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.

Today's News and Commentary

In memorium: Nancy E. Adler, Who Linked Wealth to Health, Dies at 77 “Dr. Adler was instrumental in documenting the powerful role that education, income and self-perceived status in society play in predicting health and longevity.
Today, the connection is well known — a truism among public health experts is that life expectancy is determined more by your ZIP code than your genetic code. But it was an obscure notion as recently as 30 years ago.”

About health insurance/insurers

 Payer stocks skid as Humana slashes 2023 outlook amid elevated utilization “The insurer said that while it had braced for elevated costs in the quarter, expenses exceeded those expectations, pushing its medical loss ratio to 91.4%, compared to an expected 89.5%. Its MLR for the full year was also above it projections, landing at 88% compared to an anticipated 87.5%.
Following the news, the company's stock dropped by 11%, trading at its lowest rate since it slashed its outlook in early 2022 following the Medicare Advantage enrollment window.
The reports also dragged down rival insurers. UnitedHealth Group, Elevance Health, CVS Health, Centene and Cigna were all trading down as of mid-afternoon on Thursday.”

CMS unveils new behavioral health model using a 'no wrong door' approach “The Centers for Medicare & Medicaid Services announced Thursday the Innovation in Behavioral Health Model, a new approach that is designed to test for improving outcomes for adults with mental health and substance use disorder.
Beginning this fall, the model is intended to funnel adults in Medicare and Medicaid to the "physical, behavioral and social supports" they need, according to a press release. Community-based practices under IBH will create care teams with behavioral and physical health providers. The proposal embraces a no wrong door approach that allows people to obtain all services they need no matter how they first seek out care. Screenings, assessments and referrals to other services will be available.
While the practice participant enrollment period begins this year, the implementation period takes place from 2027 to 2032, a fact sheet (PDF) released by CMS says. States have not yet been selected to participate.”

About hospitals and healthcare systems

 Hospital CEO turnover up 42% in 2023 “Hospitals and health systems reported 146 CEO changes last year, marking a 42% increase from 2022. 
Hospitals and health systems announced 103 CEO changes in 2022, according to a Jan. 18 report from Challenger, Gray & Christmas…” 

Congress passes short-term funding bill extending DSH payments to March 8 “From a healthcare perspective, the bill again pushes back a scheduled $8 billion-per-year cut to Medicaid disproportionate share hospital program payments. It also temporarily renews funding for community health centers, the National Health Service Corps and teaching health centers operating Graduate Medical Education programs. Each of the above will now be funded up to March 8.
More controversial healthcare items in lobbyists’ crosshairs, such as implementation site-neutral Medicare payments or a physician Medicare payment rate cut that went into effect Jan. 1, are not addressed in the stopgap.”

About healthcare IT

 Epic accused of patent infringement “SynKloud Technologies filed the lawsuit in the Western District of Wisconsin, alleging that Epic's MyChart uses similar software as the one listed in its U.S. patent No. 8,856,383…”

Today's News and Commentary

About Covid-19

 Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19 “Early administration of simnotrelvir plus ritonavir shortened the time to the resolution of symptoms among adult patients with Covid-19, without evident safety concerns.”
Comment: This combination is available in China.

About health insurance/insurers

 MedPAC: Medicare Advantage will receive estimated $88B in overpayments in 2024 “Coding intensity and the types of enrollees who select Medicare Advantage plans will drive an additional $88 billion in payments to the program in 2024 compared with what traditional Medicare would receive, according to estimates from the Medicare Payment and Advisory Commission. ..
The advisory group estimated that risk scores in Medicare Advantage will be 20.1% higher for patients than if they were enrolled in traditional Medicare. These higher risk scores will account for $54 billion in additional payments to Medicare Advantage plans in 2024, according to MedPACs estimates.”

About hospitals and healthcare systems

Hospitals Are Back to the Muni Market With Labor Costs Easing “So far this year, hospitals are tapping the market with more than $1.7 billion to expand and upgrade facilities, according to data compiled by Bloomberg as of Jan. 12. That figure outpaces $390.7 million of issuance by hospitals last January.
It’s cheaper to tap the muni market at the moment, with the yield on the 10-year AAA benchmark down 127 basis points since Nov. 1. Financial pressures on hospitals have also started to ease. Staffing costs — by far their heftiest expense — have steadied and operating margins have been improving.”

15 most common reasons for hospital citations in 2023 FYI

About pharma

 Drug cost trends in 2024 are 'nearly unprecedented,' research finds “Drugmakers aren't raising prices like they used to, according to data from 46brooklyn Research.
On Jan. 1, 453 branded drugs increased in cost — a similar figure to the start of 2023, which saw 452 pricier brand-name drugs. Drugmakers typically make the most drug price changes in January, and in 2023 and 2024, there seems to be a downward trend.”
Comment: The graphics in the linked site are very helpful.

Trends in Retail Prices of Prescription Drugs Widely Used by Older Americans, 2006 to 2020
“Key Findings
Average price increases for prescription drugs widely used by older Americans, including Medicare beneficiaries, outstripped the price increases for other consumer goods and services between 2006 and 2020. 

  • In 2020, the average annual cost for widely used prescription drugs used to treat chronic conditions was more than $26,000 per drug per year. This cost was:

    • More than 40 percent higher than the average Social Security retirement benefit ($18,034),

    • Nearly 90 percent of the median income for Medicare beneficiaries ($29,650), and

    • More than one-third of the median US household income ($69,639).

  • The average annual cost of drug therapy for one drug used on a chronic basis would have been more than $14,000 lower in 2020 (i.e., $12,112 v. $26,393) if retail price changes had been limited to the rate of general inflation between 2006 and 2020. 

  • The average price of therapy for the AARP combined market basket greatly exceeded the average price of therapy for the brand name and generic market baskets. The higher price of therapy for the combined market basket is due to the markedly higher price level of specialty drug products. In 2020:

    • The average annual cost of therapy for widely used generic drug products was $679,

    • The average annual cost of therapy for widely used brand name drug products was $6,604, and

    • The average annual cost of therapy for widely used specialty drug products was $84,442.”

