Today's News and Commentary

About Covid-19

The federal government is offering another round of free COVID tests  “Americans can once again order free COVID-19 tests from the federal government by visiting COVIDtests.gov. In this round, the U.S. Postal Service will deliver eight free rapid antigen tests to any household in the U.S. that wants them, according to the website. That brings to sixteen the total tests offered per household so far.”

About health insurance

Anthem, Inc. Shareholders Approve Corporate Rebranding to New Name, Elevance Health, Inc. “Shareholders approved the change of the holding company name Anthem, Inc. (ANTM) to Elevance Health, Inc. at the 2022 Annual Meeting of Shareholders, the company announced today.”

2022 Workforce Health Index Supplemental Dataset “This dataset provides an aggregate view of per member per year medical spend ($PMPY) at the state level for the prior four years, including a summary of the top five areas of spend by state.” US averages: 2018: $3,914; 2019: $4,192; 2020: $3,907; 2021: $4,248; 2022(est.): $4,232. But, the range is $5739 in Alaska to $1,422 in Hawaii.

Medicaid director owned stock in companies she awarded huge contracts “Ohio Medicaid Director Maureen Corcoran won’t discuss them, but state ethics filings she submitted on Sunday showed that she continued to own stock in three huge health care companies last year — the same year she negotiated and signed billion-dollar contracts with their subsidiaries.”

About pharma

Pharma group wins order striking down patient assistance rule “The biggest U.S. drug industry group has won a court order striking down a federal rule meant to ensure that financial assistance offered by drugmakers to patients is not captured by insurers.
U.S. District Judge Carl Nichols in Washington, D.C. sided with the Pharmaceutical Research and Manufacturers of America (PhRMA) on Tuesday in finding that the U.S. Department of Health and Human Services overstepped its authority when it passed the rule in 2020…
In recent years, some insurers have established so-called accumulator adjustment programs, in which they do not count assistance toward patients' deductibles and out-of-pocket maximums. Such programs effectively capture some of the assistance for insurers instead of patients.
In response, HHS's Center for Medicare and Medicaid Services (CMS) in December 2020 adopted a rule that would require drugmakers to pay higher rebates to state Medicaid programs unless they ensure that patients are able to keep all financial assistance for themselves.
Drugmakers already have to pay rebates to Medicaid programs in order to reduce costs, based on the "best price" available for a drug on the commercial market. The rule, which was set to take effect in January 2023, would have required drugmakers to factor the effect of accumulator adjustment programs into their best price calculations.”

 Cerebral Board Members Agree to Replace CEO Amid Federal Probe Into Prescription Practices In the continuing saga about this online behavioral health company, which is under federal investigation for online medication ordering (see pat postings): “Directors who control the board of Cerebral Inc. agreed on a plan to replace Chief Executive Kyle Robertson, sparking leadership tumult at the mental-health startup as it contends with scrutiny over its prescription practices for controlled substances, people familiar with the situation said Tuesday.”

About the public’s health

 Food deserts reduce breastfeeding initiation Since infant formula has been in short supply, more attention is being directed at increased breast feeding. However, there are a number of systemic issues that need to be addressed before that goal is achieved. In a study presented at the recent ACOG Annual Clinical and Scientific Meeting: “The researchers found that Black individuals had the highest risk for decreased initiation (aRR = 1.26), whereas Hispanic (aRR = 0.58) and Asian or Pacific Islander individuals (aRR = 0.74) had the lowest risk.
Lower education achievement was associated with decreased breastfeeding initiation (middle school: aRR = 5.42; high school: aRR = 3.46; some college: aRR = 1.95)… Education was the social factor most strongly associated with decreased breastfeeding initiation. A history of diabetes (aRR = 1.14) and preterm (aRR = 1.47) or low birth weight (aRR = 1.38) was also associated with reduced initiation, according to the researchers.”

 Newly Released Estimates Show Traffic Fatalities Reached a 16-Year High in 2021 “NHTSA projects that an estimated 42,915 people died in motor vehicle traffic crashes last year, a 10.5% increase from the 38,824 fatalities in 2020. The projection is the highest number of fatalities since 2005 and the largest annual percentage increase in the Fatality Analysis Reporting System’s history…
Preliminary data reported by the Federal Highway Administration show that vehicle miles traveled in 2021 increased by about 325 billion miles, or about 11.2%, as compared to 2020. 
Data estimates show the fatality rate for 2021 was 1.33 fatalities per 100 million VMT [vehicle miles traveled], marginally down from 1.34 fatalities in 2020. While the fatality rate continued to rise in the first quarter, it declined in the other three quarters of 2021, compared to 2020.”

Rare monkeypox case confirmed in Massachusetts “Massachusetts health authorities confirmed a case of monkeypox Wednesday after the Centers for Disease Control and Prevention said it was monitoring the possible spread of the rare but potentially serious viral illness.
A man who recently traveled to Canada was tested for the virus Tuesday, and the infection was confirmed by the CDC on Wednesday, the Massachusetts Department of Public Health said in a statement.”

About healthcare personnel

 Evolving Practice Choices by Newly Certified and More Senior General Internists “ 67,902 general internists, comprising 80% of all general internists initially certified from 1990 to 2017 (n = 84 581), were studied… By 2018, 71% of newly certified general internists practiced as hospitalists compared with only 8% practicing as outpatient-only physicians… [M]ore senior physicians increasingly see patients only in the outpatient setting.”
This study highlights one of the major reasons for the ever-growing crisis in availability of primary care physicians.

Today's News and Commentary

About Covid-19

 FDA authorizes a coronavirus booster shot for children as young as 5 “Federal regulators authorized a coronavirus booster shot Tuesday for school-age children, making a third shot of the Pfizer-BioNTech vaccine available to 5-to-11-year-olds as cases rise nationally.
The Food and Drug Administration cleared the booster for use at least five months after children are fully vaccinated with the two-shot primary series.”

US Set to Extend Covid-19 Public Health Emergency Past July “The US government will extend the Covid-19 public-health emergency past mid-July, continuing pandemic-era policies as the nearly 2 1/2-year outbreak drags on…
An HHS spokesperson said the public-health emergency remains in effect, and the department will continue to provide a 60-day notice to states before any possible termination or expiration.”

300,000 US COVID deaths could have been averted through vaccination, analysis finds “Although the national average indicated that approximately 50% of deaths were preventable, researchers said there were large differences among states -- ranging from 25% to 74% vaccine-preventable deaths.”

States Have Yet to Spend Hundreds of Millions of Federal Dollars to Tackle Covid Health Disparities “The Biden administration in March 2021 announced it was investing $2.25 billion to address covid health disparities, the largest federal funding initiative designed specifically to help underserved communities hardest hit by the virus.
Two months later, the Centers for Disease Control and Prevention awarded grants to every state health department and 58 large city and county health agencies. The money is intended to help limit the spread of covid-19 among those most at risk in rural areas and within racial and ethnic minority groups, as well as improve their health…
A year later — with covid having killed 1 million people in the U.S. since the start of the pandemic and hospitalizing millions more — little of the money has been used, according to a KHN review of about a dozen state and county agencies’ grants”

About health insurance

 Most Office-Based Physicians Accept New Patients, Including Patients With Medicare and Private Insurance The entire study is worth a read. Characteristics vary by specialty, geography, physician age and practice setting (such as group or solo practice). With that caveat, overall: “Across almost every dimension we examine, the share of physicians accepting new Medicare patients is similar to the share accepting new patients with private insurance, with the only exception being the share of obstetricians and gynecologists accepting new Medicare patients (93%) is somewhat lower than the share accepting new privately-insured patients (99%).”

Private Health Plans During 2020 Paid Hospitals 224 Percent of What Medicare Would Pay From RAND: “The analysis includes facility and professional claims for inpatient and outpatient services provided by both Medicare-certified short-stay hospitals and other facility types. For the first time, the analysis also includes more than 4,000 ambulatory surgical centers, which are free-standing facilities that perform outpatient surgical services.
Data sources include $78.8 billion in spending on hospital-based care and $2.0 billion in spending on care in ambulatory surgery centers…
The study found that the percentages remained relatively stable over the study period. Private insurers paid 222 percent of Medicare prices in 2018 and 235 percent in 2019. In 2020, relative prices for hospital facility–only services averaged 224 percent, while associated professional services such as physician fees averaged 163 percent of what Medicare would have paid for the same services.”

UNLESS CONGRESS ACTS, HEALTH CARE COSTS WILL SOON SKYROCKET FOR PEOPLE WHO BUY THEIR OWN INSURANCE “Overall, 10.3 million people in 33 states use healthcare.gov to buy their own insurance. The Centers for Medicare & Medicaid Services (CMS) has calculated what will happen if ARPA’s improvements to advance premium tax credits disappear in those states. On average, premiums will shoot up by 53%, jumping from $13.7 billion to $20.9 billion – a $7.3 billion hit to family budgets…”
See the chart for a state-by-state breakdown.

Fidelity Releases 2022 Retiree Health Care Cost Estimate: 65-Year-Old Couple Retiring Today Will Need an Average of $315,000 for Medical Expenses “Americans Will Need 7x More Than They Expect to Pay for Health Care Costs in Retirement.
Nearly Half of Health Savings Account (HSA) Owners Feel Prepared for Health Care Expenses in Retirement, Compared to just 27% of Those Without an HSA…
The 2022 estimate for single retirees is $150,000 for men and $165,000 for women. Fidelity’s estimate assumes both members of the couple are enrolled in traditional Medicare, which between Medicare Part A and Part B covers expenses such as hospital stays, doctor visits and services, physical therapy, lab tests and more, and in Medicare Part D…
This year’s estimate is up 5% from 2021 ($300,000) and has nearly doubled from its original $160,000 in 2002.”

Kemp OKs expanded Medicaid coverage for new moms, rejects coverage for HIV An illustration of the dichotomy in healthcare coverage in a Republican-run state: “Low-income moms will be eligible for a year of Medicaid coverage under a bill Gov. Brian Kemp just quietly signed into law.
But the governor caught advocates by surprise when he rejected language and funding in next year’s budget that would have started the process of expanding Medicaid eligibility to cover low-income Georgians living with HIV.”

Justices want solicitor general to weigh in on Medicare 'upcoding' ruling “The U.S. Supreme Court on Monday signaled continued interest in a whistleblower suit involving allegations of systemic exaggeration of Medicare patients’ ailments, asking Solicitor General Elizabeth Prelogar to weigh in on the level of detail required to plead fraud “with particularity” under the False Claims Act.”

Sanders reintroduces single-payer Medicare bill “Sen. Bernie Sanders and 14 other senators introduced the Medicare for All Act of 2022… to create a federally-administered single-payer healthcare system.
Under the bill, the program would be implemented over a four-year period.”
See the article for and copy of the Act for more details. When Congress won’t pass requested Covid-19 funding, is now the time to revisit this issue? It is a best an unneeded distraction.
And in a related article from the CBO: Budgetary Effects of a Policy That Would Lower the Age of Eligibility for Medicare to 60 “CBO and JCT [ Joint Committee on Taxation] that lowering the age of Medicare eligibility to 60 would increase federal budget deficits by $155 billion over the 2026–2031 period through the effects of that policy on federal revenues and mandatory spending.” Read the article and links for more details.

About hospitals and healthcare systems

HOSPITAL OVERUSE DURING COVID-How many older adults were put at risk for unnecessary procedures? From the Lown Institute, hospital-specific lists.
”KEY TAKEAWAYS

• From March-December 2020, hospitals delivered more than 100,000 low-value procedures to Medicare beneficiaries; that’s one every four minutes on average.

• Of the 100,000 procedures, 45,000 were unnecessary coronary stents and 30,000 were unnecessary back surgeries.

• From June to December 2020, with no vaccines available to vulnerable older adults, hospitals delivered low-value services to Medicare patients at rates similar to 2019.

• All of the hospitals on the US News Honor Roll ranking had rates of coronary stent overuse higher than the national average in 2020, and four had rates at least twice that.”

COVID-19 and Hospital Financial Viability in the US “The results of this cross-sectional study suggest that although hospitals experienced a sizeable reduction in operating margins in 2020, their overall profit margins remained similar to those in prior years, suggesting that the COVID-19 relief fund effectively offset the financial losses for hospitals during the COVID-19 pandemic. Government, rural, and smaller hospitals, which were supported by some targeted fund allocations, generated higher overall profit margins during 2020 than in prior years.”

 Advocate Aurora Health reports $253M net loss, 0.3% operating margin in Q1 2022 “The most recent quarter’s total revenue was a 9.1% increase over the prior year while expenses rose 11% year over year.
The increase in revenue was largely due to a 10.1% bump in patient service revenue, which the system attributed to increased outpatient (6.3%) and physician (6.7%) visits compared to the previous year’s opening quarter.
Total expenses, on the other hand, were dragged by a 13.4% year-over-year rise in salaries, wages and benefits expenses and an 8.4% increase in supplies, purchased services and other expenses.”

About pharma

 GlaxoSmithKline is no more: Meet the scaled down 'GSK'  “More than two decades ago, Glaxo Wellcome and SmithKline Beecham combined to become GlaxoSmithKline. But as the British Big Pharma looks to slim down its organization with its consumer demerger, its longstanding name is getting the same treatment.
Out with the GlaxoSmithKline moniker and in with the three-letter acronym: GSK. On Monday, the company made the three letters—which have regularly been used by journalists and in conversation to refer to the company—its official name.
This comes as the pharma is looking to spin out its consumer business, to be known as Haleon, which will be the largest London listing of a company in more than 10 years.”

24 states support federal government in 340B drugmaker lawsuit “A collection of 24 states is throwing its support to the federal government in a legal fight with several drugmakers over access to drugs discounted under the 340B program. 
The states and the District of Columbia announced in legal filings Monday that the drugmakers’ moves to cut off sales of 340B drugs to contract pharmacies are unlawful…
The states blasted the moves of six drugmakers—Sanofi, United Therapeutics, Eli Lilly, Novartis, Novo Nordisk and AstraZeneca—that started in 2020. The drugmakers cut off sales of 340B drugs to contract pharmacies, which are third parties that dispense drugs on behalf of the 340B-covered entities.”

About the public’s health

 America’s Health Rankings From the United Health Foundation, this report presents the healthiest and least health states for seniors. At the top is Utah and at the bottom (by far) is Mississippi.
”The America’s Health Rankings model… includes four drivers, or determinants of health: social and economic factors, physical environment, clinical care and behaviors, all of which influence the fifth model category, health outcomes.”
Look here for an executive summary.

Biden signs law banning infant sleep products blamed for 200 deaths “President Joe Biden on Monday signed into law legislation that prohibits the manufacture and sale of crib bumpers or inclined sleepers blamed for more than 200 infant deaths”

FDA comes to agreement with baby formula factory to resume production “Abbott Nutrition, the maker of Similac and other popular baby formulas, said Monday it has come to an agreement with the Food and Drug Administration to fix safety issues at a Sturgis, Mich., factory that has been shuttered for more than three months, contributing to a nationwide formula shortage.
The agreement represents a first step toward resolving a problem that has sent parents scrambling from store to store to find sustenance for their infants. But questions remain about what precisely the FDA will require of Abbott and the Sturgis facility operations before reopening is approved.”
And in a related story: Nestlé is flying baby formula into America as shortage continues

About healthcare IT

 At 10.8% CAGR, Healthcare Information System Market Size to hit USD 579.56 Billion in 2028, Says Brandessence Market Research “The Global Healthcare Information System Market size was Valued at USD 282.70 Billion in 2021…
Services segments will be accounting for the biggest share in the market as there is a lack of knowledge with regard to the IT applications in the professionals of healthcare.”

AI recognition of patient race in medical imaging: a modelling study Fascinating!
”In our study, we show that standard AI deep learning models can be trained to predict race from medical images with high performance across multiple imaging modalities, which was sustained under external validation conditions (x-ray imaging [area under the receiver operating characteristics curve (AUC) range 0·91–0·99], CT chest imaging [0·87–0·96], and mammography [0·81]). We also showed that this detection is not due to proxies or imaging-related surrogate covariates for race (eg, performance of possible confounders: body-mass index [AUC 0·55], disease distribution [0·61], and breast density [0·61]). Finally, we provide evidence to show that the ability of AI deep learning models persisted over all anatomical regions and frequency spectrums of the images, suggesting the efforts to control this behaviour when it is undesirable will be challenging and demand further study.”

About health technology

 FDA Authorizes First DTC Covid-19, Flu, RSV Combination Test “The FDA said it has authorized Labcorp’s combination Covid-19, flu, and RSV test for direct-to-consumer use, the first such test to be accessible without a prescription.”

Today's News and Commentary

About healthcare quality

RaDonda Vaught gets 3 years probation for fatal medication error “RaDonda Vaught, a former nurse convicted of a fatal medication error, was sentenced to three years of supervised probation May 13. She received a deferred sentence, meaning charges could be wiped from her record pending successful completion of probation. 
Ms. Vaught, 38, was convicted of criminally negligent homicide and abuse of an impaired adult for a fatal medication error she made in December 2017 after overriding an electronic medical cabinet as a nurse at Vanderbilt University Medical Center in Nashville, Tenn. The error, in which  vecuronium, a powerful paralyzer, was administered instead of the sedative Versed, led to the death of 75-year-old Charlene Murphey. Ms. Vaught faced up to eight years in prison. 
Davidson County criminal court Judge Jennifer Smith said the court in its sentencing considered Ms. Vaught's offense was not motivated by any intent to violate the law, and that she will ‘never again be in a position to repeat this fatal error.’
’She has been stripped of her nursing license and started a new livelihood outside of healthcare,’ Ms. Smith said.”

About Covid-19

FDA rejects antidepressant seen as possible Covid-19 treatment “The Food and Drug Administration declined Monday to authorize a 30-year-old generic antidepressant as a treatment for Covid-19, dealing a major blow to a small group of doctors who have organized around the pill for months, arguing that it could provide a cheap and accessible way to prevent hospitalizations and death both in the U.S. and around the world.
In an unusual two-page summary — the FDA does not generally disclose the reasoning behind rejections — regulators said that the doctors failed to provide adequate evidence of effectiveness of the drug, called fluvoxamine.”

‘A magnet for rip-off artists’: Fraud siphoned billions from pandemic unemployment benefits “The exact scope of the fraud targeting federal aid initiatives is unknown, even two years later. With unemployment benefits, however, the theft could be significant. Testifying at a little-noticed congressional hearing this spring, a top watchdog for the Labor Department estimated there could have been “at least” $163 billion in unemployment-related “overpayments,” a projection that includes wrongly paid sums as well as “significant” benefits obtained by malicious actors.
So far, the United States has recaptured just over $4 billion of that, according to state workforce data furnished by the Labor Department this March.”

 COVID-19 hospitalizations up in 43 states “Hospitalizations are up 24 percent nationwide over the last 14 days, with a daily average of 21,547 people hospitalized with COVID-19 as of May 16.”

About health insurance

 Investor Alert: Bronstein, Gewirtz & Grossman, LLC Notifies Oscar Health, Inc. (OSCR) Investors of Class Action and Encourages Shareholders to Contact the Firm “Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Oscar Health, Inc…and certain of its officers, on behalf of shareholders who purchased or otherwise acquired Oscar Class A common stock pursuant and/or traceable to the registration statement and prospectus… issued in connection with the Company's March 2021 initial public offering ("IPO" or the "Offering")…
This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1933.
The Complaint alleges that the Registration Statement was materially false and misleading and omitted to state: (1) that Oscar was experiencing growing COVID-19 testing and treatment costs; (2) that Oscar was experiencing growing net COVID costs; (3) that Oscar would be negatively impacted by an unfavorable prior year Risk Adjustment Data Validation (RADV) result relating to 2019 and 2020; (4) that Oscar was on track to be negatively impacted by significant SEP membership growth; and (5) that, as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.”

Humana’s CenterWell Senior Primary Care and Welsh, Carson, Anderson & Stowe Announce Second Joint Venture to Develop and Operate Value-Based Primary Care Clinics for Medicare Patients “Humana Inc.’s CenterWell Senior Primary Care and Welsh, Carson, Anderson & Stowe (“WCAS”) have established a second joint venture (‘JV’) to further expand access to value-based primary care clinics for Medicare patients. The new JV will deploy up to $1.2 billion of committed capital to develop approximately 100 new senior-focused, payer-agnostic primary care clinics between 2023 and 2025 and operate them to profitability. This JV between Humana’s CenterWell Senior Primary Care and WCAS follows an earlier JV that is currently deploying up to $800 million of capital to open 67 clinics by early 2023 and support their ongoing operations.
WCAS, a healthcare and technology-focused investment firm, will have majority ownership of the JV, while Humana will own a minority stake. All de novo clinics developed through the Humana-WCAS joint ventures will be managed and operated under Humana’s CenterWell Senior Primary Care brand.”

About hospitals and healthcare systems

CommonSpirit posts $591M quarterly operating loss “CommonSpirit Health, a 142-hospital system based in Chicago, reported an operating loss for the three months ended March 31, according to financial documents released May 13.”

Providence's operating loss hits $510M in Q1 “Citing inflation and labor cost pressures, Renton, Wash.-based Providence recorded an operating loss of $510.16 million in the first quarter of 2022, according to financial documents released May 13. In the same quarter one year prior, Providence posted an operating loss of $221.91 million.”

About pharma

 Lilly bags FDA approval for dual-targeted type 2 diabetes drug Mounjaro “The FDA on Friday cleared Eli Lilly's once-weekly dual GIP and GLP-1 receptor agonist Mounjaro (tirzepatide) to improve glucose control in adults with type 2 diabetes…
Mounjaro is also being evaluated as a potential weight-loss treatment in the Phase III SURMOUNT development programme in overweight and obese individuals across six clinical trials. Eli Lilly recently reported results from SURMOUNT-1 showing that the drug helped patients without type 2 diabetes lose up to 22.5% of their body weight. Readouts from the SURMOUNT-2, SURMOUNT-3 and SURMOUNT-4 studies are due in 2023.
Eli Lilly has so far not yet submitted a filing for Mounjaro as a weight-loss treatment.”

