Today's News and Commentary

About Covid-19

CDC asks Justice Department to appeal judge’s ruling that struck down mask mandate “The Centers for Disease Control and Prevention has recommended that the Justice Department appeal a federal judge’s decision that struck down the mask mandate on public transportation, the agency announced.”

 Rates of COVID-19 Among Unvaccinated Adults With Prior COVID-19 “Among 121 615 patients with more than 10 million days of follow-up, unvaccinated individuals with prior symptomatic COVID-19 had 85% lower risk of acquiring COVID-19 than unvaccinated individuals without prior COVID-19. Prior studies investigating protection against SARS-CoV-2 reinfection found similar results, with protection associated with natural immunity ranging from 80.5% to 100%. This level of protection is similar to that reported for mRNA vaccines.”

Rise in at-home testing means we could be undercounting Covid-19 cases even more than before “The Institute for Health Metrics and Evaluation estimates that only 7% of positive Covid-19 cases in the US are being detected, meaning case rates are actually 14.5 times higher than officially reported. The last time the infection detection rate was this low was at the outset of the pandemic, in March 2020.”

Omicron BA.2 overall makes up more than 90% of COVID variants in U.S. - CDC “The BA.2 sub-variant of Omicron and its sublineage BA.2.12.1 is estimated to make up more than 90% of the coronavirus variants in the United States as of April 16, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.”

About health insurance

 Anthem beats the Street with $1.8B in Q1 profit “Anthem beat the Street in the first quarter, reporting $1.8 billion in profit.
That's an 8.4% increase over the prior-year quarter, where the company earned $1.67 billion, according to its earnings report released Wednesday morning.
The insurer also surpassed Wall Street's expectations on revenue, according to Zacks Investment Research, with $38.1 billion. It reported $32.4 billion in revenue for the first quarter of 2021, making for 17.6% growth year over year.”
These figures give a 4.7% margin, which is solid in this sector.

About hospitals and healthcare systems

 Trinity to become sole owner of MercyOne, acquire CommonSpirit's share “Livonia, Mich.-based Trinity Health and Chicago-based CommonSpirit Health have signed an agreement for Trinity to acquire all MercyOne Health System assets and facilities.
Clive, Iowa-based MercyOne has 16 medical centers, 27 affiliate organizations and more than 420 care sites, according to a joint news release. It employs more than 20,000 people.”

About pharma

Promoting biosimilars could save large employers billions “In 2018, all U.S. self-insured employers could have saved $1.4 billion and realized significant savings for their employees by promoting the use of biosimilars in employer-sponsored health plans.”

 Alabama AG Ends Opioid Holdout With Deals Worth $276M “Alabama Attorney General Steve Marshall on Tuesday unveiled $276 million in settlements with opioid manufacturers and distributors, saying the deals give the state a better bargain than it would have come away with under nationwide settlements. The agreements put to rest Alabama's claims against manufacturers Endo Pharmaceuticals and Johnson & Johnson and distributor McKesson Corp. for their parts in exacerbating the opioid epidemic in Alabama…”

BREAKING: Endo Wins Reversal Of Opioid Default; Judge DQ'd “A Tennessee appeals court on Wednesday erased a trial judge's decision finding Endo Pharmaceuticals liable for opioid abuse because of discovery misconduct and disqualified the judge, saying he improperly approved the stunning sanction amid pending charges of bias against the drugmaker. In a seven-page opinion, a three-judge Tennessee Court of Appeals panel vacated the default judgment against Endo after finding that Circuit Court Judge Jonathan Lee Young appeared ‘antagonistic to the interests of those in the pharmaceutical industry’ when he discussed opioid litigation in Facebook posts and an interview with Law360.”

Johnson & Johnson to Settle Remicade Antitrust Lawsuit for $25 Million “Johnson & Johnson (J&J) has reportedly agreed to pay $25 million to settle a lawsuit over an alleged antitrust scheme involving its blockbuster immunosuppressive drug Remicade (infliximab).
The settlement, filed in a federal court in the Eastern District of Pennsylvania, is intended to resolve class-action claims against the company for its alleged obstruction of insurers covering generic versions of Remicade…”

FDA Approves Amneal’s Avastin Biosimilar “The FDA has approved Amneal Pharmaceuticals’ Alymsys (bevacizumab-maly) as a biosimilar of Roche’s blockbuster cancer drug Avastin.
The biosimilar was developed by mAbxience and licensed to Roche’s subsidiary Genentech in 2018 for supplying to the U.S. market.”

About the public’s health

Groups launch health equity coalition dedicated to chronic disease advocacy “Several civil rights, equity and healthcare groups have formed a coalition focused on advancing health equity among communities of color living with chronic diseases.
The Health Equity Coalition on Chronic Disease (HECCD) is a nationwide effort dedicated to current members—which are expected to expand—including the Association of Black Cardiologists, the Black Women’s Health Imperative, the National Association of Hispanic Nurses, the League of United Latin American Citizens and the National Minority Quality Forum. Its first year, it will focus on obesity, which disproportionately impacts communities of color.”

About healthcare IT

 Hive Ransomware HHS Cybersecurity warns that “Hive is an exceptionally aggressive, financially-motivated ransomware group known to maintain sophisticated capabilities who have historically targeted healthcare organizations frequently.”
More details are in the announcement. 

About healthcare personnel

 Investing in Primary Care: Why It Matters for Californians with Commercial Coverage “Key Findings:

  • The percentage of primary care spending varied more than twofold among the plans, from a low of 4.9% to high of 11.4%, mostly below other states’ recommended levels of 9% to 12%.

  • Greater investment in primary care among health plans was associated with better quality care and fewer hospital visits.

  • Among the provider organizations, larger investments in primary care were associated with better quality, better patient experience, and fewer hospital and emergency room visits, as well as a lower total cost of care.

  • If provider organizations in the lower brackets of primary care spending matched those in the highest bracket of spending, 25,000 acute hospital stays and 89,000 emergency room visits would be avoided, and $2.4 billion in overall health care spending would be saved in a single year.”

About health technology

 44 'breakthrough' medical devices that earned FDA approval “The FDA's Breakthrough Devices Program has helped at least 44 medical devices become authorized and enter the market since it launched in 2015, the agency said April 15.
The FDA has given a "breakthrough" designation to more than 650 medical devices, according to the agency's website. The label does not indicate safety approval, but designates a product as potentially lifesaving and fast-tracks its development, testing and approval process.”
The article lists these devices.

Today's News and Commentary

About Covid-19

COVID DATA TRACKER WEEKLY REVIEW From the CDC: “Currently, there are 14 (0.43%) counties, districts, or territories with a high COVID-19 Community Level, 175 (5.43%) counties with a medium Community Level, and 3,035 (94.14%) counties with a low Community Level. This represents a very slight (−0.19%) decrease in the number of high-level counties, a small (+1.55%) increase in the number of medium-level counties, and a corresponding (−1.36%) decrease in the number of low-level counties. Twenty-two (39.28%) of 56 jurisdictions had no high- or medium-level counties this week.
To check your COVID-19 community level, visit COVID Data Tracker.”

COVID-19 Travel Recommendations From the CDC: “There are no Level 4 COVID-19 Travel Health Notices at this time.”
See the site for country-specific recommendations.

New CDC team: A weather service to forecast what’s next in pandemic “A new team of federal health scientists officially embarks Tuesday on a mission to provide what has often been absent from the nation’s response to the coronavirus pandemic: better, faster information about what’s likely to happen next in this public health emergency and in future outbreaks…
About 100 scientists will analyze technical data and communicate policy options to decision-makers and the public about how the virus is behaving and who is most at risk — in user-friendly terms…
The Center for Forecasting and Outbreak Analytics, which starts with $200 million in funding, was created last summer to improve understanding by the CDC and the government more broadly of the coronavirus — and future outbreaks — in real time. White House officials plan to formally launch the effort Tuesday at a summit on strengthening U.S. early-warning systems for health threats.”

Moderna's bivalent beta booster betters Spikevax versus omicron, pointing to promise of variant-specific jabs “Moderna’s bivalent COVID-19 vaccine has bettered the antibody response of Spikevax against omicron when given as a booster..
The clinical data are on the bivalent vaccine Moderna developed in response to the beta variant, not the omicron-specific booster it is testing in another phase 2/3 clinical trial.”
Comment: Will we be chasing variants for Covid-19 vaccines as we do annually for influenza vaccines? Regarding the latter, researchers are looking for a “universal vaccine” that will be effective against all strains.

 4 Michiganders with COVID-19 strain unique to mink were likely 1st U.S. spillover cases “Four Michiganders — a taxidermist, his wife and two mink farm employees — were infected with a unique coronavirus strain connected to minks, leading Michigan health officials and the CDC to conclude they likely contracted the first known U.S. cases of so-called animal-to-human virus ‘spillover.’
Michigan’s four mink-connected COVID-19 cases — the only known animal-to-human cases in the U.S. to date — infected more people than was previously known.”

About health insurance

Supreme Court nixes appeal on Arkansas' Medicaid work requirements program “The Supreme Court has shot down a case surrounding the legality of Medicaid work requirements, sending the case back to a lower court with instructions to dismiss it entirely.
The decision on Monday in Becerra vs. Gresham comes more than a year after the court canceled oral arguments in the work requirements case in March 2021. While a major policy priority for the Trump administration, President Joe Biden’s Centers for Medicare and Medicaid Services has moved to unwind the requirements.
The Supreme Court remanded the case during back to the U.S. Court of Appeals for the District of Columbia, alongside instructions to dismiss the case as moot. Justices did not elaborate further on the reasons behind the decision, which was included in a list of orders on Monday.”

 Medicare Advantage Outperforms Fee-For-Service Medicare on Cost Protections for Low-Income and Diverse Populations “Low-income Medicare beneficiaries are more likely to enroll in Medicare Advantage than higher-income beneficiaries. Over 46 percent of beneficiaries under 200 percent of the Federal Poverty Level (FPL)2 were enrolled in Medicare Advantage, compared with 28 percent of beneficiaries over 400 percent of the FPL (data not shown). The difference between the two programs is growing; in 2018, 40 percent of low-income Medicare beneficiaries chose Medicare Advantage. This 6 percentage point difference is a 15 percent increase year over year in the number of low-income Medicare beneficiaries choosing Medicare Advantage….
On average, beneficiaries enrolled in Medicare Advantage spend less on out-of-pocket costs and premiums than those in FFS Medicare. Medicare Advantage beneficiaries report spending $1,965 less on out-of-pocket costs and premiums compared to FFS Medicare beneficiaries… This difference in out-of-pocket spending has grown by $325 since 2018. Between 2018 and 2019, health care spending rose 5 percent for Medicare Advantage beneficiaries and 9 percent for FFS Medicare beneficiaries.”

Anthem pays $4.5M to Indiana hospitals in ER billing dispute “For five years, health insurer Anthem Inc. has tried to clamp down on what it considered unnecessary, expensive visits to emergency rooms by denying claims or downgrading reimbursements for ER visits that turned out not to be life-threatening…
A group of 11 Indiana hospitals complained that Anthem’s policy was unlawful and breached their contracts, costing them millions of dollars. And a federal arbitrator has agreed, ordering Anthem to pay them $4.5 million.
Anthem, which fought the case for two years, says it has complied with the order.
But the hospitals say they can claim at least another $12 million from Anthem for tens of thousands of additional claims that it says Anthem has downgraded and not paid in full. And the count of improperly denied or downgraded claims, they say, is growing by the day.”

About hospitals and healthcare systems

 CMS pitches inpatient payment rule for 2023: 10 things to know “CMS released its annual Inpatient Prospective Payment System proposed rule April 18, which proposes a reimbursement boost for acute care hospitals. 
A really good summary of some of the major features of the 1,786-page proposed rule. The comment period closed on June 17.
Focusing on the overall payment and implications is: Hospitals to receive a proposed 3.2% payment increase in 2023 “CMS estimates that payments to hospitals will increase in 2023 by $1.6 billion. The proposed increase applies to acute care hospitals that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful electronic health record users.
The 3.2% increase reflects a market basket update of 3.1% reduced by a projected 0.4 percentage point productivity adjustment and an increase of 0.5% required by statute. In addition, CMS projects Medicare disproportionate share hospital payments and Medicare uncompensated care payments combined will decrease by approximately $0.8 billion…
In addition, in this proposed rule, CMS is proposing to suppress the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) and five Hospital Acquired Infection measures for the 2023 program year. Similarly, CMS is proposing to suppress all six measures in the Hospital-Acquired Condition Reduction Program for the 2023 program year. If finalized, hospitals would not be given a measure score, a Total HAC score, or receive a payment penalty.”
The AHA has expressed mixed feelings about these proposals in this press release: AHA Statement on FY 2023 Proposed IPPS Rule

About pharma

After rivals' FDA rebuffs, GSK targets class-first oral approval in chronic kidney disease anemia “The FDA has accepted GSK’s application for daprodustat as an oral therapy for patients with anemia of chronic kidney disease (CKD), the company said Tuesday. The FDA plans to deliver its daprodustat verdict by Feb. 1, 2023, GSK said…
Overall, daprodustat’s studies showed the drug helped improve or maintain target hemoglobin levels without an increase of major cardiovascular events versus standard of care—an erythropoietin stimulating agent (ESA)—across both dialysis and non-dialysis patients, GSK said.”
Comment: Dialysis is a bundled service, and, according to CMS, includes “Erythropoiesis stimulating agents (ESAs) and their oral or other forms of administration that are for the treatment of ESRD.” It will be interesting to see how GSK prices this oral medication vis-a-vis the generically-available injectable agents.

Johnson & Johnson, after weak quarter of vaccine sales, will no longer include it in guidance “Johnson & Johnson never came up with a name for its COVID-19 vaccine. Similarly, it never found a niche for the jab, despite its hype as a convenient single-shot option to the double-dose vaccines from Moderna, Pfizer-BioNTech and AstraZeneca.
And after a disappointing quarter of sales, the company will no longer includethe vaccine in its revenue projections…
J&J's COVID vaccine sales for the first quarter were $457 million, far off from Wall Street’s estimate of $785 million. In January, when the company reported that 2021's vaccine sales reached $2.4 billion, it projected 2022 sales to come in at between $3 billion and $3.5 billion.”

 Johnson & Johnson inks $99M opioid settlement with West Virginia: report  “J&J stated that the $99 million settlement will directly support local community efforts to seek “meaningful progress” in addressing the opioid crisis in West Virginia. The company emphasized that its marketing and promotion of prescription opioid medications were “appropriate and responsible” and that its three opioid medications accounted for less than 1% of total opioid prescriptions in West Virginia and the U.S. since launch.  
Echoing its previous statements regarding opioid addiction settlements, J&J said the settlement is not an admission of liability or wrongdoing.”

Biotech's top 10 money raisers of 2021 FYI

About the public’s health

Weekly U.S. Influenza Surveillance Report From the CDC:
—The cumulative hospitalization rate in the FluSurv-NET system is higher than the end-of-seasons rates for the 2020-2021 and 2011-2012 seasons, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.
—Three influenza-associated pediatric deaths were reported this week. There have been 19 pediatric deaths reported this season.
—CDC estimates that, so far this season, there have been at least 4.3 million flu illnesses, 42,000 hospitalizations, and 2,500 deaths from flu.”

Potential Gains in Life Expectancy [LE] Associated With Achieving Treatment Goals in US Adults With Type 2 Diabetes “This study quantified the potential gains in LE associated with different levels of biomarkers in patients with diabetes. Differences in HbA1c and BMI were found to have the strongest association with LE gain from a population perspective. At the individual level, we observed a large variation in the benefits associated with better diabetes care, associated with patients’ individual characteristics. The benefit of biomarker control was most pronounced in younger adults, and diminished as people aged. Better control of biomarkers can potentially increase the LE by 3 years in an average person with T2D in the US. For individuals with very high levels of HbA1c, SBP, LDL-C, and BMI, controlling biomarkers can potentially increase LE by more than 10 years.”
Comment: The benefit of “tight control” of diabetes has been contentious. This study gives some credence to its value.

 Johns Hopkins Beats $1B Guatemalan Syphilis Study Suit “A Maryland federal judge on Monday freed Johns Hopkins University and the Rockefeller Foundation against a $1 billion suit filed by Guatemalans who claimed that the institutions participated in controversial syphilis experiments on them in the 1940s, finding two doctors involved in the experiments didn't act on their behalf. U. S. District Judge Theodore D. Chuang said there wasn't sufficient evidence to show that the Rockefeller Foundation was responsible for the acts of two doctors or that university professors conspired to violate the Alien Tort Statute in a suit over experiments performed on more than 1,300 prisoners, soldiers and psychiatric patients…”
While many people are familiar with the Tuskegee study, this “research” is less well-known. For more information, see:  First, Do No Harm: The US Sexually Transmitted Disease Experiments in Guatemala

About healthcare personnel

 HHS directs $227M toward community health worker training programs “The Biden administration is directing $226.5 million in American Rescue Plan funding toward a new multiyear training program for community health workers and health support workers, the U.S. Department of Health and Human Services (HHS) announced Friday.
Funded using American Rescue Plan dollars, the Community Health Worker Training Program aims to add 13,000 new professionals the administration said play a vital role in connecting the public to local health resources.”

Today's News and Commentary

About Covid-19

Federal judge voids mask mandate for airplanes, in other transportation settings “U.S. District Judge Kathryn Kimball Mizelle of the Middle District of Florida said the mandate exceeds the statutory authority of the Centers for Disease Control and Prevention. Federal officials last week had extended the mask mandate for commercial flights and in other transportation settings, including on buses, ferries and subways, until at least May 3.”

How the Test-to-Treat Pillar of the US Covid Strategy Is Failing Patients “…large swaths of the country had no test-to-treat pharmacies or health centers listed as of April 14. And the website of the largest participant, CVS, has significant technical issues that make booking an appointment difficult.”

Americans Over 60 Should Get Second Booster, Official Says “Americans over 60 should get a second booster shot of a coronavirus vaccine, Dr. Ashish K. Jha, the new White House Covid-19 response coordinator, said on Sunday, citing “pretty compelling” new data from Israel indicating that a fourth shot significantlyreduced infections and deaths among older people there.”

HHS Distributing $1.75 Billion in Provider Relief Fund Payments to Health Care Providers Affected by the COVID-19 Pandemic “The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA)… announced more than $1.75 billion in Provider Relief Fund payments to 3,680 providers across the country. With this disbursement, HRSA has distributed approximately $13.5 billion from the Provider Relief Fund to nearly 86,000 and nearly $7.5 billion in American Rescue Plan (ARP) Rural payments to more than 44,000 providers since November 2021.

FDA greenlights first breathalyzer test for COVID-19 “A portable breathalyzer developed by InspectIR Systems aims to deliver a result within three minutes by looking for the exhaled chemical compounds that can come with an infection. 
The device includes its own miniaturized mass spectrometer, shrunk down to about the size of a carry-on suitcase. It’s designed to be used under the supervision of a healthcare professional in locations such as doctors' offices, hospitals and mobile testing sites…
While positive results should be confirmed with a secondary PCR test, the FDA said the device’s negative results could be accurate enough for use in widespread screening settings when placed in context with the person’s recent exposures and their current signs and symptoms.”

New COVID-19 nasal spray outperforms current antibody treatments in mice: A single inhaled dose treated or even prevented infection by COVID-19 and its variants “Designed computationally and refined in the laboratory, the new protein therapies thwarted infection by interfering with the virus' ability to enter cells. The top protein neutralized the virus with similar or greater potency than antibody treatments with Emergency Use Authorization status from the U.S. Food and Drug Administration (FDA). Notably, the top protein also neutralized all tested SARS-CoV-2 variants, something that many clinical antibodies have failed to do.”

HHS Distributing $1.75 Billion in Provider Relief Fund Payments to Health Care Providers Affected by the COVID-19 Pandemic “The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced more than $1.75 billion in Provider Relief Fund payments to 3,680 providers across the country. With this disbursement, HRSA has distributed approximately $13.5 billion from the Provider Relief Fund to nearly 86,000 and nearly $7.5 billion in American Rescue Plan (ARP) Rural payments to more than 44,000 providers since November 2021.”

About health insurance

Kaiser Permanente pledges $200 million to fight homelessness “Responding to a growing need for affordable housing, Kaiser Permanente announced Friday the company will invest $200 million for new housing and community needs for low-income residents.
The Oakland-based health care giant plans to shift funds from its investment portfolio to support affordable housing and support services. The company sees the investment as an extension of its health care services, saying that public health is bolstered by stable living conditions and shelter.”

5 Charts About Public Opinion on the Affordable Care Act From a Kaiser Family Foundation poll.
“Following Republican efforts to repeal the ACA in the summer of 2017, KFF Health Tracking Polls found a slight uptick in overall favorability towards the law, and since then a somewhat larger share has held a favorable than an unfavorable view. The most recent KFF Tracking Poll conducted in March 2022 found slightly more than half of the public (55%) hold a favorable opinion of the ACA while about four in ten (42%) hold a negative opinion of the law. Views of the ACA are still largely driven by partisanship: nearly nine in ten Democrats (87%) along with six in ten independents (58%) view the law favorably, while eight in ten Republicans (79%) hold unfavorable views.”
The most popular provisions are:
1. Prohibiting health insurance companies from denying coverage for people with pre-existing conditions.

