About health insurance/insurers

 Healthcare billing fraud: 8 recent cases FYI

Physician Group Practices Accrued Large Bonuses Under Medicare’s Bundled Payment Model, 2018–20 “The Bundled Payments for Care Improvement Advanced Model (BPCI-A), a voluntary Alternative Payment Model for Medicare, incentivizes hospitals and physician group practices to reduce spending for patient care episodes below preset target prices…We found that physician groups earned $421 million in incentive payments during BPCI-A’s first four performance periods (2018–20). Target prices were positively associated with bonuses, with a mean reconciliation payment of $139 per episode in the lowest decile of target prices and $2,775 in the highest decile. In the first year of the COVID-19 pandemic, mean bonuses increased from $815 per episode to $2,736 per episode. These findings suggest that further policy changes, such as improving target price accuracy and refining participation rules, will be important as the Centers for Medicare and Medicaid Services continues to expand BPCI-A and develop other bundled payment models.”

About hospitals and healthcare systems

 CommonSpirit posts $365M quarterly loss, -3.9% margin “Chicago-based CommonSpirit reported operating losses of $365 million and $411 million during the three- and nine-month periods ending March 31, 2024, compared to losses of $619 million and $1 billion during the same periods the year prior.”

Cleveland Clinic's operating margin inches up as inflation pressures hold volume gains in check “The nonprofit system reported this week a $50.2 million operating gain (1.3% operating margin) as opposed to the prior year’s $32.3 million (0.9% operating margin). Operating revenues rose 10.2% year over year to nearly $3.9 billion while operating expenses followed close behind with a 9.8% increase.”

Surging Hospital Prices Are Helping Keep Inflation High “Hospital prices specifically jumped 7.7% last month from a year ago, the highest increase in any month since October 2010, the Labor Department said Wednesday.
Among the procedures with hefty recent price increases are angioplasties placing stents in arteries to improve blood flow, which grew $670, or 4.5%, to $15,640 in the first three months of the year from the same period a year ago, according to Turquoise Health.”
Comment: Hospitals are always raising prices; but what they are paid depends on contracts (with private insurers) or regulations (with Medicare and Medicaid). So, while the Consumer Price Index includes what is actually paid (price and payment are identical or close) hospital payments diverge greatly from prices.

Performance Trends Report Market Analysis and Hospital & Patient Volume Benchmarks “Key findings include:
—U.S. hospitals experienced up to a 17.9% shortfall in payment volumes in the first quarter.
—Expansion of the Two-Midnight Rule governing how long patients can be kept in outpatient observation status could affect more than 20% of Medicare Advantage encounters in 2024.
—Median hospital operating margins continue to stabilize, with the metric holding above 4.5% throughout the first quarter as hospitals saw an 11th straight month of gross revenue growth.
—Year-over-year growth in inpatient revenue exceeded outpatient revenue increases for the first time since late 2021.
—The share of knee replacement surgeries performed on an outpatient basis exceeded 80% in Q1 2024, up from about 20% five years ago.”
Comment: The entire report is worth reading.

Calculation of Overall Hospital Quality Star Ratings With and Without Inclusion of the Peer Grouping Step “Question  What are the implications of applying a peer grouping step on hospitals’ Overall Star Ratings?
Finding  In this cross-sectional study of 3076 hospitals that received a star rating in 2023, presence of the peer grouping step resulted in 585 hospitals (19.0%) being assigned a different star rating than if the peer grouping step was absent, including considerably more hospitals having a higher star rating (517 hospitals) than a lower star rating (68 hospitals).”

About pharma

 In Big Pharma's growth rankings, Lilly took top spot from Novo Nordisk in Q1 “The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. With 18 of the industry’s top 25 companies achieving year-over-year revenue gains, the first quarter of 2024 nearly matched the final quarter of last year, when 21 of the industry's top 25 companies posted sales increases.”

About the public’s health

Justice Department formally moves to reclassify marijuana as a less dangerous drug in historic shift “A proposed rule sent to the federal register recognizes the medical uses of cannabis and acknowledges it has less potential for abuse than some of the nation’s most dangerous drugs. The plan approved by Attorney General Merrick Garland would not legalize marijuana outright for recreational use.
The Drug Enforcement Administration will next take public comment on the proposal in a potentially lengthy process.”

About healthcare IT

 Scammers send fake MyChart messages “Scammers have been trying to trick patients into giving up personal information by sending fake MyChart messages.
Tacoma, Wash.-based MultiCare Health System is the latest system to warn of the scam.” 