About the public’s health

 Cancer statistics, 2024 “In 2024, 2,001,140 new cancer cases and 611,720 cancer deaths are projected to occur in the United States. Cancer mortality continued to decline through 2021, averting over 4 million deaths since 1991 because of reductions in smoking, earlier detection for some cancers, and improved treatment options in both the adjuvant and metastatic settings. However, these gains are threatened by increasing incidence for 6 of the top 10 cancers. Incidence rates increased during 2015–2019 by 0.6%–1% annually for breast, pancreas, and uterine corpus cancers and by 2%–3% annually for prostate, liver (female), kidney, and human papillomavirus-associated oral cancers and for melanoma. Incidence rates also increased by 1%–2% annually for cervical (ages 30–44 years) and colorectal cancers (ages <55 years) in young adults. Colorectal cancer was the fourth-leading cause of cancer death in both men and women younger than 50 years in the late-1990s but is now first in men and second in women. Progress is also hampered by wide persistent cancer disparities; compared to White people, mortality rates are two-fold higher for prostate, stomach and uterine corpus cancers in Black people and for liver, stomach, and kidney cancers in Native American people.”

Citing Harms, Momentum Grows to Remove Race From Clinical Algorithms A really good article that summarizes what professional organizations are doing to remove harmful racial inputs into algorithms.

About healthcare IT

 Apple begins selling pulse ox-free Apple Watches after reinstated import ban  “Apple began selling the new versions of the Apple Watch Series 9 and Ultra 2 on its website and in Apple stores on Thursday, the company confirmed to Fierce Medtech.
To comply with the import ban, the smartwatches will not offer the blood oxygen measurement feature that the original versions of those models did; though the pulse oximetry app icon will still appear on the devices, the app itself will not be available for use, and tapping it will direct users to the Health app on a connected iPhone for more information.” 

Today's News and Commentary

About Covid-19

 Association of nirmatrelvir for acute SARS-CoV-2 infection with subsequent Long COVID symptoms in an observational cohort study “Within an online observational cohort, treatment with nirmatrelvir [Paxlovid] among vaccinated, nonhospitalized individuals during first known SARS-CoV-2 infection was not associated with a lower prevalence of patient-reported Long COVID symptoms >90 days after infection. Treatment was not associated with fewer Long COVID symptoms or severe symptoms, although these endpoints were limited by rarity of these outcomes. Rebound symptoms or test positivity after nirmatrelvir treatment were not associated with Long COVID symptoms.”

Vaccine Effectiveness Against Long COVID in Children “This large retrospective study shows a moderate protective effect of SARS-CoV-2 vaccination against long COVID. The effect is stronger in adolescents, who have higher risk of long COVID, and wanes over time.”

About health insurance/insurers

Copay coupons for some drugs must count toward deductibles, after Biden court move “Insurers will have to count drug copay coupons toward deductibles and patient spending caps in most cases, after a Biden move in federal court on Tuesday.
Drug companies use copay coupons to help patients cover the cost of their drugs.”

Employer-Sponsored Health Insurance Premium Cost Growth and Its Association With Earnings Inequality Among US Families Findings  In this economic evaluation of US families receiving employer-sponsored health insurance, the mean cumulative lost earnings from 1988 to 2019 associated with growth in health insurance premiums was $125 340 per family (in 2019 dollars) or nearly 5% of total earnings over the 32-year period. In all 32 years of the study, health care premiums as a percentage of compensation were significantly higher for non-Hispanic Black and Hispanic families than for non-Hispanic White families.
Meaning  This study suggests that increasing health insurance premium costs are likely associated with decreased earnings and increased income inequality, including by race and ethnicity, among US families receiving employer-sponsored health insurance and are meaningfully associated with wage stagnation.”

CMS finalizes prior authorization rule expected to save $15B “CMS has finalized a rule to streamline the prior authorization process and improve the electronic exchange of health information that it estimates will save $15 billion over 10 years. 
The requirements generally apply to Medicare Advantage organizations, state Medicaid and Children's Health Insurance Program agencies, Medicaid managed care plans, CHIP-managed care entities and qualified health plan insurers on the federally facilitated exchanges…
Beginning primarily in 2026, certain payers will be required to include a specific reason when denying requests, publicly report certain prior authorization metrics and send decisions within 72 hours for urgent requests and seven calendar days for standard requests. 
The rule also requires affected payers to implement a Health Level 7 Fast Healthcare Interoperability Resources standard application programming interface to support electronic prior authorization.”

About hospitals and healthcare systems

 Acute Hospital Care at Home in the United States: The Early National Experience “Early national experience in providing AHCaH shows that a diverse group of medically complex patients received care with low rates of mortality (0.5% during hospitalization and 3.2% at 30 days), escalation (6.2%), skilled-nursing facility use (2.6%), and readmission (15.6%). Among the patients receiving AHCaH were those with dual eligibility, a disability, or dementia, with similar outcomes for socially vulnerable patients.”

About pharma

 US FDA approves Vertex/CRISPR gene therapy for an inherited blood disorder “The U.S. health regulator has approved Vertex Pharmaceuticals and CRISPR Therapeutics' gene therapy to treat [transfusion-dependent beta thalassemia] in patients 12 years and older,…
The decision earns the therapy, branded as Casgevy, the second U.S. approval after it was greenlighted in December for sickle cell disease, another inherited blood disorder. “

About healthcare personnel

Henry Ford files lawsuit over work visa rejections The reason this action is important is that the U.S. has a shortage of key healthcare personnel. This hospital is choosing to fight back for these two Canadian radiology techs.

About health technology

FDA clears handheld, AI-powered optical probe to evaluate lesions for skin cancer “The FDA has cleared its first artificial intelligence-powered device that checks out suspicious moles, bumps or lesions for the signs of skin cancer, with a handheld probe developed by DermaSensor. 
Designed for use by primary care providers, the noninvasive optical spectroscopy system is capable of helping to identify the three most common skin cancers at the point of care, including melanoma, basal cell carcinoma and squamous cell carcinoma.
The FDA said its de novo clearance aims the automated device toward people ages 40 and up. While not a screening tool or a complete diagnostic by itself, the DermaSensor can be used by physicians to help decide whether to refer a patient to a trained dermatologist: After scanning, the point-and-click AI system immediately delivers results stating either ‘investigate further’ or ‘monitor.’”

