Today's News and Commentary

Why Market Power Matters for Patients, Insurers, and Hospitals “Overall, our data show that the largest health systems have, on average, a combined 43.1% of the market share (as measured by total inpatient hospital discharges) in each state, while the top three large-group insurers hold an average of 82.2% of the market share in each state…
When the market share of an insurer far exceeds the market share of an individual health system — as is the case in most states, according to our analysis — that can negatively impact the amount that insurers are willing to pay hospitals and health systems for patient care.”

About healthcare quality

A National Quality Improvement Collaborative to Improve Antibiotic Use in Pediatric Infections “This multisite collaborative increased appropriate antibiotic use for community-acquired pneumonia, skin and soft tissue infections, and urinary tract infection among diverse hospitals.”
Comment: Read the methods and look at the Figures. This effort shows it is possible to improve quality on a national scale with projects across multiple unrelated pediatric institutions.

About health insurance/insurers

Payers ranked by medical loss ratios in Q1 FYI
and in a related story: Here's how major payers fared in a Q1 dragged by a cyberattack, MA challenges

Medicare Advantage extras on the chopping block in 2025 “Medicare Advantage insurers are planning to pare down their plan offerings in 2025. 
Facing lower reimbursement rates from CMS and higher medical costs, many plan executives said they will prioritize margins over growing their membership numbers.”

NORC Report Highlights Strong Satisfaction with Access to Care Through Employer-Provided Coverage [EPC] “Key takeaways from the report include:

  • 89% of survey respondents said their EPC has a provider network that includes options that are convenient for them.

  • 88% of respondents agreed their plan offered tools that helped them find in-network providers.

  • 82% of respondents said they had access to high-quality providers through their EPC.

  • The majority of respondents across all geographic areas reported high levels of satisfaction with their access to high-quality providers – even rural respondents, who can often face more barriers to care.”

About hospitals and healthcare systems

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

 15 health system projects worth $500M or more FYI

About the public’s health

Three health foundations tackle biggest disease threats in $300mn deal “The three largest charitable foundations focused on public health are to join forces for the first time to tackle climate change’s impact, infectious diseases and measures to improve nutrition and wellbeing. Denmark’s Novo Nordisk Foundation, the Bill & Melinda Gates Foundation and UK-based Wellcome will commit an initial total of $300mn over three years and aim to expand their collaboration to other public, private and philanthropic partners.” 

Nitrogen dioxide exposure, health outcomes, and associated demographic disparities due to gas and propane combustion by U.S. stoves “Gas and propane stoves increase long-term NO2 exposure 4.0 parts per billion volume on average across the United States, 75% of the World Health Organization’s exposure guideline. This increased exposure likely causes ~50,000 cases of current pediatric asthma from long-term NO2 exposure alone. Short-term NO2exposure from typical gas stove use frequently exceeds both World Health Organization and U.S. Environmental Protection Agency benchmarks. People living in residences <800 ft2 in size incur four times more long-term NO2 exposure than people in residences >3000 ft2 in size; American Indian/Alaska Native and Black and Hispanic/Latino households incur 60 and 20% more NO2 exposure, respectively, than the national average.”

Today's News and Commentary

About health insurance/insurers

 New Medicaid rule expected to lower wait times for home-based care, raise caregiver wages “The new rule brings sweeping changes to a bevy of Medicaid programs throughout the country, including fee-for-service and managed care delivery systems. One of the most notable changes applies to the home and community-based services (HCBS) industry. CMS will now require home-based care providers to use 80% of the Medicaid reimbursements they receive toward caregiver compensation.”

Healthcare billing fraud: 11 recent cases FYI

Biden administration: DACA recipients eligible for ACA coverage “Individuals who are part of the Deferred Action for Childhood Arrivals program will be able to enroll in ACA marketplace plans beginning in November.  
In a final rule published May 3, CMS said it will extend marketplace eligibility to DACA recipients. The immigration program allows individuals brought to the U.S. as children without legal status to remain in the country. 
CMS expects 100,000 uninsured DACA recipients could receive coverage through the program.” 

More Medicare enrollees are choosing supplement plans, data shows “The share of fee-for-service Medicare enrollees choosing a Medicare Supplement plan rose to 41.4% in 2022…
A majority of Medicare Supplement (56%) policyholders are women, while 41% are 75 years old or older. At the same time, a significant percentage of Medicare Supplement enrollees are people with lower incomes. For example, 21% have incomes below $30,000…”

About pharma

Novo Nordisk cuts price of weight loss drug Wegovy as competition heats up “Novo Nordisk is lowering prices of its weight loss drug Wegovy as it boosts sales volumes and responds to higher competition from US rival Eli Lilly, leading to lower than expected quarterly revenue from the blockbuster jab. The company said it was now prescribing the drug to 25,000 new patients in the US per week, compared with 5,000 in December.”

Label Accuracy of Weight Loss Dietary Supplements Marketed Online With Military Discounts “This case series study analyzed 30 dietary supplement products purchased from online companies advertising military discounts for products with claims about weight loss. Twenty-five had inaccurate labels, 24 were misbranded, 7 had hidden components detected, and 10 contained substances prohibited for military use.” 

Coming to a CVS Near You: A Store Brand Monoclonal Antibody “Last year, CVS Health launched a venture called Cordavis, a unit that will partner with drug manufacturers to commercialize these biosimilar drugs.”

Walgreens inks deal with Boehringer Ingelheim to advance clinical trials for obesity treatment “The company signed a deal with Boehringer Ingelheim to use its community pharmacies as clinical trial sites for people living with obesity, overweight and type 2 diabetes.
Walgreens launched its clinical trials unit back in June 2022 as the company's healthcare ambitions continue to grow. The company has signed more than 35 clinical trial contracts with drugmakers including Freenome and Prothena.”

About the public’s health

 HHS' final rule to combat disability discrimination: What healthcare leaders should know “HHS finalized a rule May 1 that updates protections against disability discrimination in healthcare.”
Among the provisions:
“The final rule…bans the use of ‘any measure, assessment or tool that discounts the value of a life extension on the basis of disability to deny, limit, or otherwise condition access to an aid, benefit or service.’ Additionally, the final rule includes a definition of accessibility for websites and mobile applications; adoption of the U.S. Access Board's standards for accessible medical diagnostic equipment; details of requirements to ensure nondiscrimination in the services provided by HHS-funded child welfare agencies; and clarification around obligations to provide services in the most integrated setting appropriate for those with disabilities, according to HHS.”

Today's News and Commentary

About health insurance/insurers

Cigna writes off $1.8B of its investment in Walgreens' VillageMD “In late 2022, Cigna's Evernorth unit made a $2.5 billion investment in VillageMD, and gained a minority stake in the primary care business that was primarily owned by Walgreens.
In the first quarter of 2024, the company conducted a write-down of more than half of its investment in the provider, writing off about $1.8 billion of its stake in the company. Executives said that VillageMD has underwhelmed in growth as Walgreens shuts down large numbers of clinics.”

About hospitals and healthcare systems

 National Hospital Flash Report: April 2024 “Key Takeaways
1. Margins and other key performance indicators declined slightly in March. While
hospitals performed relatively well in the first quarter of 2024, declines in volume and
associated revenue in March may signal more challenges ahead.
2. Hospital outpatient revenue fell 5% in March, reflecting the competitive challenges of providing outpatient care.
3. Increases in bad debt and charity, along with increases in days A/R, pose challenges and opportunities for hospitals’ revenue cycles and overall collections.” 

About pharma

Novo says 25K patients a week begin Wegovy, as US starter dose supplies quadruple “Novo Nordisk has managed to quadruple supplies of introductory doses of Wegovy in the US since the end of last year, meaning that around 25,000 patients per week are starting treatment with the weight-loss therapy, compared to about 5000 each week in December.”

 Novartis drops $1B on buying radioligand therapy firm Mariana “Novartis is spending a further $1 billion to bolster its radioligand therapy (RLT) portfolio with the acquisition of Mariana Oncology, whose lead actinium-based candidate MC-339 is set to enter the clinic. The deal announced Thursday marks the second one this week for the Swiss drugmaker in the RLT space, following an agreement with PeptiDream.” 

About the public’s health

Translational Research of the Acute Effects of Negative Emotions on Vascular Endothelial Health: Findings From a Randomized Controlled Study “In this randomized controlled experimental study, a brief provocation of anger adversely affected endothelial cell health by impairing endothelium‐dependent vasodilation.”
Comment: These finding may be elucidate one reason for an increase in heart attacks when someone is angry.

Pregnancy-related deaths are dropping. “The maternal mortality rate in 2022 was 22.3 deaths per 100,000 live births, compared with 32.9 per 100,000 in 2021, according to the new report.
‘It’s looking like it’s returning to a pre-pandemic level,’ said Donna Hoyert, the report’s author and an NCHS health scientist. The same appears to be true for preliminary 2023 data, she said.
Decreases were noted across all age groups and races, though Black women continue to be disproportionately affected. Their maternal mortality rate was 49.5 deaths per 100,000 live births in 2022. In 2021, it was 69.9 deaths per 100,000.”

About health technology

Medline to buy Ecolab’s surgical product unit for nearly $1 billion “Medline Industries, the Northfield-based medical products manufacturer and distributor, has agreed to acquire the surgical equipment segment of Ecolab for nearly $1 billion.
The deal, announced this week, will give Medline innovative sterile drape products for surgeons, patients and operating room equipment as well as a fluid temperature management system.”

Today's News and Commentary

About Covid-19

 Hospitals no longer required to report COVID-19 data to CDC “Per guidance documents from the Department for Health and Human Services released in November, April 30 is the last day hospitals must report their COVID-19 data to the Centers for Disease Control and Prevention’s (CDC's) National Healthcare Safety Network (NHSN).” 

About hospitals and healthcare systems

How Safe is Your Hospital? FYI- Latest Leapfrog Group survey.

 Tenet posts $2.2B net income in Q1 “Dallas-based Tenet Healthcare posted a net income of $2.2 billion in the first quarter of 2024 up from $143 million posted in the same period last year, according to its April 30 financial report.”
About pharma

 FTC adds diabetes and weight loss drugs to its ‘junk’ patent crusade After warning drugmakers in September that it wouldn’t hesitate to take legal action against “junk” patent listings, the US Federal Trade Commission (FTC) sent warning letters to 10 manufacturers on Tuesday disputing the accuracy or relevance of more than 300 patents listed in the FDA’s Orange Book. 
Letter recipients include AstraZeneca and Novo Nordisk over patents for their obesity and type 2 diabetes injectable drugs, including the latter’s Ozempic (semaglutide), as well as Amphastar Pharmaceuticals and its type 1 diabetes treatment Baqsimi (glucagon). The biotech gained the nasal spray from Eli Lilly last year in a deal potentially worth over $1 billion.
Drugmakers now have 30 days to withdraw or amend the questioned patent listings, or certify that each is compliant with regulations.” 

CVS reports $1.1B income in Q1, cuts earnings guidance “CVS Health cut its earnings guidance for 2024 based on rising medical costs. 
CVS Health reported $1.1 billion in net income in the first quarter of 2024, according to its latest earnings documents, published May 1…
The healthcare giant revised its 2024 earnings per-share guidance to at least $5.64 from at least $7.06. This is the second time CVS has cut its earnings guidance this year based on rising medical cost trends, especially among the Medicare Advantage population.”

Pfizer plans direct-to-consumer platform for Covid and migraine treatments “Pfizer is developing an online platform for patients to order medicine including anti-Covid drug Paxlovid and a migraine nasal spray, according to people familiar with the matter, in the latest push by drugmakers to cut out industry middlemen and sell straight to consumers. The website, which is expected to launch later this year, would connect customers in the US with independent telehealth consultants to prescribe the medications, while a drug-dispensing partner would fill and ship the prescriptions, the people said.”