About health technology

Going beyond A, B and O: Thermo Fisher unveils DNA test for the rarest blood types “Thermo Fisher Scientific has put forward a DNA-based test it says can offer much more precise identification of blood and its potential compatibility—going much further than the traditional positive and negative blood types of A, B, AB and O.
Currently available for research use only, the company said its genetic approach could help support the development of cost-effective diagnostics for screening blood donations and matching them to the proper patients in need, including those with extremely rare blood types.

About healthcare quality

 2023 Sentinel Event Data Annual Report “The most prevalent event types identified in 2023 include the following:

• Falls (48%)

• Wrong surgery (8%)

• Unintended retention of foreign object (8%)

• Assault/rape/sexual assault/homicide (8%)

• Delay in treatment (6%)

• Suicide (5%)

These event types comprised 83% of all reported sentinel events in 2023. The majority of these events – 96% (1,358) – were voluntarily self-reported to The Joint Commission by an accredited or certified entity.” 

About health insurance/insurers

UnitedHealth's investments in affordable housing top $1B “UnitedHealth Group's investments in affordable housing have topped $1 billion, with the program a keystone in its overarching strategy to address health equity and disparities.
The company has made investments in housing since 2011 and, in that time, has supported the development of affordable and mixed income units across 31 states and the District of Columbia, creating more than 25,000 homes for people and families who face housing insecurity.”

About hospitals and healthcare systems

 42 health systems ranked by net income FYI

About pharma

Wegovy could bankrupt US health system, Sanders says in new report “Blockbuster weight-loss drug Wegovy could bankrupt the U.S. health care system unless the price drops, according to a staff report released Wednesday from the office of Senate Health Committee Chair Bernie Sanders (I-Vt.). 
Unless prices dramatically decline, Wegovy and weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs, the report concluded.”

Lilly’s weekly insulin works as well as daily products, new studies show “Eli Lilly reported Thursday that its experimental weekly insulin worked as well as daily basal insulin products in two late-stage studies, paving the way for the drug to compete with a similar weekly insulin developed by Novo Nordisk.
In a 52-week trial of type 2 diabetes patients using insulin for the first time, those on the weekly insulin, called efsitora alfa, had a 1.34% reduction in blood sugar levels, while people on the comparator daily insulin degludec, sold as Tresiba by Novo, had a 1.26% lowering. That resulted in patients having blood sugar levels, known as A1C readings, of 6.87% and 6.95%, respectively.”

About the public’s health

 AI predicts vape flavours can break down into potentially harmful compounds when heated “An artificial intelligence-based approach has predicted hundreds of harmful compounds that could form when e-cigarette flavour chemicals are heated in vaping devices. The research adds to mounting evidence concerning the safety of vaping, finding that many of the predicted pyrolysis products from flavours are classed as either acutely toxic, health hazards or irritants. What’s more, their impact on health might take years to emerge, say the researchers.” 

About healthcare IT

 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices FYI: “he FDA is providing this list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area.”

About healthcare personnel

Association between anaesthesia–surgery team sex diversity and major morbidity “Care in hospitals with greater anaesthesia–surgery team sex diversity was associated with better postoperative outcomes. Care in a hospital reaching a critical mass with over 35% female anaesthetists and surgeons, representing higher team sex-diversity, was associated with a 3% lower odds of 90-day major morbidity.” 

About health insurance/insurers

 CVS warns it could lose up to 10% of its Medicare members next year “The company was $900 million short of its health care benefits estimates on its medical cost line. Within that $900 million, about $400 million was attributed to high utilization among outpatient services, outpatient pharmacy and behavioral mental health.”

About hospitals and healthcare systems

The cost of unnecessary hospital days in 8 numbers FYI- Well worth reading.

 How a ransomware attack is affecting Ascension's facilities across the US FYI

Jefferson, Lehigh Valley Health Network ink definitive agreement to merge “Philadelphia-based Jefferson and Allentown, Pa.-based Lehigh Valley Health Network have signed a definitive agreement to merge into a 30-hospital system with more than 700 care sites. 
Under the agreement, Jefferson and LVHN will integrate identity, clinical care and operations. The integrated system will comprise more than 65,000 employees and offer new educational opportunities to existing physicians and allow for recruitment opportunities, according to a joint May 15 news release.”

About pharma

 Most Approved Cancer Drugs Don’t Improve Overall Survival [OS], Data Suggest “Of the 305 drugs that were approved based on a surrogate endpoint, 153 (50%) were later evaluated for OS, and 29 (8%) demonstrated an OS benefit.
Overall, 125 of the 392 drugs evaluated (32%) have demonstrated improvements in OS, and the remaining 267 drugs (68%) have not.”
 

