Today's News and Commentary

About health insurance/insurers

ICYMI: Medicare Advantage fraud in DOJ's crosshairs after agency reports $2.7B in settlements “Under the False Claims Act, more than $1.8 billion in settlements and judgments was related to health-related matters in the last fiscal year, about two-thirds of the monetary fraud recoveries by the Department of Justice (DOJ).
Scams took place across the industry, affecting managed care providers, hospitals, pharmacies and long-term acute care facilities. The agency said Feb. 22 that $1.8 billion refers to recoveries ‘arising only from federal losses,’ but it often recovered more for state Medicaid programs.The total fraud figure jumps to more than $2.68 billion once including all other types of reported fraud.”

About hospitals and healthcare systems

25 unwound, canceled hospital deals FYI

 Cooper to begin estimated $2B expansion this year “Cooper University Health Care is preparing to begin the first phase of a projected $2 billion expansion this year, according to Fitch Ratings.
In late 2022, Cooper announced a long-term vision to update its Camden, N.J., campus. The vision comprises three independent phases, with an initial public price of about $2 billion. Fitch said the phased approach gives Cooper the flexibility to pause spending and the ability to reevaluate should market conditions or business strategies change.”

Hospitals show decline in Fitch’s early 2023 analysis, but should improve (a little)Overall, Fitch expects the 2023 operating margins to rise into positive territory, albeit barely. The 2023 margins are expected to rise to 0.5% to 0.7%, which remains below pre-pandemic levels.
In 2024, Fitch projects margins should move up to 1.6%.
Hospitals are seeing some relief in their labor costs, which have risen substantially since the COVID-19 pandemic.”

About pharma

Biotech's top money raisers of 2023Nearly $23 billion in venture capital flowed to biopharma across 613 deals in 2023. The dollar total is down 21% from 2022 and 42% from 2021, according to an annual report from HSBC. The trend was worse for biotechs hunting for their first deal.” 

Prices for new US drugs rose 35% in 2023, more than the previous yearPharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry's embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found.
The median annual list price for a new drug was $300,000 in 2023, according to the Reuters analysis of 47 medicines, up from $222,000 a year earlier. In 2021, the median annual price was $180,000, the 30 drugs first marketed through mid-July, according to a study published in JAMA.”

About the public’s health

 U.S. launches probe into possible fraud by organ collection groups “The probe involves U.S. attorneys in various parts of the country who are investigating organ procurement organizations in at least five states. Their team includes investigators from the Department of Health and Human Services and the office of Michael Missal, the inspector general of the Department of Veterans Affairs. They are seeking to determine, among other things, whether any of these groups have been overbilling the government for their costs.”

About healthcare IT

 Unveiling Inferno Testing Support for Payer Data Exchange API Standards “ONC has hit a new milestone in advancing interoperability across the care continuum. A new series of voluntary tests to support standards-based application programming interfaces (APIs) leveraging Health Level Seven® (HL7®) implementation specifications developed via the Da Vinci project and the CARIN Alliance are now available in the ONC-developed Inferno testing tool. The tests are open source, with the source code freely available for use by the public on GitHub.”

About healthcare personnel

 $1 Billion Donation Will Provide Free Tuition at a Bronx Medical School “Dr. Ruth Gottesman, a longtime professor at the Albert Einstein College of Medicine, is making free tuition available to all students going forward.”  

About healthcare finance

 Private equity firm offers $5.8 billion buyout of hospital billing company R1 RCM “R1 RCM, a large publicly traded technology company that helps hospitals and physicians collect money from insurers and patients, may be going private.
Private equity firm New Mountain Capital has offered to purchase R1 for $13.75 per share, or roughly $5.8 billion in cash, according to new financial disclosures filed Monday. New Mountain Capital is R1’s second-largest investor, owning nearly one-third of the company’s shares.”

Today's News and Commentary

About Covid-19

 Covid death toll in US likely 16% higher than official tally, study says “The Covid death toll in the US is likely at least 16% higher than the official tally, according to a new study, and researchers believe the cause of the undercounting goes beyond overloaded health systems to a lack of awareness of Covid and low levels of testing.
The second year of the pandemic also had nearly as many uncounted excess deaths as the first, the study found.”

Study shows 43% to 58% lower prevalence of long COVID among vaccinated people “A new study based on 4,605 participants in the Michigan COVID-19 Recovery Surveillance Study shows that the prevalence of long COVID symptoms at 30 and 90 days post-infection was 43% to 58% lower among adults who were fully vaccinated before infection.”

About health insurance/insurers

Former CMS administrator: 'I would like to see Medicare Advantage slowed or stopped' The headline is more dramatic than the interview, which is a more nuanced and thoughtful conversation with Donald Berwick, MD, MPP.

False Claim Act settlements, judgements hit record high in 2023There were a record high 543 False Claims Act settlements and judgements in 2023, according to a Feb. 22 Justice Department news release…More than $1.8 billion of those judgements and settlements involved the healthcare industry. 
The $1.8 billion reflects recoveries arising only from federal losses, but the Justice Department was also instrumental in recovering additional funds for state Medicaid programs, according to the report.”
In a related story:Pharmacy owners, doctors, marketers charged in alleged Texas-wide kickback scheme

In-network insurance claims jumped after surprise billing ban took effectFAIR Health used its database of roughly 42 billion commercial insurance claims to examine in-network claims between 2019 and the third quarter of 2023, capturing the period before and after enactment of the No Surprises Act and surprise billing laws in multiple states.

  • During that period, the share of in-network care increased from about 84% of all claims to 90% of claims nationally.

  • There was a particularly steep increase of 2.3% between the fourth quarter of 2021 and the first quarter of 2022, when the federal protections took effect.”

What Do Medicare Beneficiaries Value About Their Coverage? From The Commonwealth Fund:
“Survey Highlights

  • Whether enrolled in Medicare Advantage or traditional Medicare, about two in three beneficiaries overall said their coverage has fully met their expectations. Those who said it fell short of expectations pointed to a lack of coverage for needed services, high costs, or uncertainty about what benefits are covered.

  • Larger shares of beneficiaries in MA plans than in traditional Medicare reported they experienced delays in getting care because of the need to obtain prior approval (22% vs. 13%) and couldn’t afford care because of copayments or deductibles (12% vs. 7%). By other metrics, access to needed health care was similar. For example, more than a third of beneficiaries in each type of Medicare coverage said they had to wait over a month to see a doctor.

  • Three in five beneficiaries in MA plans and one-quarter in traditional Medicare said they were asked to undergo a health assessment, which most frequently resulted in a discussion with their doctor. Few said it resulted in any changes to their care plan or in more services or benefits being offered.

  • Seven in 10 beneficiaries in MA said they used some of their plan’s supplemental benefits in the past year; three in 10 did not use any. Four in 10 reported using their dental or vision benefits or an allowance for over-the-counter medications.”

About hospitals and healthcare systems

 Community Health Systems discloses DOJ investigation “Community Health Systems (CHS) disclosed in a Securities and Exchange Commission filing that it is being investigated by the Department of Justice. 
The company received a Civil Investigative Demand on Jan. 11 ‘for documents and information relating to a variety of subjects, including practices and procedures related to utilization review, inpatient admissions and inpatient dialysis at our hospitals,’ according to its Form 10-K, released Wednesday.”

About pharma

 Pharmacies across America are having trouble processing some prescriptions because of a cyberattack “ Pharmacies across the United States are reporting that they are having difficulty getting prescriptions to patients because of a cyberattack on a unit of UnitedHealth.
The company said in a regulatory filing Thursday its Change Healthcare business, which processes prescriptions to insurance for tens of thousands of pharmacies nationwide, was compromised by hackers who gained access to some of its systems. The company became aware of the cyberattack Wednesday, and, in a separate statement, said it expected the attack to last at least throughout the day Thursday.
The cyberattack prevented some pharmacies from processing prescriptions to insurance companies to receive payment.”

Long-term CAR-T data bolsters autoimmune argument “After stealing the show at December’s American Society of Hematology (ASH) meeting with promising early data of lupus patients treated with CAR-T cell therapy, a team of German scientists has now published updated results in the NEJM that suggest the one-time treatment can lead to sustained remission for patients with several autoimmune diseases.
At 29 months of follow-up, all eight patients with systemic lupus erythematosus (SLE) had no signs of disease activity.”

About the public’s health

This article gets the poor wording award: Families of Infertile Men Face Higher Cancer Risks

Variability and patterns in children's media use and links with language development “The current study examines how and why young children are using media and its association with language development. It is clear that media use, especially video watching, is pervasive even by 17–30 months. Children at this age reportedly watch an average of nearly 2 hours of video each day, compared to an hour of reading. This is a 100% increase from prior estimates. Moreover, children with high video watching (but not other media) had lower vocabulary.”

Air pollution tied to signs of Alzheimer’s in brain tissue, study finds “For the study, published this week in the journal Neurology, researchers examined the association between concentrations of ambient air pollution and signs of Alzheimer’s disease in the human brain. They found that people who were exposed to higher concentrations of fine particulate matter air pollution, also known as PM2.5, at least a year before their death were more likely to have higher levels of plaques — abnormal clusters of protein fragments built up between nerve cells, which is a sign of Alzheimer’s in brain tissue. The research also found a strong association between the pollution and signs of the disease for people who were not already genetically predisposed to Alzheimer’s.”

 Deadly opioid detected in wastewater for the first time “University of Queensland researchers and international collaborators have found a deadly synthetic drug in wastewater in the United States – the first such detection globally. 
Dr Richard Bade from UQ’s Queensland Alliance for Environmental Health Sciences led a team which analysed wastewater samples from eight locations in seven US states: Arizona, Georgia, Illinois, New Jersey, New Mexico, Oregon and Washington. 
Dr Bade said wastewater from two of the sites, in Illinois and Washington, recorded a type of opioid called protonitazene.
‘Protonitazene is a novel synthetic opioid around three times more potent than fentanyl, and even very small amounts can produce life-threatening toxic effects,’ Dr Bade said.”

Florida surgeon general defies science amid measles outbreakAs a Florida elementary school tries to contain a growing measles outbreak, the state’s top health official is giving advice that runs counter to science and may leave unvaccinated children at risk of contracting one of the most contagious pathogens on Earth, clinicians and public health experts said.
Florida surgeon general Joseph A. Ladapo failed to urge parents to vaccinate their children or keep unvaccinated students home from school as a precaution in a letter to parents at the Fort Lauderdale-area school this week following six confirmed measles cases.
Instead of following what he acknowledged was the “normal” recommendation that parents keep unvaccinated children home for up to 21 days — the incubation period for measles — Ladapo said the state health department “is deferring to parents or guardians to make decisions about school attendance.” 

About healthcare IT

 AHIP, AMA and employer groups team up to accelerate digital health adoption “Fourteen organizations representing providers, payers, consumer technology companies and employers are teaming up to cut through the noise and raise higher standards for finding digital health solutions that work and are worth the investment.
The new Digital Health Collaborative, supported by the Peterson Health Technology Institute, brings together provider groups, purchasers and end users and initial work will focus on pulling together a national purchaser survey, grantmaking and convenings, the organization said.
The Peterson Health Technology Institute formed in July 2023, armed with $50 million in funding, to evaluate digital health technologies and help cut through the hype to identify innovations that actually benefit patients. PHTI focused on providing independent, evidence-based assessments of emerging products, something that is currently lacking in the market.”

About health technology

Study shows a frontline Alzheimer’s blood test could be as accurate as spinal fluid exams “The researchers—some of whom previously worked with the Washington University’s spinout C2N Diagnostics…and developer of the PrecivityAD blood tests for Alzheimer’s—say this new assay is capable of performing on par with PET scans and analyses of cerebrospinal fluid by picking out the tau and amyloid beta proteins in plasma that are associated with the neurodegenerative disease.”