About healthcare finance

 General Catalyst's new health system company to acquire Summa Health “Venture capital firm General Catalyst is making good on its October promise to purchase a health system with about eight months left to spare.
In a Wednesday morning blog post and press release, General Catalyst announced that Health Assurance Transformation Corp. (HATCo) — its recently launched company focused on the health system space — has signed a non-binding letter of intent to acquire Akron, Ohio-based Summa Health…
Summa Health is among Ohio’s largest integrated healthcare delivery systems. It spans two acute care hospital campuses, 15 community medical centers, a rehab hospital, a health insurance arm, multi-specialty group practice and a research and medical education program. It employs more than 8,000 people…”

Today's News and Commentary

JPM24: Top trends for payers, providers and health tech companies to watch A good summary of this annual conference.

About Covid-19

COVID hospitalizations increase for 9th straight week: CDCFor the week ending Jan. 6, weekly COVID hospitalizations rose to 35,801. This marks the ninth straight week of increases, but remains lower than hospitalizations recorded at the same time last year.
Nearly 40% of all counties in the U.S. are in the medium category for hospital admission levels, meaning hospitals are seeing 10.0 to 19.9 new admissions for COVID-19 per 100,000 people in the past week.”

About health insurance/insurers

 2024 Medicare Advantage Landscape Easy-to-read update with good graphics.

About pharma

Medicare Patients on Pricey Drugs Are Saving Big This Year 
“Changes brought about by the 2022 Inflation Reduction Act mean that people on Part D plans now pay no more than roughly $3,300 on drugs annually—a number that could shift a bit based on whether they take brand or generic medications. In 2025, that cap will change again to a flat $2,000.”
Comment: The article does not comment on who pays the extra amounts and what the effect on premiums will be.

About the public’s health

 Flu activity dipped slightly nationwide, but experts say the virus isn't done with us yet “As many as 40 children and teenagers, including five babies younger than 5 months old, have died from the flu so far this season, as the virus continues to spread at high levels across most of the United States.
For the first time in months, the Centers for Disease Control and Prevention reported Friday a slight dip in how many people are getting the flu or being hospitalized from it, although experts warn that the virus isn't done yet.”

Analysis of Breast Cancer Mortality in the US—1975 to 2019 “Improvements in treatment and screening after 1975 were associated with a 58% reduction in breast cancer mortality in 2019, from an estimated 64 deaths without intervention to 27 per 100 000 women (age adjusted). Approximately 29% of this reduction was associated with treating metastatic breast cancer, 25% with screening, and 47% with treating stage I to III breast cancer.”

About healthcare IT

 Towards Conversational Diagnostic AI Fascinating article about how a Large Language Model (LLM) based AI system can be successfully used to interact diagnostically with patients.

About health technology

 Apple may evade import ban by nixing pulse ox sensor from Apple Watch, Masimo says In an attempt to avoid another pause on sales of its smartwatches equipped with blood oxygen sensors—which are the subject of a patent infringement case brought by Masimo—Apple in late December submitted to U.S. Customs and Border Protection a redesign of those Apple Watches that could exempt them from an import ban imposed by the U.S. International Trade Commission
They do so by completely removing the devices’ pulse oximetry technology, according to the document, a letter from Masimo’s attorney that was filed in federal appeals court Monday.”

About healthcare finance

 Medline Industries, LP completes acquisition of United Medco  “Medline’s acquisition of United Medco sparks a significant milestone in the growth of Medline’s Health Plans business. The transaction will augment the company’s distribution capabilities and member engagement solution offerings to Medicare Advantage, Managed Medicaid and commercial insurance markets.
United Medco is a segment-leading supplemental benefits administrator focused on serving the Medicare Advantage, Managed Medicaid and commercial insurance markets.”

Today's News and Commentary

About Covid-19

 Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States Despite the title, the page has the updated recommendations by age (see Table 1.).

 Covid kills nearly 10,000 in a month as holidays fuel spread, WHO says “Almost 10,000 coronavirus deaths were reported in December, and admissions to hospitals and intensive care units surged, World Health Organization Director General Tedros Adhanom Ghebreyesus said — with data indicating that holiday gatherings fueled increased transmission of the virus…
There was a 42 percent increase in hospitalizations and a 62 percent increase in ICU admissions from the previous month. Trends are based on data reported to the WHO from fewer than 50 countries, mostly in Europe and the Americas, said Tedros, who noted that this is not the full picture.”

About health insurance/insurers

 Medicare Pay Cuts Sought for Nursing Homes, Home Health Agencies “The Medicare Payment Advisory Commission voted Thursday to recommend base payment rate cuts of 7% for home health agencies, 5% for inpatient rehabilitation facilities, and 3% for nursing homes. But the panel is urging Congress to increase Medicare payments to hospitals, doctors, and dialysis centers in 2025.”

About hospitals and healthcare systems

 Medicare reimbursement hits new low Four things to know:

1. An AHA analysis published Jan. 10 shows that Medicare paid 82 cents for every dollar hospitals spent on care for Medicare patients in 2022 — the most recent year for which data is available. 
2. Medicare underpayments to hospitals hit $99.2 billion in 2022, almost two and a half times the amount in 2012, according to the report. 
3. The Medicare Payment Advisory Commission noted that hospitals' overall fee-for-service Medicare margin dropped to a record low in 2022 and expects low fee-for-service Medicare margins to persist. 
4. Hospitals' fee-for-service Medicare margin decline was driven by higher-than-expected inflation, reduced uncompensated care payments and the reinstatement of Medicare sequestration, according to MedPAC. One offsetting factor was higher payments for 340B drugs.”

About pharma

 CVS to close dozens of pharmacies in Target stores by April CVS Health Corp. plans to close dozens of its locations in Target Corp. discount stores as the drugstore chain grapples with rising costs in its pharmacy business.
A number of CVS’s 1,800 pharmacies in Target stores will be closed between February and April, a CVS spokesperson said, without specifying the exact count.

About the public’s health

 Chemicals Used in Plastic Materials: An Estimate of the Attributable Disease Burden and Costs in the United States “Plastics contribute substantially to disease and associated social costs in the United States, accounting for 1.22% of the gross domestic product [$226 billion-$289 billion]. The costs of plastic pollution will continue to accumulate as long as exposures continue at current levels. Actions through the Global Plastics Treaty and other policy initiatives will reduce these costs in proportion to the actual reductions in chemical exposures achieved. 