About the public’s health

FDA approves self-collection screening tests for HPV, allowing women to avoid pelvic exams for cervical cancer “The FDA has approved two diagnostic devices that allow women to collect vaginal samples themselves for cervical cancer screening—a major step toward catching more early and potentially preventable cases without requiring an invasive gynecological exam.
The separate self-collection offerings from BD and Roche still need to be used in a healthcare setting—they have not received agency green lights for solo, at-home use—but the two companies said the move could improve access to screening by enabling HPV testing at locations such as retail pharmacies or mobile clinics.”

Study highlights inappropriate antibiotic prescribing in US emergency departments “A review of US emergency department (ED) visits involving antibiotic prescribing found that more than a quarter had inappropriate antibiotic prescriptions, and nearly half of those didn't even have a plausible indication for antibiotics, US researchers reported today in Antimicrobial Stewardship & Healthcare Epidemiology.”

CDC makes public influenza A wastewater data to assist bird flu probe “The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday released data on influenza A found in wastewater in a public dashboard that could assist in tracking the outbreak of H5N1 bird flu that has infected cattle herds.
Last week, an agency official told Reuters about U.S plans to make public data collected by its surveillance system.”

Drug overdose deaths fell for first time in five years, though still exceeded 100,000 “U.S. drug deaths decreased slightly in 2023, according to new data, the first decrease in five years.
Last year saw 107,543 U.S. drug overdose deaths, according to preliminary statistics released Wednesday by the Centers for Disease Control and Prevention, roughly a 3% drop from 2022.” 

About Covid-19

Data: Heart-failure patients have 82% better odds of living longer if vaccinated against COVID “The first study of COVID-19 vaccine effectiveness in a large population of adult heart-failure patients suggests that vaccinated participants are 82% more likely to live longer than their unvaccinated peers, according to
an analysis presented over the weekend at the Heart Failure 2024 scientific congress of the European Society of Cardiology (ESC) in Lisbon, Portugal.” 

Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication “The U.S. Food and Drug Administration (FDA) is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests for Home and Over-the-Counter (OTC) Use and its COVID-19 Test intended for patient care settings due to increased risk of false results.” 

About health insurance/insurers

 20 things to know about site-neutral payment policies  FYI

About hospitals and healthcare systems

 Kaiser Permanente posts 3.4% operating margin, billions in net income for Q1 2024  '‘Kaiser Permanente kicked off 2024 with $935 million of operating income (3.4% operating margin) and more than $2.7 billion of net income when excluding a one-time, $4.6 billion net asset gain from its Geisinger Health acquisition, according to top-line first-quarter numbers shared late Friday.
The performance handily outpaces the $233 million operating income (0.9% operating margin) and $1.2 billion bottom line of last year’s opening quarter.”

10 healthcare industry lawsuits, settlements FYI

About pharma

 Users of Novo Nordisk’s Wegovy sustain weight loss for 4 years, new analysis shows “Patients taking Novo Nordisk’s anti-obesity jab sustained weight loss for up to four years and had a reduced risk of heart disease regardless of their weight, according to new research that adds evidence to the drug’s broader health benefits. Two new studies published on Tuesday in Nature Medicine built on Novo Nordisk trial data first published in November, which found that patients using Wegovy had a 20 per cent reduction of risk of heart attacks and other cardiovascular events. One of the new studies based on the Select trial found that users of the drug over a period of three years and four months sustained their weight loss over four years, in a 17,604-person trial.”

AbbVie inks $2B-plus next-gen neuro deal with Gilgamesh “AbbVie has inked a new deal with Gilgamesh Pharmaceuticals aimed at developing next-gen therapies for psychiatric disorders.
The two companies have agreed to research and develop a portfolio of therapeutics using Gilgamesh’s research platform designed to discover novel neuroplastogens—compounds that improve neuroplasticity. Under the deal, AbbVie will have the option to lead development and commercialization activities.”

About the public’s health

 Four in 10 cancer cases linked to obesity, study finds “Around 40 per cent of cancer cases are linked to obesity, with excess weight being a factor in 32 types of the disease, research has found.
A study released ahead of the European Congress on Obesity in Venice tracked four million adults for decades and showed the impact of excess body fat.”
And in a related article: Breast cancer incidence and mortality by metabolic syndrome and obesity: The Women’s Health Initiative

USDA, FDA turf battles hamper responses to outbreaks like H5N1 bird flu The headline is the story.

Broad Public Support for Legal Abortion Persists 2 Years After Dobbs “About six-in-ten (63%) say abortion should be legal in all or most cases.This share has grown 4 percentage points since 2021 – the year prior to the 2022 decision in Dobbs v. Jackson Women’s Health Organization that overturned Roe.”