Today's News and Commentary

About Covid-19

 Long COVID linked to persistently high levels of inflammatory protein: a potential biomarker and target for treatments  “SARS-CoV-2 triggers the production of the antiviral protein IFN-γ, which is associated with fatigue, muscle ache and depression. New research shows that in Long COVID patients, IFN-y production persists until symptoms improve, highlighting a potential biomarker and a target for therapies.” 

About health insurance/insurers

 Medicare Advantage’s 33 million club “Roughly 33.4 million people were enrolled in a Medicare Advantage plan at the start of 2024, according to new federal data that we analyzed last week. It’s an increase of 7.1% from the same time last year, although it appears the true annual growth rate is closer to 6% after factoring in some errors within Medicare’s 2023 data…”

About hospitals and healthcare systems

 States ranked by hospital beds per 1,000 population FYI. Not a surprise that more rural states need more hospitals to provide adequate access.

About pharma

 Walgreens' VillageMD to close all Florida primary care clinics “Clinics in the Tampa and Orlando areas will close March 15 as the company exits the Florida market, a company spokesperson confirmed Feb. 21. VillageMD's website lists about 40 clinic locations in Florida, all co-located with Walgreens stores….
 The closures are part of a $1 billion cost-cutting initiative Walgreens implemented late last year that involves closing 60 VillageMD-operated clinics in five markets. As of the company's January earnings call, it had closed nearly half of those, CEO Tim Wentworth told analysts. It shuttered 10 clinics in Jacksonville, Fla., and all 12 of its clinics in Indiana last month.”

FDA approves a drug to treat severe food allergies, including milk, eggs and nuts “Xolair was greenlit by the Food and Drug Administration on Friday to help reduce severe allergic reactions brought on by accidental exposure to certain foods. It is considered the first medication approved by the FDA that can help protect people against multiple food allergies.
The medication is not intended for use during an allergic reaction. Instead, it is designed to be taken repeatedly every few weeks to help reduce the risk of reactions over time. The FDA said people taking the drug should continue to avoid foods they are allergic to…
The cost of the medication ranges from $2,900 a month for children and $5,000 a month for adults, though the cost could be brought down with insurance…”

About the public’s health

Boosting Health for Children: Transition to Electric Vehicles and Clean Power Would Prevent 2.7 Million Asthma Attacks in U.S. Kids From the American Lung Association:
“The new report is based on projected health impacts if all new passenger vehicles sold are zero-emission by 2035 and all new trucks sold are zero-emission by 2040. It also projects that the nation’s electric grid will be powered by clean, non-combustion renewable energy by 2035. According to the report, the transition to zero-emission transportation powered by clean non-combustion energy from 2020 to 2050 would prevent up to:

  • 2.79 million pediatric asthma attacks

  • 147,000 pediatric acute bronchitis cases 

  • 2.67 million pediatric upper respiratory symptoms

  • 1.87 million pediatric lower respiratory symptoms 

  • 508 infant mortality cases”

Historical Redlining, Persistent Mortgage Discrimination, and Race in Breast Cancer Outcomes “In a cohort study of 1764 women with breast cancer, living in a historically redlined area was associated with increased odds of a diagnosis of estrogen receptor–negative breast cancer in non-Hispanic Black women and increased odds of late-stage diagnosis in non-Hispanic White women. Persistent mortgage discrimination was associated with an increase in breast cancer mortality in non-Hispanic White women, and non-Hispanic Black women were more likely to die of breast cancer no matter where they lived.”

About healthcare personnel

Almost All U.S. Physicians Surveyed Feel Burned Out on a Regular Basis, with Many Having Considered Career Change, according to Recent athenahealth Physician Sentiment Survey “Excessive administrative workloads, reduced staffing, concerns over financial viability, and rising patient expectations around communications are all contributing to major challenges for America’s healthcare industry, athenahealth’s third Physician Sentiment Survey (PSS), conducted by The Harris Poll, has revealed. The survey polled 1,003 primary care and specialist physicians nationwide, with just five percent of respondents identifying as athenahealth customers.
Most physicians (93%) surveyed for the PSS said that they feel burned out on a regular basis, with doctors reporting that they spend an average of 15 hours per week working in ‘pajama time,’ outside their normal work hours. When asked about their current employment situation, a majority (56%) said they have considered leaving the field or remaining in the field but no longer seeing patients.”
 

About health technology

Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication “The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin. These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs). The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.”

About healthcare finance

 AbbVie eyes selling at least $13 billion of bonds to fund M&A “Pharmaceutical giant AbbVie Inc. is looking to sell at least $13 billion of corporate bonds to help fund its acquisitions of ImmunoGen Inc. and Cerevel Therapeutics Holdings Inc., according to people with knowledge of the matter.
The sale is expected to be announced as soon as Thursday, following fixed-income investor calls on Wednesday, said the people, who asked not to be identified because the discussions are private. The size of the offering is subject to change, and will be determined on the day of the sale. A spokesperson for AbbVie didn’t immediately respond to requests for comment.”

Today's News and Commentary

About Covid-19

 Tax records reveal the lucrative world of covid misinformation “Four major nonprofits that rose to prominence during the coronavirus pandemic by capitalizing on the spread of medical misinformation collectively gained more than $118 million between 2020 and 2022, enabling the organizations to deepen their influence in statehouses, courtrooms and communities across the country, a Washington Post analysis of tax records shows.”

About health insurance/insurers

 Who is winning surprise billing disputes? Providers, facilities and air ambulance companies prevailed in 77% of No Surprises Act payment determinations in the first half of 2023. 
Certified independent dispute resolution entities made payment determinations in 83,868 disputes during the first six months of 2023, according to a Feb. 15 report from CMS. 
Health plans and issuers were the prevailing party in 23% of payment determinations over that span, according to the report. 
The prevailing offer was higher than the qualifying payment amount in 82% of cases. Both parties submitted an offer and paid fees in 79% of cases, while only one party submitted an offer and paid fees in 21% of disputes.   |
A smaller percentage of disputes were determined to be ineligible in the first half of 2023 (22%) compared to 2022 (46%), the report said. CMS attributed this to process improvement and disputing parties' greater familiarity with eligibility requirements.”

KFF Health Tracking Poll February 2024: Voters on Two Key Health Care Issues: Affordability and ACA Worth reading the entire article, but below are some excerpts:
“Inflation and health care affordability continue to be the top issues voters want the 2024 presidential candidates to talk about on the campaign trail, and while national news has recently emphasized an improving national economy alongside expanded consumer spending, most voters (67%) rate the national economy as ‘not so good’ or ‘poor.’…
—Unexpected medical bills and health care costs top the list of expenses that adults, regardless of partisanship, say they worry about affording, with three in four adults saying they are ‘very’ or ‘somewhat worried’ about being able to afford unexpected medical bills (74%) or the cost of health care services (73%) for themselves and their family. Just over half (55%) report worrying about being able to afford prescription drug costs, and about half of insured adults (48%) say they are worried about being able to afford their monthly health insurance premium…
—Voters are divided along party lines over which candidate they think has the better approach to the future of the Affordable Care Act, with partisans overwhelmingly choosing their party’s candidate. Nine in ten Democratic voters (90%) say Biden has the better approach and nine in ten Republican voters (91%) say Trump does. Although the vast majority of Republicans say Trump has a better approach to the ACA, few (30%) Republican voters think Trump has a health care plan to replace it…”

About hospitals and healthcare systems

 Rule cuts Medicaid DSH pay for some safety-net hospitals “…some safety-net hospitals will receive lower Medicaid disproportionate share hospital [DSH] payments under a final rule…” The rule '“sets new restrictions on how Medicaid DSH payments are calculated and distributed, carrying out a congressional directive from the Consolidated Appropriations Act of 2021. ”Previously, “hospitals determined their Medicaid shortfalls – the gaps between reimbursements and costs – by estimating annual treatment costs for patients with Medicaid alone and those with other additional forms of coverage, such as Medicare or private health insurance.” Under the new rule, “hospitals will only be able to account for patients with Medicaid as their primary payer.” 

About the public’s health

Outcomes of Breast Cancer Screening Strategies Based on Cancer Intervention and Surveillance Modeling Network Estimates [CISNET] “Estimates from CISNET 2023 showed that annual screening ages 40–79 years improved breast cancer mortality reduction compared with biennial screening ages 50–74 years and biennial screening ages 40–74 years (41.7%, 25.4%, and 30%, respectively). Annual screening ages 40–79 years averted the most breast cancer deaths (11.5 per 1000) and gained the most life-years (230 per 1000) compared with other screening scenarios (range, 6.7–11.5 per 1000 and 121–230 per 1000, respectively). False-positive screening results per examination were less than 10% for all screening scenarios (range, 6.5%–9.6%) and lowest for annual screening ages 40–79 years (6.5%). Benign biopsies per examination were less than 1.33% for all screening scenarios (range, 0.88%–1.32%) and lowest for annual screening ages 40–79 years (0.88%).
Conclusion CISNET 2023 modeling estimates indicate that annual breast cancer screening starting at 40 years of age provides the greatest benefit to women and the least risk per examination.”

Ambitious survey of human diversity yields millions of undiscovered genetic variants “Analyses of up to 245,000 genomes gathered by the All of Us programme, run by the US National Institutes of Health in Bethesda, Maryland, have uncovered more than 275 million new genetic markers, nearly 150 of which might contribute to type 2 diabetes. The work has also identified gaps in genetics research on non-white populations. The findings were published on 19 February in a package of papers in Nature1,2, Communications Biology3 and Nature Medicine4.”

CARDIOVASCULAR CONDITIONS IN 2024 A really good monograph on cardiovascular epidemiology.

About healthcare IT

 Teladoc forecasts slower growth in saturated telehealth market, focuses on boosting bottom line “Teladoc offered a weaker-than-expected forecast for 2024, projecting slower revenue growth as the telehealth market has become crowded with digital health players.
The virtual care giant pulled in $661 million in revenue in the fourth quarter of 2024, up 4% from $638 million in the same period a year ago. Access fees revenue grew 4% to $574 million, and other revenue grew 3% to $87 million. U.S. revenue grew 2% to $565 million, and international revenue grew 15% to $96 million.”

Lawmakers introduce patient-matching bill for EHRs “U.S. lawmakers introduced bipartisan legislation Feb. 16 to better match patients with their EHRs…
The legislation aims to improve the standardization of patients' demographics inputted into certified health IT products and form an anonymous, voluntary system to analyze patient match rates. The College of Healthcare Information Management Executives, HIMSS, and the American Health Information Management Association all expressed their support for the bill.”
Comment: The easiest way to accomplish this goal is assigning unique patient identifiers they can use across systems. However, our fear of security has prevented doing so. Recall all entities in the healthcare system have unique identifiers—except patients.

About health technology

 Elon Musk says Neuralink patient can control computer mouse with mind “‘"[The] patient seems to have made a full recovery with no ill effects that we are aware of and is able to control the mouse, move the mouse around the screen just by thinking,’ Mr. Musk said during a live audio Spaces session on social media platform X.”

About healthcare finance

 Amazon to replace Walgreens in Dow Jones Industrial Average “The index change, which was announced after the market close on Tuesday, was prompted by Walmart Inc.’s decision to split its stock 3-to-1, the index provider said in the release. The latter move will reduce Walmart’s index weight due to the price weighted construction of the Dow. Walmart will remain in the index. The change will go into effect prior to the open of trading on Monday, Feb. 26.”