About the public’s health

Mortality and morbidity ramifications of proposed retractions in healthcare coverage for the United States “…raising Medicare age eligibility and the addition of work requirements for Medicaid qualification have been proposed, while termination of continuous enrollment for Medicaid was recently effectuated. Here, we assess the potential impact on mortality and morbidity resulting from these policy changes. Our findings indicate that the policy change to Medicare would lead to over 17,000 additional deaths among individuals aged 65 to 67 and those to Medicaid would lead to more than 8,000 deaths among those under the age of 65.”

The Women’s Health Initiative Randomized Trials and Clinical Practice “To inform clinical practice about the health effects of menopausal hormone therapy, calcium plus vitamin D supplementation, and a low-fat dietary pattern, the Women’s Health Initiative (WHI) enrolled 161 808 postmenopausal US women (N = 68 132 in the clinical trials) aged 50 to 79 years at baseline from 1993 to 1998, and followed them up for up to 20 years…
 For postmenopausal women, the WHI randomized clinical trials do not support menopausal hormone therapy to prevent cardiovascular disease or other chronic diseases. Menopausal hormone therapy is appropriate to treat bothersome vasomotor symptoms among women in early menopause, without contraindications, who are interested in taking hormone therapy. The WHI evidence does not support routine supplementation with calcium plus vitamin D for menopausal women to prevent fractures or a low-fat diet with increased fruits, vegetables, and grains to prevent breast or colorectal cancer. A potential role of a low-fat dietary pattern in reducing breast cancer mortality, a secondary outcome, warrants further study.”

Healthy lifestyle could counteract effects of life-shortening genes “An unfavorable lifestyle was associated with a 78% heightened risk of death, regardless of genetic determinants. But a favorable lifestyle could potentially mitigate the genetic risk of premature death by approximately 62%…”

Today's News and Commentary

About health insurance/insurers

Trump Association Health Plan Rule Axed by Labor Department “The US Department of Labor has rescinded a Trump-era rule that made it easier for small businesses and self-employed people to use cheaper association health plans that don’t comply with all the requirements of the Affordable Care Act.
The final Biden rule (RIN:1210-AC16) on association health plans was issued by the DOL’s Employee Benefits Security Administration Monday after clearing White House review, and will take effect 60 days after its April 30 publication in the Federal Register.”

Court says state health-care plans can’t exclude gender-affirming surgery “A federal appellate court in Richmond became the first in the country to rule that state health-care plans must pay for gender-affirming surgeries, a major win for transgender rights amid a nationwide wave of anti-trans activism and legislation.” 

About hospitals and healthcare systems

Walmart shuttering all 51 health centers, citing lack of profitability “Walmart is shuttering all 51 of its healthcare clinics along with its virtual care services, the retail giant announced Tuesday morning.
‘Through our experience managing Walmart Health centers and Walmart Health Virtual Care, we determined there is not a sustainable business model for us to continue,’ company executives announced in a press release.”
Comment: Shades of Walgreens and VillageMD?

About pharma

Judge rejects J&J, Bristol Myers Squibb challenges to Medicare drug-price negotiations “A federal judge in New Jersey rejected Johnson & Johnson’s and Bristol Myers Squibb’s legal challenges to the Biden administration’s Medicare drug-price negotiations, ruling that the program is constitutional.”

Estimated Medicare Part D Savings From Generic Drugs With a Skinny Label “Actual Medicare spending on these 15 drugs and their skinny-label generics was estimated to be $16.8 billion, and projected spending without generic competition was $31.5 billion. Thus, skinny-label generic competition saved Medicare approximately $14.6 billion. Estimated savings were the greatest for rosuvastatin (Crestor, AstraZeneca; $6.5 billion), pregabalin (Lyrica, Pfizer; $4.2 billion), and imatinib (Gleevec, Novartis; $3.1 billion)…”
Background: “To prevent these from indefinitely delaying generic competition, federal law allows the FDA to approve generic drugs that carve out brand-name drug indications protected by patents or exclusivities. For example, when generic versions of the β-blocker carvedilol (Coreg, GlaxoSmithKline) launched in 2007, their labels listed indications for hypertension and myocardial infarction but not for heart failure, because this indication remained patent protected.
These ‘skinny-label’ generic drugs are frequently the first to enter the U.S. market, can dramatically lower costs for patients and the health care system, and can be used off label for the carved-out indications.”

Enormous Demand for Weight-Loss Drugs Drives Up Total U.S. Prescription Spending “Blockbuster growth in weight-loss drugs was the main driver of a 13.5% increase in spending on prescription medications in the U.S. in 2023, according to ASHP's (American Society of Health-System Pharmacists) report, National Trends in Prescription Drug Expenditures and Projections for 2024. By contrast, hospital drug spending dipped slightly as the pandemic ended and remdesivir injections were replaced by less-costly oral COVID treatments.”

About the public’s health

Screening for Breast Cancer:US Preventive Services Task Force Recommendation Statement “The USPSTF recommends biennial screening mammography for women aged 40 to 74 years. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening mammography in women 75 years or older. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of supplemental screening for breast cancer using breast ultrasonography or MRI in women identified to have dense breasts on an otherwise negative screening mammogram. (I statement)”

DEA plans to reclassify marijuana as a lower-risk drug, officials say “The measure, if enacted, would not instantly legalize marijuana at the federal level but could broaden access to the drug for medicinal use and boost cannabis industries in states where it is legal.”

Biomarkers of metal exposure in adolescent e-cigarette users: correlations with vaping frequency and flavouring “Vaping in early life could increase the risk of exposure to metals [lead and uranium], potentially harming brain and organ development. Regulations on vaping should safeguard the youth population against addiction and exposure to metals.”

About healthcare personnel

No One Can See You Now: Five Reasons Why Access to Primary Care Is Getting Worse (and What Needs to Change) An excellent analysis of this problem.
“This assessment identifies five reasons why primary care in the United States is inaccessible for so many Americans…
Reason 1: The primary care workforce is not growing fast enough to meet population needs.
•The number of primary care physicians (PCPs) per capita has declined over time from a high of 68.4 PCPs per 100,000 people in 2012 to 67.2 PCPs per 100,000 people in 2021.
•While the rate of total clinicians in primary care, inclusive of nurse practitioners (NPs) and physician assistants (PAs), has grown over the past several years, it is still insufficient to meet the demands of overall population growth…
Reason 2: The number of trainees who enter and stay on the professional pathway to primary care practice is too low, and too few primary care residents have community-based training.
Reason 3: The US continues to underinvest in primary care.
Reason 4: Technology has become a burden to primary care.
Reason 5: Primary care research to identify, implement, and track novel care delivery and payment solutions is lacking.”

In a related article:  Med school association projects physician shortfall of 86,000 by 2036 “Based on 2036 projections:

  • There will be a shortage of 20,200 to 40,400 primary care doctors.

  • Surgical specialties will have a shortage of 10,100 to 19,900 physicians.

  • Medical specialties could have a shortage of 5,500 to a surplus of 3,700 doctors, if surpluses arise in specialties such as critical care/pulmonology and endocrinology.

  • Other specialties could face a shortage of 19,500 to a surplus of 4,300 physicians, if surpluses in emergency medicine and physical medicine and rehabilitation materialize.”

Today's News and Commentary

About health insurance/insurers

Biden administration reinstates LGBTQ+ protections in health care “The Biden administration announced Friday it is reinstating federal protections for LGBTQ+ people seeking health care that had been unraveled during the Trump administration.
The move comes after years of legal disputes and pressure from activists to protect patients who are undergoing gender affirming treatment or who received abortions from being denied other forms of health care. Conservatives oppose the rules prohibiting discrimination, contending they would force providers to provide services against their religious beliefs.”

About hospitals and healthcare systems

43 health systems ranked by long-term debt FYI

About pharma

Cardinal Health Reaffirms Fiscal 2024 non-GAAP EPS Guidance and Long-term Targets Amidst Nonrenewal of OptumRx Customer Contracts “Cardinal Health announced today that its pharmaceutical distribution contracts with OptumRx, which expire at the end of June 2024, will not be renewed… 
Sales to OptumRx generated 16% of Cardinal Health's consolidated revenue in fiscal year 2023.”
The contract is going to McKesson.

WHAT 2,500+ PATIENT GROUPS SAY ABOUT PHARMA IN 2023/4 Comment: Interesting survey, given the negative attention Congress has paid to this sector. During the Covid-19 pandemic, the favorability rating was 60%. The last survey showed it decreased to 57%, still an historically high ranking. What is very interesting is the approval rating is higher than each EU country (except Austria), Sweden, the UK and Ireland.

About the public’s health

 Updates on Highly Pathogenic Avian Influenza (HPAI) “The FDA has received additional results from an initial limited set of geographically targeted samples as part of its national commercial milk sampling study underway in coordination with USDA. The FDA continues to analyze this information; however, preliminary results of egg inoculation tests on quantitative polymerase chain reaction (qPCR)-positive retail milk samples show that pasteurization is effective in inactivating HPAI.
This additional testing did not detect any live, infectious virus. These results reaffirm our assessment that the commercial milk supply is safe.”

Respiratory Syncytial Virus vs Influenza Virus Infection: Mortality and Morbidity Comparison Over 7 Epidemic Seasons in an Elderly Population “This study included the largest cohort of patients infected with RSV aged >75 years documented in-depth thus far. RSV shares a comparable mortality rate with influenza but is associated with higher rates of consolidative pneumonia, hospitalization, ICU admissions, and extended hospital stays.”
More reasons to get RSV immunization.

Antimicrobial-resistant hospital infections remain at least 12% above pre-pandemic levels, major US study finds “Latest report on the status of antimicrobial resistance in US hospitals finds that during the COVID-19 pandemic, hospital-acquired antimicrobial-resistant infections increased by 32%, and they still remain at least 12% above pre-pandemic levels.”

About healthcare IT

FTC Finalizes Changes to the Health Breach Notification Rule [HBNR] “The HBNR requires vendors of personal health records (PHR) and related entities that are not covered by the Health Insurance Portability and Accountability Act (HIPAA) to notify individuals, the FTC, and, in some cases, the media of a breach of unsecured personally identifiable health data. It also requires third party service providers to vendors of PHRs and PHR related entities to notify such vendors and PHR related entities following the discovery of a breach.”
See the notice for more details. 

About health technology

Philips shares surge after $1.1bn settlement over sleep apnoea devices “Dutch group Philips has agreed to settle litigation linked to its machines that treat night-time breathing problems for $1.1bn, ending a long-running legal battle and sending its shares up as much as 37 per cent on Monday. The Amsterdam-listed group said it had reached a deal with plaintiffs in the US to end “uncertainty” from the litigation, without admitting liability in personal injury claims and a medical monitoring class action suit. In 2021, Philips recalled certain machines used to treat sleep apnoea after it was found that foam used in the devices could break down and be inhaled or swallowed, according to the US Food and Drug Administration.”

FDA finalizes rule to bring lab-developed tests into the regulatory fold “At its heart, the 528-page final rule looks to make clear that in vitro diagnostic tests are to be considered medical devices like any other under the Federal Food, Drug & Cosmetic Act, the decades-old law that grants the agency its authorities.
In the past, the FDA made allowances for tests that were developed for limited use within a laboratory, and did not require them to clear the agency’s review process. Commonly referred to as LDTs, they were originally categorized as a product with lower risks compared to mass-marketed diagnostic kits, because they were typically produced in small volumes using common lab equipment.”

Today's News and Commentary

About health insurance/insurers

 New California rule aims to limit health care cost increases to 3% annually “Doctors, hospitals and health insurance companies in California will be limited to annual price increases of 3% starting in 2029 under a new rule state regulators approved Wednesday in the latest attempt to corral the ever-increasing costs of medical care in the United States.
The money Californians spent on health care went up about 5.4% each year for the past two decades. Democrats who control California’s government say that’s too much, especially since most people’s income increased just 3% each year over that same time period.
The 3% cap, approved Wednesday by the Health Care Affordability Board, would be phased in over five years, starting with 3.5% in 2025. Board members said the cap likely won’t be enforced until the end of the decade.”