About health devices/technology

FACT SHEET: President Biden Takes Action to Protect American Workers and Businesses from China’s Unfair Trade Practices The last item is medical products. For example: “The tariff rates on syringes and needles will increase from 0% to 50% in 2024. For certain personal protective equipment (PPE), including certain respirators and face masks, the tariff rates will increase from 0–7.5% to 25% in 2024. Tariffs on rubber medical and surgical gloves will increase from 7.5% to 25% in 2026.”

 Salt Meter Could Improve Compliance With Low-Sodium Diet “Using a salt meter or sensor in food itself, in conjunction with other measures, can help reduce sodium intake by improving control of arterial hypertension at the community level, according to a Thai study. The results were described at the World Congress of Nephrology…
The salt meter tested in the study is immersed in liquid solutions and displays the degree of salt concentration in seconds through a smiling, surprised, or frowning face. It could be particularly appropriate for diets in Asian countries, where more than 60% of excess sodium comes from soups, sauces, and broths prepared at home.”

About health insurance/insurers

CMS extends Medicaid waivers to 2025 “CMS will extend flexibilities designed to help states keep more eligible individuals enrolled in Medicaid through June 2025. 
The waivers, previously set to expire at the end of 2024, will be extended for six more months, Daniel Tsai, deputy CMS administrator and director of the Center for Medicaid and CHIP services, wrote in a May 9 memo to states.”

Optum forgoes physician noncompetes at Oregon medical group “Optum's Eugene-based Oregon Medical Group will not enforce noncompete agreements for any departing physicians or advanced practice providers, ABC-affiliate KEZI reported May 10.
In March, the medical group dropped some patients due to a lack of available physicians, 32 of whom have departed from the organization over the last two years. Oregon Medical Group was purchased by Optum in 2020.”

State Agencies Could Be Obtaining Hundreds of Millions in Additional Medicaid Rebates Associated With Physician-Administered Drugs “State agencies could have invoiced and obtained rebates from the manufacturers for $225.7 million (Federal share) for physician-administered drugs reimbursed on a fee-for-service basis, and should have collected additional rebates associated with $236.2 million (Federal share) for physician-administered drugs administered to Medicaid managed-care organization enrollees…”

About hospitals and healthcare systems

 Here's what the CEOs and CFOs of public for-profit health systems made in 2023 FYI

 Prices Paid to Hospitals by Private Health Plans “Key Findings

• Only Arkansas had an overall relative price below 170 percent of Medicare prices, while other states (California, Florida, Georgia, New York, South Carolina, West Virginia, and Wisconsin) had relative prices that were above 300 percent of Medicare prices.

• In 2022, across all hospital inpatient and outpatient services (including both facility and related professional claims), employers and private insurers paid, on average, 254 percent of what Medicare would have paid for the same services at the same facilities.

• State-level median prices have remained stable across the past three study rounds: 254 percent of Medicare prices in 2018 (Round 3), 246 percent in 2020 (Round 4), and 253 percent in 2022 (Round 5—the current study).

• Prices for common outpatient services performed in ambulatory surgery centers (ASCs) averaged 171 percent of Medicare prices but would have averaged approximately 107 percent of Medicare prices if paid using Medicare payment rates for hospital outpatient departments (HOPDs).

• Although relative prices are lower for ASC claims priced according to HOPD rules, HOPD prices are higher than ASC prices.

• Commercial insurance prices for administered drugs received in a hospital setting averaged 278 percent of average sales price (ASP) compared with 106 percent of ASP paid by Medicare for administered drugs.

• Very little variation in prices is explained by each hospital's share of patients covered by Medicare or Medicaid; a larger portion of price variation is explained by hospital market power.”

About pharma

 Walgreens contacts potential buyers for $8.8 billion Boots chain “Walgreens Boots Alliance is reaching out to potential buyers of the $8.8 billion Boots drugstore chain in the UK, according to people familiar with the matter.”

Sanofi, Pfizer, AstraZeneca invest a combined €1.87B to bolster operations in France “Taking the bronze medal is AstraZeneca, which will spend 365 million euros ($394 million) to enhance its facilities at its manufacturing site in Dunkirk, France. Earning the silver is Pfizer with a pledge to invest 500 million euros ($540 million) over the next five years to bolster its R&D capabilities in France.But not to be outdone in its home country is gold-medal winner Sanofi. The Paris drugmaker has earmarked more than 1 billion euros ($1.1 billion) to increase its manufacturing capacity at three sites in France.”

Johnson & Johnson looks to offload remaining Kenvue stake in $3.75B deal “In a Monday securities filing, Kenvue revealed J&J's plan to offer 182.33 million shares of Kenvue in exchange for debt to be held by Goldman Sachs and J.P. Morgan Securities. The "debt-for-equity" exchange looks to be worth about $3.75 billion, based on Kenvue's Friday closing share price of $20.54.”