About the public’s health

 Texas Court Allows Abuse Inquiries of Parents of Transgender Children “The Texas Supreme Court ruled on Friday that investigations of parents with transgender children for possible child abuse could continue, after an emergency appeal by state officials including Gov. Greg Abbott. The ruling reversed lower-court decisions that had temporarily halted the inquiries statewide.” 
And in a related story: Alabama’s Transgender Youth Can Use Medicine to Transition, Judge Rules
”A federal judge temporarily halted part of a new law that prevents doctors from prescribing puberty blockers and hormone therapies to transgender youth. He upheld a ban on sex-altering operations.”

About healthcare IT

AI May Be More Prone to Errors in Image-Based Diagnoses Than Clinicians “Researchers have found that deep neural networks (DNNs) make mistakes in image-based medical diagnoses that humans are less likely to make, and they hypothesize that these mistakes may indicate that clinicians and artificial intelligence (AI) use different features for analysis when looking at medical images.
According to a study published in Scientific Reports, DNNs can fail when performing image-based medical diagnosis tasks because their predictions can be unrelated to the underlying pathology of the condition they are designed to diagnose. For example, an AI skin classifier learns to associate surgical skin markings with malignant melanoma, increasing the classifier’s false positive rate by 40 percent, according to the researchers.”

About health technology

 Medtronic completes Intersect ENT acquisition “Medtronic announced that it completed its previously announced $1.1 billion acquisition of Intersect ENT…for $28.25 per share in an all-cash transaction.
As a result of the transaction, Medtronic acquires Intersect ENT’s Propel and Sinuva drug-eluting sinus implant product lines and technology, intellectual property and the company’s Menlo Park facility. Intersect ENT’s employees also will join Medtronic, according to a news release.
Medtronic said that former Intersect ENT brand Fiagon was divested simultaneously at close [per FTC requirement], with its Cube and VenSure products not included in the acquisition.”

Shortage of Contrast Media for CT Imaging Affecting Hospitals and Health Systems “The Food and Drug Administration (FDA) continues to report shortages of GE Healthcare’s iohexol and iodixanol intravenous contrast media products for computed tomography imaging. In an April 19 letter to customers, GE Healthcare said it was rationing orders for its iohexol products after a COVID-19 lockdown temporarily shut down its production facility for iodinated contrast media in Shanghai, China…
GE Healthcare said it expects product supply availability to improve the week of May 23, but until then a 20% allocation level has been established.”

Limaca's Precision-GI Endoscopic Biopsy Device Designated a Breakthrough Device “The device, which is deployed through an instrument channel in an endoscope, features a motorized, rotational cutting needle for taking biopsies of tumors.”

Today's News and Commentary

About Covid-19

 'Unthinkable tragedy': U.S. COVID-19 death toll surpasses 1 million  The headline, unfortunately, speaks for itself.

 U.S. will share COVID-19 vaccine technology, Biden tells global summit “The United States will share technologies used to make COVID-19 vaccines through the World Health Organization and is working to expand rapid testing and antiviral treatments for hard-to-reach populations, President Joe Biden said on Thursday.
Speaking at the second global COVID-19 summit, Biden called on Congress to provide additional funds so that the U.S. may contribute more to the global pandemic response.”

COVID-19:FDA Took Steps to Help Make Tests Available; Policy for Future Public Health Emergencies Needed “GAO was asked to review FDA's oversight of tests for COVID-19. This report examines, among other things, 1) the actions FDA took to help make COVID-19 tests available for use, 2) the number of tests FDA authorized and those for which it exercised enforcement discretion, and 3) FDA's monitoring of these tests after they were available for use…
[The GAO recommends that the] Commissioner of FDA should develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies. This policy should include the conditions under which FDA would begin and end the use of such discretion.”

About health insurance

 Medicare Spending on Prescription Drugs Far Outpaces Development Costs “The AARP report also cited 2021 data from the U.S. House of Representatives Committee on Oversight and Reform, which found that from 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period. The $2.6 billion average cost of development, Purvis said, is an industry-generated estimate and other researchers have challenged that figure as too high.”

About hospitals and healthcare systems

Top teaching hospitals by net patient revenue FYI

Concordance of Hospital Ranks and Category Ratings Using the Current Technical Specification of US Hospital Star Ratings and Reasonable Alternative Specifications “In this cross-sectional study of data on 3339 US hospitals, on average half were assigned a different star rating when using reasonable alternatives to the current methods. Different changes to the technical specification had differential outcomes, but even minor changes in specification could lead to substantial reclassification between adjacent performance categories.”

 Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018  Released a few days ago from the HHS OIG. While the full report is worth reading, the following are some key findings:
”Twenty-five percent of Medicare patients experienced patient harm during their hospital stays in October 2018. Patient harm includes adverse events and temporary harm events.
Twelve percent of patients experienced adverse events, which are events that led to longer hospital stays, permanent harm, life-saving intervention, or death. In addition to the patients who experienced adverse events, 13 percent of patients experienced temporary harm events, which required intervention but did not cause lasting harm, prolong hospital stays, or require life-sustaining measures. Temporary harm events were sometimes serious and could have caused further harm if providers had not promptly treated patients.

• Categories of Harm Events. The most common type of harm event was related to medication (43 percent), such as patients experiencing delirium or other changes in mental status. The remaining events related to patient care (23 percent), such as pressure injuries; to procedures and surgeries (22 percent), such as intraoperative hypotension; and to infections (11 percent), such as hospital-acquired respiratory infections.”

Recommendations are also offered.

U.S. Not-for-Profit Hospitals and Health Systems Face Mounting Operating Stress (Pandemic, Labor and Inflation Pressures to Persist Through 2022 and Beyond) “The entire burden of any business interruption and negative margin impact due to coronavirus is now borne fully by providers. NFP healthcare is a low-margin sector, and Fitch Ratings expects operating margins will weaken in 2022. Lower margins are still currently offset by strong balance sheets, which have provided a generous cushion over the last two years of operating uncertainty. Pressures are anticipated to be within the expected range of volatility for the sector, and we do not foresee any significant deterioration of rated healthcare providers’ financial positions at this time. Our sector outlook remains neutral; however, another omicron-like surge this fall/winter may see this cushion materially eroded, and signal the beginning of downward rating momentum across the sector.”
The study was probably done before the recent stock market “correction,” so the statement about strong balance sheets may no longer be quite so accurate.

About pharma

 Three UK pharma companies go broke, costing 1,000 employees their jobs: reports “Three large U.K. pharmaceutical companies are in financial trouble and are shutting down, costing about 1,000 employees their jobs, according to local reports.
Testerworld, Doncaster Pharmaceuticals Group and Eclipse Generics are all part of the Converse Pharma Group, a U.K. group of companies founded in 2013 that focuses on wholesale distribution. The companies have entered into administration, a program to either rescue a company or wind down its operations, according to several reports in England.” 

New Japan-originated ALS treatment option available to patients in the U.S.―FDA approval of RADICAVA ORS for the treatment of ALS “Mitsubishi Tanabe Pharma Corporation…a member of the Mitsubishi Chemical Holdings Group, announced that the U.S. Food and Drug Administration (FDA) has approved RADICAVA ORS® (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS) on May 12, 2022.”

About the public’s health

 The baby formula shortage has turned political A really good review of this problem from the Washington Post.

Estimating the Burden of Influenza-like Illness on Daily Activity at the Population Scale Using Commercial Wearable Sensors “Question  How can the true burden of influenza-like illnesses (ILIs) be estimated given that most cases of ILIs are mild and go undocumented?
Findings  This cohort study of 15 122 adults who reported ILI symptoms and had data from wearable sensors at symptom onset found an overall reduction in mobility equivalent to 15% of the active US population becoming completely immobilized for 1 day. More than 60% of this reduction occurred among persons who had sought no medical care.
Meaning  This study suggests that the burden of ILIs is much greater than had previously been understood.”

About healthcare IT

 Interoperability Workgroup Report  From the Health Innovation Alliance:

“Six areas of focus were identified:

• Data That Works for Patients and Providers at the Point of Care

• Leverage State of the Art Medical Devices to Improve Patient Care

• Clear Protections from HIPAA Penalties for Patient Information Requests

• Inform Medical Research and Innovation with Better Information

• Social Determinants of Health, and

• Improve Public Health Data Collection and Reporting” 

The report makes 21 recommendations covering these categories and also assigns responsibility for their implementation and monitoring, e.g., Congress, FDA, ONC, and CMS.

IoT in Healthcare Market “The global IoT in healthcare market is projected to reach US$ 181.4 Billion in 2022, anticipated to grow at a CAGR of 18.0%, reaching US$ 952.3 Billion by 2032. The market is slated to document a Y-o-Y growth rate of 20.7% from 2021-2022, increasing from the previously registered value of US$ 150.3 Billion.”

Legacy Devicemakers Must Still Support Cybersecurity, IMDRF Says “Manufacturers of legacy devices that were not designed with cybersecurity in mind must tell customers during the procurement process when they will stop providing cybersecurity support, the International Medical Device Regulators Forum (IMDRF) advises in a just-published draft document.”

About healthcare personnel

 Michigan grants full practice authority for CRNAs “Michigan is the 20th state to allow certified registered nurse anesthetists to practice without physician supervision after Gov. Gretchen Whitmer signed a bill into law granting full practice authority for those providers…”

About health technology

Paige nets European OK for AI to spot prostate cancer biomarkers Usually biomarker identification requires special tissue stains or genetic analysis. This AI technology can pick up 4 prostate cancer biomarkers using the usual tissue stains.

 FDA clears BD’s newest molecular diagnostics machine and its first test, a three-in-one STI screener “The medtech giant recently landed the FDA’s clearance for the third component in its Cor diagnostics platform, it announced this week, and has already begun the launch of the new BD Cor MX instrument throughout the U.S.
The MX system joins the previously cleared PX and GX instruments on the Cor platform…
Alongside the launch of the MX component, BD was also given the green light to roll out the instrument’s first assay: a three-in-one test that simultaneously looks for the most common non-viral sexually transmitted infections at once, including chlamydia, gonorrhea and trichomoniasis.”

GE Healthcare aims to bring prenatal ultrasound to the home, with investment in smartphone-scanner developer “GE Healthcare and the handheld ultrasound developer Pulsenmore aim to give expectant parents the opportunity to chart their pregnancies at home and perform the scans themselves.
Pulsenmore’s device docks with a smartphone, allowing women to conduct their own exams and potentially skip an in-person doctor’s visit. The user can be guided online through a telehealth service or offline by following the steps in an app.
The Israeli startup aims to offer fast clinical feedback for periodic fetal ultrasound scans, and GE Healthcare is now supporting the company through an equity investment worth up to $50 million—to help the medtech enter what it describes as a rapidly expanding market of homecare and telemedicine services.”

Researchers uncover the brain's link to SIDS, setting up potential infant screening test “Researchers in Australia have uncovered the first chemical biomarker tied to sudden infant death syndrome, widely known as SIDS, which could help lead to a test that can screen for babies at risk for the tragic condition…
’An apparently healthy baby going to sleep and not waking up is every parent’s nightmare, and until now, there was absolutely no way of knowing which infant would succumb. But that’s not the case anymore,’ said lead researcher Carmel Harrington, M.D., an honorary fellow at The Children's Hospital at Westmead in Sydney, who lost her own child to SIDS 29 years ago.
Her team identified the nervous system enzyme butyrylcholinesterase as a strong marker of risk. Dubbed BChE for short, the chemical plays an active role in the brain’s ability to wake up the body from sleep in response to difficulty breathing or another stimulus.”
See this site for the original research article.

About healthcare finance

Trends in Real Estate Investment Trust Ownership of US Health Care Properties “In 2021, REITs owned 197 (3%) of all hospitals and 1870 (12%) of all skilled nursing facilities. Real estate investment trust hospital acquisitions have increased during the past 15 years until the COVID-19 pandemic, during which acquisitions were minimal. In a multivariate logistic analysis, some of the characteristics most strongly associated with REIT ownership were for-profit status (odds ratio, 25.05; 95% CI, 14.69-42.70; P < .001) and urban status (odds ratio, 6.8; 95% CI, 1.61-28.67; P = .01)."

Today's News and Commentary

About Covid-19

Moderna completes FDA submission for use of COVID shot in adolescents, kids “Moderna Inc has made all necessary submissions required by the U.S. Food & Drug Administration for emergency use authorization of its COVID-19 vaccine in adolescents and children, it said on Wednesday.
 The company is seeking approval for the use of its vaccines in three distinct age groups – adolescents aged 12 to 17 years, children aged six to 11 and those between six years and six months.” 
And in a related story: Evaluation of mRNA-1273 Covid-19 Vaccine [Moderna] in Children 6 to 11 Years of Age” Estimated vaccine efficacy was 88.0% (95% CI, 70.0 to 95.8) against Covid-19 occurring 14 days or more after the first injection, at a time when B.1.617.2 (delta) was the dominant circulating variant…
Two 50-μg doses of the mRNA-1273 vaccine were found to be safe and effective in inducing immune responses and preventing Covid-19 in children 6 to 11 years of age; these responses were noninferior to those in young adults.”

FDA approves Olumiant for certain adults hospitalized with COVID-19 “The FDA has approved a new indication for Olumiant as a treatment for adults hospitalized with COVID-19 who require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
The Janus kinase inhibitor Olumiant (baricitinib; Eli Lilly & Co.) is the first immunomodulatory treatment to be approved by the FDA for COVID-19, according to the agency.”

About health insurance

Better Quality, Lower Costs When Providers and Health Plans Share Financial Risk “Consistent with prior years, the results released for 2020 show that better care and lower costs typically result when plans and providers share in the financial risk through a capitation arrangement compared to fee-for-service models. This analysis is based on data from 11 health plans, representing 7.9 million commercial lives cared for under health maintenance organization (HMO), preferred provider organization (PPO), and exclusive provider organization (EPO) products, both fully insured and self-insured.”

About pharma

 Bristol Myers provides Bridge over troubled water with $905M deal to enter SHP2 race “Bristol Myers Squibb came to the rescue of a beleaguered BridgeBio today, striking a $905 million biobuck deal to secure a rival to oncology candidates in development at Merck, Novartis, Roche, Sanofi and more…
SHP2 has emerged as a hot cancer target as drug developers have sought to maximize the efficacy of KRAS inhibitors. With some research suggesting SHP2 inhibition diminishes the cycling of KRAS between two states, the mechanism could help to unlock the full power of therapies such as Amgen’s Lumakras and Mirati Therapeutics’ adagrasib.”

Lundbeck Q1 sales up as Brintellix, Rexulti, Abilify post double-digit gains “Headline results for the first quarter:

• Revenue: DKK 4.4 billion ($625 million), up 2%

• Profit: DKK 412 million ($59 million), versus DKK 631 million ($90 million) in the prior year”

About the public’s health

Primary Care Appointment Completion Rates and Telemedicine Utilization Among Black and Non-Black Patients from 2019 to 2020 “Racial differences in appointment completion rates narrowed significantly in 2020 even as the mix of disease conditions began to mirror patterns observed in 2019.” 

About healthcare personnel

 Nurse.com 2022 Nurse Salary Research Report  “A few sobering statistics:

+ The vacancy rate for registered nurses was almost 10% in 2020, almost a full point higher than the prior year. Over a third of hospitals reported a vacancy rate higher than 10%.3

+ Nurse turnover rates are increasing, standing at about 22% in 2021, compared to 18% in 2019.4

+ It takes an average of three months to recruit a qualified nurse to fill a vacancy, a period that is expected to increase in the wake of the disruptions caused by COVID-19.3

The AONL survey found that 90% of nurse leaders anticipate post-pandemic staffing shortages,2 and hospital CEOs rank personnel shortages as their top concern…
Key Takeaways

1. Nursing salaries are up for most groups
 The median RN salary reported by survey respondents was $78,000. This was a substantial increase over the median RN salary of $73,000 reported in our 2020 report…

2. The pandemic has had a profound impact on whether nurses want to stay in the profession and under what terms.
Our survey found that 29% of survey respondents were considering leaving nursing. This percentage, which includes nurses across all licensures, is substantially higher than the 11% who indicated they were consid- ering leaving in our 2020 survey…
3. The gender pay gap for RNs widened.
One factor may be that male nurses are more likely to negotiate their salary.
The current survey shows the median salary for a male RN as $14,000 higher than the median salary for a female RN. This gap was $7,297 in our 2020 survey”

Many more stats in this report.

Assessing the lingering impact of COVID-19 on the nursing workforce In a related study from McKinsey: “By 2025, we estimate the United States may have a gap of between 200,000 to 450,000 nurses available for direct patient care, equating to a 10 to 20 percent gap. To meet this demand, the United States would need to more than double the number of new graduates entering and staying in the nursing workforce every year for the next three years straight.”

About health technology

 FDA Approves Fujirebio Diagnostics’ Lumipulse G ß-Amyloid Ratio Test for Alzheimer’s “The FDA has approved Fujirebio Diagnostics’ in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.
The Lumipulse test, which is the first of its kind to be approved by the agency, is intended for patients age 55 and up who have symptoms of cognitive impairment and are being evaluated for Alzheimer’s disease and other causes of cognitive decline.” 

Today's News and Commentary

About Covid-19

 ICER panel finds Paxlovid evidence 'more persuasive' than for Lagevrio “The Institute for Clinical and Economic Review (ICER) on Tuesday said its appraisal committee voted by a margin of 11-2 that currently available evidence is ‘not adequate’ to show Merck & Co.'s oral COVID-19 drug Lagevrio (molnupiravir) offers a net health benefit over symptomatic care alone. By contrast… ICER said all 13 appraisal committee members agreed that current evidence is adequate to demonstrate a net health benefit when Paxlovid is compared to symptomatic care alone…”

16 national healthcare organizations urge HHS to continue public health emergency ”The American Hospital Association and 15 other national healthcare organizations are calling on HHS to maintain the COVID-19 public health emergency.
In a May 10 letter to HHS Secretary Xavier Becerra, the organizations cited the continued risk from COVID-19 variants, as well as rising case rates in the U.S.”

About health insurance

 Oscar Health leaves two states due to regulatory and commercial issues “Oscar Health will leave Colorado and Arkansas in pursuit of profitability, company executives said during their first-quarter earnings report…
The announcement comes as the insurance company continues to aim for its insurance division to be profitable by next year.
In the first quarter, Oscar Health reported a net loss of $77.3 million, down from $88.1 million in the same period last year. The company more than doubled its annual revenue to $972.7 million.”

Clover Health gears up for another $300M capital raise “The announcement that Clover Health is seeking outside investment comes after the startup posted a $578.8 million loss last year. In 2021, the company lost over $4,500 per member, the most among commercial public insurance companies…
During the first quarter, Clover Health spent all premiums received by members on medical expenses, with a medical loss ratio reaching 100.”

Calif. Health Care Workers Convicted In $18.5M Billing Scheme “A California jury has convicted three health care workers for their roles in an $18. 5 million scheme to defraud the state's Medicaid program by seeking reimbursement for bogus drug counseling for middle and high schoolers, the U. S. Department of Justice announced.”

About hospitals and healthcare systems

 Advocate Aurora to merge with North Carolina hospital chain in blockbuster deal, relocate HQ “Chicago’s largest health care provider Advocate Aurora Health has agreed to merge with a Charlotte-based hospital chain in a deal that will create the fifth-largest hospital chain by revenue in the country and, in the process, relocate Advocate Aurora’s headquarters to Charlotte, N.C…
The combined entity would be named Advocate Health but each provider will continue to be known by their current names in their respective markets. Wake Forest University School of Medicine in Winston-Salem, N.C., will be Advocate Health’s affiliated academic institution.”

AdventHealth posts $417.7M loss in Q1 “Although revenue was up, so were AdventHealth's expenses. In the first quarter of 2022, AdventHealth saw its expenses grow to $3.72 billion, up from $3.23 billion recorded in the same period in 2021…
’The increased expense is primarily a result of elevated premium and contract labor costs and wage inflation resulting from workforce shortages,’ AdventHealth stated in its financial report. ‘The system continues to implement workforce stabilization plans to reduce turnover and temporary labor utilization.’”

The Financial Effects of Hospital Workforce Dislocation: A Fact Base A special report from KaufmanHall:
”Following are some of our key findings:

◾  Nationally, hospital labor expenses increased by more than one-third from pre-pandemic levels

◾  The largest increases were in the South and West, while the highest expense levels consistently were in the West and Northeast/Mid-Atlantic

◾  Contract labor as a percentage of total labor expenses increased more than five times the rate from pre- pandemic levels

◾  As of March 2022, the median wage rate for contract nurses had risen to more than three times that of employed nurses

◾  In the first three months of 2022, hospitals saw dramatic declines in YTD operating margin in a perfect storm of expense, volume, and revenue pressures attributable largely to the effects of COVID”

About pharma

 Takeda swings to loss in fourth quarter “Takeda explained that the loss in the quarter was partly due to higher cost of sales and R&D expenses, while the year-earlier figure was boosted by gains from the sale of its consumer-healthcare business. In the three-month period, cost of sales rose 21.7% to JPY 308.4 billion ($2.4 billion), with R&D expenses climbing 26.8% to JPY 143.6 billion ($1.1 billion).
Revenue: JPY 873.3 billion ($6.7 billion), up 13.4%
Loss: JPY 11.4 billion ($88 million), versus profit of JPY 197.1 billion ($1.5 billion) in the prior year”
Product details are also mentioned.

