Today's News and Commentary

FY 2024 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule — CMS-1785-F and CMS-1788-F Fact Sheet
Too much content to summarize in this important document. Topics range from prospective payment adjustments to interoperability rules. It is a bit long but not difficult. Well-worth at least skimming.

About Covid-19

Comparative Risks of Potential Adverse Events Following COVID-19 mRNA Vaccination Among Older US Adults “In this cohort study of 6 388 196 older US adults, a 4% lower risk of pulmonary embolism, a 2% lower risk of thromboembolic events, and a 14% lower risk of diagnosed COVID-19 were observed among those who received the mRNA-1273 [Moderna]vaccine compared with the BNT162b2 [Pfizer] vaccine. Although both vaccines were safe across frailty subgroups, differences were generally greater in individuals without frailty.”

COVID hospital admissions jump in what could be a new norm of summer surges “Total COVID-19 hospital admissions jumped by 12.1 percent in the past week, according to the most recent data from the Centers for Disease Control and Prevention (CDC), marking the highest jump in admissions since last winter.
This week’s hospital admission rate follows last week’s rise of more than 10 percent. While this data suggests more infections, a metric the CDC does not track anymore, it remains unclear how concerned people should be.
While hospital admissions have risen by more than 10 percent in each of the past two weeks, the number of patients currently hospitalized has risen by a comparatively smaller degree. Compared with last week, the number of patients hospitalized for COVID this week rose by 7 percent to 6,121. Deaths due to COVID-19 have also not changed in recent weeks as hospital admissions have risen.”

Coronavirus Variant EG.5 Takes Top Spot from ‘Arcturus’ EG.5 was responsible for more than 17% of new coronavirus cases over the past two weeks, according to data from the Centers for Disease Control and Prevention. That’s the highest prevalence of any strain circulating, rising above the so-called “arcturus” variant, which caused nearly 16% of infections…
XBB.1.5, which will be the target of the updated COVID-19 vaccines coming in the fall, is decreasing in the U.S. Still, health experts say that the shot should work on other omicron subvariants as well.”

Dynamic role of personality in explaining COVID-19 vaccine hesitancy and refusalVaccine hesitancy and refusal are threats to sufficient response to the COVID-19 pandemic and public health efforts more broadly. We focus on personal characteristics, specifically personality, to explain what types of people are resistant to COVID-19 vaccination and how the influence of these traits changed as circumstances surrounding the COVID-19 pandemic evolved. We use a large survey of over 40,000 Canadians between November 2020 and July 2021 to examine the relationship between personality and vaccine hesitancy and refusal. We find that all five facets of the Big-5 (openness to experience, conscientiousness, extraversion, agreeableness, and negative emotionality) are associated with COVID-19 vaccine refusal. Three facets (agreeableness, conscientiousness, and openness) tended to decline in importance as the vaccination rate and COVID-19 cases grew. Two facets (extraversion and negative emotionality) maintained or increased in their importance as pandemic circumstances changed. This study highlights the influence of personal characteristics on vaccine hesitancy and refusal and the need for additional study on foundational explanations of these behaviors. It calls for additional research on the dynamics of personal characteristics in explaining vaccine hesitancy and refusal. The influence of personality may not be immutable.”

About health insurance/insurers

 Big payers ranked by Q2 profits FYI

Employer-based health coverage steady despite concerns about moving workers to ACA “Among the highlights of the study:

  • Between 2013 and 2021, the percentage of workers with employment-based health insurance was steadily between 71% and 73%.

  • At the same time, the percentage of children with employment-based coverage held steady at between 54% and 56%.

  • The percentage of non-working adults with employment-based coverage was 36% between 2013 and 2018, increased to 39% in 2019 and subsequently fell to 35% by 2021. Before 2013, the percentage of workers and their families with such insurance had been declining.”

How Do Dual-Eligible Individuals Get Their Medicare Coverage? See Figure 1. first. “Key takeaways:

  • Just over half (51%) of dual-eligible individuals received their Medicare benefits through traditional Medicare in 2020, while the remaining 49% were enrolled in Medicare Advantage plans (Figure 1).

  • Three in 10 (30%) dual-eligible individuals were enrolled in a dual-eligible plan, most of whom (24%) were in coordination-only dual eligible special needs plans (D-SNPs). Coordination-only D-SNPs are designed for dual-eligible individuals and are required to coordinate with state Medicaid programs, with some variation in the specific requirements across states.

  • Enrollment of dual-eligible individuals in traditional Medicare ranged from less than 30% in Hawaii and Puerto Rico to 70% or over in 11 states (Alaska, Delaware, Maryland, Montana, North Dakota, New Hampshire, Oklahoma, South Dakota, Vermont, West Virginia, and Wyoming).

  • Among dual-eligible individuals, Medicare Advantage enrollment rates were higher among beneficiaries who were age 65 and older than those under age 65 (53% vs 41%) and among beneficiaries who were Black (54%), Hispanic (65%), and Asian/Pacific Islander (48%) than non-Hispanic White beneficiaries (41%).”

About hospitals and healthcare systems

 Analysis of Selected Medicare Quality Measure Reporting Data by Hospital Ownership  This study compares physician-owned hospitals with non-physician-owned hospitals. Caveat: It was commissioned bt the AHA and Federation of American Hospitals.
“As compared to non-POHs in the same market as a POH, POHs appear to report fewer measures in most of the CMS Hospital Compare Star Ratings Domains and are less likely to have adequate volume to qualify for the full breadth of HRRP measures. This suggests POHs are accountable for a narrower scope of quality measure performance than non-POHs. POHs have sometimes asserted that offering more focused services facilitates stronger quality performance. Yet, this analysis shows POHs appear to have slightly higher average readmission penalties. POHs also are disproportionately more likely than similarly situated non-POH hospitals to experience the maximum HRRP penalty. These findings build on our prior work that shows POHs care for a less medically complex Medicare population than non-POHs.”

Which Drugs Are Driving Next Year’s 3.42% Increase in Hospital Pharmacy Spend?Hospitals’ pharmacy spending is projected to rise by 3.42% next year, according to a new report. Specialty drugs, including Ozempic and Humira, as well as neurology medications are the primary drivers of this increase in pharmacy expenses.”

About pharma

Below are 3 articles about the new weight-loss drugs

1.KFF Health Tracking Poll July 2023: The Public’s Views Of New Prescription Weight Loss Drugs And Prescription Drug Costs Some Key Findings:;

  • “As a relatively new class of prescription drugs, initially approved to treat type 2 diabetes, have been gaining attention for their use as effective weight loss drugs, the latest KFF Health Tracking Poll finds that nearly half of adults (45%) say they would generally be interested in taking a safe and effective prescription weight loss drug, including nearly six in ten (59%) of those who are currently trying to lose weight and half (51%) of those who are trying to lose less than 10 pounds. About seven in ten adults say they have heard at least “a little” about this new class of weight loss drugs, which include Ozempic, Wegovy and Mounjaro.

  • While there is overall interest in taking a prescription weight loss drug, interest decreases substantially once people are asked if they would take a drug administered as routine injection (23% of all adults would still be interested), if it was not covered by their insurance (16%), if it was not approved by the FDA for weight loss specifically (16%), or if they heard they may gain weight back after stopping use (14%).”

2. Employers Cut Off Access to Weight-Loss Drugs for Workers “So many people have turned to drugs used for weight loss that some employers are cutting off insurance coverage to head off climbing bills.
Spending on the popular drugs, which belong to the class including Ozempic and can cost as much as $1,350 a month for a patient, has quickly leapt into the tens of millions of dollars for insurance plans. The outlays are straining the finances of some plans, including those funded by employers…
Last month Morgan Stanley analysts raised their estimate for the anti-obesity market to $77 billion worldwide in 2030, up $23 billion from a previous forecast.”

3.Makers of Ozempic and Mounjaro sued over 'stomach paralysis' claims “The drugmakers Novo Nordisk and Eli Lilly failed to adequately warn patients about the possible risk of severe stomach problems associated with their blockbuster drugs Ozempic and Mounjaro, according to a lawsuit filed Wednesday.
The 26-page lawsuit, filed on behalf of a Louisiana woman who says she was ‘severely injured’ after taking the two diabetes drugs, is the first to allege that they can cause gastrointestinal injuries.”

Prevalence of Use of Potentially Inappropriate Medications Among Older Adults Worldwide “A total of 94 articles with 132 prevalence estimates were analyzed, including nearly 371.2 million older participants from 17 countries. Overall, the pooled prevalence of PIM use was 36.7% (95% CI, 33.4%-40.0%). Africa had the highest prevalence of PIM use (47.0%; 95% CI, 34.7%-59.4%), followed by South America (46.9%; 95% CI, 35.1%-58.9%), Asia (37.2%; 95% CI, 32.4%-42.2%), Europe (35.0%; 95% CI, 28.5%-41.8%), North America (29.0%; 95% CI, 22.1%-36.3%), and Oceania (23.6%; 95% CI, 18.8%-28.8%). In addition, the prevalence of PIM use is highest in low-income areas. Use of PIMs among older patients has become increasingly prevalent in the past 2 decades.”

FDA approves first oral drug for postpartum depression “The Food and Drug Administration on Friday approved the first pill to treat postpartum depression, a potential milestone for treating a condition that can afflict about 1 in 7 women following childbirth.
The agency announced zuranolone, under the brand name Zurzuvae, had been approved as a once-daily pill to be taken for 14 days.”

Trends in 340B Drug Pricing Program Contract Growth Among Retail Pharmacies From 2009 to 2022The number of retail pharmacies participating in 340B increased from 789 in 2009 to 25 775 in 2022 or from 1.3% to 40.9% of all retail pharmacies, respectively. Depth [number of contracts per pharmacy] increased over time. In 2009, 81% of contract pharmacies had only 1 contract, and by 2022, 40% had 1, 23% had 2, 27% had 3 to 5, 7% had 6 to 9, and 3% had 10 or more (P < .001).
Spread increased over time. In 2009, the farthest CE [covered entity]was within the same zip code for 48% of pharmacies, less than 5 miles for 19%, 5 to 15 miles for 17%, and 16 miles or more for 16%. By 2022, only 9% of the farthest CEs were in the same zip code, and for 51% of pharmacies it was 16 miles away or more (P < .001). Among pharmacies in this category, the median (IQR) distance was 35 (23-67) miles, with a 90th percentile of 176 miles.”
Comment: No surprises here as the program has proved profitable for the pharmacies. However, the problem is:
“Safety-net composition decreased over time. In 2009, 95% of pharmacies contracted exclusively with safety-net hospitals and clinics. By 2022, only 54% of pharmacies contracted exclusively with safety-net facilities, and 16% contracted with no safety-net facilities (P < .001).”

Changes in the Number of Continuation Patents on Drugs Approved by the FDA Background: “Brand-name pharmaceutical manufacturers often sustain high prices in the US by obtaining patents that delay generic competition. Patents may be obtained on active ingredients and “secondary” features of drugs such as new formulations and methods of use. One legal strategy to obtain large numbers of secondary patents is via a special type of application to the US Patent and Trademark Office (USPTO), called a continuation, in which a patent holder adds new applications to a prior submission by offering minor clarifications or additions without substantial change to the underlying invention. Continuation patents can deter competition by increasing uncertainty for generic manufacturers, since they must avoid infringing (or must challenge) evolving patent claims on drugs.”
Findings: “Brand-name drug manufacturers listed with the FDA an increasing number of continuation patents on drugs approved from 2000 to 2015. More continuation patents mean that generic firms seeking to challenge existing protections on brand-name drugs must contest and potentially litigate more patents. Continuation patents are typically invalidated at a higher rate than patents on active ingredients. However, lawsuits brought by brand-name firms on patents listed with the FDA can earn 30-month stays on generic drug approval even if these lawsuits eventually fail. Study limitations include that the frequency of successful challenges on litigated continuation patents was not examined.
These findings suggest that continuation patents are becoming increasingly common in drug patent thickets, likely delaying or deterring generic competition and thus potentially contributing to delays in patient access to generic medications and increases in health care spending.”

About the public’s health

Age of onset and cumulative risk of mental disorders: a cross-national analysis of population surveys from 29 countries “The lifetime prevalence of any mental disorder was 28·6% (95% CI 27·9–29·2) for male respondents and 29·8% (29·2–30·3) for female respondents. Morbid risk of any mental disorder by age 75 years was 46·4% (44·9–47·8) for male respondents and 53·1% (51·9–54·3) for female respondents. Conditional probabilities of first onset peaked at approximately age 15 years, with a median age of onset of 19 years (IQR 14–32) for male respondents and 20 years (12–36) for female respondents. The two most prevalent disorders were alcohol use disorder and major depressive disorder for male respondents and major depressive disorder and specific phobia for female respondents.”

A Collaborative Effort to Establish Common Metrics for Use in Mental Health The article provides an excellent explanation of the nomenclature problem and the common metrics upon which the National Institute of Mental Health and the Wellcome Trust agreed.

 US CDC panel recommends Sanofi-AstraZeneca's preventive RSV therapy for babies “The U.S. Centers for Disease Control and Prevention (CDC) said its advisory panel on Thursday recommended use of Sanofi and partner AstraZeneca's antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers.
The Advisory Committee on Immunization Practices unanimously recommended nirsevimab for preventing lower respiratory tract disease in newborns and infants below eight months of age born during or entering their first RSV season.”

Insight: Promising new Alzheimer's drugs may benefit whites more than Blacks “Groundbreaking treatments for Alzheimer's disease that work by removing a toxic protein called beta amyloid from the brain may benefit whites more than Black Americans, whose disease may be driven by other factors, leading Alzheimer's experts told Reuters…
Prospective Black volunteers with early disease symptoms did not have enough amyloid in their brain to qualify for the trials, the 10 researchers explained.
Hispanics, who experience dementia at one and a half times the rate of whites, were also excluded at a somewhat higher rate due to low amyloid, though the issue was not as pronounced as for Black people, five of the researchers said.”

About healthcare IT

Hospitals' risk of data breach doubles just before, after a merger deal, research shows “Between 2010 and 2022, U.S. hospitals on either side of a merger deal were twice as likely to report a data breach in the year before and after close, according to a recent analysis of government and proprietary data.
The peer-reviewed research, conducted by a University of Texas at Dallas doctoral student and presented at a July information security conference, found that the probability of a data breach was about 6% for buyers and sellers within the two-year deal window. Outside of that period, data breach probability was 3% among the same hospitals.”