Patent Portfolios Protecting 10 Top-Selling Prescription Drugs “In this cross-sectional study of 1429 patents and patent applications protecting the 10 highest-revenue brand-name drugs in the US in 2021, almost three-quarters were filed after US Food and Drug (FDA) approval. Patents filed after FDA approval and those protecting parts of the drug other than the active ingredient contributed to dense patent thickets.”

About the public’s health

Survey: Trust in vaccines declines among teenagers, parents “Key takeaways:

• Most parents and teenagers reported concerns about the safety of vaccines in general.

• Only 46% of parents and 33% of teenagers felt it important to receive the latest COVID-19 vaccine.”

Federal dollars to increase bird flu testing for dairy cows, farm workers “The federal government Friday unveiled a major package of financial incentives to dairy farm owners — up to $28,000 per farm over the next four months — to encourage broader testing of cattle and expanded security measures to control a growing outbreak of the bird flu virus in cows.”

About healthcare IT

50-State Survey of Telehealth Insurance Laws FYI

 About health technology

First person to receive a genetically modified pig kidney transplant dies nearly 2 months later “The first recipient of a genetically modified pig kidney transplant has died nearly two months after he underwent the procedure, his family and the hospital that performed the surgery said Saturday.
Richard “Rick” Slayman had the transplant at Massachusetts General Hospital in March at the age of 62. Surgeons said they believed the pig kidney would last for at least two years.”

About antitrust

Assistant Attorney General Jonathan Kanter Announces Task Force on Health Care Monopolies and Collusion “The Justice Department today announced the formation of the Antitrust Division’s Task Force on Health Care Monopolies and Collusion (HCMC). The HCMC will guide the division’s enforcement strategy and policy approach in health care, including by facilitating policy advocacy, investigations and, where warranted, civil and criminal enforcement in health care markets…
The HCMC will consider widespread competition concerns shared by patients, health care professionals, businesses and entrepreneurs, including issues regarding payer-provider consolidation, serial acquisitions, labor and quality of care, medical billing, health care IT services, access to and misuse of health care data and more. The HCMC will bring together civil and criminal prosecutors, economists, health care industry experts, technologists, data scientists, investigators and policy advisors from across the division’s Civil, Criminal, Litigation and Policy Programs, and the Expert Analysis Group, to identify and address pressing antitrust problems in health care markets.”

About health insurance/insurers

Community Health Systems adds another antitrust lawsuit to MultiPlan's collection “Community Health Systems is the latest health system to allege that MultiPlan’s data-driven claims repricing business meets the bar for antitrust violation.
The public for-profit system filed a lawsuit in a New York federal court Wednesday, following in the wake of similar litigation launched last year by AdventHealth and just a few weeks ago by Allegiance Health Management.
Though the new lawsuit does not name major health insurers as co-defendants, CVS Health’s Aetna, Elevance Health, Centene Corporation, Cigna, Health Care Service Corporation, UnitedHealth Group and Humana are highlighted as “co-conspirators” in the “MultiPlan Cartel,” which CHS wrote “includes virtually all of the major healthcare insurance payors in the United States.”

UnitedHealth offers to divest 100 locations in Amedisys deal: Report “UnitedHealth Group and Amedisys plan to divest more than 100 clinic locations to make its proposed acquisition more palatable to regulators, Capitol Forum reported. 

About hospitals and healthcare systems

US Hospital Service Availability and New 340B Program Participation “This longitudinal observational study including 2152 general acute care hospitals found that public hospitals were significantly more likely to sustain unprofitable services after 340B participation, but there was not a meaningful association between 340B participation and service offerings at nonprofit hospitals, except for oncologic services.” 

About pharma

KFF Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs “The latest KFF Health Tracking Poll finds that about one in eight adults (12%) say they have ever taken a GLP-1 agonist – an increasingly popular class of prescription drugs used for weight loss and to treat diabetes or prevent heart attacks or strokes for adults with heart disease – including 6% who say they are currently taking such a drug. The share who report ever taking these drugs rises to four in ten (43%) among adults who have been told by a doctor that they have diabetes, a quarter who have been told they have heart disease, and one in five (22%) who have been told by a doctor that they are overweight or obese in the past five years. Public awareness of GLP-1 drugs has increased in the past year, with about one-third (32%) of adults now saying they have heard ‘a lot’ about these drugs, up from 19% in July 2023.”