Cerebral changes online ads in the midst of overprescribing allegations The saga continues…”Telehealth startup Cerebral adjusted its marketing and advertising strategies to reflect the suspension of controlled substance prescriptions for new patients after allegations of overprescribing by providers surfaced…
Cerebral said it will update the language on its advertisements, review its existing promotional efforts and form a committee — composed of clinical and brand team members — to review paid social media ads. 
According to a social media tracking firm PranifyRx, the company posted 110 Facebook ads and 220 Instagram ads on May 9.”

AbbVie unit, Teva poised to pay $5 billion to resolve opioid suits ”Teva Pharmaceutical Industries Ltd. and Allergan Plc are willing to pay more than $5 billion combined to resolve more than 3,500 lawsuits filed against them over highly addictive opioid painkillers, according to three people familiar with settlement talks….
While Teva and Allergan indicated a willingness to settle, no formal offer has been made or finalized, and talks are continuing, according to the people.”

Israel sues Teva for $100m Copaxone royalties “The State of Israel today filed a lawsuit in the Lod District Court for $100 million against Teva Pharmaceutical Industries Ltd. claiming that the company violated the statre's rights by not paying royalties for multiple sclerosis treatment Copaxone.
Copaxone was developed by the Weizmann Institute of Science in Rehovot, while its marketing rights belong to Teva. Initially Teva marketed the drug in daily doses but close to the expiration of the patent of the active ingredient, the company filed a patent request for a longer interval dosage. The state clams that the longer interval dosage was developed by breakthrough research by Weizmann institute researchers who are neurologists at government hospitals, and therefore rights for the research belong to the state.”

About the public’s health

 U.S. surpasses record 100,000 overdose deaths in 2021 “More Americans died from drug overdoses in 2021 than any previous year, a grim milestone in an epidemic that has now claimed 1 million lives in the 21st century, according to federal data released Wednesday.
 More than 100,000 Americans died of drug overdoses in 2021, up 15 percent from the previous year, according to figures released Wednesday by the National Center for Health Statistics. The soberingtally reflects challenges exacerbated by the pandemic: lost access to treatment, social isolation and a more potent drug supply.”

Vital Signs: Changes in Firearm Homicide and Suicide Rates — United States, 2019–2020 From the CDC: “The firearm homicide rate in 2020 was the highest recorded since 1994 (1). However, the increase in firearm homicides was not equally distributed. Young persons, males, and Black persons consistently have the highest firearm homicide rates, and these groups experienced the largest increases in 2020. These increases represent the widening of long-standing disparities in firearm homicide rates. For example, the firearm homicide rate among Black males aged 10–24 years was 20.6 times as high as the rate among White males of the same age in 2019, and this ratio increased to 21.6 in 2020. Although the overall firearm suicide rate remained relatively unchanged between 2019 and 2020, young persons and some racial/ethnic minority groups experienced increases in firearm suicide. Notably, the largest increase occurred among AI/AN persons, resulting in this group having the highest firearm suicide rate as of 2020…
The findings of this study do not support causal inferences, and reasons for increasing rates and widening inequities are unclear and potentially complex.”

Screening for Chronic Obstructive Pulmonary DiseaseUS Preventive Services Task Force Reaffirmation Recommendation Statement “The USPSTF recommends against screening for COPD in asymptomatic adults. (D recommendation)”

The unhealthiest county in each US state | 2022 And The healthiest county in each US state | 2022 Both FYI

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 IT

 HHS doles out $16.3M in telehealth funding for Title X family planning program “The Department of Health and Human Services (HHS) doled out $16.3 million in new grant funding to help support an expansion of telehealth for Title X family planning clinics…
The funding, passed as part of the American Rescue Plan Act, will go toward 31 stakeholders that will help improve telehealth capacity across family planning clinics in 26 states, HHS said in a release. The funding will run for a 12-month period and is part of a larger goal by the Biden administration to improve maternal health and the family planning safety net.”

Consumer telehealth and wellness brand Hims & Hers ups 2022 revenue outlook driven by strong Q1 growth “Business is booming for consumer telehealth and wellness brand Hims & Hers as the company charted 94% revenue growth in the first quarter, surpassing $100 million during one quarter for the first time…”
After more rosy reporting, 10 paragraphs later the article notes:
”But the digital health company is still not profitable and reported a net loss of $16 million for the first quarter of 2022 compared to a loss of $51 million for the same period a year ago…
For 2022, the company also maintains its projection of adjusted EBITDA for the year in the range of a loss $30 million to a loss of $20 million.”

HHS IDs 5 most prolific cybergangs targeting healthcare FYI 

About health technology

 Mirvie’s Preeclampsia Test Designated an FDA Breakthrough Device “The test is based on the company’s RNA screening platform, which is designed to predict the risk of complications by revealing the underlying biology of each pregnancy.
Preliminary research showed that the Mirvie RNA platform can identify 75 percent of women who go on to develop preeclampsia, months before symptoms occur, the company said.”

FTC orders Medtronic to sell off Intersect ENT subsidiary in antitrust review “Staying true to its pledge to crack down on potentially anticompetitive megamergers in the healthcare industry, the U.S. Federal Trade Commission has ordered Medtronic and Intersect ENT to adjust the terms of their acquisition deal before finally tying it off.
According to this week’s order (PDF), while Medtronic is now cleared to proceed with its purchase of Intersect, it must sell off Fiagon, the latter's subsidiary, within 10 days of closing the acquisition.”

Today's News and Commentary

About Covid-19

 COVID vaccine makers shift focus to boosters “COVID-19 vaccine makers are shifting gears and planning for a smaller, more competitive booster shot market after delivering as many doses as fast as they could over the last 18 months.
Executives at the biggest COVID vaccine makers including Pfizer Inc and Moderna Inc said they believe most people who wanted to get vaccinated against COVID have already done so - more than 5 billion people worldwide.
In the coming year, most COVID vaccinations will be booster shots, or first inoculations for children, which are still gaining regulatory approvals around the world, they said.” 

About health insurance

Unwinding the PHE: What We Can Learn From Pre-Pandemic Enrollment Patterns “The Families First Coronavirus Response Act (FFCRA), passed during the coronavirus pandemic, includes a Medicaid continuous enrollment requirement that prohibits states from disenrolling people from Medicaid in exchange for additional federal funds. The continuous enrollment requirement has prevented coverage loss and churn (moving off and then back on to coverage) among enrollees during pandemic and, along with other factors, has contributed to the substantial enrollment growth in Medicaid. From February 2020 to January 2022, total Medicaid/CHIP enrollment has increased by 15.7 million enrollees (22.1%). The continuous enrollment requirement will last until the end of the month in which with national public health emergency (PHE) ends. Currently, the PHE is in effect through mid-July 2022 and, at this time, it is expected that the continuous enrollment requirement will end August 1, 2022. The Biden administration has said it will give states 60 days’ notice before the PHE ends, and so if state are not notified by mid-May, the PHE will likely be extended further.”

Anthem closes acquisition of Integra Managed Care “Anthem has closed its acquisition of New York-based Integra Managed Care.
The insurer announced plans to acquire Integra, a long-term care plan, in November. The plan will bring more than 40,000 Medicaid members into the Anthem fold and offers coverage to assist with managing long-term care needs and disabilities in the home.”

Top 100 counties with the highest rate of uninsured residents All but 2 of the top 25 are in Texas.

About hospitals and healthcare systems

 Leapfrog Group: Patients report worse hospital experiences during COVID-19 pandemic, raising safety concerns “Leapfrog’s twice-annual reports assess more than 30 patient safety measures and component measures compiled from the Centers for Medicare & Medicaid Services (CMS) and Leapfrog’s hospital surveys between July 2018 and March 2021. The most recent release assigns letter grades to nearly 3,000 U.S. general hospitals and is the second collection of scores to incorporate safety and experience data from the COVID-19 pandemic…
 The group found statistically significant declines between the survey periods in the average percentage of hospital patients who gave the most favorable responses for nine of the 10 HCAHPS measures.
The greatest decline was seen among patients’ experiences with hospital staff responsiveness (a 3.7 percentage point decrease), followed by communication about medicines (a 2.9 point decrease), and cleanliness of the hospital (a 2.9 point decrease).”
Check this site to search by hospital.

About pharma

 GoodRx stock tumbles as 2022 revenue expected to take a hit from grocery chain prescription dispute “GoodRx expects its 2022 revenue to take a hit due to recent actions by one grocery store chain that represents a sizable chunk of its grocery prescription business.
The digital healthcare platform, best known for providing prescription drug discounts, disclosed Monday that it is unlikely to achieve its full-year guidance after a grocery chain stopped accepting discounts for certain drugs. In its fourth-quarter earnings call back in February, executives said they projected revenue to grow 23% in 2022, on top of full-year revenue of $745 million in 2021.
Shares were down 31% in after-hours trading.
The company did not disclose the name of the grocery chain.”

Pfizer to buy Biohaven for $11.6 billion ”Pfizer agreed to acquire Biohaven Pharmaceuticals for $148.50 per share in cash, or approximately $11.6 billion, to gain full control of the drugmaker, the companies announced Tuesday. Last year, Pfizer paid $350 million to take a 2.6% stake in Biohaven as part of a deal for certain rights to the migraine therapies Nurtec ODT (rimegepant) and zavegepant.”
The deal is expected to close early in 2023.

Analysis paints gloomy picture for smaller biotechs “According to Jeffries analysts, the number of small- to mid-cap (SMID) biotechnology companies trading below cash has soared to 128, up from 45 last year… The latest figure, the highest ever seen in the industry, also accounts for a quarter of SMID biotech firms, and beats the previous record of 18% seen during the 2008 financial crisis.
Jeffries blames the current situation on negative clinical study readouts and record levels of clinical holds and FDA delays, particularly in the gene/cell editing space. They also pointed to the broader macro environment, in which generalist investors favour defensive, dividend-yielding large-cap biopharma companies…
Another recent analysis by Jeffries revealed that the top 20 biopharma firms now hold over $300 billion in cash – boosted in part by COVID-19 vaccine sales – enough to ‘basically buy the whole SMID-cap universe.’ Looking ahead, the analysts suggest that M&A activity in the second half of the year ‘may’ pick up if large-cap biopharma companies choose to open up their coffers, while the number of initial public offerings (IPOs) is expected to grow, albeit with more conservative valuations.”
These financial changes could cause a fundamental restructuring of the biotech industry- away from small firms that contract with larger ones, to “Big Biotech/Pharma.”

Inside the sales machine of the ‘kingpin’ of opioid makers A really good investigative reporting piece about Mallinckrodt Pharmaceuticals from The Washington Post.

About the public’s health

 Risk Factors Associated With Alzheimer Disease and Related Dementias by Sex and Race and Ethnicity in the US “In this cross-sectional study, the modifiable risk factors most prominently associated with ADRDs were midlife obesity, physical inactivity, and low education. The proportion of ADRD cases associated with modifiable risk factors was higher in men and in American Indian and Alaska Native individuals, Black individuals, and Hispanic individuals (any race) compared with Asian individuals and White individuals.” 

About healthcare IT

Amwell sees strong demand for telehealth visits in Q1, but losses deepen as it ramps up R&D “Telehealth giant Amwell saw telehealth visits grow to 1.8 million in the first quarter of 2022, up 16% compared to the tail end of 2021 and up about 11% from 1.6 million virtual care visits during the same time last year.
The total number of active providers using its virtual care platform grew to around 102,000 during the quarter, up 25% compared to 81,000 a year ago.
But the company reported greater adjusted EBITDA losses than the previous year, with a loss of $47 million, 80% deeper than its reported loss in the prior-year period. Amwell reported an adjusted EBITDA loss of $26 million in the first quarter of 2021.”

Joint Audit of the Department of Defense and the Department of Veterans Affairs Efforts to Achieve Electronic Health Record System Interoperability From the VA OIG: “The DoD and VA took action to achieve interoperability of patient health care information across DoD, VA, and external health care providers by acquiring Cerner Millennium, deploying the EHR system at 49 DoD facilities and one VA health care facility, and launching the Joint Health Information Exchange. However, the DoD did not:
• consistently migrate patient health care information from the legacy electronic health care systems into Cerner Millennium to create a single, complete patient EHR;
• develop interfaces from all medical devices to Cerner Millennium so that patient health care information will automatically upload to the system from those devices; or
• ensure that users were granted access to Cerner Millennium for only the information needed to perform their duties

Achieving interoperability between the DoD, VA, and external health care providers through the deployment of a single EHR system is critical because health care providers will have the ability to securely transfer and share health care information for the Nation’s 9.6 million DoD Armed Forces members, dependents, and retirees, and 9.21 million enrolled users. As the DoD and the VA continue to deploy Cerner Millennium, health care providers at those facilities should be confident that a patient’s EHR is accurate and complete regardless of where the point of care occurred.”
A more detailed analysis and recommendations are contained in the full document. 

About health technology

 FDA Warns Fresenius Hemodialysis Machines Could Deliver Toxic Compound “The FDA warned that silicone tubing in three models of Fresenius Medical Care’s hemodialysis machines could expose users to toxic compounds.”

Today's News and Commentary

About Covid-19

COVID DATA TRACKER WEEKLY REVIEW From the CDC: “As of May 5, 2022, there are 78 (2.42%) counties, districts, or territories with a high COVID-19 Community Level, 316 (9.81%) counties with a medium Community Level, and 2,826 (87.76%) counties with a low Community Level. This represents a slight (0.75 percentage points) increase in the number of high-level counties, a small (+1.86 percentage points) increase in the number of medium-level counties, and a corresponding (−2.61 percentage points) decrease in the number of low-level counties…
 As of May 4, 2022, the current 7-day moving average of daily new cases (64,781) increased 21.4% compared with the previous 7-day moving average (53,362).”
And in a related article: Coronavirus wave this fall could infect 100 million, administration warns “The Biden administration is warning the United States could see 100 million coronavirus infections and a potentially significant wave of deaths this fall and winter, driven by new omicron subvariants that have shown a remarkable ability to escape immunity.
The projection, made Friday by a senior administration official during a background briefing as the nation approaches a covid death toll of 1 million, is part of a broader push to boost the nation’s readiness and persuade lawmakers to appropriate billions of dollars to purchase a new tranche of vaccines, tests and therapeutics.”

 Moderna urges court to dismiss patent claims on COVID-19 shot “Moderna filed a motion to dismiss a lawsuit filed by two small biopharma companies seeking damages for violation of certain U.S. patents related to the company’s blockbuster COVID-19 shot, branded as Spikevax.
RNA therapeutics company Genevant Sciences and clinical-stage biotech Arbutus Biopharma filed the case in February, holding Moderna and an affiliate of the vaccine maker accountable for the infringement.”

Effect of oral nirmatrelvir on Long COVID symptoms: a case series NOTE: This article is a case series and not a controlled trial. It also has not been peer reviewed. Nevertheless, its potential importance is worth reporting. “We report three cases that demonstrate that variability in the timing of nirmatrelvir [ Paxlovid] may be associated with different outcomes and underscores the need for systematic study of antiviral therapy for this disease condition.”

About health insurance

Big payers ranked by Q1 revenues See the list of the “top 6” and click for individual details.
And in a related story (not one of the “top 6”):  Kaiser posts net loss of $961M in Q1 “Driven mainly by nonoperating losses, Oakland, Calif.-based Kaiser Permanente recorded a net loss of $961 million in the first quarter of 2022, down from a net income of $2 billion in the same quarter in 2021, according to financial data released May 6.”

About hospitals and healthcare systems

 Hospitals Look to Raise Treatment Costs as Nurses’ Salaries Increase “Some hospitals grappling with rising nurse salaries are seeking to raise prices by up to 15%, touching off contract fights with health insurers and businesses and threatening higher premiums.
HCA Healthcare Inc. and Universal Health Services Inc. are among the hospitals asking health plans to pay them more for care to offset mounting nurse costs.
Neither of the chains would specify the price increases they are requesting, but people familiar with negotiations say some hospitals are asking to increase their prices by 7.5% to 15%. 
The requests are more than the 4% to 6% price increases that hospitals typically seek, according to employers and insurers. The hospitals usually won an average 3% price increase in recent years, according to Altarum, a nonprofit that does healthcare research.”

About pharma

 Cerebral under federal investigation for possible violations of controlled substances law  See the last few posts on this blog for background. The story continues…”Mental health startup Cerebral said Saturday it is under investigation by the Department of Justice (DOJ) for ‘possible violations’ of the Controlled Substances Act.
Cerebral Medical Group received a grand jury subpoena from the U.S. Attorney’s Office for the Eastern District of New York on Friday evening, the company said in a statement. The Controlled Substances Act regulates the distribution of potentially addictive medicines like Adderall and Xanax.”

Walgreens Says Insurers Must Defend It In Opioid Cases “Walgreens has sued at least 25 insurance companies, including several units of AIG, Liberty Mutual and Great American Insurance, in Illinois state court, seeking a ruling they must defend and indemnify the pharmacy retailer in nationwide opioid litigation. Walgreens is facing more than 2,500 lawsuits claiming it illegally contributed to an oversupply of opioids that has caused a national addiction epidemic and is suing at least 25 insurance companies, saying they must defend and indemnify the pharmacy retailer in nationwide opioid litigation.”

About the public’s health

 E-Cigarette Use and Risk of Cardiovascular Disease: A Longitudinal Analysis of the PATH Study (2013–2019) “Dual use of cigarettes and e-cigarettes was associated with a significantly increased risk of CVD compared with nonuse. The cardiovascular risk of dual use did not differ from the risk among those exclusively smoking cigarettes. Other recent cross-sectional analyses have also reported no significant association between e-cigarette use and CVD out-comes.”

States prepare for summer launch of new 988 suicide prevention number “This summer, every state will be rolling out 988 as the new National Suicide Prevention Lifeline number to call for mental health crises -- similar to how people can call 911 for medical emergencies.
But in some states, questions remain around funding the transition, staffing call centers and having response teams ready.
The transition to 988 is ‘not optional,’ according to the US Department of Health and Human Services' Substance Abuse and Mental Health Services Administration.
No more than half of states have enacted or introduced legislation in preparation for 988's debut, scheduled for July 16, according to data from the National Academy for State Health Policy.”

About health technology

 FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions “Under the Medical Device User Fee and Modernization Act (MDUFA) and its successive amendments, the FDA must meet performance goals related to the agency’s review of medical device submissions, based on the timeliness of those reviews. The FDA’s Refuse to Accept (RTA) policy provides for an early review of all submissions in accordance with specific acceptance criteria and enables the agency to inform a submitting party whether it a submission is “administratively complete” within 15 days of its filing.
The FDA says that the guidance, titled ‘Refuse to Accept Policy for 510(k)s,’ is intended to ensure consistency in acceptance decisions made by the agency and to help submitters better understand the types of information needed by the FDA to conduct its review.”

Today's News and Commentary

About Covid-19

 FDA restricts J&J’s COVID-19 vaccine due to blood clot risk “The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J’s vaccine. U.S. authorities for months have recommended that Americans get Pfizer or Moderna shots instead of J&J’s vaccine.
FDA’s vaccine chief Dr. Peter Marks said the agency decided to restrict the vaccine after taking another look at the data on the risks of life-threatening blood clots and concluding that they are limited to J&J’s vaccine.”

About health insurance

 UnitedHealthcare rolls out new virtual physical therapy program  “UnitedHealthcare has partnered with Kaia Health on a new virtual physical therapy program.
The program aims to offer 24/7, on-demand exercise feedback to eligible members with musculoskeletal conditions, the health insurance giant said. Members who are recovering from surgery or an injury will be asked to complete an assessment of current issues and will be referred to the program based on that assessment.
Eligible members will then be able to download Kaia's app to access its physical therapy tools, which use artificial intelligence to support patients through physical therapy exercise and monitor progress.
The app tracks motion in real time to offer suggestions using the mobile phone's camera rather than a wearable device.”

About hospitals and healthcare systems

 Sutter Health sees $95M operational profit in Q1 2022, but drops to a $184M loss after poor investments “Sutter Health kicked off the year’s first quarter with higher year-over-year operating revenues and operating income, but ultimately recorded a $184 million loss for the period thanks to a troubled investment market, according to financial statements for the three months ended March 31.
The Sacramento-based nonprofit increased its first-quarter total operating revenues 3.7% year over year ($126 million) to nearly $3.6 billion.”
This finding is unusual; more frequently hospitals have negative operating margins which are made up by investment gains and charitable donations. Therefore, the recent market declines could significantly affect hospitals’ financial ability to operate.

One Medical's Q1 revenue doubles as primary care company expands into chronic care, behavioral health This article is, unfortunately, too typical of reporting on such companies.
It starts out saying: “Tech-enabled primary care provider One Medical saw its total membership count jump nearly 30% to 767,000 by the end of March, a nearly 30% increase year over year.
The company's top line doubled from a year ago, as One Medical brought in $254 million in revenue in the first quarter, up 109% from $121 million in the first quarter of 2021. The company's first-quarter revenue exceeded the high end of its guidance range by more than $4 million.”
After more rosy reportage, 16 paragraphs later, the article explains: “Yet the primary care provider deepened its losses in the first quarter, with a loss of $91 million, or a loss per share of 47 cents, compared to a loss of $39 million, or 29 cents a share a year ago. One Medical's earnings missed Wall Street estimates, with analysts expecting a loss per share of 46 cents.
Adjusted EBITDA came in at a loss of $29 million in the quarter, compared to a gain of $4 million a year ago.”

6 WAYS TO REDUCE FINANCIAL DISTRESS IN HEALTHCARE From BDO. Two statistics I found particularly disturbing:
—“42% of healthcare CFOs have defaulted on their bond or loan covenants in the past 12 months. Interestingly, 25% say they have not defaulted but are concerned they will default in the next year…
—84% of healthcare CFOs say supply chain disruption is a risk in 2022.”