Today's News and Commentary

About Covid-19

Covid Vaccines Linked To Small Increase In Heart And Brain Disorders, Study Finds—But Risk From Infection Is Far Higher “Covid vaccines from companies like Pfizer, Moderna and AstraZeneca were linked to rare occurrences of heart, brain and blood disorders, a recent peer-reviewed study found, though experts say the risks of developing Covid-19 greatly outweigh the risks of getting vaccinated.”

About health insurance/insurers

 Point32Health Signs Definitive Agreement With Baystate Health to Acquire Health New England “The acquisition is expected to improve product offerings and expand access to a broader network with wider geographic reach.  Among both organizations’ shared priorities is expanding high-quality programs and services, particularly those that cover underserved populations and seniors, as well as maximizing the benefits that not-for-profit health plans provide to communities.”

No Surprises Act dispute volume 13 times higher than estimated “There were 288,810 No Surprises Act disputes initiated during the first six months of 2023, which was 13 times greater than federal agencies initially anticipated, according to a Feb. 15 report from CMS.”

New CMS rules will throttle access researchers need to Medicare, Medicaid data Another explanation of why these new data charges will hurt research.

About hospitals and healthcare systems

 From STAT, an update on some health systems’ performances:
Allina Health
: The $5 billion system is struggling a lot more than most, posting a -6.8% operating margin in 2023. Allina laid off employees and outsourced its billing operations to Optum.

Ballad Health: The last quarter of 2023 was good for Ballad, but the system said it has been having problems with Medicare Advantage plans using proprietary criteria to push patients to lower-paying codes or outpatient observation status, “even if the admission was prior-authorized by the payer.”

Baylor Scott & White Health: Everything’s bigger in Texas, including the hospital profits.

CommonSpirit Health: Patient volumes are up so much across the country that even CommonSpirit is in the black. The hospital giant also disclosed it received $234 million last year from the extra 340B drug payments.

Johns Hopkins Health System: A 12% net margin was fueled by massive investment gains. If patient care doesn’t work out, Johns Hopkins has a future as a hedge fund.

Mass General Brigham: Holy investment income, Batman. It also banked an extra $98 million from 340B drug underpayments.

RWJBarnabas Health: Nurses went on strike for roughly four months at one of the New Jersey system’s main hospitals, and it cost RWJBarnabas $184 million, pushing it into the red. However, if the hospital would have paid its own nurses and avoided a strike, instead of having to hire expensive temporary nurses, it would have turned a profit.

Sanford Health: It turns out that not all rural hospitals are dying! Sanford is one of the largest rural health systems in the country, and yet it was profitable across the board in 2023, surpassing several years of pre-pandemic operations.”

About pharma

 Obamacare plans don’t have to cover weight loss drugs. The government is considering changing that “Drugmakers are doing everything to tap the bottomless well of demand for new obesity drugs, and they might get some government help. The agency that regulates Obamacare insurance is considering a technical change that would require insurers to cover obesity drugs in a market of more than 20 million Americans.  There is a lot of demand for the drugs, but there are barriers to coverage. Medicare by law is prohibited from paying for obesity drugs. State Medicaid programs don’t have to cover them, so most don’t.”

About health technology

Alabama Supreme Court rules frozen embryos are children, imperiling IVF “The Alabama Supreme Court ruled Friday that frozen embryos are people and someone can be held liable for destroying them, a decision that reproductive rights advocates say could imperil in vitro fertilization(IVF) and affect the hundreds of thousands of patients who depend on treatments like it each year.”

Today's News and Commentary

About health insurance/insurers

 Cigna to buy back $3.2B in stock “The Cigna Group is buying back $3.2 billion in common stock through accelerated repurchase agreements with Deutsche Bank and Bank of America, the company announced Feb. 15. 
Cigna is expecting an initial delivery of 7.6 million shares, with a final settlement expected in the second quarter of 2024.”

The burden of medical debt in the United States “This analysis shows that 20 million people (nearly 1 in 12 adults) owe medical debt. The SIPP [2021 Survey of Income and Program Participation] survey suggests people in the United States owe at least $220 billion in medical debt. Approximately 14 million people (6% of adults) in the U.S. owe over $1,000 in medical debt and about 3 million people (1% of adults) owe medical debt of more than $10,000. While medical debt occurs across demographic groups, people with disabilities or in worse health, lower-income people, and uninsured people are more likely to have medical debt.”

Postacute Care for Medicare Advantage Enrollees Who Switched to Traditional Medicare Compared With Those Who Remained in Medicare Advantage “Findings  This cohort study using Medicare data including 4613 hospitalizations of retired Ohio state employees found that after a mandatory MA plan was discontinued, enrollees who switched to traditional Medicare received more intensive postacute care. No changes in 30-day hospital readmissions or mortality were observed.
Meaning  This finding suggests that MA plans provided less intensive postacute care than traditional Medicare, with no significant difference in measured short-term outcomes; measures of postacute functional status over a longer follow-up period are needed.”

Medicare Advantage enrollment races past 33 million “Roughly 33.4 million adults older than 65 and people with disabilities were enrolled in a Medicare Advantage plan as the calendar flipped to 2024 — another year of steady, albeit slower, growth for the taxpayer-funded program.
Enrollment increased 7.1% year over year, which would make this year’s annual growth rate identical to last year’s, according to new federal Medicare Advantage enrollment data analyzed by STAT.”

About hospitals and healthcare systems

 $1.48B Kaiser Sacramento hospital could break ground in 2024 “Oakland, Calif.-based Kaiser Permanente might be breaking ground on a hospital in the Sacramento rail yards this year, the Sacramento Business Journal reported Feb. 15.
The project, which will replace the current 287-bed Arden-Arcade, Calif.-based Kaiser Permanente Sacramento Medical Center, is expected to cost $1.48 billion, according to a free estimate request the city received in December, the publication reported.” 

CommonSpirit Health's finances trend upward thanks to higher volumes, efficiency pushCommonSpirit Health reported Thursday a $356 million operating gain (3.5% operating margin) for the three months ended Dec. 31—its first quarter on the right side of zero since tthe summer of 2022—thanks to substantially higher volumes, shorter stays and other efficiency programs launched by the Catholic giant.”
Comment: The above two articles highlight the turnaround in hospital finances.

Today's News and Commentary

About health insurance/insurers

 Payers ranked by Medicare Advantage membership | Q4 2023 FYI

About hospitals and healthcare systems

Unrelenting Pressure Pushes Rural Safety Net Crisis into Uncharted Territory “MAJOR FINDINGS OF THIS STUDY ARE:
—The percentage of America’s rural hospitals operating in the red jumped from 43% to 50% in the last 12 months.
— 55% of independent rural hospitals are operating in the red, while 42% of health system-affiliated rural hospitals are operating at a loss. Nearly 60% of rural hospitals are now affiliated with a health system.
—Medicare Advantage now accounts for 35% of all Medicare-eligible patients in rural communities. In 7 states, Medicare Advantage penetration exceeds 50%.
—Access to inpatient care continues to deteriorate as 167 rural hospitals since 2010 have either closed or converted to a model that excludes inpatient care.
— 418 rural hospitals are “vulnerable to closure” according to a new, expanded statistical analysis.
—Between 2011 and 2021, 267 rural hospitals dropped OB services. This represents nearly 25% of America’s rural OB units.
—Between 2014 and 2022, 382 rural hospitals have stopped providing chemotherapy services.”

 Mark Cuban drug company unveils new offering for hospitals  “Mark Cuban Cost Plus Drug Co. now offers critical drugs in shortage to healthcare providers. 
Healthcare companies can register for the drug company's new ‘marketplace,’ which stocks key medications in short supply, according to a Feb. 14 post on X. The portfolio includes amoxicillin-potassium clavulanate, cefdinir, etoposide, capecitabine, irbesartan and budesonide inhalation. 
Mr. Cuban has previously indicated a focus on injectables that often fall into shortage. The company is still building its $11 million drug manufacturing plant in Dallas, which is expected to also ease shortages.”

About pharma

 Pfizer quells 12 years of Lipitor antitrust litigation with $93M settlement “With a $93 million settlement, Pfizer can wash its hands of more than a decade's worth of antitrust litigation over the once-lucrative cholesterol med Lipitor.
For years, Pfizer and Sun Pharma’s Ranbaxy Laboratories have been engaged in litigation from drug purchasers accusing the companies of conspiring to delay Lipitor generics through an unlawful ‘reverse payment’ agreement.
The plaintiffs first filed suit in 2011 and have since gone through ‘extensive mediation’ with the companies, the purchasers’ attorneys noted in the 64-page settlement proposal.”

Biden administration examining role of supply chain middlemen in generic drug shortages “KEY POINTS

  • The Federal Trade Commission said it is examining the role drug wholesalers and companies that purchase medicines for U.S. health-care providers play in shortages of generic drugs.

  • The move follows an unprecedented shortfall of crucial medicine over the last year, which has forced hospitals to ration drugs ranging from injectable cancer therapies to pain treatments.

  • In a joint request for information, the FTC and the Department of Health and Human Services are seeking public comment on the contracting practices, market concentration, and compensation of two types of middlemen: group purchasing organizations and drug wholesalers.”

Effectiveness and safety of telehealth medication abortion in the USA “Overall, 99.8% (99.6–99.9%) of abortions were not followed by serious adverse events. In total, 0.25% of patients experienced a serious abortion-related adverse event, 0.16% were treated for an ectopic pregnancy and 1.3% abortions were followed by emergency department visits. There were no differences in effectiveness or safety between synchronous and asynchronous models of care. Telehealth medication abortion is effective, safe and comparable to published rates of in-person medication abortion care.” [Emphasis added]

About healthcare personnel

 Healthcare layoffs in 14 numbers For example:
”Healthcare/products companies and manufacturers, including hospitals, announced 4,182 job cuts in January, according to the most recent report from Challenger, Gray & Christmas. That's a 421% increase from the previous month.
But overall, 2024 appears to be off to a better start than 2023: the healthcare industry announced 2,551 fewer job cuts in January 2024 than in January 2023.”

About healthcare finance

KKR to acquire a stake in health tech firm Cotiviti Private equity firm KKR & Co has agreed to acquire a stake in Cotiviti from investment manager Veritas Capital, the healthcare technology firm said on Wednesday.
KKR and Veritas will have equal ownership stakes in Cotiviti following the deal's closure, expected in the second quarter of 2024. Reuters reported earlier on Wednesday that KKR was a leading contender to buy a 50% stake in Cotiviti and a deal would value the company between $10 billion and $11 billion.”

Today's News and Commentary

About health insurance/insurers

Cigna partners with meal-kit company HelloFresh to provide employer discountsBloomfield-based Cigna Healthcare has partnered with a German meal-kit company, HelloFresh, to offer discounted access to healthy pre-portioned meals for Cigna customers.
Employers that are Cigna customers can select a variety of HelloFresh offerings, which they can make available to their employees. The options include e-gift cards, discounted meal-kit subscription and one-time box deliveries to employees’ homes.”

SCAN, CareOregon call off merger FYI

Medicaid Enrollment and Unwinding Tracker Monthly update from KFF: “At least 16,938,000 Medicaid enrollees have been disenrolled as of February 13, 2024, based on the most current data from all 50 states and the District of Columbia. Overall, 32% of people with a completed renewal were disenrolled in reporting states while 68%, or 34.3 million enrollees, had their coverage renewed (one reporting state does not include data on renewed enrollees). Due to varying lags for when states report data, the data reported here undercount the actual number of disenrollments to date.”

