26 billion opioid crisis settlement: “Johnson & Johnson and three major pharmaceutical wholesalers [AmerisourceBergen, Cardinal Health, and McKesson] have finalized nationwide settlements over their role in the opioid crisis, paving the way to distribute $26 billion to numerous state and local governments across the country.
The settlement is the largest so far among many lawsuits filed by communities seeking compensation for the decades-long expenses of coping with the fallout from addiction to opioid painkillers.”

 Lilly, Boehringer's Jardiance gets US nod for wider range of heart failure patients: “The FDA said Thursday that it has approved Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin) to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (HF) in adults, regardless of ejection fraction.” 

About the public’s health

 Understanding cervical cancer after the age of routine screening: Characteristics of cases, treatment, and survival in the United States: “Highlights:
Most women >65 years with cervical cancer were diagnosed at stage II or higher (63%), including 23% at Stage IV.
Nearly 15% of patients weren't treated, which was associated with age > 80, comorbidity scores ≥3, and stage IV disease.
5-year cancer-specific survival was 50% overall and treatment was associated with higher cancer-specific survival.
Increasing age and stage at diagnosis were associated with lower cancer-specific survival….
These findings, coupled with the fact that women >65 constitute an increasing proportion of the population, highlight the need to re-evaluate screening and treatment practices in this population to detect cervical cancer at earlier stages and increase survival.”

Strategies to Reduce Low-Value Cardiovascular Care: A Scientific Statement From the American Heart Association: An excellent review of the headline’s topic, but also a great overview of how to approach eliminating low-value care in general. While the entire article is worth reading, a quick read can focus on Tables 1 and 2.

Integrative Prioritization of Causal Genes for Coronary Artery Disease [CAD]: This study highlights the genetic complexity of CAD: “We identified 162 unique candidate causal CAD genes, which exerted their effect from between one and up to 7 disease-relevant tissues/cell types, including the arterial wall, blood, liver, skeletal muscle, adipose, foam cells, and macrophages. When their causal effect was ranked, the top candidate causal CAD genes were CDKN2B (associated with the 9p21.3 risk locus) and PHACTR1; both exerting their causal effect in the arterial wall. A majority of candidate causal genes were represented in cross-tissue gene regulatory co-expression networks that are involved with CAD, with 22/162 being key drivers in those networks.”

Risk of cancer in regular and low meat-eaters, fish-eaters, and vegetarians: a prospective analysis of UK Biobank participants: “In conclusion, this study found that being a low meat-eater, fish-eater, or vegetarian was associated with a lower risk of all cancer, which may be a result of dietary factors and/or non-dietary differences in lifestyle such as smoking. Low meat-eaters had a lower risk of colorectal cancer, vegetarian women had a lower risk of postmenopausal breast cancer, and men who were vegetarians or fish-eaters had a lower risk of prostate cancer. BMI was found to potentially mediate or confound the association between vegetarian diets and postmenopausal breast cancer. It is not clear if the other associations are causal or a result of differences in detection between diet groups or unmeasured and residual confounding. Future research assessing cancer risk in cohorts with large number of vegetarians is needed to provide more precise estimates of the associations and to explore other possible mechanisms or explanations for the observed differences.”

About healthcare IT

 Hims & Hers 2021 revenue jumps 83% as company expands retail collaborations: Announcements such as this one almost always lead with the rosy revenue data : “Hims & Hers grew its subscriptions by 95% in 2021, reaching 609,000 members as it significantly expanded into new categories and conditions over the past year.
The consumer telehealth and wellness brand's full-year revenue jumped 83% year over year to $272 million compared to $149 million in 2020.”
Then, way down in the article, you get a more meaningful assessment: “The digital health company's losses grew during the fourth quarter to a loss of $31 million compared to a loss $5.2 million a year ago. Hims & Hers' adjusted EBITDA for the quarter was a loss of  $7.1 million compared to a loss of $3.1 million for the fourth quarter 2020…
For 2021, the company's adjusted EBITDA was a loss of $30 million compared to a loss of $8 million in 2020. The company had been expecting a loss in the range of $35 million to $37 million.”
Are these announcements honest reporting?

About healthcare personnel

 17 'overpaid' healthcare CEOs: You decide: “Despite many CEOs cutting their base salaries last year due to the pandemic, those moves had little effect on overall CEO pay, according to an annual report from the nonprofit shareholder advocacy group As You Sow.”