2. Prohibiting health insurance companies from charging sick people more.

3. Prohibiting health insurance companies from denying coverage to pregnant women.

4. Requiring health insurance companies to cover the cost for most preventive services.

5. Prohibiting health insurance companies from setting a lifetime limit. 

Bright Health Group Continues to Drive Focus on Consumer Retail Markets with Fully Aligned Model “Bright Health Group, Inc… the first technology-enabled, Fully Aligned system of care built for healthcare's consumer retail market…announced its decision to focus Bright HealthCare’s geographic footprint by no longer offering Individual and Family Plans in Illinois, New Mexico, Oklahoma, South Carolina, Utah, and Virginia after 2022. These markets are forecasted to contribute less than 5% of total Bright Health Group revenue for 2022 and will have an immaterial impact on revenue in 2023 and beyond.
The strategic decision reflects the company’s increasing focus on growing in markets where it can deliver the greatest impact, drive differentiated value through its Fully Aligned care model and achieve operational excellence.

About hospitals and healthcare systems

Crozer Health quietly threatening to shut off paramedic services for municipalities — unless they pay up “Crozer Health, the four-hospital system in Delaware County, has been quietly reaching out to municipalities, threatening to shut off emergency medical services unless they pay up…
Crozer has delivered its Advanced Life Support response vehicles, also known as chase cars, to the municipalities for quite some time. The vehicles, while they don’t transport patients, are staffed by a paramedic, who has the highest level of prehospital care education.”

About pharma

Bristol Myers settles HIV antitrust suit, but J&J, Gilead still await their day in court “Bristol Myers Squibb will hand over up to $11 million to settle a lawsuit claiming it, Gilead Sciences and Johnson & Johnson used anticompetitive marketing tactics to block generic competition to HIV drugs. Importantly, the other two companies aren't involved in the settlement.

About the public’s health

E-cigs using synthetic nicotine come under FDA oversight “U.S. regulators will soon begin cracking down on vaping companies using a now-closed loophole, including a line of fruit-flavored e-cigarettes that have become teenagers’ top choice….
Food and Drug Administration can regulate e-cigarettes and similar products that use synthetic nicotine. 
The action targets Puff Bar and several other vaping companies that recently switched their formulas to laboratory-made nicotine to skirt FDA oversight.”

FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them “U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which help reduce exposure to, and consumption of, nicotine for smokers who use them. These are the first combusted cigarettes to be authorized as MRTPs and the second tobacco products overall to receive “exposure modification” orders, which allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance.” 

About healthcare personnel
American Board of Medical Specialties and New Standards for Continuing Certification “The Standards reflect 2 foundational changes in how ABMS and the ABMS member boards deliver on their professional self-regulatory mission. The first foundational change reflects the intent of the Standards to bring value to both the public and the profession… This is achieved through balancing formative and summative assessment methods, enhancing relevance to practice, and providing opportunities to address identified knowledge deficits prior to certificate loss. The requirement for a 10-year high-stakes examination has been removed and replaced by modular or longitudinal formative assessments that support learning through means convenient to diplomates…
The second foundational change recognizes that the network of professional self-regulation of medical care represents the collective responsibility of multiple organizations, not just the member boards… The improving health and health care standards require the member boards to work with their specialty societies and others to define a quality agenda for each specialty, including focusing on important disparities within and across specialties. To facilitate implementation of the improving health and health care standards, a learning community is being established that is codirected by leadership from ABMS and the specialty societies.”

Federal malpractice database may not work as intended “Hospitals are required by law to submit a report to the data bank if a doctor is retiring to avoid investigation. However, the only way the data bank or other government agencies can find out that a hospital has broken the law is through the actions of whistleblowers.”

First Criminal Trials Over Wage-Fixing, Hiring Practices End in Loss for Justice Department “Dialysis provider DaVita Inc… and its former chief executive officer, Kent Thiry, were acquitted Friday in Denver on three counts of conspiring with other companies to not recruit each other’s senior-level employees. Separately on Thursday, a Texas jury acquitted the former owner and clinical director of a home-health staffing company of conspiring with rivals to reduce their contractors’ pay.The two prosecutions marked the first ever federal criminal cases focused on alleged labor-market collusion. The antitrust division has pursued civil cases in recent years against companies that entered into agreements to not raid each other’s workers, but charging the conduct as a crime marked a major escalation of the government’s approach.”

  About healthcare finance

$1B joint venture sets sights on ASCs, medical office buildings “Big Sky Medical, a real estate investment manager, and Newmark, a real estate advisory and services company, have partnered to create a medical office building portfolio worth $1 billion…
The joint venture, seeded by a more than $400 million medical office portfolio that Big Sky Medical aggregated over the past year, will target medical office buildings across the country.
The seed portfolio includes 24 ASCs and medical office buildings that total more than 1 million square feet across seven states in the South and the Midwest, according to the report. Tenants include Cleveland Clinic; Winston-Salem, N.C.-based Novant Health; Dallas-based Baylor Scott & White Health and Texas A&M Health Science Center in Bryan.”

 

 

Today's News and Commentary

About Covid-19

 U.S. renews COVID-19 public health emergency “The public health emergency was initially declared in January 2020, when the coronavirus pandemic began. It has been renewed each quarter since and was due to expire on April 16.”

NY health officials say two new subvariants ‘likely’ fueling rise in cases “New York health officials on Wednesday said that two newly identified subvariants of omicron could be helping fuel an increase in COVID-19 cases in the state.  
The New York State Department of Health said the two subvariants are known as BA.2.12 and BA.2.12.1 and are thought to be even more transmissible than the original BA.2 subvariant of omicron, which already spread more easily than earlier variants.”

Covid booster shot bolsters protection in 5-to-11-year-olds, Pfizer and BioNTech say “Pfizer and BioNTech say they intend in coming days to request authorization from the Food and Drug Administration for a booster for 5-to-11-year-olds. The additional shot was given six months after children were fully vaccinated.”

About health insurance

 UnitedHealth Group posts $5B in profit for Q1 “Revenues at UnitedHealthcare were $62.6 billion, growth of 13.6% year over year from the $55.1 billion haul in the first quarter of 2021. The insurer added 1.5 million members over the quarter, including notable growth in Medicare Advantage, dual special needs plans and Medicaid.
UnitedHealth said it has added 350,000 members across its new product offerings, such as virtual-first plans, over the past year.
Optum's revenue grew 18.9% year over year, reaching $43.3 billion. At OptumRx, the company's pharmacy benefit management arm, revenues were up 11% as it grew its base with large health plan clients and further expanded offerings in behavioral health, specialty pharmacy and e-commerce.”

About pharma

 FDA Issues Manual on Complex APIs “The FDA’s Center for Drug Evaluation and Research (CDER) yesterday released a Manual of Policies and Procedures (MAPP) document that spells out how the Office of Generic Drugs (OGD) will classify complex new drug products and drug-device combination products assigned to CDER.” 

McKinsey Opened a Door in Its Firewall Between Pharma Clients and Regulators “A review by The New York Times of thousands of internal McKinsey documents found that the firm repeatedly allowed employees who served pharmaceutical companies, including opioid makers, to also consult for the F.D.A., the drug industry’s primary government regulator.
And, the documents show, McKinsey touted that inside access in pitches to private clients. In an email in 2014 to Purdue’s chief executive, a McKinsey consultant highlighted the firm’s work for the F.D.A. and stressed “who we know and what we know.”

About the public’s health

 Merck's next-gen pneumococcal vaccine receives FDA breakthrough status ahead of phase 3 trial “V116—one of three pneumococcal vaccines in Merck’s clinical pipeline—targets serotypes that account for 85% of cases of invasive pneumococcal disease among individuals aged 65 and over in the U.S., including eight serotypes not currently covered by any licensed vaccines. The company expects to begin phase 3 trials later this year.”

Today's News and Commentary

About Covid-19

Mask mandate extended for air travel and public transit through May 3 “Masks will continue to be required until at least May 3 when flying commercially and in other transportation settings, including on buses, ferries and subways, while health officials monitor an uptick in coronavirus cases, the Centers for Disease Control and Prevention said Wednesday.” 

 The world surpasses half a billion known coronavirus cases, amid concerns about testing ”The number of new cases reported around the globe each day has been declining for some time now; the average over the past week has been about 1.1 million cases a day, according to the Center for Systems Science and Engineering at Johns Hopkins University. That’s about 32 percent fewer than two weeks ago.
But over the course of the pandemic, countries with limited public health resources may only have detected and confirmed a tiny fraction of the cases in their populations. And more recent figures may miss many at-home rapid test results that are never officially reported.”

Delta Air Lines drops health insurance surcharge for unvaccinated employees “Delta Air Lines ended its $200 monthly health insurance surcharge for unvaccinated employees, CEO Ed Bastian said during an earnings call April 13. 
Delta dropped the insurance surcharge this month. The policy was announced in August 2021 and took effect in November 2021.”
This change might presage other companies’ actions.

About health insurance

 Marketplace Premiums Continue to Decline As Competition Rises From the RWJF: “Key Findings

  • Premiums for benchmark plans in the marketplace fell 1.8 percent nationally in 2022, following declines of 3.2 percent in 2020 and 1.7 percent in 2021. These trends contrast with premium increases in employer-sponsored plans of 3.6 percent in 2021 and 3.9 percent in 2020.

  • Most states saw reductions in marketplace premiums, but premium prices varied considerably across states. Eleven states had average benchmark premiums of more than $500 a month for a 40-year-old nonsmoker, while six states had premiums less than $365 per month for similar individuals.

  • Regions with higher unemployment rates saw higher premium increases.

  • The number of insurers participating in the marketplace increased from 198 to 288 between 2020 and 2022 in the regions analyzed. Additionally, increases in the number of insurers in a marketplace correlated with lower premium increases. Health premiums in markets with only one insurer were $189.50 higher, on average, relative to markets with five or more insurers.”

Judge tosses Cigna lawsuit from shareholders over loss of $1.85B termination fee in failed Anthem merger “A Delaware judge dismissed a lawsuit from Cigna shareholders April 7 that claimed executives with the company fumbled a $1.85 billion termination fee following the failed $54 billion merger with Anthem in 2017…
The lawsuit alleged that Cigna President and CEO David Cordani, six board members, Cigna's attorney and Teneo consultants spread misinformation, undermined the proposed merger and violated their fiduciary duties. Shareholders also claimed that Mr. Cordani sabotaged the proposal because he would not remain CEO of the new company.
The chancery court ruled that stockholders did not prove it would have been pointless to demand an investigation of damage claims by the payer's board.”

Optum Ventures invests in personal assistant service for aging adults “Optum Ventures is investing in senior care startup DUOS to help fuel the company's growth and build out its technology capabilities.
Launched in 2021, New York-based DUOS helps place expert personal assistants, called “Duos," into the homes of seniors. The company works directly with consumers as well as with payer and provider organizations.”

About hospitals and healthcare systems

Hospital Cost Tool “The National Academy for State Health Policy’s (NASHP) Hospital Cost Tool (HCT) dashboard aims to provide state policymakers and researchers with analytical insights into how much hospitals spend on patient care services, and how such costs relate to the hospital charges (list prices) and actual prices paid by health plans. The dashboard reports on a range of measures for hospital revenue, costs, profitability, and break-even points across over 4,600 hospitals nationwide for the period from 2011 through 2019. The dashboard offers options to view data at the hospital, state, and health system levels. The underlying HCT dataset includes approximately 60 variables extracted and calculated using data from the national Healthcare Cost Report Information System (HCRIS) as the main data source. Hospitals in this dataset represent approximately 70 million patient discharges and $49 billion hospital net income in the most recent reporting year.”
Fascinating data base and worth "playing” with entries.

Hospitals challenge Lown Institute's community benefits rankings A followup to yesterday’s article. Read the article for details, but briefly, Rick Pollack, president and CEO of the AHA, “said the report ignores certain categories of community investment, such as researching lifesaving treatments and cures and training and educating the healthcare workforce.”
Comment: Hospitals receive research grants for new technology development and graduate medical education payments.

 Providence Health & Services Agrees to Pay $22.7 Million to Resolve Liability From Medically Unnecessary Neurosurgery Procedures at Providence St. Mary’s Medical Center “Providence Health & Services Washington (Providence) has agreed to pay $22,690,458 to resolve allegations that it fraudulently billed Medicare, Medicaid, and other federal health care programs for medically unnecessary neurosurgery procedures…
 Between 2013 and 2018, Providence St. Mary’s employed neurosurgeons identified in the Settlement Agreement as Dr. A and Dr. B. Providence St. Mary’s paid neurosurgeons based on a productivity metric that provided them a financial incentive to perform more surgical procedures of greater complexity. Between 2014 and 2018, Dr. A was one of the highest producing neurosurgeons in the entire Providence system. Between 2014 and 2017, based on the productivity metric, Providence paid Dr. A between $2.5 million and $2.9 million per year.”

About pharma

 GSK adds to cancer portfolio with deal to buy Sierra Oncology “GlaxoSmithKline entered into an agreement to buy Sierra Oncology for $55 per share in cash, representing an equity value of around $1.9 billion, the companies announced Wednesday. The deal, which is expected to close by the third quarter, will bolster GlaxoSmithKline's oncology portfolio with the addition of the experimental drug momelotinib.
 Earlier this year, Sierra reported that the Phase III MOMENTUM study of momelotinib in certain patients with myelofibrosis met all of its primary and key secondary endpoints, improving anaemia and other symptoms of the disease. Regulatory submissions for the orally bioavailable JAK1, JAK2 and ACVR1/ALK2 inhibitor are expected to be made in the US this quarter and in Europe in the second half of the year.”

Halozyme to Acquire Antares Pharma to Create a Specialty Product and Drug Delivery Leader Halozyme Therapeutics, Inc. and Antares Pharma, Inc. today announced that the companies have entered into a definitive agreement pursuant to which Halozyme will acquire Antares for $5.60 per share in cash. The transaction, which values Antares at approximately $960 million, was unanimously approved by both the Halozyme and Antares Boards of Directors…
’The addition of Antares, particularly with its best-in-class auto injector platform and specialty commercial business, augments Halozyme's strategy, further strengthens our position as a leading drug delivery company and extends our strategy to include specialty products,’ said Dr. Helen Torley, president and chief executive officer of Halozyme.”

ICER finds bluebird's potential $2.1M gene therapy cost-effective as FDA adcomm scheduled for June The Institute for Clinical and Economic Review (ICER) said Wednesday “that bluebird’s [the company does not capitalize its name] potential gene therapy for a rare blood disorder [beta thalassaemia, which is not very rare]— which goes before an FDA adcomm in June — could be cost-effective even though it may be one of the most expensive drugs to ever hit the US market.
At the proposed price of $2.1 million per treatment course (to be paid across five years, given treatment success), ICER said that all eligible patients could be treated with Zynteglo, or beti-cel, which is already approved in the EU, over that span without crossing the watchdog’s budget impact threshold of $734 million per year.”

About the public’s health

 COVID-19, overdoses pushed US to highest death total ever “2021 was the deadliest year in U.S. history, and new data and research are offering more insights into how it got that bad.
The main reason for the increase in deaths? COVID-19, said Robert Anderson, who oversees the Centers for Disease Control and Prevention’s work on death statistics.
The agency this month quietly updated its provisional death tally. It showed there were 3.465 million deaths last year, or about 80,000 more than 2020′s record-setting total.”
In a related article: Changes in Life Expectancy Between 2019 and 2020 in the US and 21 Peer Countries “In this cross-sectional study, calculations of life expectancy based on official death counts revealed that US life expectancy decreased by 1.87 years overall, and by 3.70 years in Hispanic populations and 3.22 years in non-Hispanic Black populations. The decrease in life expectancy in peer countries was a mean of 0.58 years, with no country experiencing a decrease rivaling that of the US.”

STDs increased during the first year of the COVID-19 pandemic “Reported cases of sexually transmitted diseases (STDs) in the United States decreased during the early months of the COVID-19 pandemic, but most resurged by the end of that year. Reported cases of gonorrhea, syphilis, and congenital syphilis surpassed 2019 levels, while chlamydia declined (likely due to decreased STD screening and underdiagnosis during the pandemic). The data provide the clearest picture yet of COVID-19’s impact on the U.S. STD epidemic.”

Class Action Against Burger King Alleges Whoppers Packaging Contains Harmful Level of PFAS “On Monday, Azam Hussain filed a class action lawsuit in the Northern District of California against Burger King Corporation alleging unfair competition and fraud for the use of per- and polyfluoralkyl substances (PFAS) in its products packaging…
According to the complaint, the plaintiff has purchased products from Burger King including its popular Whopper product based on Burger King’s claims that the Whopper was safe for consumption and a sustainable product. However, Hussain argues that himself and other similarly situated consumers were harmed and deceived by Burger King’s false advertising due to the presence of PFASs in the Whopper’s packaging.”

Biden Administration Announces Boost for Rural Health Care in Midterm Election Push Agriculture Secretary Tom Vilsack “spoke to KHN ahead of an announcement Wednesday that the Agriculture Department has awarded $43 million in grants to 93 rural health care providers and community groups in 22 states. Biden administration Cabinet members are fanning out across the country to promote the benefits of the $1.9 trillion American Rescue Plan Act and a $1.2 trillion infrastructure package to rural Americans.”

About healthcare personnel

 Physician Partners of America to Pay $24.5 Million to Settle Allegations of Unnecessary Testing, Improper Remuneration to Physicians and a False Statement in Connection with COVID-19 Relief Funds “Physician Partners of America LLC (PPOA), headquartered in Tampa, Florida, its founder, Rodolfo Gari, and its former chief medical officer, Dr. Abraham Rivera, have agreed to pay $24.5 million to resolve allegations that they violated the False Claims Act by billing federal healthcare programs for unnecessary medical testing and services, paying unlawful remuneration to its physician employees and making a false statement in connection with a loan obtained through the Small Business Administration’s (SBA) Paycheck Protection Program (PPP)…
The United States alleged that PPOA caused the submission of claims for medically unnecessary urine drug testing (UDT), by requiring its physician employees to order multiple tests at the same time without determining whether any testing was reasonable and necessary, or even reviewing the results of initial testing (presumptive UDT) to determine whether additional testing (definitive UDT) was warranted. PPOA’s affiliated toxicology lab then billed federal healthcare programs for the highest-level UDT. In addition, PPOA incentivized its physician employees to order presumptive UDT by paying them 40% of the profits from such testing in violation of the Stark Law…” 

About health technology

Appeals court: J&J must pay $302M in pelvic mesh case “A California appeals court has upheld a lower court ruling that Johnson & Johnson must pay penalties to the state for deceptively marketing pelvic mesh implants for women, but reduced the amount by $42 million to $302 million.
Johnson & Johnson had appealed in 2020 after Superior Court Judge Eddie Sturgeon assessed the $344 million in penalties against Johnson & Johnson subsidiary Ethicon.”

Today's News and Commentary

About Covid-19

 Veru drug trial stopped early for 'overwhelming efficacy' in seriously ill COVID-19 patients “Veru said Monday that its cytoskeleton disruptor sabizabulin reduced deaths by 55% compared to placebo in a Phase III trial of seriously ill patients hospitalised for COVID-19. CEO Mitchell Steiner said the study is the first to demonstrate a clinically and statistically meaningful survival benefit in this population, adding ‘we strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties…can be that greatly needed oral therapy for hospitalised moderate-to-severe COVID-19 patients.’
Veru said the study was stopped early on the advice of an independent data monitoring committee due to ‘overwhelming’ efficacy, with company shares surging over 203% on the news.”

Many Republicans are ready to end the public health emergency “The Biden administration is widely expected to renew the declaration expiring at the end of the week, ensuring the continuation of critical resources to battle the coronavirus pandemic. But the decision comes amid increasing pressure from Republicans to wind down such supports and to treat the virus as endemic…
Here’s a snapshot of what could go away without a public health emergency: 

  • Private insurers and Medicare would no longer cover free, rapid at-home tests.

  • Telehealth services wouldn’t be available to millions of Medicare beneficiaries roughly five months after the emergency ends.

  • States would begin the lengthy process of determining who no longer qualifies for Medicaid and must be removed from the safety-net program.”
    If the PHE is extended before April 16, it would expire July 15.

Moderna Recalls Nearly 800,000 Doses of Its COVID-19 Vaccine “Moderna has recalled 764,900 doses of its COVID-19 vaccine, Spikevax, due to potential contamination with a foreign body.
The affected lot was manufactured by ROVI Pharma Industrial Services at a contract manufacturing facility in Spain.”
The recall apparently does not affect doses in the US.

FDA Updates EUA for J&J COVID-19 Vaccine to Extend Shelf Life “The FDA has amended its Emergency Use Authorization (EUA) for Johnson & Johnson’s COVID-19 vaccine, extending the vaccine’s shelf life from nine months to 11 months, provided the doses are stored between 2 and 8 degrees Celsius (between 35.6 and 46.4 Fahrenheit).”

About hospitals and healthcare systems

HHS will consider medical debt practices when making grant decisions “Service providers may be asked to provide information about their medical bill collection practices, patient litigation, financial aid, financial product offerings, and practices for contracting with third parties or foreclosing debts. 
HHS will use this information to make grant decisions. The department will also make some data public and report potential violations to law enforcement.”
This measure is part of this announcement: Harris says White House will seek to ease Americans' medical debt burden Much else in the press release has been previously discussed, like The No Surprises Act.