About pharma

 Biogen, grappling with declining sales, slapped with DOJ subpoena over foreign operations “Biogen has received a subpoena from the DOJ seeking information about its “business operations in several foreign countries,” the company disclosed in an annual filing. In addition, the company is providing information about its foreign businesses to the U.S. Securities and Exchange Commission (SEC), Biogen said.
It’s not clear which countries the DOJ and the SEC have set their sights on. Biogen is present in about 40 countries, including in Europe, China and Japan. A company spokesperson said Biogen doesn’t comment on government investigations.”

A year in, the U.S. is still not taking advantage of lower-cost biosimilars for HumiraIt’s been one year since the launch of the first adalimumab biosimilar for Humira in the United States, which was followed by eight additional adalimumab biosimilar launches. These nine FDA-approved products offer lower-cost alternatives to the world’s bestselling drug, Humira, used to treat rheumatoid arthritis, Crohn’s disease, and other autoimmune disorders. This made 2023 a watershed year for millions of U.S. patients paying too much for their necessary medications.
But so far, that vision hasn’t come to fruition, because policymakers haven’t taken the action necessary to be sure these lower-cost products are accessible for patients. If they fail to act, the U.S. health care system could lose up to $133 billion in savings and leave patients without access to the medicines they need.”

About the public’s health

 Smoking impairs immune response, even after quitting, new study says “The study, published Wednesday in Nature, underscores the importance of never lighting up that first cigarette, based on its conclusion that smoking has much longer harmful effects on immune responses than previously understood.
People who quit smoking soon regained normal function of their immune system’s power to mount fast and general innate responses to bacteria or viruses. But researchers also found that slower, more targeted adaptive T cell defenses remembered from past pathogens did not come back so soon after that last cigarette.”

About healthcare IT

 Email extortion data breach affects 2.4 million patients; FBI seeks victims “Nearly 2.4 million patients of Oklahoma City-based Integris Health were caught up in a data breach where the alleged hackers ssent extortion emails directly to some of them.The health system reported Feb. 6 that it determined an "unauthorized party" had accessed or stolen patient data Nov. 28. Integris also said it learned Dec. 24 that a group claiming responsibility for the hack was reaching out to patients.”

EY Health Pulse Survey: Digital Health Solutions Boost Efficiencies and Automation, but ROI has Yet to ComeAs COVID-19 hits its four-year anniversary, health care has seen the potential to transform through digital health solutions, including the potential to reduce nursing shortages, expedite patient care, minimize in-person costs and create more productive collaboration with insurance companies.
While a majority of executives in the health care sector (71%) say the implementation of new technologies has not decreased overall hospital expenses, nearly all executives within the sector (96%) believe that the initial financial investment of new technology is worth the cost.”

About healthcare personnel

 Patient Clinical Needs, Provider Skill Set Misalign 57% of the Time “For nearly three in five patients, the clinician they meet with is a bad fit for their current medical needs, according to new Zocdoc data, presenting a patient access issue across the industry that the online booking and provider search company is looking to fix…
 Providers are feeling it, too, with 24 percent saying in a separate provider survey that they often see new patients who are not the right match for their medical expertise.”
Comment: “It is our duty to remember at all times and anew that medicine is not only a science, but also the art of letting our own individuality interact with the individuality of the patient.”- Albert Schweitzer

Today's News and Commentary

Researchers incensed over CMS data access change [Scroll down about a quarter down the page] CMS is starting to charge hefty amounts for access to CMS data. This move can have a profound chilling effect on research initiatives.

About Covid-19

 CDC plans to drop five-day covid isolation guidelines “The CDC plans to recommend that people who test positive for the coronavirus use clinical symptoms to determine when to end isolation. Under the new approach, people would no longer need to stay home if they have been fever-free for at least 24 hours without the aid of medication and their symptoms are mild and improving, according to three agency officials who spoke on the condition of anonymity to share internal discussions.” 

About health insurance/insurers

 FTC wins $195M judgment against Simple Health over its 'sham' insurance “The health plans did not actually give customers the coverage or benefits they were promised, the FTC said in an announcement, and ‘effectively left consumers uninsured.’ This left them on the hook for medical expenses, the agency said.
The FTC initially filed a complaint against Simple Health in 2018, charging that the insurer was misleading potential enrollees with its marketing, which promoted comprehensive health coverage including prescriptions, primary care, specialty care, inpatient services, emergency care, surgery, lab testing and treatment for preexisting conditions.
Members instead enrolled in "what was actually a medical discount program or extremely limited benefit program," the FTC said, paying as much as $500 per month for insurance that left them with thousands of dollars worth of medical bills or that made it impossible to secure needed care.”

About hospitals and healthcare systems

 HCA profits dip 7%, Tenet's up 30% FYI

About pharma

 Federal Judge Tosses PhRMA’s Suit on Medicare Drug Price Plan “The Biden administration secured a major win Monday in its fight to uphold Medicare’s drug price negotiation program by persuading a federal judge to toss a lawsuit from the top group representing the brand-name prescription drug industry.
The US District Court for the Western District of Texas ruled it lacks jurisdiction over the National Infusion Center Association’s legal challenge to the negotiation program.
Given that the association was the only party residing in the district, the rest of the lawsuit—which includes the Pharmaceutical Research and Manufacturers of America, and the National Infusion Center Association and Global Colon Cancer Association—was likewise dismissed, Judge David Alan Ezra wrote in his ruling.”

About the public’s health

Atrocious Air “The results show that there are approximately 14.3 million properties (~10% of all properties) in the US that are estimated to have a week or more (7+ days) of unhealthy air quality days solely from PM2.5 in the current climate conditions. Of those, almost 5.7 million properties (~4%) may experience two or more weeks (14+ days) annually of smoke driven unhealthy air quality days. Some of the most at risk areas include large population centers such as Seattle, San Francisco, and Sacramento. It is important to understand the nature of this hazard, its link to climate, and the growing impact it will have on areas across the US into the future, including the growing negative effects on human health, labor force productivity, and even migration patterns.”

About healthcare IT

 CMS clarifies rules for HIPAA compliance when texting patient data “Texting of patient orders among members by healthcare teams is now permissible at hospitals and critical access hospitals when done through a HIPAA-compliant secure platform in compliance with CMS Conditions of Participation rules, the agency says.” 

'Best in KLAS' software and services vendors for healthcare FYI
Note: No single company dominates each category or all categories.

About healthcare personnel

 Medical Specialties Losing the Most Providers  Primary care specialties top the list of physicians.

About healthcare finance

 Fewer private equity dollars flowing to Medicare Advantage “Facing rising interest rates and regulatory scrutiny, private equity investments in the Medicare Advantage space are slowing down, according to the Private Equity Stakeholder Project. 
The watchdog group published a report Feb. 13 breaking down private equity investments in Medicare Advantage companies. Investments in the space reached a peak in 2021 before slowing down in 2022 and 2023, according to the report. The increase was possibly spurred by ‘industry-friendly’ rollbacks on marketing regulations.”

Today's News and Commentary

About Covid-19

Contralateral second dose improves antibody responses to a two-dose mRNA vaccination regimenIn previously unexposed adults receiving an initial vaccine series with the BNT162b2 mRNA COVID-19 vaccine, contralateral boosting substantially increases antibody magnitude and breadth at times beyond 3 weeks after vaccination. This effect should be considered during arm selection in the context of multi-dose vaccine regimens.” 

About health insurance/insurers

 Big payers ranked by 2023 profit FYI
and in a related article: Payers ranked by medical loss ratios in 2023

Vermont ACO model ties payer, provider payment to care quality An interesting summary of Vermont’s single payer experiment.

U.S. investigates alleged Medicare fraud scheme estimated at $2 billionThe alleged scheme was uncovered by the National Association of ACOs — known as NAACOS — a health-care nonprofit that represents hundreds of medical groups and hospitals across the nation. The nonprofit’s members concluded that seven companies allegedly operating out of Connecticut, Florida, Kentucky, New York and Texas were behind a surge of bills submitted to Medicare across the last two years for intermittent urinary catheters… While the companies used real patients’ information to submit the bills, NAACOS and its members found no evidence that any of their patients wanted the catheters or even received them.
All seven companies had become accredited with Medicare, allowing them to bill the health insurance program, although in some cases the accreditation was linked to a person who said they no longer worked at the company and had sold it last year.”
Comment: What is also incredible about this story is that over two years the companies committing the fraud went from billing just 14 patients for catheters to nearly 406,000. Who is supposed to monitor such use?

About hospitals and healthcare systems

Accrediting Organization Proposed Rule Fact SheetIn recent years, CMS has identified several concerns related to AO performance: 

  • Providers and suppliers that have been terminated from the Medicare/Medicaid program but retain accreditation despite significant quality and safety concerns;

  • AOs provide fee-based consulting services to the providers and suppliers they accredit, potentially affecting the integrity of the onsite survey process and decreasing public trust by creating conflicts of interest;

  • Inconsistent survey results due to differing AO standards or practices (such as AOs notifying facilities of the date of their onsite surveys in advance contrary to CMS policies).”

In order to address these concerns, CMS issued proposed rules detailed in the document.

 Kaiser posts $4.1B net income in 2023 “Oakland, Calif.-based Kaiser Permanente reported $329 million in operating income (0.3% margin) in 2023, a significant improvement on the $1.3 billion operating loss (-1.3% margin) it reported in 2022. 
Operating revenue for Kaiser's health plan, hospitals and their respective subsidiaries hit $100.8 billion in 2023, up from $95.4 billion the previous year. Expenses were $100.5 billion, up from $96.7 billion.  
After factoring in nonoperating items, which primarily consists of investment returns, Kaiser's net income for 2023 was $4.1 billion, compared to a $4.5 billion net loss in the prior year.”
 

About pharma

Novo bets big on Catalent deal, Lilly hits $700 billion benchmark, our Leqembi survey says?...and more Last week’s big pharma stories. Some news media are calling for Lilly to replace Tesla in The Magnificent Seven list since its market cap is now greater than the auto manufacturer.

Gilead inks $4.3-billion deal to buy CymaBay “Gilead Sciences agreed to pay $32.50 per share in cash, or around $4.3 billion, to acquire CymaBay Therapeutics, gaining the latter’s primary biliary cholangitis (PBC) drug candidate seladelpar. The oral PPARδ agonist is currently under review by the FDA with a decision expected by August 14.”

The Oncology Market: 2023 Year in Review A good review of coming (and intending) trends. Worth sat least skimming the headings.

Moderna's stock slumps after RSV shot efficacy wanes faster than GSK's ArexvyThe efficacy of Moderna’s investigational respiratory syncytial virus (RSV) vaccine appears to wane faster than GSK’s approved shot Arexvy, a revelation that sent the Big Biotech’s stock slipping.
Phase 3 data shared Thursday showed overall efficacy of 63.3% after 8.6 months in preventing RSV-associated respiratory tract disease with two or more symptoms, dropping from 84% at 3.3 months.”

About the public’s health

 US respiratory virus activity remains high, with flu B rising in 2 regions “The nation's respiratory virus activity last week remained elevated, and flu levels rose in some regions of the country, partly due to a slight rise in influenza B activity, which is sometimes seen in the latter half of the flu season.
In its respiratory virus snapshot today, the Centers for Disease Control and Prevention (CDC) said COVID-19 indicators declined last week, with respiratory syncytial virus (RSV) levels continuing to decline in many areas.”

About healthcare IT

 HHS rule goes into effect after pushback from Epic, Amazon “Health IT companies that supply artificial intelligence to health systems must meet new federal transparency requirements starting Feb. 8.
ONC's HTI-1 final rule went into effect, requiring that certified health IT developers provide clinical users a "consistent, baseline set of information" about their decision-making algorithms and their ‘fairness, appropriateness, validity, effectiveness, and safety.’ ONC-certified developers support care at over 96% of hospitals and 78% of office-based physicians, according to the HHS division.”