About health technology

 Top 10 Health Technology Hazards for 2022: The annual list from EBRI. FYI, go to its website and check past lists for the evolution of changes in top hazards.
”1. Cybersecurity Attacks Can Disrupt Healthcare Delivery, Impacting Patient Safety 
2.Supply Chain Shortfalls Pose Risks to Patient Care
3.Damaged Infusion Pumps Can Cause Medication Errors
4.Inadequate Emergency Stockpiles Could Disrupt Patient Care during a Public Health Emergency
5.Telehealth Workflow and Human Factors Shortcomings Can Cause Poor Outcomes
6.Failure to Adhere to Syringe Pump Best Practices Can Lead to Dangerous Medication Delivery Errors
7.AI-Based Reconstruction Can Distort Images, Threatening Diagnostic Outcomes
8.Poor Duodenoscope Reprocessing Ergonomics and Workflows Put Healthcare Workers and Patients at Risk
9.Disposable Gowns with Insufficient Barrier Protection Put Wearers at Risk
10.Wi-Fi Dropouts and Dead Zones Can Lead to Patient Care Delays, Injuries, and Deaths”

Today's News and Commentary

About Covid-19

 HHS Distributing $560 Million in Provider Relief Fund Payments to Health Care Providers Affected by the COVID-19 Pandemic: “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), is making more than $560 million in Provider Relief Fund (PRF) Phase 4 General Distribution payments to more than 4,100 providers across the country this week.” 

About health insurance

 Judge strikes down part of Biden surprise billing rules in win for doctors: “A federal judge in Texas on Wednesday struck down part of the Biden administration’s regulations protecting patients from getting stuck with “surprise” medical bills when they see the doctor, in a win for doctors who sued to block part of the rules.
The ruling leaves in place the protections for patients against getting bills for thousands of dollars in situations such as going to the emergency room and later finding out one of the doctors was not covered by their insurance. 
But it strikes down part of the regulations that govern how much insurers will pay doctors once the patient is taken out of the middle.”

More African Americans have gained health insurance following adoption of the Affordable Care Act, HHS report finds: “Nearly 1 million Black American adults would become eligible for medical insurance if 12 holdout states expanded Medicaid eligibility under the ACA, according to the HHS report
From 2011 to 2019, the number of Black Americans without health insurance who were younger than 65 dropped from 7.1 million people to 4.4 million — or from about 20 percent of the Black population to 12 percent, the report said.
About 37 percent of Black Americans who are uninsured live in three states: Florida, Georgia and Texas. Florida and Georgia, according to the report, have high numbers of uninsured Black children.”

DOJ sues to block UnitedHealth-Change Healthcare deal: “In an announcement, the DOJ says that the deal would harm competition in commercial health markets as well as the market for technology that insurers use to process claims and reduce healthcare costs. The deal is valued at $8 billion in cash and $5 billion in debt.
The complaint was filed Thursday in U.S. District Court for the District of Columbia.”

AFTER MEDICARE’S 14.5% PRICE INCREASE, 60% OF SENIORS WILL FACE DIFFICULTY AFFORDING HEALTHCARE IN 2022: Key Findings

  • 18% of Medicare recipients say affording healthcare expenses will be “very difficult” following the Medicare price increase, while 42% say it’ll be “somewhat difficult”

  • 20% of Medicare recipients spend 50% or more of their monthly income on healthcare expenses

  • For those facing difficulty paying healthcare expenses, half will likely have to forgo some type of medical care in 2022

  • 27% of seniors who anticipate difficulty affording healthcare expenses may be forced to come out of retirement and get a job; 22% will consider continuing to work, despite retirement eligibility”

About hospitals and healthcare systems

Lifespan, Care New England scrap merger plans amid regulatory opposition: “The Federal Trade Commission and Rhode Island Attorney General’s Office sued to block the deal last week, claiming it would increase prices, reduce quality and stifle wages. Lifespan and Care New England decided not to appeal nor pursue a legislative workaround, such as a Certificate of Public Advantage.”

 Catholic Health hit with credit downgrade after 40-day strike: “Moody's Investors Service has assigned a ‘B1’ rating to Buffalo, N.Y.-based Catholic Health System's proposed revenue bonds and downgraded existing revenue bond ratings to ‘B1’ from ‘Baa2.’
‘The downgrade to 'B1' anticipates minimal cashflow and a further significant decline in liquidity this year, following material losses in fiscal 2021 from a 40-day labor strike and the disproportionately severe impact of the pandemic, both social risks under Moody's ESG classification,’ the credit rating agency said in a Feb. 17 report. 
Catholic Health System's rating outlook is negative.”

About pharma

Michigan signs PBM reform law with new transparency requirement: Another state action less than a week after the FTC failed to go forward with PBM investigations.
”The legislation prohibits PBMs from forcing pharmacists to sign gag clauses that prevent pharmacists from telling consumers it is cheaper to purchase drugs out-of-pocket and not through their insurance.
Michigan also will now require PBMs to get licenses and to file transparency reports with state officials to give consumers information on the ‘backend cost and profits of the medications they are prescribed’…
The law bans spread pricing where a PBM can drive up costs for reimbursing a pharmacist for prescription drugs and prohibits a PBM from charging a co-pay higher than the selling cost of the drug. The state is the 15th to ban spread pricing, according to data from the National Conference of State Legislatures.
In addition, PBMs cannot discriminate against any pharmacy solely because the carrier doesn’t have a vested interest in the pharmacy nor against any 340B covered entities.”