About health technology

Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies “In this cross-sectional study, 64 devices and diagnostics authorized by the US Food and Drug Administration through premarket approval and de novo pathways between 2016 and 2019 required establishment of new Medicare coverage; at least nominal explicit or implicit Medicare coverage supportive of patient access was achieved by 28 (44%) within a median of 5.7 years.”

About healthcare finance

 After FTC scrutiny, CooperSurgical calls off $875M deal for Cook Medical's reproductive health portfolio “CooperSurgical has ended plans to acquire Cook Medical’s reproductive health portfolio—a $875 million deal that would have included medical hardware for obstetrics, gynecology and in vitro fertilization.
In a brief announcement from the Federal Trade Commission, the agency said it “has learned” of the termination and described the move as “a win for patients,” adding that it came after cooperation with international antitrust regulators in Australia and the U.K.”

Walgreens cuts stake in AmerisourceBergen to raise $1.85B: 5 notes “Proceeds from the transaction will primarily be used to pay down debt and then general corporate purposes, according to Walgreens Boots Alliance…
In June, Walgreens Boots Alliance reported profits dropped 59 percent in the third quarter of 2023, and the company revised its full-year earnings outlook.”

Today's News and Commentary

About Covid-19

Biden administration announces launch of HHS office focused on long Covid research “On Monday, HHS announced the formation of the Office of Long COVID Research and Practice to lead the federal government’s response to long Covid, a sometimes-debilitating condition marked by symptoms of Covid-19 that last weeks or months beyond the initial infection. It’s estimated that up to 23 million people in the United States have developed long Covid.”

About health insurance/insurers

 CMS announces lower Medicare Part D premium for 2024  The projected average total Part D beneficiary premium is projected to decrease by 1.8% in 2024, from $56.49 in 2023 to $55.50 in 2024, according to an announcement Monday from the Centers for Medicare and Medicaid Services.
The average total monthly premium for Medicare Part D coverage in 2024 of $55.50 represents the sum of the average basic premium and the average supplemental premium for plans with enhanced coverage. It is the most accurate current projection of what people will pay in 2024 for Part D premiums, CMS said.”

Biden-Harris administration announces new Medicare dementia care model “In the GUIDE care model, participating providers will establish dementia care programs through which they will assign people with dementia and their caregivers to ‘care navigators’ who will help them in accessing services and support. Unpaid caregivers would also be connected with training programs and education on best practices.
Medicare Part B-enrolled providers who are able to bill for Medicare Physician Fee Schedule services and agree to the requirements of the GUIDE model are eligible to apply. Suppliers of durable medical equipment and laboratory equipment are excluded from eligibility.”

Elevance Health to rebrand Amerigroup plans as Wellpoint in 6 states “Last year, Blues plan giant Anthem unveiled a corporate rebrand as Elevance Health, a move it said better illustrated its ambitions to be more than just a health plan.
Now, the company is updating the branding for its Amerigroup segment to Wellpoint in a bid to better align the government insurance business with its push toward whole health, Elevance Health tells Fierce Healthcare exclusively. The rebrand will roll out in January 2024, pending regulatory approvals, in six states: Arizona, Iowa, New Jersey, Tennessee, Texas and Washington.”

About hospitals and healthcare systems

 Best Hospitals Honor Roll  US News annual report. Twenty two hospitals are listed alphabetically as top hospitals. Specialties have rank orders.

The CMS star ratings of Leapfrog's 'F' hospitals “Two of the 12 hospitals that received "F" grades from The Leapfrog Group in spring 2023 earned four-star ratings on the CMS 2023 star rankings listing released July 26.
While six of the ‘F’-rated hospitals received one-star ratings from CMS, three earned two stars.”

About healthcare IT

 Amazon Clinic expands nationwide to provide messaging and video visits for common health conditions “ Today, we’re excited to announce that Amazon Clinic is now available to customers in all 50 states and Washington, D.C., offering more people easy access to licensed clinicians for virtual care.
In addition to message-based consultations in 34 states, Amazon Clinic now supports video visits nationwide. Amazon Clinic offers customers 24/7 access to clinicians directly through Amazon.com and the Amazon mobile app.”

CMS Responding to Data Breach at Contractor “The Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have responded to a May 2023 data breach in Progress Software’s MOVEit Transfer software on the corporate network of Maximus Federal Services, Inc. (Maximus), a contractor to the Medicare program, that involved Medicare beneficiaries’ personally identifiable information (PII) and/or protected health information (PHI). No HHS or CMS systems were impacted. Maximus is among the many organizations in the United States that have been impacted by the MOVEit vulnerability. This week, CMS and Maximus are sending letters to individuals who may have been impacted notifying them of the breach, and explaining actions being taken in response. CMS estimates the MOVEit breach impacted approximately 612,000 current Medicare beneficiaries.”

About healthcare personnel

 2023 PHYSICIAN COMPENSATION REPORT Well worth reading/perusing.

About health technology

 With 3 AA batteries and 2 acupuncture needles, a device controls gene expression in live mice Researchers have created a battery-powered device that stimulates gene expression and prompts cells to produce insulin in diabetic mice, cracking open a door to a future where wearable electronics could program cell and gene therapies.”

Thermo Fisher settles Henrietta Lacks lawsuit over 'HeLa' cell line “Laboratory equipment maker Thermo Fisher Scientific has settled a lawsuit brought by the estate of Henrietta Lacks, whose cells have fueled biomedical research for decades, lawyers for the estate said on Tuesday.
The story of Lacks, a young African-American woman who died in Baltimore in 1951, was made famous in Rebecca Skloot's 2010 best-selling book "The Immortal Life of Henrietta Lacks," which became a feature film in 2017.
Lacks' estate sued Thermo Fisher in Baltimore federal court in 2021, asserting her family had "not seen a dime" of money that Thermo Fisher made from cultivating the "HeLa" line of cells that originated from tissue taken without Lacks' consent during a medical procedure in 1951.
Terms of the agreement were confidential.”

About healthcare finance

 EQRx's low cost drug dream ends in Revolution “EQRx's mission to revolutionize drug pricing has come to an end with another type of revolution: an acquisition, to be exact. The Alexis Borisy biotech will be acquired by another of the serial biotech founder's startups, Revolution Medicines. 
The deal will add $1 billion to Revolution's balance sheet, which will be used to push a handful of oncology assets further into the clinic. The all-stock transaction—which is expected to close in November—has already been approved by the directors of both companies.”

Today's News and Commentary

About health insurance/insurers

 MEDICAL, INSURER GROUPS ASK CMS TO NOT IMPLEMENT PRIOR AUTHORIZATION PROVISIONS  “The American Hospital Association (AHA), the American Medical Association (AMA), the Blue Cross Blue Shield Association, and AHIP came together to urge CMS to not proceed with implementing proposed prior authorization (PA) standards that the organizations stated would be costly and conflicting.
In a letter penned to the federal agency, the groups argued that the provisions of the December 2022 Notice of Proposed Rule Making (NPRM) would be detrimental "due to conflicting regulatory proposals that would set the stage for multiple PA electronic standards and workflows and create the very same costly burdens that administrative simplification seeks to alleviate."
The organizations shared their concern that the provisions would establish two different sets of PA standards. While the NPRM would require a combination of both X12 and Health Level 7 (HL7) standards, the Advancing Interoperability and Improving Prior Authorization NPRM would require health plans to offer HL7 Fast Healthcare Interoperability Resources (FHIR)-based application programming interfaces to support electronic PA information exchange.”

Centene could lose its last 4-star Medicare Advantage contract “Centene could end 2023 with no four-star rated Medicare Advantage contracts, CEO Sarah London told investors on a July 28 call
The company has been working to improve its Medicare Advantage star ratings. The percentage of Centene members with four-star or higher plans dropped from 48 percent to 3 percent in 2022. 
Variability in cut points from CMS means Centene's single four-star Medicare Advantage contract's rating could drop this year, Ms. London said.”

About hospitals and healthcare systems

 2023 Median Ratios: Not-for-Profit Hospitals and Healthcare Systems “The difficult start to 2022 began with a deepening financial deficit caused by acuity reductions and labor challenges. Macro headwinds started to form in late 2021 and accelerated in early 2022, with labor shortages, inflationary expenses, reduced elective volumes and surgeries, and increased medical admissions to varying degrees across the rated portfolio. These trends continued for much of the rest of the year for the majority of the rated credits, with the median operating margin now at just 0.2%. This means that approximately one- half of our rated portfolio recorded a negative operating margin in 2022, ranging widely from a high of 27% to a low of negative 21.5%. 
The more significant signs of operational challenges (defined as operating EBITDA margin) were seen at the lower end of the rating spectrum (the below-investment-grade [BIG] categories). The BIG categories reported a very modest 0.3% operating EBITDA margin, compared with 6.9% in fiscal 2021, a 95.6% decrease. The mid investment-grade (IG) category (A category) reported a 4.8% operating EBITDA margin, versus 8.8% in fiscal 2021, a 45.5% decrease.”
And in two related articles:
Healthcare Restructuring: Trends and OutlookKey Takeaways:

  • Healthcare Bankruptcy filings* in the 6 months through June 2023 show a material increase on historical filings since 2019, even prior to the COVID-19 pandemic

  • Healthcare Bankruptcy filings* in 2023 are trending approximately 3 times the level seen in 2021, with a return of large cases with liabilities over $100 million.

  • There were 13 Healthcare Bankruptcy filings* with more than $100 million in liabilities 6 months through June 2023, compared to just 15 cases in the prior two years.

  • The acceleration in Healthcare Bankruptcy filings* seen throughout 2022, especially the uptick seen in Q4 2022, has continued into 2023.

  • Consistent with previous trends, in 2023, Senior Care and Pharmaceutical subsectors continue to comprise approximately half of the total Healthcare Bankruptcy filings*.

  • Based on annualized data, 2023 bankruptcy filings across all subsectors* (except hospitals) are trending to exceed annual filings since 2019.

  • Hospital cases are returning to relevance, with 6 hospital filings in the last 12 months, compared with just 5 filings in the preceding 24-month period.

*Cases labeled in the data source as “Healthcare and Medical” and cases from certain other SIC codes which indicate the healthcare industry. Includes only Chapter 11 cases with greater than $10MM in liabilities.”

National Hospital Flash Report: July 2023 “Key Takeaways

  1. Hospital margins underperformed in June, compared to the previous month.

    Despite an overall trend of continued improvement, most hospitals underperformed slightly compared to May. Fiscal year-end accounting adjustments may have also contributed to the performance bump in June.

  2. Average lengths of stay continue to decrease, and emergency department visits are down.

    Patient volumes continue to stabilize, and increases in outpatient revenue indicate people are continuing to shift away from inpatient settings.

  3. Bad debt and charity care are increasing.

    Hospitals are being affected as states step up efforts to redetermine Medicaid eligibility and more people are disenrolled.

  4. Inflation continues to challenge hospitals’ performance.

    Supplies and purchased service expenses remain high. Decreases in labor expenses may indicate higher staff turnover and even reductions in workforce.”

About pharma

 US FDA approves second over-the-counter opioid overdose reversal drug “The approval of the drug, called RiVive, will provide patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021.
Harm Reduction said it anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. The not-for-profit drugmaker said it would make at least 200,000 doses available for free.”

About the public’s health

Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults: A Guidance Statement From the American College of Physicians
Guidance Statement 1: Clinicians should start screening for colorectal cancer in asymptomatic average-risk adults at age 50 years.
Guidance Statement 2: Clinicians should consider not screening asymptomatic average-risk adults between the ages of 45 to 49 years. Clinicians should discuss the uncertainty around benefits and harms of screening in this population.
Guidance Statement 3: Clinicians should stop screening for colorectal cancer in asymptomatic average-risk adults older than 75 years or in asymptomatic average-risk adults with a life expectancy of 10 years or less.
Guidance Statement 4a: Clinicians should select a screening test for colorectal cancer in consultation with their patient based on a discussion of benefits, harms, costs, availability, frequency, and patient values and preferences.
Guidance Statement 4b: Clinicians should select among a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years as a screening test for colorectal cancer.
Guidance Statement 4c:Clinicians should not use stool DNA, computed tomography colonography, capsule endoscopy, urine, or serum screening tests for colorectal cancer.”

 Trends in Alcohol-Related Deaths by Sex in the US, 1999-2020 “In this cross-sectional study of 605 948 alcohol-attributed deaths, male individuals had a significantly higher burden of alcohol-involved mortality than did female individuals, with a male to female ratio of 2.88. Temporal trends revealed an increase in alcohol-related deaths among both sexes, with a significantly higher rate of increase observed for female individuals than for male individuals.”

Benefits of Bariatric Surgery Persist for 12 YearsBariatric surgery produced sustained, long-term glucose control and weight loss for at least 7 years, and for up to 12 years, in some US patients with type 2 diabetes and a baseline body mass index (BMI) of at least 27 kg/m2, according to new study results.
The findings are from ARMMS-T2D, a prospective, controlled trial with the largest cohort and longest follow-up of bariatric surgery reported to date. The results reinforce the potential role of surgery ‘as an option to improve diabetes-related outcomes, including people with a BMI of less than 35 kg/m2,’ said Anita P. Courcoulas, MD, at the recent American Diabetes Association 83rd Scientific Sessions.”

About healthcare IT

 Generative AI and the future of work in America Not healthcare specific, but the principles are still the same. One interesting finding: “By 2030, activities that account for up to 30 percent of hours currently worked across the US economy could be automated—a trend accelerated by generative AI. However, we see generative AI enhancing the way STEM, creative, and business and legal professionals work rather than eliminating a significant number of jobs outright. Automation’s biggest effects are likely to hit other job categories. Office support, customer service, and food service employment could continue to decline.”

About health technology

Quest launches blood test for Alzheimer’s disease aimed at general consumers “The clinical testing giant has put forward a blood test designed to help gauge a person’s levels of beta amyloid—one of the hallmarks of the neurodegenerative condition—and it’s now making it available directly to consumers.
Listed for sale on the company’s website, the AD-Detect test retails for $399 plus a $13 physician fee. Quest Diagnostics says the blood test, though not an official diagnostic, is designed for anyone “who has a family history of Alzheimer’s disease, is experiencing memory loss, or is experiencing early cognitive decline.”