Centene posts $1.2B profit in Q1 “Centene reported nearly $1.2 billion in net income in the first quarter and a more than 18% decrease in Medicaid membership year over year, according to its first-quarter earnings posted April 26.”

About pharma

 FDA Approves Over-the-Counter Naloxone Nasal Spray for Opioid Overdose “Amneal Pharmaceuticals announced on April 24, 2024, that the US Food and Drug Administration (FDA) approved the over-the-counter naloxone hydrochloride nasal spray for emergency treatment of an opioid overdose.”

Evernorth's Accredo to offer Humira biosimilar at $0 out-of-pocket “Evernorth's Accredo arm will make a Humira biosimilar available to patients with no out-of-pocket costs, the company announced Thursday. Accredo is the specialty pharmacy segment within Evernorth Health Services, which also houses Express Scripts, eviCore data analytics and MDLIVE telehealth services. Beginning this June, the low- and high-concentration biosimilar will be produced for Evernorth's private label distributor, Quallent Pharmaceuticals, in partnership with multiple manufacturers.
Evernorth is a subsidiary of The Cigna Group.”

GlaxoSmithKline sues Pfizer and BioNTech over Covid-19 vaccine technology “GSK said in the lawsuit that Pfizer and BioNTech's Comirnaty vaccines violate the company's patent rights in mRNA-vaccine innovations developed "more than a decade before" the outbreak of the COVID-19 pandemic.”

Pfizer scores FDA nod for hemophilia B gene therapy, will charge $3.5M per dose “The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022.
Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday to Fierce Pharma.”

About the public’s health

 U.S. Fertility Rate Falls to Record Low “The total fertility rate fell to 1.62 births per woman in 2023, a 2% decline from a year earlier, federal data released Thursday showed. It is the lowest rate recorded since the government began tracking it in the 1930s.”
Comment: This trend will have dire consequences for funding such pension-modeled programs as Medicare,

About healthcare IT

 Kaiser Permanente reports data breach impacting 13.4M health plan members  “Kaiser Permanente has begun notifying millions of its health plan members that the company was hit with a data breach in mid-April, according to a filing with the feds.
The Kaiser Foundation Health Plan said about 13.4 million people were affected and submitted the required documentation to the Department of Health and Human Services on April 12. That notice was posted publicly on Thursday.
Kaiser Permenante told Reuters it has not identified any misuse of those data.”

Teladoc posts $82M Q1 loss year over year “In the first quarter of 2024, Teladoc's revenue reached $646 million, a 3% increase compared to the $629 million in revenue it reported in the same period last year.”

 

Today's News sand Commentary

About anti-trust
FTC Chief Warns of Healthcare Price Fixing Risks Amid Tech Advancements “In a recent media event hosted by KFF, Lina Khan, chair of the Federal Trade Commission (FTC), issued a warning about the potential for price fixing in healthcare facilitated by technological advancements. Khan highlighted how algorithms enable companies to fix prices without explicit coordination, presenting a new challenge for regulators.
Khan emphasized the potential harm that technological advances can inflict on consumers. She pointed out that algorithms are increasingly utilized by companies to discriminate against individual consumers, ushering in what she termed ‘a somewhat novel era of pricing.”
Comment: For decades, actuaries have used similar (and evolving) models for insurance pricing.These algorithms are based on real world data and statistical analysis. How does this process morph into anti-trust?

FTC bans contracts that keep workers from jumping to rival employers “The Federal Trade Commission on Tuesday banned noncompete agreements for most U.S. workers, a move that will affect an estimated 30 million employees bound by contracts that restrict workers from switching employers within their industry.
The agency voted 3-2 to issue the rule, with commissioners in the majority saying they saw a mountain of evidence that noncompete agreements suppress wages, stifle entrepreneurship and gum up labor markets. The new rule makes it illegal for employers to include the agreements in employment contracts and requires companies with active noncompete agreements to inform workers that they are void.”
In a related article: FTC votes 3-2 on final rule to ban noncompete agreements, but legal challenges expected “The ban does not apply to nonprofits including many of the country’s healthcare provider organizations due to the limitations of the FTC’s jurisdiction, one of several points of contention that’s been raised by hospital industry groups that have opposed the ban.”

Is There Too Little Antitrust Enforcement in the U.S. Hospital Sector? “From 2002 to 2020, there were over 1,000 mergers of U.S. hospitals. During this period, the Federal Trade Commission (FTC) took enforcement actions against 13 transactions. However, using the FTC’s standard screening tools, we find that 20% of these mergers could have been predicted to meaningfully lessen competition. We then show that, from 2010 to 2015, predictably anticompetitive mergers resulted in price increases over 5%. We estimate that approximately half of predictably anticompetitive mergers had to be reported to the FTC per the Hart-Scott-Rodino Act. We conclude that there appears to be underenforcement of antitrust laws in the hospital sector.”

In a different article with the “same” message:
New evidence on the impacts of cross-market hospital mergers on commercial prices and measures of quality “Six years after acquisition, cross-market hospital mergers had increased acquirer prices by 12.9% (CI: 0.6%–26.6%) relative to control hospitals, but had no discernible impact on mortality and readmission rates for heart failure, heart attacks and pneumonia.
For serial acquirers, the price effect increased to 16.3% (CI: 4.8%–29.1%). For all acquisitions, the price effect was 21.8% (CI: 4.6%–41.7%) when the target's market share was greater than the acquirer's market share versus 9.7% (CI: −0.5% to 20.9%) when the opposite was true. The magnitude of the price effect was similar for out-of-state and in-state cross-market mergers.”
See, also: The Price Effects of Cross-Market Mergers: Theory and Evidence from the Hospital Industry

About health insurance/insurers

Humana plans to leave some Medicare Advantage markets in 2025 “The company reported its first quarter earnings April 24. Humana posted a $741 million in net income in the first quarter of 2024, beating investor expectations, but pulled its 2025 earnings guidance…
 On an April 24 call with investors, Humana executives said it will look to pull back benefits and exit some markets, as CMS continues phasing in risk adjustment changes.”

Optum shutting down telehealth business “UnitedHealth Group's Optum Virtual Care is shutting down, Endpoints News reported April 24.”

CMS unveils managed care rule, refutes nursing home rule complaints “Medicaid managed care plans and the Children’s Health Insurance Program (CHIP) will be subject to new wait time standards and quality ratings requirements, the Centers for Medicare & Medicaid Services (CMS) revealed during a flurry of regulatory activity Monday.
The rule implements a maximum appointment wait time of 15 business days for primary care and 10 business days for mental health and substance use disorder services.”

About hospitals and healthcare systems

 Advocate Health posts $2.2B net income in 2023 “The system posted $31.7 billion in total revenue and $31.1 billion in total expenses, according to the report. It posted a total nonoperating income of $1.6 billion.”
See the article for more details.

California Hospital Association sues Anthem Blue Cross over discharge delays “The California Hospital Association has filed suit against Anthem Blue Cross, alleging the insurer's authorization protocols for post-acute care leave patients stuck with long waits for discharge.
The lawsuit claims that Anthem failed to maintain an adequate network for these services and that it does not pay for additional hospital services incurred by patients who are waiting for discharge.”
Comment: Hospitals are held responsible for lengths of stay; however, some reasons for excess LOS are out of their control.

About pharma

 25 most popular drugs in healthcare FYI. Top 5:
1. Semaglutide — $38.6 billion (100.1% change from 2022)
2. Adalimumab — $35.3 billion  (9.1% change)
3. Apixaban — $22.1 billion (17.1% change)
4. Dulaglutide — $16.3 billion (5.1% change) 
5. Empagliflozin — $15.9 billion (34% change)

25 most expensive hospital drugs FYI. TOP 5:
Pembrolizumab — $1.4 billion (4.4% change from 2022)
Immune globulin — $1 billion (-5.1% change)
Remdesivir — $727,409,000 (-45% change)
Bictegravir/emtricitabine/tenofovir/alafenamide — $643,390,000 (18.9% change)
Sugammadex — $636,441,000 (23.9% change)

U.S. $772.5B PHARMACY SPEND IN 2023 DRIVEN BY WEIGHT-LOSS DRUGS KEY TAKEAWAYS
Hospitals' drug spending fell by 1.1%, continuing a steady period of falling expenditures that was interrupted during the COVID pandemic.
—Drug cost inflation was marginal (2.9%) and for the fourth straight year lagged the 3.4% inflation in the overall economy as measured by the Consumer Price Index.
—Spending for semaglutide doubled in 2023, making it the top-selling drug in the nation, replacing autoimmune disease drug adalimumab, which also saw sales growth despite the availability of cheaper biosimilars.
—Retail pharmacies accounted for $307.8 billion (42.6%) of total expenditures, mail-order pharmacies $206.6 billion (28.6%), clinics $135.7 billion (18.8%), and nonfederal hospitals $37.1 billion (5.1%).”
In a related article: Diabetes drugs helping to drive rise in US medication expenditures Key takeaways: —Total expenditures for diabetes medications rose from $27.15 billion in 2011 to $89.17 billion in 2020.
—Expenditures increased for insulin, incretin mimetics, DPP-IV inhibitors and combination drugs.”

Pharma groups warn of supply crunch over China spying law “Western pharmaceutical groups are warning of worsening disruption to supply chains because of problems certifying manufacturing sites in China, with some factory inspectors refusing to visit the country over fears of arrest for spying and others denied entry to facilities. China is one of the world’s largest makers of active pharmaceutical ingredients and antibiotics and a major supplier of drugs to the EU and US. However, a tightening of anti-espionage laws by Beijing has led to concerns that foreign citizens gathering data on Chinese sites could be deemed spies.”

Walgreens Launches Gene and Cell Services as Part of Newly Integrated Walgreens Specialty Pharmacy BusinessUnder the new business, Walgreens Specialty Pharmacy has an unmatched offering and is the only specialty pharmacy in the market with the following services and assets at scale:

  • Gene and Cell Services Pharmacy and Innovation Center – a dedicated 18,000-square-foot center in Pittsburgh, PA, with services and capabilities for these emerging therapies, including innovative solutions for managing the complexity of the supply chain, logistics and financing as well as clinical and social needs management to ensure success for patients and partners.

  • Four central specialty pharmacies – each holding several national pharmacy accreditations – where pharmacists and care teams across the country work together to dispense highly complex medications and help patients manage chronic or rare diseases and conditions. These pharmacies hold distinctions in oncology and rare/orphan conditions and offer patients and caregivers clinical services that drive engagement, adherence and outcomes.

  • Nearly 300 community-based specialty pharmacies across the nation – more than any other pharmacy. These specialty pharmacies are strategically located near medical office buildings and health systems, closely aligning care provision with local physicians, offering patients access to specialty medications faster than the industry average, as well as services like injection training, medication side-effect management and financial assistance coordination for medications.

  • More than 1,500 specialty-trained pharmacists, 5,000 patient advocacy support team members and dedicated Specialty360 teams that support all specialty condition and therapies.

  • A growing roster of 240 limited distribution drugs, including 40 narrow networks and 12 exclusive limited distribution drugs.”

F.D.A. Approves Antibiotic for Increasingly Hard-to-Treat Urinary Tract Infections “The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing suite of antimicrobial drugs.
The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is often a first-line therapy for women with uncomplicated U.T.I.’s, meaning the infection is confined to the bladder and has not reached the kidneys. The drug will be marketed in the U.S. as Pivya and will be made available by prescription to women 18 and older.” [Emphasis added]

Health care lobbying giants spent big as little got done in CongressCongress did nothing this spring to rein in how pharmacy benefit managers operate, which is precisely the outcome the industry’s lobbyists wanted.
And the PBM industry spent big to get that result, new disclosures show. The Pharmaceutical Care Management Association, the industry’s biggest trade group, spent a whopping 71% more on lobbying in the first three months of this year compared with 2023, increasing its spending from $2.8 million to $4.8 million.”