About healthcare personnel

 Primary care merger creates 680+ combined clinics “Denver-based Everside Health and Indianapolis-based Marathon Health, both primary care providers, have merged, combining more than 680 health centers across 41 states to serve 2.5 million eligible patients.”

About health technology

Health Resources Priorities and Allocations System (HRPAS) From HHS: “The Department of Health and Human Services (HHS) is issuing a final rule establishing standards and procedures by which it may require acceptance and priority performance of certain contracts or orders to promote the national defense over other contracts or orders with respect to health resources. This final rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense.”

Investigating the accuracy of blood oxygen saturation measurements in common consumer smartwatches “Using a clinical-grade pulse oximeter as the reference standard, there were statistically significant differences in accuracy between devices, with Apple Watch Series 7 having measurements closest to the reference standard… and the Garmin Venu 2s having measurements farthest from the reference standard…There were also significant differences in measurability across devices, with the highest data presence from the Apple Watch Series 7 (88.9% of attempted measurements were successful) and the highest data missingness from the Withings ScanWatch (only 69.5% of attempted measurements were successful).”
Unlike clinical oximeters, skin tone did not appear to play much of a role in these measurements.

About healthcare finance

INDUSTRY RESEARCH Healthcare Services A really good summary of PE investments for Q4 of 2023. Look, especially, at the graphic on page 8 for a summary of the relative sizes of investments sectors.

Report 10 of the largest US healthcare companies by revenue | 2024 FYI

Biotech bankruptcies hit 10-year peak in 2023 “2023 eclipsed all other years by far, with 18 companies filing for protection compared to eight in 2022, which had previously held the record as the highest bankruptcy year.”

Today's News and Commentary

About health insurance/insurers

 Cigna posts $1B profit in Q4 “The Cigna Group is projecting $235 billion in revenue by the end of 2024 and recorded double-digit growth in the fourth quarter across its core lines of business at Evernorth Health Services and Cigna Healthcare, according to the company's year-end earnings report published Feb. 2.
Total revenues in the fourth quarter were $51.1 billion, up 12% year over year. Total revenues in 2023 were $195.3 billion, up 8%.
In the fourth quarter, net income was more than $1 billion, down 14% from nearly $1.2 billion year over year. Year-end net income was nearly $5.2 billion, down 23% year over year.”

Medicaid Enrollment and Unwinding Tracker “At least 16,430,000 Medicaid enrollees have been disenrolled as of February 1, 2024, based on the most current data from all 50 states and the District of Columbia. Overall, 33% of people with a completed renewal were disenrolled in reporting states while 67%, or 32.5 million enrollees, had their coverage renewed (one reporting state does not include data on renewed enrollees). Due to varying lags for when states report data, the data reported here undercount the actual number of disenrollments to date.”

About hospitals and healthcare systems

 Novant completes $2.4B acquisition of Tenet hospitals “Winston-Salem, N.C.-based Novant Health has completed its $2.4 billion acquisition of three hospitals along with their affiliated physician clinics from Dallas-based Tenet Healthcare. 
Novant acquired Mount Pleasant, S.C.-based East Cooper Medical Center, Hilton Head (S.C.) Hospital and Hardeeville, S.C.-based Coastal Carolina Hospital, according to a Feb. 1 news release from Novant.”

About pharma

 Ad firm that marketed OxyContin agrees to $350M settlement “An advertising agency that helped develop a marketing strategy to sell opioids like OxyContin agreed to a $350 million national settlement, attorneys general announced Thursday.  
The settlement will be paid by Publicis Health, part of the French media conglomerate Publicis Groupe and one of the world’s largest health care advertising companies. It marks the first time an advertising company has reached a major settlement over the U.S. opioid epidemic.”

Hikma Pharmaceuticals to pay $150M for failure to monitor, report suspicious opioid ordersA multistate settlement in principle with opioid manufacturer Hikma Pharmaceuticals (Hikma) for its role in fueling the opioid crisis will provide $150 million to resolve claims by states and local communities.
Hikma produces a range of branded and generic opioid products and sells hundreds of millions of opioid doses every year. From 2006 to 2021, Hikma failed to monitor and report suspicious opioid orders from potentially illegal distributors, even while its personnel knew their systems to monitor suspicious orders were inadequate and prone to failure.
The settlement will provide $115 million in cash and $35 million in opioid addiction treatment medication. States that do not accept the medication will receive cash in lieu of product.”

Who's No. 1? With $25B in sales, Merck's Keytruda looks to be the top-selling drug of 2023With Merck reporting a whopping $25 billion sales haul for Keytruda on Thursday, the PD-1 cancer superstar appears to be the world’s top-selling drug in 2023.
Keytruda looks set to take over the top spot from Pfizer and BioNTech’s Comirnaty, which ruled the previous two years, scoring sales of $55.9 billion in 2022 and $55.1 billion in 2021, according to Drug Discovery and Development.”

 CMS to Negotiate Medicaid Outcomes-Based Agreements for Sickle Cell Gene TherapiesThe Centers for Medicare and Medicaid Services announced Tuesday that it will seek outcomes-based agreements with manufacturers of sickle cell disease gene therapies in a bid to lower healthcare expenses and expand patient access to these multimillion-dollar treatments.
Under the agency’s Cell and Gene Therapy Access Model, which it first unveiled in February 2023, CMS will negotiate with manufacturers to come up with a pricing and rebate structure that ties the costs of these therapies to their efficacy and whether they improve health outcomes for treated patients.”

About the public’s health

 WHO Report: Worldwide Cancer Cases to Double by 2050 “The latest estimates from the World Health Organization predict global cancer cases will be up 77% by 2050, resulting in an estimated 18.5 million deaths.”

About healthcare IT

 HHS finalizes rule on telehealth at opioid treatment programs Dive Brief:

  • The HHS on Thursday finalized a rule that will allow opioid treatment programs to begin some medication treatment via telehealth.

  • Under the rule, these providers will be able to initiate treatment with buprenorphine through audio-only or audio-visual telehealth. They can begin methadone treatment via an audio-visual platform — but not through an audio-only option due to its higher risk profile, the Substance Abuse and Mental Health Services Administration said. 

  • The regulation makes permanent telehealth flexibilities that began during the COVID-19 pandemic to preserve access to care and tackle a worsening opioid epidemic. “ 

Today's News and Commentary


About Healthcare Quality and Safety

 ECRI’s Top 10 Health Technology Hazards for 2024
“1. Medical Devices May Pose Usability Challenges for Home Users, Risking Misuse and Patient Harm

2. Inadequate or Onerous Device Cleaning Instructions Endanger Patients

3. Sterile Drug Compounding without the Use of Technological Safeguards Increases the Risk of Medication Errors

4. Overlooked Environmental Impacts of Patient Care Endanger Public Health

5. Insufficient Governance of AI Used in Medical Technologies Risks Inappropriate Care Decisions

6. Ransomware Targeting the Healthcare Sector Remains a Critical Threat

7. Increased Burn Risk with Single-Foil Electrosurgical Return Electrodes

8. Infusion Pump Damage Remains a Medication Safety Concern

9. Poor QC of Implantable Orthopedic Products Can Lead to Surgical Delays and Patient Harm

10. Third-Party Web Analytics Software Can Compromise Patient Confidentiality”

 Comment: It is interesting to follow this list over the years and see how it changes. Check out them out at www.ecri.org.

About health insurance/insurers

Medicare Advantage: A Policy Primer An excellent monograph from The Commonwealth Fund.

2025 Medicare Advantage and Part D Advance Notice Fact Sheet While there are a number of changes, the expected average change in revenue for MA plans is + 3.70%.

 Few Americans Know How Much Their Healthcare Costs “Seventeen percent of U.S. adults report they know how much their healthcare products or services will cost before receiving them. Results are similar across key demographic groups, including by race/ethnicity, gender, age, education level, geographic region and health insurance coverage status, suggesting a societywide lack of awareness about one’s healthcare costs, regardless of personal background.”

Cigna's Medicare sale 'clears path' for M&A “Cigna's plan to sell its Medicare business to Health Care Service Corp. is clearing a path for future mergers and acquisitions, according to S&P analysts. 
The company's Medicare segment ‘just didn't have that scale relative to where they needed to be and the margins didn't line up,’ S&P Global Ratings analyst Francesca Mannarino wrote Jan. 31. ‘So divesting this business could potentially set themselves up for future opportunity.’”

About hospitals and healthcare systems

JANUARY 2024 National Hospital Flash Report “Key Takeaways

1. Margins improved in December and are up by more than 15% compared to 2022, which marked the worst year since the beginning of the pandemic. Hospitals are experiencing general improvement across operational and financial measures.
2. Average length of stay has declined on a year-over-year basis. This continued stabilization reflects the ongoing effort by hospitals and health systems to have clear pathways for discharge. Despite current signs of improvement, acuity and average length of stay will likely rise in the long term as more lower-acuity care is shifted outside the hospital.
3. Outpatient revenue has grown significantly—increasing by more than 40% compared to 2020. This growth is being driven by the shift towards outpatient care settings due to reimbursement changes, patient preference, increased ability for care to be delivered in these settings, and further digitization.”

About pharma

Addendum to yesterday’s Biogen story about abandoning Aduhelm. The company will focus instead on Leqembi, an Alzheimer’s drug it developed with Japanese partner Eisai. 

Deal hungry Merck plans more phase 3 launches than in 2023After more than 20 phase 3 trials got underway in 2023, Merck is planning for even more this year, according to Dean Li, Ph.D., head of Merck Research Labs, on Thursday. Meanwhile, CEO Rob Davis says the company is hunting for more mid-sized deals. 
Three new assets entered phase 3 trials in the fourth quarter, all three of which came from business development. MK-1022 is the most recent, coming over in Merck’s multi-billion dollar deal with Daiichi Sankyo announced in the fall. Candidates stemming from Merck’s licensing deal with Kelun and 2022 acquisition of Imago also entered phase 3 studies.”

The FTC Is Attacking Drugmakers’ ‘Patent Thickets’ “The Federal Trade Commission has challenged the validity of over 100 drug product patents, focusing on devices used to deliver medicines, like inhalers and autoinjectors, in an effort to increase competition and potentially lower some prices.
The FTC says drugmakers illegitimately use the patents to prevent competitors from offering cheaper generic alternatives.
It’s the first time the FTC has tried the tactic, said Hannah Garden-Monheit, director of the FTC’s Office of Policy Planning.”

About the public’s health

 Updated Covid vaccine has 54% effectiveness, new data suggest “New data released Thursday by the Centers for Disease Control and Prevention suggest that the most recent Covid-19 booster offers about 54% percent protection against infection with the virus.
A study published in the CDC’s online journal Morbidity and Mortality Weekly Report showed that the updated vaccine was essentially equally effective at protecting against the strain targeted by the vaccine — called XBB.1.5 — and the JN.1 subvariant, which emerged after the vaccine was made. JN.1 is currently the dominant virus circulating in the United States.”

About healthcare IT

 2023 CAQH Index Report “ Data from the 2023 CAQH Index found that $89 billion (approximately 22 percent), is spent conducting administrative transactions tracked by the CAQH Index. Of the $89 billion, the industry can save $18.3 billion by transitioning to fully electronic transactions. This cost savings opportunity comprises roughly five percent of the cost of administrative complexity in the U.S. healthcare system.”