 FAIR SHARE SPENDING, How much are hospitals giving back to their communities?  From the Lown Institute: “The Institute calculated “fair share spending” for more than 1800 hospitals across 275 nonprofit hospital systems by comparing each system’s spending on charity care and community investment to the value of its tax exemption…
KEY TAKEAWAYS

  • Out of 275 nonprofit hospital systems evaluated, 227 spent less on charity care and community investment than the estimated value of their tax breaks — what we call a “fair share deficit.”

  • The total fair share deficit for these 227 hospital systems amounted to $18.4 billion in 2019.

  • The ten systems with the largest deficits account for $5.6 billion (30%) of the total fair share deficit. Many of these systems also received hundreds of millions from the CARES Act in 2020 and ended the year with high net incomes.

  • In seven states, the total fair share deficit for all hospitals exceeded $1 billion (CA, PA, NY, OH, IL, MI, MA).” 

Read the report for hospital and state-level details.

United States Files Suit Against Methodist Le Bonheur Healthcare And Methodist Healthcare-Memphis Hospitals “The United States today filed a complaint in intervention alleging violations of the False Claims Act (FCA) and the Anti-Kickback Statute (AKS) by Methodist Le Bonheur Healthcare (MLH) and Methodist Healthcare Memphis Hospitals (collectively, Methodist), for paying unlawful kickbacks to West Clinic, P.C. (West) in exchange for West’s patient referrals, announced U.S. Attorney Mark H. Wildasin for the Middle District of Tennessee.”
Read this Justice Department press release. The damages for Medicare and Medicaid are claimed to be more than $800M!

About pharma

 The top 20 pharma companies by 2021 revenue “Of the world’s top 20 pharmas ranked by 2021 revenues, 12 had at least 10% growth, including five that saw their sales boom at least 40%.
No company pulled in more revenue from COVID products than Pfizer. Fueled by Comirnaty, Pfizer nearly doubled its top line.
Johnson & Johnson needed a healthy 14% increase in revenue to stay comfortably in front of Pfizer and remain in the top spot, where it has resided since 2012. But that reign is in jeopardy this year, as Pfizer is projecting combined sales of $54 billion from Comirnaty and its oral COVID-19 treatment, Paxlovid.”
See the article for the full list. 

US jury sides with Seagen in Enhertu patent case against Daiichi Sankyo “Seagen announced Friday that it has been awarded close to $42 million in a lawsuit against Daichi Sankyo involving the breast cancer treatment Enhertu (trastuzumab deruxtecan). A federal jury for the Eastern District of Texas found that Daiichi Sankyo, which is partnered on the antibody-drug conjugate (ADC) with AstraZeneca, infringed Seagen's patent on technology that delivers chemotherapy drugs directly to cancer cells. Jurors also rejected arguments that the patent is invalid because it does not cover a novel invention.”

Walgreens and Other Companies Headed to Opioid Trial “A federal judge has given the go-ahead for the San Francisco county and city to take Walgreens and several pharmaceutical companies to trial on April 25 for alleged violations relating to the sale and distribution of opioids…
In the complaint, filed in December 2018, San Francisco charged the defendants with false advertising, negligence, negligent misrepresentation and fraudulent concealment, among other alleged violations.”

Pfizer announces acquisition of Australian digital health company “Pfizer has announced it will acquire ResApp Health (ASX:RAP) in an acquisition that values the Australian digital health company at $100 million.
ResApp has developed smartphone applications that support the diagnosis and management of respiratory disease.
Its machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional accessories or hardware.
Its ResAppDx is an approved smartphone-based acute respiratory disease diagnostic test for use in telehealth, emergency department and primary care settings. Its SleepCheck smartphone application allows consumers to self-assess their risk of sleep apnoea.”

CVS settles with Justice Department to make vaccine scheduling more accessible “CVS has agreed to make its COVID-19 vaccine registration website accessible for people with disabilities as part of a settlement with the Justice Department. 
In an April 11 statement, the Justice Department said CVS will conform its web content about COVID-19 vaccines to the Web Content Accessibility Guidelines, a set of voluntary industry guidelines for making website information accessible to those with disabilities. 
The Justice Department said it found the company's vaccine registration portal was not accessible to people who use screen reader softwares or have trouble using a mouse.”

UK launches world-first ‘subscription’ model for antibiotic supply “The UK is set to become the first country in the world to pay drug companies a fixed fee for supplying antibiotics in an effort to tackle the growing global crisis over resistance to the drugs. The aim is to give companies a better incentive to develop new antibiotics, which would be held back to treat patients who really need them, while restraining overprescribing that leads microbes to develop drug resistance…
Under the deal being struck by the NHS with Pfizer of the US and Shionogi of Japan, the drug companies will be paid a fixed fee of £10mn a year. The current reimbursement system based on sales volume often fails to provide sufficient revenue to justify research and development spending.
The contract value was set at a level that would give international companies an incentive to invest in antibiotic research and development, if other countries pay proportionate sums scaled to their gross domestic product.”

About the public’s health

 One HPV vaccine dose prevents cervical cancer - WHO “A single dose of human papillomavirus (HPV) vaccine is enough to protect against cervical cancer, a World Health Organization group of experts has said.
At the moment, two- or three-dose regimens are recommended, but the WHO's Strategic Advisory Group of Experts on Immunization said the evidence showed that one dose was as effective.”

Weekly U.S. Influenza Surveillance Report Some highlights from the CDC report:

—”The number of hospital admissions reported to HHS Protect has increased each week for the past nine weeks.
—The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate for the entire 2020-2021 season, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.
—Two influenza-associated pediatric deaths were reported this week. There have been 16 pediatric deaths reported this season.
—CDC estimates that, so far this season, there have been at least 3.8 million flu illnesses, 38,000 hospitalizations, and 2,300 deaths from flu.”

Black Americans’ Views of and Engagement With Science “Relatively few Black adults believe that Black people have reached the highest levels of success as scientists (36%) or engineers (43%); a 55% majority say Black people have reached this level of success as medical doctors.
By contrast, large majorities of Black adults say Black people have reached the highest levels of success as professional athletes (84%) and musicians (80%). Six-in-ten say they have done this as lawyers and 58% say they have done this in the clergy…
Most Black adults say they have either a great deal (28%) or a fair amount (50%) of confidence in medical scientists to act in the public’s best interests. About two-in-ten (21%) say they have not too much or no confidence in medical scientists.
Black Americans’ trust in medical scientists, as well as that for scientists, fell over the past year, as it also did among the general public. Even so, Black Americans’ trust in medical scientists is greater than that for other major groups and institutions including the military, K-12 public school principals and religious leaders…
The legacy of egregious medical misconduct in the U.S. Public Health Service Syphilis Study at Tuskegee, commonly known as the Tuskegee syphilis study, continues to resonate widely among Black Americans. Three-quarters of Black Americans say they have heard a lot (49%) or a little (26%) about the federal government’s study on syphilis, which withheld treatment from Black men, leading to preventable deaths and a worsening of symptoms among those study participants.”

About healthcare IT

 Expiration Date of Tender Offer for Cerner Corporation Shares Extended to May 11, 2022 The headline is the story.

About health technology

 Fitbit Gets FDA Clearance for AFib Detection Feature “Fitbit has received clearance from the US Food and Drug Administrationfor its atrial fibrillation detection algorithm, Google said Monday. 

The technology, which Google says will be coming soon to a range of heart-rate-enabled devices, passively assesses your heartbeat rhythm. If it comes across anything that suggests AFib, it will then alert you through the Irregular Heart Rhythm Notifications feature. 
Google earned clearance for the AFib-detecting technology partly because of a 2020 Heart Study which monitored over 455,000 participants for five months. The study found that Fitbit detected and correctly identified AFib episodes 98% of the time, when compared to ECG patch monitors.”

Today's News and Commentary

About Covid-19

 Covid Could Be Surging in the U.S. Right Now and We Might Not Even Know It “According to the CDC, the majority of the country is still considered low risk. Public health experts argue this is misleading though, given hospitalization and death generally occur days to weeks after initial infection. Without widespread testing, that could make it impossible to detect a surge until it’s too late to do anything about it.”

 Interpretive Summary for April 8, 2022 From the CDC: “As of April 6, 2022, the current 7-day moving average of daily new cases (26,596) increased 4.9% compared with the previous 7-day moving average (25,363). A total of 80,111,065 COVID-19 cases have been reported in the United States as of April 6, 2022.
CDC Nowcast projections* for the week ending April 2, 2022, estimate the combined national proportion of lineages designated as Omicron to be 100%.”

Philadelphia brings back mask indoor mandate as covid cases rise “Public health officials in Philadelphia announced on Monday that the city’s indoor mask mandate would return beginning April 18 as coronavirus cases there rise, making it the first major U.S. city to reinstate a mask mandate this spring.”

Biden official: Mask mandate for airplanes could be extended “Extending the federal transportation mask mandate that applies to airplanes, buses and trains is ‘absolutely on the table,’ Ashish Jha, the White House's new COVID-19 response coordinator, said Monday on the Today Show.
The transportation mask mandate was extended last month but is currently set to expire on April 18.”

White House tells agencies to delay vaccine mandate after court win ”The White House told federal agencies Thursday to hold off on reinstating a coronavirus vaccination mandate for millions of employees, hours after an appeals court rejected an earlier injunction that had blocked the executive order.
In a message to agency officials, the White House cautioned that ‘there are still procedural steps that need to take place to lift the injunction; at this time the district court’s preliminary injunction remains in effect.’”

About health insurance

 Medicare Index Report for 2022 CoverageHighlights:
Medicare Advantage and Part D plan enrollees are paying more in 2022, but premiums remain low - $6 per month is the average Medicare Advantage premium for plans selected by eHealth shoppers, up from $5 last year; $22 is the average Part D plan premium, up from $20 last year.
—Annual deductibles are higher for 2022 – Medicare Advantage enrollees are paying deductibles 4% higher than last year ($121 vs. $116) while Part D plan enrollees have deductibles 7% higher than last year ($427 vs. $400).
—Out-of-pocket limits are lower this year – The average annual out-of- pocket limit for people selecting Medicare Advantage plans decreased 5%, from $5,367 in 2021 to $5,108 for 2022.
—Zero-dollar Medicare Advantage plans remain popular – 87% of beneficiaries selecting Medicare Advantage products at eHealth chose plans with a $0 monthly premium during the Annual Enrollment Period.”

MedPAC Discusses Ambulatory Setting Payment, Social Determinants of Health, and APMs “The Medicare Payment Advisory Commission (MedPAC) met on April 7 and 8 to discuss a variety of policy issues, including recommendations to align fee-for-service payment rates across ambulatory settings, Medicare policy options for addressing social determinants of health (SDOH), and harmonizing Medicare’s portfolio of alternative payment models (APMs). The commission also discussed Medicare drug prices and Part D plan policy. These topics will be included in MedPAC’s June 2022 report to Congress.”
See the article for more details.

UnitedHealth makes $100M investment in affordable housing “UnitedHealth Group has invested an additional $100 million in affordable housing initiatives.
This latest funding brings the company's total investment in affordable housing to nearly $800 million, which has led to the creation of 19,000 housing units for individuals and families. More than 1,000 units will be established as a result of the latest investment.
UnitedHealth's housing investments are a part of the Health & Housing Fund, launched in partnership with Stewards of Affordable Housing for the Future (SAHF) and the National Affordable Housing Trust (NAHT).”

About hospitals and healthcare systems

 St. Helena Clear Lake Hospital v. Xavier Becerra, No. 21-5117 (D.C. Cir. 2022) From the US Court of Appeals for the District of Columbia Circuit: “Appellant, a California critical access hospital, sought Medicare reimbursement for the cost of keeping specialty doctors on call. Under the federal Emergency Medical Treatment and Active Labor Act, hospitals providing emergency room service must stabilize patients before releasing them or transferring them to another hospital. Additionally, California law requires all hospitals to perform certain procedures, including surgery. Appellant claims that it cannot comply with both state and federal law unless it can pay on-call compensation to specialists in surgery, obstetrics, pediatrics, and cardiology.
Affirming the district court’s ruling, the D.C. Circuit held that Appellant is not entitled to Medicare reimbursement for the cost of keeping various specialty doctors on call. Appellant’s federal obligation to stabilize patients before release does not necessarily imply the need for various specialists. Thus, the Provider Reimbursement Review Board (“the Board”) reasonably concluded that Appellant had the ability to stabilize patients with existing emergency room physicians and that specialists were not required to be on call.
Regarding Appellant’s state obligations, the Board’s conclusion that Appellant could satisfy the requirements by keeping a physician with surgical training on-site was reasonable.”

About pharma

 FDA Begins Unannounced Inspections in India “The FDA has begun a pilot program of unannounced inspections of drug manufacturing facilities in India, according to Judith McMeekin, FDA associate commissioner for regulatory affairs.
But the agency has not yet begun unannounced inspections in China, which were also anticipated as part of the pilot…
In the past, the agency has avoided unannounced foreign inspections because of logistical obstacles, such as unreliable transportation in remote areas and the need to be escorted while doing inspections in restricted economic zones.”

About health technology

 Diagnostic Performance of Electronic Nose Technology in Sarcoidosis “The electronic nose (eNose) technology profiles volatile organic compounds in exhaled breath and has potential as a point-of-care diagnostic tool…
Patients with sarcoidosis can be distinguished from ILD [interstitial lung disease] and healthy control subjects by using eNose technology, indicating that this method may facilitate accurate diagnosis in the future. Further research is warranted to understand the value of eNose in monitoring sarcoidosis activity.”
Comment: I gave a presentation at the Technion in Haifa, Israel in 2007. At that conference, another presenter talked about using volatile exhaled chemicals to diagnose a variant of diseases. Sometimes science progresses very slowly. 

Today's News and Commentary (Copy)

About Covid-19

 Congress breaks for recess with $10B COVID-19 aid in limbo “U.S. lawmakers began their two-week recess without acting on a $10 billion COVID-19 relief package, which was agreed to by Senate negotiators and then blocked by Republican lawmakers the next day.  
Senate negotiators agreed to a $10 billion COVID-19 aid package April 4, repurposing earlier unused COVID-19 funds. A day later, the legislative package was complicated by conflict over President Biden's immigration policy, with Republican senators calling for a vote on an amendment that would keep in place the Title 42 border restrictions, which allows limits on immigration due to the pandemic. The bill can't proceed without the vote, they say.”

Impact of U.S. COVID-19 Vaccination Efforts: An Update on Averted Deaths, Hospitalizations, and Health Care Costs Through March 2022 An update from the Commonwealth Fund: “Through March 2022, we estimate that COVID-19 vaccination efforts in the U.S. prevented over 2 million deaths and 17 million hospitalizations... There would have been an estimated 66 million additional infections and nearly $900 billion in associated health care costs in the absence of vaccination.”

Federal appeals court upholds Biden vaccine mandate for federal workers “A federal appeals court on Thursday ruled to uphold the Biden administration’s vaccine mandate for federal workers, ordering that a preliminary injunction issued against the requirement be eliminated.
The 5th Circuit Court of Appeals’s 2-1 ruling reversed an earlier ruling by U.S. District Judge Jeffrey Brown, a Trump appointee in Texas, who in January blocked the mandate for federal workers. The 5th Circuit Court further ordered that the district court dismiss the case.
Judge Carl Stewart, writing for the majority opinion, said plaintiffs in the case could have challenged the vaccine mandate through the federal government’s internal process for federal workers.”

About health insurance

Medicare finalizes its restrictions on new Alzheimer’s drug, despite pressure from drugmakers “Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.
The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug. However, Medicare isn’t explicitly requiring that patients be treated at hospital-based clinics like the initial proposal.”

CVS sells off health savings account arm PayFlex “CVS Health is selling off its health savings account business PayFlex to Millennium Trust, a bank that already offers retirement and financial services, but wants to expand into healthcare and benefits accounts.
PlayFlex covers 2.4 million members and 2,500 clients. With the deal, Millennium will reach 5 million individual client accounts and $47 billion in assets under administration.”

What if the American Rescue Plan Act Premium Tax Credits Expire? Another prediction/update on the impact of the tax credit expiration from the RWJ Foundation:
”Key Findings

  • Over 3 million more people (3.1M) could be uninsured in 2023 if the PTCs expire at the end of 2022, as planned.

  • Non-Hispanic Black individuals, young adults, and people with incomes between 138 and 400 percent of the federal poverty line would experience the largest coverage losses.

  • Individuals and families enrolled in the Marketplaces or other nongroup coverage will pay hundreds of dollars more per person each year in premiums if the PTCs expire. People currently eligible for PTCs with incomes between 150 and 400 percent of the federal poverty level would pay over $1,000 more per person for a silver plan. People with incomes above 400 percent of the federal poverty level who lose eligibility would pay roughly $2,000 more per year.

  • Extending the enhanced PTCs will increase the federal deficit by $305 billion over 10 years, unless legislation extending the PTCs includes raising revenue.

About hospitals and healthcare systems

 M&A Quarterly Activity Report: Q1 2022 From KaufmanHall: “The size of the transactions was smaller than usual and represented a departure from what we have seen during most of the pandemic. For all of 2021, the average size of the seller or smaller party to the transaction reached a historic high of $619 million, driven by the highest percentage of mega transactions seen in the past six years. For Q1 2022, average size of the smaller party was $246 million (Figure 2). In addition to the four transactions with smaller party revenues below $100 million, another six had revenues between $100 million and $500 million, and two had revenues between $500 million and $1 billion.”
The number of mergers and acquisitions is the lowest of any first quarter since tracking started in 2016.

About the public’s health

 U.S. life expectancy continued to drop in 2021, new analysis shows “Life expectancy in the United States, which declined dramatically in 2020 as the coronavirus slammed into the country, continued to go down in 2021, according to a new analysis that shows the United States faring worse during the pandemic than 19 other wealthy countries — and failing to see a life expectancy rebound despite the arrival of effective vaccines.
The study, written by public health experts in Colorado, Virginia and D.C. and posted online but not yet peer-reviewed, found that the continued decline in life expectancy in 2021 came largely among White Americans.” 

Fertility Rates: Declined for Younger Women, Increased for Older Women “The analysis, which looked at Census Bureau and National Center for Health Statistics data, shows fertility rates of women ages 20-24 declined by 43%, while those of women ages 35-39 increased by 67% during the roughly 30-year period.”

About healthcare personnel

 Nurse Practitioner, No. 1 Ranked Health Care Job, Reports Increase in Numbers “The American Association of Nurse Practitioners® (AANP) today released new data showing the current number of nurse practitioners (NPs) licensed to practice in the United States has risen to more than 355,000, an increase of 9% from the estimated 325,000 reported in May 2021…
 By 2026, the U.S. Bureau of Labor Statistics projects that the NP role will have grown by 36%.” 

About healthcare finance

 Pfizer boosts respiratory drug portfolio with ReViral purchase “Pfizer Inc said on Thursday it would buy privately-held ReViral Ltd in a deal worth as much as $525 million including milestone payments, to gain access to experimental drugs against the respiratory syncytial virus (RSV).
The deal marks the U.S. drugmaker's second acquisition in less than six months to boost its drug portfolio, after a $6.7 billion takeover of Arena Pharmaceuticals in December.”

AmerisourceBergen launches $150M venture fund for emerging healthcare companies “The wholesale giant's new VC fund, called AB Health Ventures, will initially look to invest in early to midstage health-related startups both in the U.S. and abroad. The fund will prioritize investments in startups focused on innovation in pharmacy and distribution, clinical development and commercialization of pharmaceuticals, practice solutions for healthcare providers and animal health, executives said in a press release.”

Today's News and Commentary

About Covid-19

Eligible Individuals Can Receive Second COVID-19 Booster Shot at No Cost CMS “announced it will pay for a second COVID-19 booster shot of either the Pfizer-BioNTech or Moderna COVID-19 vaccines without cost sharing… People with Medicare pay nothing to receive a COVID-19 vaccine and there is no applicable copayment, coinsurance or deductible. People with Medicaid coverage can also get COVID-19 vaccines, including boosters, at no cost.”

 FcγR-mediated SARS-CoV-2 infection of monocytes activates inflammation This Nature article explains the cause of the virus’ severe inflammatory action.
”These findings taken together suggest that antibody-mediated SARS-CoV-2 uptake by monocytes/macrophages triggers inflammatory cell death that aborts production of infectious virus but causes systemic inflammation that contributes to COVID-19 pathogenesis.” 

Risks of deep vein thrombosis, pulmonary embolism, and bleeding after covid-19: nationwide self-controlled cases series and matched cohort study The clotting/bleeding problems of hospitalized patients with the virus are well-known. This research investigated the longer-term complication rates.
”Compared with the control period, incidence rate ratios were significantly increased 70 days after covid-19 for deep vein thrombosis, 110 days for pulmonary embolism, and 60 days for bleeding…
These results could impact recommendations on diagnostic and prophylactic strategies against venous thromboembolism after covid-19.”