About healthcare IT

 Large language models to identify social determinants of health in electronic health records “Our models identified 93.8% of patients with adverse SDoH, while ICD-10 codes captured 2.0%. These results demonstrate the potential of LLMs in improving real-world evidence on SDoH and assisting in identifying patients who could benefit from resource support.”

About healthcare personnel

NP pay by specialty This list highlights how much primary care physicians need to pay to compete for NPs. This evidence counters those who say increased use of NPs or PAs is an easy solution to the primary care shortage.

Today's News and Commentary

About Covid-19

Vegetarian and plant-based diets associated with lower incidence of COVID-19 “Plant-based and vegetarian groups had a higher intake of vegetables, legumes and nuts, and lower intake of dairy and meat. After adjusting for important confounders, such as body mass index, physical activity and pre-existing medical conditions, the plant-based diet and vegetarian group had 39% (OR=0.61, 95% CI 0.44 to 0.85; p=0.003) and 39% (OR 0.61, 95% CI 0.42 to 0.88; p=0.009) lower odds of the incidence of COVID-19 infection, respectively, compared with the omnivorous group. No association was observed between self-reported diets and COVID-19 severity or duration.”

About health insurance/insurers

 US sets enrollment record for Obamacare plans “More than 20 million Americans have so far signed up for health insurance through the Affordable Care Act's (ACA) marketplace for this year, the highest since the inception of the law, according to data released on Wednesday.
Over 3.7 million people who have signed up for the 2024 plans are new enrollees, data from the U.S. Department of Health and Human Services (HHS) showed.”

About hospitals and healthcare systems

7 health systems selling labs Many are large systems and all are selling to Labcorp or Quest. Hospital outpatient labs are often money-makers, so this “trend” is a bit puzzling.

About the public’s health

 Recommended Adult Immunization Schedule, United States, 2024 The graphics are especially useful.

 US FDA allows import of syphilis drug to address shortages “The U.S. Food and Drug Administration will temporarily allow the import of a syphilis drug made by France's Laboratoires Delbert, the company said on Wednesday.
Laboratoires Delbert said it was coordinating with the health regulator to bring extencilline into the United States to address syphilis drug shortages, according to a letter on the FDA's website.
In June, Pfizer had warned that it would soon run out of supply of its drug, Bicillin L-A, used to treat syphilis and other bacterial infections in children because it has had to prioritize versions made for adults due to a spike in syphilis infections in that population at the time.”

About healthcare IT

 CES 2024: Elevance Health launches program to provide digital health-enabled smartphones to Medicaid members “Elevance Health is launching a new initiative that aims to put smartphones in the hands of Medicaid members who otherwise cannot connect to virtual services.
The offering is backed by funding from the Federal Communications Commissions' Affordable Connectivity Program, which seeks to ensure that individuals and families can secure affordable broadband access….
Through the program, eligible members will be provided with a phone that offers unlimited talk, text and data, and will be pre-loaded with a customized virtual health experience. Elevance is collaborating with Samsung as well as the three largest mobile carriers in Verizon, AT&T and T-Mobile.”

Today's News and Commentary

JPM24, Day 2: Hartford HealthCare touts outpatient strategy; Henry Ford Health pitches 'ambitious' $4.9B spending plan FYI

About Covid-19

With COVID on the rise, your at-home test may be taking longer to show a positive result “It used to be that someone might test positive for the coronavirus one or two days after the onset of symptoms using a rapid test, Hudson said. Now, positive results might not show up until the fourth day after symptoms start.
The delay in accurate test results is probably a result of people having accumulated immunity from COVID-19 over the years, whether from vaccinations or previous infections.”

About health insurance/insurers

 Medicaid Enrollment and Unwinding Tracker “At least 14,377,000 Medicaid enrollees have been disenrolled as of January 9, 2024, based on the most current data from all 50 states and the District of Columbia…
There is wide variation in disenrollment rates across reporting states, ranging from 62% in Texas to 10% in Maine…
Across all states with available data, 71% of all people disenrolled had their coverage terminated for procedural reasons.”

CMS rejected 1 in 3 Medicare Advantage ads in 2023 “The agency told Politico around 80% of the rejected ads were from third-party marketing organizations. 
2023 was the first year CMS required advertisers to submit television spots to the agency for prior approval to prevent misleading marketing. Over 9,500 advertisements for Medicare Advantage plans appear on the airwaves each day during the open enrollment period, according to KFF estimates.

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.

About pharma

 Rite Aid gets court approval for $575 million Elixir sale “Pharmacy chain Rite Aid Corp… received bankruptcy court approval to sell its Elixir pharmacy benefit manager business for $575 million.
Rite Aid filed for bankruptcy in October with an agreement to sell the Elixir business to pharmacy benefit manager (PBM) MedImpact Healthcare Systems for that price.”

About the public’s health

Researchers find a massive number of plastic particles in bottled water “Microscopic pieces of plastic are everywhere. Now, they've been found in bottled water in concentrations 10 to 100 times more than previously estimated.
Researchers from Columbia University and Rutgers University found roughly 240,000 detectable plastic fragments in a typical liter of bottled water. The study was published Monday in the Proceedings of the National Academy of Sciences.”

Biden administration rescinds much of Trump ‘conscience’ rule for health workers “The Biden administration will largely undo a Trump-era rule that boosted the rights of medical workers to refuse to perform abortions or other services that conflicted with their religious or moral beliefs.
The final rule released Tuesday partially rescinds the Trump administration’s 2019 policy that would have stripped federal funding from health facilities that required workers to provide any service they objected to, such as abortions, contraception, gender-affirming care and sterilization.”

About healthcare IT

 In the fight over abortion rights, the government bans its first company from tracking medical visits “The Biden administration stopped a company from selling data on people’s medical visits on Tuesday, its first settlement on a privacy issue that has many Americans concerned about who can see their most sensitive personal data — particularly visits to abortion providers.
After an investigation, the Federal Trade Commission said it had reached a settlement with Outlogic, a location data broker formerly known as X-Mode Social, which had been collecting information on people’s visits to medical centers…
According to the FTC, in one contract, Outlogic collected location data on people who visited certain medical facilities and then went to pharmacies or specialty infusion centers, and the data broker then shared its information with a clinical research company for marketing and advertising.”