FDA identifies GE HealthCare recall of sensors for defibrillators as class I “GE HealthCare announced a recall of arterial oxygen saturation sensors due to a malfunction that may reduce the amount of energy sent to the heart during defibrillation without notification to the care provider.
If the sensors (TruSignal) malfunction, that could prevent delivery of lifesaving therapy and is most hazardous to patients who are hospitalized and may need defibrillation for cardiac arrest, according to an FDA press release.”

Today's News and Commentary

About health insurance/insurers/costs

2023 retiree health care cost estimate: Expected to ‘stay flat’ from 2022 Limits to out-of-pocket prescription drug costs outlined in the Inflation Reduction Act of 2022 will temporarily offset the overall inflationary trend of health care costs for retirees for the first time in nearly a decade. According to Fidelity Investments’ 2023 Retiree Health Care Cost Estimate, a 65-year-old retiring this year can expect to spend an average of $157,500, or $315,000 per couple, in health care and medical expenses throughout retirement, unchanged from the firm’s 2022 estimate. That estimate is nearly double the firm’s 2002 estimate of $80,000 in health care expenses per retiree.”

Centene posts $1.06B profit in Q2 “Centene recorded $1.06 billion in net income in the second quarter of 2023 after recording a $172 million loss over the same period last year, according to the company's earnings report released July 28.”

Authority of Medicare to Limit Coverage of FDA-Approved Products Conservatives have recently challenged regulatory bodies’ legality to carry out laws. One recent case they successfully prosecuted before the US Supreme Court death with the EPA. This article deals with CMS’ regulatory rights. The discussion is expanded in the accompanying editorial: Statutory Authority for Medicare Coverage Decisions—CMS Is an Independent Federal Agency

About hospitals and healthcare systems

Essentia, Marshfield Clinic to form 25-hospital system in Midwest Duluth, Minn.-based Essentia Health and Marshfield (Wis.) Clinic Health System have signed an integration agreement to form a 25-hospital regional health system across four states.
The health systems announced the integration agreement July 27. In October 2022, the systems said they were in merger discussions and had signed a memorandum of understanding.”

 Sanford, Fairview halt merger “Sioux Falls, S.D.-based Sanford Health and Minneapolis-based Fairview Health Services have hit the breaks on their merger after multiple delays.
The merger, which would have created a 50-hospital health system with around 78,000 employees, has faced challenges since it was announced in November 2022. The two systems hoped to finalize the merger in March, but the transaction was extended while the Minnesota Attorney General reviewed the plan. Sanford aimed to invest $500 million in Fairview, which owns the University of Minnesota Medical Center in Minneapolis.
The university, state government, nurses unions and taxpayers have opposed the merger, wanting assurance the move would keep the local community's best interest in mind.

About pharma

 Weight loss drug market will reach $77B by 2030: Morgan Stanley “Morgan Stanley analysts predict the weight loss drug market will hit $77 billion by 2030, MarketScreener reported July 21.
The financial services firm had previously estimated the market size by 2030 would be $54 billion, but surging demand for the medications led it to raise its forecast.
According to the report, Novo Nordisk's Wegovy may have already hit $7 billion in sales this year if there were no supply shortages for the drug.”

About the public’s health

Tick-linked meat allergy may be far more common than previously known “Up to 450,000 people in the United States may have developed a rare and potentially life-threatening tick-associated allergic condition that is triggered when eating red meat, according to federal health data released Thursday.
Alpha-gal syndrome, sometimes known as red-meat allergy, is caused when a tick bites a person and injects a sugar molecule found in its saliva. In some people, that sugar causes an allergic reaction, which can be further triggered by eating red meat, including beef, pork and lamb, because the meat also contains the sugar, known as alpha-gal. Other food products from mammals, such as cow’s milk, other dairy products and gelatin, can also cause allergic reactions. The reactions range from mild, such as hives and itchy rash, to more severe, including difficulty breathing and drops in blood pressure. (Alpha-gal is not found in fish, reptiles, birds or people).”

Congress authorizes overhaul of troubled organ transplant system “Congress approved a thorough revamp of the troubled U.S. organ transplant system Thursday, providing health officials with the authority to break monopoly control of the way kidneys, livers, lungs and other organs are delivered to sick patients.
For 37 years, one nonprofit organization, the United Network for Organ Sharing, has held the federal contract to run the system, relying on a 1986 law that blocked almost all competition. With a unanimous vote Thursday night, the Senate rewrote the law to let the federal Health Resources and Services Administration break that stranglehold and solicit bids from other for-profit and nonprofit groups.
The House approved the same measure Tuesday. President Biden is expected to sign it.”

 CDC Provisional Data: Gun Suicides Reach All-time High in 2022, Gun Homicides Down Slightly from 2021 “Newly released provisional data from the Centers for Disease Control and Prevention shows that gun death rates in 2022 remained near highs not seen since the mid-90s and, in addition, rates have not returned to pre-pandemic levels.  
Guns remained the leading cause of death for children and teens in 2022. The rate of gun deaths among this group climbed 87% in the last decade (2013-2022). The data also showed gun violence continuing to have a disproportionate impact on Black children and teens, who have a gun homicide rate 20 times higher than their white counterparts. Additionally, the nation’s overall gun suicide rate increased 1.6%, reaching an all-time high, and for the first time, the gun suicide rate among Black teens surpassed the rate among white teens.”

About healthcare IT

 New SEC rule requires public companies to disclose 'material' data breaches in 4 days “The Securities and Exchange Commission has pulled back the curtain on a new final rule that requires public companies to disclose within four days all cybersecurity breaches that could impact their bottom lines.
The final rule adopted Wednesday starts the clock once “a registrant determines that a cybersecurity incident is material,” but can be bumped back should the U.S. Attorney General determine that immediately disclosing the breach “would pose a substantial risk to national security or public safety,” the SEC wrote in its announcement.
Also included is a new annual disclosure in which public companies must describe their cybersecurity processes, directors’ and management’s oversight of such risks and the impacts of previous cybersecurity incidents. Similar disclosures will be required for foreign private insurers.”

Preparing for the International Classification of Diseases, 11th Revision (ICD-11) in the US Health Care System A really good update on the ICD.

About health technology

White House launches precision surgery initiative as part of ‘cancer moonshot’ effort “The Biden administration is launching a new initiative aimed at helping surgeons to distinguish and remove cancer cells without damaging surrounding tissue, in an effort to improve health outcomes for cancer patients.
The initiative is the first cancer-focused program under the administration’s multi-billion-dollar Advanced Research Projects Agency for Health (ARPA-H), and just its second program overall. It’s paired with the administration’s “cancer moonshot,” which aims to cut the cancer death rate in half by 2047.”

About healthcare finance

Biogen to acquire Reata Pharmaceuticals for $7.3 billion “Biogen has agreed to acquire Reata Pharmaceuticals for $7.3 billion, it was announced on Friday. The acquisition is the largest in Biogen's history and first since Christopher Viehbacher was appointed as CEO late last year with a mandate to return the company to growth. Biogen will pay a 59% premium over Reata's closing share price on Thursday.
In February, Reata secured FDA approval for Skyclarys (omaveloxolone), the first and only treatment for Friedreich’s ataxia in the US and regulatory review of the drug in the European Union is ongoing.
Commercial launch of Skyclarys in the US market is ongoing having previously been delayed by a number of months due to a manufacturing issue, Reata said in May.”

7 Healthcare Private Equity Trends to Know An excellent overview by BDO. I was especially interested in one finding: “ESG assessments are integral to getting deals done. PE firms are evaluating ESG risk before making investment decisions. Eighty-four percent of respondents investing in healthcare say they have declined an investment opportunity because of ESG concerns. Surprisingly, respondents were more likely to report turning down an investment opportunity for environmental (33%) or governance (33%) reasons than for social reasons (26%). This may be due to the healthcare industry’s focus on the “S” in ESG via improving health equity, making them more advanced in social areas than governance and environmental. Overall, healthcare leaders need to recognize that private equity investors are looking for evidence of sound ESG practices as part of their criteria for evaluating investment opportunities.”

Today's News and Commentary

About health insurance/insurers

The Facts about Cigna Healthcare's Claims Review Process Cigna’s response to claims it uses algorithms to deny claims.

Medicare Advantage Supplemental Benefits Address Health-Related Social Needs A report from Elavance. See page 7 for a summary of findings. For example: “In 2022, the uptake of supplemental benefits among Elevance Health’s affiliated MA plan enrollees was strong. 83 percent of dual eligible individuals and 75 percent of non-dual eligible individuals used one or more of the available supplemental benefits during the calendar year.
Sixty-four percent of dual eligible individuals and 48 percent of non-dual eligible individuals used at least two different supplemental benefits.”

About hospitals and healthcare systems

 HCA posts $2.6B net gain in 1st 6 months “Nashville, Tenn.-based HCA Healthcare, one of the largest for-profit health systems in the U.S., reported net income of $1.19 billion for the second quarter of 2023, 3.3 percent higher than the same period in 2022 ($1.155 billion), which included $110 million in losses on debt and asset sales.
The 182-hospital system raised its guidance for the year to a net income of up to $5.255 billion from previous estimates of up to $5.16 billion. HCA also raised its revenue guidance to up to $64.75 billion for the year compared with $64.5 billion.”

UHS finance chief said company favors patients whose insurance pays more “The country’s largest private psychiatric hospital operator cherry-picks patients whose insurance will pay more, its finance chief said on an earnings call Wednesday.
It’s no secret that such hospitals, especially when run by for-profit companies, base admission decisions on how much they’ll get paid, but it’s rare to hear the practice described so bluntly. The comments came from Steve Filton, the chief financial officer of investor-owned Universal Health Services, a company that runs more than 300 behavioral health hospitals nationwide that handled just shy of 120,000 admissions in the three months that ended June 30.”

About pharma

Facing potential $10B trial loss, Teva seeks appeal of recent ruling in kickbacks case “In the case, the U.S. alleges that Teva paid two patient foundations, the Chronic Disease Fund and The Assistance Fund, more than $350 million between December 2006 and January 2017. Those payments directly covered Medicare co-pay obligations for patients on Copaxone, the government argues. At the same time, the company raised the price of Copaxone five-fold.
Lawyers for the U.S. say Teva ‘conspired’ with a specialty pharmacy and used the foundations ‘as conduits to subsidize Medicare co-pays’ for its star drug. As the Department of Justice has noted, the Anti-Kickback Statute (AKS) prohibits pharma companies from paying Medicare co-pays so that market forces remain in place, and so there isn't an undue inducement for patients to receive a specific drug.”

 GLP-1 drugs are still in demand. Insurers are cutting back coverage in response, Found study shows “As demand surges for GLP-1 therapies, insurers are pulling back on coverage, according to new data from obesity care provider Found.
The company analyzed GLP-1 benefits and access for its patient population and found that currently 69% do not have coverage for this class of drugs to treat diabetes or for weight loss, a significant decline in coverage in the past seven months. The findings, which were provided exclusively to Fierce Healthcare, track with national trends in coverage for these products, the Found team said.
Coverage for GLP-1 drugs has decreased by 50% since December 2022, according to the analysis. Nearly 70% of insurance plans included in the study did not indicate coverage for GLP-1s either for obesity or diabetes treatment.”

About the public’s health

 US Officials Weigh Deeming a Syphilis Emergency as Drugs Run Low “A shortage of penicillin to treat a skyrocketing number of syphilis cases is so dire that US health officials are debating the need to declare a public health emergency, according to people familiar with the matter.
Major US medical centers are rationing the recommended treatment for the deadly sexually transmitted disease because of a supply crunch. From Michigan to Missouri to Texas, some health-care providers are prioritizing giving a key treatment — penicillin G benzathine — to pregnant patients and babies, because the drug can pass through the placenta and also treat the fetus.”

About healthcare IT

Cost of a Data Breach Report 2023 Annual IBM report. “The average cost of a data breach reached an all-time high in 2023 of USD 4.45 million. This represents a 2.3% increase from the 2022 cost of USD 4.35 million. Taking a long-term view, the average cost has increased 15.3% from USD 3.86 million in the 2020 report….
Healthcare continues to experience the highest data breach costs of all industries, increasing from USD 10.10 million in 2022 to USD 10.93 million in 2023—an increase of 8.2%. Over the past three years, the average cost of a data breach in healthcare has grown 53.3%, increasing more than USD 3 million compared to the average cost of USD 7.13 million in 2020. Healthcare faces high levels of industry regulation and is considered critical infrastructure by the US government. Since the start of the COVID-19 pandemic, the industry has seen notably higher average data breach costs.”

US FTC settles with health information firm Surescripts over antitrust lawsuit “The U.S. Federal Trade Commission on Thursday said it settled with Surescripts over a lawsuit accusing the health information technology firm of using illegal methods to maintain monopolies over two parts of the electronic prescriptions market.
The settlement will prohibit Surescripts "from engaging in exclusionary conduct and executing or enforcing non-compete agreements with current and former employees," the FTC said in a statement.
The FTC in its 2019 lawsuit had accused Surescripts, which provides electronic records and prescription services to doctors, pharmacists and patients, of requiring long-term exclusivity from customers and punishing them with high prices if they bought some prescriptions from another company.”

About healthcare finance

From Reuters: Forecasts from HCA, Bristol Myers, Labcorp, Edwards Lifesciences and AbbVie.
Quest Diagnostics and Takeda beat profit estimates. 

Today's News and Commentary

About healthcare quality

 483 hospitals with 5 stars from CMS “CMS updated its Overall Hospital Quality Star Ratings for 2023, awarding 483 U.S. hospitals with a rating of five stars. This year, 54 more hospitals were given 5 stars than in 2022.”
The article has a list by state.
 