About health insurance

 Florida’s BayCare Health System and Hospital Affiliates Agree to Pay $20 Million to Settle False Claims Act Allegations Relating to Impermissible Medicaid Donations  This case is a good example of a prohibited Medicaid funding activity.
”BayCare Health System Inc. and entities that operate four affiliated Florida hospitals (collectively BayCare) have agreed to pay the United States $20 million to resolve allegations that BayCare violated the False Claims Act by making donations to the Juvenile Welfare Board of Pinellas County (JWB) to improperly fund the state’s share of Medicaid payments to BayCare. The four hospitals are Morton Plant Hospital, Mease Countryside Hospital, Mease Dunedin Hospital and St. Anthony’s Hospital.
The Florida Medicaid program provides medical assistance to low-income individuals and individuals with disabilities, and is jointly funded by the federal and state governments. Under federal law, Florida’s share of Medicaid payments must consist of state or local government funds, and not “non-bona fide donations” from private health care providers, such as hospitals. A non-bona fide donation is a payment — in cash or in kind — from a private provider to a governmental entity that is then returned to the private provider as the state share of Medicaid. The private provider’s donation triggers a corresponding federal expenditure for the federal share of Medicaid, which is also paid to the private provider. This unlawful conduct causes federal expenditures to increase without any corresponding increase in state expenditures, since the state share of the Medicaid payments to the provider comes from and is returned to the provider. The prohibition of this practice ensures that states are in fact paying a share of Medicaid payments and thus have an incentive to curb Medicaid costs and prevent unnecessary services.”

Optum, Change Healthcare set $650M merger reversal fee, extend agreement through 2022 “Optum and Change Healthcare are extending their merger agreement through the end of 2022 and setting a $650 million reversal fee if the deal isn't successful…
In a joint statement, the companies said, "The extended agreement reflects our firm belief in the potential of our combination to improve health care, and in our commitment to contesting the meritless legal challenge to this merger."
Optum, a subsidiary of UnitedHealth Group, first announced its intention to acquire Nashville, Tenn.-based Change Healthcare for $13 billion in January 2021.”

CMS proposes indefinite delay for Radiation Oncology model already postponed by Congress “The radiation oncology mandatory payment model is intended to reimburse oncology practices and hospital outpatient sites for total episodes of care and will make site-neutral payments for certain radiation therapies. 
But the model has generated major pushback from the oncology industry. The advocacy group Community Oncology Alliance said last August the mandatory model’s cuts will hurt oncology practices already under strain from the pandemic. 
The alliance had asked the model to be pushed back to 2023 and the cuts to be stopped. Congress agreed and passed legislation back in December to delay the start date from Jan. 1, 2022, to 2023.”

About hospitals and healthcare systems

 The National Imperative to Improve Nursing Home Quality: Honoring Our Commitment to Residents, Families, and Staff This book is now the standard on this topic. In brief:
”The Committee on the Quality of Care in Nursing Homes was charged with examining the ways in which the United States currently delivers, finances, measures, and regulates the quality of nursing home care. After a thorough review of the evidence, the committee arrived at seven overarching conclusions.”
The first conclusion drives the recommended actions:
“First, the way in which the United States finances, delivers, and regulates care in nursing home settings is ineffective, inefficient, fragmented, and unsustainable.”

About pharma

 Judge rules AIG, Chubb not obligated to defend McKesson in opioid cases  “A federal court judge in California has ruled that insurers AIG and Chubb are not obligated to pay defense costs for healthcare company McKesson, on the basis that policies issued by the carriers do not provide coverage for the massive settlements it has reached to settle its liability for costs ...”

National trends in prescription drug expenditures and projections for 2022 “In 2021, overall pharmaceutical expenditures in the US grew 7.7% compared to 2020, for a total of $576.9 billion. Utilization (a 4.8% increase), price (a 1.9% increase) and new drugs (a 1.1% increase) drove this increase. Adalimumab was the top drug in terms of overall expenditures in 2021, followed by apixaban, and dulaglutide. Drug expenditures were $39.6 billion (a 8.4% increase) and $105.0 billion (a 7.7% increase) in nonfederal hospitals and in clinics, respectively. In clinics and hospitals, new products and increased utilization growth drove growth, with decreasing prices for both sectors acting as an expense restraint. Several new drugs that are likely to influence spending are expected to be approved in 2022. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic.
Conclusion For 2022, we expect overall prescription drug spending to rise by 4.0% to 6.0%, whereas in clinics and hospitals we anticipate increases of 7.0% to 9.0% and 3.0% to 5.0%, respectively, compared to 2021.”

About the public’s health

 Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication  From the FDA: “The U.S. Food and Drug Administration (FDA) is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as new information on completed postmarket surveillance studies…
Given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or to fully disposable duodenoscopes.”

2022 Building H Index “The 2022 Building H Index ranks 37 companies in four industries – entertainment, food, housing and transportation – on how their products and services impact the health of their customers and consumers. The ranking reflects how companies score across five health-related behaviors: healthy eating, physical activity, sleep, social engagement, and time spent outdoors.” The bottom 5 are all streaming services.

About health technology

 Law groups, professors lash out against Thermo Fisher in suit over the 'immortal cells' of Henrietta Lacks “It’s been decades since medical researchers at Johns Hopkins unethically took tissue samples from Henrietta Lacks and used them to create the world’s first known “immortal” cell line.
Now, Thermo Fisher is looking to evade a lawsuit claiming it continues to profit from the cells without permission from Lacks’ estate…
Three amici curiae, or ‘friend of the court,’ briefs were filed on Tuesday against Thermo Fisher’s motion to dismiss all claims against itself…
Lacks’ estate filed a complaint back in 2021 seeking, among other stipulations, profits from the commercialization of the cell line, and an order barring the company from using the cells without permission.”

Today's News and Commentary

About Covid-19

Covid deal hampered by GOP opposition to Biden immigration policy “Just a day after Republican Sen. Mitt Romney and Majority Leader Chuck Schumer announced a deal on billions for therapeutics, vaccines and testing, GOP senators threw in a wrench that could mean Congress will break with nothing. Senate Republicans say they want a vote on an amendment that would keep in place the Title 42 border restrictions, which allows limits on immigration due to the pandemic. Without one, they say the bill can’t proceed.”

HRSA says it will reopen pandemic relief reporting to providers with 'specific extenuating circumstances' “Following industry outcry, the Health Resources and Services Administration is now planning to give another chance to providers who were unable to report on COVID-19 pandemic assistance “as a result of specific extenuating circumstances,” according to a notice recently added to the Provider Relief Funding Reporting Requirements and Auditing page of the agency’s website.
HRSA’s notice did not detail which circumstances will qualify providers for the new reporting window…
The update came shortly after a report from Bloomberg Law that the administration planned to claw back up to $100 million in Provider Relief Fund assistance from those who didn’t meet reporting requirements.”

FDA updates Sotrovimab emergency use authorization “Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant.”

FDA says Covid vaccines may need to be updated to ensure high level of effectiveness against virus ”The currently approved Covid-19 vaccines may need an update to ensure a high level of protection as the virus continues to evolve, according to the Food and Drug Administration.
The FDA, in a briefing document published ahead of an advisory committee meeting this week, said scientists still don’t entirely understand Covid variants and the effectiveness of the vaccines. For example, mutations to the spike protein, which is used by the virus to invade human cells, have reduced effectiveness of current vaccines. That’s because today’s Covid shots were developed to target the spike protein in the original strain of the virus that emerged in Wuhan, China in late 2019.”

Heart issues more common after Covid infection than vaccination, CDC reports “Compared to vaccination, Covid-19 itself is far more likely to lead to heart problems in teenage boys and young men, the Centers for Disease Control and Prevention reported…”

Protection by a Fourth Dose of BNT162b2 against Omicron in Israel “Rates of confirmed SARS-CoV-2 infection and severe Covid-19 were lower after a fourth dose of BNT162b2 vaccine than after only three doses. Protection against confirmed infection appeared short-lived, whereas protection against severe illness did not wane during the study period.”

About health insurance

 Optum continues buying spree and scoops up Houston-based Kelsey-Seybold Clinic: report “With more than 500 physicians, Kelsey-Seybold Clinic operates multi-specialty care centers, a cancer center, a women’s health center, two ambulatory surgery center locations, and a specialized sleep center with more than 30 locations in the Greater Houston area. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans…
In early 2020, TPG Capital, the private equity platform of global alternative asset firm TPG, made a minority investment in Kelsey-Seybold. At the time of the investment, the medical group's valuation was estimated to be $1.3 billion…”
Comment: Since Optum is a division of UnitedHealth Group, it remains to be seen what other insurers will do about their Clinic contracts.

Association of Maryland Global Budget Revenue With Spending and Outcomes Related to Surgical Care for Medicare Beneficiaries With Cancer Question  Is the Maryland global budget revenue (GBR) model associated with meaningful changes in 30-day episode spending and clinical outcomes among Medicare beneficiaries who undergo cancer-directed surgery?
Findings  In this difference-in-differences analysis, comparison of Maryland Medicare beneficiaries with a matched control group found that GBR was associated with a statistically significant decrease in 30-day readmissions. However, we found no consistent changes in 30-day episode spending, emergency department visits, or all-cause mortality.”

About hospitals and healthcare systems

 Payer mix in the nation's top 20 hospitals FYI: “The 2019 data released April 5 is from the coverage, cost and value team at the National Academy for State Health Policy in collaboration with Houston-based Rice University's Baker Institute for Public Policy.”

About pharma

 Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019 “…the accelerated approval (AA) program permits the FDA to approve novel drugs for serious or life-threatening diseases on the basis of changes to surrogate measures that only are reasonably likely to predict clinical benefit. Surrogate measures are laboratory values that can be observed faster than clinical end points but may not accurately estimate how a patient feels, functions, or survives. The analogous approval pathway in the European Union (EU) is the conditional marketing authorization (CMA). Special designations in the US and Europe are also available for drugs addressing rare diseases and promote regulatory flexibility when evaluating the evidence….
we found that less than one-third of novel drugs approved by the FDA and EMA in recent years had high added therapeutic value. These results are consistent with a previous study focusing on drugs approved until 2017. None of the AA or CMA drugs had high added therapeutic benefits. Because we examined only drugs approved in 2018 to 2019, our results may not be generalizable to drugs approved in earlier years. The fact that so few of the expedited drugs or those for rare diseases had a high added therapeutic value supports the need for more scrutiny about which drugs qualify for these programs.”

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments “The first guidance, “Inclusion of Older Adults in Cancer Clinical Trials,” provides recommendations to sponsors and institutional review boards for including older adult patients, aged 65 years and older, in the clinical trials of drugs for the treatment of cancer…
The second guidance for industry “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics,” provides advice on designing and conducting trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of first-in human cancer drugs…
Finally, the “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics” guidance addresses master protocol design including information on what sponsors should submit to the FDA as part of these trial design approaches. It also directs how sponsors should interact with the FDA to facilitate efficient review and mitigate risks to patients.”

About the public’s health

 Health and Health Care for Women of Reproductive Age From the Commonwealth Fund:
”Highlights:

  • Among women of reproductive age in high-income countries, rates of death from avoidable causes, including pregnancy-related complications, are highest in the United States.

  • U.S. women of reproductive age are significantly more likely to have problems paying their medical bills or to skip or delay needed care because of costs.

  • U.S. women of reproductive age have among the highest rates of multiple chronic conditions and the highest rate of mental health needs.

  • Sweden, the U.S., Canada, and Australia are the countries where women of reproductive age are the least likely to report having a regular doctor or place to go for care.”

    Comment: It is interesting to note that having a regular doctor is not solely a function of the national insurance scheme. 

Medical bills for US shooting survivors top $2.5B in 1st year after injury, study says “In the first year after a firearm injury, gunshot survivors spent on average $2,495 more in healthcare per month than those who did not suffer gunshot wounds. When extended to all gunshot survivors in the U.S., direct healthcare spending amounts to $2.5 billion in the first year. Cost-sharing, including copays and deductibles, is $102 more per person per month for gunshot survivors. 
The largest healthcare spending increases were found during the first month after injury, reaching on average $25,554 per person in spending and $1,112 per person in cost-sharing.
Each year, gun violence kills nearly 40,000 people in the U.S. and costs the nation $280 billion, including medical, criminal justice and quality-of-life expenses.”

EPA moves to ban the most common type of cancer-causing asbestos “The Environmental Protection Agency on Tuesday proposed to ban chrysotile asbestos, the most common form of the toxic mineral still used in the United States.
Also known as ‘white asbestos,’ it has remained on the market despite decades of research showing that it is a deadly carcinogen, linked to about 40,000 U.S. deaths each year. Chlorine manufacturers and companies that make vehicle braking systems and sheet gaskets still import chrysotile asbestos and use it to manufacture new products.
The proposed rule would ban all manufacturing, processing, importation and commercial distribution of six categories of products containing chrysotile asbestos, which agency officials said would cover all of its current uses in the United States.”

FDA Gains Power to Regulate Synthetic Nicotine in e-Cigarettes “Closing a loophole in the federal government’s oversight of e-cigarette products, new legislation gives the US Food and Drug Administration (FDA) the authority to regulate synthetic nicotine, used by some e-cigarette makers to evade a ban on flavored e-cigarettes, favored by teen vapers.
The new law will become effective on April 14. Closing the synthetic nicotine loophole is intended to help advance the public health goal of reducing nicotine addiction that US teens acquire through use of flavored e-cigarettes.”

About healthcare finance

 Fitness company Tivity Health to be bought by Stone Point Capital for $2 bln “Fitness company Tivity Health said on Tuesday it had agreed to be bought and taken private by investment firm Stone Point Capital for $2 billion in cash…
The company owns SilverSneakers, a fitness program offered in-person and virtually for people eligible for Medicare - the U.S. government's medical insurance program for people age 65 and older and the disabled.”

Healthcare not as ‘recession-proof’ as expected, analysts say “Healthcare corporations are at increased danger of defaulting on their loans than many different industries, a brand new report signifies. 
The healthcare {industry} had the very best chance to default over the subsequent yr at a 4.4% median, first-quarter S&P Global Market Intelligence data evaluating U.S. sectors present. That likelihood was up from 3.3% as of the top of final yr, in response to S&P’s evaluation, which is predicated on the volatility of share costs for public corporations and country- and industry-related dangers.
‘There was a perception before the pandemic that healthcare was “recession-proof.” But this is a fundamentally different environment,’ mentioned Matt Wolf, director and senior healthcare analyst with RSM. ‘Providers have had to shut down non-emergent procedures, either due to lockdowns or not having the staff to perform them. They’ve paid the staff they do have more while reimbursement levels are not going up. They are not going to hire their way out of this.’”

Today's News and Commentary

About Covid-19

Omicron sub-variant BA.2 makes up 72% of COVID variants in U.S. - CDC “The U.S. national public health agency said on Monday the BA.2 sub-variant of Omicron was estimated to account for nearly three of every four coronavirus variants in the country.
Overall COVID-19 cases in the United States have dropped sharply after hitting record levels in January, but a resurgence in cases in parts of Asia and Europe has raised concerns that another wave could follow in the United States. The country's health experts, however, believe it is unlikely.”

CMS rolls out free at-home COVID-19 tests for Part B, Medicare Advantage beneficiaries ”The Centers for Medicare and Medicaid Services announced Monday that beneficiaries can get up to eight at-home tests at participating pharmacy chains such as CVS, Rite Aid, Costco and Walmart and other providers, a few months after the Biden administration required private insurers to reimburse customers for tests.”
On the other hand: HRSA COVID-19 Uninsured Program Claims Submission Deadline FAQs “Any testing and treatment claims submitted in the Portal after March 22, 2022, will not be adjudicated for payment.
Any vaccine administration claims submitted in the Portal after April 5, 2022 [Midnight today], will not be adjudicated for payment.”

 Obesity Prevalence Among U.S. Adults During the COVID-19 Pandemic “Relative to the 2019 to prepandemic 2020 period, significantly higher average BMI (+0.6%, p<0.05, N=3,555,865) and obesity prevalence rates (+3%, p<0.05, N=3,555,865) were observed among U.S. adults during the COVID-19 pandemic. Significantly higher rates of any exercise participation (+4.4%, p<0.01, N=3,607,272), average sleep hours in a 24-hour period (+1.5%, p<0.01, N=1,907,798), average alcoholic drink days in the past month (+2.7%, p<0.05, N=3,577,090), and lower rates of smoking at least some days (−4%, p<0.01, N=3,625,180) were also observed.
Conclusions: During the COVID-19 pandemic, U.S. adult obesity rates were higher and worsened the pre-existing epidemic of adult obesity in the U.S. Higher rates of alcohol consumption and lower smoking rates may have contributed to the higher rates of adult obesity in the U.S during the COVID-19 pandemic.”
Comment: While specific to Covid-19, these results may predict behaviors during future pandemics. Anticipation of these issues may help mitigate their effects.

Senators announce $10 billion COVID-19 deal, leave out global aid “Senators announced on Monday they had reached a deal to provide $10 billion for the fight against COVID-19, but the agreement leaves out funding for the global virus response….
he deal will be paid for by repurposing previous coronavirus funding, a red line garnering at least 10 GOP votes for the bill. Those funds include redirecting money from a shuttered venues fund, transportation aviation money, a higher education emergency relief fund and a small business administration loans program. 
However, the $10 billion deal is less than half of the $22.5 billion the White House initially requested.”

Projecting COVID-19 Mortality as States Relax Nonpharmacologic Interventions Question  What is the expected trend in COVID-19 mortality if US states were to lift nonpharmacologic interventions (NPIs) at different times over the remainder of 2022?
Findings  In this simulation modeling study, lifting NPIs was likely to result in rebounding epidemics regardless of the delay in lifting. The degree of population-level immunity was associated with the size of the rebounding peak in incident deaths.
Meaning  This simulation study found no path to the end of the COVID-19 pandemic that avoided difficult trade-offs between prolonged NPIs and increased COVID-19 mortality following their removal.”

WHO Recommends Johnson & Johnson COVID-19 Booster Shot “The World Health Organization (WHO) has updated its Emergency Use Listing (EUL), which now includes a recommendation for the Johnson & Johnson COVID-19 vaccine booster in adults 18 years and older.”

About health insurance

 With Obama looking on, White House to open ACA plans to more families “The tweak involves what is known in health-policy circles as the ACA’s “family glitch.” It involves who is eligible to buy health plans with federal subsidies through HealthCare.gov, the federal ACA insurance marketplace that opened in 2014, or similar marketplaces in states that operate their own…
The wrinkle has been that, in calculating how big a bite an employers’ health plan would take out of a worker’s income, the amount has taken into account only the premiums for an individual insurance policy — not a policy that covers a workers’ spouse or children, too….
During a briefing for reporters Monday evening to preview Biden’s announcement, senior administration officials said the Treasury Department, which handles ACA subsidies because they are in the form of a tax credit, is proposing a rewrite of the ACA’s rules so that the cost of job-based coverage for an entire family is taken into account.
Assuming the proposed tweak completes the federal regulatory process, the change would begin Jan. 1 next year…”

CMS finalizes 8.5% rate hike for Medicare Advantage, Part D plans in 2023 “The Biden administration finalized an 8.5% increase in rates to Medicare Part D and Medicare Advantage plans, slightly above the 7.98% proposed earlier this year. 
The Centers for Medicare & Medicaid Services (CMS) released the final 2023 MA and Part D rate announcement on Monday and with it a 4.88% effective growth rate, slightly above the 4.75% rate released in the advance notice.”
Read the rest of the article for important background information.

UnitedHealth working to avoid class-action lawsuit from 1K independent pharmacies “UnitedHealth Group is working to avoid a major class-action lawsuit from around 1,000 independent pharmacies nationwide for alleged under-reimbursements totaling more than $100 million…
Last week, Optum Rx, UnitedHealth's pharmacy benefits manager, filed over 200 cases in California federal court to force individual arbitration instead of a joint lawsuit.
About 500 of the small pharmacies are involved in the current dispute, while the rest have filed cases in other courts. 
The pharmacies claim Optum Rx under-reimbursed them and reversed payments. They also say Optum Rx occasionally considered prescriptions as brand-name when working with payers but considered the same medications as low-cost generics when reimbursing pharmacies. The disputed payments total in excess of $100 million for nearly a decade, though no pharmacy has filed any litigation yet.”

About hospitals and healthcare systems

 Advocate Aurora acquires remote monitoring company “Advocate Aurora Health acquired MobileHelp, a company specializing in remote patient monitoring and personal emergency response systems…
MobileHelp's emergency response systems, which are used by more than 300,000 households,  track users' locations so assistance can reach them quicker. In the future, Advocate Aurora Enterprises said it may bundle the technology with Senior Helpers, an in-home personal care services company it acquired in 2021, as doing so ‘could offer an even higher level of support to those aging independently.’”

Intermountain, SCL Health form 33-hospital system “Salt Lake City-based Intermountain Healthcare and Broomfield, Colo.-based SCL Health have completed their merger after the Colorado attorney general's office signed off on the deal March 31. 
The combined system, named Intermountain Healthcare, has more than 58,000 employees and operates 33 hospitals and 385 clinics across six states. The nonprofit system also provides health insurance to about 1 million people.”

Financial Impacts And Operational Implications Of Private Equity Acquisition Of US Hospitals “We compared changes in the financial performance of 176 hospitals acquired during 2005–14 versus changes in matched control hospitals. Acquisition was associated with a $432 decrease in cost per adjusted discharge and a 1.78-percentage-point increase in operating margin. The majority of acquisitions—134 members of the Hospital Corporation of America, acquired in 2006—were associated with a $559 decrease in cost per adjusted discharge but no change in operating margin. Conversely, non-HCA hospitals exhibited a 3.27-percentage-point increase in operating margin without a concomitant change in cost per adjusted discharge. When we examined markers of hospital capacity, operational efficiency, and costs, we found that private equity acquisition was associated with decreases in total beds, ratio of outpatient to inpatient charges, and staffing (total personnel and nursing full-time equivalents and total full-time equivalents per occupied bed). Therefore, financial performance improved after acquisition, whereas patient throughput and inpatient utilization increased and staffing metrics decreased. Future research is needed to identify any unintended trade-offs with safety and quality.”