Provider markups on specialty drugs increased commercial premiums “Provider markups on specialty drugs increased 2024 commercial health insurance premiums by $13.1 billion, according to research from Oliver Wyman commissioned by AHIP…
Among the top ten specialty drugs by total claim dollars, the average cost of the drugs that were buy-and-bill was 50 percent to 103 percent higher when supplied by a hospital facility and 2 percent to 33 percent higher when supplied by a professional office compared to the cost when supplied by a specialty pharmacy.
The average markup was 42 percent, with the total amount of all markups representing 0.7 percent of total medical and pharmacy claim dollars. This rate resulted in an average premium increase of $48 per contract per year for individual and small group plan members, $61 for large group single plan members, and $175 for large group family plan members.”
Comment: Medicare has limited the markup to 6% over average sales price for 20 years. Why has the commercial sector taken so long to adopt a similar policy?

About the public’s health

 Early tests of H5N1 prevalence in milk suggest U.S. bird flu outbreak in cows is widespread “The researchers expect additional lab studies currently underway to show that those samples don’t contain live virus with the capability to cause human infections, meaning that the risk of pasteurized milk to consumer health is still very low. But the prevalence of viral genetic material in the products they sampled suggest that the H5N1 outbreak is likely far more widespread in dairy cows than official counts indicate. So far, the U.S. Department of Agriculture has reported 33 herds in eight states have tested positive for H5N1.” 
In a related article: Is There a Vaccine for H5N1 Influenza? “On the heels of a multi-state outbreak of highly pathogenic avian influenza A (H5N1) in dairy cows, experts told MedPage Today that a trio of H5N1 vaccines for humans has already been developed and approved in the U.S.”

State of the Air From the American Lung Association. Enter your zip code and get a report of the air quality in your county.

New rules will slash air, water and climate pollution from U.S. power plants “The Environmental Protection Agency on Thursday finalized an ambitious set of rules aimed at slashing air pollution, water pollution and planet-warming emissions spewing from the nation’s power plants.

Sign up for the Climate Coach newsletter and get advice for life on our changing planet, in your inbox every Tuesday. “If fully implemented, the rules will have enormous consequences for U.S. climate goals, the air Americans breathe and the ways they get their electricity. The power sector ranks as the nation’s second-largest contributor to climate change, and it is a major source of toxic air pollutants tied to various health problems.
Before the restrictions take effect, however, they will have to survive near-certain legal challenges from Republican attorneys general, who have been emboldened by the Supreme Court’s skepticism of expansive environmental regulations.”

CDC Launches Online 'Heat Forecaster' Tool as Another Summer Looms “The HeatRisk Forecast Tool is a joint effort between the CDC and the National Oceanic and Atmospheric Administration's National Weather Service to give Americans a week-long heads-up that broiling temperatures are headed their way.
It's all close at hand at the HeatRisk Dashboard online -- just plug in your zip code for the latest forecast and updates.”

About healthcare IT

 The Impact Of Telemedicine On Medicare Utilization, Spending, And Quality, 2019–22 “Patients receiving care from health systems in the highest quartile of telemedicine use had modest increases in office visits, care continuity, and medication adherence, as well as decreases in ED visits, relative to patients of health systems in the lowest quartile. We did not observe differences in testing or preventive service use. The relative increase in visits was larger among patients without chronic illness and among lower-income, non-White patients. However, these changes were accompanied by a 1.6 percent increase in health care spending, largely driven by inpatient and drug spending.
Our results are qualitatively consistent with those of other recent studies. An analysis by the Medicare Payment Advisory Commission found that geographic areas with higher telemedicine uptake through 2021 had a 3 percent relative increase in total clinical encounters and a relative spending increase of $165 per person.”

The Joint Commission Launches Telehealth Accreditation “The Joint Commission today announced it is launching a new Telehealth Accreditation Program for eligible hospitals, ambulatory and behavioral healthcare organizations, effective July 1, 2024. This accreditation program provides updated, streamlined standards to provide organizations offering telehealth services with the structures and processes necessary to help deliver safe, high-quality care using a telehealth platform.
The Telehealth Accreditation Program was developed for healthcare organizations that exclusively provide care, treatment and services via telehealth. Hospitals and other healthcare organizations that have written agreements in place to provide care, treatment and services via telehealth to another organization’s patients have the option to apply for the new accreditation.”

About healthcare personnel

 You Might Fare Better If Your Doctor Is Female, Study Finds “About 10.15% of men and 8.2% of women died while under the care of a female doctor, versus 10.23% and 8.4% when treated by a male doctor, according to results published April 22 in the Annals of Internal Medicine
 Not only were patients less likely to die with a female doctor, but they also were less likely to land back in the hospital within a month of discharge, researchers found…
More research is needed into how and why male physicians practice medicine differently, as well as the impact this difference has on patient care…”

Today's News and Commentary

About Covid-19

The pandemic cost 7 million lives, but talks to prevent a repeat stall “In late 2021, as the world reeled from the arrival of the highly contagious omicron variant of the coronavirus, representatives of almost 200 countries met — some online, some in-person in Geneva — hoping to forestall a future worldwide outbreak by developing the first-ever global pandemic accord.
The deadline for a deal? May 2024…
Even as negotiators wrestle over those points, the venture is being roiled by misinformation on social media, including hostility toward the WHO and assertions that any international agreement would threaten the sovereignty of nations — claims that WHO Director General Tedros Adhanom Ghebreyesus has condemned as ‘utterly, completely, categorically false.’ The final agreement, Tedros said in early April, won’t give the WHO power to impose lockdowns or mask mandates in individual countries.”

 About healthcare safety

WHO launches first ever Patient Safety Rights Charter “WHO launched a Patient Safety Rights Charter at the Global Ministerial Summit on Patient Safety. It is the first Charter to outline patients’ rights in the context of safety, and will support stakeholders in formulating the legislation, policies and guidelines needed to ensure patient safety…
he 10 fundamental patient safety rights outlined in the Charter are the right to:

  1. Timely, effective and appropriate care;

  2. Safe health care processes and practices;

  3. Qualified and competent health workers;

  4. Safe medical products and their safe and rational use;

  5. Safe and secure health care facilities;

  6. Dignity, respect, non-discrimination, privacy and confidentiality;

  7. Information, education and supported decision making

  8. Access medical records;

  9. To be heard and fair resolution;

  10. Patient and family engagement.”

About health insurance/insurers

Medicare Accountable Care Organizations: Past Performance and Future Directions From the CBO: “Providers participate in Medicare ACO programs voluntarily. CBO found the following:

• Certain types of ACOs are associated with greater savings. They include ACOs led by independent physician groups, ACOs with a larger proportion of primary care providers (PCPs), and ACOs whose initial baseline spending was higher than the regional average. (An ACO’s baseline spending is generally the average spending per person in the Medicare fee-for- service, or FFS, program among beneficiaries that would have been assigned to the ACO over several calendar years before the start of the ACO’s contract period.)
•Some factors limit the savings from Medicare ACOs. Those factors include weak incentives for ACOs to reduce spending, a lack of the resources necessary for providers to participate in ACO models, and providers’ ability to selectively enter and exit the program on the basis of the financial benefits or losses they anticipate from participating.”

Maryland, Vermont Apply for CMS’ State-Level Total Cost of Care Model “Both Maryland and Vermont have applied to participate in the Centers for Medicare and Medicaid Services’ States Advancing All-Payer Health Equity Approaches and Development (AHEAD) model.
AHEAD is a state-level total cost of care (TCOC) model that seeks to drive state and regional healthcare transformation and multi-payer alignment. 
The model would be in place for up to nine performance years, through 2034. The intent is to allow adequate time for changes in care delivery to be designed and implemented and for those changes to impact outcomes for the state’s residents.  
Under a TCOC approach, a participating state uses its authority to assume responsibility for managing healthcare quality and costs across all payers, including Medicare, Medicaid, and private coverage. States also assume responsibility for ensuring health providers in their state deliver high-quality care, improve population health, offer greater care coordination, and advance health equity by supporting underserved patients.”
Note: Maryland has had an all-payer system for the past 36 years.

CMS to Test Mandatory 5-Year Episode-Based Alternative Payment Model “The mandatory Transforming Episode Accountability Model (TEAM) would aim to improve the patient experience from surgery through recovery by supporting the coordination and transition of care between providers and promoting a successful recovery that can reduce avoidable hospital readmissions and emergency department use. TEAM episodes would begin with lower extremity joint replacement, surgical hip femur fracture treatment, spinal fusion, coronary artery bypass graft, and major bowel procedures.
Under the proposed model, selected acute-care hospitals would coordinate care for people with Traditional Medicare who undergo one of the surgical procedures included in the model and assume responsibility for the cost and quality of care from surgery through the first 30 days after the Medicare beneficiary leaves the hospital. 
All hospitals selected to participate in TEAM would be required to refer patients to primary care services to support patient continuity of care and positive long-term health outcomes.”

INPATIENT PROSPECTIVE PAYMENT SYSTEM DASHBOARD From McDermott + Consulting: “What is the cost of a knee implant in the inpatient setting? How much does Medicare pay for different types of cardiac valve procedures? How has Medicare inpatient volumes changed over time for inpatient hip and femur procedures?
This dashboard shows the actual costs to hospitals for providing care to Medicare fee-for-service inpatients based on data published by the Centers for Medicare & Medicaid Services (CMS) as part of its rulemaking cycle.”

 Clinically Implausible Rates are Getting the Boot “About 60% of rates are clinically implausible, and often even impossible (something along the lines of a rate for a psychiatrist performing a knee replacement). We talk about that more in-depth here. You may have heard about these rates before, and they’re usually given cute names, like zombie rates…
How these rates even came into existence in the first place is a good place to start. There are a few underlying reasons:

  1. Stock contract templates: Payers have boilerplate templates that vary from simply a single fee schedule to as complex as an inpatient hospital agreement with numerous rate types. When providers go in-network with a payer, they often sign a contract that includes rates for all billable services, even though they may bill only a subset of them.

  2. Schema Design: In the current CMS mandated schema, payers associate rates with all providers at a facility, which leads to physicians being associated with services they may not be associated with….

  3.  Errors in the Data: Due to the sheer magnitude of posting all items and services, it’s inevitable that payers make mistakes in the processes of gathering and preparing their MRFs [Machine-Readable Files].”

Elevance Health and Clayton, Dubilier & Rice Sign Agreement to Launch Strategic Partnership to Advance Primary Care Delivery “Elevance Health, Inc. and Clayton, Dubilier & Rice (CD&R) announced an agreement to form a strategic partnership to accelerate innovation in primary care delivery, enhance the healthcare experience, and improve health outcomes. This effort, which will operate across multiple regions of the United States, will bring together certain care delivery and enablement assets of Elevance Health’s Carelon Health and CD&R portfolio companies, apree health and Millennium Physician Group (MPG).”

About pharma

Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments “Most surrogate markers used as primary end points in clinical trials to support FDA approval of drugs treating nononcologic chronic diseases lacked high-strength evidence of associations with clinical outcomes from published meta-analyses.”

 Boehringer signs $1.3B deal with RNA biotech Ochre Bio to team up against MASH “Boehringer Ingelheim is making yet another bet that RNA therapies hold the key to treating metabolic-associated steatohepatitis (MASH).
The German drugmaker is paying British biotech Ochre Bio $35 million in upfront and near-term research-based milestone payments to investigate “multiple targets” for chronic liver disease. Top of the list of indications will be MASH, previously known as nonalcoholic steatohepatitis (NASH).”