About health insurance/insurers/costs

US healthcare spending to grow 10% annually through 2028, report says “U.S. consumer out-of-pocket healthcare expenditures are expected to grow 10 percent annually through 2028, according to a report from market research firm Kalorama Information.
By the end of 2023, out-of-pocket healthcare expenditures will reach $519 billion, a jump of 9 percent from 2022. The COVID-19 pandemic caused a pullback in out-of-pocket healthcare expenses, but the report sees that trend ending in 2022, according to a July 25 Kalorama Information news release.
The report cited inflation, government, regulatory and payer actions, as well as business and macroeconomic trends as reasons for the continued growth in expenses.”

Rural Americans Struggle with Medical Bills and Health Care Affordability “…geographic disparities are especially stark in the United States, where about 15 percent of the population, or roughly 46 million people, live in rural areas. Recent research, based on the Commonwealth Fund’s 2020 International Health Policy Survey, found that the U.S. had more geography-based health disparities than did 10 other high-income countries, including Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United Kingdom.”

About hospitals and healthcare systems

 Nuvance Health downgraded as system faces 'pivotal' quarters ahead “Danbury, Conn.-based Nuvance Health was downgraded to a "Baa3" rating amid weakened operating performance and reduced liquidity, Moody's said in a July 20 report.
While the seven-hospital system, which serves Eastern New York as well as Western Connecticut, has a strong market position and its management is implementing cost-cutting and strategic growth initiatives, it will face a number of cash flow issues going forward and the outlook is negative, Moody's said.”

Hospital days cash on hand dips 17% “Liquidity remains a challenge for hospitals and health systems, as many continue to see revenue outpaced by spending, according to a July 25 Fitch report.
The average days cash on hand declined by 44 days last year to 216 days on average, down 17 percent year over year. Days cash on hand for nonprofit hospitals and health systems overall peaked in 2021 at 260 days. Prior to the pandemic, in 2019, nonprofit hospitals and health systems had an average of 219 days cash on hand.”

Universal Health Services revises guidance after Q2's $171.3M profit, higher volumes “King of Prussia, Pennsylvania-based Universal Health Services (UHS) reported a $171.3 million net gain ($2.42 per diluted share) for the second quarter of 2023, up slightly from the $164.1 million it had logged this time in 2022.
The for-profit acute and behavioral health hospital operator said Tuesday after market close that its second-quarter net revenues rose 6.8% year over year to nearly $3.55 billion. Operating expenses rose 5.8% year over year to $3.27 billion for the quarter.”

About pharma

 New Model Essential List published today reaches a record number of medicines listed From WHO. Notable exclusions: “A total of 32 applications were not recommended including: glucagon-like peptide-1 receptor agonists for weight loss in obesity, risdiplam for treatment of spinal muscular atrophy, donepezil for treatment of dementia due to Alzheimer disease, CAR-T cell therapies for lymphoma and fast-acting oral transmucosal fentanyl for breakthrough cancer pain.”

Cleveland sues CVS, Eli Lilly and Evernorth over insulin prices “In a 155-page lawsuit, Cleveland leaders accused numerous retail pharmacies, drugmakers and pharmacy benefit managers of hiking insulin prices that they said cost the city millions of dollars, according to court documents. 
The defendants are drugmakers Eli Lilly, Novo Nordisk and Sanofi-Aventis; PBM Evernorth Health; Express Scripts and its subsidiaries Medco Health Solutions and Esi Mail Pharmacy Services; CVS Health and CVS Caremark; and UnitedHealth Group and its businesses Optum, OptumRx and OptumInsight.”

About the public’s health

 Good or bad? Plant-based and cow’s milk are not always nutritionally equal, study says  Not all “plant milk options are fortified to meet the levels of various nutritional ingredients contained in dairy, according to a new unpublished study presented Monday in Boston at Nutrition 2023, the annual meeting of the American Society for Nutrition.
The study analyzed nutrition labels and ingredients for 233 plant-based milk products from 23 different manufacturers and found only 28 of the beverages had as much or more protein, vitamin D and calcium as cow’s milk.”

About healthcare IT

Teladoc reports higher Q2 revenue, bullish on opportunities for virtual weight management, mental health “Teladoc's second-quarter revenue jumped 10% to $652 million, boosted by strong growth in its BetterHelp direct-to-consumer mental health segment.
The telehealth giant, which has been in operation for 20 years, also narrowed its losses this past quarter to a net loss of $65 million, or a loss of 40 cents per share, compared to a loss of $3 billion for the second quarter of 2022. Both results beat Wall Street estimates.”

AMA, AHIP, NAACOS Release Playbook on Data Sharing Best Practices for Value-Based Care “A new playbook released by the American Medical Association (AMA), AHIP, and the National Association of ACOs (NAACOS) highlights best practices around data sharing for organizations participating in value-based care models…
Overall, the organizations identified 5 voluntary best practices for data sharing.
1. Create an interoperable data ecosystem. The systems have to speak the same language and be able to interface in order to be successful in value-based care models... In addition, there need to be content standards, which ensure everyone is using standardized data elements and data sets, as well as exchange standards to get the information from one place to another.
2. Share more complete data.
3. Improve data collection and use it to advance health equity.
4. Share timely and actionable data.
5. Share methodologies, calculations, and context. Successful partnerships in value-based care arrangements are based on trust, which require transparency. Part of this includes having benchmarks that are established ahead of the performance period, performance data that are shared regularly, and feedback loops to address issues…”

About healthcare personnel

 Physician Turnover in the United States “The annual rate of turnover increased from 5.3% to 7.2% between 2010 and 2014, was stable through 2017, and increased modestly in 2018 to 7.6%. Most of the increase from 2010 to 2014 came from physicians who stopped practicing increasing from 1.6% to 3.1%; physicians moving increased modestly from 3.7% to 4.2%. Modest but statistically significant (P < 0.001) differences existed across rurality, physician sex, specialty, and patient characteristics. In the second and third quarters of 2020, quarterly turnover was slightly lower than in the corresponding quarters of 2019.”

Doctors who put lives at risk with covid misinformation rarely punished “Across the country, doctors who jeopardized patients’ lives by pushing medical misinformation during the pandemic and its aftermath have faced few repercussions, according to a Washington Post analysis of disciplinary records from medical boards in all 50 states.”

Today's News and Commentary

About Covid-19

Extensive Study Reveals Vaccination Numbers Required to Prevent COVID-19 Hospitalizations and ED Visits “The number needed to be vaccinated to prevent one COVID-19-associated hospitalization ranged from 44 to 615 (median was 205) individuals and was lower for adults aged 65 years or older and for those with underlying medical conditions. The number needed to be vaccinated decreased as the population became older because older individuals are more susceptible to the adverse effects of the virus and, therefore, the vaccine provides greater protection.
The number of patients needed to be vaccinated to prevent COVID-19-associated ED visits showed a different pattern because vaccines were more effective at preventing ED visits among younger adults than older ones. The median number needed to be vaccinated to prevent one ED visit ranged from 75 to 592 (median was 156) individuals.”

Early COVID-19 Indicators Show Increase: CDC Data “Both coronavirus emergency department visits and test positivity increased, according to CDC data. The agency no longer tracks COVID-19 cases. Instead, it focuses on hospitalizations and deaths, which don’t yet show an increase.
The CDC reported last week that it was the first time since January that COVID-19 metrics showed an increase. The uptick is small, but it’s a notable reversal after months of declining coronavirus numbers.”

About health insurance/insurers

 Blue Cross NC invests $4.3M in improving foster care in the state Insurance plans have frequently provided grants for housing and food. This subsidy is a new one.

White House unveils plan to make insurers cover mental health care “The Biden administration on Tuesday announced a proposal meant to force health insurers to cover mental health and addiction care as comprehensively as they cover treatment for physical health conditions.
If the plan is enacted, it could help end decades of whack-a-mole between government regulators and insurance companies. While insurers have been legally required to cover mental health and addiction treatment since the 1990s, many have never truly complied, forcing patients to jump through bureaucratic hoops, or even pay out-of-pocket, to obtain care.”

Today's News and Commentary

About Covid-19

Excess Death Rates for Republican and Democratic Registered Voters in Florida and Ohio During the COVID-19 Pandemic “Findings  In this cohort study evaluating 538 159 deaths in individuals aged 25 years and older in Florida and Ohio between March 2020 and December 2021, excess mortality was significantly higher for Republican voters than Democratic voters after COVID-19 vaccines were available to all adults, but not before. These differences were concentrated in counties with lower vaccination rates, and primarily noted in voters residing in Ohio.”

About health insurance/insurers

Cigna Sued Over Algorithm Allegedly Used To Deny Coverage To Hundreds Of Thousands Of Patients “Cigna, the healthcare and insurance giant, was hit with a lawsuit on Monday that alleges the company systematically rejects claims in a matter of seconds, thanks to an algorithmic system put in place to help automate the process—further raising questions about how technology could harm patients as more healthcare organizations look to embrace AI and other new tools.
The suit, which was filed in California and is seeking class action status, was brought forth by a pair of plaintiffs who were denied coverage by Cigna.”

UNNECESSARY HEALTHCARE SERVICES COST COLORADO PATIENTS AND INSURERS $134M IN 2021 “KEY TAKEAWAYS
—The Center for Improving Value in Health Care checked out Colorado claims and found unnecessary healthcare services cost patients and health insurers $134 million in 2021.
—The top five services in terms of spending were inappropriate opioid prescribing, screening for Vitamin D, prostate cancer screening, imaging test for eye disease, and coronary angiographies.
—Among payers, Medicaid and Child Health Plan Plus have the highest percent of spending on low value care, while top services by spending vary across payer type…
—Researchers examined claims from the Colorado All Payer Claims Database from 2017 to 2021 and used Milliman's MedInsight Health Waste Calculator to evaluate potentially low value services.”

About pharma

 After consumer split, Johnson & Johnson plans to drop 80% of Kenvue stake through exchange offer “Leveraging a stock exchange offer—also known as a split-off—J&J aims to reduce its stake in Kenvue by roughly 80%, the company said Monday. Under the exchange offer, which is expected to be tax-free, J&J shareholders may exchange all, some or none of their common stock for Kenvue shares, J&J said.”

FDA: No ‘immediate significant impacts’ expected on supply due to Pfizer plant damage “The Pfizer pharmaceutical plant severely damaged by a tornado this week in North Carolina will have no “immediate significant impacts” on drug supply chains, the Food and Drug Administration (FDA) said Friday.”

FTC votes to withdraw previous guidance around PBMs as probe continues “As it continues a broad probe into the operations of pharmacy benefit managers, the Federal Trade Commission has voted to rescind longstanding advocacy statements on this sector.
The commission voted 3-0 to pull the historical advocacy statements, according to an announcement from the agency, on the pretense that these previous positions no longer reflect the state of the market. The FTC said that rescinding these statements is in direct response to PBMs' reliance on them to push back against transparency or disclosure requirements.”

About the public’s health

About 1 in 10 young adults are vaping regularly, CDC report finds “A new U.S. Centers for Disease Control and Prevention report released Friday — based on 2021 data from a National Health Interview Survey — found that 11% of 18- to 24-year-olds define themselves as current e-cigarette users, more than any other age group of adults.
The report also found that White non-Hispanic Americans between 18 and 24 vape more than Latino, Asian or Black youth in the same age group.
Overall, the survey found that 4.5% of adults ages 18 and over vape. The survey defined current e-cigarette use as respondents who say they vape ‘every day’ or ‘some days.’”

About healthcare IT

Healthcare data breaches now average nearly $11M “The cost of a healthcare data breach is averaging nearly $11 million as hackers realize the value of the information stored by hospitals and health systems, a July 24 IBM report found.
Breach costs for healthcare have increased 53.3 percent since 2020 and now average $10.93 million each, nearly double the second most costly industry (financial), according to the study. Those costs surpassed $10 million for the first time in 2022, when they stood at $10.1 million.”

Today's News and Commentary

About healthcare quality

The Joint Commission eliminates additional 200 standards across all accreditation programs See the announcement for a list of the second tranche of deleted and consolidated elements of performance (EPs).

About health insurance/insurers

Drivers of 2024 Health Insurance Premium Changes From the Academy of Actuaries: “Key Points

  • Although Medicaid eligibility redeterminations due to the end of the COVID-19 public health emergency (PHE) will likely result in an increase in individual health insurance market enrollment,
    the impact on the risk pool and premiums is uncertain.

  • Inflation and other factors will increase negotiated provider payment rates and will increase premiums.

  • Shifting payment responsibility for COVID-19 vaccines and tests from the federal government to carriers could increase premiums, potentially offset by reduced carrier coverage of at-home tests.

  • A continued shift of small groups from fully insured plans to other funding arrangements such as self-funded or level-funded plans could put upward pressure on small group premiums.

  • Premium changes will reflect local market dynamics and vary by carrier and by area.”

Realigning Reality With Intent in Funding Safety-Net Hospitals A thoughtful explanation of the problems as well as proposed solutions.

 Biden administration asks employers to give more help to workers who lose Medicaid The headline is the story.

About hospitals and healthcare systems

Fifth Semi-Annual Hospital Price Transparency Compliance Report July 2023 “Our latest review, conducted two and a half years after the Hospital Price Transparency Rule took effect, analyzed the websites of 2,000 U.S. hospitals and found only 36% of them (721) to be fully compliant with all requirements of the rule. Although the majority of hospitals have posted files, the widescale noncompliance of 64% of hospitals is due to most hospitals’ files being incomplete or not having prices clearly associated with both payer and plan. In this report, 69 of the hospitals reviewed had no usable standard charges file.”
In a related article: CMS PLANS TO CRACK DOWN ON PRICE TRANSPARENCY COMPLIANCE IN 2024

CHS EBITDA dips 18.1% amid labor, payer challenges “Franklin, Tenn.-based Community Health Systems, the third-largest for-profit system, saw its EBITDA fall by 18.1 percent to $335 million in the first quarter as salaries and benefits as a share of revenue increased by 1.3 percentage points, according to Moody's "Healthcare Quarterly" report, published July 19. 
A significant portion of CHS' business is in rural areas, potentially driving up costs to recruit and retain staff, according to the report. An unfavorable payer mix in these areas may also be a contributing factor. 
However, the two largest for-profit systems — Nashville, Tenn.-based HCA Healthcare and Dallas-based Tenet Healthcare — saw improved EBITDA in the first quarter as salary and benefit obligations softened.”