About pharma

 CRISPR patent dispute not over yet as Emmanuelle Charpentier, universities appeal “Nobel Prize winner Emmanuelle Charpentier, Ph.D., and two universities have officially appealed in a dispute over certain patents for CRISPR gene editing, a long-running challenge that could have wide implications for companies working on therapeutics based on the technology.
Charpentier, the University of California, Berkeley and the University of Vienna have asked the U.S. Court of Appeals for the Federal Circuit to review a decision from the U.S. Patent and Trademark Office, which ruled in favor of the Broad Institute of MIT and Harvard.” 

The Top Pharmacy Benefit Managers of 2021: The Big Get Even Bigger “We estimate that for 2021, 80% of all equivalent prescription claims were processed by three companies: CVS Health (including Caremark and Aetna), the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group.”

Walgreens CEO: We’re Opening A New VillageMD Clinic ‘Every Three Days’ “The latest update from Walgreens CEO Roz Brewer on the company’s $6 billion investment into VillageMD revealed the opening of doctor-staffed clinics attached to drugstores is moving swiftly and ahead of Wall Street’s expectations.
Since Brewer became chief executive officer of Walgreens Boots Alliance a year ago, the iconic drugstore chain invested another $5.2 billion in VillageMD to escalate the expansion of doctor-staffed clinics across the U.S. under a new ‘Walgreens Health’ business. 
The larger investment Walgreens made last year was designed to accelerate the opening of at least 600 Village Medical at Walgreens primary care practices in more than 30 U.S. markets by 2025 and 1,000 by 2027, with more than half of those practices in medically underserved communities, the company has said. 
‘VillageMD has now opened 102 co-located clinics, and the rollout has accelerated to an average pace of one opening every three days for calendar year 2022,’ Brewer told analysts Thursday on the company’s fiscal second quarter earnings call.”

About the public’s health

 Billions of people still breathe unhealthy air: new WHO data “Almost the entire global population (99%) breathes air that exceeds WHO air quality limits, and threatens their health. A record number of over 6000 cities in 117 countries are now monitoring air quality, but the people living in them are still breathing unhealthy levels of fine particulate matter and nitrogen dioxide, with people in low and middle-income countries suffering the highest exposures.”

Association Between Residential Proximity to Hydraulic Fracturing Sites and Adverse Birth Outcomes From the University of Calgary (Alberta has large reserves of shale oil): ” In this population-based cohort study including all reproductive-aged individuals who had a pregnancy in rural Alberta, Canada, from 2013 to 2018, those individuals living within 10 km of 100 or more hydraulically fractured wells during 1 year preconception or pregnancy had a significantly increased risk of spontaneous preterm birth and small for gestational age birth.” 

CDC, under fire for covid response, announces plans to revamp agency “Centers for Disease Control and Prevention Director Rochelle Walensky announced plans Monday to revamp the agency that has come under blistering criticism for its performance leading the U.S. response to the coronavirus pandemic, saying, ‘it is time to step back and strategically position CDC to support the future of public health…’
After briefing the agency’s leadership team, Walensky sent staff the email, saying the one-month effort, set to begin April 11, would be led by Jim Macrae, associate administrator for primary health care at the Health Resources and Services Administration, or HRSA. HRSA and CDC are part of the Department of Health and Human Services.”

About healthcare IT

 The harm of heart algorithms [From STAT health tech newsletter 4/5/22] “Algorithms used to estimate risk of heart problems are becoming increasingly common in cardiovascular care. But a new study of more than 100 of these tools published in Circulation found that they often performed poorly when applied to new populations…
The study is notable for two reasons. First, it is a rare attempt to calculate net benefit versus harm for algorithmic tools, and lays out a framework for applying that assessment to other products. And second, its finding that harm is likely to result from these tools runs counter to the prevailing assumption that, even if imperfect, using such algorithms to inform risk is better than nothing. The big takeaway? If these algorithms are ever to really help patients, better evaluation before deployment and monitoring afterward are both imperative.” 

Medicaid:CMS Should Assess Effect of Increased Telehealth Use on Beneficiaries' Quality of Care From the GAO: “CMS does not collect, assess, or report information about any effect delivering services via telehealth has on the quality of care Medicaid beneficiaries receive and has no plans to do so. Doing so is important, given concerns GAO has raised about the quality of care provided via telehealth. It would also be consistent with how CMS has encouraged states to use data on quality of care to identify disparities in health care and target opportunities for improvement to advance health equity. These efforts could begin with data for quality measures CMS already collects or through other means.
CMS neither agreed nor disagreed with GAO's recommendations. GAO maintains it is crucial for CMS to collect and analyze information to assess telehealth's effect on the quality of care Medicaid beneficiaries receive.”

Q1 2022 digital health funding: Staying the course in choppy waters “Q1 2022 U.S. digital health funding closed with $6.0B across 183 deals, with an average deal size of $32.8M. This quarter fell significantly behind Q4 2021’s $7.3B and the trailing twelve month quarterly average of $7.1B. It’s worth noting that Q1 isn’t usually a blockbuster period for funding: at $6.7B, Q1 2021 was the smallest quarter last year for digital health dollars, and three of the past five years (2017-2021) had Q1 as their lowest funding quarter, possibly signaling a seasonality to funding dips. However, in three of the five past years, Q1’s funding beat its preceding quarter (Q4 of the prior year)—which isn’t the case this quarter.”

About health technology

 Landmark study reveals 42 new genes associated with increased risk of Alzheimer’s disease “A major new international study involving UK DRI researchers has identified 75 genes associated with an increased risk of developing Alzheimer’s disease, including 42 new genes which had not previously been implicated in the condition. The study is published in the journal Nature Genetics…”
Comment: This new finding highlights the complexity of understanding the genetic basis of diseases and, hence, addressing gene-based treatments.”

Today's News and Commentary

About health policy

KFF Health Tracking Poll – March 2022: Economic Concerns and Health Policy, The ACA, and Views of Long-term Care Facilities “As the nation’s economy and rising prices are on the forefront of the public’s mind, the latest KFF Health Tracking Poll finds the public wants lawmakers to prioritize out-of-pocket health care costs as Congress debates current health legislative priorities. A majority of the public (61%) say limiting how much drug companies can increase the price of prescription drugs each year to not surpass the rate of inflation should be a “top priority” for Congress. Slight majorities also say capping out-of-pocket costs for insulin at $35 a month (53%) and placing a limit on out-of-pocket costs for seniors (52%) are top priorities for Congress to take action on in the coming months. Majorities across partisans say many of the health care priorities asked about are important for Congress to work on in the coming months.”
Comment: No healthcare issue made the graphic reports on the country’s leading problems or major voting issues.

About Covid-19

Pfizer/BioNTech COVID vaccine slashes pediatric hospitalization risk -U.S. study “Children ages 5 to 11 who received the Pfizer /BioNTech COVID-19 vaccine were 68% less likely to be hospitalized during the Omicron wave in the United States than unvaccinated children…
Adolescents aged 12-18 who received two shots of the vaccine were around 40% less likely to be hospitalized with the Omicron variant of the virus… 
The risk of more serious outcomes, including need for mechanical breathing assistance or death, was nearly 80% lower for those who received the shots in that age group.”

Number of COVID patients in US hospitals reaches record low “COVID-19 hospitalization numbers have plunged to their lowest levels since the early days of the pandemic, offering a much needed break to health care workers and patients alike following the omicron surge.
The number of patients hospitalized with the coronavirus has fallen more than 90% in more than two months, and some hospitals are going days without a single COVID-19 patient in the ICU for the first time since early 2020.”

Persistent cognitive impairment after mild COVID infection linked to CSF inflammation “People with persistent cognitive symptoms after mild COVID-19 infection had elevated cerebrospinal fluid inflammatory markers, according to a presentation at the 2022 American Academy of Neurology annual meeting…
Researchers found that those with acute-onset cognitive symptoms had higher levels of CSF immunovascular marker VEGF-C compared with those with delayed-onset cognitive symptoms, as well as cognitively asymptomatic controls. 
In addition, those with acute-onset symptoms also had higher CSF levels of IP-10, IL-8, placental growth factor and intercellular adhesion molecule-1.”
Comment: The therapeutic implications of these findings are not yet clear.

About health insurance

Assessing Federal and State Network Adequacy Standards for Medicaid and the Marketplace
 “Key Findings
--There is dramatic variation in standards for health insurers’ physician networks across states and among Medicaid and Marketplace plans in the same state. Individuals’ ability to access in-network providers varies widely as a result.
--Marketplace enrollees have few federal protections. Federal regulations require states to oversee insurer networks for Medicaid managed care organizations, but no such requirements exist for Marketplace qualified health plans (QHPs).
--State regulations protecting access to primary care providers and rural health clinics are limited. Federal regulations requiring health plans to contract with essential community providers, like primary care providers and rural health clinics, offer states considerable flexibility, but most states do not enforce standards stronger than baseline requirements.
--Cultural competency requirements are lacking. There are no federal requirements that individuals be able to access healthcare that meets their language or cultural needs. Although most states have cultural competency requirements for managed care organizations, far fewer have similar requirements for QHPs.”

CMS to give $110M to boost participation in Medicaid's Money Follows the Person program “The Biden administration will distribute more than $110 million to help expand home and community-based services in Medicaid via the Money Follows the Person program that aims to boost home-based care for Medicaid beneficiaries…
Money Follows the Person was approved back in 2005 and aims to reduce the use of institutional-based services and transition beneficiaries to more home and community-based services. 
The additional funding aims to help states and territories get a new program off the ground, including recruiting home-care providers and experts for transition coordination and how to establish system assessments to understand how home-care services can support residents, according to a release on the funding.”

State-based ACA exchanges make backup plans in case Congress fails to act on enhanced ACA subsidies “…state-run exchanges are eyeing backup plans for outreach and marketing in case Congress doesn’t extend beyond this year a major driver for those enrollment gains: enhanced income-based subsidies. Some officials have warned that people could drop off coverage—and consumers may shift to less-generous plans—if Congress doesn't act in time.
The American Rescue Plan's (ARP's) enhanced subsidies ensured that anyone making more than 400% above the federal poverty level wouldn’t pay more than 8.5% of their income on healthcare. Previously, that was the cutoff for eligibility for income-based subsidies. The enhancements also ensured that some consumers qualified for zero premiums or $10 a month premiums.
According to a recent Assistant Secretary for Planning and Evaluation report, an estimated 3.4 million Americans currently insured in the individual market would lose coverage and become uninsured if the ARP’s premium tax credit provisions are not extended beyond 2022. Kaiser Family Foundation determined premiums would more than double for many.”

CMS: States can seek to extend postpartum Medicaid, CHIP coverage to 12 months “States are now able to extend Medicaid postpartum coverage for a year, with Louisiana being the first to take up the new expansion.
The Centers for Medicare & Medicaid Services (CMS) announced Friday that states can now seek to extend coverage approved under the American Rescue Plan passed last year. States will have the additional coverage for five years.”

About pharma

Novartis to save at least $1 billion by 2024 thanks to simplified structure  “Novartis said on Monday it was integrating its pharmaceuticals and oncology units into an innovative medicines (IM) business to simplify its structure, targeting savings of at least $1 billion by 2024.
"Integrating pharmaceuticals and oncology business units into an innovative medicines (IM) business with separate U.S. and international commercial organizations will increase focus, strengthen competitiveness and drive synergies," the Swiss pharmaceutical company said in a statement. 
It said it expects selling, general and administrative savings of at least $1 billion to be fully embedded by 2024 as a result of these changes.”
Comment: Companies have divided divisions by numerous segmentation categories: geography, customer type, customer size, and therapeutic product line, to name some common methods. But as far as profitability, the only “sure bet” has been achievement of economies of scale on operation functions. This action by Novartis represents a reverse trend for the industry. Let’s see if any others follow.

SGLT-2 inhibitors added to new US heart failure treatment guidelines “Updated US guidance now includes SGLT-2 inhibitors as part of recommended treatment strategies for patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), regardless of whether they have type 2 diabetes. The new joint guidelines were issued Friday by the American College of Cardiology (ACC), the American Heart Association (AHA) and the Heart Failure Society of America.”

Medicare Part D and Beneficiaries Could Realize Significant Spending Reductions With Increased Biosimilar Use From the HHS OIG: “We estimated that with increased use of biosimilars instead of reference products, Part D and beneficiary spending could have been considerably reduced in 2019. Specifically, Part D spending on biologics with available biosimilars could have decreased by $84 million, or 18 percent, if all biosimilars had been used as frequently as the most used biosimilars. Additionally, beneficiaries' out of pocket costs for these drugs could have decreased by $1.8 million, or 12 percent. Although these amounts are modest in the context of overall Part D spending, far greater spending reductions will be possible as additional biosimilars become available.”

More Than 600 Medicines in Development for Diseases Impacting Women “To address the need for new treatments, specifically for women and for diseases that are of major concern to them, America’s biopharmaceutical research companies are developing 625 medicines targeting diseases that disproportionately or solely affect women. These medicines are either in clinical trials or under review by the U.S. Food and Drug Administration (FDA)…”
This monograph from PhRMA discusses these drugs.

Big Pharma-backed $1B AMR Action Fund picks 1st antimicrobial biotech investments “The AMR Action Fund, backed by Big Pharmas such as Pfizer, Eli Lilly, Bayer and more, has selected the first beneficiaries of its $1 billion fund to address drug-resistant bacterial infections: Adaptive Phage Therapeutics and Venatorx Pharmaceuticals.
The two small biotechs will become the first portfolio companies of the AMR Action Fund, an initiative formed in collaboration with the World Health Organization, the European Investment Bank and the Wellcome Trust. Other pharma members include GlaxoSmithKline, Johnson & Johnson, Merck & Co., Merck KGaA, Novartis, Roche, Takeda, Teva and many more.”

About the public’s health

Universal Hepatitis B Vaccination in Adults Aged 19–59 Years: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2022 “In addition to groups for whom HepB vaccination is already recommended, the Advisory Committee on Immunization Practices recommends that all adults aged 19–59 years should receive HepB vaccines.
Universal adult HepB vaccination through age 59 years removes the need for risk factor screening and disclosure and could increase vaccination coverage and decrease hepatitis B cases.”

NoroSTAT Data From the CDC, a reminder of “other” public health issues:
“During August 1, 2021 – March 5, 2022, there were 448 norovirus outbreaks reported by NoroSTAT-participating states. During the same period last seasonal year, there were 78 norovirus outbreaks reported by these states.
The number of outbreaks reported during the 2021-22 seasonal year is below the range reported during the same period over the previous 8 years.”

Per- and Polyfluoroalkyl Substances (PFAS) in Facemasks: Potential Source of Human Exposure to PFAS with Implications for Disposal to Landfills “Inhalation was estimated to be the dominant exposure route (40%–50%), followed by incidental ingestion (15%–40%) and dermal (11%–20%). Exposure and risk estimates were higher for children than adults, and high physical activity substantially increased inhalation exposure. These preliminary findings indicate that wearing masks treated with high levels of PFAS for extended periods of time can be a notable source of exposure and have the potential to pose a health risk. Despite modeled annual disposal of ∼29–91 billion masks, and an assuming 100% leaching of individual PFAS into landfill leachate, mask disposal would contribute only an additional 6% of annual PFAS mass loads and less than 11 kg of PFAS discharged to U.S. wastewater.”

About health technology

The complete sequence of a human genome “Since its initial release in 2000, the human reference genome has covered only the euchromatic fraction of the genome, leaving important heterochromatic regions unfinished. Addressing the remaining 8% of the genome, the Telomere-to-Telomere (T2T) Consortium presents a complete 3.055 billion–base pair sequence of a human genome, T2T-CHM13, that includes gapless assemblies for all chromosomes except Y, corrects errors in the prior references, and introduces nearly 200 million base pairs of sequence containing 1956 gene predictions, 99 of which are predicted to be protein coding. The completed regions include all centromeric satellite arrays, recent segmental duplications, and the short arms of all five acrocentric chromosomes, unlocking these complex regions of the genome to variational and functional studies.”

About healthcare finance

Private equity firm Thomas H. Lee Partners snags Intelligent Medical Objects for $1.5B “Private equity firm Thomas H. Lee Partners plans to buy healthcare data enablement company Intelligent Medical Objects in a $1.5 billion deal.
The deal marks an exit for Warburg Pincus six years into its investment, valuing the Rosemont, Illinois-based company at north of $1.5 billion...
Founded almost 30 years ago, IMO manages more than 5 million clinical terms and maps to all major coding systems.”

Today's News and Commentary

About Covid-19

 CDC removes pandemic-era travel warnings for cruises “The Centers for Disease Control and Prevention dropped cruise voyages from its list of coronavirus travel health notices Wednesday, the latest barrier to fall for an industry seeking a semblance of pre-pandemic norms. Cruise lines still require passengers to be vaccinated and test negative before boarding.” 

Early Outpatient Treatment for Covid-19 with Convalescent Plasma “In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization.”

Abbott Rapid Diagnostics Gets $1 Billion in Federal Funding for its COVID-19 Tests: “In a recent real-world study by the University of California San Francisco, Abbott’s BinaxNOW rapid antigen test for the SARS-CoV-2 virus detected 95 percent of individuals infected with high viral loads of the Omicron variant, the company said.”

BioNTech to return almost €2bn to shareholders after Covid vaccine success “BioNTech plans to return nearly €2bn to shareholders through share buybacks and a special dividend following the commercial success of its Covid-19 vaccine, the company said on Wednesday. The German biotech, which launched the first Covid-19 vaccine in partnership with Pfizer, said it would also boost research and development spending by 50 per cent to between €1.4bn and €1.5bn, as it seeks to develop a new range of drugs based on mRNA technology.”

About hospitals and healthcare systems

 RE: U.S. Federal Trade Commission and the U.S. Department of Justice Request for Information on Merger Enforcement  The American Hospital Association wrote to Jonathan Kanter (Assistant Attorney General,
Department of Justice, Antitrust Division) and Lina M. Khan (Chair Federal Trade Commission) asking that the hospital antitrust process be modified.
” The merger guidelines do not need major revisions. But they should be revised in two specific ways to improve how the agencies analyze hospital mergers. First, the guidelines should require the agencies to correct defects in the economic models that they use to evaluate hospital transactions. Second, the guidelines should enable the antitrust agencies to account for the improved coordination of care that mergers enable. These revisions are necessary to ensure that the antitrust agencies properly recognize the benefits of hospital mergers when reviewing proposed transactions.”

About pharma

 U.S. FDA panel votes against Amylyx's ALS drug over trial data concerns “A panel of outside advisers to the U.S. Food and Drug Administration on Wednesday voted against approving Amylyx Pharmaceuticals Inc's drug for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease.
The committee voted 6 to 4 against the oral drug, AMX0035, saying the company's clinical study data failed to establish it was effective against the disease.”

CVS reaches $484M settlement with Florida over opioid case “CVS Health will pay the state of Florida $484 million to settle claims related to opioid prescriptions at its pharmacies.
The settlement will resolve claims dating back more than a decade, according to the announcement from CVS. The settlement amount will be paid over the course of 18 years.”
In a related story: Fla. Inks More Than $878M In Opioid Deals Ahead Of TrialThe Florida attorney general on Wednesday announced that her office has reached a total of more than $878 million in settlements with three drugmakers and pharmacy chain CVS to end the state's claims over the opioid epidemic, exiting a trial set to start next week. CVS is to pay $484 million to the state, with Teva and Allergan paying about $195 million and $134 million, respectively, to end claims that their opioid activities inflamed the addiction crisis, according to Attorney General Ashley Moody's office. In addition to the cash settlements, Teva will provide $84 million worth of its generic overdose medication…“

About the public’s health

 Avocado Consumption and Risk of Cardiovascular Disease [CVD] in US Adults “Replacing half a serving/day of margarine, butter, egg, yogurt, cheese, or processed meats with the equivalent amount of avocado was associated with a 16% to 22% lower risk of CVD.” 

Appeals Of J&J Talc Unit's Ch. 11 Heading Directly To 3rd Circ. “ A New Jersey bankruptcy judge on Wednesday allowed appeals of his decision not to dismiss the Chapter 11 case of Johnson & Johnson's talc unit to go straight to the Third Circuit, saying that drawing the process out would be an unnecessary waste of time. Judge Michael Kaplan of the U. S. Bankruptcy Court for the District of New Jersey said the legal issues and public interest surrounding the bankruptcy of LTL Management were sufficient to merit sending the appeals straight to the appellate court, skipping district court…”

About healthcare IT

 Ransomware group claims to have stolen 850,000 patient records from California insurer “The Hive ransomware group posted on its darkweb site that it has stolen 850,000 patient records from the Partnership HealthPlan of California…
 The ransomware group posted March 29 that it had breached the health plan's systems, taking information such as names, Social Security numbers and addresses.  
The group also claimed it has taken 400GB of stolen files from the organization's server.” 

Today's News and Commentary

HAPPY National Doctors’ Day!

