Today's News and Commentary

About health insurance/insurers

 Estimated Costs of Intervening in Health-Related Social Needs Detected in Primary Care Findings  In this decision analytical model with a simulated sample based on data of 19 225 noninstitutionalized children and adults of all ages seen in primary care practices, the cost of providing evidence-based interventions for social needs averaged $60 per member per month.
Meaning  The findings of this study suggest that substantial resources would be needed to implement a comprehensive approach to addressing social needs that falls largely outside of existing federal financing mechanisms.”
Comment: This article draws a distinction between social insurance and health insurance, despite the obvious link between health and social determinants of disease. $60 per member per month would be an expensive addition to a health insurance policy and would result in fewer people being insured. We need to find a political and financial solution to to funding these needs.
For a thoughtful editorial, see: Addressing Health-Related Social Needs—Costs and Optimism

About hospitals and healthcare systems

MAY 2023 National Hospital Flash Report
“Key Takeaways

  1. Hospitals broke even in April.

    The median operating margin for hospitals was 0% in April, leaving most hospitals with little to no financial wiggle room.

  2. Volumes dropped while lengths of stay increased.

    Hospital volumes dropped across the board—including inpatient and outpatient. Emergency department volumes were the least affected.

  3. Effects of Medicaid disenrollment could be materializing.

    Hospitals experienced increases in bad debt and charity care in April. Combined with anemic patient volumes, experts note this data could illustrate the effects of the start of widespread disenrollment from Medicaid following the end of the COVID-19 public health emergency.

  4. Inflation continued to throttle hospital finances.

    Labor costs jumped in April and the costs of goods and services continued to be well above pre-pandemic levels. Though expenses generally fell in April, revenues declined at a faster rate.”


Advocate Health reports 0.1% operating margin, $579M net gain for its first post-merger quarter “Advocate Health, the newly formed marriage of major nonprofits Advocate Aurora Health and Atrium Health, reported a $10.4 million operating income (0.1% operating margin) and $578.7 million net gain in its first-ever first-quarter earnings report released Tuesday.
The 67-hospital entity tallied more than $7.54 billion in total revenue during the three months ended March 1 thanks to year-over-year increases across each of its major divisions—Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist.”

About pharma

 FDA proposes revamping medication guides that come with prescriptions “The US Food and Drug Administration proposed Tuesday to add to what you get with your prescription drugs.
The proposed rule would require the prescriptions you get to come with a new kind of single-page medication guide with an easy-to-use set of directions and easy-to-understand safety information, a goal the FDA has been working toward for years.”

This panel will decide whose medicine to make more affordable. Its choice will be tricky An excellent review of state-initiated pharma cost controls. Some of the questions that must be answered are: “Do they tackle drugs with extremely high costs taken by only a handful of patients, or drugs with merely very high costs taken by a larger group? Should they consider only out-of-pocket costs paid by consumers…, or the total cost of the drug to the health system? Will they weigh only drug prices, or will they try to right social wrongs with their choices?”

About healthcare IT

 AI Improves Stroke Recognition in Emergency Calls “The model was trained using data on 1.5 million calls to the emergency services between 2015 and 2020, of which 7370 turned out to be actual stroke cases. It was then tested on 2021 data on 344,000 calls of which 750 were stroke cases.
Results showed that the AI model correctly identified 63% of patients who were having a stroke, a better result than the human emergency call dispatchers who recognized just 52.7% of stroke cases.”

Today's News and Commentary

What's in — and out — of the debt ceiling deal A really good summary of the healthcare terms of the proposed budget compromise. Highlights include the exclusion of Medicaid work requirements and a claw back of billions in covid-19 relief funds.

About health insurance/insurers

The Value of Employer-Provided Coverage in 2023 “Most consumers (63%) are satisfied with their current employer-provided coverage, and the vast majority (68%) prefer to get their coverage through their employer rather than through the federal or state government. This satisfaction is driven by the comprehensive coverage, affordability, and choice of providers their plans provide. In addition, a majority (59%) feel the quality of their current health insurance plan is high.
During this time of high inflation and rising cost of living, costs remain a top concern for consumers. Encouragingly, a majority of those with employer-provided coverage (53%) report that what they currently pay for coverage overall is reasonable.”
Note: This independent study was commissioned by AHIP.

Milliman Medical Index: Healthcare costs exceed $31,000 for hypothetical American family of four “In 2023, healthcare costs for our hypothetical family of four reached $31,065. Costs for the average person reached $7,221. While these are averages, the MMI provides greater specificity thanks to an interactive tool that allows people to calculate costs for themselves or their own family. To use the interactive tool, go to http://us.milliman.com/MMIfamilies/.”
Note: The figures are averages for an employer-sponsored PPO.

The Shadowy Financial Empire Built Around Liberty HealthShare Is Showing Signs of Strain A great investigative piece by ProPublica that points out the flimsy coverage of ministry-based insurance plans.

Payers ranked by Medicaid membership | Q1 2023 FYI

Healthcare billing fraud: 10 recent cases FYI. Amazing what people attempt to do.

About hospitals and healthcare systems

Ascension posts $1.4B Q1 operating loss  “A decline in COVID-19 funding and sustained expenses issues helped lead St. Louis-based Ascension to a $1.8 billion operating loss in the nine months ending March 31.
The nine-month loss was on revenue of $21.3 billion. In the quarter ending March 31, the 140-hospital system reported an operating loss of $1.4 billion on $6.9 billion in revenue.
Such losses compared with $640 million and $671 million deficits in the nine-month and three-month periods, respectively, ending March 31, 2022.”

Trinity Health reports $283.5M operating loss “Livonia, Mich.-based Trinity Health, one of the largest nonprofit health systems in the country, reported an operating loss of $283.5 million for the first nine months of its fiscal year up to March 31.
The loss, which included a reduction of $137.2 million from pandemic-related provider relief funds compared with the same period in 2022, also compared with an operating gain of $139.7 million in 2022.”

About pharma

Sacklers win appeal that shields them from opioid lawsuits, clearing way for bankruptcy settlement “Afederal appeals court ruled Tuesday Purdue Pharma can shield its owners — members of the wealthy Sackler family — from thousands of lawsuits over the role the company played in the opioid crisis in exchange for a contribution of up to $6 billion to a proposed bankruptcy settlement.”

About the public’s health

With population of aging Americans growing, U.S. median age jumps to nearly 39 “The share of residents 65 or older grew by more than a third from 2010 to 2020 and at the fastest rate of any decade in 130 years, while the share of children declined, according to new figures from the most recent census.
The declining percentage of children under age 5 was particularly noteworthy in the figures from the 2020 head count released Thursday. Combined, the trends mean the median age in the U.S. jumped from 37.2 to 38.8 over the decade.
America’s two largest age groups propelled the changes: more baby boomers turning 65 or older and millennials who became adults or pushed further into their 20s and early 30s. Also, fewer children were born between 2010 and 2020, according to numbers from the once-a-decade head count of every U.S. resident.”

About healthcare IT

New collaboration opens CPT content for developers Under a new collaboration between Health Level Seven® International (HL7®) and the American Medical Association (AMA), technology developers using HL7 data interoperability standards and guides will have increased accessibility to AMA-published medical codes and descriptors. The collaboration will work to fully integrate HL7 Fast Healthcare Interoperability Resources (FHIR®) with the AMA’s Current Procedure Terminology (CPT®) code set to advance the organizations’ mutual goal of promoting the efficient exchange of interoperable health information.”

 Top 10 remote patient monitoring platforms, per KLAS FYI

About healthcare personnel

Comparison of Hospital Outcomes for Patients Treated by Allopathic Versus Osteopathic Hospitalists “The results can rule out important differences in quality and costs of care between allopathic versus osteopathic physicians for patient mortality (adjusted mortality, 9.4% for allopathic physicians vs. 9.5% [reference] for osteopathic hospitalists; average marginal effect [AME], −0.1 percentage point [95% CI, −0.4 to 0.1 percentage point]; P = 0.36), readmission (15.7% vs. 15.6%; AME, 0.1 percentage point [CI, −0.4 to 0.3 percentage point; P = 0.72), LOS (4.5 vs. 4.5 days; adjusted difference, −0.001 day [CI, −0.04 to 0.04 day]; P = 0.96), and health care spending ($1004 vs. $1003; adjusted difference, $1 [CI, −$8 to $10]; P = 0.85).
Limitation: Data were limited to elderly Medicare patients hospitalized with medical conditions.
Conclusion: The quality and costs of care were similar between allopathic and osteopathic hospitalists when they cared for elderly patients and worked as the principal physician in a team of health care professionals that often included other allopathic and osteopathic physicians.”

About health technology

 Groundbreaking Israeli cancer treatment has 90% success rate “The treatment [for multiple myeloma] is based on genetic engineering technology, which is an effective and groundbreaking solution for patients whose life expectancy was only two years until a few years ago. They have used a genetic engineering technology called CAR-T, or Chimeric Antigen Receptor T-Cell Therapy, which boosts the patient’s own immune system to destroy the cancer. More than 90% of the 74 patients treated at Hadassah [Medical Center in Jerusalem] went into complete remission, the oncologists said.”

Today's News and Commentary

About Covid-19

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults Thursday, “the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
Paxlovid manufactured and packaged under the emergency use authorization (EUA) and distributed by the U.S. Department of Health and Human Services will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today’s approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.”

BioNTech is proceeding with COVID-shot in line with WHO guidance “Germany's BioNTech said it was on track to introduce a COVID-19 shot by the early fall in the northern hemisphere that is adapted to currently dominant virus variants in line with recommendations by the World Health Organization.”

Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection Question  What symptoms are differentially present in SARS-CoV-2–infected individuals 6 months or more after infection compared with uninfected individuals, and what symptom-based criteria can be used to identify postacute sequelae of SARS-CoV-2 infection (PASC) cases?…
Adjusted odds ratios were 1.5 or greater (infected vs uninfected participants) for 37 symptoms. Symptoms contributing to PASC score included postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements. Among 2231 participants first infected on or after December 1, 2021, and enrolled within 30 days of infection, 224 (10% [95% CI, 8.8%-11%]) were PASC positive at 6 months.”
Comment: Clearly, these non-specific symptoms do not constitute solid diagnostic criteria. As the authors point out: “iterative refinement that further incorporates other clinical features is needed to support actionable definitions of PASC.”

About health insurance/insurers

Average hospital payer mix in every state FYI. While you might guess Florida, Maryland has the highest Medicare mix (29.6 percent), closely followed by Delaware (29.5 percent).

Than Age 65: Expiration Of Temporary Policies Projected To Reshuffle Coverage, 2023–33 “The Congressional Budget Office estimates that in 2023, 248 million people in the US who are younger than age sixty-five have health insurance coverage (mostly through employment-based plans), and twenty-three million people, or 8.3 percent of that age group, are uninsured—with significant variations in coverage by income and, to a lesser extent, by race and ethnicity. The unprecedented low uninsurance rate is largely attributable to temporary policies that kept beneficiaries enrolled in Medicaid and enhanced the subsidies available through the health insurance Marketplaces during the COVID-19 pandemic. As the continuous eligibility provisions unwind in 2023 and 2024, an estimated 9.3 million people in that age group will transition to other forms of coverage, and 6.2 million will become uninsured. If the enhanced subsidies expire after 2025, 4.9 million fewer people are estimated to enroll in Marketplace coverage, instead enrolling in unsubsidized nongroup or employment-based coverage or becoming uninsured. By 2033 the uninsurance rate is projected to be 10.1 percent, which is still below the 2019 rate of about 12 percent.”

Home Health Value-Based Purchasing Model Lowered Medicare Spending “The Home Health Value-Based Purchasing (HHVBP) Model reduced Medicare spending by $1.38 billion and improved care quality during its first six years, according to a report from CMS.
The CMS Innovation Center implemented the original HHVBP Model in nine states from January 2016 to December 2021: Arizona, Florida, Iowa, Massachusetts, Maryland, Nebraska, North Carolina, Tennessee, and Washington.
The model aimed to improve the quality of home healthcare services for Medicare beneficiaries by providing financial incentives to home health agencies for quality improvements. Home health agencies received performance scores for individual measures of quality of care that were combined into a total performance score to determine their payment adjustment.”

Comparison of Out-of-Pocket Spending on Ultra-Expensive Drugs in Medicare Part D vs Commercial Insurance “Findings  This cohort study including 37 324 Part D beneficiaries and 24 159 commercially insured individuals showed that Medicare Part D beneficiaries without low-income subsidies spent 2.5 times more out of pocket on ultra-expensive drugs and were subject to greater variation in this spending compared with commercially insured patients aged 45 to 64 years.
Meaning  Recent legislation establishing a $2000 out-of-pocket cap in Part D has the potential to lower out-of-pocket costs for more than 125 000 Part D beneficiaries who use ultra-expensive drugs and are ineligible for low-income subsidies, thus ameliorating increases in out-of-pocket spending when transitioning from commercial insurance to Part D.”

CVS could lose up to $1B next year from MA star ratings drop Dive Brief:

  • CVS expects its 2024 operating income to drop by $800 million to $1 billion next year due to lost bonus payments from lower plan star ratings in the Medicare Advantage program.

  • Just 21% of CVS’ MA members are currently in plans with a star rating of at least four, down from 87% at the end of 2021, the payer disclosed in a filing with the Securities and Exchange Commission on Thursday. Plans with a rating of four or above are eligible for bonus payments.

  • CVS’ score for its largest MA plan, Aetna National PPO, dropped from 4.5 to 3.5 stars. That was the main driver of the overall decrease in MA members in highly rated plans, CVS said. As a result, the plan — one of the largest in the U.S., with more than 1.9 million members — is no longer eligible for quality bonus payments in 2024.”