Pfizer agrees to settle more than 10,000 Zantac cancer suits “Pfizer Inc. has agreed to settle more than 10,000 cases accusing it of hiding the cancer risks of its Zantac heartburn drug, according to people familiar with the deal, the biggest of the litigation. 
The agreements cover cases in state courts across the US but don’t completely resolve the company’s exposure to Zantac claims, according to the people, who spoke on the condition of anonymity because they weren’t authorized to discuss the settlement publicly. Financial details of the accords weren’t immediately available.
The deal is likely to reassure investors, who have seen other Zantac makers, including GSK Plc and Sanofi, sign settlements. Concerns about the drugmakers’ exposure to Zantac suits helped wipe out about $45 billion in combined market value in the summer of 2022. The shares have since recovered and have risen on news of the earlier deals.”

About the public’s health

Prevalence of Cardiovascular-Kidney-Metabolic [CKM] Syndrome Stages in US Adults, 2011-2020 “Almost 90% of US adults met criteria for CKM syndrome (stage 1 or higher) and 15% met criteria for advanced stages, neither of which improved between 2011 and 2020. The lack of progress, in part, may reflect concomitant improvement and worsening of different risk factors over time.2,5 Substantial between-subgroup differences in advanced stages were observed, with older age, men, and Black adults at increased risk.” 

About healthcare IT

White House to push cybersecurity standards on hospitals “In parallel to pushing out rules for hospital cybersecurity, the Biden administration intends to offer free training to 1,400 small, rural hospitals across the country, according to Neuberger. She said the training will become available ‘in the next few weeks.’”

About healthcare personnel

Medical residents are increasingly avoiding states with abortion restrictions “Fourteen states, primarily in the Midwest and South, have banned nearly all abortions. The new analysis by the AAMC—a preliminary copy of which was exclusively reviewed by KFF Health News before its public release—found that the number of applicants to residency programs in states with near-total abortion bans declined by 4.2%, compared with a 0.6% drop in states where abortion remains legal.
Notably, the AAMC’s findings illuminate the broader problems abortion bans can create for a state’s medical community, particularly in an era of provider shortages: The organization tracked a larger decrease in interest in residencies in states with abortion restrictions not only among those in specialties most likely to treat pregnant patients, like OB-GYNs and emergency room doctors, but also among aspiring doctors in other specialties.”

Fewer nurses intend to leave healthcare, surveys suggest “AMN Healthcare's Nurses in 2024 report, a survey of 1,155 nurses, found that only 35% of nurses plan to change jobs and about 20% said they are optimistic that their work will improve this year. A February report by AMN also found 31% of nursing leaders are considering leaving their jobs.” 

About Covid-19

 There's a New Set of COVID Variants Called FLiRT: What You Need to Know “Key Takeaways

• New COVID-19 variants dubbed FLiRT have fast become the dominant strains in the United States, the CDC says

• Symptoms appear to be similar those of the prior dominant variant, JN.1

• There's concern that FLiRT may not be as susceptible to the last updated COVID-19 vaccine” 

About health insurance/insurers

Cigna, Oscar Health to shutter small group business “Oscar Health and Cigna will discontinue their co-branded Cigna + Oscar business at the end of 2024. 
On a May 7 call with investors, Oscar CEO Mark Bertolini said it chose not to renew the offering in 2025 as part of its strategy to focus on the individual market.” 

CMS proposes new mandatory organ transplant model for end-stage renal disease “The Centers for Medicare & Medicaid Services (CMS) has unveiled a new mandatory model proposal it says will improve access for individuals needing kidney transplants, reduce disparities and help selected hospitals better perform transplants.
The proposed Increasing Organ Transplant Access (IOTA) Model, announced Wednesday afternoon, is a six-year model to be carried out by the CMS Innovation Center beginning Jan. 1, 2025.
The proposed model will also help reduce Medicare spending and pinpoint living donors, according to a CMS fact sheet.”

About hospitals and healthcare systems

 Nonprofit hospitals aren't immune to FTC's noncompete ban, lawyers, Fitch analysts warn “The FTC’s jurisdiction extends to corporations that are organized to carry out business for their own profit or for those of its members—a limitation that puts it at odds with an industry in which more than half of all acute care hospitals are classified as nonprofits. These organizations would ostensibly be the source of a substantial portion of the noncompete clauses that, per the American Medical Association, bind an estimated 35% to 45% of physicians.
During last week’s open hearing and vote on the final rule, Commissioner Rebecca Slaughter acknowledged that there are numerous healthcare workers with noncompetes ‘that our rule will struggle to reach.’”

Ascension reports systems, clinical operations disrupted amid apparent 'cybersecurity event' “St. Louis-based Ascension’s statement did not describe the scale of the interruptions nor whether any of its data have been compromised, writing that it is still assessing an ongoing situation. The system said it has also notified the ‘appropriate authorities’ and will provide further updates as they are made available.”