About Covid-19

 Biden administration launches '1-stop shop' COVID-19 website “President Joe Biden's administration is launching a website March 30 that is meant to be a "one-stop shop" to help people access vaccines, tests, treatments and high-quality masks, the White House said in a fact sheet.
The website, COVID.gov, also provides updated information about COVID-19 spread….
COVID.gov will feature a new test-to-treat locator tool to help people who are sick with COVID-19 access locations nationwide that offer tests and antiviral pills…”

Risk of SARS-CoV-2 reinfections in children: a prospective national surveillance study between January, 2020, and July, 2021, in England “The risk of SARS-CoV-2 reinfection is strongly related to exposure due to community infection rates, especially during the delta variant wave. Children had a lower risk of reinfection than did adults, but reinfections were not associated with more severe disease or fatal outcomes.”

COVID Personal Precautions on the Decline “Just 25% of Americans are extremely or very worried about themselves or a family member being infected with COVID-19, while 43% are not at all or not too worried. This is similar to a month ago and down from 36% who were worried in January during a spike of cases due to the omicron variant…
Older adults are more likely than younger adults to take… precautions, other than avoiding other people as much as possible. About half of adults age 60 and older are still avoiding nonessential travel, staying away from large groups, and wearing a face mask outside their home.”

21 states sue Biden administration to end transportation mask mandate “Twenty-one states filed suit Tuesday seeking an immediate end to a federal mandate that requires people to wear masks when traveling on airplanes, buses, subways and other modes of public transportation.
The effort in mostly Republican-led states is the latest effort seeking to abolish the mandate, put into place in February 2021, shortly after President Biden took office. The mandate was extended this month through April 18.”

New nasal spray treats Delta variant infection in mice, indicating broad spectrum results “Researchers have shown a new compound delivered in a nasal spray is highly effective in preventing and treating COVID-19 caused by the Delta variant in mice. The researchers believe this is the first treatment of its kind proven to be effective against all COVID-19 variants of concern reported to date, including alpha, beta, gamma and delta.”

About health insurance

 Average charges for 8 common procedures across ER, retail and urgent care settings FYI.
Note how the same CPT code (same service)generates higher charges in different locations.

About pharma

Walgreens turns to robots to fill prescriptions, as pharmacists take on more responsibilities “KEY POINTS

  • Walgreens Boots Alliance is opening robot-powered micro-fulfillment centers across the U.S. to fill customers’ prescriptions as the role of stores and pharmacists change.

  • The drugstore chain plans to open 22 facilities across the country.

  • By 2025, as much as half of Walgreens’ total prescription volume could be filled at the automated hubs, said Rex Swords, who oversees the network of facilities as Walgreens’ group president of centralized services, operations and planning.”

 Common drugs ‘do not work properly’ in up to 70pc of cases “Common drugs do not work properly for up to 70 per cent of patients, [British] royal colleges have warned, as they call for routine rollout of gene tests before treatment.
The British Pharmacological Society and the Royal College of Physicians called for more personalised treatment, with genetic tests to ensure that medication is not prescribed if it would do more harm than good…
Sir Munir said that by the time people reached the age of 70, there is a 70 per cent chance that they would be taking at least one drug which has such variable responses.
He said: ‘In the 21st century, we need to move away from the paradigm of 'one drug and one dose fits all' to a more personalised approach, where patients are given the right drug at the right dose to improve the effectiveness and safety of medicines.’”

About the public’s health

 2022’s Most Overweight and Obese Cities in the U.S. Except for Youngstown, Ohio all the “top” 15 cities are in the South.

Fats found in Nordic diet play ‘significant’ role in health You’ve heard of the Mediterranean Diet. This one is the Nordic variant.
”While the Nordic diet of berries, veggies, fish, whole grains and rapeseed oil is known to help prevent obesity and reduce the risk of serious illness, researchers from the University of Copenhagen have identified other health benefits, even without weight loss…
[University of Copenhagen researcher] Lars Ove Dragsted said: ‘The group that had been on the Nordic diet for six months became significantly healthier, with lower cholesterol levels, lower overall levels of both saturated and unsaturated fat in the blood, and better regulation of glucose, compared to the control group. We kept the group on the Nordic diet weight stable, meaning that we asked them to eat more if they lost weight. Even without weight loss, we could see an improvement in their health.’”

McDonald’s Hit With Class Complaint Over PFAS in Food Packaging A followup to yesterday’s story from Consumer Reports.
”McDonald’s Corp. concealed from consumers the presence of the dangerous ‘forever chemicals’ known as PFAS in its products, according to a new class complaint filed in federal court in Illinois.”

Warmer summer nocturnal surface air temperatures and cardiovascular disease death risk: a population-based study Perhaps another consequence of global warming?
”From 2001 to 2015, within these specific cohorts, 39 912 CVD deaths (68.9% men) were recorded in England and Wales and 488 deaths in King County. In England and Wales, after controlling for covariates, a 1°C rise in anomalous summer nocturnal SAT associated significantly with a 3.1% (95% CI 0.3% to 5.9%) increased risk of CVD mortality among men aged 60–64, but not older men or either women age groups. In King County, after controlling for covariates, a 1°C rise associated significantly with a 4.8% (95% CI 1.7% to 8.1%) increased risk of CVD mortality among those <65 years but not older men.”

Fine Particulate Matter Exposure From Secondhand Cannabis Bong Smoking “The PM2.5 [fine particulate matter] concentrations generated in a home during social cannabis bong smoking to which a nonsmoking resident might be exposed were greatly increased compared with background levels, and PM2.5 decayed only gradually after smoking ceased. After 15 minutes of smoking, mean PM2.5 (570 μg/m3) was more than twice the US Environmental Protection Agency (EPA) hazardous air quality threshold (>250 μg/m3).”

FDA approves long-acting injectable HIV regimen for adolescents “Cabenuva, which includes shots of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Pharmaceuticals), was first approved for adults last year as a monthly regimen and remains the only long-acting HIV treatment. The FDA recently approved a bimonthly dosing schedule for the injectable regimen, meaning it can be administered as few as six times per year.
The expanded indications means both options will now be available to virologically suppressed adolescents aged 12 years or older who weigh at least 35 kg, are on a stable ART regimen and have no history of treatment failure or resistance to either drug.”

About healthcare IT

Project ECHO Demonstrates Potential For Primary Care Telehealth Programs in Diabetes Care “An analysis of data from Project ECHO [Extension for Community Healthcare Outcomes] results of the study suggest participation in the primary care-based tele-mentoring program was associated with a 44% decrease in inpatient admissions and a more than 60% decrease in inpatient spending, which investigators purport demonstrate the potential for similar programs to improve care and improve patient outcomes on a larger level.”

An online weight loss intervention for people with obesity and poorly controlled asthma “An online weight loss intervention has potential to meet FDA guidance for product evaluation (at least 5% weight loss in 35% of people) for obesity, and is associated with a clinically significant improvement in asthma control, quality of life, and overall health-related quality of life.”
In a related article: Effectiveness of Motivational Interviewing in Managing Overweight and Obesity “Motivational interviewing (MI) is potentially useful in management of overweight and obesity, but staff training and increased delivery time are barriers, and its effectiveness independent of other behavioral components is unclear…
There is no evidence that MI increases effectiveness of BWMPs in controlling weight. Given the intensive training required for its delivery, MI may not be a worthwhile addition to BWMPs.”

Today's News and Commentary

FDA authorizes second coronavirus booster shot for people 50 and older: “The Food and Drug Administration on Tuesday authorized a second booster shot of the Pfizer-BioNTech and Moderna coronavirus vaccines for people 50 and older, a decision intended to help shore up protection against severe illness.
The shots, which can be given at least four months after a first booster dose, are not a permanent solution to the pandemic…
The second booster is expected to become available immediately after the Centers for Disease Control and Prevention reaches a decision on who should get it.”

About Covid-19

 If you got J&J vaccine, consider two mRNA booster shots, CDC data suggest: “The nearly 17 million Americans who received the one-shot Johnson & Johnson coronavirus vaccine are less protected against serious illness and hospitalizations than those who got the Pfizer-BioNTech and Moderna shots, according to federal data released Tuesday.
The latest data suggest Johnson & Johnson recipients should get a booster with one of the messenger RNA vaccines, if they haven’t already done so — and even consider a second messenger RNA booster for the greatest protection. The data come from a Centers for Disease Control and Prevention report that analyzed the results of mix-and-match vaccine-and-booster combinations during a four-month period when the highly transmissible omicron variant was dominant.”

COVID-19 tracker: Cost watchdog ICER endorses Pfizer, Merck antiviral pricing: “After reviewing the cost and efficacy of treatments from GlaxoSmithKline, Merck and Pfizer, the Institute for Clinical and Economic Review concluded that the meds "have prices reasonably aligned with patient benefits." In a statement, ICER president Steven Pearson said data show the medicines are ‘able to reduce hospitalizations among patients with mild-to moderate COVID-19 who are at high risk of progression to severe disease.’”
And in a related post: Special Assessment of Outpatient Treatments for COVID-19: “In this revised Evidence Report, ICER is presenting a full evaluation of clinical and economic outcomes of four treatments for mild-to-moderate COVID-19 among outpatients at high risk of progression to severe disease: sotrovimab, molnupiravir, PaxlovidTM, and fluvoxamine.”

Shifting Support for Some, But Not All, Covid Mandates: From a Monmouth University poll: “More than 3 in 4 Americans (77%) endorse the C.D.C. relaxing its face mask and social distancing recommendations in areas with low Covid rates. Just 34% of the public supports instituting or reinstituting face mask and social distancing guidelines in their state at the current time, which is down significantly from 52% in January. At the same time, support for requiring people to show proof of vaccination in order to work in an office or around people has held steady – 44% now and 43% in January. A majority of Democrats continue to back vaccine (69%) and mask (60%) mandates, while at the same time saying they support the C.D.C. relaxing its Covid guidance (67%).”
Read the entire article for results of extensive questioning.

About health insurance

 CMS Office of the Actuary Releases 2021-2030 Projections of National Health Expenditures: This CMS posting further explains yesterday’s lead from Health Affairs.

Optum and LHC Group to Combine, Advancing Abilities to Extend Value-Based Care into Patients’ Homes: “Optum, a diversified health services company, and LHC Group…, a national patient-focused provider of high-quality in-home health care services, have agreed to combine to further strengthen their shared ability to advance value-based care, especially in the comfort of a patient’s own home. The agreement calls for the acquisition of LHC Group’s outstanding common stock for $170 per share [more than $5.5 Billion].
The combination of LHC Group with Optum Health, which works with over 100 health plans, unites two organizations dedicated to providing compassionate and comprehensive care to patients and their families. LHC Group’s history of high-quality home and community-based care matched with Optum’s extensive value-based care experience and resources will accelerate the combined companies’ ability to deliver integrated care, improving outcomes and patient experiences.”
Comment: A further vertical diversification for UnitedHealth Group through its Optum subsidiary.

Impact of the American Rescue Plan Act [ARPA] on State-Based Health Insurance Marketplaces [SBMs]: Increased Affordability and Access for Consumers: “ARPA enhanced the amount of tax credits available to marketplace consumers and extended eligibility for premium tax credits to more middle-income Americans (individuals making over $54,360 per year or over $111,000 for a family of four). Currently, these provisions are set to expire on December 31, 2022…
SBMs estimate most of their enrollees will lose financial support if the enhanced subsidies are not extended. SBMs estimate that consumers’ average spending on premiums may increase by 15-70%.v Connecticut, Minnesota, and New York estimate consumers will spend over $1,300 per year in additional premium costs.”

About hospitals and healthcare systems

Feds restore billions in halted payments to Texas hospitals, but the fight over uninsured care continues: “Federal health officials…restored $7 million a day in funding to Texas hospitals after stopping it six months ago over concerns about how the state pays for health care for uninsured Texans.
Until last September, Texas had tapped this funding, which comes through what is known as the 1115 Medicaid waiver, to reimburse hospitals for patients who use Medicaid…
But Texas had come up with its own mechanism known as the Local Provider Participation Funds, in which private hospitals set up taxing districts and sent that money through local and state governments to the U.S. Centers for Medicare and Medicaid Services.
However, after it was discovered some hospitals profited from the Medicaid payments and covered the tax for other hospitals, CMS halted the payments in September while it argued with the state over whether that LPPF system is allowed.
Whether the system violates the rules of the state’s 10-year 1115 funding agreement with CMS remains an open question.”
Comment: This funding dispute is not just a Texas issue. The method that state used to get Medicaid funds has been disputed for many years.

About pharma

Inflation caused ‘unprecedented’ drops in net pharmaceutical prices, analysis finds: “Amid ongoing turmoil over the cost of prescription medicines, a new analysis finds that brand-name drugmakers increased their wholesale prices by 4.4% in the last quarter of 2021, up slightly from 3.8% a year earlier. But when accounting for inflation, wholesale prices fell by 2.3%.
At the same time, net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — dropped by 0.7%. But after considering inflation, net prices actually fell 5.4%.”

 HHS is investigating how consumers are marketed accelerated approval drugs: “Not surprisingly, most pharma companies don’t call attention to the fact that the drug has received this fast track when advertising to the consumer…
 According to the submission from the HHS about the new study:
‘A content analysis of DTC websites for accelerated approval products found that 21 percent of the disclosures used language directly from the approved physician labeling, 79 percent of the disclosures used at least some medical language, but 27 percent of the websites did not include any disclosure that the products attained approval through this pathway... The same analysis found that 84 percent of accelerated approval disclosures on DTC websites mentioned the approval basis, 68 percent mentioned unknown outcomes, and 47 percent mentioned confirmatory trials.’”

Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases: “This systematic review and meta-analysis of RCTs found that use of GLP-1 RAs was associated with increased risk of gallbladder or biliary diseases, especially when used at higher doses, for longer durations, and for weight loss.”

About the public’s health

Biden proposes $81.7 billion in spending to prepare for future pandemics: “About $15 billion in funding for vaccines, tests and treatments was stripped out of the government funding bill earlier this month and is stalled amid disputes about how to pay for it, with lawmakers seeking new ways to offset the funds.
The president’s budget calls for $40 billion for the development and manufacturing of vaccines, treatments and tests aimed at future threats.
Another $28 billion would go to the Centers for Disease Control and Prevention for surveillance, lab capacity and the public health workforce.
The National Institutes of Health would get $12.1 billion for research on vaccines and other measures, while the Food and Drug Administration would get $1.6 billion for its labs and information technology.”

Association of Habitual Alcohol Intake With Risk of Cardiovascular Disease: Findings  In this cohort study of 371 463 individuals, genetic evidence supported a nonlinear, consistently risk-increasing association between all amounts of alcohol consumption and both hypertension and coronary artery disease, with modest increases in risk with light alcohol intake and exponentially greater risk increases at higher levels of consumption.
Meaning  In this study, alcohol consumption at all levels was associated with increased risk of cardiovascular disease, but clinical and public health guidance around habitual alcohol use should account for the considerable differences in cardiovascular risk across different levels of alcohol consumption, even those within current guideline-recommended limits.”

Dangerous PFAS Chemicals Are in Your Food Packaging: From Consumer Reports: “CR found 'forever chemicals' in bowls, bags, plates, and wrappers, even from some companies that say they've phased them out…
These per- and polyfluoroalkyl substances (PFAS), known as ‘forever chemicals,’ can be found not only in nonstick pans and waterproof gear but also in the grease-resistant packaging that holds your food from takeout chains and supermarkets. Packaging made with PFAS often resembles paper or cardboard—a seemingly virtuous alternative to plastic—but salad dressing and fry oil do not leak through…
CR tested multiple samples of 118 products and calculated average organic fluorine levels for each. Overall, CR detected that element in more than half the food packaging tested. Almost a third—37 products—had organic fluorine levels above 20 ppm, and 22 were above 100 ppm. 
Among the 24 retailers we looked at, nearly half had at least one product above that level, and most had one or more above 20 ppm [a commonly accepted cutoff for toxicity].”
See the end of the article for fast food brand products and PFAS content.

FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs: “U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President’s fiscal year (FY) 2023 budget – a nearly 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level for investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure. The request includes $3.7 billion in budget authority – including an increase of $356 million, and $3 billion in user fees – an increase of $153 million. The request also includes $1.6 billion in mandatory funding to support the FDA’s ability to prepare for future pandemics.”

About healthcare IT

 Secret World of Pro-Russia Hacking Group Exposed in Leak: This article is a detailed account of how Russian-based Trickbot Group was planning to install ransomeware in 400 US hospitals during the height of the Covid-19 pandemic in 2020. Fortunately US cyber security experts and Homeland Security thwarted the effort. A Ukrainian researcher provided details of the operation.

About healthcare personnel

 Find the Best Medical Schools: From US News. The first link is for research rankings, but you should look at other rankings by specialty and focus (like primary care and rural health). You can also check rankings of nursing masters programs and a variety of “allied health” offerings.

About health technology

 Producing faster CAR-T cell therapy inside the body with a spongelike implant: “The researchers developed the all-in-one implant, called Multifunctional Alginate Scaffolds for T cell Engineering and Release (MASTER), to take the cumbersome CAR-T cell manufacturing steps from outside the body to the inside.
In a proof-of-concept study in a lymphoma mouse model, the researchers isolated and implanted patient-derived T cells with the MASTER platform on the same day to generate CAR-T cells inside the animals’ bodies. Compared with conventional CAR-T cells, CAR-T cells made with MASTER showed improved anticancer potency, the team reported in a study published in Nature Biotechnology.”

Today's News and Commentary

National Health Expenditure Projections, 2021–30: Growth To Moderate As COVID-19 Impacts Wane: Each year, Health Affairs publishes the latest healthcare expenditures (in this case, 2020) and 10 year projections. The site is by subscription only, but over the next few days, undoubtedly there will be mentions of the findings in other, accessible, outlets. Here is a summary:
”National health spending growth is expected to have decelerated from 9.7 percent in 2020 to 4.2 percent in 2021 as federal supplemental funding was expected to decline substantially relative to 2020. Through 2024 health care use is expected to normalize after the declines observed in 2020, health insurance enrollments are assumed to evolve toward their prepandemic distributions, and the remaining federal supplemental funding is expected to wane. Economic growth is expected to outpace health spending growth for much of this period, leading the projected health share of gross domestic product (GDP) to decline from 19.7 percent in 2020 to just over 18 percent over the course of 2022–24. For 2025–30, factors that typically drive changes in health spending and enrollment, such as economic, demographic, and health-specific factors, are again expected to primarily influence trends in the health sector. By 2030 the health spending share of GDP is projected to reach 19.6 percent.”
In 2020, healthcare costs were $4,124 Billion or 19.7% of GDP.

About Covid-19

 FDA says current dose of GSK-Vir COVID therapy unlikely to work against BA.2 variant: “The U.S. health regulator said on Friday the current authorized dose of GlaxoSmithKline and Vir Biotechnology's COVID-19 antibody therapy is unlikely to be effective against the Omicron BA.2 variant.
The agency pulled its authorization for the therapy, sotrovimab, in much of the U.S. northeast where the subvariant is dominant. The extremely contagious BA.2 causes about one-in-three COVID-19 cases in the United States now, according to government data earlier this week.”

Free COVID-19 tests ending for uninsured Americans: “Americans who don't have health insurance will now start to see some of the free COVID-19 testing options disappear, even if they are showing symptoms.
Quest Diagnostics, one of the largest testing companies in the country, told ABC News that patients who are not on Medicare, Medicaid or a private health plan will now be charged $125 dollars ($119 and a $6 physician fee) when using one of its QuestDirect PCR tests either by ordering a kit online or visiting one of the 1,500 Quest or major retail locations that administer the tests, such as Walmart or Giant Eagle.
More than 30 million Americans had no insurance during the first half of 2021, according to CDC estimates.”

About health insurance

Florida Suspends Centene Medicaid Enrollment, Penalizes Insurer for Technical Error: “The Florida Health Agency immediately suspended Medicaid and long-term care enrollment at subsidiary Centene and fined an insurance company nearly $9.1 million after a computer glitch caused Sunshine State Health Plan to mistakenly deny medical claims for more than 121,100 adults and children with low incomes.”

Florida doctor convicted in addiction treatment fraud scheme: “The medical director overseeing a pair of Florida addiction treatment facilities was convicted in an addiction treatment fraud scheme, the Justice Department said Thursday.
Jose Santeiro, 72, was part of a scheme that unlawfully billed approximately $112 million worth of addiction treatment services that were never rendered, or were medically unnecessary, the Justice Department said in a release.

About hospitals and healthcare systems

 Hospital Global Budgets: A Promising State Tool for Controlling Health Care Spending: From the Commonwealth Fund, a review of literature: “A flexible global budget pays hospitals based on their variable costs for incremental increases or decreases in volumes. This approach may help remove fee-for-service incentives that induce hospitals to provide unnecessary and low-value care, while at the same time giving states a tool to effectively constrain hospital expenditure growth for all payers. Such a payment system is also less complex than systems that set explicit prices or price caps for every service.”
Commentary: The problem with global budgets, as evidenced in Ontario, is that they do not allow hospitals to save any money to cope with financial crises, plan for capital investment, or budget for charitable care.
Global budgets are a feasible solution to the perverse incentives of fee-for-service, but the entire healthcare system needs to be restructured to make it work.