WHO creates training hub to boost pharmaceutical production in poor countries: “The World Health Organization is establishing a facility in South Korea to provide training for drug manufacturing in poorer countries to increase local production, combat chronic diseases and enhance preparation for the next global health crisis… Health experts have said the uneven distribution of vaccines worldwide was largely because of a lack of trained staff and the concentration of jab manufacturing in richer nations. The South Korean training hub will provide technical and hands-on training in the production of a range of pharmaceutical products, including vaccines, monoclonal antibodies and cancer treatments…”

Two related stories about different approval agencies:
FDA’s Pre-Approval Inspections Fell by More Than 50 Percent in 2021, Report Says
EMA Recommended 53 Medicines With a New Active Substance in 2021, up 35 Percent Over 2020

 Baxter reaches $18M settlement with SEC over decades of allegedly inflating income: “Baxter International will pay the U.S. Securities and Exchange Commission a penalty of $18 million after settling charges over the medtech giant’s alleged decades-long practice of improperly inflating its reported net income.
According to the SEC, from at least 1995 until 2019, Baxter converted its internal foreign transactions, assets and liabilities into U.S. dollars on its financial statements using a method that ‘was not in accordance with U.S. GAAP or generally accepted accounting principles.’”

About the public’s health

 Firearms: the leading cause of years of potential life lost: “Firearms are now the leading cause of YPLL [individual years of potential life lost] in trauma. Firearm deaths have overtaken MVC [motor vehicle crashes] as the mechanism for the main cause of potential years of life lost since 2017. Suicide in white males accounts for more YPLL than homicides. Deaths related to firearms are potentially preventable causes of death and prevention efforts should be redirected.” 

About healthcare IT

 Trends Shaping the Health Economy: TELEHEALTH: A great review from Trilliant. After all the hype, one statistic that stood out: “The total addressable market for telehealth is <1% of the health economy...and declining.

Today's News and Commentary

February 2022 Health Sector Economic Indicators Briefs: “National health spending for all of 2021 grew by 3.4%, reflecting significant federal government support in response to the COVID-induced recession in 2020 and a lower level of such support in 2021. Taking these support dollars out of both 2020 and 2021 estimates, spending growth from 2020 to 2021 would have been 8.4%, as the economy continued to recover…
Including the federal support, health spending in December 2021 represented 18.8% of GDP; it was 17.8% of GDP if the additional government expenditures are excluded. For all of 2021, health spending represented 18.5% of GDP with the support and would have been 18.1% without it.”
See the article for February trends.

About Covid-19

Covid infections plummet 90% from U.S. pandemic high, states lift mask mandates: “The U.S. is reporting about 84,000 new cases per day on average, according to data compiled by Johns Hopkins University, down from a pandemic high of more than 800,000 daily cases on Jan. 15. And the decline is widespread across the nation, with average daily cases down by at least 40% in all U.S. regions over the past two weeks, according to a CNBC analysis of Hopkins data.
Hospitalizations have also fallen sharply. There are about 66,000 patients in U.S. hospitals with Covid as of Monday, according to a seven-day average of data from the Department of Health and Human Services, down from the Jan. 20 peak of 159,000 patients.”

Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States: The CDC added “considerations for an 8-week interval between the first and second doses of a primary mRNA vaccine schedule.”

 Effectiveness of mRNA-1273 against SARS-CoV-2 Omicron and Delta variants: “The 3-dose VE [ vaccine effectiveness] against hospitalization with Delta or Omicron was >99% across the entire study population. Our findings demonstrate high, durable 3-dose VE against Delta infection but lower effectiveness against Omicron infection, particularly among immunocompromised people. However, 3-dose VE of mRNA-1273 was high against hospitalization with Delta and Omicron variants.”

Sanofi, GSK to seek approval of COVID-19 vaccine: “Sanofi and GlaxoSmithKline said Wednesday that they plan to seek approval of their candidate COVID-19 vaccine following positive data from studies as both a primary series and booster. The companies noted that they are in discussions with the FDA and European Medicines Agency regarding submissions for the adjuvanted protein-based vaccine.
In the Phase III VAT08 trial, two doses of the vaccine in seronegative populations demonstrated 100% efficacy against severe COVID-19 disease and hospitalisations, as well as 75% efficacy against moderate or severe illness. Meanwhile, the vaccine offered 57.9% protection against any symptomatic COVID-19 disease.”

Rural hospitals stave off mass exodus of workers to vaccine mandate: “Rural hospital officials who expected Covid vaccine mandates to cause a staffing crisis are facing a pleasant surprise: Religious exemptions and education efforts for the hesitant are keeping almost all health care workers on the job.
Nearly two dozen rural hospital officials and state hospital association leaders told POLITICO they have lost just a fraction of their staff to the federal immunization requirement, which mandated that health care workers in every state except Texas received at least one shot of the vaccine by last week.”