About hospitals and healthcare systems

Kaiser, Cleveland Clinic and more: 6 nonprofit systems back in the black “March was the first time in 15 months that revenue growth outpaced expense increases, according to a report from Syntellis. The median hospital year-to-date operating margin in March was 0.4 percent, up from -1.1 percent in February.”

About pharma

 FDA pushes back Sarepta DMD gene therapy decision Sarepta Therapeutics announced that the FDA has delayed a decision on its gene therapy application for ambulant patients with Duchenne muscular dystrophy (DMD)…The agency had been expected to render a decision on SRP-9001 (delandistrogene moxeparvovec) by May 29, but that has now been pushed back to June 22 to allow ‘modest additional time’ to complete its review, including final label negotiations and post-marketing commitment discussions, the drugmaker said.
The deferral comes on the heels of an FDA advisory panel that narrowly backed an accelerated approval for the AAV vector-based gene therapy with a vote of 8 to 6 in favour.”

About the public’s health

Multivitamin supplementation improves memory in older adults: A randomized clinical trial “…we estimate that the effect of the multivitamin intervention improved memory performance above placebo by the equivalent of 3.1 years of age-related memory change.”
For your comparison, the authors used Centrum Silver vitamins.

The top 5 medical services Americans are skipping “Financial uncertainty and the high cost of medical expenses have caused many people to forgo medical treatment, a Federal Reserve report released in May found
In 2022, 28 percent of adults went without some form of medical care because they could not afford it. The following were the top five medical services Americans did not undergo due to cost (Note: Survey participants could vote for more than one option):

1. Dental care: 21 percent

2. Physician or specialist visit: 16 percent

3. Prescription medication: 10 percent

3. Follow-up care: 10 percent

3. Mental healthcare: 10 percent”

About healthcare IT

Logging on for health: More older adults use patient portals, but access and attitudes vary widely “Overall, 78% of people aged 50 to 80 have used at least one patient portal, up from 51% in a poll taken five years ago, according to findings from the University of Michigan National Poll on Healthy Aging. Of those with portal access, 55% had used it in the past month, and 49% have accounts on more than one portal…
Older adults with annual household incomes below $60,000, and those who are Black or Hispanic, have lower rates of portal use, and were less likely to say they’re comfortable using a portal, than respondents who are higher-income or non-Hispanic white. 
There were also differences among older adults who don’t use portals, or haven’t used one in three or more years. Those who say they’re in fair or poor health physically or mentally were much more likely to say they’re not confident about their ability to log in and navigate a portal than those with better physical or mental health.”

Diverse patients’ attitudes towards Artificial Intelligence (AI) in diagnosis “Our main outcome measure was selection of AI clinic or human physician specialist clinic (binary, “AI uptake”). We found that with weighting representative to the U.S. population, respondents were almost evenly split (52.9% chose human doctor and 47.1% chose AI clinic). In unweighted experimental contrasts of respondents who met pre-registered criteria for engagement, a PCP’s explanation that AI has proven superior accuracy increased uptake (OR = 1.48, CI 1.24–1.77, p < .001), as did a PCP’s nudge towards AI as the established choice (OR = 1.25, CI: 1.05–1.50, p = .013), as did reassurance that the AI clinic had trained counselors to listen to the patient’s unique perspectives (OR = 1.27, CI: 1.07–1.52, p = .008). Disease severity (leukemia versus sleep apnea) and other manipulations did not affect AI uptake significantly. Compared to White respondents, Black respondents selected AI less often (OR = .73, CI: .55-.96, p = .023) and Native Americans selected it more often (OR: 1.37, CI: 1.01–1.87, p = .041). Older respondents were less likely to choose AI (OR: .99, CI: .987-.999, p = .03), as were those who identified as politically conservative (OR: .65, CI: .52-.81, p < .001) or viewed religion as important (OR: .64, CI: .52-.77, p < .001). For each unit increase in education, the odds are 1.10 greater for selecting an AI provider (OR: 1.10, CI: 1.03–1.18, p = .004). While many patients appear resistant to the use of AI, accuracy information, nudges and a listening patient experience may help increase acceptance. To ensure that the benefits of AI are secured in clinical practice, future research on best methods of physician incorporation and patient decision making is required.”

Startup Florence acquires Zipnosis from Bright Health to build out telehealth services “On the heels of its official launch last month, health tech startup Florence picked up Zipnosis from Bright Health to expand its virtual care capabilities.
Bright Health, which is looking to shed business lines as it tries to stave off bankruptcy, bought the white-labeled virtual care solution just two years ago. Bright Health revealed March 1 that it had overdrawn its credit and would need to secure $300 million by the end of April to stay afloat.”

About healthcare personnel

Flash Report: Health System Workforce Market & Solutions A great quick look at the state if this issue. Among the findings: Health system labor expenses increased 20% in the twelve months prior to March 2023 compared to pre-pandemic levels, largely driven by growth of contract labor. Contract hours relative to paid hours were up 91% in March 2023 from March 2020.
Nursing shortages are at the forefront of workforce difficulties.The average professional tenure of nurses dropped from 3.6 years prior to the pandemic to just 2.8 years in 2023.”

A REUTERS SPECIAL REPORT How doctors buy their way out of trouble “Over the last decade alone, at least 540 doctors and healthcare practitioners collectively paid the government hundreds of millions of dollars to negotiate their way out of trouble via civil settlements, then continued to practice medicine without restrictions on their licenses despite allegations that included fraud and patient harm, a Reuters investigation found. That figure is the result of the first-ever comprehensive analysis of federal civil settlements and state disciplinary actions.”

About health technology

Medtronic acquires insulin patch pump maker EOFlow for $738M amid new MiniMed rollout “Medtronic is set to acquire EOFlow, the South Korea-based maker of an insulin patch pump. In its announcement of the deal Thursday, Medtronic suggested that integrating the tubeless device with its own continuous glucose monitors and meal-detection algorithm—both of which can also be used alongside the MiniMed pumps—could create a new closed-loop system for largely hands-off diabetes management.”

Today's News and Commentary

About health insurance/insurers

 Payers ranked by commercial membership | Q1 2023 Elevance (formerly Anthem) is #1.

About hospitals and healthcare systems

 1,129 hospitals reporting losses on patient services, state-by-state “Rural hospitals across the U.S. are taking losses on patient services, meaning insurers aren't paying enough to cover the cost of care delivery, according to a report from the Center for Healthcare Quality & Payment Reform.
Losses on patient services have forced some hospitals to close service lines and reduce access to care in already underserved communities. There are more than 600 hospitals at risk of closure across the U.S. as well due to financial constraints and inflation.”

About pharma

 Top PBMs by 2022 market share FYI. CVS Caremark is at the top with 33% market share.

 New overdose antidote approved, but concerns raised about cost, side effects “The Food and Drug Administration on Monday approved a nasal-spray medication touted as another option to reverse overdoses caused by synthetic opioids, including fentanyl, the drug killing tens of thousands of Americans each year.
Drugmaker Indivior describes Opvee, a spray version of the drug nalmefene, as a potent medication that will save lives by acting quickly to reverse an overdose while potentially protecting against more overdoses for hours. But some public health experts, physicians and community groups are raising concerns that Opvee may burden taxpayers despite other proven, cheaper medications such a naloxone while causing agonizing, long-lasting withdrawal symptoms for some drug users after they are revived.”

Purdue Pharma to Sell Consumer Business for $397 Million “Purdue Pharma on Tuesday received a US judge's permission to offload its consumer health business for $397 million to a subsidiary of Arcadia Consumer Healthcare, reported U.S. News & World Report.
US Bankruptcy Judge Sean Lane approved Purdue's sale of Avrio Health, allowing Purdue to begin liquidating its assets while it awaits a final ruling on a $10-billion settlement that would devote the company's remaining resources to combating the US opioid epidemic.”

U.S. proposes new rule to increase transparency of prescription drug costs for Medicaid “The U.S. health department on Tuesday proposed a rule aimed at cutting costs of prescription drugs for the Medicaid healthcare program for the poor by increasing transparency around how much those drugs actually cost.
The proposed rule would also hold drugmakers accountable for providing the correct discounts to the state-based Medicaid plans for drugs.
The Centers for Medicare and Medicaid Services (CMS) proposed that contracts between states, health insurers and third-party contractors such as pharmacy benefit managers show how much those PBMs are paying for the drugs to avoid discrepancies in what they charge Medicaid and what they reimburse pharmacies.”

Walgreens asks federal court to toss 'staggering' $642M arbitration award to Humana Read the entire article for the complete story. It will be in the news for a long time.

Walgreens Nears Settlement In Theranos MDL “Walgreens has reached a settlement in principle with a class of customers who submitted Theranos blood tests in a years-long case alleging the pharmacy chain should have known the tests were faulty when it helped market them.”

About the public’s health

 What is Driving Widening Racial Disparities in Life Expectancy? “This analysis examines trends in life expectancy and leading causes of death by race and ethnicity and discusses the factors that contribute to racial disparities in life expectancy. In sum, it finds:

  • There was a sharp drop-off in life expectancy between 2019 and 2021, with particularly large declines among some groups. American Indian and Alaska Native (AIAN) people experienced the largest decline in life expectancy of 6.6 years during this time, followed by Hispanic and Black people (4.2 and 4.0 years, respectively).

  • Reflecting these declines, provisional data for 2021 show that life expectancy was lowest for AIAN people at 65.2 years, followed by Black people, whose expectancy was 70.8 years, compared with 76.4 years for White people and 77.7 years for Hispanic people. It was highest for Asian people at 83.5 years. Data were not reported for Native Hawaiian and Other Pacific Islander (NHOPI) people.

  • These declines were largely due to COVID-19 deaths and reflect the disproportionate burden of excess deaths, including premature excess deaths (before age 75), among people of color during the pandemic. Although COVID-19 mortality was a primary contributor to the recent decrease in life expectancy across groups, leading causes of death vary by race and ethnicity.”

Surgeon General issues advisory that social media is contributing to youth mental health crisis “Murthy specifically pointed to the possibility of a link between time spent on social media and depression and anxiety.
He cited one 2019 study that found adolescents between the ages of 12 and 15 who spent more than three hours on social media daily had double the risk of developing symptoms of depression and anxiety.
Teenagers on average spend 3 1/2 hours on social media every day, according to data cited in the advisory.

About healthcare IT

Mayo Clinic, Johns Hopkins and 20 others pledge to join TEFCA, prioritize interoperability “Epic announced the first cohort of health systems pledging to join the national health information-sharing network dubbed the Trusted Exchange Framework and the Common Agreement (TEFCA).
Epic is a member of the inaugural group of six prospective Qualified Health Information Networks (QHINs) that were recognized by the Department of Health and Human Services (HHS) earlier this year. Today, Epic announced that 20 health systems along with health tech company KeyCare and health information exchange OCHIN will be joining TEFCA with the goal of increasing interoperability in healthcare.”
Note: See the Information Technology chapter in the Book for more information about TEFCA. 

State Telehealth Laws and Reimbursement Policies “This chart provides a quick reference summary of each state’s telehealth policy on Medicaid reimbursement, private payer reimbursement laws (both if a law exists and whether or not payment parity is required), and professional requirements around interstate compacts and consent based on information gathered between January and March 2023.”

EHR vendors ranked by hospital market share gains (and losses) No surprises on this list.

Today's News and Commentary

About health insurance/insurers

 Per a report from Stat: Why Medicare hospital spending is down
”Health policy gurus have been scratching their heads a little bit lately, because the amount of money Medicare’s trust fund has spent on hospital care in the latter half of 2022 is still well below what they expected. Now, the government’s top health care actuary has some answers.
Paul Spitalnic, the chief actuary at CMS, spoke during a webinar hosted by the American Academy of Actuaries last week and detailed three reasons for the tempered hospital spending among beneficiaries in the traditional Medicare program:  

  • The pandemic, of course. Adults who are 65 and older continue to be the most vulnerable to Covid (this demographic makes up only 13% of reported Covid cases, but 75% of Covid deaths). Medicare beneficiaries who survived Covid also are less costly.

  • People who are eligible for both Medicare and Medicaid — people who are poor, older, and often have severe disabilities or serious health conditions — increasingly are moving to Medicare Advantage.

  • Hip and knee replacements have moved to outpatient settings, which has taken pressure off Medicare’s Part A trust fund that pays for hospital care.”

An Update to the Budget Outlook: 2023 to 2033 From the CBO. Some Medicare/Medicaid highlights:
—In CBO’s current projections, federal outlays (adjusted to exclude the effects of timing shifts) rise from $6.3 trillion in 2023 to $9.8 trillion in 2033, an average annual ncrease of 4.5 percent. Outlays for Social Security
and Medicare account for over half of that $3.5 trillion increase. By 2033, outlays for Social Security, the major health care programs, and interest account for 65 percent of projected spending.
—…
two underlying factors—the aging of the population and growth in federal health care costs—put upward pressure on mandatory spending. The increase in the average age of the population causes the number of beneficiaries of Social Security and Medicare to grow faster than the overall population, and federal health care costs per beneficiary continue to rise faster than GDP per person. As a result of those two trends, outlays for Social Security and Medicare will increase from 8.2 percent of GDP in 2023 to 10.1 percent in 2033, CBO projects. The effects of those trends on fed- eral spending will persist beyond the next decade.
—The announced policy changes affecting payments to MA plans caused CBO to decrease projected spending over the 2024–2033 period by $223 billion, compared with the February baseline.

What Could New Anti-Obesity Drugs Mean for Medicare? “Lifting the current law prohibition on coverage of weight-loss drugs would come at a cost to Medicare, given the high price and expected demand. Wegovy, for example, has an annual estimated net price of $13,600. According to a recent study, if 10% of Medicare beneficiaries with obesity use Wegovy, the annual cost to Medicare could be $13.6 billion (based on a 19% obesity rate from traditional Medicare diagnoses in 2021) to $26.8 billion (based on a 41.5% obesity rate from survey data for adults ages 60 and older). Higher take-up rates would mean higher Medicare spending. For context, total annual Part D spending in 2021 was $98 billion. Of note, these estimates do not account for potential reductions in Medicare spending that could occur if weight loss drugs reduce medical spending associated with other diseases, such as heart disease.”