About pharma

 After 2 years, Sanofi's drug ingredients spinoff takes flight “Two years and one pandemic after Sanofi unveiled plans to spin off its European drug ingredients business, EUROAPI has debuted on the Euronext exchange. Shares in the new active pharmaceutical ingredient (API) outfit rose more than 3% in early trading despite a wider market slump.
EUROAPI is touting its position as a ‘leading player’ on the API scene. Its launch comes as COVID-19 and, more recently, the war in Ukraine expose gaps in the world’s pharmaceutical supply chain. Many of the ingredients the pharmaceutical industry relies on are made in countries like China and India.”

Trends of Prescription Drug Manufacturer Rebates in Commercial Health Insurance Plans, 2015-2019 “Results of this economic evaluation show that from 2015 to 2019, the growth of prerebate prescription drug costs (used for patients’ cost sharing) outpaced the growth of postrebate drug costs for all 3 commercial plan types. The consistently negative association between prerebate drug cost PCL [per covered life] per year and Rebate% documented in this study might reflect the fact that many expensive drugs with little competition rarely offer large manufacturer rebates.”

About the public’s health

Age at Initiation of Lower Gastrointestinal Endoscopy and Colorectal Cancer Risk Among US Women “ In this cohort study of 111 801 US women, compared with no endoscopy, initiation of endoscopy before 50 years of age was associated with reduced risk of colorectal cancer and specifically colorectal cancer diagnosed before 55 years of age. Initiation of endoscopy from 45 to 49 years of age was associated with a greater reduction in the absolute risk of colorectal cancer through 60 years of age compared with initiation from 50 to 54 years of age…
These findings support guidelines recommending initiation of colorectal cancer screening before 50 years of age among women.”

About healthcare IT

 Hospital, payer, IT groups urge Congress to overturn ban on unique patient identifier “Dive Brief:

• Members of the healthcare industry are once again pressuring Congress to remove what they say is a major pain point in their operations and in the delivery of patient care: the ban on a nationwide unique patient identifier.

• Almost 120 health IT groups, EHR vendors, hospitals, physicians and health insurers sent letters on Wednesday to House and Senateappropriators urging them to remove decades-old rider language in a 2023 appropriations bill that prevents the HHS from spending federal dollars to create or adopt a UPI standard.”

Today's News and Commentary

About Covid-19

Nearly 15 million deaths related to covid-19, WHO estimates “The coronavirus pandemic led to nearly 15 million excess deathsworldwide, according to a new estimate by the World Health Organization, including people who died from covid-19 and others who died from indirect causes such as health care shortages as the virus surged and overwhelmed hospitals. The WHO defines excess deaths as ‘the difference between the number of deaths that have occurred and the number that would be expected in the absence of the pandemic based on data from earlier years.’
Most of the excess deaths during the first two years of the pandemic were concentrated in Southeast Asia, Europe, and the Americas, the WHO said in a news release. More than two-thirds occurred in just 10 countries.”
And in a related article: Covid's toll in the U.S. reaches a once unfathomable number: 1 million deaths “The U.S. on Wednesday surpassed 1 million Covid-19 deaths, according to data compiled by NBC News — a once unthinkable scale of loss even for the country with the world's highest recorded toll from the virus.
The number — equivalent to the population of San Jose, California, the 10th largest city in the U.S. — was reached at stunning speed: 27 months after the country confirmed its first case of the virus.”

Vaccines Effective Against New Omicron Subvariants, WHO Chief Says “‘It’s too soon to know whether these new sub-variants can cause more severe disease than other omicron sub-variants, but early data suggest vaccination remains protective against severe disease and death,’ Tedros Adhanom Ghebreyesus, said at a media briefing in Geneva Wednesday.”
And in a related article: Moderna targets autumn release for Omicron vaccine

COVID-19 Vaccination—Becoming Part of the New Normal From leaders at the FDA:
”…it is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal. It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza. And it likely will require similar annual consideration for vaccine composition updates in consultation with the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC)….
By summer, decisions will need to be made for the 2022-2023 season about who should be eligible for vaccination with additional boosters and regarding vaccine composition. Administering additional COVID-19 vaccine doses to appropriate individuals this fall around the time of the usual influenza vaccine campaign has the potential to protect susceptible individuals against hospitalization and death, and therefore will be a topic for FDA consideration”

1 in 5 Parents of Children Under 5 Intend to Get Them a COVID-19 Vaccine Right Away Once Eligible; Most Say Approval Delays Have Not Shaken Their Confidence in Vaccine’s Safety and Effectiveness From a KFF survey: “About a fifth (18%) of parents with children under age 5 say they intend to get their child vaccinated ‘right away’ once federal regulators authorize its use for their child’s age group… Another 38% say they would want to ‘wait and see’ how it works for other young children before getting their child vaccinated…
significant shares of these parents are reluctant, with 27% saying they will ‘definitely not’ get their child vaccinated and 11% saying they would do so ‘only if required’ for school or daycare.”
Also: “As COVID-19 cases have begun to rise nationally in recent weeks, a little more than a third (35%) of adults think there is a new wave of COVID-19 infections hitting the country. Most say either that there is not a new wave (50%) or that they aren’t sure if there is (14%).”

FDA rebukes Pfizer CEO's suggestion to take more Paxlovid if COVID-19 symptoms return “The FDA rebuked Pfizer CEO Albert Bourla’s proposed solution to reports that some patients experienced a relapse of COVID-19 symptoms after treatment with the company's antiviral Paxlovid.”

 The Impact of COVID-19 on the Rural Health Care Landscape “Before the COVID-19 pandemic began, hospital closures were increasing in rural communities across the nation: 116 rural hospitals closed between 2010 and 2019. Over the past two years, federal relief has helped stabilize facilities, and the pace of closures slowed. However, this assistance was temporary, and rural hospitals continue to struggle financially and to recruit and retain nurses and other health care employees…
[For example] out of 2,176 rural hospitals, 441 face three or more concurrent financial risk factors, putting them at risk of service reduction or closure…
[Recommendations:] TO PROVIDE IMMEDIATE STABILIZATION, CONGRESS OR THE SECRETARY OF HHS SHOULD:

• Provide full relief to rural hospitals from Medicare sequestration pay- ment reductions until two years after the Public Health Emergency (PHE) ends.

• Increase reimbursement for Medicare CAH [Critical Access Hospital]
  services by 3% starting in FY2023.

• Re-establish the CAH “necessary provider” designation process.

• Allow additional flexibility in CAH eligibility criteria.

• Update the Medicare base payment rate for SCHs [Sole Community Hospitals]
  and MDHs [Medicare Dependent Hospitals]
  to ensure that reimbursement reflects current costs.

• Make available capital infrastructure grants or loans that rural hospitals can use to modify services lines or improve structural or patient safety.”

Evaluation of Trends in Alcohol Use Disorder [AUD] –Related Mortality in the US Before and During the COVID-19 Pandemic “In this cross-sectional study, we used data from 2012 to 2019 to project 2020 and 2021 mortality rates and found that AUD-related mortality rates increased among all ages and sexes during the pandemic. Younger persons, particularly those aged 25 to 44 years, had the steepest upward trend. The small proportion of COVID-19–related deaths suggests that excess deaths were more likely attributable to indirect effects of the pandemic such as stay-at-home policies and reduced medical and social resources for patients with AUD.”

About health insurance

Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, 2021 Highlights from the National Center for Health Statistics, National Health Interview Survey, 2021:

•   In 2021, among people of all ages, 9.2% were uninsured, 39.5% had public coverage, and 60.4% had private coverage at the time of interview…

•   Adults aged 18–64 were the most likely to be uninsured (13.5%),f ollowed by children aged 0–17 years (4.1%) and adults aged 65 and over (0.6%).

•   Adults aged 65 and over were the most likely to have public coverage (96.1%), followed by children aged 0–17 years (44.3%) and adults aged 18–64 (21.7%).

HHS' surprise-billing appeal on hold “HHS requested a hold on its appeal of a Texas federal court ruling that voided part of the arbitration process outlined under the No Surprises Act. 
HHS filed an appeal on the decision April 22 but later asked the court to hold its appeal until it releases the final surprise billing rule this summer. The court granted the hold to pause the legal challenge on May 3. 

Centene to sell Magellan, Pantherx pharmacy businesses for $2.8B “Centene has signed a definitive agreement to sell Magellan Rx and Pantherx Rare in two separate deals for a total of $2.8 billion.
Centene intends to use the proceeds to repurchase stock and the balance to reduce debt, according to a May 5 press release.
Magellan Rx focuses on specialty drug management, Medicaid administration and pharmacy benefits management. It will be sold to Eagan, Minn.-based Prime Therapeutics…
Pantherx is a specialty and rare drug pharmacy in Pittsburgh that Centene purchased in December 2020. The company is being sold to a group: the Vistria Group, General Atlantic, and Nautic Partners. The sale is subject to federal regulatory approvals and is expected to close in the next two to four months.”

 Cigna launching provider consult service for oncology care “The program, backed by the capabilities of the insurer's Evernorth subsidiary, allows community oncologists to connect with cancer subspecialty experts at centers designated by the National Cancer Institute (NCI). These connections will allow patients to benefit from the latest innovations in cancer care while also keeping their care close to home, Cigna said.
In a pilot, community oncologists had their treatment plans reviewed by experts at PinnacleHealth. In 40% of cases reviewed, patients were recommended alternative tests or treatment based on new advancements in research.”

About hospitals and healthcare systems

 Banner invests in Atlas Health Partners, plans to double ASC footprint “Phoenix-based Banner Health has invested in Atlas Healthcare Partners, a group that develops and manages ambulatory surgery centers with health systems and physicians.
Atlas and Banner entered a joint venture in 2018 to build and operate a network of ASCs in Arizona, Colorado and Wyoming, according to a May 3 news release. 
In the last three years, the venture grew the system's ASC footprint from eight to 26, increased volume by 155 percent and revenue by 475 percent. 
By the end of 2025, the Banner Atlas joint venture anticipates doubling in size and owning and operating more than 50 ASCs.”

Supply-Chain Snags Create Shortages Of Lifesaving Medical Supplies In U.S. “The U.S. healthcare system is facing supply shortages that dwarf the problems experienced in the early days of the Covid-19 pandemic, when needed personal protective equipment, like masks and gowns, was nearly impossible to come by. Back then, shortages might have been more urgent, but today’s problems include a much wider array of equipment. They can be traced to component scarcities, backlogged ports, transportation glitches and lockdowns in China to combat the spread of Covid-19…
The list of scarce items is long. It includes latex and vinyl examination gloves, surgical gowns, laboratory reagents, specimen-collection testing supplies, saline-flush syringes and dialysis-related products, according to the U.S. Food and Drug Administration.” 

CONTRACT PHARMACY RESTRICTIONS REPRESENT GROWING THREAT TO 340B HOSPITALS AND PATIENTS Highlights:
—”The estimated annualized impact of the restrictions on 340B hospitals has more than doubled since the end of 2021 to a median of $2.2 million for DSH/RRC/SCHs and $448,000 for CAHs. 
—More than three-quarters of hospitals report they likely will need to make cuts to programs and services if these restrictions become permanent.”

About pharma

 Moderna Revenue Triples on Soaring Covid-19 Vaccine Sales “The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RNA-based vaccine, branded as Spikevax.”

 Walgreens to pay $683M to settle Florida opioid suit “Walgreens has agreed to pay Florida $683 million to resolve all claims related to the ‘distribution and dispensing of prescription opioid medications.’
The suit alleged Walgreens dispensed more than 4.3 billion total opioid pills in Florida from May 2006 to June 2021 and that more than half of them showed indicators of fraud or addiction that the company should have noticed and addressed…”

Johnson & Johnson sues benefits company for allegedly overusing drug cost assistance program “Drug manufacturer Johnson & Johnson has filed a lawsuit against drug benefit company SaveOnSP for allegedly taking advantage of a J&J program that covers out-of-pocket costs for patients who use some of the more expensive prescription drugs…
In the civil lawsuit filed in federal court in New Jersey, J&J said it overpaid in copay assistance by at least $100 million due to the services provided by SaveOnSP. This, said J&J, is due to contract interference and deceptive trade practices by the company.”

About the public’s health

 2022 National Survey on LGBTQ Youth Mental Health Among the findings that indicate an urgent need for mental health interventions in this group:
—45% of LGBTQ youth seriously considered suicide in the past year 
—14% of LGBTQ youth attempted suicide in the past year
—73% of LGBTQ youth reported experiencing symptoms of anxiety
—58% of LGBTQ youth reported experiencing symptoms of depression

Subsequent primary cancer risk among five-year survivors of adolescent and young adult [AYA] cancers “AYA cancer survivors are almost twice as likely to die from a new primary cancer as the general population, highlighting the need for primary care clinicians to prioritize cancer prevention and targeted surveillance strategies in these individuals.”

Tobacco manufacturers agree to point-of-sale warning settlement “The Big Three U.S. tobacco manufacturers and the federal government have reached a settlement on “corrective statements” addressing the health risks of smoking and secondhand smoke to be displayed in retail outlets.
The settlement covers point-of-sale displays of tobacco products, including the placement and the number of corrective-statement signs.
The settlement could represent the next phase of rolling out corrective statements ordered by a federal judge in 2006.”
See the article for specifics of the agreement.

Sex and Race Differences in the Evaluation and Treatment of Young Adults Presenting to the Emergency Department With Chest Pain “Women and people of color with CP waited longer to be seen by physicians, independent of clinical features. Women were independently less likely to be admitted when presenting with CP. These differences could impact downstream treatment and outcomes.”

About healthcare IT

 Review of the Department of Health and Human Services' Compliance with the Federal Information Security Modernization Act of 2014 for Fiscal Year 2021  From the HHS OIG: “The Federal Information Security Modernization Act of 2014 (FISMA) requires Inspectors General to perform an annual independent evaluation of their agency's information security programs and practices to determine the effectiveness of those programs and practices. HHS OIG engaged Ernst & Young LLP (EY) to conduct this audit…
Overall, through the evaluation of FISMA metrics, it was determined that the HHS' information security program was 'Not Effective'. This determination was made based on HHS not meeting the 'Managed and Measurable' maturity level for the Identify, Protect, Detect, and Recover function areas as required by DHS guidance and the FY 2021 Inspector General FISMA Reporting Metrics. However, HHS continues to implement changes to strengthen the maturity of its enterprise-wide cybersecurity program.”
The report has some recommendations for improvement.

CDC Tracked Millions of Phones to See If Americans Followed COVID Lockdown Orders “The Centers for Disease Control and Prevention (CDC) bought access to location data harvested from tens of millions of phones in the United States to perform analysis of compliance with curfews, track patterns of people visiting K-12 schools, and specifically monitor the effectiveness of policy in the Navajo Nation, according to CDC documents obtained by Motherboard. The documents also show that although the CDC used COVID-19 as a reason to buy access to the data more quickly, it intended to use it for more-general CDC purposes.”

Mental health apps have terrible privacy protections, report finds “As a category, mental health apps have worse privacy protections for users than most other types of apps, according to a new analysis from researchers at Mozilla. Prayer apps also had poor privacy standards, the team found…
In the latest iteration of the guide, the team analyzed 32 mental health and prayer apps. Of those apps, 29 were given a “privacy not included” warning label, indicating that the team had concerns about how the app managed user data. The apps are designed for sensitive issues like mental health conditions, yet collect large amounts of personal data under vague privacy policies, the team said in the statement. Most apps also had poor security practices, letting users create accounts with weak passwords despite containing deeply personal information. 
The apps with the worst practices, according to Mozilla, are Better Help, Youper, Woebot, Better Stop Suicide, Pray.com, and Talkspace.”

The 10 largest data breaches ever reported in healthcare FYI

About healthcare personnel

 Affirmative Action Bans and Enrollment of Students From Underrepresented Racial and Ethnic Groups in U.S. Public Medical Schools “State affirmative action bans were associated with significant reductions in the percentage of students in U.S. public medical schools from underrepresented racial and ethnic groups.”

About health technology

 FDA clears Abbott test to spot 4 STIs at once amid soaring case rates “Abbott’s assay runs on its Alinity m molecular PCR platform. Using just one swab or urine sample, it simultaneously tests for several bacteria: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium, which cause, respectively, chlamydia, gonorrhea, trichomoniasis and both urethritis and cervicitis.” 

Today's News and Commentary

About Covid-19

Newer, fitter descendants of Omicron variant begin to drive their own coronavirus waves Average daily hospitalizations are up about 10% since last week, according to data collected by the US Department of Health and Human Services.
The culprit this time appears to be a spinoff of Omicron's BA.2 subvariant called BA.2.12.1, which was first flagged by New York state health officials in April.
BA.2.12.1, which is growing about 25% faster than its parent virus, BA.2, accounts for nearly 37% all Covid-19 cases across the US, according to new estimates from the CDC.
BA.2 caused an estimated 62% of all Covid-19 cases last week, down from 70% the week before.”

Pfizer Says Patients Who Relapse After Covid Pill Can Repeat Treatment “The Food and Drug Administration didn’t immediately respond to a request for comment on how the antiviral should be prescribed to Covid-19 patients who experience the rebound in viral load. While Paxlovid is available under emergency use authorization, it hasn’t yet gained full approval. Prescribing directions suggest that the drug is ‘not authorized for use for longer than 5 consecutive days.’”

HHS extends risk adjustment for COVID-19 telehealth, telephone-only services  “In response to the ongoing pandemic and need to use telehealth and virtual care options, the Department of Health and Human Services will continue to include certain telehealth and telephone-only services in its risk adjustment program for qualified health plans in plan year 2022, the Centers for Medicare & Medicaid Services announced…”

Hospitals on Edge as States Scrap Covid Emergency Declarations “Governors and legislators in states including Arizona, Idaho, Indiana, Kentucky, Louisiana, New Jersey, Oregon, Virginia, and Wyoming have rescinded their emergency declarations in the past two months, according to the National Academy for State Health Policy. More are set to expire in the coming months unless renewed. Disaster declarations in other states ended as long as a year ago, while about a third of states are holding onto their emergency measures.”

CDC reiterates importance of masks on airplanes, public transportation “Federal health officials on Tuesday repeated their recommendation that masks be worn on airplanes, buses and in other public transportation settings where large numbers of people congregate.
Despite a federal judge’s order last month striking down the federal transportation mask mandate, the Centers for Disease Control and Prevention said masks continue to be an important tool for stopping the spread of the coronavirus.”

About health insurance

CVS Health hits 44M unique digital customers in Q1 “CVS Health reported $2.3 billion in profit for the first quarter, which exceeded Wall Street's expectations.
The healthcare giant also beat the Street on revenue, posting $76.8 billion for the first quarter. Both figures are up from the first quarter of 2021, where the company reported $69.1 billion in revenue and $2.2 billion in profit.
That's a revenue increase of 11.2% year over year, according to CVS' earnings report filed Wednesday morning.”

Bright Health reports major enrollment boost, $180M loss in Q1 “Bright Health Group reported massive enrollment growth across its commercial, Medicare Advantage and value-based lines, but recorded a net loss of more than $180 million in the quarter ending March 31, according to its first-quarter earnings report…”

Oregon, Kentucky dust off an Obama-era policy to expand health insurance
Oregon and Kentucky are pursuing an Obama-era policy that uses federal dollars to establish a health insurance plan for people who make too much money to qualify for their state’s Medicaid programs…
While the policy, known as the basic health program, was included in the Affordable Care Act, only Minnesota and New York took advantage, and it has been six years since a new one was created…
A basic health program offers low-cost insurance for people who make up to twice the federal poverty level – about $55,000 for a family of four – and do not qualify for Medicaid. New York and Minnesota offer plans with little or no premiums, co-pays or deductibles, a key selling point for proponents.”

About pharma

 Vaxxinity Receives FDA Fast Track Designation for UB-311 for Treatment of Alzheimer’s Disease “Vaxxinity, Inc… . announced that UB-311, an anti-amyloid beta immunotherapeutic vaccine, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease….
 UB-311 is an immunotherapeutic vaccine candidate targeting toxic forms of aggregated amyloid beta in the brain to treat Alzheimer’s disease. Phase 1, Phase 2a, and Phase 2a Long Term Extension trials have shown UB-311 to be well tolerated in mild-to-moderate AD patients over three years of repeat dosing, with a safety profile comparable to placebo and no cases of amyloid-related imaging abnormalities-edema (“ARIA-E”) in the main study. UB-311 also elicited robust and durable anti-amyloid beta antibody responses in patients. A Phase 2b trial is expected to be initiated in late 2022.”
Perhaps before the company does its pricing it can take a lesson from Aduhelm.

Washington Reaches $518M Settlement With Opioid Distributors “The agreement still requires approval from a judge and from dozens of Washington cities that pursued their own cases against the distributors — McKesson Corp., Cardinal Health Inc. and AmerisourceBergen Corp.
Under the settlement, the state would have to spend $476 million of the total to address the opioid crisis, including on substance abuse treatment; expanding access to overdose-reversal drugs; and providing housing, job placement and other services for those struggling with addiction. The rest of the money would go toward litigation costs.”

Teva cuts sales guidance amid competitive pressures, currency exchange woes “The Israeli generics giant reaped revenues of $3.66 billion, down 8% from $3.98 billion during the same period last year. After the performance, the drugmaker cut its revenue guidance for the full year.”

GSK to Acquire Sierra Oncology and Its Promising Blood Cancer Drug for $1.9 Billion “GlaxoSmithKline (GSK) has prevailed over six other bidders with its $1.9 billion offer to purchase Sierra Oncology, gaining the Canadian company’s promising investigational Janus kinase (JAK) inhibitor, momelotinib, for the treatment of the rare blood cancer myelofibrosis.”