Johnson & Johnson, Moderna set to face shareholder votes on vaccine pricing strategy, manufacturing tech sharing: “At J&J's upcoming annual meeting, shareholders will have a chance to vote on an Oxfam proposal to force the company to release its COVID-19 vaccine pricing strategy. Oxfam previously asked J&J to share the information considering the drugmaker received substantial funding assistance from the U.S. government while it was developing the shot. During the company's shareholder meeting last year, 32% of J&J's shareholders voted for a similar resolution…
Meanwhile, at Moderna, shareholders will vote on whether the company should study the feasibility of sharing vaccine technology to help increase global production.”

About health insurance

 Oregon agrees to sunset limit on benefits for kids on Medicaid: “In an email earlier this month, two top state officials said that in response to public feedback, Oregon will not seek to renew a waiver in its Medicaid plan that has allowed it to deviate from a federal standard, known as Early and Periodic Screening, Diagnostic, and Treatment, or EPSDT.
The EPSDT standard requires states to cover all medically necessary treatment for children on Medicaid, regardless of what services states provide to adults.
Oregon has been the only state with federal approval to take a different approach. It limits children’s coverage to a prioritized list of services determined by the legislature and a commission of medical experts appointed by the governor.
The agency is now saying that after a phase-out period, some medical treatments that the state has historically categorized as not prioritized for coverage will be funded on a case-by-case basis.”
This program highlights the great variations in care that are possible with a Medicaid waiver.

CMS ends ACO track in rural payment model: “CMS said Feb. 22 it is ending the ACO Transformation Track in the Community Health Access and Rural Transformation Model.
The ACO track was part of an alternative payment model for rural health system transformation, which was created by the Trump administration's HHS in 2020. The goal of the ACO track was to increase ACO adoption in rural areas.”
The CMS website lists only 4 participants in this program.

Association of Dual Medicare and Medicaid Eligibility [DE] With Outcomes and Spending for Cancer Surgery in High-Quality Hospitals: “The findings of this study indicate that, even among the highest-quality hospitals, DE patients had poorer outcomes and higher spending. Dually eligible patients were more likely to be discharged to a facility and therefore incurred higher postacute care costs. Although treatment at high-quality hospitals is associated with reduced differences in outcomes, DE patients remain at high risk for adverse postoperative outcomes and increased readmissions and postacute care use.”

About hospitals and healthcare systems

 Expenses push major health systems to operating margins under 1%: “Although hospital revenue and volume saw an upswing in the last quarter of 2021 — largely driven by COVID-19 hospitalization surges and higher-acuity patients — growing expenses are still offsetting gains in these areas for many hospitals…
 While [some] major hospital operators saw narrow operating margins, many ended the period with profits, mainly driven by nonoperating gains.
Many hospitals across the U.S. have been sounding the alarm over rising expenses. This has led the American Hospital Association to urge Congress to add $25 billion in additional relief to help providers across the nation address financial challenges attributed to surges tied to the omicron and delta variants.”

 About pharma

 California officials win an empty victory as they try to salvage a pay-to-delay law: “In a closely watched battle, California officials convinced a federal judge to modify a temporary hold on a law that bans so-called pay-to-delay deals between pharmaceutical companies, a contentious issue that has factored into the larger debate over the cost of prescription medicines. But as a practical matter, the ruling likely amounts to an empty victory for the state, because little may change. At issue is a law that went into effect in the fall of 2019 that made California the first state in the nation to outlaw pay-to-delay deals, a step California officials said was necessary to prevent drug companies from thwarting competition and maintaining higher prices. The move was also significant because California is generally seen as a bellwether state.”

Eli Lilly Launches Genetic Medicine and RNA-Focused Facility: “Eli Lilly has invested $700 million to launch a Boston, Mass., facility focusing on RNA-based therapeutics and genetic medicines.
Called the Lilly Institute for Genetic Medicine, the new site will focus on medicines acting at the nucleic acid level to advance a new class of drugs that target the root cause of diseases…
Genetic medicines already account for 20 percent of Lilly’s diabetes, immunology and central nervous system portfolio, but the goal is to push that further.”

GSK announces independent Consumer Healthcare company is to be called Haleon: “Haleon (pronounced ‘Hay-Lee-On’) is inspired by the merging of the words 'Hale', which is an old English word that means 'in good health' and Leon, which is associated with the word 'strength'. The new brand identity was developed with input from employees, healthcare practitioners and consumers and will be deployed in more than 100 markets around the world where the business operates.”

About the public’s health

 Task Force Issues Draft Recommendation Statement on Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: From the USPTF: “People ages 40 to 75 who are at high risk for CVD should take a statin to prevent a first heart attack or stroke. This is a B grade. People ages 40 to 75 who are at
increased risk, but not at high risk, for CVD may benefit from statin use and should decide with their clinician if taking a statin is right for them. This is a C grade. More research is needed on whether people 76 or older should start taking a statin. This is an I statement. These recommendations only apply to people without a history of CVD and who are not already taking statins.
Grades in this recommendation:
B:  Recommended.
C:  The recommendation depends on the patient’s situation.
I: The balance of benefits and harms cannot be determined.”