March 2022 National Hospital Flash Report: “Takeaways at a Glance:
1. 2022 is off to a bad start for U.S. hospitals and health systems.
Median hospital operating margins remained in the red for a second consecutive month in February, with most organizations experiencing declines in margins, revenues, and inpatient volumes in the aftermath of the Omicron surge.
2. Outpatient care signaled slow returns despite a steep decline in COVID-19 cases.
Consistent with past surges, delays in nonurgent care led to declines in outpatient metrics during Omicron. A moderate rise in surgery volumes showed some patients returned in February, but overall outpatient volumes and revenues remained low.
3. Inpatient volumes receded on the tail of the Omicron surge.
A drop in COVID-related hospitalizations contributed to sizable declines in inpatient volumes and lengths of stay in February, as fewer patients required care for severe symptoms of the virus following inpatient increases in January.
4. Hospitals got some temporary relief from rising expenses.
Expenses decreased across most metrics from January to February as pressures from the Omicron surge subsided, but nationwide labor shortages and global supply chain issues continue to drive up expenses compared to prior years.”

About the public’s health

 Today’s “The Health 202” from The Washington Post has an excellent summary of national abortion law initiatives.  

Artificial sweeteners and cancer risk: Results from the NutriNet-Santé population-based cohort study: “In this large cohort study, artificial sweeteners (especially aspartame and acesulfame-K), which are used in many food and beverage brands worldwide, were associated with increased cancer risk. These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally.”

Weekly U.S. Influenza Surveillance Report: “The percentage of outpatient visits due to respiratory illness increased slightly this week but is still below baseline. Influenza is contributing to levels of respiratory illness, but other respiratory viruses are also circulating. The relative contribution of influenza varies by location.
The number of hospital admissions reported to HHS Protect has increased each week for the past seven weeks.
The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate for the entire 2020-2021 season, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.
CDC estimates that, so far this season, there have been at least 3.1 million flu illnesses, 31,000 hospitalizations, and 1,800 deaths from flu.”

Walmart Stops Selling Cigarettes in Some Stores: “Walmart Inc. is ending cigarette sales in some U.S. stores after years of debate within the retail company’s leadership ranks about the sale of tobacco products, according to people familiar with the matter.
Cigarettes are being removed in various markets, including some stores in California, Florida, Arkansas and New Mexico, according to the people and store visits.”

Citing ‘outbreak,’ [Israeli] Health Ministry to launch polio vaccination drive, official says: “A top health official said Sunday that the Health Ministry will later this week launch a polio vaccination drive to counter what she called ‘a real outbreak’ of the disease.
The move comes after earlier this month health officials confirmed the first case of the potentially debilitating disease in the country in over 30 years…
She explained that during the years 2005-2013, polio vaccinations were cut back as the disease was vanquished in the country and many babies who have since gone through the health system did not get both doses.”

New study reveals why HIV remains in human tissue even after antiretroviral therapy: “Now, new research by University of Alberta immunologist Shokrollah Elahi reveals a possible answer to the mystery of why infected people can't get rid of HIV altogether.
Elahi and his team found that in HIV patients, killer T cells -- a type of white blood cells responsible for identifying and destroying cells infected with viruses -- have very little to none of a protein called CD73.
Because CD73 is responsible for migration and cell movement into the tissue, the lack of the protein compromises the ability of killer T cells to find and eliminate HIV-infected cells, explained Elahi…
‘This provides us the opportunity to come up with potential new treatments that would help killer T cells migrate better to gain access to the infected cells in different tissues.’”

About healthcare IT

 DOJ joins whistleblower case against EHR vendor Modernizing Medicine and co-founder: “The US Department of Justice has filed notice that it intends to join a whistleblower lawsuit filed by Phillips & Cohen LLP against Modernizing Medicine and a co-founder alleging serious violations of the False Claims Act involving the company's electronic health records (EHR) software and illegal kickbacks to physicians.
ModMed sells a cloud-based electronic health records (EHR) system, through subscription services, to specialty medical practices, including, gastroenterology, orthopedics, ophthalmology, otolaryngology, pain management, plastic surgery, rheumatology, urology and dermatology practices. Medical practices use the software for clinical documentation, prescribing medications, telemedicine, billing and more.”

About healthcare personnel

 Former nurse guilty of homicide in medication error death: “A former Tennessee nurse is guilty of criminally negligent homicide in the death of a patient who was accidentally given the wrong medication, a jury found Friday. She was also found guilty of gross neglect of an impaired adult in a case that has fixed the attention of patient safety advocates and nurses’ organizations around the country.
RaDonda Vaught, 37, injected the paralyzing drug vecuronium into 75-year-old Charlene Murphey instead of the sedative Versed on Dec. 26, 2017.”
This case raises many questions about individual versus system responsibility for errors.
Additional relevant facts:
” Leanna Craft, a nurse educator at the neuro-ICU unit where Vaught worked, testified that it was common for nurses at that time to override the system in order to get drugs. The hospital had recently updated an electronic records system, which led to delays in retrieving medications from the automatic drug dispensing cabinets. There was also no scanner in the imaging area for Vaught to scan the medication against the patient’s ID bracelet.”

Examining How the Social Drivers of Health Affect the Nation’s Physicians and their Patients: From a Physicians Foundation survey:
“• Six in 10 physicians (61%) feel they have little to no time and ability to effectively address their patients’ SDOH 
• However, a majority of physicians (87%) want greater time and ability in the future 
• Community resources not available, inadequate or difficult to access” (77%), ‘inadequate information about availability/access to community resources’ (77%), ‘lack of reimbursement for screening for or addressing SDOH’ (73%) and ‘existing payer reporting requirements taking time away from being able to address patients’ SDOH’ (73%) were also identified as top challenges 
• Eight in 10 physicians (83%) believe that addressing patients’ SDOH contributes to physician burnout rates 
• Six in 10 physicians (63%) report they often have feelings of burnout when trying to address their patients’ SDOH 
• Six in 10 physicians (68%) also report managing patients’ SDOH has a major impact on physician mental health and wellbeing”

Female and Millennial Patients Most Likely to Worry about Provider Perceptions, New Research Finds: “The research, commissioned by athenahealth, found that more than half of female respondents of all ages (55%) and millennial respondents (61%), defined as Americans born between 1981-1996, report they have interacted with a provider who they felt did not take their health concerns seriously. Furthermore, a similar number of women (54%) and millennials (67%) surveyed say they have had health concerns they did not bring up to their doctor due to fear of appearing anxious, dramatic, or silly. In both cases, these were the highest percentages of all age and gender groups.
In addition, female and millennial respondents are the most likely to report mental and physical effects from the pandemic…”

Today's News and Commentary

About Covid-19

Binding and neutralizing antibody responses to SARS-CoV-2 in young children exceed those in adults: “Among 56 participants seropositive at enrollment, children aged 0-4 years had >10-fold higher RBDAb titers than adults (416 vs. 31, P<0.0001), and the highest RBDAb titers in 11/12 households with seropositive children and adults. Children aged 0-4 years had only 2-fold higher neutralizing Ab than adults, resulting in higher binding to neutralizing (B/N) Ab ratios compared to adults (2.36 vs. 0.35 for ID50, P=0.0002). 
CONCLUSIONS. These findings suggest that young children mount robust antibody responses to SARS-CoV-2 following community infections. Additionally, these results support using neutralizing Ab to measure the immunogenicity of COVID-19 vaccines in children aged 0-4 years.”

Evidence grows that vaccines lower the risk of getting long COVID: “‘…even without a clear sense of what's exactly driving long COVID, there's good reason to believe that vaccines would help guard against the condition, says Dr. Steven Deeks, a professor of medicine at the University of California, San Francisco.
There's overwhelming evidence that someone who's vaccinated has less virus in their body during an infection, he says, ‘so it would make great sense that the amount of virus-related complications over time would also be lower.’”
Comment: This finding should give pause to those who advocate for “natural immunity” instead of immunization.

COVID booster provides protection for over-65s after 15 weeks -UK data: “A booster dose of vaccine against COVID-19 continues to provide robust protection against hospitalisation for older people nearly four months after getting the third dose, new data from the UK's Health Security Agency on Thursday showed.
Vaccine effectiveness against hospitalisation for people aged over 65, 15 weeks after a booster, was 85%, down from 91% two weeks after getting the third dose, the latest vaccine surveillance report from the agency estimated.
The data is the first released by the UK on the longer-term durability of boosters. The UK is administering fourth doses to vulnerable age groups, joining a number of other countries including Israel as the world fights the more infectious Omicron variant of the coronavirus.
Fourth doses will be given six months after the third dose and a wider campaign is being considered for the autumn.”

Covid vaccinations — including boosters — fall to lowest levels since 2020: “On Wednesday, the seven-day average of vaccinations fell to fewer than 182,000 per day, according to data compiled by The Washington Post. That is lower than at any time since the first days of the
The daily total has been in free fall for the past six weeks. On Feb. 10, the nation was averaging more than 692,000 shots a day. Booster shots have been more common than first or second doses since October, and the low rates have long caused concern among some experts.
Now, with authorities bracing for a possible increase in covid-19 cases caused by the BA.2 subvariant, 65.4 percent of Americans are fully vaccinated and just 44 percent have received a booster shot. That is substantially less than the totals in many Western European nations — which nevertheless have seen a sharp rise in cases in recent weeks and months.”

About health insurance

Optum acquires Refresh Mental Health: report: “Optum has quietly acquired Refresh Mental Health from private equity firm Kelso & Company, Axios reported Thursday.
The company confirmed the deal in a statement to the outlet. The acquisition has not been announced publicly as of yet…
The deal would give the UnitedHealth Group subsidiary a greater foothold in the behavioral health space, which has garnered greater interest under the pandemic. The value of the purchase is unclear, but Kelso bought Refresh at a valuation of around $700 million in December 2020…”

Appeals court overturns ruling against UnitedHealth in landmark mental health parity class action: “A district court judge ruled in 2019 that United Behavioral Health committed "pervasive and long-standing violations" of the Employee Retirement Income Security Act by denying thousands of claims to protect its bottom line between 2011 and 2017. The company was ordered to reprocess all of the claims included in the lawsuit as well as reform its protocols for processing claims…
However, the 9th Circuit argued that the company does not have to cover every service as long as it follows generally accepted standards of care. The plaintiffs did not prove that the plans in question mandate coverage for all services under generally accepted standards of care, according to the order.
‘Even if UBH has a conflict of interest because it serves as plan administrator and insurer for fully insured plans that are the main source of its revenue, this would not change the outcome on these facts,’ the court said.”

Rates of Diabetes-Related Major Amputations Among Racial and Ethnic Minority Adults Following Medicaid Expansion Under the Patient Protection and Affordable Care Act: “In a cohort study of 115 071 hospitalizations for DFUs among racial and ethnic minority adults, early Medicaid expansion was associated with decreased major amputation and hospitalization rates in early-adoption states compared with nonadoption states.”

About pharma

After Supreme Court win, Merck prevails against 500 Fosamax cases: report: “For more than a decade, Merck has been defending itself against claims its osteoporosis drug Fosamax caused patients to suffer “atypical femoral fractures," even taking its fight to the Supreme Court, where it eked out a win. Now, after that SCOTUS fight, the company has prevailed against 500 Fosamax lawsuits.
In a Wednesday ruling, a federal judge in New Jersey tossed hundreds of Fosamax cases, siding with Merck's argument that federal law preempted the state-law injury claims…”

About the public’s health

Good news for coffee lovers: Daily coffee may benefit the heart: “Drinking coffee—particularly two to three cups a day—is not only associated with a lower risk of heart disease and dangerous heart rhythms but also with living longer, according to studies being presented at the American College of Cardiology’s 71st Annual Scientific Session. These trends held true for both people with and without cardiovascular disease. Researchers said the analyses—the largest to look at coffee’s potential role in heart disease and death—provide reassurance that coffee isn’t tied to new or worsening heart disease and may actually be heart protective.”

Association of Habitual Alcohol Intake With Risk of Cardiovascular Disease: “In this cohort study, coincident, favorable lifestyle factors attenuated the observational benefits of modest alcohol intake. Genetic epidemiology suggested that alcohol consumption of all amounts was associated with increased cardiovascular risk, but marked risk differences exist across levels of intake, including those accepted by current national guidelines.”

FDA permits another e-cigarette, pledges decisions soon on big brands: The Food and Drug Administration, kicking off what is expected to be a period of intensified activity on the contentious issue of e-cigarettes, on Thursday authorized several tobacco-flavored vaping products made by the company Logic, and signaled it would soon announce whether other big-name brands will be allowed to keep selling their wares in the United States.
The FDA said Logic can continue marketing certain e-cigarette devices and prefilled cartridges because the benefits — in helping adult smokers move away from traditional cigarettes — outweigh the risk of young people starting to use e-cigarettes. The agency noted that tobacco is not a popular vaping flavor among young people. The FDA has not yet decided on Logic’s request to sell menthol-flavored cartridges.”

Deaths outpace births in most counties as U.S. growth slowed in 2020: “Almost three-fourths of all U.S. counties reported more deaths than births last year, a development largely caused by the pandemic, which contributed to a dramatic slowing in the overall population growth of the nation, according to data released Thursday by the Census Bureau.
Low fertility rates, which have persisted since the end of the Great Recession, and the continuing demographic shift toward an older population also combined to create the smallest population increase in 100 years...”

About healthcare IT

Gender Differences in Time Spent on Documentation and the Electronic Health Record in a Large Ambulatory Network: “In this cross-sectional study across ambulatory specialties, we demonstrated that female physicians spend more time on the EHR overall, after-hours, and on EHR-based documentation than male physicians. Clinical documentation is the primary activity driving gender differences in EHR time. These differences persisted after accounting for hours worked, physician specialty, and other characteristics, despite female physicians caring for slightly fewer patients on average.
Our findings provide a potential mechanism for the gender gap in burnout,3 which has implications for workforce mental health5 and physician retention.6 They suggest that women physicians may benefit from policy changes, workflows, and technologies that reduce documentation burden, including scribes, team documentation, and artificial intelligence–powered solutions.”

About healthcare personnel

Wisconsin, Utah governors sign bills penalizing violence, threats against healthcare workers: “Two state governors signed bills this week that increase penalties of battery or assault against healthcare workers and make violent threats against healthcare workers a felony.”

About health technology

NIH’s All of Us Research Program Releases First Genomic Dataset of Nearly 100,000 Whole Genome Sequences: “Nearly 100,000 highly diverse whole genome sequences are now available through the National Institutes of Health's All of Us Research Program. About 50% of the data is from individuals who identify with racial or ethnic groups that have historically been underrepresented in research. This data will enable researchers to address yet unanswerable questions about health and disease, leading to new breakthroughs and advancing discoveries to reduce persistent health disparities.”

Today's News and Commentary

About Covid-19

 IRS-CI releases latest COVID-related fraud investigational statistics: “The agency investigated 660 tax and money laundering cases related to COVID fraud, with alleged fraud in these cases totaling $1.8 billion. These cases included a broad range of criminal activity, including fraudulently obtained loans, credits and payments meant for American workers, families, and small businesses.”
The posting has case examples. 

About health insurance

 Ten Texas Doctors and a Healthcare Executive Agree to Pay over $1.68 Million to Settle Kickback Allegations: “Ten additional Texas doctors and a healthcare executive have agreed to pay a total of $1,680,430 to resolve False Claims Act allegations involving illegal kickbacks in violation of the Anti-Kickback Statute and Stark Law, and to cooperate with the Department’s investigations of and litigation against other parties, announced Eastern District of Texas U.S. Attorney Brit Featherston…
In addition, the United States announced a settlement with Brett Markowitz, the founder and CEO of Florida Rejuvenation Holdings, LLC, which operates medical practices in Tampa, Florida (collectively, the Tampa Practices). From October 18, 2016 through February 19, 2018, True Health representatives allegedly arranged for True Health to pay for each patient that physicians at the Tampa Practices referred to True Health for clinical laboratory services.”

About hospitals and healthcare systems

 Howard University to receive $100M in federal funding for $650M hospital: “Howard University will receive $100 million from the federal government to replace its hospital in Washington, D.C…
The money comes from the $1.5 trillion spending bill President Joe Biden signed into law March 15, which includes $344 million for Howard University, with $100 million specifically for the hospital.
The total cost of the hospital is $650 million, and it's expected to open in 2026.”

About pharma

U.S. Pharmacopeia Medicine Supply Map releases global API manufacturing findings: The results of this survey have supply chain implications. India is by far the #1 source for APIs (active pharmaceutical ingredients).  #2 is the EU -way ahead of China, which has long been considered to be in the second spot.

 8 drugmakers scaling back operations in Russia: An update FYI.

Sun Pharmaceuticals to pay $485 million to settle claims its Ranbaxy unit caused customers to overpay for generics: “On the eve of a trial, Sun Pharmaceuticals has agreed in principle to pay $485 million to settle lawsuits that alleged its Ranbaxy Pharmaceuticals unit misled regulators in order to win exclusive approvals for generic medicines, which delayed competition and forced consumers to overpay for the drugs. The settlement was disclosed in a filing with the Bombay Stock Exchange.
The lawsuits stemmed from a scandal that erupted more than a decade ago after U.S. authorities learned Ranbaxy, which was one of the biggest generic makers, falsified testing data and manufactured drugs that failed to meet safety standards. In 2013, the company, which is now part of Sun, pleaded guilty to felony charges and paid a $150 million penalty, as well as $350 million to settle civil claims.”

About the public’s health

Pfizer grabs another breakthrough tag for RSV shot in older adults: “PF-06482077, or RSVpreF, snagged the FDA tag Thursday to prevent lower respiratory tract infections from RSV in adults aged 60 and over. The designation comes thanks to phase 2a data Pfizer presented on the shot’s safety, immunogenicity and efficacy after a single shot in healthy adults aged 18 to 50.”

About healthcare IT

2021 Telehealth Survey Report: This AMA report is a quick read, but has too many interesting findings to summarize; but one did stand out: More than 50% of physicians said that telehealth has increased their professional satisfaction.

 Healthcare data breaches by the numbers: 9 stats:
1. Healthcare is one of the most highly targeted industries for cyberattacks, with hospitals representing the victims of 30 percent of large data breaches.
2. Nearly 50 million Americans had their protected health information breached in 2021, a threefold increase in three years.
3. In 2021, the share of residents whose protected health information was exposed in a data breach was 10 percent or higher in 22 states.
4. The number of reported healthcare breaches in 2021 increased by 19 percent. There were 905 reported in 2021 compared to 758 in 2020.
5. Midsize hospitals report that a cyberattack creates an average shutdown time of 10 hours that costs on average $45,700 per hour.
6. Hacking accounted for 74 percent of all healthcare data breaches in 2021, up from 35 percent in 2016.
7. About 5 percent of cyberattacks are motivated by fun. The motive for 91 percent of hackers is financially driven. Another 4 percent of attacks are motivated by espionage.
8. More than 50 percent of the most commonly used internet-connected hospital devices are vulnerable to cyberattacks.
9. A February HHS threat brief outlined 18 identifiers that "provide criminals with more information than any other breached record." They include Social Security numbers, health plan beneficiary numbers and biometric identifiers.”
And in a related article: Health data breaches swell in 2021 amid hacking surge, POLITICO analysis finds: “Nearly 50 million people in the U.S. had their sensitive health data breached in 2021, a threefold increase in three years, according to a POLITICO analysis of the latest HHS data.
Health care organizations including providers and insurers in every state except South Dakota reported such incidents last year. About half of states and Washington, D.C., saw more than 1 in 10 of their residents directly impacted by unauthorized access to their health information, according to the analysis. And hacking accounted for nearly 75 percent of all such breaches — up from 35 percent in 2016.”

About healthcare personnel

 Racial, Ethnic, and Language Concordance Between Patients and Their Usual Healthcare Providers: From the RWJ Foundation:
”Key Findings

  • Black adults were less likely to report being the same race as their healthcare providers (22.2 percent) than White adults (73.8 percent) or adults of other races (34.4 percent).

  • Less than one in four Hispanic/Latinx adults (23.1 percent) reported sharing a racial, ethnic, or language background with their usual health provider.

  • Hispanic/Latinx adults (55.8 percent) and non-Hispanic/Latinx Black adults (65.6 percent) were less likely to have a usual healthcare provider than non-Hispanic/Latinx White adults (70.4 percent). Similarly, uninsured adults were much less likely to have a usual healthcare provider (28.5 percent) than adults with public or private insurance (68.3 percent and 72.8 percent).” 

About health technology

Johnson & Johnson renames medical device branch: “Johnson & Johnson renamed its medical device company to Johnson & Johnson MedTech, dropping the previous name.
On March 8, the company announced it was changing Johnson & Johnson Medical Devices to MedTech in order to ‘reflect the company's global leadership as a medtech innovator,’ according to the press release.” 

Today's News and Commentary

As someone who has worked in the healthcare quality field for the past 30 years, I am proud to announce that, last week, my article "Total quality management at Motorola: a successful blueprint for manufacturing and service organizations"(The Journal of Health Administration Education 13(1):15-23, 1995) surpassed 10,000 reads on the Research Gate website alone. It has been among the top 15% of read articles on the site.

About Covid-19

Latest version of omicron accounts for most new infections in many parts of the U.S., genomics testing shows: “The recently emerged version of the coronavirus called BA.2 that has driven a wave of cases in Europe now accounts for as much as 70 percent of new infections in many parts of the United States, according to an estimate from the genomics company Helix that could signal a new chapter in the third year of the pandemic.”