About healthcare personnel

Multistate Licensure for Docs, Others Continues to Gain Steam “For physicians, the ability to practice in multiple states has been simplified through the Interstate Medical Licensure Compact (IMLC), a project coordinated in part by the Federation of State Medical Boards. A total of 39 states as well as Guam and the District of Columbia currently participate in the compact, which "is an agreement among participating U.S. states and territories to work together to significantly streamline the licensing process for physicians who want to practice in multiple states," according to the IMLC Commission
In 2022, more than 17% of all licenses issued to physicians were issued through the compact process, according to the commission's fiscal year 2023 annual reportopens in a new tab or window. In fiscal year 2023, the compact processed more than 19,000 applications, and nearly 31,000 licenses were issued through the compact's process.”

About health technology

The Future of People-Centred Health Innovation OECD High-Level Policy Forum 22 January 2024, available by signing up for remote viewing.

Nanowear gets FDA clearance for undergarment that estimates blood pressureDive Brief:

  • Nanowear has received 510(k) clearance for AI-enabled software that allows its wearable undergarment to estimate blood pressure.

  • The Food and Drug Administration decision covers software that processes electrocardiogram (ECG) data, heart sounds and thoracic impedance captured by the Simplesense wearable device to monitor blood pressure at home, in healthcare facilities and during medical research.

  • Nanowear is pitching the software as the “first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic.” The company cited Biobeat Technologies’ wrist and chest monitor as a predicate blood pressure device in its 510(k) filing.”

About healthcare finance

Payer M&A deals to watch in 2024 FYI

 

Today's News and Commentary

This week is the annual JP Morgan conference. For yesterday’s highlights, see:
JPM24, Day 1: Mayo Clinic partners with Cerebras; Corewell Health's post-merger savings
JPM24: Uber Health, Socially Determined team up to connect patients to healthy food, prescription delivery

For your amusement and chagrin: 10 healthcare names get Shkreli Awards for bad behavior

 About healthcare quality and patient safety

Diagnostic Errors in Hospitalized Adults Who Died or Were Transferred to Intensive Care Findings  In this cohort study of 2428 patient records, a missed or delayed diagnosis took place in 23%, with 17% of these errors causing temporary or permanent harm to patients. The underlying diagnostic process problems with greatest effect sizes associated with diagnostic errors, and which might be an initial focus for safety improvement efforts, were faults in testing and clinical assessment.
Meaning  Among hospitalized adults transferred to the ICU or who died in the hospital, diagnostic errors were common, harmful, and had underlying causes, which can be used to design future interventions.”

About pharma

 Walgreens to Pay Humana $360 Million to Settle Drug-Pricing Dispute “Walgreens… has agreed to pay $360 million to insurance company Humana to settle a lawsuit alleging the retail-pharmacy chain overcharged for prescription-drug reimbursements.
Walgreens disclosed the settlement in a securities filing last week. The company said it had asked a federal court to vacate a previous award in Humana’s favor for $642 million.”

J&J to pay $700 mln to settle states' talc-marketing probeJohnson & Johnson has come to a tentative agreement to pay about $700 million for settling claims by over 40 U.S. states that it wrongfully marketed its talc-based baby powder, Bloomberg News reported on Monday.
The settlement would avert potential lawsuits alleging J&J hid any links between the talc in its powder and various cancers, the report said citing people familiar with the deal.
J&J and representatives for state attorneys general are still working out the specific terms of the deal but have agreed on the total amount, Bloomberg News reported.”

About the public’s health

 Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis “In a sample of 58,529 people with a new insurer-approved PrEP prescription, we estimated risk-adjusted percentages of patients who abandoned (did not fill) their initial prescription across six out-of-pocket cost categories. We then simulated the percentage of patients who would abandon PrEP under hypothetical changes to out-of-pocket costs, ranging from $0 to more than $500. PrEP abandonment rates of 5.5 percent at $0 rose to 42.6 percent at more than $500; even a small increase from $0 to $10 doubled the rate of abandonment. Conversely, abandonment rates that were 48.0 percent with out-of-pocket costs of more than $500 dropped to 7.3 percent when those costs were cut to $0. HIV diagnoses were two to three times higher among patients who abandoned PrEP prescriptions than among those who filled them. These results imply that recent legal challenges to the provision of PrEP with no cost sharing could substantially increase PrEP abandonment and HIV rates, upending progress on the HIV/AIDS epidemic.”

Red Cross facing severe blood shortage “The American Red Cross sounded the alarm Sunday over a severe blood shortage facing the U.S. as the number of donors dropped to the lowest levels in two decades. 
The Red Cross said in an announcement that the number of people donating blood in the U.S. dropped 40 percent over the last 20 years, which can majorly disrupt those needing emergency blood transfusions and other operations. The organization added there was a 7,000-unit shortfall in blood donations between Christmas Day and New Year’s Day alone.”

About healthcare IT

 2023 year-end digital health funding: Break on through to the other side Following trends in the broader venture market, 2023 saw venture funding dive in digital health—continuing the downhill trajectory that began in 2022. Annual venture funding for 2023 closed out at $10.7B raised across 492 deals, the lowest amount of capital invested in U.S.-based digital health startups since 2019.”

 About healthcare finance

 Medical device maker Boston Scientific to buy Axonics for $3.7 billion “Medical device maker Boston Scientific said on Monday it had agreed to buy Axonics Inc for $3.7 billion, gaining access to devices used to improve bladder function.
The deal marks Boston Scientific's entry into sacral neuromodulation, a minimally invasive procedure used in the treatment of overactive bladder and fecal incontinence, and is the latest in efforts to scale up its urology business.”

Merck to Acquire Harpoon Therapeutics, Further Diversifying Oncology Pipeline “Merck… and Harpoon Therapeutics, Inc. today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Harpoon for $23.00 per share in cash for an approximate total equity value of $680 million…
Harpoon has developed a portfolio of novel T-cell engagers that employ the company’s proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, an engineered protein technology designed to direct a patient’s own immune cells to kill tumor cells, and ProTriTAC™ platform, applying a prodrug concept to its TriTAC® platform to create a therapeutic T-cell engager that is designed to remain inactive until it reaches the tumor.”