About the public’s health

 Why US Cervical Cancer Survival Rates Haven’t Improved for Decade “Although screening has been on the frontlines of the battle against cervical cancer for more than 60 years, the disease’s survival rate has barely budged since the 1970s. That’s in stark contrast with the overall cancer mortality rate in the US, which the American Cancer Society (ACS) reported has decreased by 32% since 1991.”
Read this interesting article for reasons for this lack of progress.

HHS Awards Nearly $25 Million to Expand Access to School-Based Health Services “…Health Resources and Services Administration (HRSA), awarded nearly $25 million to improve and strengthen access to school-based health services in communities across the country. Awards will support local partnerships between schools and health centers to provide children and youth the comprehensive physical and mental health care they need.”

Relationship Between Ambient Air Pollution And Incidence Of Head And Neck Cancers In Illinois “Diesel particulate matter levels were found to be associated with oral/pharyngeal cancer incidence. Greater ambient air pollution exposure may be a factor that increases pre-disposition to developing certain head and neck cancers.”

Sex-Specific Risk Factors Associated With First Acute Myocardial Infarction in Young Adults “In this case-control study, 7 risk factors (diabetes, depression, hypertension, current smoking, family history of premature MI, low household income, hypercholesterolemia) accounted for 85% of the risk of first AMI in young men and women. We further found that risk factors accounted for different risk of AMI in women compared with men, and that some of the significant factors varied by sex. Risk factors also varied by subtype of AMI, with traditional cardiovascular risk factors having higher prevalence and stronger associations for type 1 AMI compared with other types of AMI not resulting from acute plaque rupture.”

Cannabinoid receptor 1 antagonist genistein attenuates marijuana-induced vascular inflammation “A UK Biobank analysis found that cannabis was an risk factor for CVD. We found that marijuana smoking activated inflammatory cytokines implicated in CVD.”

About healthcare IT

Athenahealth adds Nuance to its digital marketplace “The Nuance Dragon Ambient eXperience, which includes API integration with athenaClinicals and Athenahealth's EHR system, automates administrative tasks during virtual and in-person visits…”

About healthcare personnel

 agilon health and United Physicians form Long-term Partnership to Provide a Value-Based Care Model for Medicare Advantage in Southeast Michigan “Through the partnership, United Physicians will work with agilon health to transform its primary care delivery system for Medicare Advantage patients to a sustainable, full-risk value-based care model that will improve quality outcomes within Southeast Michigan’s healthcare system….
Today, agilon health is partnering with 16 of the nation’s best physician groups including Answer Health, Western Michigan’s largest physician organization. agilon is accelerating at scale the transition to a value-based Total Care Model for senior patients through its aligned partnerships, purpose-built platform, and peer network of like-minded physicians. Following the announcement of its partnership with MaineHealth and United Physicians, as well as the expected announcements of five additional partners for 2023, agilon health will have 23 physician partners across 12 states and 25 diverse geographies, and more than 2,200 primary care physicians in its peer network.”

Physician Flash Report: April 2022 “For the first time in two years, the median Investment/Subsidy per Physician FTE surpassed levels seen during the start of the COVID-19 pandemic. The metric was up 1.5% compared Q1 2020 at $288,227 in Q1 2022.

Other key findings from the first quarter compared to Q1 2021 include:

• Physician wRVUs per FTE increased 15%

• Physician Compensation per FTE rose 7% to $349,072

• Net Revenue per Physician FTE was up 10% to $636,674

• Total Direct Expense per Physician FTE rose 11% to $946,602”

Today's News and Commentary

Supreme Court has voted to overturn abortion rights, draft opinion shows Here is the Politico article that leaked the draft of the Court’s upcoming decision.
“The Supreme Court has voted to strike down the landmark Roe v. Wade decision, according to an initial draft majority opinion written by Justice Samuel Alito circulated inside the court and obtained by POLITICO…
’We hold that Roe and Casey must be overruled,’ he writes in the document, labeled as the ‘Opinion of the Court.’ ‘It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.’..
A person familiar with the court’s deliberations said that four of the other Republican-appointed justices – Clarence Thomas, Neil Gorsuch, Brett Kavanaugh and Amy Coney Barrett – had voted with Alito in the conference held among the justices after hearing oral arguments in December, and that line-up remains unchanged as of this week.”
In a related story: BREAKING: Chief Justice Roberts Launches Probe Into Leaked Abortion Draft Opinion “Chief Justice John Roberts on Tuesday asked the marshal of the U.S. Supreme Court to launch an investigation into a leaked draft opinion that suggests the high court is prepared to strike down the landmark 1973 ruling Roe v. Wade that made abortion legal in all 50 states.”
For additional background: What the Supreme Court justices have said about abortion and Roe v. Wade
Comment: Justice Alito is correct that the right to abortion is not mentioned in the Constitution—but neither is the right to receive any healthcare. If Congress ever addresses that latter right, the Court conservatives would have had to use another line of reasoning to justify their decision. Or would they have opined that abortions are not healthcare?

About Covid-19

 Post COVID-19 Syndrome in Patients with Asymptomatic/Mild Form “According to the analysis of original articles on PCS [Post Covid-19 Syndrome] among asymptomatic/mild COVID-19 patients, PCS develops on average in 30–60% of patients, mainly among women, with fatigue, shortness of breath, cough, and anosmia being the most common symptoms. The possible association between the described PCS symptoms and brain damage during coronavirus infection suggests an alternative form of the course of the disease that develops in genetically predisposed individuals with a stronger immune response (in particular women), in which it predominantly affects the cells of the nervous system with the presence of an autoimmune component, which has similarities with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome or autoimmune disautonomia. In summary, the female gender and the presence of anosmia during an asymptomatic or mild form of the disease could be predictive factors of the development of PCS, which might be caused by autoimmune damage to neurons, glia, and cerebral vessels.” [Emphasis added]

About health insurance

California Opens Medicaid to Older Unauthorized Immigrants ”On May 1, California opened Medi-Cal to older immigrants residing in the state without legal permission.
Unauthorized immigrants over age 49 who fall below certain income thresholds are now eligible for full coverage by Medi-Cal, California’s version of Medicaid, the federal-state partnership that provides health insurance to low-income people.
Unauthorized immigrants of all ages account for 40% of the state’s approximately 3.2 million uninsured residents.”

Massachusetts Supreme Judicial Court approves Optum's acquisition of Atrius “The court approved the transaction with certain conditions. These include the stipulation that Atrius will no longer be a public charity under Massachusetts law, once Atrius causes the net proceeds of the proposed transaction to be transferred to the Atrius Health Equity Foundation, and that it amend its articles of organization to remove its charitable purposes…
Atrius is a large, independent physician-led healthcare organization that provides care to more than 690,000 adult and pediatric patients. It employs 645 physicians and primary care providers, along with 421 additional clinicians.”

Maven Clinic partners with Blue Shield of California to reach 2.4M eligible members “Maven Clinic, a virtual clinic for women’s and family health, inked a partnership with Blue Shield of California to expand access to pregnancy and postpartum support.
The partnership, which began in January, opens up Maven’s virtual care platform for fertility, pregnancy and parenting to more than half of the plan’s total membership—to 2.4 million eligible members…
The launch comes amid delays in prenatal care during the pandemic, with many mothers experiencing worsening mental health and more than a third of Black mothers reporting experiencing racism during care in the past year.”

U.S. Attorney Announces Settlement Of Fraud Lawsuit Against Online Pharmacy For Overdispensing Insulin “…the United States filed and settled a healthcare fraud lawsuit against online retail pharmacy PillPack, LLC (‘PillPack’), a wholly-owned subsidiary of Amazon.com, Inc. The settlement resolves allegations that PillPack improperly billed Government healthcare programs (‘GHPs’), including Medicare and Medicaid, for more insulin pens than patients needed according to their prescriptions and falsely under-reported the days-of-supply of insulin dispensed. Under the settlement, PillPack agreed to pay approximately $5.79 million to the United States and various States that were fraudulently overbilled for insulin. As part of the settlement, PillPack also admitted and accepted responsibility for certain conduct the Government alleged in its Complaint, including that it dispensed insulin pens that exceeded days-of-supply limits imposed by GHPs.”

Medicare Advantage Plans Hit Back at Report on Coverage Denials These health plans responded to the recent HHS OIG Report (previously presented) that pointed to inappropriate denials of care. One criticism was “ that investigators raised concerns about just 33 of 247 preauth requests.”

Medicaid: Changes to outpatient prior authorization process for non-oncology drugs “Effective Aug. 1, 2022, Optum®, an affiliate of UnitedHealthcare, will manage prior authorization requests for non-oncology injectable medications that are covered on the medical benefit for UnitedHealthcare Community Plans.
This change does not apply to the following states at this time: Colorado, Indiana, Maryland, Missouri, Nevada, New York, North Carolina and Ohio.
The prior authorization request process for oncology-related medications will also remain unchanged.”
About hospitals and healthcare systems

 National Hospital Flash Report, April 2022 [With data through the end of March] “The median change in Operating Margin rose 32.7% from February to March and 85.6% compared to March 2020.2 The median change in Operating EBITDA Margin increased 26.7% month-over-month and 98.1% versus March 2020.
Year-over-year (YOY), however, the median change in Operating Margin was down 48.7% and the median change in Operating EBITDA Margin declined 37.8% compared to March 2021.
Outpatient volumes improved for the month. Inpatient volumes increased, but at a slower pace compared to recent months…Surgery volumes increased as patients continued to return after the Omicron surge delayed many nonurgent procedures…
Hospitals saw some improvements in adjusted expenses month-over-month as volume growth outpaced expense growth in March, but labor shortages, supply chain issues, and inflation continue to push expenses up relative to prior years.
Compared to February, Total Expense per Adjusted Discharge and Non- Labor Expense per Adjusted Discharge both decreased 9%, and Labor Expense per Adjusted Discharge was down 8.3%.”

About pharma

Biogen scraps commercial support for Aduhelm, searches for new CEO In a MAJOR reversal, “Biogen said Tuesday alongside its first-quarter financial results that it will "substantially eliminate" the commercial infrastructure supporting its Alzheimer's disease therapy Aduhelm (aducanumab) following restrictions placed on its use in the US. The company noted that it will only retain "minimal resources" to manage patient access programmes for the anti-amyloid antibody.
The move is part of a wider reset at Biogen, which also sees the start of a search for a new CEO to replace Michel Vounatsos, as well as a number of cost-reduction measures. The drugmaker indicated that the elimination of the commercial infrastructure around Aduhelm will lead to savings of about $500 million.”
And somewhat anticlimactically: UnitedHealthcare limits Aduhelm for all health plans: 'unproven and not medically necessary' 

 Cerebral’s Preferred Pharmacy Truepill Halts Adderall Prescriptions for All Customers “Online pharmacy company Truepill Inc. said it is temporarily halting prescriptions for Adderall and other controlled substances used to treat attention-deficit hyperactivity disorder, and partner Cerebral Inc. told its clinicians to direct those orders to patients’ local pharmacies…
 [As previously reported:] Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the past year from clinicians working for telehealth startups that have sprung up to treat ADHD, according to pharmacies and people familiar with the issue.”

FDA expands approval of non-stimulant ADHD drug to adults “The Food and Drug Administration (FDA) has expanded its approval of a non-stimulant drug for ADHD, the first in about 20 years, to include adults along with children.
Viloxazine, sold commercially as Qelbree in extended-release capsules, has been approved to help treat ADHD in adults 18 and over, its maker, Supernus Pharmaceuticals, announced. 
Qelbree was first approved for treating children ages 6 to 17 with ADHD last April. At the time, it was the first such drug approved in more than 10 years for children.”

About the public’s health

Impact of Canada’s menthol cigarette ban on quitting among menthol smokers: pooled analysis of pre–post evaluation from the ITC Project and the Ontario Menthol Ban Study and projections of impact in the USA “After the menthol cigarette ban, menthol smokers were more likely than non-menthol smokers to have quit smoking among daily smokers (difference=8.0%; 95% CI: 2.4% to 13.7%,p=0.005) and all (daily+non-daily) smokers (difference=7.3%; 95% CI: 2.1% to 12.5%,p=0.006). The projected number of smokers who would quit after a US menthol ban would be 789 724 daily smokers (including 199 732 African Americans) and 1 337 988 daily+non-daily smokers (including 381 272 African Americans).” 

Vegetarian Diet, Growth, and Nutrition in Early Childhood: A Longitudinal Cohort Study “Evidence of clinically meaningful differences in growth or biochemical measures of nutrition for children with vegetarian diet was not found. However, vegetarian diet was associated with higher odds of underweight.”
Before accepting the message as a blanket endorsement, read the article for the diet’s characteristics.

The brain structure and genetic mechanisms underlying the nonlinear association between sleep duration, cognition and mental health Among the findings of this research: “Using data from the UK Biobank for participants primarily of European ancestry aged 38–73 years, including 94% white people, we identified a nonlinear association between sleep, with approximately 7 h as the optimal sleep duration, and genetic and cognitive factors, brain structure, and mental health as key measures.”

About healthcare IT

 FDA Says It Won’t Regulate Public Health Software as a Medical Device  “The FDA has clarified that it does not plan to regulate most software apps used in public health — such as the case-counting software programs that have been in use throughout the pandemic — as medical devices.” 

Mayo Clinic uses AI and Apple Watch to detect weak heart pump “Researchers at the Mayo Clinic developed an algorithm that, using the ECG from an Apple Watch, could identify patients with a weak heart pump.
In a post on the Mayo Clinic website, researchers announced the results of the study which was also presented at the Heart Rhythm Society conference on Sunday, May 1.”

Validation of artificial intelligence prediction models for skin cancer diagnosis using dermoscopy images: the 2019 International Skin Imaging Collaboration Grand Challenge “When comparing algorithms to expert dermatologists (2460 ratings on 1269 images), algorithms performed better than experts in most categories, except for actinic keratoses (similar accuracy on average) and images from categories not included in training data (26% correct for experts vs 6% correct for algorithms, p<0·0001). For the top 25 submitted algorithms, 47·1% of the images from categories not included in training data were misclassified as malignant diagnoses, which would lead to a substantial number of unnecessary biopsies if current state-of-the-art AI technologies were clinically deployed.
Interpretation: We have identified specific deficiencies and safety issues in AI diagnostic systems for skin cancer that should be addressed in future diagnostic evaluation protocols to improve safety and reliability in clinical practice.”

Allscripts Closes Sale of Hospital and Large Physician Practices Business to Constellation Software Yesterday, Allscripts “announced that it has completed the sale of the net assets of the Allscripts Hospital and Large Physician Practices business segment to Constellation Software Inc., through its wholly-owned subsidiary N. Harris Computer Corporation.”
The deal does not include Veradigm, Allscripts' payer and life sciences division.

CERNER REPORTS FIRST QUARTER 2022 RESULTS “2022 First Quarter Highlights

• Revenue of $1.430 billion, up 3% compared to $1.388 billion in the first quarter of 2021.

• GAAP operating margin of 17.6%, up 190 basis points from 15.7% in the year-ago quarter.

• Adjusted Operating Margin (non-GAAP) of 22.7%, up 130 basis points from 21.4% in the year-ago quarter.”

Today's News and Commentary

About Covid-19

COVID DATA TRACKER WEEKLY REVIEW “This week, the U.S. COVID-19 Vaccination Program marks two milestones: 500 days since the first COVID-19 vaccine was approved for use in the United States, and 100 million first booster doses administered. While 100 million boosters is certainly something to celebrate, the fact remains that half of those eligible for a COVID-19 booster shot—about 91 million people—have not yet received one…
As of April 27, 2022, the current 7-day moving average of daily new cases (53,133) increased 25.2% compared with the previous 7-day moving average (42,427). A total of 81,028,797 COVID-19 cases have been reported in the United States as of April 27, 2022.”

Paxlovid fails in study for post-exposure prophylactic use While useful for treating those who become infected with SARS CoV-2, Paxlovid does not work for post-exposure prophylaxis.

 Trump officials muzzled CDC on church covid guidance, emails confirm “Trump White House officials in May 2020 removed public health advice urging churches to consider virtual religious services as the coronavirus spread, delivering a messaging change sought by the president’s supporters, according to emails from former top officials released by a House panel on Friday.
The Centers for Disease Control and Prevention sent its planned public health guidance for religious communities to the White House on May 21, 2020, seeking approval to publish it. The agency had days earlier released reports saying that the virus had killed three and infected dozens at church events in Arkansas and infected 87 percent of attendees at a choir practice in Washington state, and health experts had warned that houses of worship had become hot spots for virus transmission.”

Big Three COVID-19 Vaccine Maker Shareholders Vote No on Sharing Intellectual Property With LMICs “Shareholders of the U.S.’ big three COVID-19 vaccine makers have voted no on proposals asking the companies to share their intellectual property with low- and middle-income countries (LMICs) so that those countries could make their own versions of the vaccines.”

About health insurance

CY 2023 Medicare Advantage [MA] and Part D Final Rule (CMS-4192-F) “This final rule revises the MA and Part D regulations related to marketing and communications; the criteria used to review applications for new or expanded MA and Part D plans, including compliance with MA provider network adequacy requirements; quality ratings for MA and Part D plans; medical loss ratio reporting; special requirements during disasters or public emergencies; how MA organizations calculate attainment of the maximum out-of-pocket (MOOP) limit for Parts A and B services; and the use of pharmacy price concessions to reduce beneficiary out of pocket costs for prescription drugs under Part D. This final rule also revises regulations for D-SNPs [MA dual eligible special needs plans] and in some cases, other special needs plans, related to enrollee advisory committees, health risk assessments, and ways to improve integration of Medicare and Medicaid. Many finalized policies are based on lessons learned from the Medicare-Medicaid Financial Alignment Initiative.”
Each of these items is briefly explained.

Feds Block Georgia's Plan to Have Private Sector Handle ACA “President Joe Biden's administration on Friday halted Gov. Brian Kemp’s plan to have the private sector, not the government, engage in outreach to get state residents to sign up for insurance under the Affordable Care Act.
Kemp, a Republican, had planned to bypass healthcare.gov and have residents shop for federally subsidized health insurance through private agents. Former President Donald Trump’s administration approved that plan in 2020, and state officials had touted it as a way to boost insurance coverage.”

 Health Coverage Changes Under the Affordable Care Act: End of 2021 Update “KEY POINTS:

• Newly-released data from the National Health Interview Survey shows that the uninsured rate for the U.S. population was 8.8 percent in Q4 2021 (October – December 2021), down 1.5 percentage points from 10.3 percent in Q4 2020. This reflects approximately 4.9 million people gaining health coverage since the end of 2020.

• Individuals with incomes below 200 percent of the Federal Poverty Level experienced larger decreases in the uninsured rate than higher income households.

• Coverage gains for adults ages 18-64 from the second half of 2020 to the second half of 2021 occurred across all racial and ethnic groups reported in the new data, with the uninsured rate declining by 3.5 percentage points among Latino adults, 1.8 percentage points among Black adults, and 0.5 percentage points among White adults.

• Meanwhile, administrative data from late 2021 and early 2022 show a record-high number of people with coverage related to the Affordable Care Act (ACA) – with more than 35 million people estimated to be enrolled in the Medicaid expansion, Basic Health Program, or Marketplace coverage.

• These data suggest that policies including the American Rescue Plan, new state Medicaid expansions, and the 2021 Marketplace Special Enrollment Period, in addition to the economic recovery, have helped Americans gain insurance coverage during the COVID -19 public health crisis.”

A reduction in Medicare Part B premiums remains in play. Here’s where things stand “More than three months after Health and Human Services Secretary Xavier Becerra ordered a reassessment of this year’s $170.10 standard monthly premium — a bigger-than-expected jump from $148.50 in 2021 — it remains uncertain when a determination will come and whether it would affect what beneficiaries pay this year…
About half of the larger-than-expected 2022 premium increase, set last fall, was attributed to the potential cost of covering Aduhelm — a drug that battles Alzheimer’s disease — despite actuaries not yet knowing the particulars of how it would be covered because Medicare officials were still determining that…
Several weeks ago, CMS officials announced that the program will only cover Aduhelm for beneficiaries who receive it as part of a clinical trial. Additionally, the per-patient price tag that actuaries had used in their calculation last year was cut in half, effective Jan. 1, by manufacturer Biogen — to $28,000 annually from $56,000.”

About hospitals and healthcare systems

 At US Hospitals, a Drug Mix-Up Is Just a Few Keystrokes Away “More than four years ago, Tennessee nurse RaDonda Vaught typed two letters into a hospital’s computerized medication cabinet, selected the wrong drug from the search results, and gave a patient a fatal dose.
Vaught was prosecuted this year in an extremely rare criminal trial for a medical mistake, but the drug mix-up at the center of her case is anything but rare. Computerized cabinets have become nearly ubiquitous in modern health care, and the technological vulnerability that made Vaught’s error possible persists in many U.S. hospitals.”
This KFF report provides suggestions to address this problem.

Ascension posts $884M quarterly loss “St. Louis-based Ascension reported higher expenses in the three months ended March 31 and ended the quarter with a loss, according to financial documents filed April 29. 
The 143-hospital system reported operating revenue of $6.69 billion in the first three months of this year, up from $6.56 billion in the same period of 2021. 
Ascension's operating expenses climbed to $7.34 billion in the first three months of 2022, up from $6.59 billion in the same period a year earlier. The increase was attributed to several factors, including higher salaries, wages and supply expenses.”