Denials of health-insurance claims are rising — and getting weirder Great opinion piece in The Washington Post. Here is the strangest case (in my opinion):
”An insurer’s letter was sent directly to a newborn child denying coverage for his fourth day in a neonatal intensive-care unit. ‘You are drinking from a bottle,’ the denial notification said, and ‘you are breathing on your own.’”

Crowe RCA benchmarking analysis “Crowe RCA data shows that commercial payors reimburse providers at a higher amount on a per-case basis compared with Medicare:

  • $18,156.50 is paid by commercial payors compared with $14,887.10 paid by Medicare in average net revenue per inpatient case.

  • $1,606.86 is paid by commercial payors compared with $707.30 paid by Medicare in average net revenue per outpatient case.

    It’s true that commercial payors might generate more net revenue than public payors on a per-case basis. But at what cost?

    The comprehensive Crowe RCA database tracks all aspects of payor performance, and the performance across commercial and public payors varies widely. In fact, commercial payors take the longest to pay, require providers to jump through more administrative hoops to get paid, and delay payments to providers via claim denials at a higher frequency than government payors…
    In 2022, the initial prior authorization/precertification denial rate for inpatient claims for commercial payors was 2.8%, up from 2.4% in 2021. We’re seeing more of the same again this year with the rate at more than 3% through the first three months of the year. By comparison, the denial rate for traditional Medicare was 0.2% through the first quarter of 2023.”

About pharma

 Most expensive drugs in the US in 2023 FYI

Time to Confirmatory Study Initiation After Accelerated Approval of Cancer and Noncancer Drugs in the US “The Consolidated Appropriations Act of 2023 provided that the FDA “may require” confirmatory studies to be “underway prior to approval, or within a specified time period after” accelerated approval. Since the statute permits, but does not require, the FDA to use this authority, further information regarding the timing of confirmatory study initiation and completion for cancer and noncancer products may benefit both the FDA and policy makers as they implement this legislation and consider future reforms to the accelerated approval pathway…
[This study showed that] “For 103 cancer–indication pairs and noncancer products, 20.31% (26 of 128) of confirmatory studies were not underway at the time of accelerated approval, and the median (IQR) time from approval to study initiation was 1.41 (1.10-2.04) years.”
Comment: Pharma companies are getting accelerated approvals but, in a large portion of cases, confirmatory studies were not started on time and are much delayed when started. The FDA needs to assure these studies are in progress when it grants accelerated approvals.

About the public’s health

 Global Burden, Risk Factors Analysis, and Prediction Study of Ischemic Stroke [IS], 1990–2030 “Between 1990 and 2019, the global number of IS deaths increased from 2.04 million to 3.29 million and is expected to increase further to 4.90 million by 2030. The downward trend was more pronounced in women, young people, and high social-demographic index (SDI) regions. At the same time, a study of attributable risk factors for IS found that two behavioral factors, smoking and diet in high sodium, and five metabolic factors, including high systolic blood pressure, high low-density lipoprotein cholesterol, kidney dysfunction, high fast plasma glucose, and high BMI, are major contributors to the increased disease burden of IS now and in the future.” 

About health technology

 FDA okays Krystal's Vyjuvek as first topical gene therapy for dystrophic epidermolysis bullosa You can read about the clinical indications but of significance is that this treatment is “the first redosable gene therapy…” 

Thermo Fisher's test to detect pregnancy-related complication gets FDA nod “The U.S. Food and Drug Administration (FDA) has cleared Thermo Fisher Scientific Inc's test, the first of its kind in the country, to detect women with risk of severe preeclampsia…”
Comment: Could become a standard of care, which means tremendous sales for Thermo Fisher.

Today's News and Commentary

About Covid-19

 WHO recommends new COVID shots should target only XBB variants “A World Health Organization (WHO) advisory group on Thursday recommended that this year's COVID-19 booster shots be updated to target one of the currently dominant XBB variants.
New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered.” 

About health insurance/insurers

 IRS Gives Big Boost to HSA, HDHP Limits in 2024 “Annual HSA contribution limits for 2024 are increasing in one of the biggest jumps in recent years, the IRS announced May 16: The annual limit on HSA contributions for self-only coverage will be $4,150, a 7.8 percent increase from the $3,850 limit in 2023. For family coverage, the HSA contribution limit jumps to $8,300, up 7.1 percent from $7,750 in 2023.
Participants 55 and older can contribute an extra $1,000 to their HSAs. This amount will remain unchanged.
Meanwhile, for 2024, a high-deductible health plan (HDHP) must have a deductible of at least $1,600 for self-only coverage, up from $1,500 in 2023, or $3,200 for family coverage, up from $3,000, the IRS noted. Annual out-of-pocket expense maximums (deductibles, co-payments and other amounts, but not premiums) cannot exceed $8,050 for self-only coverage in 2024, up from $7,500 in 2023, or $16,100 for family coverage, up from $15,000.
The IRS also announced it will raise the maximum amount that employers may contribute to an excepted-benefit health reimbursement arrangement (HRA) in 2024 to $2,100—up from the 2023 amount of $1,950.”

Government stats show number of uninsured declined in 2022, though experts question methodology, conclusion “The number of uninsured individuals dropped slightly in 2022, with 8.4% or 27.6 million people of all ages in the U.S. falling into that category compared to 9.2% or 30 million in 2021, according to initial estimates (PDF) from the National Center for Health Statistics (NCHS).
The data, from surveys of 27,654 adults and 7,464 children taken throughout 2022, also show that 12.2% of adults aged 18 to 64 were uninsured, while 22% in that age group had public coverage, and 67.8% had private health insurance.
Among children from birth to 17 years old, 4.2% were uninsured, 43.7% had public coverage and 54.3% had private health insurance coverage.
The report found that among non-Hispanic white adults aged 18 to 64, the percentage of uninsured people declined from 10.5% in 2019 to 7.4% in 2022. Meanwhile, people under 65 who purchased coverage on the Affordable Care Act (ACA) exchanges rose from 3.7% in 2019 to 4.3% in 2022.”

Engaging Primary Care in Value-Based Payment: New Findings from the 2022 Commonwealth Fund Survey of Primary Care Physicians “While our survey doesn’t reveal what share of a physician’s total payments are value-based, it does reveal that more PCPs are receiving FFS payment than VBP. Seventy-one percent of respondents reported that their practice was receiving any FFS payments, while fewer than half (46%) reported receiving any VBP. Similar rates of primary care practices report receiving two common types of VBP, shared savings or capitation (30% and 32%, respectively). Practices are likely receiving a combination of payments because they are paid differently by different payers.”
Comment: The first sentence is critical. Without substantial percentages of total compensation in VBPs, physician behavior will not change.

2023 EDITION High-cost claims and injectable drug trends analysis More analysis from Sun Life:
Some key insights included in this year’s report are:
—71% of all stop-loss claims came from the top 10 conditions.
—While cancer continues to be the largest driver of high-cost claims, cardiovascular disease rose one spot to the #2 claim condition in 2022, with $142.4M in reimbursements for over 2,300 members.
—11 of the top 20 high-cost injectable drugs are related to the treatment of
cancer. Rylaze, the cancer drug with the highest average cost ($808.7K), is new to the top 20 injectables drug list this year.
—Approximately one in nine employers (11%) experienced a birth-related stop- loss claim in the four-year benefit period of 2018 through 2021. Newborn/ infant care ranks at #5 in 2022, consistent with its previous ranking in the topfive last year and has one of the highest average costs at $371.8K.
—20% of employers had at least one member with over $1M in claims during
the four-year benefit period from 2018 through 2021.
—Million-dollar claims on a per million covered employees basis rose 15% in the
past year and 45% over the past four years.”

About hospitals and healthcare systems

 CMS: Hospitals Can Continue to Bill for Remote Outpatient Therapies “In a Frequently Asked Questions (FAQs) document, the Centers for Medicare and Medicaid Services (CMS) stated that hospitals could continue to bill for various outpatient therapies delivered via remote care technologies in patients' homes through the end of calendar year (CY) 2023.”

About the public’s health

Pfizer’s maternal RSV vaccine effective at preventing severe infections in newborns, FDA says, but flags potential risk of preterm birth “Pfizer’s vaccine to protect newborns from respiratory syncytial virus, or RSV, by vaccinating their moms late in pregnancy cuts the risk that infants will need to see a doctor or be admitted to the hospital with a moderate to severe infection before 6 months of age, according to a new analysis by government regulators…
 Safety data published in an agency analysis Tuesday also showed a slightly higher proportion of preterm birth in babies whose moms got the experimental RSV vaccine compared with those who got a placebo: 5.7% vs. 4.7%, respectively.
The difference between the groups was not statistically significant, meaning it could have been due to chance.”

About healthcare finance

At request of FTC, Amgen agrees to delay closure of $27.8B Horizon acquisition until September “Amgen has complied with an FTC request for a temporary restraining order, agreeing not to close its proposed $27.8 billion deal to acquire Horizon Therapeutics while the agency's lawsuit plays out.
The move comes in response to the FTC filing an antitrust lawsuit earlier this week which is attempting to block the sale.”

Today's News and Commentary

About health insurance/insurers

 2023 Medical Loss Ratio Rebates “We find that insurers estimate they will issue a total of about $1.1 billion in MLR rebates across all commercial markets in 2023…”

Senate passes resolution to overturn Biden administration rule that does not penalize immigrants for receiving government benefits “The Senate passed a resolution Wednesday to stop a Biden administration immigration rule that eliminates potential hurdles for immigrants using some public benefits and trying to obtain legal status, known as ‘public charge.’
It passed 50-47, with two Democratic senators crossing party lines – Joe Manchin of West Virginia and Jon Tester of Montana – both of whom are up for reelection.
The resolution is an effort to return to the Trump administration policy, which made it more difficult for immigrants to obtain legal status if they use public benefits.
It is a joint resolution, meaning it would need to pass in the House as well before it would reach President Joe Biden’s desk. The House has not yet voted on it.”
It is likely that the Biden administration would issue a veto if the resolution also passes in the House.”

About hospitals and healthcare systems

 Hospitals' revenues continue to decline due to increasing delays and denials by commercial insurers “Hospitals and health systems hoping to financially rebound from the pandemic-induced downturn have found themselves struggling to collect payments for services rendered, especially among commercial payors. A new Crowe report, "Time for a Commercial Break," analyzes information pulled by Crowe Revenue Cycle Analytics software and reveals when it comes to denial rates, accounts receivable, bad debt and takebacks, healthcare providers are having a much more favorable experience working with traditional Medicare over commercial insurers….
Traditional Medicare also fared better across prior authorization/precertification, initial and request for information (RFI) denial rates. Through the first quarter of 2023:

  • Initial prior authorization/precertification denial rate for inpatient claims for commercial payors was 3.2% compared with 0.2% for Medicare.

  • Commercial payors initially denied 15.1% of inpatient and outpatient claims for any reason compared with 3.9% for Medicare.

  • The RFI denial rate for inpatient and outpatient claims submitted by providers to commercial payors was 4.8%, 12 times Medicare's denial rate of 0.4%.”

About pharma

FTC expands probe into pharmacy benefit managers to GPOs “The Federal Trade Commission (FTC) is expanding its probe into pharmacy benefit managers by issuing compulsory orders to two group purchasing organizations that negotiate rebates on behalf of PBMs.
The FTC said late Wednesday that the orders will require Zinc Health Services and Ascent Health Services to provide key details and information on their business practices. Last summer, the agency sent similar orders to the six largest PBMs in the country: CVS Caremark, Express Scripts, Optum Rx, Humana Pharmacy Solutions, Prime Therapeutics and MedImpact Healthcare Systems.”

Supreme Court rules against Amgen in closely watched case over scope of patent claims “n a case that had the pharmaceutical industry on edge, the U.S. Supreme Court upheld a lower court ruling that Amgen failed to disclose sufficient information about patent claims for a best-selling drug.
The court ruled unanimously that Amgen failed to provide what amounts to a roadmap for others to recreate the claims made in two patents for Repatha, a cholesterol medication. A federal appeals court had previously invalidated the patents after deciding that Amgen filed an overly expansive patent claim that failed to disclose enough information so someone else can make the same product.”

Walgreens to pay San Francisco $230M for its role in opioid epidemic “Walgreens has agreed to pay $230 million to San Francisco for its role in the city’s opioid epidemic following last year’s landmark trial that found the pharmacy chain liable for not performing proper screenings.”

About health technology

New Biden science agency ARPA-H launches first program, targeting bone regrowth “The Advanced Research Projects Agency for Health, launched a little more than a year ago, announced Thursday that its first official program would target bone and joint damage from osteoarthritis, a condition affecting more than 32 million Americans.”

Today's News and Commentary

Exclusive: More Than 70% of Americans Feel Failed by the Health Care System “More than 70% of U.S. adults feel the health care system is failing to meet their needs in at least one way, according to new data from the Harris Poll, shared exclusively with TIME.
Affordability and “It takes too long to get an appointment” were major complaints. The graphics are very instructive.

About hospitals and healthcare systems

Kaiser Permanente discloses timeline, financial commitments for its VBC megadeal with Geisinger Health  FYI 

About pharma

Patterns of Manufacturer Coupon Use for Prescription Drugs in the US, 2017-2019 “In this cohort analysis of 35 352 individuals receiving pharmaceutical treatment for chronic diseases, nearly all of the first coupon use occurred with the first prescription fills. The frequency of manufacturer drug coupon use was associated with drugs operating in competitive environments but not with patient’s out-of-pocket costs or the characteristics of neighborhoods where the patients reside.” 