About pharma

 Tornado damage to Pfizer plant will probably create long-term shortages of some drugs hospitals need “Wednesday’s tornado touched down near Rocky Mount, North Carolina, and ripped up the roof of a Pfizer factory that makes nearly 25% of Pfizer’s sterile injectable medicines used in U.S. hospitals, according to the drugmaker.”

About the public’s health

Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021 “In 2021, there were 529 million (95% uncertainty interval [UI] 500–564) people living with diabetes worldwide, and the global age-standardised total diabetes prevalence was 6·1% (5·8–6·5). At the super-region level, the highest age-standardised rates were observed in north Africa and the Middle East (9·3% [8·7–9·9]) and, at the regional level, in Oceania (12·3% [11·5–13·0])…By 2050, more than 1·31 billion (1·22–1·39) people are projected to have diabetes.”

White House Launches Office of Pandemic Preparedness and Response PolicyFrom The White House: “As part of the President’s commitment to ensure that our country is more prepared for a pandemic than we were when he took office, the Administration is standing up the Office of Pandemic Preparedness and Response Policy (OPPR). This will be a permanent office in the Executive Office of the President (EOP) charged with leading, coordinating, and implementing actions related to preparedness for, and response to, known and unknown biological threats or pathogens that could lead to a pandemic or to significant public health-related disruptions in the United States. OPPR will take over the duties of the current COVID-19 Response Team and Mpox Team at the White House and will continue to coordinate and develop policies and priorities related to pandemic preparedness and response.”

About healthcare IT

 From the Office of Civil Rights Copy of a letter warning healthcare entities: “The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and the Federal Trade Commission (FTC) are writing to draw your attention to serious privacy and security risks related to the use of online tracking technologies that may be present on your website or mobile application (app) and impermissibly disclosing consumers’ sensitive personal health information to third parties.
Recent research, news reports, FTC enforcement actions, and an OCR bulletin have highlighted risks and concerns about the use of technologies, such as the Meta/Facebook pixel and Google Analytics, that can track a user’s online activities. These tracking technologies gather identifiable information about users as they interact with a website or mobile app, often in ways which are not avoidable by and largely unknown to users.”

Today's News and Commentary

About Covid-19

 A Positive Covid Milestone “The United States has reached a milestone in the long struggle against Covid: The total number of Americans dying each day — from any cause — is no longer historically abnormal.” 

About health insurance/insurers

 CMS halts Medicaid redeterminations in 'half-dozen states' “One of the most common issues the agency has identified is enrollees not being matched with the correct data to automatically re-enroll them in Medicaid…”

Medicare Households Spend More on Health Care Than Other Households “Medicare households spent an average of $6,557 on health care, accounting for 15% of their total household spending ($44,686), while non-Medicare households spent $4,598 on their health care, accounting for 7% of their total household spending ($67,769)… Health care expenses include health insurance premiums, medical services (e.g., hospital and physician services), prescription drugs, and medical supplies (e.g., crutches, eyeglasses, hearing aids).
The larger burden of health care spending among Medicare households than non-Medicare households is a function of both lower average total household spending for Medicare households than non-Medicare households and higher health care use, which results in higher health care spending by Medicare households.”

High Rates of Prior Authorization Denials by Some Plans and Limited State Oversight Raise Concerns About Access to Care in Medicaid Managed Care From the HHS OIG: “Three factors raise concerns that some people enrolled in Medicaid managed care may not be receiving all medically necessary health care services intended to be covered: (1) the high number and rates of denied prior authorization requests by some MCOs, (2) the limited oversight of prior authorization denials in most States, and (3) the limited access to external medical reviews.”

Making Care Primary (MCP) Model Applications will be open next month for this previously announced program.

About hospitals and healthcare systems

 Private equity takeovers are harming patients “Study findings on quality and outcomes were similarly skewed toward worse results for patients at providers acquired by private equity firms. Among 27 studies that measured quality of care, 12 reported worse quality scores associated with private equity ownership, nine reported mixed results (some quality measures declined, some improved), and three reported neutral results after private equity acquisition….
Although study methodologies varied widely, eliminating the possibility of formal meta-analysis, the preponderance of evidence clearly suggests that quality and outcomes deteriorate after a private equity takeover.”

About pharma

Blue-state doctors launch abortion pill pipeline into states with bans “A new procedure adopted in mid-June by one of the largest abortion pill suppliers, Europe-based Aid Access, now allows U.S. medical professionals in certain Democrat-led states that have passed abortion ‘shield’ laws to prescribe and mail pills directly to patients in antiabortion states.”

Medicine is plagued by untrustworthy clinical trials. How many studies are faked or flawed? Well-worth reading!

About healthcare IT

 1.2 million Tampa General patients' data breached in cyberattack Another instance of why the public is reluctant to trust institutions with sensitive information.

 About healthcare finance

 TPG strikes $1.4B deal to buy EHR, practice management software firm Nextech “Asset management firm TPG is buying healthcare IT company Nextech from Thomas H. Lee Partners for $1.4 billion, the company announced Wednesday.
Tampa, Florida-based Nextech provides electronic medical record and practice management software to specialty physician practices. The company services more than 11,000 physicians and over 60,000 office staff members in the clinical specialties of dermatology, ophthalmology, orthopedics, plastic surgery, and medical spa practices, according to a press release.”

Today's News and Commentary

About Covid-19

Gene variant may be why some test positive for virus with no covid symptoms “During the nine-month study period, 1,428 unvaccinated individuals reported a positive coronavirus test, and 136 of them had no symptoms. Among the asymptomatic participants, 20 percent carried a common HLA variant called HLA-B*15:01. People carrying two copies of this variant — one passed down from each parent — were more than eight times more likely to remain asymptomatic than those carrying other HLA variants.”

About health insurance/insurers

 2 brothers plead guilty to roles in $67M Medicare fraud scheme “Daniel M. Carver owned and managed call centers that he used to target Medicare beneficiaries, talking the individuals into paying for unnecessary genetic testing and durable medical equipment, the DOJ said. Meanwhile, his brother, Louis, worked the phones at the call centers and pretended to own a laboratory where false genetic testing claims were submitted, according to the release.”
Comment: When did you last hear about such fraud occurring with a private insurance company?

Elevance Health grows profits 13.2% in Q2, reaching $1.9B “The company reported $1.6 billion in the prior year quarter, according to its earnings report released Wednesday morning. Revenues also grew by double digits, increasing by 13% to $43.7 billion in the second quarter from $38.6 billion in the second quarter of 2022. The results both surpassed Wall Street's expectations, according to Zacks Investment Research.”
Comment: Despite the resumption of pre-Covid elective procedures, insurance companies continue to be very profitable.

About pharma

 Cost Plus Drugs could be selling drugs to hospitals by this fall “Mark Cuban Cost Plus Drug Co. plans to be selling drugs to hospitals and clinics by September or October, the company's CEO and co-founder Alex Oshmyansky, MD, PhD, told Dallas-based D Magazine
The pharmaceutical company launched its mail-order pharmacy services in January 2022 with about 100 drugs. It now sells more than 1,000 generics and 10 brand-name medications, has a network of independent pharmacies spanning 38 states, and partners with pharmacy benefit managers and Capital Blue Cross.”

About the public’s health

They're illegal. So why is it so easy to buy the disposable vapes favored by teens? A very informative piece from NPR. Read the entire article. One interesting fact: “Nearly all the world's e-cigarettes — 90% — come from factories in Shenzhen, China…”

Extreme heat drives $1B in excess healthcare utilization per year, study estimates “The study—released online Monday and currently being submitted for publication in a scientific journal—found between 2016 and 2020 an average of roughly 234,000 excess emergency department visits across the country tied to heat event days. Excess hospital admissions averaged just over 56,000, according to the study conducted by Virginia Commonwealth University (VCU) and the Center for American Progress, a nonpartisan public policy advocacy group.”
Comment: Another cost of global warming.

Screening for Lipid Disorders in Children and AdolescentsUpdated Evidence Report and Systematic Review for the US Preventive Services Task Force “No direct evidence on the benefits or harms of pediatric lipid screening was identified. While multifactorial dyslipidemia is common, no evidence was found that treatment is effective for this condition. In contrast, FH [familial hypercholesterolemia] is relatively rare; evidence shows that statins reduce lipid levels in children with FH, and observational studies suggest that such treatment has long-term benefit for this condition.”

About healthcare IT

Teladoc doubles down on Microsoft partnership to bring AI, voice tech into telehealth visits “Teladoc and Microsoft teamed up in 2021, during the height of the COVID-19 pandemic, to streamline the technology and administrative processes associated with virtual care and integrate the company's Solo enterprise platform within Microsoft Teams.
The company is taking that collaboration a step further and leveraging Microsoft's 2022 acquisition of speech recognition tech company Nuance to bring Azure OpenAI Service, Azure Cognitive Services and the Nuance Dragon Ambient eXperience into its virtual care solution for hospitals and health systems.”

About healthcare personnel

 Should nurses with doctorates be called doctor? Lawsuit targets Calif. rule.  “…last month, Palmer and two other nurses with doctorates of nursing practice sued the California attorney general and leaders of the Medical Board of California and California Board of Registered Nursing, arguing that they have a right to call themselves doctors. The lawsuit seeks to permanently prevent the state from enforcing the law.”
Comment: Physician Assistants are still lobbying to change their designation to Physician Associates.

Association of Established Primary Care Use With Postoperative Mortality Following Emergency General Surgery ProceduresAbout health technologyQuestion  Is preoperative primary care utilization associated with postoperative mortality following an emergency general surgery operation?
Findings  In this cohort study of 102 384 Medicare patients, those with preoperative primary care exposure had significantly lower rates of in-hospital, 30-day, 60-day, 90-day, and 180-day mortality following an emergency general surgery operation.
Meaning  Preoperative primary care utilization was associated with lower odds of postoperative mortality; this protective association may be due to improved diagnosis and management of medical comorbidities.”

About healthcare technology

 Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy The story is in the headline from the FDA. Other news media estimate there are 350,000 units subject to the recall.

Today's News and Commentary

About healthcare quality and safety

 Burden of serious harms from diagnostic error in the USA “An estimated 795 000 Americans become permanently disabled or die annually across care settings because dangerous diseases are misdiagnosed. Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined.”

FDA announces Class I recall of nearly 8,000 heart attack tests due to inaccurate resultsThe U.S. Food and Drug Administration (FDA) has announced that Quidel Cardiovascular Inc. is recalling certain blood tests used to detect myocardial infarctions. The agency has categorized this as a Class 1 recall, which means using these devices “may cause serious injuries or death.”
The Quidel Triage Cardiac Panel is a blood test designed to identify amounts of different enzymes and proteins associated with a heightened risk of myocardial infarctions or other potentially fatal cardiac conditions. The recall is in place because there have been multiple reports of inaccurate tests.”

About hospitals and healthcare systems

Ochsner Health, Novant Health Announce Partnership to Expand Patient-Centered Senior Care “The partners plan to build 65 Plus clinics throughout the Southeast, giving older adult patients access to extended visits with their primary care physician and a multidisciplinary team to design a customized care plan to meet individual needs. Each clinic will have several service offerings to encourage patients to live active, healthier lives well into their senior years. Beyond medical needs, 65 Plus clinics will offer a community environment with regular social events, fitness centers, health coaching and more.”

About pharma

Donanemab in Early Symptomatic Alzheimer Disease The TRAILBLAZER-ALZ 2 Randomized Clinical Trial “Question  Does donanemab, a monoclonal antibody designed to clear brain amyloid plaque, provide clinical benefit in early symptomatic Alzheimer disease?
Findings  In this randomized clinical trial that included 1736 participants with early symptomatic Alzheimer disease and amyloid and tau pathology, the least-squares mean change in the integrated Alzheimer Disease Rating Scale score (range, 0-144; lower score indicates greater impairment) at 76 weeks was −6.02 in the donanemab group and −9.27 in the placebo group for the low/medium tau population and −10.19 in the donanemab group and −13.11 in the placebo group in the combined study population, both of which were significant differences.
Meaning 
Among participants with early symptomatic Alzheimer disease and amyloid and tau pathology, donanemab treatment significantly slowed clinical progression at 76 weeks.”
In a related article: Eli Lilly’s experimental Alzheimer’s drug slows disease, data show

An innovation supply chain: Pfizer taps Flagship for 10-program pipeline pact worth $7B in biobucks “Pfizer and Flagship Pioneering have each put down $50 million to build a new pipeline of 10 programs, with the Big Pharma offering the VC firm and its bioplatform companies the chance to make up to $700 million in biobucks for each successful drug.”

Sanofi taps Scribe for in vivo partnership worth more than $1.2B biobucks aimed at sickle cell and beyond The new collaboration gives Sanofi exclusive access to Scribe’s gene editing tech to develop new therapies, including for sickle cell disease, in exchange for $40 million in upfront cash and up to $1.2 billion in biobucks. Back in September 2022, Sanofi tapped up Scribe to develop ex vivo therapies—where edits are made to cells in a lab before being given to patients—handing over $25 million upfront.”

Johnson & Johnson sues to stop Medicare negotiation “Pharmaceutical giant Johnson & Johnson on Tuesday became the third drugmaker to sue the Biden administration over its new Medicare drug price negotiation program.”

About healthcare IT

 EHR vendor NextGen to pay $31 million to settle False Claims Act allegations  “Electronic health record vendor NextGen Healthcare on Friday agreed to pay $31 million to settle allegations that it violated the False Claims Act by misrepresenting versions of its product and providing illegal incentives to induce referrals to its software, according to the Department of Justice.
In a complaint filed along with the settlement, the DOJ contends that NextGen improperly sought HHS certification for its software by using an “auxiliary product” designed only to perform the certification, thereby concealing that its product lacked “critical functionality.”
NextGen also violated the Anti-Kickback Statute by providing “remuneration” to clients — with tickets to sporting events and credits worth up to $10,000 — to incentivize purchases and referrals of NextGen’s software, according to the DOJ.”

PETERSON CENTER ON HEALTHCARE LAUNCHES NEW $50 MILLION INSTITUTE TO EVALUATE DIGITAL HEALTH TECHNOLOGIES “The Peterson Center on Healthcare today launched the Peterson Health Technology Institute (PHTI), a nonprofit organization that provides independent evaluations of innovative healthcare technologies to improve health and lower costs. Launched with a commitment of $50 million, PHTI will deliver rigorous, evidence-based assessments that will analyze the clinical benefits and economic impact of digital health solutions, as well as their effects on health equity, privacy, and security.”