White House officials say U.S. has exhausted funds to buy potential fourth vaccine dose for all Americans: “Federal officials have secured enough doses to cover a fourth shot for Americans age 65 and older as well as the initial regimen for children under 5, should regulators determine those shots are necessary, said three officials, speaking on the condition of anonymity to detail funding decisions. But the officials say they cannot place advance orders for additional vaccine doses for those in other age groups, unless Congress passes a stalled $15 billion funding package.

Smartphone-based COVID-19 detection test from Australia shows high accuracy“ASX-listed digital health firm ResApp Health has announced that its pilot clinical trial for a smartphone-based COVID-19 screening test has achieved positive results. 
The new diagnostic app, which uses machine learning to analyse the sound of a patient's cough, was reported to correctly detect COVID-19 in 92% of participants with the infection during the trial. With a 92% sensitivity, it exceeds real-world measured sensitivity of rapid antigen tests, ResApp claims.”

Moderna says its coronavirus vaccine for young children is safe, but efficacy is a more complicated picture: “Vaccine maker Moderna announced Wednesday its two-dose pediatric coronavirus vaccine was safe in young children, toddlers and babies in a study. But the effectiveness of the shot in children 6 months to 5 years old was more of a mixed picture because of the challenge presented by the highly transmissible omicron variant…
in the face of omicron, the immune defenses mustered by two doses in adults were less robust, particularly in preventing infections — and the same pattern was seen in children, with vaccine efficacy of about 40 percent.”

HHS Distributing an Additional $413 Million in Provider Relief Fund Payments to Health Care Providers Impacted by the COVID-19 Pandemic“The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), … announced more than $413 million in Provider Relief Fund (PRF) payments to more than 3,600 providers across the country. This is the fourth round of PRF Phase 4 payments, totaling nearly $12 billion that has been distributed to more than 82,000 providers in all 50 states, Washington D.C., and five territories since November 2021. This is in addition to HRSA’s distribution of American Rescue Plan (ARP) Rural payments totaling nearly $7.5 billion in funding to more than 44,000 providers across the country over the past four months.”

About health insurance

Low-income Americans now can sign up for Obamacare plans with $0 premiums on federal exchange:“Those with incomes less than 150% of the federal poverty level -- $19,320 for an individual and $39,750 for a family of four -- can select policies on healthcare.gov through a special enrollment period, the Centers for Medicare and Medicaid Services told CNN exclusively on Monday. Most people will be able to select plans with no premiums, while others may have to pay a few dollars.
The agency is launching advertising and outreach campaigns to spread the word about the new special enrollment period, which lasts for the rest of the year. The effort will also target those experiencing certain life changes, such as losing job-based coverage, getting divorced or aging out of a parent's policy, which have always allowed them to sign up for Obamacare policies during the year.”

Survey: 4 in 10 misunderstand Medicare Advantage coverage must stay in-network: “A new survey found that four out of 10 Medicare Advantage (MA) customers mistakenly believe they don’t have to stay in-network for care, which is a key difference between the program and traditional Medicare. 
The survey was released Tuesday by MedicareGuide.com, which helps with Medicare enrollment and contains responses from 1,148 seniors. It comes as the MA market has increased in size and become a lucrative option for insurers.”

THE RACIAL HEALTH AND WEALTH GAP IMPACT OF MEDICAL DEBT ON BLACK FAMILIES“Despite the aims of the Affordable Care Act (“ACA”), medical debt remains a looming crisis, disproportionately affecting Black households and communities. 

  • 62% of bankruptcies are related to medical debt2

  • 1 in 3 Black adults have past-due medical bills, compared to fewer than 1 in 4 white adults

  • 17% of Black adults lack health insurance compared to 12% of white adults

An array of issues contribute to the current medical debt crisis: rising healthcare costs, lack of insurance, narrow insurance networks, surprise medical bills, high out-of-pocket costs, high deductibles, and inaccessibility of charity care or financial assistance.” 

About hospitals and healthcare systems

 Advocate Aurora's net income more than triples to $1.8B: Advocate Aurora Health saw its revenue, operating margin and net income increase in 2021, according to financial documents released March 21…
Advocate Aurora's expenses rose 4.9 percent year over year to $13.4 billion. This included $7.7 billion in salaries, wages and benefits and $564.6 million in contract labor expenses. When compared to 2020, expenses for salaries, wages and benefits were up just 3.2 percent and contract labor was up 12 percent. 
After factoring in all expenses, Advocate Aurora ended the period with an operating income of $593.6 million.” 
In a related story: Advocate Aurora Health Bucks Labor Cost Inflation Trend: Salary, wage and benefit costs only increased 3.2% from 2020 to 2021 across the 26-hospital system in Wisconsin and Illinois, Advocate Aurora reported Monday. National hospital labor expenses jumped 13% over that span, according to Kaufman Hall. 
Advocate Aurora did not have to rely as heavily on staffing agencies last year because it did not cut benefits, furlough staff or lay off employees, the not-for-profit system said in a statement. Contract labor wages surged 44% from 2020 to 2021, Kaufman Hall data show.”

Henry Ford Health System gets new name, logo in rebranding campaign: It will now be known as Henry Ford Health. The article has an interesting video of the evolution of the organization’s name and logos.

About pharma

Study Shows That Intranasal Rx Halts Memory Decay in Experimental Alzheimer’s Model“A research collaboration between scientists at LSU Health New Orleans and the Karolinska Institute in Sweden has found that applying specialized pro-resolving lipid mediators intranasally arrested memory loss and brain degeneration in an experimental model of Alzheimer's Disease (AD). The results are published in the Nature journal, Communications Biology
The authors conclude that the noninvasive administration route, intranasal delivery, of biologically active lipid messengers opens avenues for therapeutic exploration for AD and other neurodegenerative diseases.”

Cancer giants BMS, AstraZeneca clash in new checkpoint inhibitor patent suit“After Bristol Myers Squibb took Merck & Co. and Roche to task for patent infringement with their big-selling immuno-oncology drugs, the drugmaker is now pressing its case against AstraZeneca.
In a newly filed lawsuit in Delaware, Bristol Myers says AZ is ‘exploiting’ its research and patents by marketing a ‘later-developed anti-PD-L1 drug,’ than its own Opdivo, which scored FDA approval in 2014. Because the companies are ‘direct competitors,’ BMS says it's suffering ‘substantial damages, including lost profits’ because of AZ's Imfinzi marketing.”

J&J to restrict 340B discounts for 29 drugs: Johnson & Johnson 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 21…
This announcement makes Johnson & Johnson the 16th drugmaker to limit 340B discounts to safety-net hospitals for drugs dispensed at community-based pharmacies.”

Pfizer pulls blood pressure medicines in US over cancer-causing impurities: On Monday, Pfizer issued a voluntary recall of its blood pressure drug Accuretic along with a pair of its generic hypertension treatments distributed by Greenstone.
All of the recalls—in addition to several rounds of recalls last summer of Pfizer’s smoking-cessation drug Chantix—were triggered because of the presence of nitrosamines. The impurities are commonly found in the air, drinking water, dairy products, vegetables and cured and grilled meats and “may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” Pfizer said in its statement.
The company said it has not received any reports of adverse events linked to any of the treatments and there is no immediate risk to patients taking the medication. 

Pioneer Institute report calls 340B an 'increasingly dysfunctional' program: “The free market-focused think tank's analysis found that while the revenue hospitals generate in the program has grown exponentially, major Massachusetts hospitals have been cutting back on charity care. Drug sales in the 340B program grew from $9 billion in 2014 to $38 billion in 2020, according to the report.
In 2005, just 583 hospitals participated in the program, according to the report. By 2019, under the Affordable Care Act, the program grew to include more than 2,500 hospitals and to account for 8% of all prescriptions in the U.S.
The program's explosive growth has likely led to "mission drift," according to the report. Many hospitals view the program the way a for-profit entity would, buying drugs at a low cost and then reselling them to both government and commercial payers at higher profits, according to the report.”

FDA Declares Some Ophthalmic Products Combo Instead of Just Drug Products“The FDA has reclassified ophthalmic drugs packaged with eye cups, eye droppers or other dispensers as ‘drug-led combination products’ rather than just drugs, the agency said in a final guidance.”
Comment: This action demonstrates the “slippery slope” of what constitutes a drug versus a combination product.

About the public’s health

Food Insecurity and Cardiometabolic Markers: Results From the Study of Latino Youth:  Lower FS [food security] is associated with unfavorable MetS-relevant cardiometabolic markers in Hispanic/Latino youth. These findings also support the use of a child-level versus a household-level measure to capture the health implications of food insecurity in this population.”

Failed Attempts to Quit Combustible Cigarettes and e-Cigarettes Among US Adolescents: “Among adolescents, reported prevalence of an unsuccessful cigarette quit attempt declined between 1997 and 2020. In 2020, the prevalence of unsuccessful quit attempts among adolescents who had used either e-cigarettes or cigarettes was higher than the prevalence of unsuccessful cigarette quit attempts in each of the previous 13 years.”

About healthcare IT

Telehealth Was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic:  From the HHS OIG: “This data brief provides insight into the use of telehealth in both Medicare fee-for-service and Medicare Advantage during the first year of the COVID-19 pandemic…
Key Takeaways:

o Over 28 million Medicare beneficiaries used telehealth during the first year of the pandemic. This was more than 2 in 5 Medicare beneficiaries.

o Beneficiaries used 88 times more telehealth services during the first year of the pandemic than they used in the prior year.

o Beneficiaries’ use of telehealth peaked at the beginning of the pandemic and remained high through early 2021.

o Beneficiaries most commonly used telehealth for office visits during the first year of the pandemic.”

6 Top Telehealth Companies: Teledoc is #1. Read the article for more information on these companies

About health technology

MIT, Mass General researchers develop handheld robot for tapping into blood vessels“Researchers at the Massachusetts Institute of Technology and Massachusetts General Hospital are developing a robotically guided handheld device that can quickly tap into a patient’s central artery, allowing first responders and other healthcare professionals to easily apply emergency therapies with little training.
The system uses an artificial intelligence-powered ultrasound scanner to guide needles and catheter hardware, to help stem severe bleeding, or deliver fluids and medications—all while potentially in the back of an ambulance.”

About healthcare finance

Humana Prices $750 Million Debt Offering“Humana Inc. announced… that it has priced a public offering of $750 million aggregate principal amount of the company’s 3.700 percent senior notes, due 2029 (the ‘Senior Notes Offering’). The Senior Notes Offering is expected to close on March 23, 2022, subject to the satisfaction of customary closing conditions.
The company expects net proceeds from the Senior Notes Offering will be approximately $741.1 million, after deducting underwriters’ discounts and estimated offering expenses. The company intends to use the net proceeds from the Senior Notes Offering for general corporate purposes, which may include the repayment of existing indebtedness, including borrowings under the company’s commercial paper program.”

Today's News and Commentary

About Covid-19

Becerra shoots down giving more than 60 days notice on ending COVID-19 public health emergency: “Giving more than 60 days notice that the COVID-19 public health emergency will end is going to be difficult, as states and lawmakers have pressed for a longer heads-up, according to Department of Health and Human Services (HHS) Secretary Xavier Becerra.
The secretary spoke with reporters Friday during a press conference that included remarks on the status of unwinding the public health emergency (PHE) and how the agency’s COVID-19 relief efforts will be impacted if Congress doesn’t approve additional funding.”

 AstraZeneca’s Evusheld Wins UK Nod for Preventing COVID-19: “The UK’s Medicines and Healthcare products Regulatory Agency has approved AstraZeneca’s Evusheld (tixagevimab and cilgavimab) for the prevention of COVID-19, making it the first antibody combination cleared in the country for the indication…
One dose of Evusheld confers protection for an estimated six months for immunocompromised individuals and others who are unlikely to mount an adequate response to COVID-19 vaccination, AstraZeneca said.”

Black adult hospitalizations reached a pandemic high during the omicron wave, CDC study finds: “Black adults were four times as likely to be hospitalized compared with White adults during the height of the omicron variant surge, which started in mid-December and continued through January, the report said. In January, the CDC found, hospitalization rates for Black patients reached the highest level for any racial or ethnic group since the dawn of the pandemic…
And fewer Black adults had been immunized compared with White adults…
According to the report, as of Jan. 26, only 39.6 percent of Black people older than 18 had received their primary series of two shots and just 43.9 percent of that group had received a booster once eligible. Meanwhile, 47.3 percent of White adults had been vaccinated with the initial series of shots, and 54.5 percent of eligible White adults had been boosted during that same time period, the report said.”

U.S. health officials seek Covid-19 hospital safety complaints following POLITICO report: “The Centers for Medicare and Medicaid Services plans to notify hospitals that patients should be allowed to wear their N95s when entering, said Ives-Rublee, who works at the Center for American Progress, a liberal think tank. CMS also wants to ensure patients know where to lodge complaints if a facility requests someone remove their mask or doesn’t follow Centers for Disease Control and Prevention guidance. Next week, CMS plans to discuss the matter with state survey agencies, which consider complaints about health care facilities, two of the people familiar said.
The agency moves follow POLITICO’s report on Wednesday, which found that hospitals around the country ask patients to replace their N95s with less protective surgical masks.”

Looming COVID drug cuts prompt plans to reclaim, redistribute unused supply: “With President Joe Biden’s $15.6 billion request for COVID-19 relief stalled in Congress, the federal government plans to begin significantly cutting the number of viral treatments available to the states, according to internal planning documents obtained by ABC News, which show a decrease of some 30%.
The drawdown, which begins Monday, includes monoclonal antibodies that have been shown to work against the omicron variant.”

Judge bars D.C. from vaccinating children without parental consent: “A federal judge barred the District of Columbia from enforcing a law that allowed minors to be vaccinated without their parents’ knowledge after parents said the legislation violates religious liberty.”

About health insurance

 HHS wants to get 'money's worth' on Medicare Advantage, will look into coding practices: “The Department of Health and Human Services (HHS) is examining risk adjustment tactics that have led to overpayments to some Medicare Advantage plans, Secretary Xavier Becerra told reporters Friday. 
Becerra said the agency has seen evidence of charges going beyond what would be necessary for MA plans using tactics such as up-coding. The remarks come as some progressive lawmakers have clamored for more scrutiny of the popular program that enables seniors to use their Medicare benefit to buy a private plan.”

Credit Companies Will Remove Stains From Repaid Medical Debts: “The companies [Equifax, Experian and TransUnion] said the changes would eliminate up to 70 percent of the medical debt accounts on consumers’ credit reports, which contain reams of data used to calculate the all-important three-digit credit score that is the key to mortgages, car loans, rental agreements and more.
Starting on July 1, medical debts that were paid after they went to collections will no longer appear on consumers’ credit reports, where they can currently linger for up to seven years.”

About hospitals and healthcare systems

 3 kidney care providers—Fresenius Health Partners, Cricket Health and InterWell Health—plan to merge in deal valued at $2.4B: Three big players in the kidney care market—Fresenius Health Partners, Cricket Health, and InterWell Health—plan to form a new value-based care company to expand in the care of earlier stages of kidney disease.
The deal, announced Monday morning, will create a company valued at $2.4 billion, according to the companies.
The merger brings together expertise in value-based kidney care contracting of Fresenius Health Partners, a division of Fresenius Medical Care North America, InterWell Health’s network of more than 1,600 nephrologists and startup Cricket Health’s technology-enabled care model and patient engagement platform. Fresenius Medical Care is the world's largest operator of dialysis centers.”

About pharma

 Humira monopoly nears its end: “Next January, the first copycat version of Humira, an injectable drug approved for an array of inflammatory diseases, is set to launch in the U.S. Its arrival will mark the end of a two-decade run of market exclusivity during which Humira's maker, AbbVie, has earned nearly $200 billion from sales of the drug.
Eight more biosimilars — as copies of biologic drugs are called — are expected to become available over the course of 2023, putting AbbVie under pressure. Anticipating the competition, the company has spent the past several years attempting to lessen its reliance on Humira, which as recently as 2019 accounted for more than half its revenue.” 

Merck KGaA to Pay Over $3 Million to Patients After Thyroid Drug Formulation Change: “France’s highest court has ordered European drugmaker Merck KGaA to pay more than $3.6 million to patients who received a thyroid drug Levothyrox (levothyroxine sodium) with diminished quality following a change in its formulation.  
In 2017, the company removed lactose and added mannitol and citric acid to the drug’s formulation to make it easier to tolerate.”

About the public’s health

 Alcohol-Related Deaths During the COVID-19 Pandemic: “The number and rate of alcohol-related deaths increased approximately 25% between 2019 and 2020, the first year of the COVID-19 pandemic. Rates increased prior to the pandemic, but less rapidly (2.2% mean annual percent change between 1999 and 2017). The rate increase for alcohol-related deaths in 2020 outpaced the increase in all-cause mortality, which was 16.6%.” 

US adult smoking rate fell during first year of pandemic: “U.S. cigarette smoking dropped to a new all-time low in 2020, with 1 in 8 adults saying they were current smokers, according to survey data released Thursday by the Centers for Disease Control and Prevention. Adult e-cigarette use also dropped, the CDC reported...
Use of cigars, smokeless tobacco and pipes was flat. Current use of electronic cigarettes dropped to 3.7%, down from 4.5% the year before.
Cigarettes were the most commonly used tobacco product, with 12.5% of adults using them, down from 14%.”

Effect of Medical Marijuana Card Ownership on Pain, Insomnia, and Affective Disorder Symptoms in Adults: “In this randomized clinical trial involving 186 participants, immediate acquisition of a medical marijuana card increased the incidence and severity of cannabis use disorder (CUD) and resulted in no significant improvement in pain, anxiety, or depressive symptoms, but improved self-reported sleep quality.”

‘Alarming’ Trend in Uterine Cancer Incidence: High-Risk Histologies on the Rise: “The incidence of high-risk uterine cancer is increasing in the United States, particularly among Black patients, according to a study presented at the SGO 2022 Annual Meeting on Women’s Cancer.
This finding may be partially explained by increasing obesity rates, and it may be time to reconsider the role of obesity in uterine cancer, according to Cortney Eakin, MD, of the University of California, Los Angeles, who presented the study at the meeting.”

Senate plan for permanent daylight saving time faces doubts in the House: “‘It could be weeks — or it could be months’ before House Democratic leaders decide whether to tee up a vote on eliminating the biannual clock changes that have governed daily life in most states for decades, said Rep. Frank Pallone Jr. (D.-N.J.), who chairs the House Energy and Commerce Committee that oversees time change policies. While the Sunshine Protection Act, which unanimously passed the Senate on Tuesday, would nationally shift clocks an hour later to maximize daylight, some doctors have argued that adopting permanent standard time would be a healthier option and better align with humans’ natural rhythms.”

Nine out of Ten Healthcare Executives Say That Health Equity Initiatives are a Top Business Priority, according to Accenture and HIMSS Insights: “Nine out of Ten Healthcare Executives Say That Health Equity Initiatives are a Top Business Priority, according to Accenture and HIMSS Insights.
Yet only 36% have a dedicated health equity agenda budget.”

As Cigarette Taxes Rise, Infant Deaths Decline: “A 10 percentage-point increase in total cigarette tax was associated with a 2.6% decrease in newborn deaths and a 1.9% decline in infant deaths, according to researcher Anthony Laverty, from Imperial College London, and his colleagues.”

The SEC proposed a landmark climate disclosure rule. Here’s what to know: “The Securities and Exchange Commission on Monday approved a landmark proposal to require all publicly traded companies to disclose their greenhouse gas emissions and the risks they face from climate change.
The proposed rule from the Wall Street regulator mandates that hundreds of businesses report their planet-warming emissions in a standardized way for the first time.”
About healthcare IT

 Becerra: HHS Will Fight For More Telehealth After Public Health Emergency Ends: “‘The Department of Health and Human Services will seek to sustain and expand access to telemedicine after the federal government declares the COVID-19 public health emergency to be over,’ Secretary Xavier Becerra said Friday.”

HIMSS22: 3 interoperability policy updates: “Here are three details policymakers shared at the conference: 1. Penalties for providers who violate information-blocking regulations…
2. Payer-to-payer data-sharing regulations will build on FHIR…
3. Bringing public health agencies into health information networks.”

Smartphone App Can Help Detect Genetic Risk for Heart Attacks: “Researchers from Scripps Research Institute developed a new app called MyGeneRank that can predict the genetic risk for heart attacks along with information from 23andMe…
Users can connect their 23andMe information to the MyGeneRank app using an iPhone or Android smartphone. After syncing the data, the app calculates the user's risk score for a heart attack based on the latest genetic risk factors for coronary artery disease (CAD). One year later, the app follows up, asking the user questions about their use of lipid-lowering medications.”

About healthcare personnel

 Socioeconomic Diversity of the Matriculating US Medical Student Body by Race, Ethnicity, and Sex, 2017-2019: “In this exploratory survey study, high-income households were overrepresented in the medical student body both overall and within each racial and ethnic group. The underrepresentation of low-income groups was nearly ubiquitous across race and ethnicity groups.” 

Nursing Facility Staffing Shortages During the COVID-19 Pandemic: “As of the week ending February 27, 2022, the most recent data available, 29% of nursing facilities reported at least one staffing shortage (approximately 4,000 out of 14,000 facilities)…
Nursing facilities were most likely to report a shortage of aides and least likely to report a shortage of clinical staff as of February 27, 2022…
The Biden Administration plans to propose new regulations that would establish a minimum nursing facility staffing requirement within the next year.”

About health technology

 Medtech's top 10 money raisers of 2021: “2021’s total looks… like $11.2 billion” See the article for company specifics.