About the public’s health

Pesticides pose a significant risk in 20% of fruits and vegetables, Consumer Reports finds “An examination of 59 common fruits and vegetables found pesticides posed significant risks in 20% of them, from bell peppers, blueberries and green beans to potatoes and strawberries, according to findings published Thursday by the nonprofit consumer advocacy group…
Imported produce, especially from Mexico, was particularly likely to carry risky levels of pesticide residues, CR found…
The good news? There's no need to worry about pesticides in almost two-thirds of produce, including nearly all of the organic fruits and vegetables examined. 
The analysis found broccoli to be a safe bet, for instance, not because the vegetable did not contain pesticide residues but because higher-risk chemicals were at low levels and on only a few samples.”

USDA releases H5N1 bird flu genetic data eagerly awaited by scientists “The U.S. Department of Agriculture, which has been under pressure from scientists both at home and abroad to share more data on the H5N1 bird flu outbreaks in dairy cows, uploaded a large number of genetic sequences of the pathogen late Sunday.
Access to the 239 genetic sequences will help scientists assess whether the dangerous virus has acquired mutations that might make it easier for it to spread to and among mammals, and whether additional changes have been seen as it moves from cow to cow and herd to herd. In addition to virus sequences from cattle, the trove includes sequences of viruses retrieved from cats, chickens, a skunk, a raccoon, a grackle, a blackbird, and a goose, the agency said.”

Today's News and Commentary

Federal agencies open online portal for reporting anticompetitive practices in healthcare “Thursday, the Federal Trade Commission (FTC), the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) unveiled HealthyCompetition.gov, an online portal where anyone can submit a healthcare competition complaint for potential investigation.”

These submissions, the agencies said, can help the agencies ensure healthcare organizations provide quality care and pay their employees a fair wage.

About health insurance/insurers

 Medicare’s Push To Improve Chronic Care Attracts Businesses, but Not Many Doctors Federal data from 2019 shows just 4% of potentially eligible enrollees participated in the program, a figure that appears to have held steady through 2023, according to a Mathematica analysis. About 12,000 physicians billed Medicare under the CCM mantle in 2021, according to the latest Medicare data analyzed by KFF Health News. (The Medicare data includes doctors who have annually billed CCM at least a dozen times.)
By comparison, federal data shows about 1 million providers participate in Medicare.”

About pharma

Employers feel the side effects of drugmaker control over Wegovy, Ozempic costs Good review of the topic, with examples from different states.

HHS finalizes rule on 340B Administrative Dispute Resolution  process “The Department of Health and Human Services April 18 finalized its rule to establish a 340B Administrative Dispute Resolution process as required under the Affordable Care Act. The rule establishes an ADR process that allows all 340B covered entities, regardless of the size of the organization or monetary value of the claim, to avail themselves of this important process to address claims at dispute with drug companies.  
Specifically, the new finalized ADR process would:

  • Create a more conventional administrative process that is less trial-like consisting of 340B program subject matter experts from the Health Resources and Services Administration’s Office of Pharmacy Affairs.

  • Allow covered entities to bring forth claims where they have been overcharged by a drug company including where the drug company or its wholesaler denies access to 340B pricing.

  • Allow claims for ADR panel review even if the particular issue at stake is subject to concurrent federal court review.

  • Require decisions be reached by the ADR process within one year of submission of claims for ADR review.

  • Include a reconsideration process for parties dissatisfied with the 340B ADR panel decision.”

About the public’s health

For the first time, U.S. may force polluters to clean up these ‘forever chemicals’ “The Biden administration on Friday moved to force polluters to clean up two of the most pervasive forms of “forever chemicals,” designating them as hazardous substances under the nation’s Superfund law.
The long-awaited rule from the Environmental Protection Agency could mean billions of dollars of liabilities for major chemical manufacturers and users of certain types of compounds known as polyfluoroalkyl and perfluoroalkyl substances, or PFAS.”

Advancing Racial Equity in U.S. Health Care The Commonwealth Fund 2024 State Health Disparities Report An excellent overview of a pervasive problem. At least look at Exhibit 1.

About healthcare IT

 AI-Powered World Health Chatbot Is Flubbing Some Answers
“· SARAH doesn’t have up-to-date medical data, can ‘hallucinate’
· WHO bot falls back on ‘consult with your health-care provider’ 
The World Health Organization is wading into the world of AI to provide basic health information through a human-like avatar. But while the bot responds sympathetically to users’ facial expressions, it doesn’t always know what it’s talking about.
SARAH, short for Smart AI Resource Assistant for Health, is a virtual health worker that’s available to talk 24/7 in eight different languages to explain topics like mental health, tobacco use and healthy eating. It’s part of the WHO’s campaign to find technology that can both educate people and fill staffing gaps with the world facing a health-care worker shortage.”

Two-thirds of top 20 pharmas have banned ChatGPT—and many in life sci call AI ‘overrated,’ survey finds “In a recent ZoomRx survey of more than 200 life sciences professionals, more than half said their companies have banned employees from using OpenAI’s popular generative AI tool ChatGPT, including 65% of the top 20 Big Pharmas. Respondents said those policies were largely linked to concerns that sensitive internal data could be leaked to competitors.”

About healthcare finance

 States Aim to Combat Private-Equity Healthcare Takeovers “More than a dozen states are pushing back against private-equity-backed consolidation of medical businesses.”

Today's News and Commentary

About health insurance/insurers

 Elevance Health posts $2.2B profit in Q1  “Elevance Health posted $2.2 billion in net income during the first quarter, a nearly 13% increase compared to the same period last year, according to the company's earnings report published April 18.”

Examining how Improper Payments Cost Taxpayers Billions and Weaken Medicare and Medicaid [From the HHS OIG] In the appeal to Congress she said: “Every day HHS-OIG makes tough choices on cases and issues to decline for lack of resources. HHS-OIG has been turning down between 300 and 400 viable criminal and civil health care fraud cases each year. In addition to these cases, for the past several years, OIG has been turning down more than half of the referrals of potential fraud CMS’s contractors make as part of OIG’s major case coordination effort with CMS. Uninvestigated cases represent real, potential unchecked fraud; the potential for patients to be put in harm’s way; and missed opportunities for deterrence and monetary recoveries.”
Page 9 has a great graphic on the flows of pharma funds.

About hospitals and healthcare systems

 20 large health systems ranked by reputation score FYI

 M&A Quarterly Activity Report: Q1 2024 With 20 announced transactions, Q1 2024 showed a significant uptick in M&A activity and represents the strongest Q1 we have seen since 2020.
Of the 20 announced transactions, four were “mega mergers” (transactions in which the smaller party has annual revenues of $1 billion or more).This is one of the highest numbers of mega mergers we have seen and contributed to average seller size and total transacted revenue figures that remain at historically high levels.
Academic health systems also had an active quarter, acting as the acquirer (or larger party) in six of the 20 announced transactions.”

About the public’s health

Whooping cough rising sharply in some countries. Why you may need a booster. “Whooping cough outbreaks in Europe, Asia and parts of the U.S.should be a reminder to get vaccinated, experts say.
Since January, cases of whooping cough have risen sharply in the U.K. and Europe, the largest surge since 2012. 

Age-Friendly System-Wide Spread Collaborative “IHI is excited to announce the Age-Friendly System-Wide Spread Collaborative, which will be the learning and action community for US health systems interested in fully embedding the 4Ms [What Matters, Medication, Mentation and Mobility] system-wide, to have an equitable impact on older adults across all of their sites and settings of care.
The Collaborative will convene a cohort of 30 teams from health systems with sites of care recognized as Committed to Care Excellence to accelerate system-wide adoption of the 4Ms, with guidance from expert faculty and an ‘all-teach, all-learn’ approach. Collaborative participants will have the opportunity to be among the first to achieve an ambitious new IHI recognition for system-wide spread of age-friendly care.”

About healthcare IT

 Emergency services a likely target for cyberattacks, warns DHS “The analysis, compiled by the Department of Homeland Security (DHS) and obtained by ABC News, outlines concerns that the Emergency Service Sector can be exploited and mined for sensitive data, in turn hampering medical and law enforcement services and posing an ongoing threat to personal information and public safety.”

About healthcare finance

 23andme CEO Anne Wojcicki moves to take company private “Wojcicki disclosed her plans in a filing with the Securities and Exchange Commission late Wednesday, saying that she intends to seek out potential partners and financiers to help. Wojcicki currently holds 49.99% of the voting power in the company, according to the Wall Street Journal, which first reported on the plan.”

Today's News and Commentary

About health insurance/insurers

Man charged in $70M Medicare fraud scheme “A Mississippi man faces up to 25 years in prison for his alleged role in a Medicare fraud scheme exceeding $70 million…
 Prosecutors claim he used the companies to bill Medicare for orthotic braces obtained by the use of fraudulent physician orders, which were generated by contacting Medicare beneficiaries and obtaining ​​personally identifiable information through call centers. The indictment alleges that kickbacks and bribes were also used to obtain medical providers' signatures, generating the fraudulent physician orders. Mr. French also allegedly paid for physicians' orders for orthotic braces that were then sold to suppliers and brokers in exchange for millions in kickbacks and bribes.”
Comment: Never ceases to amaze me how Medicare lets this magnitude of fraud get by for so long.

Are employees getting fed up with high-deductible health plans? “According to ValuePenguin, a financial resource platform by LendingTree, HDHP enrollment has dropped by 2%, the first decline since 2013. While nearly 56% of American private-sector workers were enrolled in HDHPs as of 2021, that number fell to just under 54% in 2022, marking a small but possibly significant shift in U.S. healthcare. Overall, 32 states saw decreased HDHP enrollment…
Notably, large employers seem intent on offering a more diverse array of health plans. In 2018, 22% of employers with 20,000 employees or more offered only HDHPs — that number dropped to 9% in 2022….
According to exclusive research by EBN's parent company Arizent, employees with HDHPs are 30% less confident they will know what their healthcare costs will be, at least most of the time, compared to employees with preferred provider organization plans, or PPOs, which usually have lower deductibles. Unsurprisingly, Arizent found that 70% of HDHP users found their healthcare costs too expensive, versus 50% of PPO users.”

About pharma

Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus “One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said.
A subcutaneous formulation of Ocrevus helped 97% of MS patients achieve no relapse up to 48 weeks of treatment, according to updated data from the phase 3 OCARINA II study presented at the American Academy of Neurology (AAN) annual meeting.
Besides lowering the annual relapse rate to an estimated 0.04, subcutaneous Ocrevus also suppressed brain lesions as shown on MRI imaging by 97%. Most patients had no T1 gadolinium-enhancing lesions or worsening T2 lesions, which are markers of active inflammation and burden of disease, respectively.”

Top 15 specialty pharmacies by 2023 revenue FYI

 AbbVie links up with Medincell for $2B injectables deal “AbbVie said Tuesday it will pay Medincell $35 million upfront to co-develop up to six therapies using the latter’s BEPO platform for long-acting injectables. 
Medincell is eligible for up to $315 million in development and commercial milestones for each programme, for a total of $1.9 billion, plus mid-single- to low-double-digit royalties.
While the pharma said the partnership covers “multiple therapeutic areas and indications,” details were sparse on whether the injectable therapies will be reformulations of existing AbbVie drugs, or novel therapeutics. 
Medincell’s platform enables bioresorbable delivery of a drug at therapeutic levels for several days, weeks or months from one injection.”