GSK boosts respiratory portfolio with $1.4 bln Aiolos Bio deal “GSK on Tuesday said it would acquire asthma drug maker Aiolos Bio in a deal worth up to $1.4 billion, as the British drugmaker boosts its growing respiratory diseases portfolio.
Founded in 2023, Aiolos is focused on developing therapies for respiratory and inflammatory conditions. It is currently developing 'AIO-001', a treatment for asthma which is ready to enter mid-stage clinical trials.”

Today's News and Commentary

State healthcare laws debuting in 2024 FYI

About Covid-19

CDC says JN.1 variant accounts for about 62% of COVID cases in US “The CDC said currently there is no evidence that JN.1 causes more severe disease and added current vaccines are expected to increase protection against JN.1.”
And in a related article: New COVID vaccine induces good antibody response to mutated viral variants “Researchers at Karolinska Institutet and Danderyd Hospital in Sweden have followed recipients of the new updated COVID-19 vaccine and analysed the antibody response to different SARS-CoV-2 variants. The results published in The Lancet Infectious Diseases show a surprisingly strong response to the now dominant and highly mutated Omicron variants.”

Hydroxychloroquine could have caused 17,000 deaths during Covid, study finds “The anti-malaria drug was prescribed to some patients hospitalized with Covid-19 during the first wave of the pandemic, "despite the absence of evidence documenting its clinical benefits," the researchers point out in their paper, published in the February issue of Biomedicine & Pharmacotherapy.
Now, researchers have estimated that some 16,990 people in six countries — France, Belgium, Italy, Spain, Turkey and the U.S. — may have died as a result.”

About health insurance/insurers

 Medpac public meeting Go to this site to sign up for the January meeting on the web.

Elevance Health sues HHS over Medicare Advantage star ratings changes “Elevance Health and its insurance subsidiaries are suing HHS for "unlawful, and arbitrary and capricious" methodology changes to how Medicare Advantage and Part D star ratings are calculated.
Using a system of 40 quality and performance measures, Medicare Advantage plans must receive star ratings of four or higher to earn quality bonus payments from CMS. The overall average MA star rating declined slightly in 2024, to an average of 4.04. 
In October, Elevance said it is expecting to lose around $500 million in revenue in 2025 as a result of declining star ratings.”

About hospitals and healthcare systems

Midwest systems Essentia Health, Marshfield Clinic call off merger plans “Duluth, Minnesota-based Essentia Health and Marshfield, Wisconsin-based Marshfield Clinic Health System have scrapped their plan to merge into a 25-hospital Midwest system.
The two nonprofit health systems said in a statement that they have ‘engaged in meaningful discussion’ over the last two years about how the organizations could combine their unique strengths.
’We have decided that a combination at this time is not the right path forward for our respective organizations, colleagues and patients,’ the health systems said in a statement posted to Essentia Health's website Friday.”

About healthcare IT

 Amazon rolls out service to connect customers with digital health benefits, taps Omada Health as launch partner “Amazon plans to collaborate with digital health companies to connect customers with virtual care benefits for managing conditions like diabetes and hypertension. The online retail giant tapped virtual-first chronic care provider Omada Health as its first partner.
Amazon's new health conditions program, which officially launched on Monday, aims to help customers find and enroll in virtual care benefits available to them through their employer or health plan at no extra cost.
Omada will be the first virtual diabetes prevention, diabetes and hypertension provider available in Amazon’s health conditions program…”

About healthcare finance

 J&J beefs up ADC pipeline by acquiring Ambrx for $2B  Johnson & Johnson has fattened up its antibody-drug conjugate (ADC) pipeline via the acquisition of Ambrx Biopharma for $2 billion.
By paying $28 per share, which J&J noted was a 105% premium of the La Jolla, Calif-based biotech’s closing price Friday, the pharma giant will get its hands on ARX517, an ADC that has had some success in prostate cancer during an early-stage trial.”

Isomorphic signs $3B in AI drug discovery pacts with Lilly, NovartisAlphabet launched Isomorphic Labs in 2021 to build on Google DeepMind's AlphaFold 2 AI technology that can be used to predict the structure of proteins in the human body, and ultimately help scientists identify new target pathways to deliver drugs for fighting disease. The latest version of AlphaFold extends its application to small molecules and nucleic acids.”

Today's News and Commentary

About Covid-19

Study Finds Paxlovid Treatment Does Not Reduce Risk of Long COVID “A team of researchers from UC San Francisco has found that Paxlovid (Nirmatrelvir-ritonavir) did not reduce the risk of developing long COVID for vaccinated, non-hospitalized individuals during their first COVID-19 infection. They also found a higher proportion of individuals than previously reported with rebound symptoms and test-positivity after taking Paxlovid.
The study appears Jan. 4, 2024, in the Journal of Medical Virology.”

Inpatient Costs of Treating Patients With COVID-19 “Findings  In this cross-sectional study of more than 1.3 million inpatient stays across the US, the adjusted direct cost to provide treatment increased from $10 394 at the end of March 2020 to $13 072 by March 2022, on average, adjusting for patient, stay, and hospital-level characteristics. Significant heterogeneity in costs by the comorbid conditions across US geographic regions and by patient discharge status were observed.
Meaning  The findings of this study suggest that average hospital cost to provide inpatient treatment during the largest pandemic in more than 100 years in the US increased 26% over a 2-year period; costs to provide inpatient care increased even as care practices changed, vaccination rates increased, and the variants of concern evolved.”

About health insurance/insurers

 Elevance's deal to buy Paragon Healthcare valued at over $1 billion “Elevance Health will buy private firm Paragon Healthcare for more than $1 billion, according to three people familiar with the matter, Axios reported on Thursday.
The health insurer had said earlier on Thursday it would acquire Paragon Healthcare, but did not disclose the financials of the deal.
After the acquisition, Paragon, which provides drug infusion services to patients at home and at its centres, will operate as part of CarelonRx, the pharmacy services segment within Elevance's health services division, Carelon.”

About hospitals and healthcare systems

Hospitals face more credit rating downgrades ahead, Fitch saysWhile 2023 didn’t face the same intensity of challenges as its predecessor, namely higher labor costs and disappointing revenues, not-for-profit hospitals are still a ways off from being stable, Fitch Ratings senior director Kevin Holloran said during a presentation Thursday…
 About two-thirds of the operators Holloran speaks with are meeting or exceeding pre-pandemic patient admittance levels, he said. But more of those beds are filled with sick patients, rather than those who are there for more profitable, elective surgeries.
’We’re not seeing improvements in margins fast enough,’ he said, and operating margins are still below the 3% level that allows hospitals to pay bills and bondholders, invest in capital projects and put some money aside.
The biggest reason for the delayed recovery is still labor shortages, not only for nurses but also for other essential staff like laboratory workers. As the population ages, the need for these critical roles continues to mount.” 