Maternal Mortality Rates in the United States, 2020: “In 2020, 861 women were identified as having died of maternal causes in the United States, compared with 754 in 2019. The maternal mortality rate for 2020 was 23.8 deaths per 100,000 live births compared with a rate of 20.1 in 2019.
In 2020, the maternal mortality rate for non-Hispanic Black women was 55.3 deaths per 100,000 live births, 2.9 times the rate for non-Hispanic White women (19.1). Rates for non-Hispanic Black women were significantly higher than rates for non-Hispanic White and Hispanic women. The increases from 2019 to 2020 for non-Hispanic Black and Hispanic women were significant. The observed increase from 2019 to 2020 for non-Hispanic White women was not significant.”

Rural vs Urban Residents More Likely to Have Cancer Fatalism, Information Overload: “Rural residents were more inclined to believe that everything causes cancer (OR, 1.29; 95% CI, 1.17-1.43), prevention is not possible (OR, 1.34; 95% CI, 1.19-1.51), there are too many recommendations to prevent cancer (OR = 1.26; 95% CI, 1.13-1.41), and cancer is always fatal (OR = 1.21; 95% CI, 1.11-1.33) when compared with their urban counterparts. These concepts were referred to as the study’s ‘4 core beliefs…’
When comparing between rural and urban residents, investigators noted significant differences. Those in rural areas were older, White, and were more likely to be female, have lower income, abd be less educated. Additionally, the population was more likely to be retired, be receiving Medicare, married, a smoker, and classified as obese according to their body mass index.”

Racial Disparities in Dementia Diagnoses: “In studies across 39 Alzheimer’s Disease Research Centers (ADRCs) funded by the National Institute on Aging (NIA), the prevalence of dementia diagnoses at baseline visits was far greater among White individuals recruited for ADRC studies than Black recruits—despite population-based research showing that among people who are 65 years or older, Black individuals are more likely than those of other races and ethnicities to have Alzheimer disease and related dementias (ADRD).The findings, which demonstrate that participants enrolled in ADRC studies may not be representative of the general population of individuals with ADRD, were published in Alzheimer's & Dementia.”

About healthcare quality and safety

Sentinel Event Data—General Information & 2021 Update: From the Joint Commission. A must-read for those working in this area. By far, the single most frequent event category is falls, which largely accounts for the marked increase in sentinel events this past year.

About healthcare IT

 State of Telemedicine Report: From a Doximity survey. Some highlights:  “The percentage of patients who participated in a telemedicine visit in the past year jumped from 42% in 2020 to 67% in 2021. We found that patients with chronic illness adopted telemedicine earlier in the pandemic…
 58% of patients reported an intention to use telemedicine ‘more’ frequently or at ‘the same’ frequency after the end of the pandemic.
In 2021, over 73% of patients surveyed reported they planned to receive ‘some’ or ‘all’ of their care through telemedicine after the pandemic. It’s clear that telemedicine is now an expected part of their health-care experience, even as they think about life beyond the pandemic. Notably, this was consistent across race/ethnicity.”

Teladoc stock faces turbulence with shrinking Q4 losses but modest 2022 guidance: “The company reported a net loss of $10.9 million in the fourth quarter of 2021, or a loss of seven cents per share, dwarfing Wall Street’s projections of a loss of 59 cents per share.
That leaves Teladoc with a full-year loss of $428.8 million or $2.73 per share, compared with a loss of $485.1 million or $5.86 per share in 2020…
Teladoc also predicts losses to widen in the first quarter to between 50 and 60 cents per share.”

Oracle's waiting period to acquire Cerner has expired: “Under the Hart-Scott-Rodino Act, the waiting period for Oracle to acquire Cerner expired at 11:59 p.m. EST on Feb. 22.
Oracle's tender offer for Cerner shares remains under review.”
In a related article: CERNER REPORTS FOURTH QUARTER AND FULL YEAR 2021 RESULTS:
2021 Full Year Highlights

  • “Revenue of $5.765 billion, up 5% compared to $5.506 billion for 2020.

  • GAAP Operating Margin of 12.3%, down from 16.6% for 2020.

  • Adjusted Operating Margin (non-GAAP) of 21.7% up 180 basis points from 19.9% for 2020.

  • GAAP diluted EPS of $1.84, down 27% compared with $2.52 for 2020.

  • Adjusted Diluted EPS (non-GAAP) of $3.35 up 18% compared to $2.84 for 2020.

  • GAAP cash flow from operating activities of $1.772 billion, up 23% compared to $1.437 billion for 2020.

  • Free Cash Flow (non-GAAP) of $1.174 billion, up 37% compared to $857 million for 2020.

  • Share Repurchases of $1.500 billion at an average purchase price of $74.96.

  • Quarterly dividend increased by 23%.”