 Walgreens to pay San Francisco $230M for its role in opioid epidemic “Walgreens has agreed to pay $230 million to San Francisco for its role in the city’s opioid epidemic following last year’s landmark trial that found the pharmacy chain liable for not performing proper screenings.”

Drug Shortages Near an All-Time High, Leading to Rationing From The NY Times, a great review of the problems and its causes.

About the public’s health

 U.S. Depression Rates Reach New Highs “Over one-third of women (36.7%) now report having been diagnosed with depression at some point in their lifetime, compared with 20.4% of men, and their rate has risen at nearly twice the rate of men since 2017. Those aged 18 to 29 (34.3%) and 30 to 44 (34.9%) have significantly greater depression diagnosis rates in their lifetime than those older than 44.
Women (23.8%) and adults aged 18 to 29 (24.6%) also have the highest rates of current depression or treatment for depression. These two groups (up 6.2 and 11.6 percentage points, respectively), as well as adults aged 30 to 44, have the fastest-rising rates compared with 2017 estimates.
Lifetime depression rates are also climbing fast among Black and Hispanic adults and have now surpassed those of White respondents.”

2023 County Health Rankings National Findings Report Interactive report that allows you to search for a wealth of health-related data about your county.

About healthcare IT

VA renegotiates $10B Oracle Cerner EHR contract with stronger performance metrics, bigger penalties  After many years of false starts: “The Department of Veterans Affairs renegotiated its contract with Oracle Cerner to beef up accountability for tech glitches and patient safety issues with its beleaguered electronic health records project.
The renegotiated contract ‘dramatically increases’ VA’s ability to hold the technology company to account for the system’s performance, including reliability, responsiveness and interoperability, according to a statement from Dr. Neil Evans, the VA's acting program executive director for the Electronic Health Record Modernization project.”

About healthcare personnel

 Concern grows around US health-care workforce shortage: ‘We don’t have enough doctors’ “As of Monday, in areas where a health workforce shortage has been identified, the United States needs more than 17,000 additional primary care practitioners, 12,000 dental health practitioners and 8,200 mental health practitioners, according to data from the Health Resources & Services Administration. Those numbers are based on data that HRSA receives from state offices and health departments.”

About health technology

 Quick blood tests to spot cancer: will they help or harm patients? An excellent review of this topic from the Financial Times. Worthwhile if you can get a copy. 

Today's News and Commentary

About health insurance/insurers

Appeals court pauses Texas ruling against ACA preventive care coverage “The U.S. 5th Circuit Court of Appeals has temporarily blocked a Texas court's ruling earlier this year that struck down an ACA provision requiring payers and employers to provide coverage for preventive services.”

2023 EDITION High-cost claims and injectable drug trends analysis [From Sun Life] “Some key insights included in this year’s report are:
—71% of all stop-loss claims came from the top 10 conditions.
—While cancer continues to be the largest driver of high-cost claims, cardiovascular disease rose one spot to the #2 claim condition in 2022, with $142.4M in reimbursements for over 2,300 members.
—11 of the top 20 high-cost injectable drugs are related to the treatment of cancer.
—Rylaze, the cancer drug with the highest average cost ($808.7K), is new to the
top 20 injectables drug list this year.
—Approximately one in nine employers (11%) experienced a birth-related stop-loss claim in the four-year benefit period of 2018 through 2021. Newborn/infant care ranks at #5 in 2022, consistent with its previous ranking in the top five last year and has one of the highest average costs at $371.8K.
—20% of employers had at least one member with over $1M in claims during the four-year benefit period from 2018 through 2021.
—Million-dollar claims on a per million covered employees basis rose 15% in the past year and 45% over the past four year.”

About hospitals and healthcare systems

 30 most trusted healthcare brands When evaluating these lists, consider if they make sense. The facts that Mayo is #4 and Cleveland Clinic did not make the top 30 list is not believable.

 CommonSpirit reports $1.1B operating loss in 9-month period “Chicago-based CommonSpirit, one of the largest nonprofit health systems in the country, recorded operating losses of $658 million and $1.1 billion for the three- and nine-month periods ended March 31.
Those figures compared with operating losses of $591 million and $638 million for the same periods in the prior year. Lower contract labor costs helped stem some of the operating losses, although hiring challenges remain, the system said.
Improved investment returns also helped mitigate the overall loss..”

About pharma

 CVS closing down clinical trials business after 2 years “CVS Health is closing down its clinical trials arm just two years after its launch, a company spokesperson confirmed to Fierce Healthcare.
The spokesperson said the healthcare giant routinely reviews its portfolio to ensure its assets are ‘aligned with our long-term strategic priorities.’ The company will wind down Clinical Trial Services in "a phased way" and expects a full exit by Dec. 31, 2024.”

AstraZeneca is third member to leave PhRMA in five months “AstraZeneca has decided to leave the brand drug lobbying powerhouse PhRMA halfway through the year, the organization said.
The exit is the group’s third in five months, as AbbVie exited PhRMA in December and Teva Pharmaceuticals left in February.”
Comment: The company did not furnish a specific reason for the withdrawal.

About the public’s health

Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial “Among under-screened women from low-income backgrounds, mailed HPV self-collection kits with scheduling assistance led to greater uptake of cervical cancer screening than scheduling assistance alone. At-home HPV self-collection testing has the potential to increase screening uptake among under-screened women.” 

Black communities endured wave of excess deaths in past 2 decades, studies find “America’s Black communities experienced an excess 1.6 million deaths compared with the White population during the past two decades, a staggering loss that comes at a cost of hundreds of billions of dollars, according to two new studies that build on a generation of research into health disparities and inequity.
In one study, researchers conclude that the gap in health outcomes translated into 80 million years of potential life lost — years of life that could have been preserved if the gap between Black and White mortality rates had been eliminated. The second report determined the price society pays for failing to achieve health equity and allowing Black people to die prematurely: $238 billion in 2018 alone.”

World Health Organization Warns Against Using Artificial Sweeteners “The World Health Organization on Monday warned against using artificial sweeteners to control body weight or reduce the risk of noncommunicable diseases, saying that long-term use is not effective and could pose health risks.
These alternatives to sugar, when consumed long term, do not serve to reduce body fat in either adults or children, the W.H.O. said in a recommendation, adding that continued consumption could increase the risk of Type 2 diabetes, cardiovascular diseases and mortality in adults.”

About healthcare IT

 Google Cloud Launches AI-powered Solutions to Safely Accelerate Drug Discovery and Precision Medicine “Google Cloud announced two new AI-powered life sciences solutions to accelerate drug discovery and precision medicine for biotech companies, pharmaceutical firms, and public sector organizations. Available worldwide today, the Target and Lead Identification Suite helps researchers better identify the function of amino acids and predict the structure of proteins; and the Multiomics Suite accelerates the discovery and interpretation of genomic data, helping companies design precision treatments.”

About health technology

 Your DNA Can Now Be Pulled From Thin Air. Privacy Experts Are Worried. “Over the last decade, wildlife researchers have refined techniques for recovering environmental DNA, or eDNA — trace amounts of genetic material that all living things leave behind. A powerful and inexpensive tool for ecologists, eDNA is all over — floating in the air, or lingering in water, snow, honey and even your cup of tea. Researchers have used the method to detect invasive species before they take over, to track vulnerable or secretive wildlife populations and even to rediscover species thought to be extinct. The eDNA technology is also used in wastewater surveillance systems to monitor Covid and other pathogens.
But all along, scientists using eDNA were quietly recovering gobs and gobs of human DNA.”
Comment: Fascinating article in The NY Times. Read it if you can get access. Some questions that remain: who can use this DNA and for what purpose?

About healthcare finance

Trade commission fights Amgen's $28B purchase of Horizon Therapeutics “The Federal Trade Commission said on Tuesday it will try to block an effort by biopharmaceutical leader Amgen Inc. from purchasing Horizon Therapeutics for $28.3 billion, charging the move could force insurance companies to favor their products.
The FTC said the coupling of Amgen and Horizon could have allowed Amgen to leverage its portfolio of top-selling drugs to entrench a monopoly position in treatments for thyroid eye disease and chronic refractory gout.”

Scribe's CRISPR tech Prevails in new $1.5B biobucks deal with Lilly unit “Eli Lilly’s Prevail Therapeutics is jotting down up to $1.5 billion for Scribe Therapeutics in hopes of writing some new CRISPR-based genetic medicines for neurological and neuromuscular diseases into history.
Prevail, a wholly owned Lilly subsidiary developing genetic medicines for Parkinson’s disease and other neurodegenerative conditions, will also give California-based Scribe $75 million in an upfront payment and equity investment. Additionally, Prevail will provide R&D funding and pay Scribe certain royalties on future sales, offering the biotech more than $1.5 billion in milestone payments tied to the collaboration.
In return, Prevail gets exclusive rights to Scribe’s CRISPR X-Editing (XE) technologies to develop new in vivo therapies for certain targets known to cause serious neurological and neuromuscular diseases. Scribe will also have the chance to co-fund one program and share the profits for it in the U.S.”

Today's News and Commentary

About Covid-19

CDC sets first target for indoor air ventilation to prevent spread of Covid-19 “The US Centers for Disease Control and Prevention has extensively updated its ventilation guidance on helping prevent indoor transmission of the virus that causes Covid-19.
The agency had advised people to ventilate indoor air before, but this is the first time a federal agency has set a target – five air changes per hour – for how much rooms and buildings should be ventilated.”
Air quality experts cheered the updated recommendations.”

Getting to the Truth About the Effectiveness of Masks in Preventing COVID-19 The effectiveness of masking at the community level has been debated since the onset of the Covid-19 pandemic. The answers are not straightforward, but this editorial from the editors of the Annals of Internal Medicine is a great summary of what we know and how to interpret results.

About health insurance/insurers

 CMS redefines its definition of “Marketing” for Medicare Advantage plans and requires sign-off on materials. “…we are expanding our interpretation of the regulatory definition of ‘marketing’ to include content that mentions any type of benefit covered by the plan and is intended to draw a beneficiary's attention to plan or plans, influence a beneficiary's decision-making process when selecting a plan, or influence a beneficiary's decision to stay enrolled in a plan (that is, retention-based marketing) and thus subject to review.”

About pharma

 Estimated Annual Spending on Lecanemab and Its Ancillary Costs in the US Medicare Program “Lecanemab, an antidementia medication with modest clinical benefit, received accelerated US Food and Drug Administration (FDA) approval. Traditional FDA approval of lecanemab could occur in 2023, prompting Medicare to reconsider coverage restrictions and potentially enabling widespread use. Lecanemab’s $26 500 proposed annual acquisition cost and ancillary spending (eg, imaging) could increase Medicare spending, possibly leading to beneficiary premium increases…
If 85 687 (lower bound) eligible patients received lecanemab, Medicare would spend $2.0 billion annually (95% CI, $1.8-2.2 billion). If 216 536 (upper bound) eligible patients received lecanemab, Medicare would spend $5.1 billion annually (95% CI, $4.6-5.7 billion). Estimated annual per-patient coinsurance could reach $6636.”

New menopause drug for hot flashes gets FDA approval “The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can include sweating, flushing and chills.
Astellas’ drug, Veozah, uses a new approach, targeting brain connections that help control body temperature. The FDA said the medication will provide “an additional safe and effective treatment option for women,” in a statement.”

U.S. Supreme Court declines bid by Teva to hear ‘skinny labeling’ case with implications for generic drug access “After months of anticipation, the U.S. Supreme Court declined to hear an appeal of a lower court ruling that throws into question whether generic companies can ‘carve out’ uses for their medicines and supply Americans with cheaper alternatives to brand-name drugs.
At issue is skinny labeling, which happens when a generic company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.”

About the public’s health

FDA blocks marketing on 6,500 flavored e-cigarette products “The Food and Drug Administration on Friday blocked 10 companies from marketing or distributing 6,500 flavored e-liquid and e-cigarette products, part of its campaign against tobacco products being marketed to youths.
The agency said the product applications covered a variety of flavored e-cigarettes, including some with flavors such as Citrus and Strawberry Cheesecake, as well as Cool Mint and Menthol. The FDA said the companies in question did not provide sufficient evidence that marketing the products would be appropriate for public health.”

 About healthcare personnel

Envision files for bankruptcy: 6 details “Nashville, Tenn.-based Envision Healthcare has filed for Chapter 11 bankruptcy five years after New York City-based KKR & Co. acquired Envision in a $9.8 billion deal.”

 Federal government’s $1 billion effort to recruit next generation of doctors at risk “Over the last three years, millions of taxpayer dollars were pumped into the National Health Service Corps to hire thousands more doctors and nurses willing to serve the country’s most desperate regions during the COVID-19 pandemic in exchange for forgiving medical school debts. Now, with the health emergency over, the program’s expansion is in jeopardy – even as people struggle to get timely and quality care because of an industry-wide dearth of workers.
Funding for the program expires at the end of September, although President Joe Biden asked Congress to sign off an extra half-billion dollar for the project in his budget.” 

Today's News and Commentary

About health insurance/insurers

 Payers ranked by Medicare Advantage membership | Q1 2023 FYI.

About hospitals and healthcare systems

 15 health systems reporting Q1 financial results FYI.

 Humana partners with 2 durable medical equipment companies for home care “The Medicare Advantage insurer reached agreements with AdaptHealth Corp. and Rotech Healthcare to provide value-based DME services to members in its HMO plans starting July 1. Each company will service a different region of the country, Humana said in the announcement.”

About pharma

 Senate panel advances bill that would ban spread pricing “Despite pushback from Republicans, a key Senate committee has advanced a bill that aims to reform pharmacy benefit managers, including a ban on spread pricing.
The PBM bill was among four passed by the Senate Health, Education, Labor and Pensions (HELP) committee on Thursday, one day after the senators heard input from major PBM and pharmaceutical manufacturer executives. The HELP committee approved the bill by a vote of 18 to 3.
The most contentious part of the PBM bill was a provision that would prevent these firms from deploying spread pricing models for their clients. In this model, a PBM would charge the insurer or plan sponsor more for a drug than it costs at the pharmacy and then pocket the difference.”
Comment: I do not usually report committee actions, but this one may have “legs.”