About pharma

Drug supplies for millions would be jeopardized by U.S. crackdown on China biopharma industry, trade group says “U.S. legislation that would sever ties with Chinese drugmakers would jeopardize the drug supply for millions of American patients if it’s passed, the biotechnology industry’s main trade group has told Congress.
Congress is considering legislation, called the BIOSECURE Act, that would make it difficult for Chinese contract development and manufacturing organizations to do business with biotechnology companies that work with the U.S. federal government. Biotechs hire Chinese CDMOs, as they’re often called, for services that include product manufacturing, development, formulation, packaging, and distribution.”

About the public’s health

 A meta-analysis on global change drivers and the risk of infectious disease “Specifically, reducing greenhouse gas emissions, managing ecosystem health, and preventing biological invasions and biodiversity loss could help to reduce the burden of plant, animal and human diseases, especially when coupled with improvements to social and economic determinants of health.”

About healthcare finance

'We have not seen anything similar': Novo Nordisk pens $600M obesity pact with Flagship's Metaphore “In its ongoing mission to find the next Wegovy, Novo Nordisk has penned another partnership to seek out next-gen obesity treatments. This time, it's a $600 million biobucks pact with Flagship-founded Metaphore Biotechnologies to develop up to two candidates.
The latest agreement is part of a broader partnership between Flagship Pioneering and Novo that takes aim at cardiometabolic and rare diseases.”

About Covid-19

HHS's COVID vaccine campaign saved $732 billion in averted infections, costs “The US Department of Health and Human Services' (HHS's) COVID-19 vaccination campaign saved $732 billion by averting illness and related costs during the Delta and Omicron variant waves, with a return of nearly $90 for every dollar spent, estimates a study by HHS and the research firm Fors Marsh.” 

About health insurance/insurers

Centene to Face Proposed Class Fraud Claims Over Health Plans 
About 2 million people in 26 states have these groups’ plans.
Health insurance consumers can proceed with a proposed class action alleging that Centene Corp. and its subsidiaries deceived them into buying plans their doctors wouldn’t accept.
The plaintiffs adequately alleged a civil violation of the federal Racketeer Influenced and Corrupt Organizations Act and violations of consumer protection laws in 11 states, the US District Court for the Northern District of Illinois said Thursday.
Centene is the largest provider of Medicaid managed care plans and Affordable Care Act exchange plans in the country…”

About hospitals and healthcare systems

Steward plans sale of all hospitals, reports $9B in debt “Dallas-based Steward Health Care has placed its 31 U.S. hospitals up for purchase to help offload its $9 billion debt after the health system filed for Chapter 11 bankruptcy…
During a court hearing May 7 in Houston, Steward attorney Ray Schrock told U.S. Bankruptcy Judge Chris Lopez that the for-profit health system is aiming to keep all of its hospitals open and to finalize the sale of the facilities by the end of this summer, the news agency reported.”
For a summary of events leading up to this action, see: The Private-Equity Deal That Flattened a Hospital Chain and Its Landlord

About the public’s health

 Flame Retardant [FR] Exposure in Vehicles Is Influenced by Use in Seat Foam and Temperature “These results suggest that FRs used in vehicle interiors, such as in seat foam, are a source of OPE exposure, which is increased in warmer temperatures.”

U.S. Tightens Rules on Risky Virus Research “The White House has unveiled tighter rules for research on potentially dangerous microbes and toxins, in an effort to stave off laboratory accidents that could unleash a pandemic.
The new policy, published Monday evening, arrives after years of deliberations by an expert panel and a charged public debate over whether Covid arose from an animal market or a laboratory in China.” 

About healthcare quality

The Safety of Outpatient Health Care: Review of Electronic Health Records “Overall, 7.0% (95% CI, 4.6% to 9.3%) of patients had at least 1 AE [adverse event] (8.6 events per 100 patients annually). Adverse drug events were the most common AE (63.8%), followed by health care–associated infections (14.8%) and surgical or procedural events (14.2%). Severity was serious in 17.4% of AEs, life-threatening in 2.1%, and never fatal. Overall, 23.2% of AEs were preventable. Having at least 1 AE was less often associated with ages 18 to 44 years than with ages 65 to 84 years (standardized risk difference, −0.05 [CI, −0.09 to −0.02]) and more often associated with Black race than with Asian race (standardized risk difference, 0.09 [CI, 0.01 to 0.17]). Across study sites, 1.8% to 23.6% of patients had at least 1 AE and clinical category of AEs varied substantially.”