About healthcare finance

FTC Sues to Block IQVIA’s Acquisition of Propel Media to Prevent Increased Concentration in Health Care Programmatic Advertising “The Federal Trade Commission is seeking to block IQVIA Holdings Inc. (IQVIA), the world’s largest health care data provider, from acquiring Propel Media, Inc. (PMI), alleging in an administrative complaint (link to redacted complaint when made available) that the proposed acquisition would give IQVIA a market- leading position in programmatic advertising for health care products, namely prescription drugs, to doctors and other health care professionals. The merger would also increase IQVIA’s incentive to withhold key information to prevent rival companies and potential entrants from effectively competing, the complaint states.”

Today's News and Commentary

About Covid-19

 Moderna submits authorisation application for coronavirus vaccine Spikevax XBB.1.5  “Moderna Switzerland GmbH has submitted an application to Swissmedic, the Swiss Agency for Therapeutic Products, for authorisation of its updated monovalent COVID-19 vaccine. It encodes the spike protein for Omicron subvariant XBB.1.5 of SARS-CoV-2.”

About health insurance/insurers

Blue Cross Blue Shield plans in California evaded $170 million in taxes, whistleblower says Blue Shield of California evaded $111 million in taxes between 2016 and 2020, according to a complaint that was filed with the Internal Revenue Service on June 27. Elevance Health, the parent company of Anthem Blue Cross in California, evaded $60 million in taxes during the same time period, according to a separate complaint filed with the IRS.”

Medicaid Enrollment and Unwinding Tracker “At least 2,181,000 Medicaid enrollees have been disenrolled as of July 14, 2023, based on the most current data from 30 states and the District of Columbia. Overall, 37% of people with a completed renewal were disenrolled in reporting states while 63%, or 3.4 million enrollees, had their coverage renewed (four of the reporting states do not provide data on renewed enrollees). Because not all states have publicly available data on total disenrollments, the data reported here undercount the actual number of disenrollments.”

Obamacare Eligibility Match Program to Be Re-Established “Verification of eligibility to enroll in Obamacare plans and get subsidies will be re-established, the Department of Health and Human Services said Friday.
A ‘matching program’ between the Centers for Medicare & Medicaid Services and the Social Security Administration will be re-established for an initial term of 18 months from Sept. 9 to March 8, 2025, and may be renewed for an additional year if no changes are made, the notice said. Comments may be submitted. The notice will be published in the July 17 Federal Register.”

About hospitals and healthcare systems

 Changes in US Hospital Financial Performance During the COVID-19 Public Health Emergency  “Question  How did the financial position of hospitals change during the COVID-19 public health emergency?
Findings  In this national cohort study of 4423 hospitals, 3337 (75%) hospitals had a positive net operating income during 2020/2021, and 720 (16%) experienced new financial distress. Hospitals serving Hispanic populations were more likely to experience financial distress, even after receiving public health emergency funding; however, COVID-19 relief funding aided in hospital net operating margins reaching all-time highs.
Meaning  Although the majority of US hospitals were financially healthy across 2020 and 2021, partly due to the provision of COVID-19 relief funds, the size of COVID-19 relief funds may have been larger than was necessary for many hospitals.”

CMS to raise hospital payments to buy N95 masks, proposes 2.7% pay hike for facilities “The Biden administration is proposing a 2.7% increase to outpatient payment rates for hospitals for 2023 and an enhanced payment if a facility buys domestically manufactured N95 respirator masks.”

Hospital M&A deal volume returns to pre-pandemic levels as systems seek out complementary services “Twenty new deals were announced from April to June, up from the 15 of the first quarter and squarely above the 14 announced in the second quarter of 2020 along with the 14 and 13 transactions announced in the second quartesr of 2021 and 2022, respectively, healthcare consultancy Kaufman Hall wrote in an analysis released Thursday. The most recent count is in line with the 21 deals tallied by the firm in the second quarter of 2018 and the 19 deals that were inked in the second quarter of 2019.
Deal size, on the other hand, remains elevated compared to the years leading up to the pandemic. Second-quarter average deal size, as measured by the smaller organization’s revenue, was $664 million—down from the second quarter of 2022’s $852 million average but still above every other year dating back at least to 2017, Kaufman Hall wrote.”

About pharma

 A stroke of good luck for Sangamo: Biotech snags $1B+ biobucks deal with Lilly’s Prevail after layoffs, 2 other deals dissolve Prevail is set to pay Sangamo an undisclosed upfront payment for providing the capsids for evaluation. If the Lilly unit moves forward with certain capsids, it would take the lead on all further development, manufacturing and commercialization activities. If Prevail decides to exercise its option for all targets and a Prevail product is approved in the U.S. and Europe for each target, Sangamo could receive developmental milestones of up to $415 million and commercial payments of up to $775 million, plus tiered royalties.”

About the public’s health

First RSV antibody treatment to protect all infants approved in the U.S. “Federal regulators on Monday approved a shot to protect healthy babies and some vulnerable toddlers against the respiratory ailment RSV, the leading cause of hospitalization among young children in the United States.
The preventive shot, called Beyfortus, isn’t a vaccine, but it works in a similar way, delivering a temporary shield of protection that lasts for a single winter respiratory virus season. It is made up of laboratory-brewed antibodies that block the virus from entering cells.”

About health technology

 They Lost Their Legs. Doctors and Health Care Giants Profited. This NY Times article is well-worth reading if you can get access. It combines the principles of the link between fincanial incentives and actions as well as the technological imperative.

About healthcare finance

FTC asks Pfizer, Seagen for more information on proposed $43B merger “The Federal Trade Commission (FTC) has asked Pfizer and Seagen for more information on their proposed $43 billion merger, the Seattle biotech revealed(PDF) in a Securities and Exchange Comission (SEC) filing Friday.
This is the second round of documentation the antitrust regulator has requested from the companies since their deal was announced in March.”

Lilly to boost obesity drug portfolio with $1.93-billion Versanis buy “Eli Lilly announced Friday that it will acquire Versanis for potentially up to $1.93 billion in cash, gaining the latter's lead drug bimagrumab, which is under development for obesity.”

Today's News and Commentary

About Covid-19

 Biden administration to provide free Covid vaccines to uninsured Americans this fall through end of 2024  “The Biden administration on Thursday announced a program to provide free Covid vaccines to uninsured Americans through December 2024 after the federal government’s supply of shots runs out this fall.
Those free shots, which the government is purchasing at a discount, will be available to the uninsured at pharmacies and 64 state and local health departments.”

About health insurance/insurers

CMS outlines 2.8% pay increase for outpatient facilities, ASCs in 2024 proposed rule “In the proposed calendar year 2024 rule, set to be published in the Federal Register, CMS floated payment rates for hospitals that meet applicable requirements for quality reporting at 2.8%, reflecting a projected 3% hospital market basket increase reduced by 0.2% percentage points for a required productivity adjustment.”

CMS proposes payment cuts in physician fee schedule, and docs are crying foul “The Biden administration has released the proposed physician fee schedule for 2024, and a 3.34% decrease in the conversion factor is likely to draw plenty of ire from docs.
The agency said in a press release that under the proposed rule, payments overall would decrease by 1.25% compared to 2023. However, the Centers for Medicare & Medicaid Services (CMS) set the conversion factor at $32.75, down $1.14 or 3.34% from last year.”

FIRST ANNUAL NO SURPRISES ACT REPORT RELEASED “The Department of Health and Human Services' (HHS) Office of the Assistant Secretary for Planning and Evaluation recently released the first annual report on the impact of the No Surprises Act.
According to the report, there was a downward trend in out-of-network claims prior to the No Surprises Act implementation. The prevalence of claims that were out-of-network decreased from 6.0 percent to 4.7 percent from 2012 to 2020. In addition, the share of total payments that were out-of-network declined over this period from 9.2 percent in 2012 to 6.8 percent in 2020, the report said.
The report also says that during that time, out-of-network billing was highly concentrated among a small percentage of physicians from certain specialties.”

UnitedHealth kicks off Q2 earnings with $5.5B in profit, double-digit revenue growth “Profits were up year over year, as the company posted $5.1 billion in profit for the second quarter of 2022. Revenues grew by 16% from the prior year quarter, reaching $92.9 billion compared to $80.3 billion. Both figures surpassed Wall Street analysts' projections…
UnitedHealth Group's double-digit revenue growth overall was bolstered by double-digit gains at both UnitedHealthcare and Optum, according to the report. Revenues at UnitedHealthcare were up 13%, hitting $70.2 billion…
Revenues at Optum were up 25% in the second quarter, reaching $56.3 billion. The Optum arm has been a major growth engine for UnitedHealth Group in recent quarters.”

About hospitals and healthcare systems

 Why hospitals are cutting ties with Moody’s rating agency “Not-for-profit hospitals have been cutting ties with Moody’s Investors Service in recent years, citing the high cost and time commitment required to maintain their relationships with the rating agency.
With labor and supply costs inflated and margins thin following the Covid-19 pandemic, hospitals are eager to trim any expenses they can. Increasingly, that means cutting a bond rating. It’s common for health systems to have their bonds rated by just two or even one of the three major credit rating agencies —Moody’s, S&P Global Ratings, and Fitch Ratings.
But when deciding which one to ditch, data show they’ve more commonly targeted Moody’s in recent years. At least 10 health systems have ended their agreements with Moody’s since July 2020…”

About pharma

Ozempic demand is driving up care costs nationwide The headline is the story.

About the public’s health

Medicare proposes coverage for PrEP without patient cost sharing “The Centers for Medicare & Medicaid Services (CMS) is recommending preexposure prophylaxis (PrEP) with oral or injectable antiretroviral therapy to people at risk of HIV without patient cost sharing.
In addition, CMS is proposing to cover the administration of injectable PrEP and up to seven individual counseling visits every 12 months that include HIV risk assessment, reduction and medication adherence. The agency is also pitching coverage for HIV screening up to seven times annually and a single screening for hepatitis B virus, according to a press release.”

White House planning to tap retired general to lead new pandemic office “Maj. Gen. Paul Friedrichs, who retired from the military this summer and joined the National Security Council to work on biodefense and global health security, is the planned selection to lead the White House’s Office of Pandemic Preparedness and Response Policy, according to three people who spoke on the condition of anonymity to discuss a pending personnel move.”

About healthcare finance

 Hungry for more, Lilly tops off weight loss pipeline with $1.9B deal to acquire Versanis “The Indianapolis-based company has signed off on a $1.92 billion deal, which covers an upfront payment and potential milestones, for Boston-based Versanis and lead asset bimagrumab.
The monoclonal antibody is already in a phase 2 trial both alone and in combination with semaglutide in adults who are overweight or obese.”

Today's News and Commentary

About hospitals and healthcare systems

 Aspirus Health, St. Luke's Duluth unveil plans to form 19-hospital Midwest nonprofit system “St. Luke’s Duluth in Minnesota is working on a deal to join Wisconsin-based nonprofit Aspirus Health, representing the latest in a string of Midwest hospital consolidation deals currently in the works.
The organizations announced Wednesday that they have signed a letter of intent for the two-hospital Minnesota system to become an affiliate of the 17-hospital Aspirus Health. They said they expect the deal to close in early 2024 pending due diligence, regulatory reviews and other approvals.”

About pharma

FDA clears first over-the-counter oral contraceptive “The FDA on Thursday approved Perrigo's Opill for over-the-counter (OTC) use, making it the first hormonal oral contraceptive available in the US without a prescription. "When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy," stated Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research.”

 A Small Number of Drugs Account for a Large Share of Medicare Part D Spending FYI. Eliquis is by far the most costly as far as total spending.

Chamber of Commerce asks judge to block Medicare drug price negotiations before October
The U.S. Chamber of Commerce on Wednesday asked a federal judge in Ohio to block Medicare’s new powers to negotiate drug prices before October 1.
—The Chamber argued that the negotiations violate the due process clause under the Fifth Amendment of the U.S. Constitution.
—Drugmaker Abbvie, a chamber member, is worried its blood cancer drug Imbruvica will be selected for price negotiations this fall.

Leqembi could cost Medicare up to $17.8B “Eisai and Biogen, the manufacturer of Leqembi, estimated around 100,000 individuals will be prescribed the drug by year three of its approval. At this rate of uptake, it would cost Medicare $2.7 billion each year, KFF found.”
And, in a related article: How are insurers handling the Alzheimer’s drug Leqembi and related scans? A week after the Food and Drug Administration granted full, traditional approval to a new Alzheimer’s treatment, insurers are finalizing their plans to cover it as well as associated scans and diagnostic tests.
Medicare will cover most patients eligible for Leqembi, a new treatment developed by Eisai and Biogen to help slow the progression of Alzheimer’s disease. The drug, which has modest benefits, has potentially serious side effects for some patients including brain swelling and bleeding.
Medicare told STAT that it would cover brain scans and genetic testing that will help screen for and monitor potential side effects. Medicare already covers one amyloid PET scan per lifetime, but the agency is reconsidering that policy and plans to release a new proposed policy ‘soon,’ an agency spokesperson said.”

CVS Caremark, GoodRx team up on prescription discounts “The two companies announced on Wednesday the launch of Caremark Cost Saver. In the program, eligible Caremark members will able to automatically access GoodRx's pricing, which will allow them to pay lower prices on generic medications when applicable.”

Recursion Announces Collaboration and $50 Million Investment from NVIDIA to Accelerate Groundbreaking Foundation Models in AI-Enabled Drug Discovery “Recursion plans to utilize its vast proprietary biological and chemical dataset, which exceeds 23 petabytes and 3 trillion searchable gene and compound relationships, to accelerate the training of foundation models on NVIDIA DGX™ Cloud for possible commercial license/release on BioNeMo, NVIDIA’s cloud service for generative AI in drug discovery. NVIDIA will also help optimize and scale Recursion foundation models leveraging the NVIDIA AI stack and NVIDIA’s full-stack computing expertise. BioNeMo was announced earlier this year as a cloud service for generative AI in drug discovery, offering tools to quickly customize and deploy domain-specific, state-of-the-art biomolecular models at-scale through cloud APIs. Recursion anticipates using this software to support its internal pipeline as well as its current and future partners.”