About the public’s health

 WHO says mpox is no longer a global health emergency “After a heated meeting this week, WHO’s emergency committee for mpox recommended an end to the emergency, and WHO Director-General Tedros Adhanom Ghebreyesus agreed with its assessment.” However: Monkeypox is back, coinciding with a rise of STD rates in Chicago. And the CDC is reporting a rise in all STIs.
 

US FDA eases restrictions on blood donation “The U.S. Food and Drug Administration on Thursday set guidelines for blood donation organizations, recommending they screen donors based on one set of criteria, ending a restrictive policy that applied only to men who have sex with men and their female partners…
Individuals, other than those who report having a new sexual partner or multiple partners and had anal sex in the past three months, will be eligible to donate blood, provided all other eligibility criteria are met.”

About healthcare IT

Physician Electronic Health Record Use After Changes in US Centers for Medicare & Medicaid Services Documentation Requirements “On January 1, 2021, the US Centers for Medicare & Medicaid Services (CMS) modified outpatient evaluation and management (E/M) coding requirements, including the elimination of history and physical examination documentation. Centers for Medicare & Medicaid Services sought to reduce physician documentation burden by reducing electronic health record (EHR) documentation time. This study assesses changes in outpatient physician documentation time after these changes…
Across the 2 largest EHR vendors in the US, this study, along with that of Apathy et al, 3 found small reductions in documentation time following the changes in CMS E/M coding requirements, but not at clinically meaningful levels. Apathy et al observed a small decrease immediately postimplementation, while reductions took longer to manifest in the Cerner EHR sample. The magnitude of reduction was modest in both studies and less than the 19-second CMS-estimated reduction in documentation time per visit.”

About healthcare personnel

Medical Liability Claim Frequency Among U.S. Physicians “ In 2022, 31.2 percent of physicians had been sued during their careers to date.
The risk of getting sued varies widely by certain factors, especially over the longer term. In both the short and longer term, the widest variation in liability risk comes from specialty. Among the strongest and most consistent results is that OB/GYNs, general surgeons, orthopedic surgeons and other surgeons have a much higher incidence of claims.
Of OB/GYNs, 62.4 percent have been sued in their careers, followed by 59.3 percent of general surgeons. Controlling for other factors, OB/GYNs and general surgeons are 33.6 and 28.6 percentage points more likely than general internists to have ever been sued…
Twenty four percent of women physicians have been sued in their careers compared to 36.8 percent of their male counterparts…
 Finally, there is a strong positive correlation between longer-term claim frequency and age. Physicians under the age of 40 are 15.6 percentage points less likely and those over 54 are 21.9 percentage points more likely to have ever been sued than their age 40-54 counterparts.”

About health technology

Fake Publications in Biomedical Science: Red-flagging Method Indicates Mass Production[Preprint and not yet peer reviewed] “From 2010 to 2020 the RFP [red-flagged fake publications] rate increased from 16% to 28%. Given the 1.3 million biomedical Scimago-listed publications in 2020, we estimate the scope of >300,000 RFPs annually. Countries with the highest RFP proportion are Russia, Turkey, China, Egypt, and India (39%-48%), with China, in absolute terms, as the largest contributor of all RFPs (55%).”

Today's News and Commentary

About Covid-19

 The Public Health Emergency Ends Today

 What the end of the covid public health emergency means for you A really good summary of the practical implications of the PHE’s end.

About hospitals and healthcare systems

 17 health systems commit to hiring, promoting more low-income workers by 2027 “Seventeen health systems including big names like CommonSpirit Health and Providence have signed onto a pledge that at least 10% of their new hires will hail from ‘economically disadvantaged areas’ by 2027, according to a release from social determinants of health leadership organization the Healthcare Anchor Network (HAN).
The so-called Impact Workforce Commitment agreed upon by the systems also includes a promise to increase the number of employees they will promote into skilled, high wage roles from positions that do not require a bachelor’s degree by 2027, according to HAN’s announcement.”

About pharma

 White House Assembles Secret Team to Tackle Drug Shortages, Quality Woes “As US drug shortages hit a five-year high and concerns mount about the safety of medicines, the Biden administration has quietly assembled a team to address chronic problems hurting America’s drug supply.
Since the beginning of the year, a group of White House officials has been meeting frequently to increase the availability and quality of medications, according to several people familiar with the matter. The effort has intensified as Americans struggle to find common drugs like antibiotics and amid high-profile safety lapses like deadly eye drops.”
Despite your reading this article, it is still a secret team- all the reports here are from anonymous sources.

About healthcare IT

 A couple new product entries into the AI field:

IBM unveils new watsonx, AI and data platform  “IBM said companies can use the watsonx platform to train and deploy AI models, automatically generate code using natural language and use various large language models built for different purposes such as chemical creation or climate change modeling.”
It is supposed to be less costly than the Watson version it is replacing.

Introducing PaLM 2 [From Google] Among the many applications is: “Med-PaLM 2, trained by our health research teams with medical knowledge, can answer questions and summarize insights from a variety of dense medical texts. It achieves state-of-the-art results in medical competency, and was the first large language model to perform at ‘expert’ level on U.S. Medical Licensing Exam-style questions. We're now adding multimodal capabilities to synthesize information like x-rays and mammograms to one day improve patient outcomes. Med-PaLM 2 will open up to a small group of Cloud customers for feedback later this summer to identify safe, helpful use cases.”

About healthcare personnel

 KKR-Backed Envision Healthcare Plans Chapter 11 Bankruptcy Filing “Envision Healthcare is planning to file for chapter 11 bankruptcy protection, according to people familiar with the matter, capping one of the biggest losses ever for the physician-staffing company’s backers at private-equity firm KKR
The bankruptcy filing, which could be made as soon as this weekend, will wipe out the investment of KKR, which took Envision private in a $5.5 billion buyout in 2018. Including debt, the deal was worth about $10 billion, making it one of KKR’s largest investments in the healthcare industry.
Envision now has around $7 billion of debt outstanding, much of which trades at under 10 cents on the dollar as the company’s finances have steadily deteriorated over the last two years.” 

Part-Time Physician: Is It a Viable Career Choice?On average, physicians reported in the Medscape Physician Compensation Report 2023 that they worked 50 hours per week. Five specialties, including critical care, cardiology, and general surgery reported working 55 or more hours weekly.
But there's a small segment of physicians that has bucked the norm. They've scaled back their hours to part-time, clocking in only 25-30 hours a week.”

Today's News and Commentary

About health insurance/insurers

Clover Health execs say MCR improvements, cost reduction program put it on path toward profitability “Clover Health made significant strides in addressing its medical cost ratio (MCR), which executives said Tuesday sets the company up for its future profitability goals.
The Medicare Advantage insurtech reported an MCR of 86.6% in the first quarter of 2023, down from 96.4% in the prior-year quarter. Clover Health also slimmed its losses to $72.6 million in the first quarter, down from $75.5 million in the first quarter of 2022.
Revenues were down substantially, however. Clover brought in $527.8 million in revenue for the first quarter, compared to its $874.4 million haul in the first quarter of 2022. That said, premium revenue grew year over year, reaching $317.1 million.”

Troubled insurtech Bright Health focused on sale of California MA plans, execs say “Selling off the last of its insurance business is critical to staving off bankruptcy. The company secured an extension to its credit facility through June 30. According to a company spokesperson, ‘Bright must deliver an initial draft purchase agreement with respect to the proposed sale of the California Medicare Advantage business to one or more interested buyers no later than May 31, 2023.’
The company overdrew its credit facility and needs to raise about $300 million to avoid going under.”

Oscar Health to exit California's ACA exchange in 2024 “Oscar Health will pull out of California's individual market for the 2024 plan year, CEO Mark Bertolini told investors Tuesday…
Oscar Health posted a net loss of $39.7 million in the first quarter of 2023, slimming its losses considerably from $75.1 million in the prior-year quarter. Revenues in the quarter were $1.5 billion in the first quarter of 2023, up from $972.8 million in the first quarter of 2022.
The company reported about 1 million total members in its plans in both 2022 and 2023, although there were 56,000 fewer members this year than last. Membership in its individual and small group plans dropped from 1,032,768 in 2022 to 948,431 in 2023.”

About hospitals and healthcare systems

 Market Analysis and Monthly Hospital & Physician KPIs MARCH 2023 DATA Lots of interesting stats in this report, but focus on these:
”Per-physician expenses continued to rise in the first quarter of 2023, as they have each quarter for more than two years. Total Direct Expense per Full-Time Equivalent (FTE) — including advanced practice providers — rose to $973,420 in Q1 2023, up 14.2% versus the same quarter of 2022…
Per-physician revenues increased in the first quarter, as they have each quarter for the past year. Median Net Revenue per Physician FTE reached $668,775 in Q1 2023, up 15.7% from Q1 2022 and up 6.8% from Q4 2022.”
How are hospitals profiting by employing physicians?

Group purchasing organization Premier exploring potential sale, other strategic alternatives “The board of healthcare group purchasing organization Premier Inc. announced Monday that it has retained financial and legal advisers to explore a potential sale or other strategic alternatives…
In quarterly earnings reported last week, the company reported nine-month net revenues had fallen roughly 8.8% from the previous year. Nine-month net income attributable to stockholders had also dropped from $236 million in fiscal 2022 to $154 million in fiscal 2023.”

CommonSpirit plans to have virtual nursing in every market by end of '23 “Chicago-based CommonSpirit Health intends to have virtual nursing in each of its markets by the end of 2023, with plans to have it across the entire system within five years.
The health system, which has more than 140 hospitals across 21 states, has started rolling out its proprietary virtual nursing technology with a recent launch at Saint Joseph Hospital in Lexington, Ky…
CommonSpirit has two types of virtual nurses: ones who work at a command center to help with admissions, discharges and transfers, and ones who are part of the care team, attending rounds with physicians and being available to patients at the push of the button. The system is debuting the initiative in its medical-surgical units.”

About pharma

 3rd Circ. Says J&J Talc Unit's Ch. 11 Should Proceed The headline is the story.

 DEA extends telemedicine option for prescribing controlled medications “The federal government will allow doctors to keep using telemedicine to prescribe certain medications for anxiety, pain and opioid addiction, extending for six months emergency flexibilities established during the coronavirus pandemic…
The ability to prescribe controlled medications remotely will run through Nov. 11, 2023. And that deadline will be longer still if doctors have already established a telemedicine relationship with patients. In that circumstance, physicians can keep prescribing the medications virtually through Nov. 11, 2024.”

Eli Lilly damages tripled to $184M in Medicaid rebate fraud case “When a federal jury last year ordered Eli Lilly to pay $61 million for skimping out on Medicaid rebates, the company vowed to fight the verdict. But instead of the result Lilly wanted, the award has been tripled to more than $183 million.
On Tuesday, Illinois federal judge Harry Leinenweber ruled that Eli Lilly owes triple damages from last year's award after whistleblower Ronald Streck convinced a jury that the company violated the False Claims Act and short-changed Medicaid on rebate payments.
Since the case falls under the False Claims Act, the award was eligible for ‘trebled’ damages, according to court filings.”

About the public’s health

 FDA advisers endorse making birth control pill available over the counter “Advisers to the Food and Drug Administration on Wednesday unanimously endorsed making birth control pills available without a prescription, overriding concerns raised by the agency about whether the medication could be used in a safe and effective manner without physician oversight.
The FDA’s outside experts expressed confidence, in a 17-0 vote, that consumers could use an oral contraceptive called Opill correctly. They said the benefits of over-the-counter status, such as increased access to contraception, outweighed the risks, including a potential lack of adherence to daily pill-taking that could result in unintended pregnancies…
The FDA does not have to follow the guidance of its advisers, but a rejection of the OTC application — especially given the committee’s view — would be awkward for an administration that has repeatedly pledged to protect reproductive rights following the Supreme Court’s overturning of Roe v. Wade, which guaranteed the nationwide right to abortion.”

About health technology

 Human ‘pangenome’ published, with goal of making genomics more useful for diverse populations  Read the entire article- it is fascinating!
“An international team of scientists has assembled the first human ‘pangenome’ — an attempt to make a more representative reference genome, one that captures almost all the genetic variability residing in the DNA of humans around the globe.
The technological achievement, published Wednesday in Nature, is the result of years of work by more than 100 researchers behind The Human Pangenome Project, a $30 million effort launched in 2019 and funded by the U.S. National Human Genome Research Institute.”

About healthcare finance

Bicycle rides to 2nd $1.7B Big Pharma deal in 2 months, this time with Bayer “Bayer has taken its radiopharmaceutical pipeline up a gear, paying out $45 million upfront to Bicycle Therapeutics in a collaboration spanning multiple oncology targets.
Bicycle will use its phage platform to discover and develop so-called bicyclic peptides, which consist of 9 to 20 amino acids that can bind to specific targets. This morning’s release offers few clues to the number and exact application of the peptides to be covered by the deal beyond ‘several undisclosed oncology targets.’
The German Big Pharma will oversee and bankroll all development from preclinical work through potential commercialization. Including the upfront payment, Bayer’s total payout to Bicycle could top out at $1.7 billion once development and commercial milestone fees are taken into account.”

All the rumors are true: Syneos Health inks $7.1B acquisition with investment firm trio “All the rumors are true. After months of sale speculation, Syneos Health has officially been snapped up by three private investment firm affiliates for the eye-watering sum of $7.1 billion.
The North Carolina-based CRO has inked a deal to be acquired by Elliott Investment Management, Patient Square Capital and Veritas Capital for $43 per share in cash. The total transaction is valued at $7.1 billion, a figure that includes outstanding debt. The purchase price adds a 24% premium to Syneos’ closing stock price on Feb. 13—the last day of trading before media reports surfaced suggesting the CRO was searching for a buyer.”