Hospital, payer price transparency compliance improves, but new requirements are kicking in this year “Across a total of 6,357 hospitals, 5,763 (90.7%) posted a machine-readable file (MRF) with at least some necessary service rates in 2023. This was an increase of 562 hospitals over the end of 2022, with Turquoise noting that most of the additions ‘were individual hospitals, often with unique MRF formats.’
Turquoise gave 2,634 of the hospitals posting MRFs a five-star rating for publishing ‘a complete MRF that contains cash, list and negotiated rates for a significant quantity of items and services,’ the group wrote. That list of top scorers grew 24% from the end of 2022, and now represent more than half of the total hospital field.
Specifically, Turquoise found that 83.1% of all hospitals have posted negotiated rates, 77.3% cash rates, 80.4% surgery rates, 80.8% imaging rates, 81.3% “BUCAH” rates (those from major insurers BCBS, United Healthcare, Cigna, Aetna and Humana) and 65.1% diagnostic-related group rates.”

About pharma

FDA approves Florida's plan to import cheaper drugs from Canada “The Food and Drug Administration says it has authorized Florida's proposed program to import selected drugs.
Under federal law, any state or tribe can submit a proposal for importation, and a few have. The law allows importation of certain prescription drugs in bulk if doing so would save Americans money without adding safety risks. The FDA also has to give its blessing…
The state has to clear a lot more hurdles, however, before imports could begin. Among other things, it has to specify which drugs it wants to import, verify that they meet FDA's standards and relabel them.”

 Eli Lilly to sell weight loss drugs directly to consumers; warns against 'cosmetic' usage  “Eli Lilly has launched a new website for customers with migraines, obesity and diabetes to order prescription drugs directly from the manufacturer, including weight loss medications such as Zepbound.
LillyDirect now offers disease management resources, including access to virtual or in-person provider support, and direct home delivery of prescriptions through third-party services, according to a Jan. 4 news release. Prescription deliveries will take place through LillyDirect Pharmacy Solutions, the manufacturer's digital pharmacy, and will have no shipping costs.”

Q1 2024 Walgreens Boots Alliance Inc Earnings Call Among the highlights are:
1. Boots continues to perform very well. Comment: Wonder why the division is for sale.
2. Plans to implement a cost-plus basis for drugs. Comment: Guess they are listening to Mark Cuban.
3. Completing planned closures of some VillageMD sites with plans to expand market penetration at the remaining offices. Comment: Nothing was revealed about how the company plans to improve its performance with financial risk models.

About healthcare finance

Healthcare Dealmakers — Jefferson Health, LVHN's $14B merger; Cigna's M&A shuffle and more A good recap of these deals.

Today's News and Commentary

Ave atque vale: Sidney M. Wolfe, Scourge of the Pharmaceutical Industry, Dies at 86 “Sidney M. Wolfe, a physician and consumer advocate who for more than 40 years hounded the pharmaceutical industry and the Food and Drug Administration over high prices, dangerous side effects and overlooked health hazards, bringing a new level of transparency and accountability to the world of medical care, died on Monday at his home in Washington.”

About Covid-19

 Another covid wave hits U.S. as JN.1 becomes dominant variant “While photos of positive coronavirus tests are once again proliferating across social media, fewer people are going to the hospital than a year ago. The Centers for Disease Control and Prevention reported 29,000 covid hospitalizations in the week before Christmas, the most recent data, compared with 39,000 the previous year. The agency has reported an average of 1,400 weekly deaths since Thanksgiving, less than half of the fatalities at the same point last year.”

About health insurance/insurers

 Cigna near deal to sell Medicare Advantage business to HCSC “Cigna is nearing a deal to sell its Medicare Advantage business to Health Care Service Corp., the Wall Street Journal reported Jan. 3. 
The outlet previously reported both Elevance Health and HCSC were eyeing the business. People familiar with the deal told the Journal Cigna is in exclusive talks with HCSC to sell the Medicare Advantage business for between $3 and $4 billion. 
Cigna had 599,000 Medicare Advantage members as of Sept. 30, a small portion of the company's 19 million insurance members.”

About pharma

New antibiotic uses novel method to target deadly drug-resistant bacteria, study says “The researchers began developing zosurabalpin by examining about 45,000 small antibiotic molecules called tethered macrocyclic peptides and identifying those that could inhibit the growth of different types of bacteria. After years of improving the potency and safety of a smaller number of compounds, the researchers landed on one modified molecule.
Zosurabalpin inhibits the growth of Acinetobacter baumannii by preventing the movement of large molecules called lipopolysaccharides to the outer membrane, where they’re needed to maintain the membrane’s integrity. This causes the molecules to accumulate inside the bacterial cell. Levels inside the cell become so toxic that the cell itself dies.”

 How Prices for the First 10 Drugs Up for U.S. Medicare Price Negotiations Compare Internationally “Highlights

  • List retail prices for the 10 selected drugs are, on average, three times higher in the United States than in the other high-income countries.

  • Prices after discounts and rebates in the U.S. are higher than almost all prices before discounts and rebates in peer countries, except for Xarelto, leaving significant room for further reductions in negotiation when compared with other countries.

  • Switzerland has the second-highest prices for most of the 10 drugs, but U.S. prices remain substantially higher.”

FDA looking into reports of hair loss, suicidal thoughts in people using popular drugs for diabetes and weight loss “The US Food and Drug Administration is evaluating reports of side effects such as hair loss and suicidal thoughts in people taking medications like Ozempic, Mounjaro and Wegovy.
These drugs, known as GLP-1 receptor agonists, are approved to treat diabetes or weight loss. They include semaglutide, branded as Ozempic, Rybelsus and Wegovy; liraglutide, branded as Saxenda and Victoza; and tirzepatide, branded as Mounjaro and Zepbound. They mimic GLP-1, a hormone made naturally in the body whose roles include slowing the passage of food through the stomach.”