IU Health reports $358M net loss as labor expenses climb 25% “Indianapolis-based Indiana University Health reported a net loss of $358.54 million for the first quarter of 2022 as its labor expenses soared, according to its financial results released April 28. The system had a net income of $330.5 million for the same period last year.
IU Health, a 16-hospital system, had $1.93 billion in revenue for the three months ended March 31, a 2.9 percent increase year over year from $1.87 billion. Its largest source of revenue was patient services, which rose 6.6 percent year over year to $1.79 billion for the first quarter of 2022 from $1.68 billion last year.
The system's expenses climbed 16.4 percent, to $1.96 billion, for the first quarter of 2022, compared to $1.68 billion for the same period last year.”

About pharma

 Biotech Stocks Set for More Pain After Worst April in Decades “
”Biotech stocks closed out “their worst April since at least 1997, with the sector having tumbled more than 60% from its February 2021 peak and sinking 19% in April alone…
Jefferies strategist Will Sevush notes that the 2000 tech crash was similarly led by companies at an early stage of development with little to show in the way of revenue. He pointed out that retail traders also spurred the exuberance that drove both sectors to all-time highs.”

Novo Nordisk reaches primary endpoint in phase III of once-weekly insulin “Danish diabetes care giant Novo Nordisk (NOV: N) today announced headline results from the ONWARDS 2 trial, a Phase IIIa, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec versus insulin degludec in 526 people with type 2 diabetes switching from daily insulin.
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin icodec compared to insulin degludec.”
”Basal” insulin may go from being dosed daily to weekly.

About the public’s health

 American Academy of Pediatrics Calls for Elimination of Race-Based Medicine “In a new policy statement, “Eliminating Race-Based Medicine,” pre-published online May 2, 2022, in Pediatrics, the AAP observes that race is a historically derived social construct that has no place as a biologic proxy. Over the years, the medical field has inaccurately applied race correction or race adjustment factors in its work, resulting in differential approaches to disease management and disparate clinical outcomes.” 

Disparities in Health Care in Medicare Advantage by Race, Ethnicity, and Sex “This report presents summary information on the quality of health care reported in 2021 by Medicare Advantage (MA) enrollees nationwide. Two types of quality-of-care data are presented: (1) measures of patient experience [from the HCAPS reports], which describe how well the care that patients receive meets their needs for such things as timely appointments, respectful care, clear communication, and access to information; and (2) measures of clinical care, which describe the extent to which patients receive appropriate screening and treatment for specific health conditions. In 2021, 42 percent of all people with Medicare were enrolled in MA [from the HEDIS reports]…”
Among the findings: ”Racial and ethnic differences were evident more often for the 36 clinical care measures presented in this report than for the patient experience measures…”

About healthcare IT

1.1M health records breached in April: 5 biggest cyberattacks The article has more details.

 As Teladoc shares tumbled after dismal Q1 earnings, analysts question telehealth giant's growth strategy “Shares of Teladoc plunged more than 45% Thursday after the telehealth giant reported disappointing first-quarter results.
The company reported earnings in the first quarter that missed on both the top and bottom lines. Teladoc's revenues grew 25% year over year to $565.4 million, below the $568.9 million that analysts were expecting. Earnings per share came in at a loss of $41.58, well below the loss of 62 cents expected, largely due to a write-down of assets related to its acquisition of Livongo in 2020. The company's sizable net loss included a noncash goodwill impairment charge of $6.6 billion, or a loss of $41.11 per share.” 

About healthcare personnel

 Use of Preventive Care Services Associated with Patient-Provider Sex Concordance in the US 
“Key Points:

• For women, having a female physician was related to greater use of multiple preventive services.

• Sex concordance was not associated with greater use of preventive care services for men.

• Men’s use of preventive care services increases with age at a greater rate relative to women. However, use of preventive care services by women is higher than for men to begin with.” 

About health technology

Predicting pancreatic ductal adenocarcinoma using artificial intelligence analysis of pre-diagnostic computed tomography images “A set of 108 retrospective CT scans (36 scans from each healthy control, pre-diagnostic, and diagnostic group) from 72 subjects was used for the study. Model development was performed on 66 multiphase CT scans, whereas external validation was performed on 42 venous-phase CT scans…
The system achieved an average classification accuracy of 86% on the external dataset.”
Use of such AI can identify tumors before thy become symptomatic. The problem is identifying those who need to be screened.

Guardant debuts first cancer screening blood test for catching colorectal tumors “Guardant’s Shield test, meanwhile, is intended for adults over age 45 who have an average risk for colorectal cancer and show no symptoms..
The test searches for early signs of colorectal cancer from pieces of tumor DNA found floating in the bloodstream. In a clinical study of about 300 samples, the assay showed 91% sensitivity in detecting positive cases, including 90% for people with early, stage I cancers, 97% for stage II and 86% for stage III. Shield also demonstrated a low rate of false positives, at 8%, but the company said that a negative result does not fully rule out the presence of cancer.” 

Today's News and Commentary

About Covid-19

Covid deaths no longer overwhelmingly among unvaccinated as toll on elderly grows “Unvaccinated people accounted for the overwhelming majority of deaths in the United States throughout much of the coronavirus pandemic. But that has changed in recent months, according to a Washington Post analysis of state and federal data…
The vaccinated made up 42 percent of fatalities in January and February during the highly contagious omicron variant’s surge, compared with 23 percent of the dead in September, the peak of the delta wave, according to nationwide data from the Centers for Disease Control and Prevention…
As a group, the unvaccinated remain far more vulnerable to the worst consequences of infection — and are far more likely to die — than people who are vaccinated, and they are especially more at risk than people who have received a booster shot.”

 Comparison of Home Antigen Testing With RT-PCR and Viral Culture During the Course of SARS-CoV-2 Infection “Findings  In this prospective cohort study of 225 adults and children with reverse transcription–polymerase chain reaction (RT-PCR)–confirmed SARS-CoV-2 infection, antigen test sensitivity was 64% and 84% when compared with same-day RT-PCR and viral culture, respectively. Antigen test sensitivity peaked 4 days after illness onset (77%); a second test 1 to 2 days later showed improved sensitivity (81%-85%).
Meaning  The study results suggest that symptomatic individuals with an initial negative home antigen test result for SARS-CoV-2 infection should test again 1 to 2 days later because test sensitivity seems to peak several days after illness onset.”

Vaccines for young kids could be available in June, FDA official says “The remarks by Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, came in an interview about the agency’s new, but tentative, timeline for handling vaccine issues during the next two months. The FDA announced plans to convene meetings with its outside advisers on June 8, 21 and 22 to consider emergency use authorizations for pediatric coronavirus shots and to hold additional sessions for other pressing vaccine matters.”

About health insurance

 Racial and Ethnic Disparities in Insurance Coverage Among US Adults Aged 60 to 64 Years “…the coverage disparity between low-income Hispanic adults and low-income White adults was 11.4 percentage points larger in [Medicaid] nonexpansion states vs expansion states (95% CI, 3.2-19.5 percentage points; P = .007). We did not detect significant Black-White coverage disparities in expansion or nonexpansion states.”

Doctor Sentenced in $12 Million Medicare Fraud and Device Adulteration Scheme “A California doctor was sentenced today to 93 months in prison for defrauding Medicare, re-packaging single-use catheters for re-use on patients, and submitting false declarations in a bankruptcy proceeding. 
According to court documents, Donald Woo Lee, 55, of Temecula, recruited Medicare beneficiaries to his clinics, falsely diagnosed the beneficiaries, and provided the beneficiaries with medically unnecessary procedures. Lee billed these unnecessary procedures to Medicare using an inappropriate code in order to obtain a higher reimbursement, a practice known as ‘upcoding.’”

UK healthcare is already being privatised, but not in the way you think Among the findings: “In 1990, out-of-pocket spending by Britons on medical expenses was equivalent to 1 per cent of GDP, while across the Atlantic, uninsured Americans forked out more than twice as much, at 2.2 per cent. Thirty years on, that gap has all but disappeared. Americans’ non-reimbursable spending now stands at 1.9 per cent, and Britons’ has doubled to 1.8 per cent.”
The delays in care from the NHS have forced many to seek fee-for-service private care.

Employers to tackle employee healthcare affordability amid rising costs “The vast majority of U.S. employers (94%) say managing healthcare benefit costs will be their top priority over the next two years, followed by enhancing mental health benefits (87%), according to a new survey by WTW (Willis Towers Watson)…
When asked what their greatest challenges will be to effectively deliver on their healthcare strategy over the next two years, 73% cited increasing healthcare prices due to rising inflation and provider consolidation. More than half (54%) identified lack of employee awareness about where to find programs to support their needs as a key challenge.”

About hospitals and healthcare systems

 Association Between Hospital Private Equity Acquisition and Outcomes of Acute Medical Conditions Among Medicare Beneficiaries “In this cross-sectional study of more than 21 million Medicare beneficiaries with 5 different acute medical conditions who were hospitalized at short-term acute care hospitals, PE acquisition was associated with significantly lower inpatient mortality (−1.1 percentage points) and lower 30-day mortality (−1.4 percentage points) among patients admitted with acute myocardial infarction. However, PE acquisition was not associated with significant differences in other dimensions of quality and spending or with differences across other medical conditions.”

19 Tenet hospitals sue Cigna over alleged low reimbursement rates, denied claims “Tenet Healthcare and 19 of its hospitals are accusing Cigna of reimbursing claims at low rates and wrongfully denying claims for emergency care in a lawsuit…
Nineteen hospitals managed by Tenet across Arizona, Florida, Tennessee, Alabama, South Carolina and Massachusetts allege Cigna engaged in ‘an ongoing pattern of financial misconduct.’
The hospitals allege Cigna created ‘narrow’ networks — which Tenet is not part of — to maximize the discounts it receives from the limited number of hospitals participating in those networks, thereby creating the risk of members seeking care at out-of-network emergency departments that have not agreed to offer discounted rates. The lawsuit claims Cigna forced Tenet hospitals to treat members at artificially low rates by reimbursing the hospitals at rates they did not agree to.
The lawsuit also claims Cigna ‘arbitrarily denied numerous claims for emergency medical services.’”

HCA agrees to acquire urgent care chain “Nashville, Tenn.-based HCA Healthcare signed an agreement to acquire Richmond, Va.-based BetterMed, an urgent care practice with 12 locations, Tim McManus, president of HCA Healthcare Capital Division…
The deal is not final, he added. The HCA Healthcare Capital Division has locations in Indiana, Kentucky, New Hampshire and Virginia…”

SSM Health, Saint Louis University Collaborate to Form the Region’s Leading Fully Integrated Healthcare Delivery Network SLU press release: “Under a new agreement reached in principle, the two organizations will formally bring together the world-class academic medical expertise of SLUCare Physician Group with SSM Health’s high-quality community-based care model to create the region’s leading integrated healthcare network. Ownership of SLUCare Physician Group will transition from Saint Louis University to SSM Health when the transaction closes. The agreement is expected to be finalized later this summer, pending all regulatory and other approvals.”

Memorial Sloan Kettering reports operating loss of $13.5M “New York City-based Memorial Sloan Kettering Cancer Center's operating loss narrowed to $13.5 million in the three months ended March 31, compared to a loss of $33 million in the same period last year, according to its financial results released April 25.
The organization, which has locations in New York and New Jersey, reported a total operating revenue of $1.6 billion in the first quarter of 2022, a 10.3 percent increase from the same period last year at $1.5 billion.
Its expenses reached $1.6 billion for the first quarter of 2022, an 8.7 percent increase year over year from $1.5 billion. Its compensation and fringe benefits also rose by 7.2 percent year over year, from $824 million in the first quarter of 2021, to $882.9 million in the first quarter of 2022.”
Keep in mind that MSK is one of the named cancer hospitals exempt from DRGs and often does not negotiate rates with private payers.

About pharma

Ex-Cerebral executive files lawsuit claiming the startup overprescribed ADHD meds “The lawsuit, filed Wednesday in California state court, alleges that Cerebral planned to increase customer retention by prescribing stimulants to 100% of its ADHD patients.”
See the related story in yesterday’s blog about Walmart and CVS blocking prescriptions from this and other similar companies.

 Latest pharma financial reports
Lilly bumps up annual sales guidance as Trulicity revenue climbs 20% in Q1 
Merck & Co. raises annual guidance as COVID-19 drug sales top $3 billion in Q1 
Gilead's Q1 sales edge past estimates lifted by Biktarvy, Veklury
Novo Nordisk hikes full-year forecast after Q1 sales climb 24%
AstraZeneca backs annual guidance as Farxiga sales reach $1 billion in Q1

About the public’s health

 U.S. Case of Human Avian Influenza A(H5) Virus Reported “A person has tested positive for avian influenza A(H5) virus (H5 bird flu) in the U.S., as reported by Colorado and confirmed by CDC. This case occurred in a person who had direct exposure to poultry and was involved in the culling (depopulating) of poultry with presumptive H5N1 bird flu.” 

About healthcare IT

 Walmart Health rolls out virtual diabetes program as retail giant moves deeper into treating chronic conditions “Building on its acquisition of telehealth provider MeMD last year, Walmart Health is rolling out a virtual care diabetes program for employers and payers.”

About health technology

 Baxter's revenue climbs with acquisition of Hillrom “Medical products giant Baxter International reported rising revenue in the first quarter coming on the heels of its acquisition of Hillrom.
Deerfield-based Baxter saw revenue grow 26% to $3.7 billion in the first quarter, the company announced in an earnings call today. U.S. sales totaled $1.76 billion, a nearly 50% increase from the same period a year earlier, with international sales increasing 10% to $1.95 billion. Net income was $71 million.”

Today's News and Commentary

About Covid-19

Moderna seeks authorization of coronavirus vaccine for youngest children “Vaccine maker Moderna requested emergency use authorization Thursday of its coronavirus vaccine for babies, toddlers and youngchildren — a highly anticipated step toward making shots available to the last group in U.S. society lacking access…
The full data supporting the application is expected to be filed by early in the second week of May, according to a senior Biden administration official, who spoke on the condition of anonymity because they were not authorized to discuss the matter publicly.”

AMA announces CPT update for COVID-19 booster candidates “The American Medical Association (AMA) …announced an editorial update to Current Procedural Terminology (CPT®)… for describing health care procedures and services, that includes newly assigned provisional CPT codes for COVID-19 booster candidates from Pfizer and Sanofi-GlaxoSmithKline.
The Pfizer booster candidate is proposed for use in children ages 5 to 11 who have completed a COVID-19 vaccine primary series, while the Sanofi-GSK booster candidate is proposed for use in persons age 18 and older who have completed a COVID-19 vaccine primary series.”

About health insurance

HHS Announces New Policy to Make Coverage More Accessible and Affordable for Millions of Americans in 2023 Some highlights:

The rule:
— “helps simplify the consumer shopping experience by establishing standardized plan options for issuers offering Qualified Health Plans (QHPs) on HealthCare.gov. With standardized maximum out-of-pocket limitations, deductibles, and cost-sharing features, consumers will be able to more directly compare other important plan attributes, such as premiums, provider networks, prescription drug coverage, and quality ratings when choosing a plan…
—requires QHPs on the Federally-facilitated Marketplace (FFM) to ensure that certain classes of providers are available within required time and distance parameters…
—aims to protect consumers from discriminatory practices related to the coverage of the essential health benefits (EHB) by refining the CMS nondiscrimination policy.”

By The Numbers: New AHIP Resource Illustrates How Employer-Provided Coverage Supports Better Health and Financial Stability This article provides state-specific data on employer-sponsored health insurance. Some “big picture” findings:
1. “Nearly half of Black Americans (47%) are enrolled in employer-provided coverage

2. More than 40% of Hispanic Americans are enrolled in employer-provided coverage

3. About two-thirds of Asian Americans and Native Hawaiian and Pacific Islanders are enrolled in employer-provided coverage

4. 50% of children (age 0-18) in the United States receive health coverage through a parent/guardian’s job

5. 60% of those with incomes between 200-399% of the Federal Poverty Line (FPL) — $20,578 for a family of 3 — are enrolled in employer-provided coverage”

The Facts About Medicare Spending From the KFF. “Medicare provides health insurance coverage for 65 million people, nearly 20% of the U.S population – a share which will grow larger in the coming decades. In 2020, Medicare spending comprised 12% of the federal budget and 20% of national health care spending.”
See the monograph for more details.

 Some Medicare Advantage Organization [MAO] Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care From the HHS OIG:
”Key Takeaway
[Some] MAOs denied prior authorization and payment requests that met Medicare coverage rules by:

• using MAO clinical criteria that are not contained in Medicare coverage rules;

• requesting unnecessary documentation; and

• making manual review errors and system errors.

…we recommend that CMS:
(1) issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews;
(2) update its audit protocols to address the issues identified in this report, such as MAO use of clinical criteria and/or examining particular service types; and
(3) direct MAOs to take steps to identify and address vulnerabilities that can lead to manual review errors and system errors.
CMS concurred with all three recommendations.”

Urgent Care Doctor and his Facilities Settle Allegations of Federal Health Care Fraud “Breon Peace, United States Attorney for the Eastern District of New York, announced today that Dr. Josef Schenker and two urgent care facilities owned by him, Josef Schenker, M.D., P.C., and Care Partners Medical Management, LLC, have agreed to pay $564,217.70 to resolve allegations that they submitted false claims to Medicare for services not provided in administering COVID-19 vaccines and tests.”

About hospitals and healthcare systems

 CHS posts $1M loss in Q1 after COVID-19 surge as contract labor rates remain high “Hospital chain Community Health Systems posted a $1 million loss for the first quarter of 2022 after experiencing its largest COVID-19 surge to date and continued high rates for contract labor.
CHS generated $3.1 billion in net operating revenues for the first quarter and adjusted earnings before interest, taxes, deductions and amortization (EBITDA) of $409 million, including $47 million in pandemic relief funds. Admissions for the system also declined slightly by 0.3% compared to the same period in 2021…
Overall, CHS’ operating costs and expenses increased to $2.8 billion, slightly above the $2.6 billion it generated in the same period in 2021.”

About pharma

 Amgen vows to fight $7.1B tax bill tied to Puerto Rico manufacturing unit “When Amgen released first-quarter results on Wednesday, its sales and profit numbers were again overshadowed by a bombshell tax disclosure.
Earlier this month, the company received a notice of deficiency from the Internal Revenue Service centered on the 2013 to 2015 period, Amgen said. The agency seeks to increase Amgen's taxable income for the period to an amount that would leave the company with a $5.1 billion bill, plus interest. On top of that, the IRS is proposing penalties of approximately $2 billion.
The notice is similar to the adjustments Amgen received from the IRS for the 2010 to 2012 period. In that case, the IRS handed Amgen a $3.6 billion bill. Amgen vowed to fight that bill as well.”

Association of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class “This cohort study of 45 RCTs found that a minority (24%) of new medicines were associated with improved QOL. Only 22% of trials showing improved progression-free survival also showed improved QOL, and approximately one-half of trials that failed to show improvement in QOL reported these outcomes positively.”

McKinsey rebuts conflict claims over work for health regulator and opioid makers “ McKinsey’s managing partner has pushed back against allegations that the consultancy breached conflict of interest rules by advising opioids producers on how to “turbocharge” sales while also working for US health regulators seeking to tackle a deadly painkiller overdose epidemic. Bob Sternfels told a US congressional committee on Wednesday that he regretted McKinsey did not act sooner to cut ties with opioid producers and help solve a crisis that has led to more than 500,000 American deaths in a decade. But he rejected the interim findings of a congressional report that suggested the consultancy’s work ‘appears potentially’ to have violated rules for federal contractors that require disclosures of potential conflicts of interest.”

Walmart, CVS Pharmacies Have Blocked or Delayed Telehealth Adderall Prescriptions “Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the last year from clinicians working for telehealth startups that have sprung up to treat attention-deficit hyperactivity disorder, according to pharmacies and people familiar with the issue.
The pharmacies in certain cases have expressed concerns that clinicians at Done Health and Cerebral Inc. are writing too many prescriptions for Adderall and other stimulants, the people said. The federal government considers the drugs controlled substances because of their potential for abuse and places them in the same category as cocaine.”

About the public’s health

In a milestone, FDA proposes ban on menthol cigarettes and flavored cigars “The Food and Drug Administration on Thursday proposed banning menthol cigarettes, a landmark action applauded by leading health and civil rights groups that say the industry has a history of aggressively marketing to Black communities and causing severe harm, including higher rates of smoking-related illness and death.
The FDA also proposed prohibiting flavors in cigars, including in small ones called cigarillos that are popular among teenagers.”

 Which Animal Viruses Could Infect People? Computers Are Racing to Find Out. Interesting article about the use of machine learning to identify threats from animal viruses and trace sources for emerging known infections (like Covid-19).

 Measles cases jump 79% in 2022 after COVID hit vaccination campaigns “ Measles cases jumped by 79% in the first two months of this year compared to 2021, after COVID-19 and lockdowns disrupted child vaccination campaigns around the world, according to data from UNICEF and the World Health Organization (WHO).
In January and February, there were 17,338 measles cases reported worldwide, up from 9,665 in the same period last year.”

Antibiotic Use and Vaccine Antibody Levels Another reason for judicious use of antibiotics:
”Antibiotic use in children <2 years of age is associated with lower vaccine-induced antibody levels to several vaccines.”

About healthcare IT

Teladoc slashes earnings outlook, takes $6.6B impairment charge on Livongo deal “In its first-quarter 2022 earnings press release (PDF), the company reported losses in the first quarter of 2022 ballooned to $6.7 million, or a loss of $41.58 per share, compared to $199.6 million, or a loss of $1.31 per share, in the first quarter of 2021. 
The company recorded a ‘non-cash goodwill impairment charge,’ which does not impact the company's cash or liquidity.  Companies opt for impairment when the value of assets or goodwill on their books is no longer fully recoverable. 
Teladoc shares plummeted 33% after-hours Wednesday.
Teladoc completed its massive $18.5 billion acquisition of digital chronic condition management company Livongo in October 2020…”

About health technology

 OIG Approves Physician-Owned Medical Device Company “On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the Company’s products hold a majority ownership interest. The Company manufactures medical device products that may be ordered by the physician owners and a physician spouse of one of the physician owners.”
The Advisory Opinion is specific to this circumstance but may have broader application.