About healthcare personnel

 Surveyed nurses consider leaving direct patient care at elevated rates: “Thirty-two percent of registered nurses (RNs) surveyed in the United States in November said they may leave their current direct-patient-care role, according to McKinsey’s latest research. That is an increase of ten percentage points in under ten months.”

About health technology

 Permanente doctor helps create open-source O2 concentrator: A great story of a truly disruptive technology: “Family physician Ted O’Connell, MD, wants COVID-19 patients around the world to have access to unlimited oxygen if they need it. Anticipating that oxygen-equipment shortages would get to crisis levels during the pandemic, he provided clinical expertise for a small team of experts to help conceive an oxygen-concentrator kit—dubbed OxiKit—that people could use anywhere, with locally sourced materials.”

Medtronic's earnings flatten out as COVID pandemic, healthcare worker shortage rage on: “…as the year has gone on, the medtech giant has been set back by ever more variants of the virus, global supply chain and manufacturing issues and, most recently, a growing shortage of healthcare workers.
Those factors sent its second-quarter gains down to just about 3% and, now, have more than flattened revenues during the company's third fiscal quarter ended Jan. 28.
For the latest three-month period, Medtronic raked in $7.76 billion, about 1% lower than the previous quarter’s haul and 0.2% below its earnings for the same period in 2021.”

Today's News and Commentary

Global health champion Dr. Paul Farmer has died: “In 1987, Farmer co-founded Partners in Health in Haiti with the mission to provide high-quality care to patients from impoverished backgrounds and those living far from health care facilities. Over the next three decades, PIH expanded to countries across Africa and Latin America, to Russia and to the Navajo Nation in the United States.”

About Covid-19

Biden to extend U.S. national emergency due to COVID-19 health risk: “President Joe Biden said on Friday the U.S. national emergency declared in March 2020 due to the COVID-19 pandemic will be extended beyond March 1 due to the ongoing risk to public health posed by the coronavirus…
The emergency would have been automatically terminated unless, within 90 days prior to the anniversary date of its declaration, the president sent a notice to the Congress stating it is to continue beyond the anniversary date.”
And in a related article: Payers, Medicaid officials ask Congress for 90-day glide path to end of COVID-19 emergency: “Several major payer groups and Medicaid advocates are pressing Congress for a 90-day heads up when the COVID-19 public health emergency ends, arguing they need as much time as possible to make Medicaid enrollees aware they could lose coverage.”

New York State Department of Health Highlights Healthcare Workforce Booster Progress and Announces Additional Efforts To Bring Boosters Directly To Healthcare Workers: “In order to avoid potential staffing issues and give healthcare workers more time to get boosted, the State will no longer enforce the booster requirement that will go into effect on February 21.The State will reassess in three months whether additional steps need to be taken to increase booster rates among the healthcare work force. The original vaccination requirement for healthcare workers remains in effect.”

 The C.D.C. Isn’t Publishing Large Portions of the Covid Data It Collects: “Two full years into the pandemic, the agency leading the country’s response to the public health emergency has published only a tiny fraction of the data it has collected, several people familiar with the data said….
Kristen Nordlund, a spokeswoman for the C.D.C., said the agency has been slow to release the different streams of data ‘because basically, at the end of the day, it’s not yet ready for prime time.’ She said the agency’s ‘priority when gathering any data is to ensure that it’s accurate and actionable.’
Another reason is fear that the information might be misinterpreted, Ms. Nordlund said.”

Got a Covid Booster? You Probably Won’t Need Another for a Long Time: “The Omicron variant can dodge antibodies — immune molecules that prevent the virus from infecting cells produced after two doses of a Covid vaccine. But a third shot of the mRNA vaccines made by Pfizer-BioNTech or by Moderna prompts the body to make a much wider variety of antibodies, which would be difficult for any variant of the virus to evade, according to the most recent study…”
In a related article: A fourth Covid-19 shot might be recommended this fall, as officials 'continually' look at emerging data: “In the United States, health officials emphasized late last year that fourth doses were not yet needed and said it was too premature to be discussing a potential fourth dose of coronavirus vaccine for most people.
Now, the US Food and Drug Administration ‘is indeed continually looking at the emerging data on the pandemic and variants in the United States and overseas in order to evaluate the potential utility and composition of booster doses,’ FDA spokesperson Alison Hunt wrote in an email to CNN on Friday.”

Estimated 73% of US now immune to omicron: Is that enough?: “The IHME [Institute for Health Metrics and Evaluation] estimates a wide range — from 63% to 81% of Americans.”
The answer to the headline’s question is not revealed in the article, which emphasizes the measurement difficulties in assessing immunity and the wide variation among estimates and localities.

About health insurance

 Early Changes in Billing and Notes After Evaluation and Management Guideline Change: “The American Medical Association updated guid- ance in 2021 for frequently used billing codes for outpatient eval- uation and management (E/M) visits. The intent was to account for provider time outside of face-to-face encounters and to reduce onerous documentation requirements…”
As a result of these changes, level 3 codes decreased slightly, while levels 4 and 5 increased slightly. “These changes varied by specialty. We found no meaningful changes in measures of note length or time spent in the EHR.”