About healthcare personnel

Healthcare job cuts up 91% from 2022 “Healthcare/products companies and manufacturers, including hospitals, announced the third-most job cuts in 2023 among 30 industries and sectors measured, according to one new analysis
Healthcare/products companies and manufacturers, including hospitals, announced 58,560 job cuts in 2023, a 91% increase from the 30,626 cuts announced the year prior.”

About health technology

 Ultrasound Blood–Brain Barrier Opening and Aducanumab in Alzheimer’s Disease “We applied focused ultrasound with each of six monthly aducanumab infusions to temporarily open the blood–brain barrier with the goal of enhancing amyloid removal in selected brain regions in three participants over a period of 6 months. The reduction in the level of Aβ was numerically greater in regions treated with focused ultrasound than in the homologous regions in the contralateral hemisphere that were not treated with focused ultrasound, as measured by fluorine-18 florbetaben positron-emission tomography. Cognitive tests and safety evaluations were conducted over a period of 30 to 180 days after treatment.”

About healthcare finance

 KKR-backed BrightSpring revives US IPO plan “KKR-backed BrightSpring Health Services on Tuesday filed for an initial public offering in the United States, reviving its plan to go public more than a year after aborting it.”

Today's News and Commentary

NY Gov. Hochul vetoes ‘wrongful death’ legislation opposed by insurers “New York Gov. Kathy Hochul again vetoed legislation that would permit families of ‘wrongful death’ victims to receive additional compensation for emotional suffering…
Her decision pleased the American Property Casualty Insurance Association, which lobbied against the bill. The APCIA claims the legislation would have resulted in ‘a major expansion of damages associated with wrongful death actions.’
The bill would have allowed unlimited noneconomic damages, including damages for grief and anguish. Likewise, it would have expanded the people that could bring a wrongful death action, extended the statute of limitations for wrongful death actions, and it would have had a retroactive impact.
Hochul’s concerns include the possibility of increased insurance premiums for consumers and a risk to the financial well-being of public hospitals and other health care facilities.”
Comment: This type of legislation is usually pushed by The American Association for Justice (AAJ), formerly the Association of Trial Lawyers of America (ATLA), whose members are paid on contingency.

About health insurance/insurers

Bundled Payments for Care Improvement and Quality of Care and Outcomes in Heart Failure “BPCI Model 2 was not associated with improved quality performance or outcomes in heart failure among participating hospitals.”

 Bright Health closes sale of Medicare Advantage business to Molina “Bright Health has closed the sale of its last insurance business to Molina Healthcare. 
The deal closed Jan. 1, according to a Jan. 2 news release from Molina. 
Long Beach, Calif.-based Molina paid $425 million for Bright Health's Medicare Advantage business in California, down from the originally announced purchase price of $510 million.”

About hospitals and healthcare systems

 BJC HealthCare, Saint Luke's Health System close $10B nonprofit health system merger “BJC HealthCare of St. Louis and Saint Luke’s Health System of Kansas City have officially completed their cross-market deal to merge into a single integrated, academic nonprofit health system.
The Missouri organizations’ arrangement brought Saint Luke’s under BJC’s organizational umbrella on Jan. 1. Though the two are maintaining responsibility for their original markets and branding, the new partners said they now operate as a single healthcare organization of 24 hospitals and 44,000 employees.”

About pharma

US FDA approvals bounce back in 2023, sparking hopes of a biotech recovery “The U.S. Food and Drug Administration approved nearly 50% more novel drugs in 2023 than in 2022, putting it back on pace with historical levels, an improvement analysts and investors said could lead to increased investment in biotech firms.
FDA nods for innovative therapies containing an active ingredient or molecule not previously approved, rose to 55 in 2023, up from 37 in 2022 and 51 in 2021. Historical data shows the FDA typically green lights about 45-50 new drugs a year and hit a peak of 59 in 2018.”

Three Warning Letters for Amazon in 2023, Company Named in Five OthersAmazon was hit with its third FDA warning letter of the year last week, this time for selling unapproved and incorrectly labeled products that contain the active ingredient in erectile dysfunction (ED) drugs Cialis and Viagra.
Just a month earlier, the mega online retailer got a warning letter for selling unapproved pink eye remedies. And in August, Amazon was slapped with a warning letter for selling unapproved products to treat molluscum contagiosum, an infection caused by a poxvirus that results in bumps on the skin.
Amazon was also named in five other warning letters this year aimed at companies selling unapproved and mislabeled drugs via Amazon’s site.”

FDA slams trio of Indian drugmakers with Form 483 filings after December inspectionsDr. Reddy’s Labs, Laurus Synthesis and Torrent Pharmaceuticals were each slammed with Form 483 filings from the FDA after the regulatory agency conducted a series of inspections in December.”

About the public’s health

Emergency rooms not required to perform life-saving abortions, federal appeals court rules “Federal regulations do not require emergency rooms to perform life-saving abortions if it would run afoul of state law, a federal appeals court ruled Tuesday.
After the overturn of Roe v. Wade in June 2022, the U.S. Department of Health and Human Services sent hospitals guidance, reminding them of their obligation to offer stabilizing care, including medically necessary abortions, under the Emergency Medical Treatment and Labor Act (EMTALA)…
Texas sued, saying this was tantamount to a “nationwide mandate that every hospital and emergency-room physician perform abortions.” Several anti-abortion medical associations joined the lawsuit as well.”

 Self-Reported Frequency of Adding Salt to Food and Risk of Incident Chronic Kidney Disease “These findings suggest that adding salt to foods is associated with increased risk of CKD in the general population, emphasizing the possible value of limiting discretionary salt to reduce CKD risk.”

Advance Provision of Mifepristone and Misoprostol via Online Telemedicine in the US According to this study, women are ordering these medications in advance of an unwanted pregnancy; they are worried the drugs will not be available if they should need them.

About healthcare IT

 When health records don’t capture patient deaths The point of this article is that IT systems are fragmented and not always interoperable,. The statistic that caught my attention was: “The average health system uses 18 different EHR vendors across affiliated providers.”

About healthcare finance

Goldman Sachs Asset Management raises $650 mln for life sciences fund “Goldman Sachs Asset Management said on Wednesday it had raised $650 million for a new fund that will invest in startups related to the life sciences sector.
The fund, West Street Life Sciences I, will specifically target early to mid-stage therapeutic companies with multi-asset portfolios as well as tools and diagnostics firms.”