About health insurance/insurers

US Social Security, Medicare get slight boost from strong economy “The Medicare Hospital Insurance Trust Fund's reserves are now expected to be depleted in 2036, five years later than was forecast in last year's report, Treasury said. After that date, the program that provides healthcare to seniors and some people who are disabled would be able to pay only 89% of total scheduled benefits, based on annual tax collections.”
See also:Fact Sheet: 2024 Social Security and Medicare Trustees Reports and
Strong Economy, Low Unemployment, and Higher Job and Wage Growth Extend Social Security Trust Funds to 2035

Medicare Advantage Health Risk Assessments [HRAs]Contribute Up To $12 Billion Per Year To Risk-Adjusted Payments “In this study, we evaluated the impact of HRAs on Hierarchical Condition Categories (HCC) risk scores, variation in this impact across contracts, and the aggregate payment impact of HRAs, using 2019 MA encounter data. We found that 44.4 percent of MA beneficiaries had at least one HRA. Among those with at least one HRA, HCC scores increased by 12.8 percent, on average, as a result of HRAs. More than one in five enrollees had at least one additional HRA-captured diagnosis, which raised their HCC score. Potential scenarios restricting the risk-score impact of HRAs correspond with $4.5–$12.3 billion in reduced Medicare spending in 2020. Addressing increased coding intensity due to HRAs will improve the value of Medicare spending and ensure appropriate payment in the MA program.”

 Oscar Health Announces Results for First Quarter 2024 First profitable quarter due to 43% increase in membership and lower than expected costs. However, insurance companies are almost always profitable after rapid growth. The revenue is high but the Incurred But Not Reported (IBNR) claims are not yet realized. Before breaking out the champagne, let’s see what happens over the next year.

About hospitals and healthcare systems

 Hospital operator Steward Health Care files for bankruptcy protection “Hospital operator Steward Health Care filed for bankruptcy protection early Monday morning, but pledged to maintain the eight hospitals it operates in Massachusetts…
 Steward said it is finalizing the terms of ‘debtor-in-possession financing’ from its landlord Medical Properties Trust for initial funding of $75 million and ‘up to an additional $225 million upon the satisfaction of certain conditions.’”
The company’s debt is more than $9B.

About pharma

 As drug shortages reach record highs, regulators weigh next steps “Drug shortages hit a new high in the first quarter of 2024, forcing patients and doctors to scramble to secure ADHD medications, cancer treatments and other needed drugs. While shortages have been rising for some time, the persisting struggle to get them under control has spurred new calls for action…
 Manufacturing quality issues often contribute to shortages, as do production delays and problems with the flow of needed raw materials or components. Companies can also spark shortages when they decide to abandon low-priced generic drugs that are no longer worth their time to manufacture and distribute.”

 About healthcare personnel

Physician Flash Report “Key Takeaways

1. Investment/subsidy per provider is up 2% since Q1 2023. Overall labor expenses continue to rise, and Q1 2024 data show that labor represented 84% of total expenses.
2. Revenue and expenses remain on an upward trajectory. Net Patient Revenue per Provider FTE is up 4% from Q1 2023, while Total Direct Expense per Provider FTE is up 3% in the same time frame.
3. Provider productivity as measured by unit of work (wRVUs) per FTE rose 4% from Q1 2023. However, the ratio of support staff per 10,000 provider wRVUs is not keeping pace, and has decreased by 6% since Q1 2023.”

About health technology

 First Patient Begins Newly Approved Sickle Cell Gene Therapy  “…Kendric Cromer, a 12-year-old boy from a suburb of Washington, became the first person in the world with sickle cell disease to begin a commercially approved gene therapy that may cure the condition….
[Manufacturer] bluebird bio [the firm does not use caps in its name] says the cost is $3.1million.”
Although 20,000 patients are thought to be eligible for the treatment, bluebird can only handle treatments for 85 to 105 patients each year.
In a related article: Young boy dies in trial for Pfizer Duchenne gene therapy “Pfizer said the boy died of cardiac arrest, but that researchers had not yet determined precisely what happened or whether the death was linked to the treatment.”

FDA approves ColoSense stool RNA test to detect colorectal cancer in average-risk adults “The FDA has approved Geneoscopy Inc.’s ColoSense multitarget stool RNA test for adults aged 45 years or older at average-risk for developing colorectal cancer, according to a company press release.
Previously granted FDA breakthrough device designation in January 2020, ColoSense is the ‘first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers,’ Geneoscopy noted…”

About healthcare finance

Healthcare Dealmakers—Kaiser wraps Geisinger buy; Advocate Health sells off MobileHelp and more FYI

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.”

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.”

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.”

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%…”

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.”

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.”

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.”

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 Business “Under 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 Congress “Congress 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…”

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.”

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.”

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.”