About hospitals and healthcare systems

 342 hospitals have received price transparency noncompliance notices from CMS: “CMS told Becker's that no monetary penalties have been issued to date. The maximum penalty for noncompliance is $2 million.
’To date, each hospital that has come under compliance review has resolved its deficiencies, or is in the process of doing so,’ CMS said. ‘Therefore, it has not been necessary for CMS to issue any penalties.’”

Ascension's operating margin falls below 1% in Q2: “Although the health system's overall revenue decreased, its expenses increased year over year to just under $7.3 billion. In the same period last year, Ascension's expenses totaled $6.7 billion.” 

About pharma

 Risk Factors and Hospital-Level Characteristics With Medicare Part B Drug Spending Differences Between 340B and Non-340B Hospitals: “In this cross-sectional study that included 35 364 beneficiaries and 2446 hospitals, there was no statistically significant difference in Medicare Part B drug spending between 340B hospitals and non-340B hospitals, after controlling for beneficiary-level risk factors and hospital-level characteristics.
Meaning  These findings raise doubt about the financial incentive theory of 340B program drug discounts and the Centers for Medicare & Medicaid Services’ 340B drug payment policy rationale.”

The top 10 biotech IPOs of 2021: FYI

About the public’s health

 New DNA computer assesses water quality: Genetic networks mimic electronic circuits to perform a range of logic functions: “Northwestern University synthetic biologists have developed a low-cost, easy-to-use, hand-held device that can let users know — within mere minutes — if their water is safe to drink.
The new device works by using powerful and programmable genetic networks, which mimic electronic circuits, to perform a range of logic functions.”

Raw and Cooked Vegetable Consumption and Risk of Cardiovascular Disease: A Study of 400,000 Adults in UK Biobank: “Higher intakes of raw, but not cooked, vegetables were associated with lower CVD risk. Residual confounding is likely to account for much, if not all, of the observed associations. This study suggests the need to reappraise the evidence on the burden of CVD disease attributable to low vegetable intake in the high-income populations.”

About healthcare IT

Electronic Medical Records in Healthcare: An excellent monograph on the security of EHRs, from the HHS Office of Information Security.

Hospitals should be wary of these 5 cyberthreats: “Cyberattacks on healthcare organizations remain frequent, as nearly 2 million health records were breached in the U.S. in January.” The article explains five significant cyberthreats, according to recent federal advisories.

 About healthcare personnel

 Physician Burnout & Depression Report 2022: Stress, Anxiety, and Anger: The top three on the burnout list are emergency, critical are and OB/GYN physicians. At les than half the rate, at the bottom, are public health and preventive medicine practitioners.

6 schools launching nursing programs: Examples of 6 organizations launching or expanding programs.

American Healthcare Workers Persevering, but Remain Stressed: Highlights from the poll:

  • Four in five (80%) of healthcare workers report being somewhat or very satisfied with their current job, down slightly from the 89% saying the same in a Spring 2021 Kaiser Family Foundation/Washington Post poll.

  • Three quarters (73%) agree with the statement “I love working in healthcare”.

  • A majority report feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. However, the number saying hopeful (to 59% from 76%) or optimistic (to 56% from 67%) is down compared to last year.

  • About half (52%) report feeling “burned out”, on par with the 2021 numbers (55%).

  • Over a third (39%) report agreeing with the statement “the American healthcare system is on the verge of collapse”.

  • A third either disagree (16%) or don’t know how they feel (18%) regarding if they could pick a career over again, “I would still decide to go into health care”.

  • A quarter of healthcare workers (23%) say they are likely to leave the field in the near future.[Emphasis added]

About health technology

 The top 10 medtech IPOs of 2021 : FYI

Today's News and Commentary

About Covid-19

 Cuba's vaccine coverage and focus on children helped beat back Omicron, experts say: Lessons from another country that developed its own vaccine:
”Omicron arrived in Cuba in December but fell far short of the pronounced spike in cases seen in many other places and infections have since fallen off by more than 80%, official data shows.
Deaths have remained at around 10% or less of their peak throughout the Omicron wave, according to a Reuters tally…
Health workers on the Caribbean island have since fully inoculated 1.8 million children between 2 and 18 years of age, or upwards of 96% of the total, with no serious side effects reported, according to official Cuban data…
Cuba has fully vaccinated 87% of its total population, and nearly 94% have received at least one dose, placing it among the top three globally among countries of at least 1 million people, according to official statistics compiled by ‘Our World in Data.’”