About healthcare personnel

Is the nation’s primary care shortage as bad as federal data suggest? An excellent article on this topic from The Washington Post.

The No. 1 problem still keeping hospital CEOs up at night “Hospital CEOs ranked workforce challenges as their No. 1 concern in 2023. Financial challenges, which held the top spot for 16 consecutive years prior to 2021, were listed the second-most pressing concern in the American College of Healthcare Executives' annual survey. Behavioral health and addiction issues ranked third.”

Today's News and Commentary

About health insurance/insurers

Cigna inks deal to sell Medicare business to HCSC for $3.7BCigna will sell off its Medicare business to Health Care Service Corporation in a deal valued at $3.7 billion, the company announced Wednesday.
HCSC will acquire Cigna's Medicare Advantage, Part D, supplemental benefits and CareAllies businesses, and the parties expect the deal to close in the first quarter of 2025. In addition, the Blues insurer has entered into a four-year arrangement with Cigna's Evernorth subsidiary, which will continue to provide pharmacy services to the Medicare plans should the sale close.”
Comment: Cigna announced an expansion of its Medicare business line last September. What changed so quickly? One challenge for HCSC is how it will enter the many states where it does not currently do business and compete with other Blue Cross/Blue Shield plans.

 ACOs to receive $20M in advance investment payments A good summary of the current status of ACOs.

About pharma

 Cardinal Health acquiring Specialty Networks to expand tech offerings for independent practices “Healthcare product distributor and data analytics services company Cardinal Health has announced a $1.2 billion cash deal to acquire Specialty Networks, which the former said will help it expand across specialty therapeutic areas and enhance other provider offerings.”

GSK confirms Arexvy is a blockbuster but says the RSV battle has just begunBeaten to the punch by Pfizer in developing a vaccine for COVID, GSK has regained some of its lost luster as a vaccine powerhouse with its advancement of respiratory syncytial virus (RSV) shot Arexvy.
Wednesday, when GSK reported its quarterly and annual earnings, it confirmed that Arexvy was blockbuster in its first year on the market. And it took the company just two quarters—or “four months” as CEO Emma Walmsley was quick to point out during a conference call—to accomplish the feat as Arexvy generated sales of 1.2 billion pounds sterling ($1.5 billion).
Making the achievement that much more satisfying for the British pharma major is that it stared down a challenge from Pfizer. A day earlier, Pfizer reported 2023 sales of its RSV vaccine Abrysvo at $890 million.”
And in a related story: GSK tips 12 blockbuster launches to soften HIV patent loss, power sales toward $50B

Biogen officially chucks AduhelmSoon going on two years since it pulled back investment for Aduhelm (aducanumab), Biogen is now officially closing the book on the Alzheimer's disease drug, which has been a commercial flop since its controversy-ridden accelerated approval from the FDA back in 2021. In a statement Wednesday, Biogen said it has also terminated a licensing deal for the anti-amyloid antibody, with all rights reverting to Neurimmune.”

About the public’s health

 Recommended Adult Immunization Schedule, United States, 2024 FYI

 CDC’s 2022 STI Surveillance Report underscores that STIs must be a public health priority “In 2022, more than 2.5 million cases of syphilis, gonorrhea, and chlamydia were reported in the United States. The most alarming concerns center around the syphilis and congenital syphilis epidemics, signaling an urgent need for swift innovation and collaboration from all STI prevention partners. In addition to the syphilis epidemic worsening, reported gonorrhea cases declined for the first time in at least a decade while reported chlamydia cases were level.”
Comment: The number of cases of syphilis has not been this high since 1950!

The Healthiest & Unhealthiest Communities in the U.S. FYI. Eight of the top ten are from different states. Six of the lowest rated are in Texas, three in Arizona and one in Louisiana.

About healthcare IT

 DOJ’s Healthcare Probes of AI Tools Rooted in Purdue Pharma Case “Justice Department investigators are scrutinizing the healthcare industry’s use of AI embedded in patient records that prompts doctors to recommend treatments.
Prosecutors have started subpoenaing pharmaceuticals and digital health companies to learn more about generative technology’s role in facilitating anti-kickback and false claims violations, said three sources familiar with the matter. It comes as electronic health record vendors are integrating more sophisticated artificial intelligence tools to match patients with particular drugs and devices.”

About health technology

Ultima Genomics launching high-end DNA sequencers that can read genome for $100Ultima Genomics, an upstart some observers have called a ‘dark horse’ in the world of DNA sequencing, will soon launch a line of high-power instruments that can read a human genome for as little as $100, the company’s leadership told STAT.
The sequencer, dubbed the UG 100, is a $1.5 million machine that can read up to 20,000 human genomes a year. The reagents required to operate the instrument cost as little as $1 per billion sequenced DNA bases; that translates to $100 per genome assuming each base in the 3-gigabase human genome is read 33 times, a common industry standard. The company plans to officially launch the product at this year’s Advances in Genome Biology and Technology meeting, which kicks off in Orlando, Fla., on Feb. 5.”

What to know about Elon Musk's Neuralink, which put an implant into a human brain A really good explanation of this technology.

AI-Powered Alzheimer’s Diagnosis Accelerator Receives De Novo OKThe product uses AI algorithms to study brain MRI results and generates a score predicting the likelihood of a patient’s progression to Alzheimer’s within five years. San Francisco-based Darmiyan expects BrainSee to reduce both the emotional and financial hardships of aMCI patients with a lower risk of progression. Physicians can now access the platform through a secure web portal.”

About healthcare finance

 M&A in Healthcare and Life Sciences: A Shrinking Margin for Error in Deals At a Glance

  • In 2023, deal volume declined across sectors, but deal value rose because of notable megadeals in pharma and medtech.

  • Revenue growth is more important than margin growth in healthcare, making M&A an attractive path—and the industry has a lot of cash.

  • 80% of healthcare executives surveyed expect to do the same amount or more deals in 2024.

  • As the margin for error shrinks, dealmakers must double down on fundamentals to improve their M&A strategy and capability.”

    Comment: I do not agree with the second point. Many companies are growing revenue but, because of expenses, are not producing profits. For example, look at VillageMD, which Walgreens bought.

Today's News and Commentary

About health insurance/insurers

 Moody's: Why Medicare Advantage's profitability may be on the decline  “The analysis found that margins declined from 4.9% in 2019 to 3.4% in 2022. Margins also fell in the commercial risk-based sector, but by a smaller amount, and they grew in Medicaid during that window, according to the report.
These data are based on reports from 10 payers rated by Moody's, which encompass two-thirds of all MA enrollees.”

Participation Continues to Grow in CMS’ Accountable Care Organization Initiatives in 2024 “Overall, in 2024 there are about 13.7 million people with Traditional Medicare aligned to an ACO. ACOs are now serving nearly half of the people with Traditional Medicare, a 3% increase since 2023. This growth in ACOs is important since ACOs have been shown to have superior quality performance compared to similar physician groups not participating in an ACO, and ACOs have generated year-over-year savings for the Medicare Trust Fund.”

No Surprises Act prevents 10M surprise bills, insurance groups say “The federal No Surprises Act is estimated to have prevented more than 10 million surprise medical bills during the first nine months of 2023, according to a Jan. 26 report from AHIP and the Blue Cross Blue Shield Association. 
The findings come from a November survey of 21 health insurance providers representing 65% of the total commercial market, according to the report.”

DOJ, HHS press state Medicaid admins to cover Hepatitis C meds “In a joint letter by the Department of Justice and the Department of Health and Human Services, the agencies reminded states of their obligation, referring to an old settlement agreement between the DOJ and Alabama's Medicaid agency, or Alabama Medicaid.
Under the Americans with Disabilities Act, state Medicaid programs are not allowed to reject health services, such as administering HCV drugs to individuals with substance use disorder, if an individual is eligible.”
Comment: As the costs for very expensive medications grows, dyads are finning it difficult to balance the needs of the many with the needs of the few. See yesterday’s post about North Carolina removing weight loss drugs like Wegovy from coverage.

About hospitals and healthcare systems

 Will there be new baselines for nonprofit hospitals' financial metrics? Fitch weighs in “Several nonprofit hospitals have found their operations and balance sheets settling into new ranges following a tough couple years, though that doesn’t necessarily mean that credit ratings will dive-bomb and investors should run for the hills, Fitch Ratings analysts said Monday.
The more substantial shift for the nonprofit hospital sector—and “The biggest question long term for rating agencies” like Fitch—is whether the nonprofit hospital sector sees operating margins “reset” from the ideal of 3% or higher to a range of 1% to 2%, analysts wrote in a new report.”

HCA posts $5.2B profit in 2023Nashville, Tenn.-based HCA Healthcare saw revenues of $17.3 billion in the fourth quarter of 2023, up from $15.5 billion over the same period in 2022, according to its financial report released Jan. 30.”

About healthcare IT

Specialty-Driven Platforms Outperform Broad-Spectrum EHRs in Top 2024 Physician Satisfaction Ratings, 14th Annual Black Book Ambulatory Practice SurveysPhysician practices reaffirm their confidence in specialty-distinctive electronic health record systems according to 32,854 medical and surgical practitioners surveyed by Black Book™ and the continued trend in physician technology replacements to specialty-driven EHRs with integrated RCM, interoperability, and analytics.”
Read the announcement for the specialty-specific preferred EMRs.

2024 State Policy Agenda for Telehealth Innovation A great source for understanding all the state-specific telehealth laws. 

About health technology

 Musk’s Neuralink implants brain chip in its first human subject “Brain chip start-up Neuralink implanted a device in its first live human subject Sunday, Elon Musk, the company’s founder, said on social media. The patient “is recovering well,” Musk wrote Monday, adding that initial data from the device was promising.
Placed in the part of the brain that plans movements, the device is designed to interpret a person’s neural activity, so they can control external devices such as a smartphone or computer with their thoughts, Neuralink’s website says. The device is currently in clinical trials, which are open to some individuals who have quadriplegia due to amyotrophic lateral sclerosis (ALS) or a spinal cord injury, according to a recruitment pamphlet.”

Today's News and Commentary

About health insurance/insurers

Blue Shield of California Promise Health Plan offers to pick up the tab for Medicaid enrollees who want GEDsBlue Shield of California Promise Health Plan is offering to foot the bill for Medicaid enrollees who want to earn a General Education Diploma and become high school graduates.
The program began this month and is being offered to enrollees in Los Angeles and San Diego Counties, where the Medi-Cal Blue Shield Promise Health Plan operates.
The program is in keeping with the insurer’s increased focus on the social determinants of health, which experts see as crucial in keeping individuals healthy. Individuals who obtain a GED can earn on average $9,000 more a year than those who don’t graduate high school, the health plan noted in a press release.”

BENEFICIARIES DUALLY ELIGIBLE FOR MEDICARE AND MEDICAID This CMS-issued report is dated January 2024, but uses 2021 data. Making policy decisions on data at least 2 years old is one of the ongoing problems with federal healthcare programs.

Medicaid Advisers Back New Protections for Patients Denied Care “Congress’s Medicaid advisers on Friday endorsed a series of steps policymakers could take to overhaul the appeal process for beneficiaries denied access to care by a managed care organization.
The proposals from the Medicaid and Chip Payment and Access Commission include allowing impartial third-party doctors to review claims in the event a claims appeal is denied by a managed care organization (MCO).
The move to protect Medicaid beneficiaries’ access to coverage comes after a July 2023 report from the Department of Health and Human Services Office of Inspector General found many MCOs had high rates of prior authorization denials, something the watchdogs said could have been mitigated with additional safeguards to protect patients, like external medical reviews.
The report found 115 managed care organizations in 37 states denied about one in eight requests for prior authorization. Twelve MCOs surveyed had denial rates above 25%.
The Congressional Budget Office estimates that implementing external medical reviews of MCO denials could cost the Medicaid program up to $500 million over the next 10 years.”