About the public’s health

 Johnson & Johnson sues researchers who linked talc to cancer “J&J alleges researchers used ‘junk science’ to disparage company's products…
J&J's subsidiary LTL Management, which absorbed the company's talc liability in a controversial 2021 spinoff, last week filed a lawsuit in New Jersey federal court asking it to force three researchers to "retract and/or issue a correction" of a study that said asbestos-contaminated consumer talc products sometimes caused patients to develop mesothelioma.”

About healthcare IT

Hacker claims to have posted HCA data for saleA hacker has claimed responsibility for a data theft incident at Nashville, Tenn.-based HCA Healthcare and has allegedly stolen and posted more than 27 million records for sale on the dark web, DMagazine reported July 11.”

Today's News and Commentary

About health insurance/insurers

HHS: Medicare Part D enrollees will save $400 on average in 2025 “Caps on Medicare prescription drug costs will save Part D enrollees a collective $7.4 billion in 2025, according to a report from HHS' Office of the Assistant Secretary for Planning and Evaluation. 
The report, published July 7, broke down expected savings from price caps by state. An estimated 18.7 million people, around 1 in 3 Medicare Part D enrollees, will save on drug costs in 2025. The average annual saving per person is estimated at $396.08.”

Federal inquiry aims to protect consumers against predatory medical debt and collection practices “The Consumer Financial Protection Bureau (CFPB) is launching an inquiry into a practice used to coax patients into paying for routine care with medical credit cards and installment loans.
In partnership with the Department of Health and Human Services (HHS) and the Department of the Treasury, the three agencies hope to examine patients’ experiences with credit cards and loans as well as healthcare providers’ incentives to offer high-cost products.”
 

About hospitals and healthcare systems

 US News won't rank honor roll hospitals “The publication will no longer attribute ordinal rankings to its honor roll hospitals, it said in a July 11 letter addressed to hospital leaders…
Ordinal rankings will still be listed for the 15 specialties U.S. News gauges, as well as the regions where it publishes.”
 
About pharma

Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report “The new lawsuits add to a complex web of ongoing mRNA patent litigation. The legal melee began last August when Moderna filed patent infringement lawsuits in the U.S. and Germany. Separately, Moderna has also sued Pfizer and its German partner BioNTech in the Netherlands, plus the U.K.
Moderna’s goal isn’t to remove Pfizer’s shot Comirnaty from the market, nor is it trying to target Pfizer’s sales in low- and middle-income countries covered by the COVAX initiative, the company insists. Instead, Moderna is pursuing compensation and damages to make up for Pfizer-BioNTech’s alleged trampling of patents detailing lipid nanoparticle delivery, spike protein encoding and more.”

About the public’s health

Millions of homes, schools may have to eliminate lead dust under EPA plan “In one of its strongest measures yet against a contaminant that poisons children, the Environmental Protection Agency on Wednesday proposed tougher standards on lead in paint in older homes and schools, potentially triggering its removal in millions of buildings.
The new rules would almost completely prohibit lead dust in older buildings. The only contamination allowed would be the lowest levels that current removal efforts can’t eliminate, the agency said. It estimates that those requirements each year would reduce lead exposures for 250,000 to 500,000 children younger than 6.
The rules apply to homes, schools, day-care centers and other facilities.” 

About healthcare IT

Digital health funding settles down in 2023 with fewer deals, lower check sizes “In the first six months of 2023, U.S. digital health startups raised $6.1 billion across 244 deals, with an average deal size of $24.8 million, according to an analysis by Rock Health, a venture fund dedicated to digital health. While that $6 billion seems like a hefty amount of cash, that's down considerably from $10.4 billion raised in the first half of 2022 and an eye-popping $15.1 billion raised in the first six months of 2021.”

About healthcare personnel

MONETIZING MEDICINE: PRIVATE EQUITY AND COMPETITION IN PHYSICIAN PRACTICE MARKETS  “SUMMARY OF MAJOR CONCLUSIONS
●  PE acquisitions of physician practices are increasing. We find that private equity (PE) firms have been increasingly acquiring physician practices across a number of physician specialties since 2012, increasing from 75 deals in 2012 to 484 deals in 2021, or more than six-fold increase in only 10 years.
●  PE firms are amassing high market shares in local physician practice markets. At the local level, we find that individual PE firms are acquiring competitively significant shares of physician practice markets. In particular, in 28% of metropolitan statistical areas (MSAs), a single PE firm has more than 30% market share by full-time-equivalent physicians, and in 13% of MSAs, the single PE firm market share exceeds 50%.
●  PE acquisitions are associated with price and expenditure increases. In 8 of the 10 physician practice specialties we study, we find statistically significant price increases associated with PE’s acquisition of a practice. These price increases range from 16% in oncology to 4% in primary care and dermatology. PE acquisitions are also associated with per-patient expenditure increases for 6 of 10 specialties, ranging from 4% to 16% depending on the specialty.
●  Price increases associated with PE acquisitions are exceptionally high where a PE firm controls a competitively significant share of the local market. When we focus our analysis on markets where a single PE firm controls more than 30% of the market, we find further elevated prices associated with PE acquisitions in each of the 3 specialties with statistically significant results, for gastroenterology (18%), obstetrics and gynecology (16%), and dermatology (13%).”  

About health technology

 Illumina hit with record $476 million EU antitrust fine over Grail deal “U.S. genetic testing company Illumina was fined a record 432-million-euro ($476 million) by the EU on Wednesday for closing its takeover of cancer test maker Grail before securing EU antitrust approval.
Illumina has been fighting the EU competition watchdog on several fronts since it was forced to seek its approval in 2021 despite the deal falling short of the EU turnover threshold for scrutiny.”

Today's News and Commentary

About health insurance/insurers/costs

 Healthy Marketplace Index Using nearly 4.3 billion commercial claims from 2017 to 2021, HCCI [Health Care Cost Institute]tracks drivers of health care spending across 183 U.S. cities through the Healthy Marketplace Index (HMI) project.” You can enter your location on this interactive site. It is set to Chicago as default.

Employers are increasingly suing their health plan for claims data “Lawsuits from large companies and employers are increasingly being filed against third-party health plan administrators in an effort to access complete employee medical claims data. 
Through lawsuits recently filed against Aetna, Elevance Health and BCBS Massachusetts, employers claim payers have breached their fiduciary duties by not allowing complete access to claims data and how claims are processed.
In a June 30 complaint, Kraft Heinz alleged Aetna has used its role as its TPA "to enrich itself to Kraft Heinz's detriment" through undisclosed fees and processing medical and dental claims without human review.”

Medicaid work requirements resurface, threatening health A really good review of the topic.

Who Enrolls in Medicare Advantage vs. Medicare Fee-for-Service Excerpts:
Demographically, MA enrollees differ meaningfully from FFS enrollees (Table 1). MA has a slightly higher proportion of males. Compared to FFS, those in MA are also twice as likely to be non-white, and much more likely to be Black, Hispanic, or Asian…
—Perhaps the starkest difference between the two groups is in the types of commercial plans in which they were enrolled, pre-65: MA enrollees are over 50% more likely than those in FFS to have been enrolled in an HMO plan (recall that 100% of both groups were in commercial coverage, pre-65). Given that MA plans tend to have relatively more restrictive care management policies, it makes sense that individuals who have previous exposure to care management would be more comfortable with that type of coverage under MA…
—The average income of an FFS enrollee (based on their corresponding ZIP9) is $85,085, compared to $76,720 for an MA enrollee. This gap arises from the relative lack of MA enrollees in the most affluent segments: while 35.5% of FFS enrollees live in a ZIP9 with incomes above $100,000, this is true for only 23.8% of MA enrollees. The average MA enrollee has a net worth that is only 74.2% of that of the average FFS enrollee…
—MA enrollees are more likely to face many other socioeconomic disadvantages relative to their FFS enrollee counterparts. Those in their near neighborhood are more likely to have only a high school education or less and slightly more likely to live in a high unemployment area, though the latter comparison is not statistically significant. They are less likely to own their home, to be married, and to own a vehicle, and more likely to have difficulty speaking English. Additionally, based on two aggregate measures of social risk, the Area Deprivation Index and the Socioeconomic Status (SES) index, MA enrollees are more socioeconomically disadvantaged than those in FFS.
—We find that, immediately prior to enrollment, those going into MA are modestly less sick than their FFS enrollee counterparts, having about 10% lower Hierarchical condition category (HCC) risk scores (0.566 vs 0.517) and Charlson Comorbidity Index (CCI) scores (0.853 vs. 0.751).
—MA and FFS enrollees have similar prevalence of the top chronic conditions among Medicare beneficiaries including hypertension and hyperlipidemia. FFS enrollees are more likely to have certain conditions, including cancer, joint issues (rheumatoid arthritis, osteoarthritis, and osteoporosis), and heart issues (ischemic heart disease and prior experience with heart failure). On the other hand, MA enrollees are more likely to have diabetes.”

About hospitals and healthcare systems

 CMS to return $9B to 340B hospitals under new plan The CMS’ long-awaited fix to repay hospitals for what the Supreme Court last year determined to be years of underpayments in the 340B drug discount program is garnering a mixed reaction from hospital groups.
The remedy proposed by regulators Friday would have Medicare send $9 billion in lump-sum payments to more than 1,600 hospitals that participate in 340B. To pay for the proposal, which needs to be budget-neutral, the CMS would cut payments to all hospitals for non-drug items and services by 0.5% over the next 16 years.”

About the public’s health

What is the cost-effectiveness of menu calorie labelling on reducing obesity-associated cancer burdens? An economic evaluation of a federal policy intervention among 235 million adults in the USA “Considering consumer behaviour alone, this policy was associated with 28 000 (95% UI 16 300 to 39 100) new cancer cases and 16 700 (9610 to 23 600) cancer deaths averted, 111 000 (64 800 to 158 000) QALYs gained, and US$1480 (884 to 2080) million saved in cancer-related medical costs among US adults. The policy was associated with net cost savings of US$1460 (864 to 2060) million and US$1350 (486 to 2260) million from healthcare and societal perspectives, respectively. Additional industry reformulation would substantially increase policy impact. Greater health gains and cost savings were predicted among young adults, Hispanic and non-Hispanic Black individuals.” 

Half of US adults skip common health screenings, including tests for certain diseases, survey finds “Americans are likely to skip important health screenings, and women have a less positive outlook than men regarding their current and future health prospects, according to a survey released by Aflac.
The survey, based on about 2,000 employed adults, examined attitudes, habits and opinions about health and preventive care and found that half of adults have avoided at least one common health screening. These screenings include tests for certain diseases.
But for the 51% of respondents who said they have had cancer, that diagnosis came following a routine checkup or screening. For Hispanic survey respondents, 72% of individuals said a diagnosis was discovered at a routine checkup.”

About healthcare IT

Two Years After Coding Changes Sought to Decrease Documentation, Notes Remain ‘Bloated’ “We evaluated 1.7 billion clinical notes written by 166,318 outpatient providers in the U.S. from May 2020 to April 2023 to determine the average length in characters for each note. We found that the average note length across all clinical notes has increased 8.1%, from 4,628 characters in May 2020 to 5,002 characters in April 2023…
However, despite these increases in note length, the average time spent writing notes decreased 11.1% over this same period, from an average of 5.4 minutes per note to 4.8 minutes per note. Additionally, providers are spending less time in clinical review activities in the EHR…
These findings align with previous research that found increased use of SmartTools and copy/paste functions were correlated with longer notes.”

HCA Healthcare Reports Data Security IncidentHCA Healthcare, Inc..recently discovered that a list of certain information with respect to some of its patients was made available by an unknown and unauthorized party on an online forum. [It is estimated that about 11 million people are affected.] The list includes:

  • Patient name, city, state, and zip code;

  • Patient email, telephone number, date of birth, gender; and

  • Patient service date, location and next appointment date.”

About healthcare personnel

 THE EMPLOYMENT SITUATION — JUNE 2023 From the Bureau of Labor statistics. “Health care added 41,000 jobs in June. Job growth occurred in hospitals (+15,000), nursing and residential care facilities (+12,000), and home health care services (+9,000). Offices of dentists lost 7,000 jobs. Health care has added an average of 42,000 jobs per month thus far this year, similar to the average gain of 46,000 per month in 2022.”

Today's News and Commentary

About health insurance/insurers

Biden administration aims to crack down on short-term health plans, surprise medical billing The Biden administration announced plans on Friday to tamp down on short-term health plans and surprise medical fees as part of an ongoing effort to lower healthcare costs.
Under the new rules, if finalized, plans that claim to be “short-term” health insurance would be limited to just three months, or a maximum of four months, if extended – instead of the current three-year maximum. And, under the proposed rules, plans are required to provide consumers with a clear disclaimer that explains the limits of their benefits, including to existing consumers currently enrolled in these plans…
And, nonparticipating providers and nonparticipating emergency facilities cannot evade the protections of the No Surprises Act, including the prohibition on balance billing, by renaming charges otherwise prohibited under the No Surprises Act as ‘facility fees,’ the White House said.”

A Closer Look at the Five Largest Publicly Traded Companies Operating Medicaid Managed Care Plans FYI.

About hospitals and healthcare systems

CMS Hospital Value-Based Programs: Refinements Are Needed To Reduce Health Disparities And Improve Outcomes Note that the study was sponsored by the Federation of American Hospitals.
“We found statistically significant positive relationships between hospital penalties and several factors that affect hospital performance but that hospitals cannot control—namely, medical complexity (as measured by Hierarchical Condition Categories scores), uncompensated care, and the portion of hospital catchment area populations who live alone. Moreover, these environmental conditions can be worse for hospitals that operate in areas with historically underserved populations. This suggests that the CMS programs might not adequately account for health equity factors at the community level. Refinements to these programs (including an explicit incorporation of patient and community health equity risk factors) and continued monitoring will help ensure that the programs work as intended in a fair and equitable fashion.”