Today's News and Commentary

About health insurance/insurers

 Healthcare billing fraud: 11 recent cases As usual, they largely involve Medicare and/or Medicaid.

About pharma

Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation  “In this study, drugs initially approved for an orphan-designated condition were just as lucrative for their manufacturers as drugs developed for more common conditions. In 6 cases, indications for orphan-designated drugs were expanded to nonorphan indications within 5 years; in such cases, drug manufacturers benefit from Orphan Drug Act incentives and can extend to all uses the high prices set for the first indication. The study was limited to drugs made by public companies, excluded sales in non-US markets, and lacked data on sales volume.
Manufacturers offset smaller volumes of orphan drugs with higher prices; from 2008 to 2018, launch prices for orphan-designated drugs were 7 times higher than prices for nonorphan drugs.3 Congress could reform the statutory incentives in the Orphan Drug Act, such as by requiring manufacturers to repay tax credits when orphan-designated products are commercial successes.”

Gilead Sciences prevails in US government lawsuit over HIV drug patents “A federal jury on Tuesday found that Gilead Sciences Inc did not infringe U.S. patents with its HIV-prevention regimens using the drugs Truvada and Descovy, handing the government a defeat in its billion-dollar lawsuit.
The Delaware jury found the government's patents were invalid and not infringed following a five-day trial and a morning of deliberations.
The federal government had argued that Gilead failed to compensate the U.S. Centers for Disease Control and Prevention (CDC) for discovering that its drug Truvada, which was first approved to treat HIV, could also help prevent infection by the virus.”

About the public’s health

Draft Recommendation Statement- Breast Cancer: Screening “The USPSTF recommends biennial screening mammography for women ages 40 to 74 years.” 

About health technology

Mighty Mice to the Rescue: How Mice in Microgravity Help Patients With Muscle and Bone Loss on Earth No comment…just read this decimating article.l;

Today's News and Commentary

About Covid-19

 Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity “This systematic review and meta-analysis of secondary data from 40 studies found that the estimated vaccine effectiveness against both laboratory-confirmed Omicron infection and symptomatic disease was lower than 20% at 6 months from the administration of the primary vaccination cycle and less than 30% at 9 months from the administration of a booster dose. Compared with the Delta variant, a more prominent and quicker waning of protection was found.” 

About health insurance/insurers

The Health Coverage of Noncitizens in the United States, 2024 “Key Findings

  • The uninsurance rate among nonelderly people who are not citizens will be nearly four times higher than it is for the entire nonelderly U.S. population in 2024 (39.2% vs. 9.8%).

  • More than 80 percent of uninsured people who are not citizens live in families that include at least one employed worker, but many work in industries that do not offer employer-sponsored coverage. More than 1 in 3 (36.0%) people who are not citizens have employer coverage, compared to 54.4 percent of all nonelderly people in the United States.

  • People who are not citizens are less likely to have public health coverage, with many facing federal and/or state eligibility restrictions.

    • Only 16.5 percent of uninsured people who are not citizens are eligible for Medicaid, Children's Health Insurance Program (CHIP), or subsidized Marketplace coverage.

    • Two-thirds of uninsured noncitizen adults are ineligible for public health coverage based solely on their immigration status.”

Medicare Improperly Paid Providers for Some Psychotherapy Services, Including Those Provided via Telehealth, During the First Year of the COVID-19 Public Health Emergency From the HHS OIG: “Based on our sample results, we estimated that of the $1 billion that Medicare paid for psychotherapy services, providers received $580 million in improper payments for services that did not comply with Medicare requirements, consisting of $348 million for telehealth services and $232 million for non-telehealth services…
We recommend that CMS: (1) work with Medicare contractors to recover $35,560 in improper payments for the sampled enrollee days, (2) implement system edits for psychotherapy services to prevent payments for incorrectly billed services, and (3) strengthen educational efforts to make providers aware of educational materials on meeting requirements and guidance for psychotherapy services. The report contains three other recommendations.”

Kaiser posts $233M operating profit in Q1, health plan adds 120,000 members “Oakland, Calif.-based Kaiser Permanente reported $233 million in operating income for the first quarter, up from a $72 million operating loss in the first quarter of 2022. Its operating margin grew from -0.3 percent in the first quarter of 2022 to 0.9 percent in the first quarter of this year.”

Blue Shield of California posts $910M loss in 2022 “Blue Shield of California lost $910 million in 2022 as medical costs rose, according to the company's 2022 annual report.
Medical benefits cost the company $22.1 billion in 2022, up from $20.1 billion in 2021 and $18 billion in 2020…”

Benchmarking Changes And Selective Participation In The Medicare Shared Savings Program “In contrast to earlier participation patterns, the composition of the MSSP after 2017 increasingly shifted to providers with lower preexisting levels of spending relative to their region, consistent with a selection response. Changes occurred through the entry of new ACOs with lower baseline spending, the exit of higher-spending ACOs, and the reconfiguration of participant lists favoring lower-spending practices within continuing ACOs.”
Comment: Those who tout the success of the MSSP should study this article. Self-selection is skewing the results.

About pharma

Paul Girolami, businessman, 1926-2023 This FT obituary is well worthy reading.
“Sir Paul Girolami was one of Britain’s outstanding postwar business leaders. As chief executive and later chair of Glaxo in the 1980s, Girolami, who has died aged 97, transformed a minor player in the pharmaceutical industry into a world leader. That Glaxo, now GSK, still holds that position is due in no small measure to the decisions taken by Girolami during his period at the helm.”

 About healthcare personnel

Nursing School Enrollment Drops After 20-Year Rise, Worsening Shortage “For the first time in two decades, the number of students enrolled in entry-level baccalaureate nursing programs declined, according to the American Association of Colleges of Nurses (AACN) latest enrollment data. The 1.4% drop in students training to be registered nurses (RNs) last year hampers ongoing efforts to fill the nursing pipeline during a national nursing shortage. The number of applications to nursing schools also has decreased…
Despite the recent drop in enrollment, AACN reported that nursing schools turned away thousands of qualified applicants last year because of a shortage of faculty and clinical training sites. Last year, more than 78,000 qualified applications were turned away from nursing schools nationwide, AACN reported. The majority of those were in the entry-level bachelor's programs.”

About healthcare finance

Baxter breaks off biopharma solutions segment in $4.25B private equity deal “In a deal announced Monday, the medtech giant is set to separate out its biopharma solutions business, which offers drugmakers support in the form of products like injectable delivery systems and services that include regulatory resources, help with drug formulation and development, and packaging capabilities.
Private equity firms Warburg Pincus and Advent International are snapping up the segment. They’ll pay Baxter $4.25 billion in cash, which the devicemaker said will translate into net proceeds of about $3.4 billion after taxes. The deal is set to close sometime in the second half of this year.
The biopharma solutions business is among Baxter’s smallest. In 2022, it brought in $644 million in sales—a decline of 4% year over year—representing just 4% of the company’s $15.1 billion in total sales for the year.”

How Low Can It Go? Health Care Leads With Nearly $5.7B Invested In Bummer Month For Global Venture Funding “Global funding reached $21 billion, down 56% from $47.8 billion in a year-over-year comparison. This is the second-lowest amount recorded in a single month since July 2022 when venture capital started to scale below $30 billion. 
The slowdown has impacted all funding stages. Seed was down more than 50% year over year, while early-stage funding dropped 48%. Late-stage funding was down the most at 62%…
Health care was the sector that raised the largest amounts with close to $5.7 billion invested. Companies that raised large rounds at the early stages include RNA-based medicine provider Orbital Therapeutics, medical robotics company Noah Medical and drugs from plants developer Enveda Biosciences.”

Today's News and Commentary

12 top healthcare companies by revenue FYI
“UnitedHealth Group is the top healthcare company by revenue, with the average revenue for the last four quarters hitting $333.5 billion.”

About Covid-19

WHO declares end to Covid global health emergency “The World Health Organization ended the Covid-19 global health emergency on Friday, saying it was time for countries to transition from treating Covid as an emergency to dealing with it as a disease that is here to stay.
The decision was made on the advice of a panel of independent experts, the so-called Covid-19 emergency committee, which met Thursday.”

 Disease experts warn White House of potential for omicron-like wave of illness “The White House recently received a sobering warning about the potential for the coronavirus to come roaring back, with experts reaching a consensus that there’s a roughly 20 percent chance during the next two years of an outbreak rivaling the onslaught of illness inflicted by the omicron variant.
A forecast from one widely regarded scientist pegged the risk at a more alarming level, suggesting a 40 percent chance of an omicron-like wave.”

About health insurance/insurers

Cigna boosts guidance as it reports $1.3B in profit in Q1 beat “The Cigna Group rounded out earnings for the large national insurers Friday morning when it reported $1.3 billion in profit for the first quarter of 2023.
That's on par with the prior-year quarter, where the company reported $1.2 billion in profit, and with the fourth quarter of 2022, where Cigna also reported $1.2 billion in profit.”

Gaps in Medicare Advantage Data Limit Transparency in Plan Performance for Policymakers and Beneficiaries Read the entire report (or at least Table 1). While CMS seems to have control of many aspects of MA plans, a large amount of data is either not available or not being disclosed.

Medical Credit Cards and Financing Plans CONSUMER FINANCIAL PROTECTION BUREAU REPORT. Some important highlights:
—Many medical credit cards offer people deferred interest, or springing interest, terms for a time period of between six and eighteen months. If someone has a remaining balance after the designated promotional period, they are charged all the interest that would have accrued since their original purchase date. These products are typically more expensive than other forms of payment due to the higher interest payments.
—People paid $1billion in deferred interest payments for these healthcare charges from 2018-2020. People used cards or loans with deferred interest terms to pay for almost $23 billion in healthcare expenses, and over 17 million medical purchases, from 2018 to 2020.
—From 2017 to 2020, the share of medical borrowing on deferred interest grew relative to other deferred interest borrowing. This is true across all ranges of credit scores.
—CFPB analysis indicates that, between 2015 and 2020, people incurred interest on 20 percent of their healthcare purchases when using deferred interest cards or loans. People with credit scores below 619 incurred interest more frequently, for about 34 percent of their healthcare purchases. In part, people with lower credit scores may have been more likely to incur interest because they were more likely to have shorter periods before they were charged deferred interest.
—Patients who should be eligible to receive reduced or free care through a financial assistance program or their insurance plan may instead be signed up for a medical card or loan. Many people would be better off without these products for two reasons: the financial burden can be higher and their ability to challenge an inaccurate bill is complicated when they are working through a third party financial institution.
—The terms of credit for medical credit cards and financing plans can vary greatly in terms of annual percentage rates (APRs), length of the special financing period, and other terms. The APR of the typical medical credit card is 26.99 percent; currently, the mean APR for all general purpose credit cards is approximately 16 percent.”
Comment: States have cracked down on exorbitant “payday loans;” they need to pay attention to these highly usurious and unethical credit cards.

About pharma

 Acelyrin readies biggest biotech IPO so far this year with $540M upsized offering “The upsized public offering will now see the California biotech offer 30 million shares of common stock at $18 apiece. There will also be the option for underwriters to snap up a further 4.5 million shares at the same price, which could potentially boost proceeds to around $620 million.
It would mark a significant cash injection for a company that has already raised$408 million from private investors in recent years. The biotech’s backers have been attracted by izokibep, a small therapeutic protein inhibitor of IL-17A that Acelyrin licensed from Affibody and is in late-phase development in three immunological diseases.”

About the public’s health

 Cigarette Smoking in the US Drops to Lowest Level Since 1965, CDC Says “Just 11.5% of Americans regularly lit up cigarettes last year, better than the 12% goal set by the US government’s Healthy People 2020 plan and the lowest level since 1965, according to a report from the Centers for Disease Control and Prevention. Still, about one in five adults reported using a tobacco product in 2021, nearly unchanged from the previous year, with e-cigarette use rising to 4.5%.”

Achieving Whole Health for Veterans and the Nation: A National Academies of Sciences, Engineering, and Medicine Report A really good summary of the Academy’s publication: Achieving Whole Health: A New Approach for Veterans and the Nation. National Academies Press; 2023.
Whole health is physical, behavioral, spiritual, and socioeconomic well-being as defined by individuals, families, and communities. To achieve this, whole health care is an interprofessional, team-based approach anchored in trusted longitudinal relationships to promote resilience, prevent disease, and restore health. It aligns with a person’s life mission, aspiration, and purpose.”

About healthcare IT

 Community Health Systems sued for data breach affecting 1 million “Franklin, Tenn.-based Community Health Systems is facing a lawsuit for a January data breach that compromised the protected health information of 1 million patients…
The patient-led lawsuit, filed May 3 in the U.S. District Court of Tennessee, alleges that the breach happened as a result of the health system not implementing adequate security measures.”

Today's News and Commentary

About Covid-19

 Covid was fourth leading cause of death in 2022, CDC data shows “The waning of the pandemic led to fewer deaths in America in 2022 than in 2021, according to preliminary data from the Centers for Disease Control and Prevention. But heart disease and cancer deaths rose, and covid-19 remained remarkably lethal, killing more than 500 people a day.
The report shows an overall drop of 5.3 percent in the death rate from all causes, a signal that the country last year had exited the worst phase of the pandemic. Deaths from covid dropped 47 percent between 2021 and 2022.”

About health insurance/insurers

 CVS pressing pause on M&A after Oak Street, Signify buys “CVS Health said it will not pursue any major acquisitions in the near future following its recent purchases of Dallas-based Signify Health and Chicago-based Oak Street Health.
’I think over time we'll look at other assets, but right now we need to focus on execution of the assets that we just acquired,’ President and CEO Karen Lynch told investors during the company's first-quarter earnings call May 3.”