About hospitals and healthcare systems

 DECEMBER 2023 National Hospital Flash Report “Key Takeaways
1. Hospital performance in November signals continued stabilization and growth. Operating margins improved compared to the previous month and last year, and other data points indicate movement towards recovery, though the gap between high and low performers remains quite wide.
2. Revenue per adjusted discharge has increased while total expense per adjusted discharge has decreased month-over-month and year-over-year—a sign of financial recovery. This reflects the efforts organizations have taken to deliver care in the most effective settings and reduce reliance on contract labor where possible.
3. Average length of stay declined indicating a shift towards more normal patient acuity. Organizations that have adopted value-based and bundled payment models will benefit further as they transition and provide care at the appropriate clinical setting.”

Community health centers serve 1 in 11 Americans. They’re a safety net under stress “[There are] nearly 1,400 federally designated community health centers. One in 11 Americans rely on these to get routine medical care, social services and, in some cases, fresh food.” Read this article to understand the population these centers serve and the challenges they face.

About pharma

Top 10 most anticipated drug launches of 2024 FYI

White House pharmacy problems Watch this short video and then decide if you want the government to administer your pharma benefits. Let me emphasize, these events were at the WHITE HOUSE PHARMACY.

Insurer, PBMs break into top 10 of health lobbying [Scroll down the page after clicking the link]
The Pharmaceutical Care Management Association, which represents PBMs, spent $5.3 million in the last three months of last year — double the amount it had spent during the same time in 2022.”

Buried in Wegovy Costs, North Carolina Will Stop Paying for Obesity DrugsIn June 2021, the insurance plan for North Carolina state employees was paying for 2800 people to take weight-loss drugs.
Last year, it paid for nearly 25,000. Medications like Wegovy cost the North Carolina State Health Plan $100 million last year, rising seemingly out of nowhere to represent 10 percent of its spending on prescription drugs…
Alarmed by the ballooning costs, the health plan’s governing board voted on Thursday to end all coverage of medications for weight loss, including Wegovy, which accounts for the vast majority of its spending on obesity drugs. The plan will continue covering versions of the drugs for people with diabetes.”

About the public’s health

 CDC warns health care workers to be on alert for measles amid rising number of cases Between Dec. 1, 2023, and Jan. 23, 2024, there have been 23 confirmed cases of measles including seven cases from international travelers and two outbreaks with five or more infections each, according to an email sent this week.
Cases have been reported in Pennsylvania, New Jersey, Delaware and the Washington, D.C. area so far.
Most of these cases were among children and adolescents who had not been vaccinated against measles, despite being eligible.”

About healthcare IT

FDA accepts first AI algorithm to drug development tool pilot, with Deliberate AI’s anxiety and depression assessment “For the first time since it launched in 2020 and began accepting submissions in 2022, a program started by the FDA to provide support for unconventional drug development tools has accepted its first artificial intelligence-powered tool.
The Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot was designed to create a new pathway to FDA review for novel tools that may not fit into currently existing routes of evaluation, but that could potentially improve the development of new drugs.
The newest tool accepted into ISTAND comes from Deliberate AI. The AI-generated Clinical Outcome Assessment—AI-COA for short—uses multimodal behavioral signal processing and machine learning technology to record mental health symptoms and assess the severity of cases of anxiety and depression.”

About healthcare personnel

Why doctors are calling it quits A great article about physician burnout.

About health technology

 Google captures FDA de novo clearance for Pixel smartphone thermometer app “Google has secured an FDA clearance that finally unlocks human use of the temperature sensor built into its highest-end smartphone. When the Pixel 8 Pro was first announced last October, the company said its sensor was well-suited to gauging the warmth of household objects, but that it shouldn’t be used to check someone out for a fever.
That’s changed with the agency’s green light, clearing what Google describes as the first smartphone body temperature app—and one that’s on par with other FDA-cleared thermometers that scan the temporal arteries around the forehead.”

Disparities in National Cancer Institute and Nonprofit Organization Funding Disproportionately Affect Cancers With Higher Incidence Among Black Patients and Higher Mortality Rates “Diseases with the largest combined NCI and NPO funding were breast cancer ($3.75 billion in US dollars [USD]) and leukemia ($1.99 billion USD). Those with the least funding were endometrial ($94 million USD), cervical ($292 million USD), and hepatobiliary cancers ($348 million USD). Disease-specific funding correlated well with incidence but correlated poorly with mortality (Pearson CCs, 0.74; P = .006 and .30, P = .346, respectively). Breast cancer, leukemia, and lymphoma were well-funded while colorectal, lung, hepatobiliary and uterine cancers were underfunded. Higher incidence among Black patients correlated with underfunding. The amount of funding for a particular cancer correlated strongly with the number of clinical trials for that disease (Pearson CC, 0.91; P < .0001).” Emphases added.

Today's News and Commentary

About health insurance/insurers

 CMS seeks input on improving transparency in Medicare Advantage “The Centers for Medicare & Medicaid Services is seeking feedback on how to increase transparency around Medicare Advantage and improve data capabilities.
The request for information is the latest MA-focused action the agency has taken this month. Last week, the agency finalized a rule that gives stricter limits on when insurers must respond to prior authorization requests.”

About hospitals and healthcare systems

FTC sues to block $320M Novant, CHS dealThe Federal Trade Commission said it is suing Winston-Salem, N.C.-based Novant Health in a move to block its $320 million acquisition of two North Carolina hospitals from Franklin, Tenn.-based Community Health Systems…
The FTC claims that Novant's proposed agreement to acquire the two hospitals from Community Health Systems poses a risk of increased prices and diminished incentives for investing in quality and innovative care.”

About pharma

 Merck & Co. signs $220M macrocyclic peptide deal after hailing ‘next wave of drug discovery’ “Months after hailing macrocyclic peptides as the “next wave of drug discovery,” Merck & Co. has pushed further into the space by penning a $220 million biobucks deal with Unnatural Products.
The California-based biotech uses its combination of AI and chemistry expertise to ‘address the complexities of medicinal chemistry in the macrocycle space,’ the company said in a Jan. 23 release….
There is a long history of using macrocycle drugs, such as the immunosuppressant cyclosporine and the antibiotic erythromycin. However, efforts to systematically develop macrocycles have run into a range of challenges related to pharmacokinetics, cell permeability and oral bioavailability.” 

Walgreens shareholders reject disclosing abortion pill sale risks “Walgreens Boots Alliance investors rejected a proposal asking the Deerfield-based company to issue a report on any known or potential risks related to how the company chooses to sell an abortion drug in certain parts of the country.
The proposal came from the Presbyterian Church, which also asked the pharmacy, retail and health care giant to disclose strategies beyond litigation and legal compliance that the company might use to mitigate risks associated with selling mifepristone. The church also asked for Walgreens to provide clarity on its stance related to selling the drug.”

About healthcare IT

Gaps in internet use narrowed among older adults with Medicare during the COVID-19 pandemic but persist “Consistent with prior research, we find lower internet access for racially or ethnically minoritized and limited-income people with Medicare. Although “digital equity” gaps may be narrowing, large differences (>20 pp) persist. Less healthy, less economically advantaged, older, Spanish-preferring, and racially or ethnically minoritized people with Medicare may be less likely to have access to telemedicine because of unreliable internet access but might nonetheless benefit from telemedicine if they had reliable internet access.”

Florida lawmakers vote to restrict children's access to social media “The Florida House of Representatives approved on Wednesday a bill aimed at barring children aged 16 and younger from social media platforms, following similar action in several states to limit online risks to young teenagers.
Passed by a bipartisan vote of 106 to 13, the measure would require social media platforms to terminate the accounts of anyone under 17 years old and use a third-party verification system to screen out the underaged.”

About healthcare finance

Healthcare bankruptcies hit 5-year high “Seventy-three healthcare companies, including 12 hospitals and health systems, filed for bankruptcy in 2023, the highest number of filings since 2019, according to a Jan. 25 report published by Gibbins Advisors, a healthcare restructuring consulting firm.
Hospital bankruptcy filings spiked in 2023 with 12 filings compared to a total of 11 filings from the previous three years combined. The senior care and pharmaceutical sectors comprised nearly half the total healthcare bankruptcy filings in 2023, in line with previous trends, according to the report.”

CFTC Approves Intelligent Medicine Exchange (IMX) as New Futures Exchange “Intelligent Medicine Exchange (IMX)™ has been designated by the Commodity Futures Trading Commission as a contract market – a new futures and options exchange that allows market participants to hedge and invest in the health care economy.IMX will enable market participants to manage risk across the health care ecosystem in transparent, two-sided markets that represent many facets of the health care sector. Trading operations are expected to commence in the first half of 2024.”
Comment: Details are not supplied about which contract will be available for which healthcare services or products. A word of caution: options are available on products whose prices can fluctuate. Healthcare prices almost always increase.

Today's News and Commentary

About health insurance/insurers

 Humana's stock tumbles pre-market as it posts $541M loss in Q4 “The insurer issued a filing with the Securities and Exchange Commission last week, saying that it saw a significant spike in utilization during the fourth quarter that dragged its finances. That reveal sent its stock price, as well as that of major competitors, into a downward slide.”

About hospitals and healthcare systems

Administration’s Share of Personnel in Veterans Health Administration and Private Sector Care “These findings suggest that if health care employment patterns in the private sector mirrored those in the VHA, nearly 900 000 fewer administrative staff might be needed.”
Comment: The lead author, Steffie Woolhandler, is a long-standing single payer advocate. with an obvious agenda for doing this study. Because the VA system is a single payer/provider entity, the only way the results could be helpful is if the U.S. converted to a single payer system.

About pharma

 Sanofi to Buy Assets From Inhibrx in Deal Valued at Up to $2.2 Billion -- Update “Sanofi plans to buy assets from biopharmaceutical company Inhibrx in a deal worth up to $2.2 billion as it looks to diversify its product base and boost its pipeline of rare disease treatments.
The French pharmaceutical giant said Tuesday that it will acquire Inhibrx's INBRX-101 therapy, a potential treatment for a genetic disorder that raises a patient's risk of developing lung diseases and other illnesses.”

 Walgreens exploring sale of specialty pharmacy company Shields Health: media report “Walgreens is exploring a potential sale of its specialty pharmacy business Shields Health Solutions, just two-and-half years after it bought a majority stake in the business.
Bloomberg reported Tuesday that the pharmacy chain is working with advisers to assess the level of interest in a potential sale, citing people familiar with the matter.
The sale could be valued at more than $4 billion, according to the report. The specialty pharmacy company is expected to draw interest from private equity firms and healthcare companies.”

The FTC escalates Biden’s fight against drug prices A good review of how the FTC is combatting high drug prices by investigating the validity of patents.

Apotex, Heritage and Breckenridge settle with purchasers in generics price-fixing case “Apotex plans to settle with the group of direct purchaser plaintiffs for $30 million, while Heritage Pharmaceuticals and Breckenridge Pharmaceutical will hand over $10 million and $5 million, respectively, according to a trio of motions filed Tuesday in the multidistrict litigation in Pennsylvania federal court.
Each of the settlement amounts has the potential to increase or decrease, depending on the outcome of the legal proceedings. Apotex, for instance, could have its settlement fund reduced by up to $3.6 million if certain parties opt out of the deal.”