Racial, Ethnic Divide in U.S. Views of Pandemic, Healthcare: “Nearly seven in 10 Black adults (69%) and Hispanic adults (68%) are very or somewhat stressed about contracting COVID-19, compared with 57% of White adults, according to a survey by West Health and Gallup…
The West Health-Gallup study highlights continued disparities in access to healthcare and in health outcomes in the U.S. Black Americans (8%) are twice as likely as White Americans (4%) to say they know someone who has died in the past year due to an inability to pay for treatment.
At the same time, Americans across racial and ethnic groups agree that healthcare is too expensive and that costs do not match the quality of care. More than 90% of adults among each group say the general cost of care is too high and that they pay too much for the quality of care they receive, and about 70% indicate that healthcare costs are a financial burden for them. Additionally, 51% of U.S. adults overall -- including 51% of White, 47% of Black and 56% of Hispanic adults -- say the cost of healthcare causes them daily stress.”

About health insurance

 CMS to launch new special enrollment period in late March: “The Centers for Medicare & Medicaid Services plans in late March to launch at the federally facilitated health insurance marketplace a new monthly special enrollment period for consumers with household incomes below 150% of the federal poverty level who aren’t eligible for Medicaid or the Children’s Health Insurance Program.”

About hospitals and healthcare systems

Medicare Paid $6.6 Billion In Non-Hospice Care For Hospice Patients: “Medicare may be paying twice for some items and services provided to hospice patients, according to a Health and Human Services Department Office of Inspector General report Wednesday. 
Medicare claims data shows the government paid out $6.6 billion in non-hospice claims for hospice patients between 2010 and 2019, primarily from costs associated with for-profit hospices. The findings indicate that Medicare could be double paying for these services if providers bill for non-hospice items and services that should already be covered through the hospice bundle, the OIG report said.”

 FTC, Rhode Island AG will sue to block Lifespan, Care New England merger: “Rhode Island Attorney General Peter Neronha has denied the application for the proposed merger between Lifespan and Care New England and said he will join the Federal Trade Commission in filing a lawsuit challenging the deal…”

AHIP study claims hospitals charge double for specialty drugs compared to pharmacies: “Hospitals on average charge double the price for the same drugs compared to those offered by specialty pharmacies, according to a new insurer-funded study released as federal regulators ponder a probe into the pharmacy benefit management industry.
The study…, by insurance lobbying group AHIP, comes as specialty pharmacies have grown in use among PBMs and payers to dispense specialty products.”

About pharma

 Pharmacy Middlemen Dodge FTC Competition Probe in Split Vote: “The Federal Trade Commission Thursday failed to reach consensus on launching a study into the reimbursement rates set by the entities that manage prescription drug benefits on behalf of health insurers and Medicare Part D plans. 
The FTC in a 2-2 party-line vote decided to not open a probe into pharmacy benefit managers (PBMs) and whether their drug price setting practices unfairly favor PBM-affiliated pharmacies at the expense of independent or specialty ones. 
The move comes despite fervent demands from pharmacy and patient advocacy groups to look into a complex component of the health-care industry that has traditionally remained without strong federal oversight.”

Teva Suffers Another Blow in ‘Skinny Labeling’ Case Against GSK: “A federal appeals court has upheld a decision ordering Teva Pharmaceuticals to pay $235.5 million to GlaxoSmithKline for infringing on the latter’s patent for its congestive heart failure drug Coreg (carvedilol).
The U.S. Court of Appeals for the Federal Circuit, in a 7-to-3 ruling, rejected Teva’s request to convene a new hearing on the case.
The decision has implications for the future of “skinny labeling” — a practice allowed under the Hatch-Waxman Act of 1984, which enables generics makers to manufacture a patented brand-name drug for certain narrow indications not covered by the patent.
Teva said it will seek a Supreme Court review of its case.”

BREAKING: Sacklers Offer Another $1.6B For Purdue Ch. 11 Settlement: The headline is the story.

About healthcare IT

 Overuse and Underuse of Health Care: New Insights From Economics and Machine Learning: Read the whole article; but here are some good takeaways:
”Comparing algorithmic predictions to physicians’ decisions reveals substantial overtesting.1About two-thirds of tests were performed on patients with predictably low risk, making the tests extremely low value—some costing up to $1 million per life-year saved. But, critically, we also find substantial undertesting, with predictably high-risk patients going untested and then having adverse outcomes of missed ACS, including death. These findings suggest that reallocating low-value tests to high-risk untested patients could save lives, at a cost of only $46 017 per life-year…
 So it is no surprise that higher across-the-board testing has little aggregate health benefit because most patients are low risk. But for the small fraction of predictably high-risk patients, we find a dramatic reduction in adverse events and death—34% lower 1-year mortality—when they arrive during higher-testing shifts.1 We estimate that the optimal policy would cut testing by 46.8% overall, but with a 62.4% reduction in the tests physicians currently do and a 15.6% increase in testing for patients who currently go untested.”

About health technology

 Foundation Medicine’s FoundationOne Cancer Tracker Named Breakthrough Device: “Foundation Medicine’s circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOne Tracker, has been granted the FDA’s Breakthrough Device designation.
The assay uses algorithms to identify patient-specific variants that allows for the detection of ctDNA in plasma. The Breakthrough Device designation covers the assay’s use in the detection of residual disease in early-stage cancer after curative therapy.”