Takeda bets up to $1.2B on Kumquat's immuno-oncology candidate “akeda has entered into a strategic collaboration and exclusive global licensing agreement with Kumquat Biosciences potentially worth over $1.2 billion to develop and commercialise an oral immuno-oncology small molecule inhibitor.
As part of the deal announced Tuesday, Kumquat will receive up to $130 million in near-term payments from Takeda. It is also eligible for over $1.2 billion in future clinical, regulatory, and commercial milestones, as well as tiered royalties on net sales of any approved products resulting from the tie-up.
Kumquat will lead research efforts and fund early clinical development through Phase I testing of the undisclosed cancer candidate, which can be developed as a monotherapy or in combination with other drugs. Subject to Kumquat's option, Takeda will assume and fund all development and commercialisation activities beyond Phase I activities led by the San Diego-based biotech.”

Sandoz bucks trend with “explosion” in US prescriptions for Humira biosimilar “CVS Caremark’s decision to replace AbbVie’s Humira (adalimumab) with biosimilar versions of the anti-TNF-α monoclonal antibody has led to a recent “explosion” in new prescriptions for Sandoz’s Hyrimoz (adalimumab-adaz). The numbers, detailed in a recent analyst note from Evercore ISI, signal that biosimilars may be able to finally break Humira's market dominance in the US.
Humira lost patent protection in the US at the start of 2023 and currently faces competition from nine biosimilars, including interchangeable versions in Boehringer Ingelheim's Cyltezo (adalimumab-adbm) and more recently Teva/Alvotech's Simlandi (adalimumab-ryvk). However, Evercore ISI analysts noted that as of the end of March, AbbVie’s drug still held on to around 95% market share for new prescriptions.”

About the public’s health

New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade Summary:
—”End-of-trial data show 79.7% efficacy in participants aged 50 years and over, six to 11 years after vaccination1
—Vaccine efficacy remains high at 82.0% at year 11 after initial vaccination1
—No new safety concerns were identified during the follow-up period.” 

About healthcare personnel

 New AACN Data Points to Enrollment Challenges Facing U.S. Schools of Nursing “New data released today by the show that sustaining student enrollment in baccalaureate and graduate programs continues to be a challenge at U.S. schools of nursing. Though enrollment in programs designed to prepare entry-level registered nurses held steady (up 0.3%), fewer students are entering baccalaureate degree-completion, master’s, and PhD programs, which poses a threat to meeting the nation’s healthcare needs.”
See the article for further details.

About healthcare finance

Private equity healthcare bankruptcies are on the rise: 8 things to know One interesting fact is that: “About 460 U.S. hospitals are owned by private equity firms. That represents 8% of all private hospitals and 22% of all proprietary for-profit hospitals… At least 26% of private equity-owned hospitals serve rural populations.”

Today's News and Commentary

About health insurance/insurers

 UnitedHealth Group posts $1.4B loss in Q1 amid Change cyberattack fallout “UnitedHealth Group released its first-quarter earnings Tuesday morning as the industry continues to reel from the massive cyberattack on its Change Healthcare unit.
UHG reported a loss of $1.4 billion in the quarter, compared to $5.6 billion in profit for the first quarter of 2023. Revenues reached $99.8 billion, up from $91.9 billion in the prior-year quarter. The hack was a major factor in the company's performance, along with the sale of its Brazil-based business Amil, which drove $7 billion charge in the quarter.”

Hackers leak Change Healthcare contracts, patient data “Hackers leaked contracts and patient records purportedly stolen in the Change Healthcare cyberattack, TechCrunch reported April 15.
Ransomware group RansomHub posted files on its dark web leak site April 15 comprising personal and protected health information on patients whose data was taken in the Change hack, according to the story. The files also include contracts and agreements between Change and its clients. It marked the first time hackers have posted data from the cyberattack.”

HSAs Reduce Use of Outpatient Services and Prescription Drugs, Increase Use of Inpatient Services; Overall Spending Unaffected A few highlights:
“• Office visits shifted from specialist visits to primary care visits among HSA plan enrollees.
• HSA plan enrollees filled fewer prescriptions as compared with PPO enrollees.
• Overall, HSA plan enrollment had no impact on total spending — there was no statistically significant difference in overall spending between HSA plan and PPO enrollees. However, spending was $60.30 or 2 percent lower PMPY among HSA plan enrollees with no health conditions as compared with PPO enrollees, but spending was $2,490 or 6 percent higher PMPY among HSA plan enrollees with two or more health conditions. This higher spending was driven by 21 percent higher spending on inpatient services.”

CMS delays implementation of new Medicare, Medicaid data rules “CMS will delay implementation of new policies designed to heighten security around Medicare and Medicaid data that drew criticism from researchers. 
On April 15, the agency said it will delay implementation of the policies, originally slated to take effect in August, to 2025 at the earliest. CMS also extended the deadline for public comment on the rules to May 15. 
The new proposal would up starting costs for Medicare and Medicaid data to $35,000 and allow only one researcher access to the requested data, which will be stored on a CMS platform. In January, more than 300 researchers signed a draft letter opposing the change, writing it would have a ‘catastrophic impact’ on health policy research, limiting access to data to institutions able to pay higher costs for it.”

Elevance Health strikes primary care deal with private equity firm “Elevance Health will enter a partnership with private equity firm Clayton, Dubilier & Rice to develop advanced primary care models. 
The joint effort will operate across multiple states and commercial, individual, Medicare and Medicaid markets, according to an April 15 news release. The payer-agnostic platform will serve more than 1 million members, the companies said. 
The deal is financed primarily "through a combination of cash and our equity interest in certain care delivery and enablement assets of Carelon Health," according to the news release. The two companies did not disclose the financial terms of the deal, and it is not expected to have a material impact on Elevance's 2024 earnings.”

About pharma

CVS' Oak Street Health to open clinics at retail pharmacies “CVS Health is opening Oak Street Health primary care clinics at its retail pharmacy stores — a move that hasn’t always worked out for competitors.
CVS acquired Chicago-based primary care provider Oak Street in May for $10.6 billion and announced plans to add 50 to 60 Oak Street clinics in 2024. Most of those clinics are expected to be standalone locations, including some located in closed CVS stores. But CVS also is piloting a setup that replaces much of the retail space in existing stores with clinics.”
Comment: It is unclear how this strategy/management will differ from the failing VillageMD efforts of Walgreens.

About the public’s health

 Biden administration announces new partnership with 50 countries to stifle future pandemics “U.S. government officials will offer support in the countries, most of them located in Africa and Asia, to develop better testing, surveillance, communication, and preparedness for such outbreaks in those countries.”

Today's News and Commentary

About Covid-19

Executive Order on COVID-⁠19 and Public Health Preparedness and Response “At this stage of my Administration’s response to COVID-19, I have determined that certain Executive Orders are no longer necessary and that certain roles and responsibilities established by other Executive Orders related to COVID-19 should be transferred to the OPPR[Office of Pandemic Preparedness and Response Policy]…
Revocations.  Executive Order 13910 of March 23, 2020 (Preventing Hoarding of Health and Medical Resources to Respond to the Spread of COVID-19), Executive Order 13991 of January 20, 2021 (Protecting the Federal Workforce and Requiring Mask-Wearing), and Executive Order 13998 of January 21, 2021 (Promoting COVID-19 Safety in Domestic and International Travel), are hereby revoked.”

About healthcare quality

 Groups unveil value-based care playbook “AHIP, the American Medical Association and the National Association of ACOs have released a playbook of voluntary best practices for value-based care payment arrangements…
The voluntary best practices are broken into seven domains:

  1. Patient attribution

  2. Benchmarking 

  3. Risk adjustment

  4. Quality performance impact on payment 

  5. Levels of financial risk 

  6. Payment timing and accuracy 

  7. Incentivizing for value-based care practice participant performance”

About health insurance/insurers

CMS officials say agency is monitoring concerns from ACOs about DME costs “The National Association of ACOs (NAACOS) told the feds that a review of data from CMS' Virtual Research Data Center found a spike in payments related to two billing codes. Payments for urinary catheters grew from $153 million in 2021 to an eye-popping $2.1 billion in 2023.”

 Healthcare billing fraud: 12 recent cases FYI

Medicaid Enrollment and Unwinding TrackerAt Least 20,104,000 Medicaid Enrollees Have Been Disenrolled and 43,640,000 Have Had Their Coverage Renewed, as of April 11, 2024.”

About pharma

 The top 20 pharma companies by 2023 revenue FYI. J&J replaced Pfizer at the top spot.

 About healthcare personnel

Updated Report: Hospital and Corporate Acquisition of Physician Practices and Physician Employment 2019-2023 Summary:
●  “Employment by hospitals and corporate entities is nearing 80%.
19,100 additional physicians became employees of hospitals or other corporate entities over the last two years
● This represents a 5.1% increase in the percentage of employed physicians since 2022
● Hospitals and other corporate entities acquired 8,100 additional physician practices over the last two years
● This represents a 6.0% increase in the percentage of hospital or corporate-owned practices since 2022”

Life Cycle of Private Equity Investments in Physician Practices: An Overview of Private Equity Exits “Private equity firms acquire and grow physician practices through add-on consolidation, generating outsized returns on the sale of the acquisition in 3-8 years (“exit”). PE’s abbreviated investment timeline and exit incentives may deter long-term investments in care delivery and workforce needed for high quality care…
Of 807 acquisitions, over half (51.6%) of PE-acquired practices underwent an exit within 3 years of initial investment. In nearly all instances (97.8%), PE firms exited investments through secondary buyouts, where physician practices were resold to other PE firms with larger investment funds. Between investment and exit, PE firms increased the number of physician practices affiliated with the PE firm by an average of 595% in 3 years.”

About health technology

Alzheimer's blood test from Roche, Eli Lilly nabs FDA breakthrough tag “After more than a year in the works, Roche and Eli Lilly have taken a step closer to delivering their blood test designed to aid in the diagnosis of earlier cases of Alzheimer’s disease.
The FDA has granted their work a breakthrough designation to help accelerate its development. Roche’s Elecsys plasma assay searches for and quantifies phosphorylated fragments of the brain protein tau, known as pTau-217, with the goal of capturing a biomarker that can distinguish Alzheimer’s from other neurodegenerative disorders.”

 Illumina gets go-ahead from European Commission to part ways with Grail “Illumina has received a green light from the European Commission to proceed with unwinding its ownership of Grail, though the details of that plan have yet to be unveiled.
The DNA sequencing giant still has the freedom to choose between selling the cancer blood test developer to another party outright or supporting its journey to the public markets as an independent spinout—and previously set a deadline for that decision at the end of June, after missing out on appeal in U.S. courts last December.
The commission officially ordered Illumina to cut ties with Grail last October, more than a year after the companies completed their $8 billion takeover deal ahead of clearing the European Union’s antitrust review process. The U.S. Federal Trade Commission delivered a similar edict last year on its side of the pond.”

Today's News and Commentary

About health insurance/insurers

CMS pitches inpatient payment rule for 2025: 8 things to know FYI from CMS

About hospitals and healthcare systems

M&A Quarterly Activity Report: Q1 2024 “With 20 announced transactions, Q1 2024 showed a significant uptick in M&A activity and represents the strongest Q1 we have seen since 2020.
Of the 20 announced transactions, four were “mega mergers” (transactions in which the smaller party has annual revenues of $1 billion or more).This is one of the highest numbers of mega mergers we have seen and contributed to average seller size and total transacted revenue figures that remain at historically high levels.Academic health systems also had an active quarter, acting as the acquirer (or larger party) in six of the 20 announced transactions.”

User Information Sharing and Hospital Website Privacy Policies “In this cross-sectional analysis of a nationally representative sample of 100 nonfederal acute care hospitals, 96.0% of hospital websites transmitted user information to third parties, whereas 71.0% of websites included a publicly accessible privacy policy. Of 71 privacy policies, 40 (56.3%) disclosed specific third-party companies receiving user information.”