About healthcare finance

 Healthcare M&A slowed in Q1, but investment in IT, telehealth is expected to remain hot “The pace of healthcare and life sciences mergers and acquisitions has slowed, according to KPMG’s latest report. 
The report, which examines the dealmaking pace for the first quarter of 2022, found this quarter’s deal volume has declined by 34% to 427 deals compared to the fourth quarter of 2021. Private equity has pulled back the most, making 50% fewer deals.”

Today's News and Commentary

About Covid-19

Pfizer, BioNTech ask FDA to allow Comirnaty boosters in kids 5 through 11 “Pfizer and BioNTech said Tuesday that they asked the FDA to allow a third 10µg dose of their COVID-19 vaccine Comirnaty to be given to children ages 5 through 11 under an emergency-use authorisation (EUA). The companies also plan to seek authorisations to permit Comirnaty boosters in this group "in the coming weeks" from the European Medicines Agency and other global regulatory bodies.”

Vice President Harris tests positive for the coronavirus “Vice President Harris has tested positive for the coronavirus, the White House said Tuesday, becoming the most senior Biden administration official to contract a virus that has afflicted millions of Americans.
Harris tested positive on both rapid and PCR tests but has exhibited no symptoms, said Harris’s press secretary, Kirsten Allen.”
She had been vaccinated and “boosted.” The VP will be isolated and has started on Paxlovid.

Cerner, Epic collaborate with White House on COVID-19 therapeutics “The White House announced in an April 26 press release that it is calling on EHR vendors to incorporate information about oral antivirals directly into their health records interface. 
Cerner and Epic reinforced their commitment to connecting clinicians and patients with correct information about COVID-19 treatments and is rolling out enhancements to its systems to support the White House's efforts.”
Read the article for specifics of EHR enhancements.

Longer intervals between COVID-19 vaccine doses produce higher antibody levels “A longer period between doses also was associated with higher antibody levels — up to nine times higher [2 to 4 weeks = 1,268.72 (95% CI, 1,043.25-1,542.91); more than 10 weeks = 11,479.73 (95% CI, 10,742-12,267.24)].”

About health insurance

CMS Plans to Reweight 2021 MIPS Cost Performance Category “CMS will reweight the cost performance category under the Merit-Based Incentive Payment System (MIPS) for the 2021 performance period due to the COVID-19 pandemic’s impact on clinicians and cost measures…
The cost performance category weight will change from 20 percent to 0 percent. The 20 percent will be redistributed to other performance categories, including the quality performance category, improvement activities performance category, and promoting interoperability performance category.”

 Humana's Q1 profit jumps 12% year over year to $930M “Humana reported $930 million in profit for the first quarter of 2022, up 12.3% year over year from an $828 million haul in the first quarter of 2021.
Revenues were also up by double digits from the prior-year quarter, hitting $24 billion, the company reported Wednesday. That's a 16% hike from the first quarter of 2021, when the insurer earned $20.7 billion in revenue.”

Pharmacist Sentenced for $180 Million Health Care Fraud Scheme “A former Mississippi pharmacist was sentenced today to 10 years in the Southern District of Mississippi for a multimillion-dollar scheme to defraud TRICARE and private insurance companies by paying kickbacks to distributors for the referral of medically unnecessary prescriptions. The conduct resulted in more than $180 million in fraudulent billings, including more than $50 million paid by federal health care programs. 
According to court documents, Mitchell ‘Chad’ Barrett, 55, now of Gulf Breeze, Florida, and formerly of Mississippi, participated in a scheme to defraud TRICARE and other health care benefit programs by distributing medically unnecessary compounded medications.”

About pharma

 Arizona Passes Goldwater Institute’s Right to Try Law “Arizona has become the 41st state to enact a ‘right-to-try’ law that allows patients to access drugs that are still in clinical trials without asking the FDA for permission under the agency’s expanded access program.”
The exact  terms of these laws vary by state. For example, in Illinois one of the qualifying criteria is that a patient “has a terminal illness.”

About the public’s health

 1 death, 17 liver transplants in multi-country outbreak of hepatitis in children, WHO says  “At least 169 cases of acute hepatitis in children aged one month to 16 years old have been identified in an outbreak that now involves 11 countries, the World Health Organization (WHO) said on Saturday. 
Among the cases of acute hepatitis, at least one child has died and 17 children have required liver transplants, the WHO said in a news release…
’While adenovirus is a possible hypothesis, investigations are ongoing for the causative agent.’”

FDA Issues Marketing Decisions on NJOY Ace E-Cigarette Products “On April 26, the FDA issued decisions on multiple NJOY Ace e-cigarette products, including the authorization of four new tobacco products through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods, specifically: 

• NJOY Ace Device

• NJOY Ace Pod Classic Tobacco 2.4%

• NJOY Ace Pod Classic Tobacco 5%

• NJOY Ace Pod Rich Tobacco 5%

This authorization allows these products to be legally marketed in the U.S. While this action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they ‘FDA approved.’ All tobacco products are harmful and potentially addictive. Those who do not use tobacco products shouldn’t start.”

About healthcare IT

 FBI chief says espionage threat posed by China ‘unprecedented in history’  “‘The biggest threat we face as a country from a counterintelligence perspective is from the People’s Republic of China and especially the Chinese Communist Party,’ Wray said during an interview on CBS News’s ‘60 Minutes.’
‘They are targeting our innovation, our trade secrets, our intellectual property, on a scale that’s unprecedented in history,’ he added, noting that China’s hacking program is larger ‘than that of every other major nation combined.’”

Fiscal Considerations for the Future of Telehealth “When thinking about the long-term direction for telehealth authorities, we suggest attention to the following challenges related to the federal budget, and to national health expenditures.
Utilization – telehealth services should ideally help reduce over-utilization of care, but could end up substantially increasing patient utilization of health care services.
Provider incentives – telehealth services should ideally help providers reduce the cost of care, but payment incentives might lead to more costly care – especially if telehealth services continue to be reimbursed at parity with in-person care.
Fraud and abuse – telehealth services are at particular risk for fraudulent billing.”
For example: “Since telehealth's entrance into the health care market, overall recoveries in health care fraud have doubled from $2.6 billion in FY 2019 to over $5 billion in FY 2021.”

Outcomes of In-Person and Telehealth Ambulatory Encounters During COVID-19 Within a Large Commercially Insured Cohort “In this cohort study of 40.7 million commercially insured adults, telehealth accounted for a large share of ambulatory encounters at the peak of the pandemic and remained prevalent after infection rates subsided. Telehealth encounters for chronic conditions had similar rates of follow-up to in-person encounters for these conditions, whereas telehealth encounters for acute conditions seemed to be more likely than in-person encounters to require follow-up. These findings suggest a direction for future work and are relevant to policy makers, payers, and practitioners as they manage the use of telehealth during the COVID-19 pandemic and afterward.”
The study examined what happened once patients had a telehealth visit. It did not measure how many extra visits may have occurred because of easier access.

About health technology

 Mount Sinai spinout developed algorithm that accurately diagnoses early-stage Parkinson's, per new study “The research, in a collaboration with the Michael J. Fox Foundation for Parkinson’s Research, used technology developed by a Mount Sinai spinout focused on cancer diagnostics. The study leveraged PreciseDx’s algorithms to detect a protein in salivary glands, which is linked to the disease. It was able to detect Parkinson’s with 99% sensitivity and 99% specificity and was more accurate than human pathologists in predicting the disease.”

FDA: Medtronic Issues Recall of Harmony Delivery Catheter “Medtronic is recalling the Harmony Delivery Catheter because it is possible that the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the TPV [Transcatheter Pulmonary Valve System].”

Boston Scientific surges 10% in Q1 amid slew of FDA nods, company reorganization “The medtech's net sales jumped 10% over its performance during the same period last year. The total reached just past the $3 billion threshold, compared to the $2.75 billion it earned in the first three months of 2021.
The jump came even though its earnings sheet for the quarter was short one division compared to the previous year’s. The disparity comes from the sale of Boston Scientific’s BTG specialty pharmaceuticals division, which was completed in March 2021. Until that point, BTG added $13 million that quarter that wasn’t present this time around.”

About healthcare finance

 Biofourmis banks $300M megaround to fuel its growth in remote care, potential M&A deal “Three years ago, technology startup Biofourmis had raised $10 million in total funding. This week, the virtual care and digital medicine-focused company announced a massive $300 million cash injection to fuel its growth.
The funding round has boosted Biofourmis' valuation to more than $1 billion, according to executives…
The Boston-based digital therapeutics company combines AI-based data analytics and biosensors to monitor the progress of medical treatment.”

Today's News and Commentary

About Covid-19

 Coronavirus has infected majority of Americans “Before omicron, one-third of Americans had been infected with the coronavirus, but by the end of February, that rate had climbed to nearly 60 percent — including about 75 percent of kids and 60 percent of people age 18 to 49, according to federal health data released Tuesday.”

Know your variants: A coronavirus 'cheat sheet' A good summary of the topic.

Abbott Makes $3.3B on COVID-19 Tests in First Quarter of 2022 “Abbott said it earned $3.3 billion in global COVID-19 testing-related sales in the first quarter, an increase of more than 57 percent over the same period last year, led by sales of its rapid testing products.
But the company expects that windfall to come to an end in the coming months, with its projection for the entire year set at $4.5 billion — and most of that in the first half.”

Covid-19 data reporting is becoming less frequent, making trends harder to track “Many states are scaling back on how often they report key Covid-19 statistics, a shift that some experts worry might hinder efforts to mitigate outbreaks and negative effects of the coronavirus.
A year ago, all 50 states were reporting new Covid-19 cases on a daily basis. But that has gradually trailed off. This week, Pennsylvania will be the latest state to switch from daily to weekly updates, leaving just six states that will still be reporting new Covid-19 cases every day of the week.”

About health insurance

 HHS to appeal Texas ruling that struck down key parts of surprise billing rule “The Biden administration has filed an appeal to a ruling that vacated key parts of a rule that bans surprise medical bills. 
The Department of Health and Human Services announced in a legal filing late Friday that it is appealing the ruling to the U.S. Court of Appeals for the Fifth Circuit. The decision to appeal the ruling originally issued back in February comes as HHS has other legal fights over the regulation.”

UnitedHealth Aims To Sell Change Healthcare’s $2.2B Claims Editing Service “UnitedHealth Group will sell Change Healthcare’s CHNG.O claims editing business for $2.2 billion to private equity firm TPG Capital if regulators approve a proposed merger between the two health companies.
Change Healthcare disclosed the plan in a filing made to the Securities and Exchange Commission Friday. UnitedHealth Group declined to comment and Change Healthcare didn’t immediately respond to an interview request.”

Illinois expands Medicaid to more noncitizens, midwives “The Illinois General Assembly has passed legislation that expands Medicaid coverage to midwife services and to noncitizen residents ages 42 and older.
Medicaid coverage of licensed midwife services will begin Jan. 1, 2023.
Illinois expanded Medicaid coverage to noncitizens 65 and older in 2020, becoming the first state to do so, according to the State-Journal Register.. On July 1, the age will decrease to 42.”

About hospitals and healthcare systems

 UHS improves on revenue, dips on profits in Q1 2022 “UHS reported $153.9 million in net income for the quarter, down from the $209.1 million it logged during the same period last year. However, net revenues grew year over year from $3 billion to nearly $3.3 billion.”

A systematic review of the prediction of hospital length of stay [LoS]: Towards a unified framework Despite the continuing efforts to predict and reduce the LoS of patients, current research in this domain remains ad-hoc; as such, the model tuning and data preprocessing steps are too specific and result in a large proportion of the current prediction mechanisms being restricted to the hospital that they were employed in. Adopting a unified framework for the prediction of LoS could yield a more reliable estimate of the LoS as a unified framework enables the direct comparison of length of stay methods.

Massive Growth in Expenses and Rising Inflation Fuel Continued Financial Challenges for America’s Hospitals and Health Systems An analysis from the AHA provides background on cost increases in drugs, labor and supplies, as well as the impact of inflation.

About pharma

 FDA plans study into how patients and physicians make prescription decisions “he FDA’s Office of Prescription Drug Promotion (OPDP) wants to find out how patients and physicians weigh the trade-offs between risks and benefits when starting a new prescription drug. What characteristics influence treatment choices and how do people reach the decision for one drug over another? The OPDP will be answering these questions through a new study (PDF).
The study will focus on Type 2 diabetes and psoriasis, splitting 800 patients and 800 physicians who have or specialize in those diseases to compare the preferences of the two groups. Participants will be asked to make specific choices based on profiles of fake prescription drugs in a process that will take 20 minutes.”

Novartis backs full-year outlook as Q1 growth led by Entresto Details by drug are provided.

About the public’s health

 Aspirin Use to Prevent Cardiovascular Disease: Preventive Medication  “The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older.” 

Judge Says Migrants Must Still Be Denied Entry for Health Reasons “The federal government has announced plans to lift the order, known as Title 42, on May 23 — a move that is expected to create a considerable surge of migration from Mexico. Several states have challenged the plan, saying it will create chaos on the border and lead to significant impacts on states forced to handle the newly arriving migrants.
Judge Robert R. Summerhays of the United States District Court for the Western District of Louisiana did not yet rule on the issue of whether Title 42, adopted early in the coronavirus pandemic, should be kept in place. But he said he would in the meantime grant a request from the states of Missouri, Louisiana and Arizona to prevent the federal government from taking any early steps to disregard Title 42 for certain migrants and process them under normal immigration procedures.”

About healthcare IT

 EHR vendors ranked by ​​percentage of hospital market share FYI

 US agency unveils framework to evaluate health apps “The Defense Health Agency's branch for connected health developed a framework to evaluate the thousands of health apps available. 
The framework, called the App Rating Inventory, was created to support clinical decisions regarding app selection, according to a study published April 15 in the Journal of Medical Internet Research.
The App Rating Inventory produces scores for three categories: evidence, content and customizability. The evidence category is based on six measures, and the content and customizability categories are based on 11 measures each. All 28 measures are weighted equally.”

About healthcare personnel

 PAI-Avalere Health Report on Trends in Physician Employment and Acquisitions of Medical Practices: 2019-2021 “Key Findings:

Nearly 3 of 4 physicians are now employed by hospitals, health systems and other corporate entities such as private equity firms and health insurers.      

• More than one hundred thousand (108,700) physicians shifted to employment since January 2019. This growth split nearly evenly between hospital employees (58,200 additional physician employees) and other corporate entities (50,500 additional physician employees).

• Of those, 83,000 physicians (76%) became employees since the pandemic began.

• 2021 alone saw a marked increase in employed physicians, growing by 19%, from 69.3% to 73.9% of all physicians…

• Hospitals and corporate entities, including private equity firms and insurance companies, now own over half (52.1%) of physician practices (hospitals own 26.4% and other corporate entities own 27.2%).

• While hospital and health system acquisitions continued at a steady pace (9% growth), the sharpest increase (86% growth) in medical practice acquisitions over the three-year study period was by corporate entities.

• The COVID-19 pandemic accelerated corporate ownership of physician practices and physician employment by hospital systems and other corporate entities in the last half of 2020 and throughout 2021.

• Every region of the country saw a steady trend towards increased employment and hospital and corporate ownership of practices, but there are distinct differences among regions.

  • The South saw the highest rate of acquisitions by corporate entities (94% increase).

  • The Midwest continued to have the highest percentage of physicians employed by hospitals and health systems (63.5%, growing 9% over the study period).”

About health technology

 Philips Subpoenaed by DOJ Over Sleep-Apnea Device Recall “Royal Philips NV has been subpoenaed by the Justice Department in relation to a sprawling and costly recall of breathing-aid devices affecting millions of sleep-apnea patients.
The Dutch healthcare conglomerate is amid a huge recall over concerns that a type of foam used in certain breathing-aid devices could degrade and release harmful, possibly cancer-causing particles. Philips said its Respironics division and some other subsidiaries received the subpoena on April 8 to ‘provide information relating to events leading to the Respironics recall.’ It said it was cooperating with the agency.”

Today's News and Commentary

About Covid-19

Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children “Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are:

• Hospitalized, or

• Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population.”

Oral Antiviral Medications for COVID-19 A good, easy to understand review of the topic

 Biden admin to promote availability of COVID antiviral pill “First approved in December, supply of the Pfizer regimen was initially very limited, but as COVID-19 cases across the country have fallen and manufacturing has increased it is now far more abundant. The White House is now moving to raise awareness of the pill and taking steps to make it easier to access. 
Paxlovid, when administered within five days of symptoms appearing, has been proven to bring about 90% reduction in hospitalizations and deaths among patients most likely to get severe disease…
The U.S. has ordered enough supply of the pills for 20 million people, which is estimated to last for several more months. The administration has warned that subsequent deliveries are dependent on Congress approving additional COVID-19 response funding.”
In a related story: WHO recommends highly successful COVID-19 therapy and calls for wide geographical distribution and transparency from originator “WHO made a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at highest risk of hospital admission, calling it the best therapeutic choice for high-risk patients to date. However, availability, lack of price transparency in bilateral deals made by the producer, and the need for prompt and accurate testing before administering it, are turning this life-saving medicine into a major challenge for low- and middle-income countries.” 

Quarter of US COVID-19 deaths could have been prevented by vaccination: analysis “The analysis from the Peterson Center on Healthcare and the Kaiser Family Foundation underscores the importance of vaccination, and indicates a significant portion of the heavy toll from the virus could have been prevented.  
The 234,000 preventable deaths translates to about one quarter of the nearly 1 million U.S. deaths from the virus since the pandemic began, and 60 percent of the deaths since June 2021, when vaccines became widely available.”

COVID-19 third leading cause of death for 2nd year straight: 4 updates “About 415,000 Americans died of COVID-19 in 2021, making it the third leading cause of death in the U.S. for the second consecutive year, according to provisional data from the CDC. 
The two leading causes of deaths last year were heart disease and cancer, respectively, with provisional death tolls of about 693,000 and 605,000, respectively, according to the data published April 22. 

About health insurance

 Biden administration says it won’t keep messing with Texas' Trump-era Medicaid waiver “The Biden administration is dropping out of litigation against a Texas Medicaid waiver that the Trump administration approved during its final week in office, saying the yearlong court fight has overtaxed the federal government’s resources.
Last spring, the Centers for Medicare and Medicaid Services revoked a 10-year waiver for Texas’ Medicaid program that the Trump administration approved on Jan. 15, 2021, without going through a required public comment period. The provision, which extended the state’s waiver for a decade, included significant money for health providers to cover the cost of caring for uninsured patients. Texas sued the Biden administration, and in August a federal district court judge reinstated the waiver. With CMS’ decision not to challenge that judge’s ruling, the provision will continue through 2030.”

CMS Proposes Updates to Reduce Barriers to Coverage, Simplify Medicare Enrollment and Expand Access “CMS) issued a proposed rule to update Medicare enrollment and eligibility rules that would expand coverage for people with Medicare and advance health equity. This proposed rule would provide Medicare coverage the month immediately after enrollment, thereby reducing the uninsured period and expand access through Medicare special enrollment periods (SEPs). It would also allow eligible beneficiaries to receive Medicare Part B coverage without a late enrollment penalty. This proposed rule would make it easier for people to enroll in Medicare and eliminate delays in coverage.”

About pharma

The top advertisers in Big Pharma FYI. The list is by drug.

 Pfizer recalls some batches of blood pressure drug over carcinogen presence “Pfizer said on Friday it was voluntarily recalling five batches of its Accupril blood pressure tablets after finding elevated levels of a potential cancer-causing agent in the medicine.
The drugmaker said it was not aware of any reports of adverse events related to the recalled batches, which were distributed in the United States and Puerto Rico from December 2019 to April 2022.”
This problem has recently occurred with a number of other medications.

British Regulatory Watchdog Lambasts Seven Pharmaceutical Companies for Code of Practice Breaches “The UK’s self-regulatory industry watchdog, the Association of the British Pharmaceutical Industry (ABPI) has cited seven drugmakers for violations of its code of practice — LEO Pharma, Janssen, Teva Pharmaceuticals, Lundbeck, Otsuka Europe, Daiichi-Sankyo and Roche.
LEO Pharma, for example, was dinged for promoting its psoriasis drug Enstilar (betamethasone dipropionate/calcipotriol monohydrate) before it was given marketing authorization and for its failure to disclose payments made to patient organizations in 2019.”

About the public’s health

 HHS Launches Pledge Initiative to Mobilize Health Care Sector to Reduce Emissions “The voluntary pledge asks signees to, at a minimum, commit to: (1) reducing their organization’s emissions (by 50% by 2030 and to net zero by 2050) and publicly reporting on their progress; (2) completing an inventory of Scope 3 (supply chain) emissions; and (3) developing climate resilience plans for their facilities and communities. It also asks them to designate an executive lead for this work. 

Showa Group Receives FDA’s 510(k) Approval for Biodegradable Nitrile Glove “Fayette, Ala.-based Showa Group’s single-use nitrile gloves have been granted the FDA’s 510(k) marketing clearance.
The company claims to be the only U.S. domestic manufacturer of FDA-cleared, Berry Amendment-compliant medical gloves. The Berry Amendment requires the Department of Defense to give preference in procurement to domestically manufactured products.”