About pharma

Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021 In this qualitative study, there was consistent alignment between advisory votes and FDA action across years and subject areas, but the number of meetings decreased over time. Discordance between FDA actions and advisory committee votes was most frequently an approval after a negative vote. This study demonstrated that these committees have played a key role in the FDA’s decision-making process but that the FDA sought independent expert advice less frequently over time even as it continued to follow it. The role of advisory committees in the current regulatory landscape should be more clearly and publicly defined.”

About healthcare IT

A Buyer’s Guide to Digitally-Assisted Provider Documentation Look at the chart in the article. The value of the method must take into account the time reduction benefit. That said, the scribe systems have a higher value than “Tech-enabled humans” or “Intelligent documentation.” 

About health technology

Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices  Question  Are medical devices that are marketed as enabled for artificial intelligence (AI) or machine learning (ML) being appropriately approved for AI or ML capabilities in their US Food and Drug Administration (FDA) 510(k) clearance?
Findings  In this systematic review of 119 public 510(k) application summaries and corresponding marketing materials, devices with significant software components similar to devices flagged in the FDA’s published list of AI- or ML-enabled devices were defined and taxonomized into categories of adherent, contentious, and discrepant devices. Of 119 devices queried, 12.6% were considered discrepant, 6.7% were considered contentious, and 80.6% were consistent between marketing and FDA 510(k) clearance summaries.
Meaning  These findings suggest that there were discrepancies between the marketing and 510(k) clearance of AI- or ML-enabled medical devices, with some devices marketed as having such capabilities not approved by the FDA for use of AI or ML.”

About healthcare finance

Coloplast casts $1.3B to reel in fish skin-based wound care company Kerecis “The Danish medtech announced plans on Friday to acquire Kerecis, which uses fish skin as the basis of its wound care products for humans.
Coloplast has offered up 8.9 billion Danish kroner, or around $1.3 billion, in the deal. The vast majority—8.2 billion kroner ($1.2 billion)—will be doled out as an upfront cash payment. Coloplast intends to finance the acquisition with help from an equity capital raise.”

Today's News and Commentary

About Covid-19

Performance of Rapid Antigen Tests [(Ag-RDTs]to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection “The performance of Ag-RDTs was optimized when asymptomatic participants tested 3 times at 48-hour intervals and when symptomatic participants tested 2 times separated by 48 hours.”

About health insurance/insurers

The Medicare Advantage Quality Bonus Program The Urban Institute points out flaws in this Program and suggests remedies. Among the findings: While clinical quality measures account for over half of the measures used in the star rating system, after weighting, about two-thirds of a contract’s star rating is determined by beneficiary experience with care and MA administrative effectiveness. On review, however, we find that:
—measures of beneficiary experience do not permit meaningful distinctions across MA contracts and
—administrative effectiveness measures do not target important deficiencies regulators have identified within MA organizations.”

About hospitals and healthcare systems

 13 healthcare mergers and acquisitions making headlines in June  FYI

About pharma

FDA approves first Alzheimer’s therapy shown to clearly slow cognitive decline “The Food and Drug Administration on Thursday granted full approval to the first therapy for Alzheimer’s disease clearly shown to slow the cognitive decline associated with the disease — a milestone in treatment, even if the benefits are modest.
The drug, called Leqembi, was developed by Eisai, the Japanese pharmaceutical company, and sold in partnership with Biogen. It previously secured conditional approval in January. The FDA’s decision will broaden patient access to the drug under the Medicare program and is likely to boost sales, even as Leqembi’s benefits and safety risks continue to be a source of debate.”

Location, Location, Location: Spending Differences for Biologic and Biosimilar Medications by Site of Treatment Highlights:
“With the exception of biosimilars for Neupogen, the market share for the innovator biologics was between 65 percent and 87 percent in 2020…
For all seven innovator biologics examined, allowed charges were higher in HOPDs [hospital outpatient departments] than in POs [physician offices.] HOPD markups on innovator biologics are roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition. Allowed charges were about double in 2019, averaging 98 percent higher. In 2020, allowed charges were more than twice as high in HOPDs, averaging 121 percent.
In 2020, the HOPD markup ranged from 75 percent to 183 percent. The HOPD markup increased between 2019 and 2020 for all innovator biologics examined.”

Sarepta sells FDA priority review voucher to mystery buyer for $102M as prices continue to slip “While the price of just about everything has increased over the last six years in the U.S., the same can’t be said for the cost of an FDA priority review voucher. Just ask Sarepta Therapeutics.
Since 2017, the Massachusetts rare disease specialist has sold off three PRVs—getting less in return for each one.
The most recent sale came Wednesday as Sarepta revealed a $102 million deal for its PRV that came along with the FDA’s endorsement two weeks ago of the company’s latest Duchenne muscular dystrophy (DMD) treatment, gene therapy Elevidys.”

AbbVie's Skyrizi retakes TV drug ad spenders' crown in June as overall spend falls by $40M “AbbVie remained at the top of the TV drug ad spenders ranking for yet another month in June, although its immunology drug Skyrizi replaced Rinvoq, its other blockbuster medication, which held the top spot in May.
Skyrizi was in fact up two places in June from May, with AbbVie spending $26.6 million on all TV ads for the drug last month. That was $1.3 million more than it spent on Rinvoq.”

 Takeda adds another F-Star collab to constellation, this time for $1B in biobucks “Takeda and F-Star Therapeutics are tacking on another bispecific antibody deal worth $1 billion in potential milestones, marking the third time the two have partnered up in a year. 
Few details were disclosed in the companies’ announcement Wednesday, beyond the $1 billion in potential biobucks being on the table. The two drug developers will jointly research and develop antibodies for new immuno-oncology targets, with Takeda having an exclusive option to take select candidates forward.  

About the public’s health

 Study says drinking water from nearly half of US faucets contains potentially harmful chemicals “Drinking water from nearly half of U.S. faucets likely contains “forever chemicals” that may cause cancer and other health problems, according to a government study released Wednesday.
The synthetic compounds known collectively as PFAS are contaminating drinking water to varying extents in large cities and small towns — and in private wells and public systems, the U.S. Geological Survey said.”

Supplemental Nutrition Assistance Program Access and Racial Disparities in Food Insecurity
Findings In this cross-sectional study of 4974 US households, Black and multiracial households had higher rates of food insecurity than White households in adjusted analyses. This disparity was not found among households that had access to SNAP benefits.
Meaning  These findings suggest that SNAP likely plays a key role in addressing food insecurity, but there are racial disparities in food insecurity among those not participating in the program.”

CDC to Reduce Funding for States’ Child Vaccination Programs “The reduction comes from a federal immunization grant — totaling about $680 million in the latest year — that supports vaccination programs for children, according to the Association of Immunization Managers…
The debt deal rescinded about $27 billion in unspent federal money that had been allocated to fight covid. It also led the CDC to remove $400 million in funding to states for workers who fight the spread of sexually transmitted infections, according to an email obtained by CQ Roll Call.”

About healthcare IT

10 largest healthcare data breaches so far in '23 FYI

 HL7, WHO Partner to Drive Global Interoperability Standards Adoption “Standards-development organization Health Level Seven International (HL7) and The World Health Organization (WHO) have signed a Project Collaboration Agreement to support the global adoption of open interoperability standards.
Adopting interoperability standards is critical for consistently representing health data and information to support data exchange, regardless of the software used.
The Global Strategy on Digital Health 2020-2025 outlines a call for WHO to provide global guidance on interoperability standards adoption.”

Digital Therapeutics Alliance and Health Advances Release Definitive Framework and Definitions for Classifying Digital Health Technologies Look at the graphic- it is a useful conceptual framework for healthcare IT.

About healthcare personnel

Healthcare job cuts up 97% from 1st half of 2022 “Healthcare/products companies and manufacturers, including hospitals, announced the fourth-most job cuts among 30 industries and sectors measured in the first half of 2023, according to one new analysis.
The finding comes from a July 6 report from Challenger, Gray & Christmas…”

About healthcare finance

Eli Lilly Surpasses UnitedHealth as World’s Biggest Health-Care Firm “The drugmaker gained 0.9% on Wednesday, extending its advance after four straight months of gains while adding more than $94 billion to its value this year. Lilly ended June at a record high…
UnitedHealth closed down 1.4% and has fallen 11% so far this year.”

 Thermo Fisher fronts over $900M for data intelligence company as M&A strategy takes shape “The deal will see the life sciences giant hand over $912.5 million for the Waltham, Massachusetts-based company. CorEvitas, which oversees around 300 employees, has developed a multi-therapeutic data intelligence platform to gather structured patient clinical data spanning more than 400 investigator sites and over 100,000 patients. It does this by managing 12 clinical registries, including nine autoimmune and inflammatory syndicated registries.”

Today's News and Commentary

About Covid-19

How many Americans still haven't caught COVID-19? CDC publishes final 2022 estimates “Virtually every American ages 16 and older — 96.7% — had antibodies either from getting vaccinated, surviving the virus or some combination of the two by December, the CDC now estimates. The study found 77.5% had at least some of their immunity from a prior infection.
Of all age groups, seniors have the smallest share of Americans with at least one prior infection, at 56.5% of people ages 65 and over. Young adults and teens had the largest proportion of people with a prior infection, at 87.1% of people ages 16 to 29.” 

About health insurance/insurers

 CMS proposes $375M cut to home health Medicare payments in 2024 “The Biden administration issued a proposal Friday to cut reimbursements to home health providers by 2.2% next year, or an estimated $375 million less than 2023 payment levels.”

Healthcare billing fraud: 11 recent cases FYI

National Health Expenditure Projections, 2022–31: Growth To Stabilize Once The COVID-19 Public Health Emergency Ends “National health expenditures are projected to grow 5.4 percent, on average, over the course of 2022–31 and to account for roughly 20 percent of the economy by the end of that period. The insured share of the population is anticipated to exceed 92 percent through 2023, in part as a result of record-high Medicaid enrollment, and then decline toward 90 percent as coverage requirements related to the COVID-19 public health emergency expire. The prescription drug provisions of the Inflation Reduction Act of 2022 are anticipated to lower out-of-pocket spending for Medicare Part D enrollees beginning in 2024 and to result in savings to Medicare beginning in 2031.”

About hospitals and healthcare systems

 Some Hospitals That Spent Big on Nurses During Pandemic Are Now Short on Cash “Hospitals have disclosed some kind of repayment difficulty for more than $10 billion in municipal bonds in the past 12 months, according to Municipal Market Analytics. Overall, about $12 billion in hospital bonds is impaired—nearly 4% of all hospital muni debt outstanding. That is the most in the past 15 years, including during the 2008-09 financial crisis.”

About pharma

 Pfizer taps Samsung Biologics in manufacturing deals worth $897 million “Pfizer has finalised a pair of deals worth a combined $897 million for Samsung Biologics to manufacture products for the pharmaceutical company. Samsung Biologics made the disclosures on Tuesday, saying the arrangements would see it produce biosimilar products at its new Plant 4 facility in South Korea.”

Moderna strikes deal worth up to $1B to develop, produce mRNA drugs in China: reports “In a deal that could be worth up to $1 billion, Massachusetts-based Moderna inked a memorandum of understanding, plus a land collaboration agreement, to identify opportunities to research, develop and manufacture mRNA medicines in China, Yicai Global, Reuters and others have reported.”

 Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry FYI from the FDA

About the public’s health

Low-Density Lipoprotein Cholesterol Levels in Adults With Coronary Artery Disease in the US, January 2015 to March 2020 “Achievement of guideline-directed targets for LDL-C among adults with reported CAD was low, with almost 3 in 4 participants not meeting ACC/AHA guideline targets and 9 in 10 not meeting ESC guideline targets. Rates of statin use in adults with reported CAD were suboptimal.
Even among adults receiving statins, rates of achieving guideline goals for LDL-C were low. This is concerning because evidence suggests LDL-C levels are improving in the overall population. Factors contributing to low rates of attaining guideline goals may include inadequate statin treatment intensification, insufficient add-on therapy use (eg, ezetimibe), and low use of novel therapies (monoclonal antibody PCSK-9 inhibitors, inclisiran, and bempedoic acid). Low rates of statin use and intensification may relate to prescriber or patient hesitation.”

A Blood Test Predicts Pre-eclampsia in Pregnant Women “The Food and Drug Administration has approved a blood test that can identify pregnant women who are at imminent risk of developing a severe form of high blood pressure called pre-eclampsia, a leading cause of disability and death among childbearing women…
The new blood test, made by Thermo Fisher Scientific, has been available in Europe for several years. It is intended for pregnant women who are hospitalized for a blood pressure disorder in the 23rd to 35th weeks of gestation.
The test can tell, with up to 96 percent accuracy, who will not develop pre-eclampsia within the next two weeks and so can safely be discharged from the hospital. Two-thirds of the women who get a positive result, on the other hand, will progress to severe pre-eclampsia in that time, and their babies may need to be delivered early.”
 

About healthcare IT

 Need to Get Plan B or an HIV Test Online? Facebook May Know About It “An investigation by The Markup and KFF Health News found trackers on CVS.com telling some of the biggest social media and advertising platforms the products customers viewed.
And CVS is not the only pharmacy sharing this kind of sensitive data.
We found trackers collecting browsing- and purchase-related data on websites of 12 of the U.S.’ biggest drugstores, including grocery store chains with pharmacies, and sharing the sensitive information with companies like Meta (formerly Facebook); Google, through its advertising and analytics products; and Microsoft, through its search engine, Bing.”

About health technology

 Illumina faces record European Union fine over Grail deal next week - report “Illumina faces a record fine from the European Union as early as next week after completing its purchase of cancer-screening company Grail without the antitrust regulator's approval.
The fine may be as much as $453 million, or 10% of the company's revenue…”

Abbott reels in FDA approval for dual-chamber leadless pacemaker “Just a few weeks after Abbott presented the successful results of a trial of its Aveir DR dual-chamber leadless pacemaker system—data that it said had been promptly submitted for regulatory review—the company has secured FDA approval for the technology.”

Medtronic finds hacking risk in heart device data management system “Medtronic has identified a vulnerability that could potentially allow hackers to access the cardiac device data stored in its Paceart Optima data workflow systems.
The technology is used by healthcare providers as a single place to compile the health data of patients using heart devices. It accepts transmissions from implants, programmers and remote monitoring devices made by both Medtronic and competitors like Boston Scientific and Abbott, including data gathered in the clinic and at a patient’s own home.”