One Year After Medicaid Unwinding Began, Community Health Centers, Their Patients, and Their Communities are Feeling the Impact “This analysis confirms that consistent with the nationwide unwinding process, patient disenrollment is experienced by virtually all community health centers. An estimated one in four health center patients has lost coverage to date…
If these coverage loss estimates (disenrollment of 1 in 4 health center patients) remain consistent as unwinding continues into 2024, CHCs can expect that more than 3.5 million patients will experience coverage disruptions. Similarly, if the low reenrollment rate seen here remains constant, then three-fourths of all patients losing Medicaid will remain disenrolled, leading to disruption not only in coverage but in care itself, along with substantial revenue loss that will further affect ongoing CHC operations. Most concerning, perhaps, is disruption in pediatric coverage…” 

State public option plans don't reduce premiums, result in low enrollment: industry-backed study “Instead of enacting public option plans, states should target reinsurance programs, a new report from the Partnership for America's Health Care Future argues…
States with public options fail to curb premium spending and fail to meet reimbursement rate targets, the analysis contends.
Public option advocates believe widespread implementation will reduce premiums and expand coverage. State public option plans rely on insurers to administer plans.”

About the public’s health

Recent increase in measles cases threatens elimination status in the US, CDC says “More than 100 cases of measles have been reported in the United States since the start of the year, and the US Centers for Disease Control and Prevention warns that a rapid rise in cases — significantly more than in recent years — poses a renewed threat to the country’s disease elimination status.” 

Today's News and Commentary

About health insurance/insurers

 CMS proposes 2.6% bump to inpatient pay in fiscal 2025 “The Biden administration is proposing a 2.6% increase for inpatient hospitals’ payments for the coming fiscal year, a $3.3 billion increase over the current year’s payout, as well as other policy adjustments intended to shore up surgical care coordination, drug supply, emergency preparedness monitoring, maternal health and care for the underserved.”

About hospitals and healthcare systems

 472 hospitals honored for patient safety, price transparency FYI

 About pharma

Drugmakers race to find alternative suppliers as US cracks down on Chinese biotech “Western pharmaceutical companies are in talks with alternative suppliers in response to draft US legislation seeking to restrict an important Chinese drug developer and manufacturer over national security concerns. The Biosecure Act would prohibit US companies receiving federal grant money from working with four Chinese biotech companies, including WuXi AppTec and its sister company WuXi Biologics, which produce active pharmaceutical ingredients (API) for hundreds of US and European drugmakers. Companies, including US-based Eli Lilly, Vertex Pharmaceuticals and BeiGene in Switzerland, have been talking with rival contract manufacturers to diversify production away from WuXi companies, according to several people familiar with discussions.”

Medicare expects to spend $3.5 billion on new Alzheimer’s drug in 2025 “Medicare’s actuaries expect the drug Leqembi, made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medicare program $3.5 billion in 2025, a spokesperson for the Centers for Medicare and Medicaid Services confirmed to STAT. That projection forecasts a large increase in uptake over the next year and a half.
The estimate was buried in a new CMS document that addressed questions about next year’s payments for Medicare Advantage plans…”

Drug Shortages Statistics Summary

  • Ongoing and active shortages are the highest number (323) since we began tracking data in 2001.

  • Basic and life-saving products are in short supply including oxytocin, Rho(D) immune globulin, standard of care chemotherapy, pain and sedation medications, and ADHD medications.

  • New DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances (12% of all active shortages).

  • Workload required to manage shortages, including work to change pharmacy automation and electronic health records, adds to the challenges of pharmacy staff shortages.” 

 

About the public’s health

Lunchables under fire after reports of concerning lead, sodium levels “Consumer Reports is calling for the removal of Lunchables from school trays across the country after discovering concerning levels of lead and sodium and a potentially harmful chemical in their packaging in products sold in stores.
A petition lobbying the U.S. Department of Agriculture to get rid of the Kraft Heinz products from the National School Lunch Program has more than 14,000 signatures…
Consumer Reports’ findings follow a Washington Post investigation last year that showed how powerful food companies get ultra-processed foods such as Lunchables to qualify for the National School Lunch Program through years of extensive lobbying to lower government nutrition standards.”

About healthcare personnel

Top Factors in Nurses Ending Health Care Employment Between 2018 and 2021 “In this cross-sectional study of 7887 nurses who were employed in a non–health care job, not currently employed, or retired, the top contributing factors for leaving health care employment were planned retirement (39% of nurses), burnout (26%), insufficient staffing (21%), and family obligations (18%). Age distributions of nurses not employed in health care were similar to nurses currently employed in health care.”

Top 5 Reasons for Medical Malpractice Lawsuits “There are numerous reasons a patient or caregiver might name physicians in a medical malpractice lawsuit, but these were the top five cited and the percentage of claims they comprised in the 2023 survey vs. the 2021 report:

  1. Failure to diagnose or delayed diagnosis: 35%, up from 31%

  2. Complications from treatment or surgery: 27%, down from 29%

  3. Failure to treat or delayed treatment: 22%, up considerably from 16%

  4. Poor outcomes or disease progression: 20%, down from 26%

  5. Wrongful death: 15%, up from 13%”

About healthcare finance

Data for Alpine’s kidney disease candidate drive Vertex’s $4.9B takeover “Alpine Immune Sciences’ pivot away from cancer in 2022 has proven to be a profitable choice. After doubling down on its autoimmune and inflammatory disease pipeline, the biotech on Wednesday shared new data for its kidney disease programme — and announced a $4.9 billion buyout by Vertex Pharmaceuticals.”

Today's News and Commentary

About pharma

Top PBMs by 2023 market share
“CVS Caremark: 34%
Express Scripts: 23%
OptumRx (UnitedHealth): 22%
Humana Pharmacy Solutions: 7%
MedImpact Healthcare Systems: 5%
Prime Therapeutics: 3%
All other PBMs and cash pay: 6% “

About the public’s health

 EPA to crack down on toxic emissions from more than 200 chemical plants “The Environmental Protection Agency (EPA) finalized rules Tuesday that it said would dramatically reduce the number of people facing elevated cancer risks because of their exposure to air pollution. 
The number of people who have elevated cancer risks because they live within 6 miles of a chemical plant would drop by 96 percent, the EPA said. Cancer cases within about 31 miles of facilities that release toxic pollution into the air are expected to fall by about 60 percent under the rule.
That’s because the new regulations on 218 chemical plants are expected to cause them to reduce their releases of toxic pollution by more than 6,200 tons per year.”

In a first, EPA sets limit for ‘forever chemicals’ in drinking water “The Environmental Protection Agency has finalized the nation’s first drinking water standard for “forever chemicals,” a group of persistent human-made chemicals that can pose a health risk to people at even the smallest detectable levels of exposure.
The new rules are part of the Biden administration’s efforts to limit pollution from these per- and polyfluoroalkyl substances, or PFAS, which can persist in the environment for centuries. Exposure to PFAS has been linked to an increased risk of certain types of cancer, low birth weights, high cholesterol, and negative effects on the liver, thyroid and immune system.”

The Nature of the Rural-Urban Mortality Gap “The 2019 age-adjusted natural-cause mortality (NCM) rate for the prime working-age population (aged 25–54) was 43 percent higher in rural (nonmetropolitan) areas than in urban (metropolitan) areas. This is a shift from 25 years ago when NCM rates in urban and rural areas were similar for this age group. As a first step to understanding the increasing gap between rural and urban NCM rates, this report examines natural (disease-related) deaths for prime working-age adults in rural and urban areas between 1999 and 2019 using data from the U.S. Department of Health and Human Services, Centers for Disease Control’s Wide-ranging Online Data for Epidemiology Research (WONDER).”

Long-Term Effect of Salt Substitution for Cardiovascular Outcomes: A Systematic Review and Meta-Analysis  “Salt substitution may reduce all-cause or cardiovascular mortality, but the evidence for reducing cardiovascular events and for not increasing serious adverse events is uncertain, particularly for a Western population. The certainty of evidence is higher among populations at higher cardiovascular risk and/or following a Chinese diet.”

About healthcare IT

 Healthcare Should Look to Other Industries to Drive Digital Transformation, J.D. Power Says “Navigating health insurance digital channels is not easy. A surprising 42% of insured adults say they have experienced a problem using their health insurance website and/or app the past 12 months,1 and according to the inaugural J.D. Power U.S. Healthcare Digital Experience Study,SM released today, the websites and digital apps provided by commercial member health plans and Medicare Advantage plans are not helping matters. In fact, nearly one-third (32%) of health insurance websites and apps don’t meet the foundational level of functionality and intuitive organization of information.”

Today's News and Commentary

About health insurance/insurers

The Effects of Medical Debt Relief: Evidence from Two Randomized Experiments “Two in five Americans have medical debt, nearly half of whom owe at least $2,500. Concerned by this burden, governments and private donors have undertaken large, high-profile efforts to relieve medical debt. We partnered with RIP Medical Debt to conduct two randomized experiments that relieved medical debt with a face value of $169 million for 83,401 people between 2018 and 2020. We track outcomes using credit reports, collections account data, and a multimodal survey. There are three sets of results. First, we find no impact of debt relief on credit access, utilization, and financial distress on average. Second, we estimate that debt relief causes a moderate but statistically significant reduction in payment of existing medical bills. Third, we find no effect of medical debt relief on mental health on average, with detrimental effects for some groups in pre-registered heterogeneity analysis.”

MA enrollees like breadth of plan options, Harvard research finds “Previous research from Harvard and Inovalon has found that MA enrollees have fewer hospitalizations, have greater challenge in overcoming social determinants of health, and have fewer inpatient hospital stays.
This white paper (PDF) also looks at enrollees in health maintenance organizations (HMOs), finding these individuals are three times more likely to be nonwhite than people in MA preferred provider organizations (PPO) plans. Additionally, utilization in HMOs is 29% lower than comparable MA PPO populations, meaning nearly $2,500 lower utilization per person.”

About hospitals and healthcare systems

How labor costs are tracking at 30 health systems FYI

About pharma

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval “ In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did not improve overall survival or quality of life in confirmatory trials after more than 5 years of follow-up, with results not yet available for another 15% (7/46). Among drugs converted to regular approval, 60% (29/48) of conversions relied on surrogate measures.”

About healthcare IT

 One-third of Healthcare Websites Still Use Meta Pixel Tracking Code “A recent analysis of healthcare websites by Lokker found widespread use of Meta Pixel tracking code. 33% of the analyzed healthcare websites still use Meta pixel tracking code, despite the risk of lawsuits, data breaches, and fines for non-compliance with the HIPAA Rules.”

How Regenstrief and HL7 are driving SDOH data standards “Launched in 2019, the Gravity Project is a national public-private collaborative aimed at creating consensus-based data standards for SDOH interoperability across the health, social services, public health and research sectors.
The community includes over 2,500 stakeholders across healthcare, health IT, payers, community-based organizations, government agencies and research institutions like Regenstrief Institute…
A new $4.4 million grant from the Regenstrief Foundation is looking to take the Gravity Project to the next level by standardizing social risk factors in appropriate terminologies…”

Surescripts exploring a sale: report Dive Brief:

  • Healthcare IT giant Surescripts is looking for a buyer, according to a Tuesday report from Business Insider. 

  • The electronic prescribing company has hired healthcare investment bank TripleTree to explore a sale — potentially to a private equity firm, according to the Business Insider report, citing sources familiar. 

  • A private equity deal is logical, as a sale to a strategic player — like a payer with its own pharmacy benefit manager — could raise antitrust concerns, one expert told Healthcare Dive.”

Another ransomware group is seeking a payout from Change Healthcare, according to cybersecurity analysts “After the hackers responsible for the cyberattack on Change Healthcare took the ransom and ran in a reported exit scam, cybersecurity experts have found a new post that is seeking a payout from UnitedHealth Group to recover the data.
A post from RansomHub claims to have four terabytes of data stolen from Change, according to analyst Dominic Alvieri. The listing alleges that the administration of BlackCat, or ALPHV, stole a $22 million ransom payment made to recover the data.
Neither UnitedHealth nor Optum have confirmed that the payment was made, but researchers have identified payment logs that suggest the money changed hands.”