About healthcare IT

 SAS and Microsoft Drive Toward Health Care Interoperability “Global analytics leader SAS and Microsoft are working together to build deep technology integrations, making advanced health analytics more accessible to health care and life science organizations. The collaboration boosts health care interoperability by enabling the use of Fast Healthcare Interoperability Resources (FHIR®) standards and through integration from Azure Health Data Services to SAS® Health on Azure. 
Microsoft recently announced the availability of Azure Health Data Services, a platform as a service (PaaS) offering designed to support Protected Health Information (PHI) in the cloud. By connecting to Azure Health Data Services, the embedded AI capabilities of SAS Health are more efficient and secure, expanding the possibilities of patient-centric innovation and trusted collaboration across the health landscape.”

About health technology

 Labcorp beefs up at-home testing options with Getlabs’ on-demand blood draw service  “Only a few months after launching its Labcorp OnDemand direct-to-consumer testing service, allowing individuals to order tests straight to their doorsteps, the diagnostics giant has inked a deal with Getlabs allowing them to schedule their own sample collection services, too.
Getlabs offers a staff of full-time phlebotomists who are authorized to collect blood, saliva, stool, urine and breath samples. Patients can book a sample collection appointment online, arranging for the Getlabs staffer to meet them at either their home or workplace. Prices start at $25.”

Today's News and Commentary

About Covid-19

CDC panel skeptical of fourth Covid shots for broader population, says U.S. needs clear vaccine strategy “The CDC’s panel of independent vaccine experts signaled an unwillingness to endorse fourth Covid shots for the broader U.S. population until the agency adopts a clear strategy.
The group, in a five-hour meeting Wednesday, largely agreed that repeatedly deploying boosters to prevent infection isn’t a realistic goal with the current generation of shots.”

 Philly ends mask mandate and nixes response levels; Kenney said SEPTA’s move influenced the decision “Mayor Jim Kenney said the decision to scrap the mandate after just a few days was influenced in part by SEPTA’s announcement on Monday that masks would no longer be required on public transit.
SEPTA lifted its mandate shortly after a federal judge in Florida struck down the CDC’s rule requiring masks on most forms of transit.”

About health insurance

 Dozens of Hospitals Sue HHS Over Medicare Billing “On Wednesday a case was filed in the Central District of California by the Cleveland Clinic, Paradise Valley Hospital, and over 125 other hospitals against Xavier Becerra as Secretary of Health and Human Services. The case is regarding the calculation of payments owed under Medicare Part A bills and the Disproportionate Share Hospital (DSH) payment adjustment.
The complaint explained that one of the factors included in the DSH payment adjustment calculation is the number of ‘days entitled to benefits under part A.’
This particular factor comes into play on the “denominator” side of the calculation and on the “numerator” side of the calculation of the disproportionate patient percentage . However, the plaintiffs in the case accuse HHS and Medicare of using different definitions for ‘entitled’ depending on which side of the fraction is being reviewed, resulting in a lower payment to the hospital than would otherwise be calculated.”

KLAS: Hospitals say price transparency remains too confusing and pricey to implement “KLAS spoke with 66 revenue cycle leaders to get a sense of how hospitals feel about the shift towards price transparency and the nuts and bolts of implementing the rule more than a year after its compliance deadline…
Among those surveyed, 52% said that the rule requires a significant number of resources to comply while 40% put resource requirements at a moderate level and 8% at a small number. 
Many of the respondents lashed out at two parts of the rule: the requirement that facilities use machine-readable files for the pricing information and that they put online a master list of rates. 
Respondents cited problems with ‘software used to publish the pricing information. Some say the published rates mainly benefit payer and provider organizations instead of patients.’”

About hospitals and healthcare systems

Rural hospitals have been particularly challenged during the Covid-19 pandemic. Below are two papers explaining the problems they face:
Pandemic Increases Pressure on Rural Hospitals & Communities and
THE IMPACT OF THE PANDEMIC ON RURAL HOSPITALS

 HCA's profit dips to $1.2B as labor costs rise “The 182-hospital system reported revenues of $14.95 billion in the first quarter of this year, up from $13.98 billion in the same period of 2021. The for-profit hospital operator said same-facility admissions, emergency room visits and inpatient and outpatient surgeries increased year over year. 
HCA reported higher expenses. Salaries and benefits climbed 10.1 percent year over year to $6.94 billion. Supplies expenses were $2.32 billion, up 4.4 percent from the same quarter of 2021. “

About pharma

Spending on U.S. Medicines Rose 12% in 2021 Due to COVID-19 Vaccines and Therapies, Says IQVIA Institute for Human Data Science “Spending on medicines in the United States, at estimated net manufacturer prices, reached $407 billion in 2021, up 12% over 2020, as COVID-19 vaccines and therapeutics became widely available and added $29 billion in related spending…In the same year, the non-COVID medicines market grew more slowly, at 5%, from the growing impact of biosimilars, which increased significantly, offsetting increased use of branded medicines. 
Patient out-of-pocket (OOP) costs in aggregate rose $4 billion, or 5.3%, in 2021 to a total of $79 billion, back to the level seen in 2018 after two years of declining costs. Those OOP costs remain a significant burden for a relatively small part of the population, even as average costs per prescription were flat or slightly declining.”

 As US launch falters, Biogen ditches Aduhelm application in Europe “Biogen has scrapped its filing for the Alzheimer’s disease drug in the European Union after talks with regulators made it clear the data provided so far are unlikely to support marketing approval, the company said Friday.”

About the public’s health

What's the State of YOUR Air? Annual American Lung Association report on air quality, by county. Enter your zip code to get local information.

Study finds disparities in improper antibiotic prescribing “The analysis found that 11.3% of visits included a prescription for an oral antibiotic, with patients under 18 years (114.1 prescriptions per 1,000 patient visits), Black patients (122.2/1,000 patient visits), Hispanics (138.6/1,000 patient visits), and women (169.6/1,000 patient visits) having the highest antibiotic prescribing rates.
When the researchers broke down the data on inappropriate prescribing, they found that nearly three quarters of the antibiotic prescriptions (73.9%) written for patients 65 and older were inappropriate. They also found high rates of inappropriate antibiotic prescribing for Black patients (63.8%), Hispanic patients (57.5%), and men (57.7%).
The most common reasons for inappropriate antibiotic prescriptions were non-bacterial skin conditions, viral respiratory tract infections, and bronchitis.”

 Effects of mango and mint pod-based e-cigarette aerosol inhalation on inflammatory states of the brain, lung, heart, and colon in mice  “Our findings suggest that daily e-cigarette use may cause neuroinflammation, which may contribute to behavioral changes and mood disorders. In addition, e-cigarette use may cause gut inflammation, which has been tied to poor systemic health, and cardiac inflammation, which leads to cardiovascular disease.” 

Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Persons New draft recommendation: “The USPSTF recommends against the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal persons.” and
”The USPSTF recommends against the use of estrogen alone for the primary prevention of chronic conditions in postmenopausal persons who have had a hysterectomy.”
This document is available for Public Comments until May 16, 2022.

How Discrimination in Health Care Affects Older Americans, and What Health Systems and Providers Can Do From The Commonwealth Fund:
Highlights

• “Older adults in the United States are more likely to report racial and ethnic discrimination in the health system exists, compared with their peers in 10 other high-income countries.

• In the U.S., one in four Black and Latinx/Hispanic adults age 60 and older reported that they have been treated unfairly or have felt that their health concerns were not taken seriously by health professionals because of their racial or ethnic background.

• More than a quarter of U.S. older adults said they did not get the care or treatment they felt they needed because of discrimination.

• U.S. older adults who have experienced discrimination in a health care setting were more likely to have worse health status, face economic hardships, and be more dissatisfied with their care than those who did not experience discrimination.”

About healthcare IT

 RCM company suffers 3rd-largest health data breach of 2022 “Adaptive Health Integrations, a Williston, N.D.-based company providing healthcare billing services, suffered a breach in October that exposed510,574 individuals' data.
The incident is the third-largest healthcare data breach to occur in 2022, according to HHS' reporting portal.”

Physician Indicted in $10 Million Telemedicine Health Care Fraud Scheme “According to the indictment, Dr. Raffai purported to practice telemedicine with the AffordADoc Network and other telemedicine companies that paid the defendant for each consultation with a beneficiary. Between July 2016 and June 2017, Dr. Raffai allegedly participated in a health care fraud scheme in which he signed prescriptions and order forms via purported telemedicine services for durable medical equipment (DME), including orthotic braces, that were not medically necessary. Dr. Raffai caused the submission of these claims based solely on a short telephone conversation for beneficiaries he had not physically examined and evaluated, and that were induced, in part, by the payments of bribes and kickbacks. Dr. Raffai was paid by telemedicine companies approximately $25 or $30 per patient consultation. The indictment further alleges that Dr. Raffai, together with others, submitted or caused the submission of approximately $10 million in false and fraudulent claims to Medicare for DME on behalf of beneficiaries who were residents of the Eastern District of New York, and Medicare paid more than $4 million on those claims.”

About healthcare personnel

 PAI-Avalere Health Report on Trends in Physician Employment and Acquisitions of Medical Practices: 2019-2021  Key Findings:

“Nearly 3 of 4 physicians are now employed by hospitals, health systems and other corporate entities such as private equity firms and health insurers.      

• More than one hundred thousand (108,700) physicians shifted to employment since January 2019. This growth split nearly evenly between hospital employees (58,200 additional physician employees) and other corporate entities (50,500 additional physician employees).

• Of those, 83,000 physicians (76%) became employees since the pandemic began.

• 2021 alone saw a marked increase in employed physicians, growing by 19%, from 69.3% to 73.9% of all physicians.”

About health technology

 Intuitive Surgical pulls off 15% revenue growth despite ongoing COVID, supply chain challenges “…Intuitive Surgical was able to kick off the year with a modest win, putting up first-quarter revenues of $1.49 billion—a 15% jump compared to the $1.29 billion it earned in the same period of last year, but a minor slip from the $1.55 billion it raked in during the prior quarter, the final three months of 2021.
The year-over-year growth stemmed from a 19% surge in the number of procedures performed around the world using Intuitive’s da Vinci robotic surgery system. Those additional uses were led by ‘bariatric procedures, cholecystectomy, hernia repair and rectal surgery”’in the U.S., CEO Gary Guthart said during a call with investors on Thursday.”

Today's News and Commentary

About Covid-19

 Moderna to file for EUA of COVID-19 shot for very young kids by April end “Moderna plans to submit an application to the U.S. health regulator for emergency use authorization (EUA) of its COVID-19 vaccine among kids between the ages of six months to five years by end of the month, a company spokesperson said on Wednesday.”

Most People Under 50 Don’t Need 4th Shot Yet, CDC Panel Suggests  “Most Americans under 50 should wait for the next generation of booster shots rather than getting a fourth dose now to prevent Covid-19 infections, according to several members of a panel of advisers to the U.S. Centers for Disease Control and Prevention.
The goal of booster shots should be to limit severe outcomes rather than to prevent transmission of the virus, the advisers said in a meeting Wednesday. That means people with high risk of grave illness from an infection should consider an extra shot, but most people should hold out for better vaccines later this year, they said.”

Justice Department Announces Nationwide Coordinated Law Enforcement Action to Combat Health Care Related COVID-19 Fraud “The Department of Justice today announced criminal charges against 21 defendants in nine federal districts across the United States for their alleged participation in various health care related fraud schemes that exploited the COVID-19 pandemic. These cases allegedly resulted in over $149 million in COVID-19-related false billings to federal programs and theft from federally-funded pandemic assistance programs. In connection with the enforcement action, the department seized over $8 million in cash and other fraud proceeds.”

After rejecting COVID rule, Arizona could lose oversight of workplace safety “The U.S. Occupational Safety and Health Administration on Wednesday moved to revoke Arizona's ability to police workplace safety within the state after it refused to adopt a federal rule requiring COVID-19 protections for healthcare workers.”
OSHA has also warned Utah, South Carolina.

COVID-19 tracker: UK study finds strong responses 84 days after booster shot “A U.K.-wide study found prolonged ‘strong immune responses’ 84 days after participants received a booster COVID-19 shot. The study, led by the University Hospital Southampton (UHS) and published in the Journal of Infection, tested immune responses after seven different vaccines used as a boosters 28 days after receiving two doses of AstraZeneca or Pfizer vaccines. While different initial vaccines yielded different results from the booster, “the rate that immune cell responses declined after third doses was similar between all the vaccine combinations and doses,” according to a UHS spokeswoman…”

Novavax touts early data for flu-COVID combo vaccine as FDA decision looms for single shot “Novavax says its combo flu and COVID vaccine elicits a strong immune response similar to standalone flu and COVID jabs, according to initial results of a phase 1/2 trial. 
The results, announced Wednesday, came from a phase 1/2 trial in 642 older adults between 50 to 70 conducted in Australia. One hundred percent of the participants had been vaccinated by an initial series of one of the available COVID vaccines. The objective of the trial was to identify an optimal dose of the vaccine using a modelling-based approach.”

About health insurance

CMS Updates Guidance for Independent Dispute Resolution [IDR] Entities “CMS has updated its surprise billing guidance to require independent dispute resolution (IDR) entities to consider more than just the qualifying payment amount (QPA) when determining reimbursement amounts for out-of-network services under the No Surprises Act…
The No Surprises Act states that IDR entities should consider several different factors when determining a reimbursement rate.
The revised guidance from CMS addresses these concerns. It states that IDR entities must consider the QPA—the payer’s median contracted rate for the service—and other information that either party submits or the IDR entity requests.
For non-air ambulance items and services, additional factors include:

• the provider’s level of training, experience, quality, and outcomes measurements

• the provider’s regional market share

• the acuity of the individual who received the item or service, or the complexity of providing the service

• the teaching status, case mix, and scope of services that the provider or facility offers

• demonstration of good faith efforts, or lack of efforts, from the provider and payer to enter into network agreements…

The guidance also stated that IDR entities may not consider usual and customary charges for the service, the amount that providers would have billed without the No Surprises Act provisions, or the reimbursement rate for the service by public payers.
The CMS guidance noted that it is not the IDR entity’s responsibility to determine whether the QPA is correct, make determinations of medical necessity, or review coverage denials.”
The No Surprises Act has two components: Provider provision of estimated treatment costs and balance billing guidelines.
Here are three additional resources:
Implementing the No Surprises Act From the MGMA
GOOD FAITH ESTIMATES (GFE) FOR UNINSURED (OR SELF-PAY) INDIVIDUALS From CMS
Notice of IDR Initiation Just-opened site from CMS

 Louisiana AG sues UnitedHealth, alleging drug overcharges in Medicaid “Louisiana Attorney General Jeff Landry has sued UnitedHealth Group, claiming that the healthcare and insurance giant has inflated drug charges in the state's Medicaid program by billions.
The suit was filed April 13 in state court, Bloomberg reported, and alleges that the company's pharmacy benefit manager Optum Rx took advantage of the secrecy of the pharmacy supply chain to "needlessly" charge Medicaid billions for prescription drug benefits.”

Bankrupt health sharing ministry leaves families with $50M in unpaid bills “About 10,000 families have been left with $50 million in unpaid medical bills after the shuttering of their health sharing ministry…
Sharity Ministries, formerly known as Trinity HealthShare, filed for bankruptcy and started the liquidation process in 2021, according to the report… 
The Atlanta-based nonprofit had faced challenges, class-action lawsuits, and cease-and-desist-orders in several states, where regulators said it had been operating as an unauthorized insurance provider, according to the report.”

Association of Medical Financial Hardship and Mortality Among Cancer Survivors in the United States “Among cancer survivors aged 18-64 years and 65-79 years, 29.6% and 11.0%, respectively, reported financial hardship in the past 12 months. Survivors with hardship had higher adjusted mortality risk than their counterparts in both age groups: 18-64 years (hazard ratio [HR] = 1.17, 95% confidence interval [CI] = 1.04 to 1.30) and 65-79 years (HR = 1.14, 95% CI = 1.02 to 1.28). Further adjustment for health insurance reduced the magnitude of association of hardship and mortality among survivors aged 18-64 years (HR = 1.09, 95% CI = 0.97 to 1.24). Adjustment for supplemental Medicare coverage had little effect among survivors aged 65-79 years (HR = 1.15, 95% CI = 1.02 to 1.29).” {Emphases added]

About hospitals and healthcare systems

Changes in Ownership of Hospital and Skilled Nursing Facilities: An Analysis of Newly-Released CMS Data Some Key Points:
—“Analysis of this dataset indicates that 348 hospitals and more than 3,000 skilled nursing facilities experienced a change in ownership between 2016 and 2021, with wide variation in hospital rates across states.
—Ownership changes were more common in medium and larger hospitals (compared to small hospitals), hospitals with negative profit margins, and long-term care hospitals.
—Future research can link this new dataset to other sources of information to support policymaking and research on consolidation, health care quality, and health care costs.”

 Tenet Healthcare reports $139M profit, above-expectations EBITDA for Q1 2022 “As a whole, the company logged net operating revenues and operating income of more than $4.7 billion and $648 million, respectively, during the first quarter of the year. This is down slightly from 2021’s nearly $4.8 billion net operating revenues but up from its $520 million operating income.” 

About pharma

 EMA Reports Record Numbers of Adverse Drug Reactions in 2021 “The European Medicines Agency (EMA) said its EudraVigilance system for tracking suspected adverse reactions to medicines last year logged the highest number of cases ever, driven by COVID-19 vaccine reporting.
The agency said that more than 3.5 million individual case safety reports were recorded. The EudraVigilance database currently holds more than 22.3 million individual case safety reports relating to 12.9 million suspected adverse drug reactions. Adverse reactions can lead to several individual case safety reports, including the initial report and follow-ups.
More than 25 percent of the adverse event reports in 2021 discussed by the agency’s Pharmacovigilance Risk Assessment Committee were related to COVID-19 vaccines, the agency said.”

About the public’s health

 White House unveils national drug control strategy amid rising overdoses “The Biden administration on Thursday is sending its National Drug Control Strategy to Congress, amid a record level of drug overdoses…
he White House plan is centered on increasing treatment for addiction while also fighting trafficking for drugs. It calls for greater access to naloxone, a drug to fight overdoses that first responders can carry.  
It also includes measures aimed at boosting treatment for people at highest risk for overdoses, ‘which includes people experiencing homelessness [and] those who are incarcerated or re-entering society,’ the White House said.”

CMS releases health equity strategy centering on outreach, data collection “CMS’ equity action plan, released Wednesday, calls for increased efforts to expand outreach efforts to enroll people in coverage and standardize the use of data on social risk factors and other demographics. The agency has sought comments over the past year from stakeholders on how to incorporate equity into regulations…
Some of the actions CMS seeks to take on equity are:

• Building on outreach effort to get more people into coverage via Medicare, Medicaid, Children’s Health Insurance Program and the Affordable Care Act’s exchanges.

• Evaluating policies to ensure they help safety net providers that often care for underserved communities.

• Promoting services in the culture and language of patients’ preferred languages and health literacy.

• Incorporating screening on social needs and promoting broader access.”

MITIGATING AND PREVENTING MEDICAL DEVICE SHORTAGES AND PRIORITIZING PUBLIC HEALTH From the FDA’s Center for Devices and Radiological Health (CDRH): “The CARES Act, enacted in March 2020, gave the FDA device shortages authority for the first time. It required certain medical device manufacturers to provide information to the FDA on product availability, and on potential meaningful supply chain disruptions, during or in advance of a PHE [Public Health Emergency]. Thanks to that authority, CDRH has been able to better understand and monitor the complex web of supply chains that feed the medical device industry, and to be more proactive in solving problems before they occur…
To better protect public health, the statutory authority should be revised to require notifications from manufacturers to CDRH any time there is the potential for a device shortage (similar to the FDA’s broader authority for drugs)—and not just during or in anticipation of a PHE. Without more comprehensive authority, our device supply chain and U.S public health remain at risk.”

 About healthcare finance

 Wallaby hops to €500M acquisition of fellow stroke devicemaker Phenox  “Both companies have developed lines of neurovascular devices meant for use in interventional stroke treatments. Wallaby’s include a neuro-embolic coil system to treat aneurysms and a handful of stroke-focused catheters—while Phenox has put out ranges of flow diverters and stent retrievers, plus coating technologies for those implants. Phenox also owns its subsidiary Femtos, which uses femtosecond laser technology to churn out stents and other neurovascular implants.
Wallaby and Phenox have been partners since 2019 when the latter began serving as the exclusive distributor for several of Wallaby’s offerings in the U.S. and Europe.”

FTC Gives OK to Hikma’s Acquisition of Custopharm “The Federal Trade Commission (FTC) has granted approval to UK-based Hikma Pharmaceuticals to acquire generic drugmaker Custopharm from Water Street Healthcare Partners.
The approval is contingent on Custopharm, which is headquartered in Carlsbad, Calif., divesting its corticosteroid drug triamcinolone acetonide (TCA) to another Water Street subsidiary, Long Grove Pharmaceuticals.
Hikma sells several injectable generic medicines in the U.S. market. Without the divestment, the FTC believes Hikma would stop developing its own injectable TCA drug, which would limit competition in the market.”

Regeneron to Acquire Checkmate Pharmaceuticals for $250 Million “Regeneron has inked a deal to acquire Cambridge, Mass.-based Checkmate Pharmaceuticals for $250 million.
The purchase gives Regeneron access to Checkmate’s vitudolimod, an investigational toll-like receptor 9 (TLR 9) agonist that has shown promising antitumor activity.”

Humana to sell 60% stake in Kindred at Home to private equity firm “Humana is selling a 60 percent stake in its Kindred at Home hospice and personal care business to the private equity firm Clayton, Dubilier & Rice. 
The deal is worth $2.8 billion, according to an April 21 news release. The transaction is expected to close in the third quarter of 2022.”