About hospitals and healthcare systems

15 healthcare mergers and acquisitions making headlines in April FYI

Option Care Health to acquire health and hospice firm for $3.6 billion “Option Care Health, the largest independent provider of home health services, announced a deal Wednesday to acquire home health and hospice firm Amedisys for $3.6 billion.
The all-stock transaction will turn the Bannockburn [IL]-based Option into a mammoth provider of post-acute care services that also will include hospital-at-home and palliative care. The combined firm will generate approximately $6.2 billion in annual revenue.”

North Carolina Senate passes bill waiving UNC Health from state, federal antitrust enforcement “According to the bill’s text, UNC Health’s board would be able to ‘enter into cooperative agreements with any other entity for the provision of healthcare, including the acquisition, allocation, sharing or joint operation of hospitals or any other healthcare facilities or healthcare provider, without regard to their effect on market competition.
When partnering with community hospitals and other health systems in various regions of the State, the System is acting according to State policy by ensuring that healthcare is made available to all parts of North Carolina; its activities constitute State action for purposes of antitrust law, the bill reads.”

This action by North Carolina is a good reminder to review how states can exempt healthcare organizations from federal anti-trust actions. [Note: This response was generated by CHAT GPT and I checked it for accuracy.]
Antitrust exemptions for healthcare entities at the state level are granted through state laws or regulations, which can vary depending on the state. Each state may have its own criteria and procedures for granting such exemptions.
One common approach for states to obtain antitrust exemptions for healthcare entities is to establish a Certificate of Public Advantage (COPA) program. Under a COPA program, state regulators grant antitrust immunity to certain healthcare providers or systems in exchange for their commitment to fulfill certain public health goals, such as improving access to healthcare services or enhancing the quality of care.
To establish a COPA program, a state must pass a law or issue regulations that provide a legal framework for granting antitrust exemptions. The state may then create a regulatory body or designate an existing agency to oversee the COPA program and review applications from healthcare providers seeking antitrust immunity.
Once a healthcare provider is granted a COPA, it is immune from certain federal antitrust laws, such as the Sherman Antitrust Act, while operating within the parameters of the program. However, the immunity is not absolute, and the state can revoke a COPA if the provider fails to fulfill its public health commitments or engages in anticompetitive behavior that harms consumers.
It is worth noting that antitrust exemptions for healthcare entities are controversial, as they can potentially limit competition and lead to higher healthcare costs. Therefore, states considering such exemptions should carefully weigh the potential benefits and drawbacks before implementing them.

About pharma

 Kroger paying $68M to settle opioid claims in West Virginia Just a reminder that these lawsuits are ongoing.

 J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year “J&J's consumer group Kenvue will be listed on the New York Stock Exchange starting today, May 4, for $22 per share, according to a statement from the two companies. The companies are selling more than 172 million shares to the public, pricing the offering at around $41 billion.
This will be the largest IPO in U.S. markets in more than a year, according to CNBC. Kenvue will trade under the ticker ‘KVUE.’
After the IPO closes, which is expected on May 8, J&J will hold around 90% of the total shares in Kenvue.”

Florida passes PBM regulation bill While Congress debates what to do about drug costs: “Florida Gov. Ron DeSantis signed the Prescription Drug Reform Act on May 3 to limit pharmacy benefit manager practices and hold "Big Pharma accountable."
The law bans clawbacks, mail-order rebates, spread pricing, patient steering and networks solely composed of affiliate pharmacies, according to a news release. It also aims to block data-sharing without patients' consent. 
On the ‘Big Pharma’ side, the legislation requires drugmakers to report price increases surpassing 15 percent after one year and cumulative list price increasing 30 percent or more within three years.”

About the public’s health

One Dose of HPV Vaccine Prevents Infection for at Least Three Years “A single dose of the human papillomavirus vaccine is highly effective at preventing infections over three years, most likely lowering rates of cervical cancer and other diseases linked to the virus, according to a new study in Kenya.
A single-dose strategy would dramatically extend supplies of the vaccine, lower costs and simplify distribution, which would make vaccination a more viable option in countries with limited resources, experts said.”

About healthcare IT

 CMS Officials Provide Update on National Quality Strategy Goals “A year ago, officials from the Center for Medicare and Medicaid Services unveiled a National Quality Strategy. In a May 1 update on the strategy, CMS officials discussed several goals, including annually increasing the percentage of digital measures used in CMS quality programs. CMS officials also said the organization would build one or more quality data systems that can receive data using the FHIR data standard by 2027…
[Also,] CMS is incorporating equity into the measurement strategy of every quality and value-based program possible…”

Today's News and Commentary

About Covid-19

Wisconsin Supreme Court won't order ivermectin use for COVID “Wisconsin's conservative-controlled Supreme Court ruled Tuesday that a hospital could not be forced to give ivermectin to a patient with COVID-19, saying a county judge did not cite a legal basis for ordering the facility to administer the drug, as reported by ABC News.
The FDA has not approved ivermectin for use in treating COVID-19 and warns that misusing it can be harmful, even fatal. The Wisconsin lawsuit is one of dozens filed across the US seeking to force hospitals to administer ivermectin for COVID-19…
In Tuesday's ruling, the Wisconsin Supreme Court ruled 6-1 in favor of Aurora Health Care, with three liberals and three conservatives in support and only conservative Justice Rebecca Bradley dissenting. The decision upholds an appeal court's ruling against Allen Gahl, who sued Aurora in October 2021 when doctors refused to treat his uncle with ivermectin.”
Comment: Common sense and science prevails.

About health insurance/insurers

 Arbitration panel hands Envision a victory over UnitedHealth, awards $91.3M judgment “An arbitration panel has handed Envision Healthcare a $91.3 million judgment against UnitedHealthcare over underpaid claims, the physician staffing firm said Tuesday.
The independent, three-member panel from the American Arbitration Association made the ruling March 30, Envision said. The arbitrators will also weigh whether Envision is entitled to attorney's fees as well as prejudgment interest, according to the news release.
The $91,270,257 award covers claims for services provided to UnitedHealthcare members in 2017 and 2018, when Envision was still in UHC's network. The arbitration panel determined that the insurer ‘unilaterally reduced reimbursement to Envision clinicians in violation of the network agreement,’ according to the release.”

About hospitals and healthcare systems

 National Hospital Flash Report End of April report on March Data:
“Key Takeaways

  1. Hospital finances improved in March.

    Hospital margins continued to stabilize in March with a slight improvement over February. Margins, however, continue to sit at razor-thin, near-zero levels, putting hospitals in a vulnerable position should a recession or a new public health emergency materialize.

  2. Material expenses are burdening hospitals.

    Increased material costs associated with drugs and supplies as a result of inflationary pressures continue to negatively affect hospital margins. Additionally, workforce shortages persist, driving up the cost of labor, albeit at a slower pace than material costs.

  3. Patient volumes continue to rebound.

    Outpatient volumes remained strong in March, while lengths of stay decreased hinting at a reduction in patient acuity. Hospitals still face a bottleneck discharging patients to post-acute sites of care. Furthermore, workforce shortages still hamper hospitals' ability to treat patients admitted to their institutions.”

Spring 2023 Leapfrog Hospital Safety Grade You can look up all surveyed hospitals. Some highlights:

  • “Twenty-nine percent of hospitals received an “A,” 26% received a “B,” 39% received a “C,” 6% received a “D,” and less than 1% received an “F.”

  • The top ten states with the highest percentages of “A” hospitals are: New Jersey, Idaho, Utah, Pennsylvania, Connecticut, North Carolina, South Carolina, Colorado, Virginia and Massachusetts.

  • There were no “A” hospitals in Delaware, District of Columbia or North Dakota.”

About pharma

Pfizer to start selling stake in Advil maker Haleon within months, says CFO “Pfizer said it would begin offloading its 32 per cent stake in consumer health business Haleon as it focuses on reducing debt linked to its $43bn acquisition of Seagen and boosting returns to shareholders…
GSK and Pfizer combined their consumer healthcare businesses in a joint venture in 2019 that sat within GSK before it was spun off via a listing on the London Stock Exchange. The listing created the world’s biggest pureplay consumer health company with a valuation of £30.5bn.”

EU states push for law to limit dependency on drug ingredients from China “A majority of EU member states are pushing for legislation to address shortages of critical drugs and to reduce dependency on imported chemicals from China and other countries. In a paper seen by the Financial Times, Belgium and 18 other countries — including Germany and France — have gone further than Brussels’ recent proposals to overhaul the bloc’s pharmaceuticals laws, calling for a ‘last-resort’ mechanism to swap medicines between member states and the establishment of a list of critical drugs whose supply chains must be monitored.”

About the public’s health

 First vaccine targeting RSV wins FDA approval. More are coming. “U.S. regulators Wednesday approved the first vaccine to prevent the respiratory ailment RSV, a decision that marks a turning point in the six-decade-long quest to protect vulnerable people against the virus.
A shot developed by pharmaceutical giant GSK to protect older adults against the respiratory syncytial virus is the first to get a greenlight from the Food and Drug Administration.”

Gut Microbiome Changes Throughout the Day and With the Seasons “The investigators found that nearly 60% of related bacterial groups fluctuate with a distinct 24-hour cycle…
Seasonal fluctuations were even more pronounced, with certain types of bacteria following one of two distinct patterns over the course of a year…
Seasonal fluctuations might be influenced by location, climate, pollen, humidity and other environmental factors, he suggested. These findings could offer a potential explanation why humans are more susceptible to colds and flu during specific seasons, since the microbiome is known to influence immune response.
The fluctuating microbiome also plays a role in how drugs are metabolized, and therefore could alter the results of clinical trials unless it's taken into account…”
Comment: If the microbiome is constantly changing, how effective are probiotics?

About healthcare IT

Telehealth providers cheer DEA move to temporarily extend virtual prescribing flexibilities “Under the proposed rule, Schedule 2 medications or narcotics would require an in-person prescription. Schedule 3 or higher medications, including buprenorphine, can be prescribed for 30 days via telehealth but would require an in-person visit before a refill. Non-narcotic drugs like Ambien, Valium, Xanax and ketamine also fall into this category. If a patient is referred to a provider, an in-person appointment is not required as long as one took place with the referring physician.
If a telemedicine relationship was established during the COVID-19 public health emergency, the DEA will extend the in-person exam waiver for an additional 180 days.”

Toolkit: Analyzing Telehealth Claims to Assess Program Integrity Risks From the HHS OIG: “This toolkit provides detailed information on methods to analyze telehealth claims to identify program integrity risks associated with telehealth services… [It] is intended to assist public and private sector partners—such as Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units, and other Federal health care agencies—in analyzing their own telehealth claims data to assess program integrity risks in their programs…
Through the use of proactive, data-driven analyses, including measures such as those detailed in this toolkit, public and private partners can more effectively identify potential fraud, waste, and abuse schemes in their health care programs.”

About healthcare personnel

In pandemic’s wake, over 40% of doctors regret career choice “Between Dec. 9, 2021, and Jan. 24, 2022, nearly 2,500 U.S. physicians responded to a survey by researchers from the AMA, the Mayo Clinic, Stanford University School of Medicine and the University of Colorado School of Medicine. The researchers found that professional fulfillment scores fell, dropping from 40% in 2020 to 22.4% in 2021.
Published in Mayo Clinic Proceedings, the study, Changes in Burnout and Satisfaction With Work-Life Integration in Physicians Over the First 2 Years of the COVID-19 Pandemic, also found that—consistent with those trends in professional fulfillment—57.5% of physicians indicated they would choose to become a doctor again, dropping from 72.2% in 2020. This is also a decrease from 68.5% in 2017, 67% in 2014, and 70.2% in 2011.”

About health technology

 Nanox scores clearance for cloud-connected X-ray bed after years of FDA review “Nanox has secured a long-awaited clearance from the FDA for its multi-source X-ray bed, designed to operate as a smaller, lighter imaging system in clinics and hospitals.
The Nanox.ARC can employ up to five separate X-ray-emitting tubes at once—mounted together above the patient on a tiltable gantry—to take multiple pictures of the inner body and digitally reconstruct them into a three-dimensional image, similar to a CT scan…
In its announcement this week, Nanox said it plans to offer access to its multi-source imager through a pay-per-scan business model—with scan readings and analyses being performed remotely through its teleradiology network.”
Comment: Look at the photo in the article. The possibilities for diagnostics in remote areas are exciting.

FDA: The heart-checking smart toilet seat is a go “The battery-powered, Internet-connected Heart Seat is designed to replace a standard home toilet seat, automatically capturing and uploading SpO2 and heart rate data using the same types of sensors built into smartwatches and other devices for checking vital signs. 
The system can also flag readings for healthcare providers The FDA cleared its use in adults ages 22 and older.”

Today's News and Commentary

About Covid-19

Most federal covid vaccine mandates to end May 11 “The Biden administration will end its requirements that most international travelers, federal workers and contractors, health-care workers and Head Start educators be vaccinated against the coronavirus effective on May 11 — the same day it terminates the pandemic-related public health emergency.” 

About health insurance/insurers

Milliman Retiree Health Cost Index “A healthy 65 year old retiree needs to save between $90,000 and $203,000 for healthcare costs if they retire in 2023.”

Medicare Advantage, Part D Premiums Increased Slightly in 2023 “The average monthly Medicare Advantage premium grew by 50 percent from 2022 to 2023. The average premium in 2023 was $9 per month, compared to $6 in 2022, marking the second year in a row that premiums increased.
However, the average premium was still relatively low due to high enrollment in zero-dollar premium plans.
In 2023, 84 percent of Medicare Advantage plans selected by eHealth consumers had a zero-dollar monthly premium. This figure is down slightly from 87 percent in 2022 but is up significantly from 63 percent in 2018.”