Today's News and Commentary

About quality and safety

Safety in healthcare 2024 From PressGaney: “Key safety takeaways for 2024: 

  • The gap in patient perceptions of safety in inpatient and outpatient settings is now 2.5x wider than pre-pandemic. While patients in medical practices and ambulatory settings felt substantially safer in 2023 (81.9%) compared to pre-pandemic levels (78.1%), perceptions of safety in hospitals fell 5.1%.   

  • Following record lows in 2021, workplace safety culture is increasing. Employee views of safety within their organization have risen 1.2% over the last two years, but nearly half still report low perceptions of safety culture.  

  • Reported assaults against nursing personnel jumped 5% YOY. In 2023, the rate of reported assaults against nurses increased to 2.71 per 100 nursing personnel, from 2.59 the previous year.  

  • Safety outcomes show continued momentum. The biggest improvement was seen in catheter-associated urinary tract infection (CAUTI) rates, which are now better than pre-pandemic levels.”

About health insurance/insurers

In Battle Over Health Care Costs, Private Equity Plays Both Sides An excellent article worth reading in its entirety. An excerpt:
”Insurance companies have long blamed private-equity-owned hospitals and physician groups for exorbitant billing that drives up health care costs. But a tool backed by private equity is helping insurers make billions of dollars and shift costs to patients.
The tool, Data iSight, is the premier offering of a cost-containment firm called MultiPlan that has attracted round after round of private equity investment since positioning itself as a central player in the lucrative medical payments field. Today Hellman & Friedman, the California-based private equity giant, and the Saudi Arabian government’s sovereign wealth fund are among the firm’s largest investors.
The evolution of Data iSight, which recommends how much of each medical bill should be paid, is an untold chapter in the story of private equity’s influence on American health care.”
See, also: Insurers Reap Hidden Fees by Slashing Payments. You May Get the Bill.

Contract Year 2025 Medicare Advantage and Part D Final Rule (CMS-4205-F) From CMS. Well-wroth skimming the major points.

Medicare billing forms are running out of space for growing health care prices “CMS last month said it was adding two digits to the Medicare claims processing system for hospital and doctor office charges, called the Fiscal Intermediary Shared System, so that it can now accommodate prices just a penny shy of $100 million.”

Healthcare services ranked by Medicare Advantage utilization increases “Medicare Advantage plans saw utilization rates rise 8.1% in the fourth quarter of 2023, primarily driven by outpatient and emergency room services, according to an AHIP survey.”
The article details specific service changes.

About hospitals and healthcare systems

 HHS pitches rewards for hospitals with drug shortage solutions “Every year, U.S. hospitals spend at least $600 million to mitigate drug shortages, according to HHS. On April 2, the department proposed financial incentives for hospitals with resilient drug supplies. 
In an 18-page policy recommendation, HHS recommended a Manufacturer Resiliency Assessment Program and a Hospital Resilient Supply Program. The programs, which HHS defined as long-term solutions, would assess and rank drug manufacturers based on their reliability. 
Hospitals would then be rewarded for buying drugs from diverse and reliable suppliers.”
See, also:Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States

From -6.8% to 12.2%: 42 health systems ranked by operating margins FYI

March 2024 National Hospital Flash Report “Key Takeaways
1. Margins this month were at 3.96%, continuing a strong start to 2024. However, data this month do not reflect the full impact of the Change Healthcare outage, which began February 21st.
2. Gross revenue continues to rise at a faster rate than net revenue, highlighting payer mix changes. Bad debt and charity care have also risen over the last few years.
3. Revenue growth is primarily being driven from the outpatient setting. There continues to be a decline in inpatient revenue and increase in outpatient revenue.”

About pharma

Sanofi agrees to settle thousands of Zantac cancer claimsSanofi confirmed to FirstWord on Friday that it reached a deal in principle to settle approximately 4000 personal injury lawsuits accusing the company of selling the now-discontinued heartburn medicine Zantac (ranitidine) without warning patients that it could potentially cause cancer.
The settlement, which marks the first major resolution of cases related to the product, will apply to litigation pending in courts in US states other than Delaware, where the company is still facing some 20,000 lawsuits.”

 Healthy Returns: Weight loss, diabetes drug ad spending tops $1 billion “Companies spent more than $1 billion on ads for weight loss and diabetes medicines in 2023, up 51% from the prior year, according to new data from advertising analytics firm MediaRadar. That’s nearly 15% of drugmakers’ $7.6 billion in ad spending for prescription drugs last year.
Diabetes treatments accounted for nearly $790 million in ad spending in 2023, while weight loss drugs made up almost $264 million.”

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval Question  What is the clinical benefit of cancer drugs granted accelerated approval, and on what basis are they converted to regular approval?
Findings  In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did not improve overall survival or quality of life in confirmatory trials after more than 5 years of follow-up, with results not yet available for another 15% (7/46). Among drugs converted to regular approval, 60% (29/48) of conversions relied on surrogate measures.”

Patient Out-of-Pocket [OOP] Costs for Biologic Drugs After Biosimilar Competition “In this cohort study of 190 364 outpatients with 1.7 million claims for 7 biologics between 2009 and 2022, annual OOP spending did not decrease after the start of biosimilar competition, and OOP costs were similar for biosimilars and their reference biologics.”
See, also: Revisiting Expectations of US Biosimilars—Panacea or One Piece of the Puzzle?

About healthcare finance

 Johnson & Johnson adds Shockwave Medical to its cardiovascular collection with $13.1B deal “J&J MedTech sees Shockwave’s pioneering portfolio of intravascular lithotripsy catheters—minimally invasive devices that use acoustic energy to shatter the hard, calcified blockages found deep within coronary and peripheral arteries—as the ticket to its 13th priority platform: one that will join its pantheon of products that each claim more than $1 billion in annual sales.
The deal follows up on 2023’s integration of the miniature heart pump maker Abiomed, a $16.6 billion buy, as well as J&J’s $400 million purchase of cardiac implant developer Laminar, aimed at reducing a person’s long-term risk of stroke linked to atrial fibrillation.”

Healthcare Dealmakers—Elevance to acquire Kroger Specialty Pharmacy; Optum to buy Steward's physician group and more FYI

Today's News and Commentary

NIH’s Role in Sustaining the U.S. Economy “In Fiscal Year 2023, the $37.81 billion NIH awarded to researchers in the 50 U.S. states and the District of Columbia supported 412,041 jobs and $92.89 billion in economic activity.”

About Covid-19

 The new COVID-19 drug “The medication, Pemgarda, is a monoclonal antibody that targets the SARS-CoV-2 spike protein, and it is indicated for patients 12 and older. The authorization is not an approval, meaning the FDA greenlit the medicine ‘based on a reasonable belief that the product may be effective based on the best evidence available at the time,’ its website says, ‘without waiting for all the information that would be needed for an FDA approval.’”

About health insurance/insurers

Medicare Spending on Ozempic and Other GLP-1s Is Skyrocketing “KFF’s analysis of newly released Medicare Part D spending data from CMS shows that total gross Medicare spending on these medications has skyrocketed in recent years, rising from $57 million in 2018 to $5.7 billion in 2022 (Figure 1). (Gross spending does not account for rebates that would result in lower net spending.) As of 2022, Part D covered three GLP-1s for diabetes: Ozempic (semaglutide injection), approved in December 2017; Rybelsus (semaglutide tablets), approved in September 2019; and Mounjaro (tirzepatide) approved in May 2022.”

Medicaid disenrollments surpass 18M, exceeding HHS projections “The Families First Coronavirus Response Act required Medicaid to provide continuous coverage for beneficiaries throughout the COVID-19 pandemic. With disenrollments paused, Medicaid and the Children’s Health Insurance Program (CHIP) enrollment grew by over 23 million beneficiaries.
The continuous coverage policy ended with the public health emergency, and states could begin coverage redeterminations on April 1, 2023. HHS had projected that 15 million beneficiaries would lose Medicaid coverage. However, as of March 20, 2024, more than 18 million people have been disenrolled. What’s more, 35 million beneficiaries’ eligibility redeterminations have either still not been completed or have not been reported.”

About hospitals and healthcare systems

 FAIR SHARE SPENDING Are hospitals giving back as much as they take? “KEY TAKEAWAYS

  • Of 2,425 nonprofit hospitals evaluated, 80% spent less on financial assistance and community investment than the estimated value of their tax breaks (what we call a fair share deficit).

  • The combined fair share deficit for all hospitals studied is $25.7 billion for 2021. That’s enough to erase 29% of the country’s medical debt (as reported on the CFPB’s Consumer Credit Panel).

  • The ten hospitals with the largest fair share deficits also reported at least one hundred million dollars in net income in 2021.

  • Hospitals spent 3.87% of their budget on community investments, on average, but this proportion varied widely. For example, the Hospital of the University of Pennsylvania (0.25%) would have spent $248 million more in community investments had it spent at the rate of North Shore University Hospital (8.84%).

  • Five Catholic health systems are among the ten systems with the greatest fair share deficits: Providence, CommonSpirit, Trinity, Ascension, and Bon Secours Mercy.

  • There are only five states in which a majority of hospitals have a fair share surplus: Delaware, Montana, Maryland, Texas, and Utah.

  • These five states have 97% or more hospitals with a fair share deficit: Michigan, West Virginia, Louisiana, Washington, Rhode Island.” 

About pharma

Pharmaceutical company Amgen sues Colorado over price-setting prescription drug board “Amgen, the multinational pharmaceutical company that makes the blockbuster arthritis drug Enbrel, has sued Colorado over a state board’s efforts to possibly cap the price of the drug.
In a lawsuit filed Friday in U.S. District Court in Denver, Amgen argues that the actions of Colorado’s Prescription Drug Affordability Board are unconstitutional because they conflict with federal laws and because they violate rights to due process. The company is seeking not just to overturn the board’s recent decisions about Enbrel but also to strike down major parts of the law creating the board.”
Other drugs are being considered as well. For more analysis, see: Colorado is pushing to cap drug prices. It’s likely to be in for a fight.

Association of State Insulin Out-of-Pocket [OOP] Caps With Insulin Cost-Sharing and Use Among Commercially Insured Patients With Diabetes “State insulin caps were not associated with changes in insulin use in the overall population (relative change in fills per month, 1.8% [95% CI, −3.2% to 6.9%]). Insulin users in intervention states saw a 17.4% (CI, −23.9% to −10.9%) relative reduction in insulin OOP costs, largely driven by reductions among HSA enrollees; there was no difference in OOP costs among nonaccount plan members. More generous ($25 to $30) state insulin OOP caps were associated with insulin OOP cost reductions of 40.0% (CI, −62.5% to −17.6%), again primarily driven by a larger reduction in the subgroup with HSA plans.”

Merck & Co.’s Winrevair nabs highly-anticipated approval in PAH “After Merck & Co. posted data last year showing the extent to which Winrevair (sotatercept-csrk) can boost exercise capacity and prolong survival, the FDA's approval Tuesday of the first-in-class activin signalling inhibitor to treat adults with pulmonary arterial hypertension (PAH) took few by surprise. The outstanding question, however, is how and when the disease-modifying therapy gets incorporated into PAH treatment regimens that haven’t seen a drug with a novel mechanism of action in years.”

About the public’s health

Deaths from Excessive Alcohol Use — United States, 2016–2021 “Average annual number of deaths from excessive alcohol use, including partially and fully alcohol-attributable conditions, increased approximately 29% from 137,927 during 2016–2017 to 178,307 during 2020–2021, and age-standardized death rates increased from approximately 38 to 48 per 100,000 population. During this time, deaths from excessive drinking among males increased approximately 27%, from 94,362 per year to 119,606, and among females increased approximately 35%, from 43,565 per year to 58,701.”