Lilly’s gene therapy hits high note, restores child’s hearing “The first person to receive Eli Lilly’s hearing loss gene therapy can now hear within a normal range, the pharma reported Tuesday. 
The patient, an 11-year-old boy born with hearing loss due to a mutation in the otoferlin gene, received a single, unilateral intracochlear dose of AK-OTOF, comprising 410 billion total vector genomes. Within 30 days, his hearing was restored across all tested frequencies, achieving thresholds of 65 to 20 dB HL, Eli Lilly said.”

About the public’s health

Invasive cervical cancer incidence following bivalent human papillomavirus vaccination: a population-based observational study of age at immunization, dose, and deprivation “Our findings confirm that the bivalent vaccine prevents the development of invasive cervical cancer and that even 1 or 2 doses 1 month apart confer benefit if given at 12-13 years of age. At older ages, 3 doses are required for statistically significant vaccine effectiveness. Women from more deprived areas benefit more from vaccination than those from less deprived areas.”

About healthcare IT

 Data Compromises Hit a New High As Cyber Criminals Leverage GenAI And New Attack Vectors “Data compromises reported in the United States reached a record high in 2023, totaling 3,205, a 78% rise over 2022 and up 72% from the then record high of 1,860 in 2021, according to the Identity Theft Resource Center’s annual Data Breach Report. It is the first time the number of U.S. data compromises reported in a single year exceeded 2,000, the ITRC says, as new technology like generative artificial intelligence began to play a role…
Three industries—health care, financial services, and transportation—reported more than double the number of compromises reported in 2022. Some 809 data compromises were reported in the health-care industry, up from 343 in 2022.”

HPH Cybersecurity Performance Goals FYI: “As outlined in the HHS Healthcare Sector Cybersecurity concept paper, HHS is publishing these voluntary healthcare specific Cybersecurity Performance Goals (CPGs) to help healthcare organizations prioritize implementation of high-impact cybersecurity practices.”

Today's News and Commentary

About health insurance/insurers

 MedPAC mulls standardizing Medicare Advantage supplemental benefits “The Medicare Payment and Advisory Commission is considering standardizing the supplemental benefits Medicare Advantage insurers can offer, to make it easier for beneficiaries to compare plans. 
At its Jan. 12 meeting, commission staff, which advises Congress on Medicare, put forth several options for standardizing Part A and B cost sharing and hearing, vision and dental benefits. The proposed standardizations would not apply to additional supplemental benefits, or employer-sponsored or special needs Medicare Advantage plans.”

Obamacare enrollment hits record level as Trump vows repeal “More than 21 million people have signed up for health plans through the Affordable Care Act’s health insurance marketplaces, the Biden administration announced Wednesday. The record level of enrollment comes as former president Donald Trump, seeking the GOP nomination, is again vowing to repeal the program if elected.
Sign-ups in the health insurance marketplaces — a jump of 5 million since last year and the third straight year of record enrollment — were partly driven by states “unwinding” pandemic-era protections in Medicaid, with millions of people culled from the safety net health program…”

Elevance Health posts $856M in profit in Q4 earnings beatElevance Health beat the Street on both earnings and revenue for the fourth quarter of 2023, reporting $856 million in profit.
The company also posted $42.6 billion in revenue for Q4, according to its earnings report released Wednesday morning. That's up nearly 7% from the $39.9 billion in revenue reported for the prior year quarter. Profit declined slightly year-over-year. In the fourth quarter of 2022, Elevance Health reported $865 million in profit, making for a 1% decrease.”

Healthcare billing fraud: 10 recent cases FYI


About hospitals and healthcare systems

 Cleveland Clinic confiscated 30K weapons last year “In 2023, Cleveland Clinic saw a record 14 million patients — and took 30,000 weapons from those patients and their visitors.”

About pharma

 Many Patients Maintain Weight Loss a Year After Stopping Semaglutide and Liraglutide 

“Key Findings

  • Two-thirds of patients are able to maintain weight loss achieved while on semaglutide or liraglutide even a year after discontinuing the medication.  

  • However, a portion of patients who stop taking either medication experience weight regain, with 18.7% of liraglutide users and 17.7% of semaglutide users regaining all the weight they had lost or more.”

Today's News and Commentary

About Covid-19

Persistent complement dysregulation with signs of thromboinflammation in active Long Covid “Comparing the blood of patients with confirmed SARS-CoV-2 infection with that of uninfected controls, Cervia-Hasler et al. found that patients experiencing Long COVID exhibited changes to blood serum proteins indicating activation of the immune system’s complement cascade, altered coagulation, and tissue injury... At the cellular level, Long Covid was linked to aggregates comprising monocytes and platelets. These findings provide a resource of potential biomarkers for diagnosis and may inform directions for treatments.”

About health insurance/insurers

Medicaid Enrollment and Unwinding Tracker “At least 15,755,000 Medicaid enrollees have been disenrolled as of January 22, 2024, based on the most current data from all 50 states and the District of Columbia. Overall, 33% of people with a completed renewal were disenrolled in reporting states while 67%, or 30.6 million enrollees, had their coverage renewed (one reporting state does not include data on renewed enrollees). Due to varying lags for when states report data, the data reported here undercount the actual number of disenrollments to date.
There is wide variation in disenrollment rates across reporting states, ranging from 61% in Texas to 13% in Maine and Oregon…
Across all states with available data, 71% of all people disenrolled had their coverage terminated for procedural reasons.”

About hospitals and healthcare systems

Healthgrades America's 50 Best Hospitals Latest ratings from Healthgrades.

Long-term care hospitals can't afford to treat their sickest Medicare patients, AHA says “The cutoff for an expensive LTCH case to qualify for extra reimbursement, known as the high-cost outlier policy’s “fixed-loss amount,” rose 55% from FY 2023’s $38,518 to FY 2024's $59,873. The hospital lobby wrote that it projects the cutoff to again increase by 17% in FY 2025 to $70,117—bringing an extra $54 million in losses to a subsector with total annual Medicare payments of $2.6 billion.”

About pharma

US FDA seeks 'boxed warning' for CAR-T cancer therapiesLast November, the U.S Food and Drug Administration said it had received reports of patients developing a type of T-cell blood cancer after being treated with CAR-T therapies.
The FDA said in its letters to the companies on Monday that since the approval, it had identified adverse events and clinical trial reports describing T-cell malignancies.”

Clinically Important Benefits and Harms of Monoclonal Antibodies Targeting Amyloid for the Treatment of Alzheimer Disease: A Systematic Review and Meta-Analysis “We conducted a meta-analysis to evaluate clinically meaningful benefits and harms of monoclonal antibodies targeting amyloid in patients with Alzheimer dementia…
Although monoclonal antibodies targeting amyloid provide small benefits on cognitive and functional scales in patients with Alzheimer dementia, these improvements are far below the MCID [minimal clinically important difference] for each outcome and are accompanied by clinically meaningful harms.”

J&J agrees to resolve 42 U.S. states' talc investigationsJohnson & Johnson on Tuesday said it had reached a tentative settlement to resolve probes by U.S. states into whether it misled consumers about the safety of its talc products, which thousands of lawsuits claim can cause cancer.
The deal includes 42 states and Washington, D.C. The company tentatively agreed to pay about $700 million to settle the states' claims, according to the Wall Street Journal…
The company, which reported fourth-quarter results on Tuesday, still faces more than 50,000 lawsuits over talc, most by women with ovarian cancer. A minority of the cases involve people with mesothelioma, a type of cancer linked to asbestos. It recently settled some of the mesothelioma cases for an undisclosed amount but has maintained that its talc did not contain asbestos.”

About the public’s health

 Biden administration reinforces reproductive health obligations for payers, providers “The actions address barriers to contraceptives and other reproductive services that have arisen since the Supreme Court's 2022 decision to reverse the 1973 Roe ruling, and, in some cases, will soon reach the same Supreme Court that struck down the landmark decision.”

About healthcare IT

 Healthcare Data Breaches Continue to Impact Patients in New YearIn 2023, more than 540 organizations reported healthcare data breaches to HHS, impacting upwards of 112 million individuals.”
The article has examples of significant breaches.

Ethics and governance of artificial intelligence for health: Guidance on large multi-modal models[LLMs] “WHO is issuing this guidance to assist Member States in mapping the benefits and challenges associated with use of LMMs for health and in developing policies and practices for appropriate development, provision and use. The guidance includes recommendations for governance, within companies, by governments and through international collaboration, aligned with the guiding principles. The principles and recommendations, which account for the unique ways in which humans can use generative AI for health, are the basis of this guidance.”

About health technology

Harvard Teaching Hospital Seeks Retraction of Six Papers by Top Researchers “The Dana-Farber Cancer Institute, a Harvard Medical School affiliate, is seeking to retract six studies and correct 31 other papers as part of a probe involving four of its senior cancer researchers and administrators.
More than 50 papers, including four co-authored by Chief Executive and President Dr. Laurie Glimcher, are part of a continuing review, according to Dr. Barrett Rollins, the cancer institute’s research-integrity officer. Some requests for retractions and corrections have already been sent to journals, he said. Others are being prepared. The institute has yet to determine whether misconduct occurred.”

Today's News and Commentary

What to expect in US healthcare in 2024 and beyond A nice summary of projections from McKinsey.

About Covid-19

 COVID, flu admissions fall: 4 virus updates Respiratory virus season's burden on the healthcare system may begin to ease after weeks of crowded emergency departments and hospital strain, the latest data suggests. 
In the second week of January, COVID-19 admissions fell nearly 10%, though more than 32,000 people with the virus were still admitted to U.S. hospitals, CDC data shows. The drop comes after nine straight weeks of increases…
Flu admissions fell for the second week straight, with 14,874 lab-confirmed flu patients hospitalized during the week ending Jan. 13. However, experts have been hesitant to call this a trend since cases typically rise again later in the winter months. 

About hospitals and healthcare systems

 Intermountain ends precision medicine programIntermountain Health will end and divest its Precision Genomics Laboratory Feb. 1. 
The 33-hospital system introduced Intermountain Precision Genomics in 2014. ‘Over the past 10 years, the precision medicine market has rapidly evolved, new partners have entered, and this work has become financially unsustainable,’ the nonprofit health system said.”
Comment: As hospitals (which serve “local” markets) diversify their services, commercial competition from national companies can cause these projects to become “financially unsustainable.”

New York Is Planning to Shutter a Major Brooklyn Teaching Hospital The state is planning to drastically shrink or even close University Hospital at Downstate in Brooklyn, the only state-run medical hospital in New York City.
A number of concerns — too few patients, annual operating deficits of about $100 million and a deteriorating hospital building — have led to the proposal, which hospital administrators shared with doctors this week.
It is unclear how the plan will affect access to medical care for residents of central Brooklyn and beyond.”

About health insurance/payers

Payers ranked by Medicare Advantage enrollment in 2024 As the final open enrollment numbers are in, United, Humana and CVS take the top 3 slots, respectively.

About pharma

 2023's top 10 clinical trial flops FYI

About healthcare IT

 United States Core Data for Interoperability “The United States Core Data for Interoperability (USCDI) is a standardized set of data elements for nationwide, interoperable health information exchange. USCDI establishes a baseline set of data that can be commonly exchanged across care settings for a wide range of uses. USCDI version 1 (USCDI v1) was adopted as a standard (at 45 CFR 170.213) in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (Cures Act Final Rule). Since then, ONC has released three more versions of USCDI for which two have been approved under the ONC StandardsVersion Advancement Process (SVAP). The SVAP permits health IT developers with health IT products certified under the ONC Health IT Certification Program (Certification Program) to voluntarily update their conformance to newer versions of adopted standards as part of the “Real World Testing” Condition and Maintenance of Certification requirement (§ 170.405).”
Comment: See the graphics starting on Page 7.