Half of All Eligible Medicare Beneficiaries Are Now Enrolled in Private Medicare Advantage Plans “According to recently released data from the Centers for Medicare & Medicaid Services (CMS), Medicare Advantage now provides Medicare coverage for just over half of eligible beneficiaries. In January 2023, 30.19 million of the 59.82 million people with both Medicare Part A and Part B were enrolled in a private plan.”

CVS closes $10.6B acquisition of Oak Street Health to expand primary care footprint “CVS Health has sealed the deal on its acquisition of Oak Street Health, picking up about 169 medical centers in 21 states. 
The acquisition will broaden CVS Health's value-based primary care platform and significantly benefit patients' long-term health by improving outcomes and reducing costs – particularly for those in underserved communities, according to the company in a press release Tuesday.”

Insurer Market Power And Hospital Prices In The US “We found that the market-leading insurer in the least competitive (most concentrated) insurance markets pays 15 percent less to hospitals than the market-leading insurer in the most competitive (least concentrated) markets. We also found the price relationship to be more pronounced for for-profit hospitals than for not-for-profit hospitals. Our results invite the question of whether dominant insurers are passing savings on to employers in the form of lower premiums.”

About hospitals and healthcare systems

How CHS, Tenet, HCA and UHS fared in Q1 FYI

 CommonSpirit Health finalizes acquisition of 5 Utah hospitals, 35 medical clinics “CommonSpirit Health officially sealed the deal on picking up five hospitals and 35 medical group clinics from Steward Health Care, the health systems said Monday.
The deal, announced in February, also includes imaging and urgent care centers, other outpatient ventures and a clinically integrated network of providers. Colorado-based Centura Health will manage all the operations.”

About pharma

 Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets “With analysts expecting a free-fall in sales from COVID products, Pfizer pulled off a surprise Tuesday morning with its first-quarter earnings report.
Revenue for the period came in at $18.3 billion, routing the analyst consensus of $16.6 billion. With the performance, Pfizer reaffirmed its expectations for 2023 revenue to fall between $67 billion and $71 billion.”

J&J refuels CAR-T ambitions with $245M upfront to Cellular Biomedicine for pair of therapies “J&J’s pharma unit Janssen has handed over $245 million in upfront cash and the promise of further milestone payments to Cellular Biomedicine for two autologous CAR-T therapies being investigated in non-Hodgkin lymphoma. In return, Janssen gets the exclusive ex-China rights to the therapies as well as an option on commercializing the drugs in China.”

The Role Of Financial Incentives In Biosimilar Uptake In Medicare: Evidence From The 340B Program “We investigated whether the 340B Drug Pricing Program, which offers eligible hospitals substantial discounts on drug purchases, inhibits biosimilar uptake. Almost one-third of US hospitals participate in the 340B program. Using a regression discontinuity design and two high-volume biologics with biosimilar competitors, filgrastim and infliximab, we estimated that 340B program eligibility was associated with a 22.9-percentage-point reduction in biosimilar adoption. In addition, 340B program eligibility was associated with 13.3 more biologic administrations annually per hospital and $17,919 more biologic revenue per hospital. Our findings suggest that the program inhibited biosimilar uptake, possibly as a result of financial incentives making reference drugs more profitable than biosimilar medications.”

About the public’s health

A new Supreme Court case seeks to make the nine justices even more powerful This case could have serious implications in all fields, but especially in healthcare.
“The Supreme Court announced on Monday that it will reconsider one of its modern foundational decisions, Chevron v. National Resources Defense Council (1984), which for decades defined the balance of power between the federal judiciary and the executive branch of government.
Chevron established that courts ordinarily should defer to policymaking decisions made by federal agencies, such as the Environmental Protection Agency or the Department of Labor, for two reasons: Agencies typically have far greater expertise in the areas they regulate than judges, and thus are more likely to make wise policy decisions. And, while federal judges are largely immune from democratic accountability, federal agencies typically are run by officials who serve at the pleasure of an elected president — and thus have far more democratic legitimacy to make policy choices.
Nevertheless, next term the Court will hear a case, Loper Bright Enterprises v. Raimondo, which explicitly asks ‘whether the court should overrule Chevron.’ In the reasonably likely event that the Court does overrule this seminal decision, that would mean the death of one of the most cited decisions in the federal judiciary — according to the legal database Lexis Nexis, federal courts have cited Chevron in over 19,000 different judicial opinions.”

Study: Ingredient found in salad bowls and burger wrappers less safe than previously thought “Acompostable salad bowl seems like an Earth-friendly way to enjoy a healthy lunch. But the toxic chemicals used in containers like molded-fiber salad bowls, sandwich wrappers, and French fry pouches may be leaching into food despite efforts to make those materials safer, according to the results of a study published in March in the journal Environmental Science and Technology.
The presence of “forever chemicals” in materials used to contain or carry food is far from new. Various formulations of compounds called per- and polyfluoroalkyl substances, or PFAS, are used in materials like pizza boxes, popcorn bags, and paper straws because they’re both water-proof and oil-proof. That means they’re perfect for keeping fake butter or salad dressing from seeping out of microwave popcorn packets and takeout salad bowls, as well as for maintaining structural integrity while protecting a steaming, cheesy pizza.
But PFAS are also toxic. They’ve been linked to testicular and kidney cancers, ulcerative colitis, low birth weights, and even decreased immune response to vaccines.”

 Feds: Hospitals that denied emergency abortion broke the law “Two hospitals that refused to provide an emergency abortion to a pregnant woman who was experiencing premature labor put her life in jeopardy and violated federal law, a first-of-its-kind investigation by the federal government has found…
The federal agency’s investigation centers on two hospitals — Freeman Health System in Joplin, Missouri, and University of Kansas Health System in Kansas City, Kansas — that in August refused to provide an abortion to a Missouri woman whose water broke early at 17 weeks of pregnancy. Doctors at both hospitals told Mylissa Farmer that her fetus would not survive, that her amniotic fluid had emptied and that she was at risk for serious infection or losing her uterus, but they would not terminate the pregnancy because a fetal heartbeat was still detectable.
Ultimately, Farmer had to travel to an abortion clinic in Illinois.”

US News State rankings: Health Care FYI

About healthcare IT

Merck entitled to $1.4B in cyberattack case after court rejects insurers' 'warlike action' claim “A New Jersey appellate court on Monday ruled that a group of insurers can’t use war as an argument to deny Merck coverage from the notorious cyberattack that afflicted the company and others back in 2017.
Upholding a prior ruling, the appeals court said in an opinion (PDF) that the ‘hostile/warlike action’ exclusion clause shouldn’t be applied to a cyberattack on a non-military company—even if it originated from a government or sovereign power. In this case, the hack was tied to Russia as part of its aggression against Ukraine, according to U.S. officials.”

Are mental health apps better or worse at privacy in 2023? See the article for improved and worsened sites as well as a comparison chart.

About healthcare personnel

 Hospital-Physician Integration Is Associated With Greater Use Of Cardiac Catheterization And Angioplasty “We used Medicare claims data from the period 2013–20 to identify patients who received a new diagnosis of stable angina, a common cardiovascular condition that entails clinical discretion in treatment choice. Using linear probability models and an instrumental variables model, we found that patients whose care was managed by a hospital-integrated cardiologist were no more likely to receive stress tests (an office-based procedure) than those whose care was managed by an independent cardiologist. However, these patients were much more likely to receive high-intensity, hospital-based coronary interventions.” 

About health technology

 Dual CRISPR therapy plus long-acting ART eliminates HIV in mice “In a study published May 1 in Proceedings of the National Academy of Sciences, a research team led by scientists from the Lewis Katz School of Medicine at Temple University and the University of Nebraska Medical Center (UNMC) described how they used CRISPR to inactivate or snip out two different genes in HIV-infected humanized mice. By combining this approach with a long-acting form of antiretroviral therapy, the researchers were able to eliminate the virus in around 60% of the models—a big boost from the 29% they reported back in 2019.”

Today's News and Commentary

About health insurance/insurers

 Reported by STAT: “A new report from A.M. Best, a ratings agency for insurance companies, shows that premiums and claims have increased quite a bit for stop-loss insurance from 2014 through 2021. Stop-loss is the coverage that self-insured employers buy to protect themselves against expensive and unexpected medical claims from their workers…
Back in 2014, stop-loss insurers spent a little more than 74 cents of every $1 in premiums to cover these catastrophic claims. By 2021, that soared to 85 cents of every dollar, according to A.M. Best’s data. What gives? The main reason is there have just been more big-dollar claims. The main culprit? New, incredibly expensive drugs.
‘Cell and gene therapies have been frequently named as the top cause of catastrophic claims,’ A.M. Best analysts wrote in their report. ‘Regulators might see a need to intervene to avoid potential insolvencies given an enormous financial impact from these new drugs, especially on small and medium-sized groups.’” 

Medicare Could Have Saved Up To $128 Million Over 5 Years if CMS Had Implemented Controls
To Address Duplicate Payments for Services Provided to Individuals With Medicare and Veterans Health Administration Benefits
The headline explains the story.

About hospitals and healthcare systems

 Post-pandemic, even hospital care goes remote “The Mayo Clinic was among the first hospitals in the country to experiment with sending acute patients home for remote care four years ago. Now, some 250 similar programs exist throughout the country.
That's largely because during the pandemic, the federal agency that runs Medicare and Medicaid relaxed normal rules requiring around-the-clock, on-site nurses for hospitals requesting the exception. This allowed at-home hospital care programs to rapidly expand. Those pandemic-era waivers will remain in place until at least the end of 2024, although some experts anticipate policy changes allowing such programs to remain in place permanently.”

About pharma

 The top 10 pharma drug ad spenders for 2022 FYI. The list is by drug.

 Astellas inks deal to buy Iveric Bio for $5.9 billion “Astellas on Monday announced that it entered into an agreement to acquire Iveric Bio for $40 per share in cash, or a total equity value of about $5.9 billion, in a move the Japanese drugmaker says will sharpen its focus on therapies for blindness and regeneration.”

About the public’s health

More than One in Five Adults with Limited Public Transit Access Forgo Health Care Because of Transportation Barriers Key Findings

  • 21 percent of U.S. adults without access to a vehicle or public transit went without needed medical care last year. Individuals who lacked access to a vehicle but reported neighborhood access to public transportation services were less likely to skip needed care (9%). 

  • 5 percent of all U.S. adults reported forgoing healthcare due to transportation barriers. 

  • Black adults (8%), adults with low family incomes (14%), and adults with public health insurance (12%) were all more likely to forgo needed care due to difficulty finding transportation. 

  • Adults with a disability (17%) were more than three times as likely to report skipping care due to transportation concerns.

Conclusion
Reliable access to transportation, whether it be a vehicle or neighborhood public transit, is a social driver of health in the United States.”

About healthcare IT

Comparing Physician and Artificial Intelligence Chatbot Responses to Patient Questions Posted to a Public Social Media Forum  “In this cross-sectional study of 195 randomly drawn patient questions from a social media forum, a team of licensed health care professionals compared physician’s and chatbot’s responses to patient’s questions asked publicly on a public social media forum. The chatbot responses were preferred over physician responses and rated significantly higher for both quality and empathy.”
Comment: If it is easy to teach a machine empathy and it performs better than physicians, what does that say about medical education? 

Video Telemedicine Experiences In COVID-19 Were Positive, But Physicians And Patients Prefer In-Person Care For The Future “Although majorities of both populations reported satisfaction with video visits during the pandemic, 80 percent of physicians would prefer to provide only a small share of care or no care via telemedicine in the future, and only 36 percent of patients would prefer to seek care by video or phone. Most physicians (60 percent) felt that the quality of video telemedicine care was generally inferior to the quality of in-person care, and both patients and physicians cited the lack of physical exam as a key reason (90 percent and 92 percent, respectively). Patients who were older, had less education, or were Asian were less likely to want to use video for future care. Although improvements to home-based diagnostic tools could improve both the quality of and the desire to use telemedicine, virtual primary care will likely be limited in the immediate future. Policies to enhance quality, sustain virtual care, and address inequities in the online setting may be needed.”

Data Breach Lawsuits Tied to Tracking Pixel Use On the Rise In Healthcare “As data breach notifications tied to the use of tracking pixels continue to surface, experts have observed a wave of lawsuits following close behind. BakerHostetler observed more than 50 lawsuits being filed against hospital systems related to third-party tracking tech since August 2022, according to the firm’s 2023 Data Security Incident Response Report (DSIR).
The DSIR was based on BakerHostetler’s analysis of the more than 1,160 incidents that its Digital Assets and Data Management Practice Group helped clients manage in 2022.”

About healthcare personnel

85% of nurses plan to leave hospital roles 1 year from nowA nursing workforce that has been shrinking dramatically may be headed toward even greater challenges. Only 15 percent of nurses working in hospital settings say they plan to stay in their current positions one year from now, according to a survey of more than 18,000 nurses conducted by AMN Healthcare, the largest healthcare staffing company in the country.
The 85 percent who said they are making other career plans reported they are seeking travel nursing opportunities, considering going back to school, looking into part-time or per diem work or departing the profession completely. 
Additionally, 55 percent of nurses across the profession reported feeling like they want to quit often.”

About health technology

Medtronic’s next-gen leadless pacemakers score FDA approval “Medtronic has secured the FDA’s approval for the latest generation of its miniaturized, wireless pacemaker implants, the Micra AV2 and VR2. 
According to the company, the newest models can offer up to 40% more battery life over their predecessors—boosting them out to 16 and 17 years, respectively—and making them a more attractive option for comparatively younger patients while requiring fewer replacement procedures. In fact, Medtronic estimates that the time span will cover more than 80% of the patients who receive pacemaker implants.
Compared to traditional pacemakers, the Micra is less than a tenth the size and weighs less than 2 grams, comparable to a small capsule. While past implants have been placed under the skin near the collarbone and wired into the cardiac muscle with small leads, these devices are embedded within the heart’s chambers through a minimally invasive procedure.”